COVAX

Trade and Health at the WTO’s 12th Ministerial Conference

Terence P. Stewart · November 22, 2021 · COVID-19 vaccinations, trade and health · Bahrain, Benin, Botswana, Bulgaria, Cameroon, Cayman Islands, Chile, China, COVAX, Cuba, European Union, GAVI, Gibraltar, India, Maldives, Malta, Morocco, Nigeria, Romania, Rwanda, Seychelles, South Africa, UAE, UNICEF, United States, Uruguay, Zimbabwe · No Comments

An area of focus the last two years at the WTO has been addressing the COVID-19 pandemic. This has included various statements from Members, monitoring by the Secretariat of export and import actions either impeding or expediting the flow of medical goods and services, and various proposals for actions to address the pandemic or for future preparation. The proposal for a waiver from various TRIPS obligations from India and South Africa (and now supported by a range of countries) is one proposal. A number of countries (Ottawa Group) have put forward a proposal for a trade and health initiative to permit a more rapid response by WTO Members in the future. See COVID-19 AND BEYOND: TRADE AND HEALTH, COMMUNICATION FROM AUSTRALIA, BRAZIL, CANADA, CHILE, THE EUROPEAN UNION, JAPAN,
KENYA, REPUBLIC OF KOREA, MEXICO, NEW ZEALAND, NORWAY, SINGAPORE AND SWITZERLAND, 24 November 2020, WT/GC/223; November 27, 2020: The Ottawa Group’s November 23 communication and draft elements of a trade and health initiative, https://currentthoughtsontrade.com/2020/11/27/the-ottawa-groups-november-23-communication-and-draft-elements-of-a-trade-and-health-initiative/. The WTO Director-General and the Members have engaged in a number of meetings with other multilateral organizations and the private sector exploring options for expanding production of COVID-19 vaccines and expanding distribution to countries in need.

Amb. David Walker of New Zealand has been tasked to work with Members to see if a declaration on trade and health can be agreed to at the 12th WTO Ministerial Conference that starts on November 30.

A former Deputy Director-General of the WTO, Alan Wolff, provided his thoughts on likely outcomes at the 12th Ministerial during a WITA virtual event on November 18th and opined that a declaration on trade and health was likely only if there was some resolution of the waiver proposal for vaccines. See PIIE, Alan Wm. Wolff, Defining Success for MC12, 18 November 2021, Presented at WITA, slides 5, 7, 10-11. Slide 10 is presented below.

I have written before on the challenges of the waiver of TRIPs obligations proposal put forward by India and South Africa. See, e.g., November 2, 2020: India and South Africa seek waiver from WTO intellectual property obligations to add COVID-19 – issues presented, https://currentthoughtsontrade.com/2020/11/02/india-and-south-africa-seek-waiver-from-wto-intellectual-property-obligations-to-address-covid-19-issues-presented/.

The EU and some others have not agreed to a waiver but have focused on making compulsory licensing more effective. See, e.g., DRAFT GENERAL COUNCIL DECLARATION ON THE TRIPS AGREEMENT AND PUBLIC HEALTH IN THE CIRCUMSTANCES OF A PANDEMIC, COMMUNICATION FROM THE EUROPEAN UNION TO THE COUNCIL FOR TRIPS, 18 June 2021, IP/C/W/681.

Thus, the outcome on trade and health heading into the Ministerial is uncertain. See WTO News Release, Members to continue discussion on a common COVID-19 IP response up until MC12, 19 November 2021, https://www.wto.org/english/news_e/news21_e/trip_18nov21_e.htm.

A driver behind the waiver proposal has been the limited availability of vaccines to least developed and some developing countries. Vaccine equity is the shorthand term for the concerns about availability and affordability of vaccines for all people. While the issue of availability and access is complicated and beyond just WTO competence, the world’s vaccine manufacturers have ramped up capacity and production, governments have belatedly gotten involved in expanding donations and some of the major bottlenecks to getting vaccines to COVAX in 2021 appear to be resolved going forward, though many LDCs and developing countries will not get large volumes of vaccines until 2022.

The pandemic and the challenges of ramping up production and ensuring access to all people has been the subject of dozens of my prior posts. See, e.g., October 12, 2021: See WTO Information Notes on COVID-19 Vaccine Production and Potential Bottlenecks, https://currentthoughtsontrade.com/2021/10/12/wto-information-notes-on-covid-19-vaccine-production-and-potential-bottlenecks/; September 27, 2021: Global efforts to expand COVID-19 vaccine production and distribution — an all hands on deck effort being led by the U.S. and EU with active support of many governments and others, https://currentthoughtsontrade.com/2021/09/27/global-efforts-to-expand-covid-19-vaccine-production-and-distribution-an-all-hands-on-deck-effort-being-led-by-the-u-s-and-eu-with-active-support-of-many-governments-and-others/; May 6, 2021: COVID-19 vaccines — role of WTO and developments at May 5-6, 2021 General Council meeting on TRIPS Waiver, https://currentthoughtsontrade.com/2021/05/06/covid-19-vaccines-role-of-wto-and-developments-at-may-5-6-2021-general-council-on-trips-waiver/.

Prior to 2021, global capacity for all vaccines was estimated at 5 billion doses/year. In 2021, COVID-19 vaccine production alone will be around 10 billion doses. As of November 20, 2021, UNICEF’s COVID Vaccine Market Dashboard shows 8.624 billion doses delivered to countries and territories of which COVAX deliveries were 524 million (and 565 million delivered or cleared for shipment). https://www.unicef.org/supply/covid-19-vaccine-market-dashboard (visited on November 20, 2021).

Administration of vaccine doses to populations has been less than doses delivered. Data from Blomberg’s COVID Vaccine Tracker as of November 19, 2021 9:34 a.m., shows 7.63 billion doses administered. https://www.bloomberg.com/graphics/covid-vaccine-tracker-global-distribution/ (visited November 20, 2021). From the Vaccine Tracker data, there are a large number of countries or territories (95) that have administered 100 or more doses to every 100 people in the country. As major vaccines like Pfizer and Moderna need two shots, and as some countries have started supplying boosters, data are not necessarily comparable across countries in terms of percentage of people vaccinated. But the doses administered per 100 people is a reasonable measure of equitable distribution. A review of the data do show large differences in administration of doses. However, which countries or territories have administered large numbers of doses/100 people is not tied to a country or territory having vaccine production capacity, nor is it tied to level of income in the country or territory.

For example, the top ten countries or territories for administering doses of COVID-19 vaccine in the Bloomberg report were:

Gibraltar, 279.2 doses/100 people

Cuba, 244.2 doses/100 people

Chile, 207.5 doses/100 people

Maldives, 204.8 doses/100 people

UAE, 201.6 doses/100 people

Bahrain, 191.7 doses/100 people

Uruguay, 190.7 doses/100 people

Malta, 185.9 doses/100 people

Cayman Islands, 183.7 doses/100 people

Seychelles, 182.7 doses/100 people

China ranked 16th at 172.1 doses/100 people; the United States ranked 66th at 134.0/100 people; EU members were generally greater than 100 doses/100 people but had several member states below that (Bulgaria at 45.4 doses/100 people; Romania at 73.0 doses/100 people) and had an overall average of 138.7. Morocco had the most doses/100 people for a country from Africa — 136.5.

Twenty-eight countries or territories have administered between 75 and 99.4 doses/100 people (including India at 84.6 doses/100 people); twenty-three countries or territories have administered between 50 and 73 doses/100 people (including Rwanda at 65.2 doses/100 people and Botswana at 52.8 doses/100 people); twenty-two countries or territories have administered between 25 and 47.1 doses/100 people (including South Africa at 41.4 doses/100 people); thirty-three countries or territories have administered between 0.2 and 18.7 doses/100 people.

Obviously, there are a large number of countries (including some developed countries) where vaccines administered are far too limited. For many developing and LDC countries with low numbers of doses administered, the failure of supplies to be delivered to COVAX for shipment is certainly a significant cause. India’s need to keep vaccine doses at home was a major cause of the shortfall to COVAX in 2021, but not the only reason.

Belatedly larger volumes of vaccine doses are making it to those in greatest need. The increases flow from a combination of increased production volumes globally, India resuming exports, increases in donations from a number of countries and more. For example, the UNICEF data on deliveries shows that there have been some significant increases in doses available to the countries or territories with very low doses administered levels. For example, Nigeria shows only 4.6 doses/100 people administered in the Bloomberg vaccine tracker data. The UNICEF vaccine market dashboard shows roughly three times the number of doses delivered to Nigeria as are reported administered (29.689 million vs. 9.254 million). Benin has 1.968 million doses delivered and just 0.347 million administered (2.9/100 people). It is also true for countries receiving doses from COVAX with higher existing doses administered. For example, Zimbabwe which had 42.3 doses administered per 100 people in the Bloomberg data showed nearly twice as many doses delivered in the UNICEF data as had been administered (11.322 million doses delivered vs. 6.31 million doses administered).

What the two reports suggest is that while vaccine equity is a real issue, the causes of the very different experiences of different countries or territories in the same general area are complex and not easily or completely understood by the current discussion. For example, Zimbabwe’s per capital GNI in 2020 was $1,090 and yet they had administered 42.3 COVID vaccine doses/100 people. Cameroon, with a per capita GNI in 2020 of $1,100, had COVID vaccines administered of only 2.4/100 people. Similarly, Morocco had a 2020 per capita GNI of $2,980 and COVID vaccines administered of 136.5/100 people. In comparison, South Africa with a much higher per capita GNI in 2020 ($5,410) had COVID vaccines administered at less than 1/3rd the rate of Morocco – 41.4 vs.136.5/100 people. Nigeria, with a 2020 per capita GNI of $2,000 had administered only 4.6 COVID vaccines/100 people.

Thus, those working on improving vaccine equity need to identify and address the other causes besides vaccine production and availability through COVAX in the coming months.

I paste below the data from the Bloomberg COVID Vaccine Tracker ranked in descending order of COVID vaccine doses administered per 100 people as of November 19, 2021.

Countryvaccines

Global efforts to expand COVID-19 vaccine production and distribution — an all hands on deck effort being led by the U.S. and EU with active support of many governments and others.

Terence P. Stewart · September 27, 2021 · COVID-19 vaccinations · China, COVAX, European Union, India, United States, WHO, WTO · No Comments

The COVID-19 pandemic continues to present unprecedented challenges to global health and the global economy. With some 230 million infections globally and some 4.7 million deaths reported globally to date and with likely actual numbers a multiple of what has been reported, governments around the world have taken strong measures to control the spread of COVID-19, and there have been efforts to improve the equitable access to vaccines and other medical treatments and personal protective equipment for all peoples. The economic costs flowing from the pandemic to countries have been considerable, with many poorer countries experiencing loss of progress made over recent decades in terms of poverty levels, income, educational opportunities, trade and more.

While the pharmaceutical industry has responded impressively and will likely produce more than twice the number of COVID-19 vaccine doses in 2021 compared to all vaccines produced in 2020, access to vaccines has not been as equitable as desired or needed to end the pandemic. The lack of equitable access flows from a number of factors including some production challenges, early acquisition of large quantities of vaccines by wealthier countries, export restraints imposed by some countries, failure of Indian producers (who had been identified as a major source of vaccines for distribution through COVAX to low- and middle-income countries) to honor export contracts during 2021 in light of COVID challenges within India and others.

Vaccine distribution does not match population distribution but also doesn’t correspond to level of infections or deaths in most countries. When inequitable access is flagged by organizations or the media, it is based on population. But where some countries or regions are suffering greater levels of infections or deaths from the pandemic than others, one could argue that equitable access could also be measured by comparing to level of infections or deaths.

Bloomberg in a recent COVID-19 Tracker reports that the least wealthy 52 countries have received 3.6% of the vaccinations while having 20.5% of the global population. Bloomberg, More than 6.1 Billion Shots Given; Covid-19 Tracker, https://www.bloomberg.com/graphics/covid-vaccine-tracker-global-distribution/ (September 25, 2021). Obviously such low levels of vaccination for poor countries present pressing challenges. Fortunately, to date, infections and deaths have been much higher in higher income countries than in many low- and middle-income countries, so there is less of a mismatch with access to vaccines if measured by reference to infections or deaths. Some of the lower numbers for low- and middle-income countries may be due to reporting challenges in some of these countries, but the picture needs to be looked at from multiple angles to understand whether and the extent of equitable distribution challenges facing the world and individual countries. Let’s look at a few countries to understand the complexity of the analysis.

China, which has a population of 1.439 billion people in 2020 (18.45% of global totals) had administered 2.194 billion doses of COVID-19 according to the Bloomberg September 25, 2021 Tracker (35.98% of global doses distributed) yet has reported only 107,981 cases of infections since December 2019 (just 0.04% of global cases) and just 4,849 deaths (just 0.1% of global deaths). See ECDC, COVID-19 situation update worldwide, as of week 37, updated 23 September 2021, https://www.ecdc.europa.eu/en/geographical-distribution-2019-ncov-cases. Thus, China, while being the first country to report cases, has been successful in limiting the case spread both before and after the development of vaccines. Which highlights the question, where there are global shortages of vaccines, is the correct analysis vaccine doses as a share of global population or the short-term need based on infections or deaths? If China distribution of doses reflected its share of population, it would have administered 1.125 billion does, meaning an extra 1.069 billion doses could have been redirected to other countries in need. If done on the basis of the number of infections, China would have administered 2.44 million doses, meaning 2.192 billion doses could have been redirected to other countries in need. If done on the basis of the number of deaths, it would have administered 6.1 million doses to date, meaning 2.188 billion doses could have been redirected to other countries. Under any analysis, China is a major cause of inequitable access to vaccines through late September and that is regardless of doses sold or given to trading partners by China.

India had a population in 2020 of 1.38 billion people (17.69% of the global population). According to the recent Bloomberg Tracker, India has administered 850.372 million doses (13.94% of global doses). India, which has had a serious outbreak of COVID-19 cases in the summer, has recorded 33,478,419 cases of infection (14.59% of global cases) and 445,133 deaths (9.47% of global deaths). Press accounts have indicated that the case and death counts in India are likely significantly understated. However, equitable access to vaccines if based on population or based on percent of global infections as reported by India would show India needing additional doses (an additional 228.718 million based on population; an additional 39.618 million based on percent of global infections). Based on percent of global deaths, India arguably has consumed 272.702 million more doses than death percentage would warrant (if deaths were substantially higher, obviously the answer would differ). Thus, India is almost certainly a country that has been in need of larger volumes of COVID-19 vaccines than it has obtained and explains the country’s decision to halt exports of COVID-19 vaccines for many months this year.

The United States had a population in 2020 of 331 million people (4.24% of global population. It has administered 388.567 million doses of vaccine (6.37% of global doses administered). As a major developed country, one would have expected the United States to have gotten control of the pandemic early or at least to have been able to get the pandemic under control within the United States after vaccines were approved for emergency use authoriztaion. However, the U.S. has recorded 42.288 million cases of infection (18.43% of global cases) (and has recorded 676,075 deaths (9.67% of global deaths) — the most of any nation. Moreover, while the early roll out of vaccines sharply reduced infections, hospitalizations and deaths a few months ago, the large percentage of adults who remain unvaccinated, the opposition of many to basic public health requirements (e.g., mask wearing in many situations) and failure to get vaccinated has resulted in the U.S. having a very large outbreak in the last month or so with the spread of the delta variant — a wave of infections, hospitalizations and deaths of the unvaccinated. If the number of doses administered matched the U.S. share of global population, the U.S. would have administered 129.93 million fewer doses. However, if based on percent of infections or deaths, the U.S. should have administered far more doses — 735.66 million more based on infections and 201.3 million based on deaths — although such numbers would be capped by the number needed for full vaccination.

The above analysis is not to say vaccine equity of access and distribution isn’t important. Rather the analysis is meant to stress the complexity of the analysis, particularly for countries that have suffered large rates of infection and death.

Recent efforts to improve the equitable access to and distribution of COVID-19 vaccines and other medical materials

A great deal of effort has gone into establishing entities to facilitate equitable access to COVID-19 vaccines. For example, COVAX is described on the GAVI webpage as follows (https://www.gavi.org/covax-facility):

“COVAX is the vaccines pillar of the Access to COVID-19 Tools (ACT) Accelerator

“The ACT Accelerator is a ground-breaking global collaboration to accelerate the development, production, and equitable access to COVID-19 tests, treatments, and vaccines.

“COVAX is co-led by the Coalition for Epidemic Preparedness Innovations (CEPI), Gavi and the World Health Organization (WHO), alongside key delivery partner UNICEF. Its aim is to accelerate the development and manufacture of COVID-19 vaccines, and to guarantee fair and equitable access for every country in the world.”

COVAX had hoped to get at least 2 billion doses to countries participating (including 92 low- and middle income countries who would get vaccine doses at no- or low-cost) in 2021. As of September 22, 2021, COVAX had distributed over 301 million doses in 142 countries. https://www.gavi.org/covax-vaccine-roll-out. This is out of the 6.1 billion doses administered globally. Recent projections suggest COVAX will get at least 500 million fewer doses in 2021 than originally expected, though higher volumes could happen under certain circumstances. See World Health Organization, Joint COVAX Statement on Supply Forecast for 2021 and early 2022, 8 September 2021, https://www.who.int/news/item/08-09-2021-joint-covax-statement-on-supply-forecast-for-2021-and-early-2022 (“According to its latest Supply Forecast, COVAX expects to have access to 1.425 billion doses of vaccine in 2021, in the most likely scenario and in the absence of urgent action by producers and high-coverage countries to prioritize COVAX.”).

Amidst a constant drumbeat from the WHO that no one is safe until all are safe and that the 2021 distribution to date has left many countries behind, most countries have agreed for the need for greater equitable distribution going forward. Some countries (India, South Africa and others) have called for waiving intellectual property rights at the WTO on vaccines and other medical goods needed to address the pandemic. Some organizations and countries have argued for the need for development of local production capabilities in low income countries. The WTO has monitored export restrictions imposed and tracked the level and elimination of such restrictions as well as market liberalization efforts. Events have been held to gather information on production bottlenecks, efforts of pharmaceutical companies to expand production around the world and countries have been urged to release surplus doses and give up their place in line with pharmaceutical companies to permit larger volumes to be shipped earlier to low- and middle-income countries.

In recent months both the U.S. and the EU have been working to facilitate these efforts and recently announced joint actions. See A U.S.-EU Agenda for Beating the Global Pandemic Vaccinating the World, Saving Lives Now, and Building Back Better Health Security, September 22, 2021, https://www.whitehouse.gov/briefing-room/statements-releases/2021/09/22/a-u-s-eu-agenda-for-beating-the-global-pandemic-vaccinating-the-world-saving-lives-now-and-building-back-better-health-security/.

“Vaccination is the most effective response to the COVID pandemic. The United States and the EU are technological leaders in advanced vaccine platforms, given decades of investments in research and development.

“It is vital that we aggressively pursue an agenda to vaccinate the world. Coordinated U.S. and EU leadership will help expand supply, deliver in a more coordinated and efficient manner, and manage constraints to supply chains. This will showcase the force of a Transatlantic partnership in facilitating global vaccination while enabling more progress by multilateral and regional initiatives.

“Building on the outcome of the May 2021 G20 Global Health Summit, the G7 and U.S.-EU Summits in June, and on the upcoming G20 Summit, U.S. and the EU will expand cooperation for global action toward vaccinating the world, saving lives now, and building better health security.

“Pillar I: A Joint EU/US Vaccine Sharing Commitment: the United States and the EU will share doses globally to enhance vaccination rates, with a priority on sharing through COVAX and improving vaccination rates urgently in low and lower-middle income countries. The United States is donating over 1.1 billion doses, and the EU will donate over 500 million doses. This is in addition to the doses we have financed through COVAX.

“We call for nations that are able to vaccinate their populations to double their dose-sharing commitments or to make meaningful contributions to vaccine readiness. They will place a premium on predictable and effective dose-sharing to maximize sustainability and minimize waste.

“Pillar II: A Joint EU/US Commitment to Vaccine Readiness: the United States and the EU will both support and coordinate with relevant organizations for vaccine delivery, cold chain, logistics, and immunization programs to translate doses in vials into shots in arms. They will share lessons learned from dose sharing, including delivery via COVAX, and promote equitable distribution of vaccines.

“Pillar III: A Joint EU/US partnership on bolstering global vaccine supply and therapeutics: the EU and the United States will leverage their newly launched Joint COVID-19 Manufacturing and Supply Chain Taskforce to support vaccine and therapeutic manufacturing and distribution and overcome supply chain challenges. Collaborative efforts, outlined below, will include monitoring global supply chains, assessing global demand against the supply of ingredients and production materials, and identifying and addressing in real time bottlenecks and other disruptive factors for global vaccine and therapeutics production, as well as coordinating potential solutions and initiatives to boost global production of vaccines, critical inputs, and ancillary supplies.

“Pillar IV: A Joint EU/US Proposal to achieve Global Health Security. The United States and the EU will support the establishment of a Financial Intermediary Fund (FIF) by the end of 2021 and will support its sustainable capitalization. The EU and United States will also support global pandemic surveillance, including the concept of a global pandemic radar. The EU and the United States, through the European Health Emergency preparedness and Response Authority, and the Department of Health and Human Services Biomedical Advanced Research and Development Authority, respectively, will cooperate in line with our G7 commitment to expedite the development of new vaccines and make recommendations on enhancing the world’s capacity to deliver these vaccines in real time.

“We call on partners to join in establishing and financing the FIF to support to prepare countries for COVID-19 and future biological threats.

“Pillar V: A Joint EU/US/Partners Roadmap for regional vaccine production. The EU and the United States will coordinate investments in regional manufacturing capacity with low and lower-middle income countries, as well as targeted efforts to enhance capacity for medical countermeasures under the Build Back Better World infrastructure and the newly established Global Gateway partnership. The EU and the United States will align efforts to bolster local vaccine manufacturing capacity in Africa and forge ahead on discussions on expanding the production of COVID-19 vaccines and treatments and ensure their equitable access.

“We call on partners to join in supporting coordinated investments to expand global and regional manufacturing, including for mRNA, viral vector, and/or protein subunit COVID-19 vaccines.“

See also United States–European Commission Joint Statement: Launch of the joint COVID-19 Manufacturing and Supply Chain Taskforce, September 22, 2021, https://www.whitehouse.gov/briefing-room/statements-releases/2021/09/22/united-stateseuropean-commission-joint-statement/.

The announced joint efforts of the U.S. and the EU occurred at the same time as the U.S. hosted another event with governments, multilateral organizations and the private sector to find solutions to the COVID pandemic. The event was held on the margins of the UN General Assembly meeting in New York last week. See White House Briefing Room, Global COVID-⁠19 Summit: Ending the Pandemic and Building Back Better, September 24, 2021, https://www.whitehouse.gov/briefing-room/statements-releases/2021/09/24/global-covid-19-summit-ending-the-pandemic-and-building-back-better/. The write-up is copied below.

“On September 22, 2021, President Biden convened a virtual Global COVID-19 Summit focused on ending the pandemic and building better health security to prevent and prepare for future biological threats.

“The President called on the world to collectively end the COVID-19 pandemic as soon as possible, with every country, partner, and organization doing its part, aligning around shared goals and targets, and holding each other to account. At the same time, all countries need the capacity to prevent, detect, and respond to biological threats, including future pandemics. The Summit introduced ambitious targets in three critical areas for ending this pandemic and preventing and preparing for the next: Vaccinate the World; Save Lives Now; and Build Back Better.

“President Biden hosted the virtual Global COVID Summit: Ending the Pandemic and Building Back Better, which included participation by representatives from more than 100 governments and other partners and more than 100 leaders from international organizations, the private sector, the philanthropic sector, civil society, academia, and other stakeholders. These are listed below.

“The COVID-19 pandemic has already claimed over 4.5 million lives and continues to ravage communities and economies around the world. President Biden called on Summit participants to not only do more, but to do enough to end the pandemic and build back better.

“President Biden was also joined at the Summit by Vice President Kamala Harris, Secretary of State Antony Blinken, U.S. Ambassador to the United Nations Linda Thomas-Greenfield, U.S. Agency for International Development Administrator Samantha Power, Department of Health and Human Services Director of the Office of Global Affairs Loyce Pace, and State Department Coordinator for the Global COVID-19 Response and Health Security Gayle Smith. The full list of participants is available below.

“Throughout the Summit, leaders of countries and organizations underscored the importance of coalescing around shared targets to align commitments with outcomes, as all parties worked together to: Vaccinate the World, Save Lives Now, and Build Back Better Global Health Security over the months ahead. Reaching these targets will require leadership, ambition, boldness, collaboration, transparency, and new commitments.

“In advance of and during the Summit, many countries and stakeholders announced their intention to donate vaccines and financial support to critical vaccine readiness activities to ensure shots get into arms around the world. Leaders broadly aligned around the World Health Organization (WHO) target of vaccinating at least 70 percent of the global population in every country by UNGA 2022 and expressed shared urgency to do more, to act now, to enhance accountability, and to monitor progress. To advance this effort, President Biden called for another Heads of State-level Summit in the first quarter of 2022, and Secretary Blinken committed to convene Foreign Ministers in 2021. Countries made new commitments to share doses and/or double or triple previous pledges for vaccines, delivery, oxygen and testing support, and health security.

“Participants from around the world and across sectors, listed below, brought commitments to the Summit – further details will be available over the coming days. While the event was not a pledging conference, participants’ combined commitments exceeded 850 million additional COVID-19 vaccine doses and major new commitments for vaccine readiness, oxygen, testing, health systems, and health security financing.

“A list of new commitments announced by the United States at or around the Summit can be found in this Fact Sheet.

“A link to the common targets released by the United States during the Summit for tracking and accountability can be found here.

“###

“Session 1. Calling the World to Account and Vaccinating the World

“President Biden chaired the opening session of the Summit, which was focused on the need for all countries, organizations, and stakeholders to do more to make COVID-19 vaccines available to all people, everywhere. He was joined by U.S. Ambassador to the United Nations Linda Thomas-Greenfield. Participants echoed President Biden’s call to align around common targets, more urgently track progress, and support one another in fulfilling commitments. World leaders embraced the World Health Organization goal of fully vaccinating at least 70 percent of the population in every country and income category with quality, safe, and effective vaccines by UNGA 2022, and leaders called for more urgent and equitable distribution of vaccine doses.

“President Biden announced bold new commitments from the United States to supply an additional 500 million doses of Pfizer vaccine that will all be shipped by this time next year, bringing the U.S. total commitment of donated vaccines to over 1.1 billion.

“He also announced that the United States is stepping up efforts to get shots into arms and boost global manufacturing. He encouraged countries to join the United States in upholding a set of principles to ensure we can fulfill our collective global commitments for equitable global distribution of safe and effective WHO Emergency Use Listed-authorized COVID-19 vaccines. Those principles include committing to donate, rather than sell, doses to low- and lower-middle income countries with no political strings attached; to support COVAX as the main mechanism for sharing WHO-authorized vaccines; to fight vaccine disinformation; to exercise transparency; to build public trust; and to work toward common goals and targets to measure progress and to hold ourselves and each accountable. The President acknowledged efforts through the Quad partnership to help produce at least 1 billion vaccine doses in India to boost the global vaccine supply by the end of 2022, as well as U.S. financing to help strengthen manufacturing in South Africa and produce more than 500 million J&J doses in Africa for Africa by next year.

“President Biden also emphasized the vital logistical challenge of getting those vaccines into the arms of people, and he called on all participants to significantly step up investments in this area. He announced a commitment of an additional $370 million to support global vaccine readiness and delivery, and he committed more than $380 million in assistance for Gavi, The Vaccine Alliance, to provide political risk insurance to facilitate shipment of vaccines to nine countries across three continents. In addition, he called on countries, vaccine manufacturers, and other partners to expand global and regional vaccine manufacturing capacity and enhance transparency to make vaccine production and distribution more predictable and coordinated. He emphasized the United States is working with partner nations and manufacturer to increase their capability to produce and make safe and highly effective vaccines in their own countries.

“The President also underscored the importance of saving lives now, and noted the United States is providing nearly $1.4 billion to reduce COVID-19 deaths and mitigate transmission through bulk oxygen support, expanded testing, strengthening healthcare systems and more.

“Finally, President Biden emphasized U.S. support for the establishment of a global health security financing mechanism to prepare for the next pandemic, which Vice President Harris detailed later in the Summit. He closed the meeting by calling on leaders to set targets that require us to aim high, follow through on our commitments, and hold each other accountable to end the pandemic and advance health security for all.

“Finally, President Biden called for a whole of society response, with an ask for the private sector, country governments, philanthropies, and civil society to take up the U.S. call to action to solve core challenges toward ending the pandemic and building back better – including making vaccinations available to everyone, everywhere; solving the oxygen crisis; financing health security, and more. Representatives from businesses, foundations, and civil society joined global leaders at the Summit. Some of those leaders announced coalitions to combine funds, expertise, and capacity to help realize specific challenges within each of the goals, for example addressing the global oxygen crisis, closing the testing gap, and ensuring vaccines are delivered and administered.

“United Nations Secretary-General António Guterres called for a global vaccination plan to at least double vaccine production and ensure 2.3 billion doses are equitably distributed through COVAX to reach 40 percent of people in all countries by the end of this year, and 70 percent in the first half of 2022 as WHO recommends. He framed global vaccination not as philanthropy but as self-interest for all parties, emphasizing the need for low and lower-middle income countries (LMICs) to have the resources and technology to manufacture their own vaccines. He also called for better resourced and stronger global health security architecture. The United Nations will continue to support vaccine rollout in countries and communities that are hardest to reach.

“World Health Organization Director-General Dr. Tedros Adhanom-Ghebreyesus emphasized the importance of multilateralism in addressing the disparity in vaccine access between high- and low-income countries. He praised the new U.S. vaccine commitment and called on countries to work with companies to swap places with other countries in vaccine queues, for countries to fulfill dose share pledges immediately, and for sharing the intellectual property necessary to facilitate manufacturing around the world. He observed that we owe it to those who lost their lives to build better governance, financing, systems, and tools to ensure global health security. He called on leaders to support the vaccination of at least 40 percent of the population of every country by the end of this year and 70 percent by mid-2022. He also called on those who control existing vaccine supplies to ensure that 2 billion doses are provided rapidly to LMICs in order to begin meeting these targets, as the Secretary General highlighted.

“Republic of South Africa’s President Matamela Cyril Ramaphosa highlighted the risks of not reaching the vaccination targets set out in the Summit, and discussed how the pandemic exacerbates the global vaccine gap and the ways it undermines global health security. He also affirmed the importance of enabling countries to do their own vaccine manufacturing and procurement, and called on WTO member states to approve the TRIPS waiver proposal from South Africa, India, and other co-sponsors. He shared the African Union’s impactful work in hosting the first mRNA tech transfer on the African continent, then called for a sustainable plan to support LMICs through technology and finance to meet vaccine targets. He also supported the establishment of a global health security financial intermediary fund for pandemic preparedness, a Global Health Threats Council, and Secretary-General Guterres’ proposal for a global vaccination plan.

“European Commission President Ursula von der Leyen described the pandemic as one of the most pressing societal challenges we have ever faced. To help address this challenge, she announced a new European Union partnership with the United States to help vaccinate the world with a joint objective of a 70 percent global vaccination rate by UNGA 2022. The EU-U.S. global vaccination partnership seeks to expand supply and improve delivery while managing constraints to supply chains. This partnership will seek to boost vaccine production in LMICs and coordinate investments to build regional manufacturing. The EU is investing more than €1 billion with partners in Africa and the pharmaceutical sector to bring mRNA technology to the continent beginning with hubs in South Africa, and Senegal, and Rwanda. She reaffirmed the EU’s commitment to share more than 500 million doses by the middle of next year, and the EU commitment that every second dose of vaccine produced in Europe is shipped abroad (to date, 800 million doses). President von der Leyen also committed that the EU will work with the United States and within the G20 to establish a global health security FIF to help build a healthy and secure future.

“Republic of Indonesia President Joko Widodo called for the strengthening of theglobal health architecture and for a new mechanism to mobilize resources. He articulated the need for LMICs to be part of the solution, by enhancing capacity to manufacture of vaccines, medicines, and supplies. He appealed for an end to vaccine nationalism, and said Indonesia as G20 chair next year will focus on strengthening the global health security architecture and preparing for future challenges.

“World Trade Organization Director-General Dr. Ngozi Okonjo-Iweala noted the urgency of preventing more people from dying in poor countries due to lack of access to lifesaving vaccines and other medical countermeasures. She emphasized the risk of the pandemic to economic recovery, if slow vaccination progress allows the emergence of even more dangerous variants, saying, “Either we converge downwards by allowing the virus to drag all of us back down, or we converge upwards by vaccinating the world.” She noted the centrality of trade in this effort, and she provided the example of the Pfizer- BioNTech and Moderna vaccines requiring inputs from nineteen countries. She reiterated the importance of the WTO’s work to reduce export restrictions, address supply bottlenecks, and smooth regulatory obstacles. She called on industry to donate doses and swap contracts so that COVAX and less advantaged countries can move up in the queue and receive supplies for distribution. She urged leaders to find pragmatic compromises on intellectual property rules for COVID-19 vaccines, therapeutics, and diagnostics, and she underscored the need for cooperative action to ensure a stable, predictable and fair multilateral trading system.

“Canada’s Prime Minister Justin Trudeau reiterated Canada’s commitment to being a trusted partner, and emphasized the target of equitably vaccinating 70 percent of the world by next September and both to protect the world’s population and ensure economic recovery. He called for a focus on vaccine readiness and delivery, and to increase the production and supply of shots. He outlined Canada’s contributions of more than $2.5 billion, including investing to share tens of millions of doses with the rest of the world and support the ACT Accelerator and COVAX. He referenced Canada’s interest in developing domestic vaccine production capacity, which would help Canada to help the world. He expressed support for working through the WTO to resolve intellectual property issues and also called for strengthened global health security infrastructure over the long term by investing in shared health institutions and strengthening global cooperation.

“Gavi, the Vaccine Alliance Chief Executive Officer Dr. Seth Berkley outlined COVAX’s leadership of the most complex, global vaccine deployment in history, which has – to date — shipped more than 300 million doses to 142 economies. He also said by the end of the year, COVAX seeks to deliver enough doses to protect about 40 percent of the adult population in the 92 lower income countries. 800 million doses have already been committed through COVAX, with 119 million received and delivered. He called leaders’ attention to serious obstacles and unacceptable inequalities in the global distribution of COVID-19 vaccines, and he thanked President Biden for the new U.S. commitment to donate of 500 million additional doses of Pfizer vaccine, as well as embraced the ambitious summit goal of vaccinating the world and accelerating vaccination in lower income countries. He urged leaders to provide more doses, remove export restrictions, leverage innovative financing and contingency funding to support surge manufacturing capacity, give up their place in production queues to COVAX where possible, and for vaccine manufacturers to commit to greater transparency on orders and delivery timelines, and asked them to waive requirements for indemnification for the humanitarian buffer.

“President Biden and U.S. Ambassador to the United Nations Linda Thomas-Greenfield closed the session by thanking participants and reiterating the goal of ending the pandemic, which will require ambitious, coordinated global action. President Biden noted we should set targets that require us to aim high, follow through on our commitments, and hold each other accountable in order to end this pandemic for everyone, everywhere. He concluded by noting this won’t be our last meeting.

“Session I. Video Interventions

King Abdullah II bin Al-Hussein, Hashemite Kingdom of Jordan (video)
Prime Minister Narendra Modi, Republic of India (video)
Chancellor Angela Merkel, Federal Republic of Germany (video)
Bill Gates, Bill & Melinda Gates Foundation (video)

“Session 2. Saving Lives Now

“USAID Administrator Samantha Power chaired the session, which was focused on ensuring equal access to the testing, therapeutics, and personal protective equipment that help prevent, diagnose, and treat COVID-19. She pointed out that even as the world focuses on the goal of achieving 70 percent vaccination, we must – at the same time – come together to ensure countries have the PPE to keep health workers safe, supply oxygen to treat people with COVID, and close the testing gap. She announced an intention to commit $50 million to increase access to oxygen in countries around the world, and that USAID would work to build a multi-sectoral coalition to coordinate global investment in oxygen access.

“Rockefeller Foundation President Dr. Rajiv Shah moderated the session. In his framing remarks, he reinforced the importance of the Save Lives Now agenda to helping communities and economies reopen safely amidst the pandemic. He highlighted the Rockefeller Foundation’s investment of $1 billion for pandemic response, recovery, and prevention, and announced a group of 18 diagnostic companies that are convening with the help of the Foundation to commit to expanding COVID-19 testing around the world.

“Vietnam’s President Nguyễn Xuân Phúc noted the toll the pandemic has taken on ASEAN members and expressed support for the goals set out by President Biden, including the creation of a global health security fund and increased vaccine production in developing countries. He emphasized the importance of early detection and public health measures, as well as treatment and large-scale vaccination, in responding to and ending the pandemic. President Phúc noted the need to improve global cooperation and take a systemic approach, including transforming health systems and industries that produce pharmaceuticals and supplies, particularly in developing countries. He noted that Vietnam donated $500,000 to COVAX and will continue to contribute, and that Vietnam and fellow ASEAN countries have used $10.5 million from a joint COVID-19 Response Fund to purchase vaccines.

“Director of the Pan American Health Organization (PAHO) Dr. Carissa Etienne emphasized that COVID-19 has particularly highlighted inequities in the Americas, and explained the path to recovery will only be through an equitable approach, with a focus on resilient, high-quality health systems for all. She discussed the challenges faced by people living in poverty in following public health measures, and the particular burdens on those in the informal economy, indigenous communities, Afro descendent populations and migrants. Dr. Etienne spoke about PAHO’s delivery of 33 million COVID tests and more than $14 million worth of PPE to countries, and announced that, along with WHO, PAHO had identified two countries to initiate a mRNA vaccine manufacturing hub in the Americas.

“Global Fund to Fight AIDS, TB, and Malaria Executive Director Peter Sands endorsed the Save Lives Now targets, noting that while vaccines are the most potent weapon against COVID-19, ending the pandemic will require stepped-up support to LMICS for testing, treatment, and PPE, as well as critical infection prevention and control. He noted that the Global Fund, which is the largest provider of grants to LMICS for non-vaccine COVID response, has already approved more than $3.6 billion to over 100 countries, including $478 million for oxygen equipment and supplies, $815 million for diagnostics, and $745 million for PPE. However, at a time when we must scale up these responses, Sands said that current funding will be exhausted by the end of the month, and urged increased investment in this critical response mechanism.

“Skoll Foundation CEO Don Gips discussed the role of philanthropy in taking risks, supporting civil society, testing out solutions that government can adopt, and connecting civil society and government– all important components of an all-society response to COVID-19. He announced that Skoll Foundation founder Jeff Skoll has prioritized ending the pandemic and will build on the Foundation’s previous $100 million commitment with an additional $100 million to support Summit objectives, with a focus on saving lives now – particularly oxygen – and building strong health and preparedness systems for the future as a global public good. Part of their investment will support Build Health International, which will increase medical oxygen supplies in Africa. Mr. Gips emphasized the importance of alignment and coordination around a global plan to end the pandemic, saying that the success of global COVID-19 response will be an indication of our ability to tackle other complex, interconnected global problems.

“Mastercard Foundation President and CEO Reeta Roy emphasized that achieving global health security requires bold and simultaneous action on all fronts. She also highlighted that we are all interconnected, and that there is no global health security without regional health security. She noted that African leaders have mobilized a collective response to the pandemic, and that the next step is to manufacture vaccines on the continent. Ms. Roy focused on African public health institutions, and expressed support for the Africa CDC’s efforts to achieve sustainable public health, detailing the Foundation’s $1.3 billion partnership with Africa CDC to purchase vaccines for 50 million people; equipping health care workers, encouraging vaccine acceptance, and increasing genomic sequencing; developing the workforce to manufacture vaccines in Africa; and strengthening the Africa CDC. She appealed to funders to support existing public health institutions.

“Amref Health Africa CEO Dr. Githinji Gitahi reminded attendees of the way COVID-19 affects individual people, including those lacking oxygen treatment and health workers who lack PPE. He pointed out that the toll of COVID-19 is much larger than what has been officially counted, due to the number of people in underserved areas dying at home without treatment. He noted that saving lives now requires making connections between the global mechanisms with resources and people in affected communities and includes strengthening health systems to respond at the local level, with a focus on community ownership and accountability. He emphasized the importance of grant funding rather than loans and stressed the need to invest quickly in local systems and existing mechanisms.

“Moderator Dr. Shah asked each panelist to comment briefly on the single most important thing needed to ensure we save lives now, equitably. Dr. Etienne replied with an emphasis on adequate tools to predict, prevent, and protect against COVID, as well as expanding regional vaccine production. Mr. Sands advised to “act now; act big.” Mr. Gips advocated for a coordinated global plan with real political commitment. Ms. Roy advocated for including everyone at the table to ensure an equitable response, including those hardest hit: “We act in our self-interest when we act together.” Mr.D Gitahi advised that rich countries take a step back from the vaccine queue to allow COVAX to access more, and that we strengthen existing mechanisms before building new ones.

“Administrator Power closed the session by noting that we have the ability to ramp up testing, improve availability of PPE, and develop sufficient oxygen capacity to treat those in need. She advised that today’s Summit should be the start of a more coordinated effort to save lives that would be lost without our support.

“Session II. Video Interventions

Prime Minister Suga Yoshihide Japan (video)
Prime Minister Jacinda Ardern, New Zealand (video)
Tom Hart, ONE Campaign (video)
Prime Minister Stefan Löfven, Sweden (video)
Prime Minister Sheikh Hasina, Bangladesh (video)

“Session 3. Building Back Better Global Health Security

“Vice President Kamala Harris chaired the session, which was focused on building back better global health security to mitigate future biological threats and pandemics. She pointed out that nations need greater capacity now, and the world as a whole must be ready before, not after, the next pandemic. Vice President Harris issued a clear call to action to establish a global health security financial intermediary fund (FIF) to bring together new resources for pandemic preparedness, with an initial goal of reaching $10 billion in seed funding for country and corporations. She announced that the United States is prepared to contribute at least $250 million to help seed the FIF. Those funds will combat this pandemic while helping prevent the next, with an additional $850 million requested from the U.S. Congress. She also called for greater political leadership and accountability, calling for the establishment of a Global Health Threats Council to monitor progress and sound the alarm to prevent future pandemics.

“Loyce Pace, U.S. Department of Health and Human Services Office of Global Affairs Director, moderated the panel with an emphasis on urgency and equity of the global response.

“Prime Minister Solberg of Norway reiterated Vice President Harris’ perspective that we were not sufficiently prepared, and that we must transform ad-hoc solutions for the future. She also called for predictable health security financing, a future health security fund, and burden-sharing as an approach to funding for it. She stressed the importance of assistance beyond official development assistance, emphasized health security as a global public good, and stressed the need to strengthen WHO financing in parallel. She also strongly supported achieving global early warning networks to detect and respond to outbreaks early, research and development on vaccines, tests and treatment, with accessible technologies to all and regional production capacity, with universal equitable access. She emphasized that Norway stands ready to do its part.

“Prime Minister Gaston Alphonso Browne, Antigua and Barbuda, Chair of the Conference of the Heads of Government of the Caribbean Community (CARICOM) stated that CARICOM governments are committed to the 70% global vaccination target by September 2022, including in their own governments. He discussed his resolve to strengthen the Caribbean Public Health Agency (CARPHA) and called for international partnership. In discussing the goal of building back better, Prime Minister Browne reiterated that recovering from economic effects will be protracted because economic progress has been reversed. He discussed the importance of global public goods and the need to build health infrastructure, and stressed that none of us are safe until all of us are safe.

“Senior Minister Tharman Shanmugaratnam, Republic of Singapore and Co-chair of the G20 High Level Independent Panel on Financing the Global Commons for Pandemic Preparedness and Response focused on the need for substantially more investments in pandemic preparedness. He spoke of collective investments in areas such as global networks of surveillance and early warning, health security and public health capacities at national and regional level, and vaccines and critical medical supplies. He called for urgent establishment of a new multilateral Fund of $10 billion per year, less than 0.02 percent of most national GDPs, which could catalyze public, private, and philanthropic sources, besides domestic investments within nations. He also stressed the importance of an inclusive G20-Plus Board for governance, comprising health and finance ministers, and the leaders of the WHO and the other key multilateral institutions. He ended by noting, “It will be both morally indefensible and financially myopic to defer these investments or wait for the next pandemic to overwhelm us.”

“Ellen Johnson Sirleaf, former President of Liberia, Nobel Peace Prize recipient, and Co-Chair of the Independent Panel for Pandemic Preparedness and Response (IPPPR) called on the UN General Assembly to hold a Special Session to approve a political declaration on the reforms required for pandemic preparedness and response, including to establish a Global Health Threats Council led by Heads of State and Government, representative of the world’s regions, and focused on both accountability and political leadership. She noted the IPPPR’s call for an International Pandemic Financing Facility to mobilize $10 billion per year and disbursements of up to $100 billion for biological crises, and commended the United States’ call for a FIF with seed contribution. She expressed concerns about the severe inequality in vaccine availability and access (50-80 per cent of wealthy populations, with only 5 per cent in poorer countries), commended efforts to redistribute surplus vaccines to the 92 low-and middle-income countries, as well as technology transfers and voluntary licensing agreements for vaccine manufacturers. Finally, she called for adequate financing to the WHO, support for community health workers as a hallmark of the COVID19 response, and the burden COVID-19 has placed on women and girls. “It is clear that the current international system failed to protect us all from this catastrophic pandemic—and it is not fit to prevent another.”

“Dr. John Nkengasong, Director of the Africa Centers for Disease Control and Prevention, called for a “reset” button” on architecture for global health security, recognizing that this starts at the national, then regional, then global levels. Reflecting on urgent needs, Dr. Nkengasong pointed to the need for scaling up the workforce and frontline health workers – in order to be better prepared for the next pandemic. He discussed the need for all countries to house their own Centers for Disease Control that can serve as an emergency operation center, strengthen laboratory systems, and train the workforce. With regards to lessons learned from this pandemic, Dr. Nkengasong raised regional manufacturing and the gap between African manufacturing and African consumption of vaccines. Finally he called for innovative financing at the global and regional level, and that funding needs predictability, sustainability, and rapid access.

“Chief Executive Officer Marcel Arsenault, PAX sapiens, One Earth Future Foundation, stated that COVID-19 was our “dress rehearsal” for a far more devastating pandemic. He reiterated that an effective plan and implementation will require the whole of global society to join together. In that regard, he spoke to the role of philanthropies can play since they operate by more flexible rules than government, including their capacity for long term commitments. He announced a new $200 million commitment to help future pandemics, to partner with other donors and global institutions to build a better global system. Mr. Arsenault also committed to convene other donors and experts to finance pandemic preparedness and explore creative financing mechanisms outside of transitional development assistance. He also applauded the call by Vice President Harris to establish a FIF.

“Director Pace closed the session by highlighting the importance of global action toward “predictable, sustainable financing” allocated equitably to the most urgent needs and rooted in regional or local community perspectives. She emphasized the opportunity to mobilize public and private sector funds through multisector collaboration, and stressed the value of high-level political engagement and oversight.

“Session III. Video Interventions

President Moon Jae-in, Republic of Korea (video)
Carolyn Reynolds, Pandemic Action Network (video)
Prime Minister Scott Morrison, Australia (video)
Dr. Roopa Dhatt, Women in Global Health (video)
Prime Minister Pedro Sánchez, Spain (video)
Prime Minister Sheikh Hasina of Bangladesh (video)

“Session 4. Closing of Summit

“Coordinator for Global COVID-19 Response and Health Security Gayle Smith moderated the panel and focused on creating momentum, checking our progress, and constantly doing more. She asked G20 President Prime Minister Draghi to share a preview of the G20 Summit and areas in need of additional support.

“Secretary Blinken announced called on leaders to end the pandemic rather than just “doing better,” and announced his intent to personally convene foreign ministers before the end of the year to follow up with commitments made at the Summit, as well as the G20. He reiterated President Biden’s call for heads of state to reconvene on this issue in the first quarter of 2022. He also called for a multilateral leaders task force made up of experts from inside and outside the government to transparently and rigorously evaluate progress in the run-up to the G20 and at regular intervals thereafter.

“He stressed the target of vaccinating at least 70% of the population of every country, in every major income category, by UNGA 2022 and called on leaders to set ambitious targets with timelines that are openly tracked for progress and with accountability. He reiterated the United States’ willingness to lead, President Biden’s commitment to supply an additional 500 million doses of the Pfizer vaccine, and his commitment to work with global vaccine manufacturers to expand global and regional manufacturing for mRNA, viral vector, and protein subunit COVID-19 vaccines, as well as pledged to enhance transparency for the data on production and projections for dose manufacturing.

“He also called on leaders to accelerate efforts to get more shots into arms, to reduce morbidity and mortality from the virus, to expand access to oxygen, testing, and more, building on historic support for Gavi and the Global Fund, aid to countries and communities through USAID and the CDC, Treasury Secretary Yellen’s call to action on Special Drawing Rights, and U.S. support for a waiver of intellectual property protections in the WTO TRIPS Agreement for COVID-19 vaccines in service of ending this pandemic. Finally, he recognized community and healthcare workers on the frontlines of the pandemic, noting that the people are what’s critical to winning the fight against COVID-19. ‘It comes down to us. What we do in this critical moment, in the weeks ahead, in the months ahead.’

“Prime Minister Mario Draghi of the Italian Republic addressed the Summit and announced a new commitment that will triple Italy’s existing dose donation pledge by providing 30 million additional doses by the end of the year. These are in addition to the 15 million doses pledged for donation, largely through COVAX, during the G20 Global Health Summit of which nearly half have been distributed to date. He called on leaders, as they work to end this pandemic, to also improve preparation for future pandemics, including by expanding the production capacity of vaccines and other medical tools worldwide – especially in the most vulnerable countries. He welcomed the U.S. proposal to establish a FIF for health security and stressed that it is fully complementary with the G20 proposal for a Global Health and Finance Board. He recalled the G20 Health Summit Rome Declaration and progress achieved since that time, including more than 2.5 million fully vaccinated worldwide. However, he stressed the grave inequalities in vaccine availability and emphasized the ACT-Accelerator and COVAX as the most effective ways to deliver and build capacity to administer. He asked countries to stand by existing pledges and make more generous ones and gave support to the EU plan to develop regional manufacturing hubs in Africa, and the U.S.-EU global vaccination partnership that launched this week. Finally, he committed that the G20 Summit will build on the outcomes from today’s summit.

“Ms. Zipporah Iregi of the National Nurses Association of Kenya called on leaders to support healthcare workers and include them in decision-making. She thanked leaders for committing to these targets to save lives, vaccinate people, and build back better. She also provided insight for leaders into the plight of healthcare workers serving on the front lines of the COVID-19 pandemic. She recounted staying home at the beginning of the pandemic, watching peers explore other careers. She urged leaders to support healthcare workers and help them to be prepared for the next crisis. She welcomed the U.S. announcement of additional vaccine sharing. She expressed concerns about impending shortages of healthcare workers and called on leaders to support and recruit more healthcare workers, including ensuring they are paid on time and provided with personal protective equipment that is necessary to provide care.

“Mr. Lwazi Mlaba a COVID-19 Survivor and Global Health and Global Fund Champion, provided final remarks for the Summit, sharing his personal journey with long COVID and advocating for urgency to strengthen community assistance and support investments to expand community healthcare workers. He noted that his survival depended on them. He called for Universal Health Coverage and for global solidarity and leadership to beat the COVID-19 pandemic. He ended by saying, powerfully, “We know what we need to do. We know how we need to do it. The time has come to actually do it. Invest now, invest big. Let’s go now and do it.”

“Summit Participants

“More than 100 governments and other partners participated in the President Biden’s Global COVID-19 Summit on September 22, 2021.

Principality of Andorra; Antigua and Barbuda; Argentine Republic; Republic of Armenia; Commonwealth of Australia; Republic of Austria; Commonwealth of The Bahamas; Kingdom of Bahrain; People’s Republic of Bangladesh; Barbados; Kingdom of Belgium; Belize; Kingdom of Bhutan; Bosnia and Herzegovina; Republic of Botswana; Brunei Darussalam; Kingdom of Cambodia; Republic of Cameroon; Canada; Republic of Chile; Republic of Colombia; Republic of Cote d’Ivoire; Republic of Croatia; Czech Republic; Kingdom of Denmark; Commonwealth of Dominica; Arab Republic of Egypt; Republic of Estonia; Kingdom of Eswatini; Federal Democratic Republic of Ethiopia; European Commission; Republic of Finland; Gabonese Republic; Georgia; Federal Republic of Germany; Republic of Ghana; Hellenic Republic (Greece); Grenada; Republic of Guatemala; Republic of Guinea-Bissau; Cooperative Republic of Guyana; Republic of Haiti; Republic of Iceland; Republic of India; Republic of Indonesia; Ireland; State of Israel; Italian Republic; Jamaica; Japan; Hashemite Kingdom of Jordan; Republic of Kazakhstan; Republic of Kenya; Republic of Kiribati; Republic of Korea; Republic of Kosovo; Kyrgyz Republic; Lao People’s Democratic Republic; Republic of Latvia; State of Libya; Republic of Lithuania; Grand Duchy of Luxembourg; Republic of Malawi; Malaysia; Republic of Malta; Republic of Mauritius; Federated States of Micronesia; Republic of Moldova; Mongolia; Montenegro; Kingdom of Morocco; Republic of Mozambique; Republic of Namibia; Nepal; Kingdom of the Netherlands; New Zealand; Federal Republic of Nigeria; Republic of North Macedonia; Kingdom of Norway; Sultanate of Oman; Islamic Republic of Pakistan; Republic of Palau; Palestinian Authority; Republic of Peru; Republic of the Philippines; Republic of Poland; Portugal; Romania; Russian Federation; Kingdom of Saudi Arabia; Republic of Serbia; Republic of Sierra Leone; Republic of Singapore; Federal Republic of Somalia; Republic of South Africa; Kingdom of Spain; Sri Lanka; Federation of Saint Kitts and Nevis; Democratic Socialist Republic of Sri Lanka; St Vincent and Grenadines; Republic of the Sudan; Republic of Suriname; Kingdom of Sweden; Swiss Confederation; Taiwan; Kingdom of Thailand; Togolese Republic; Republic of Trinidad and Tobago; Republic of Tunisia; Republic of Turkey; Ukraine; United Arab Emirates; United Kingdom of Great Britain and Northern Ireland; United Nations General Assembly (Republic of Maldives); Republic of Uzbekistan; Republic of Vanuatu; Socialist Republic of Vietnam; Republic of Yemen; Republic of Zambia; Zimbabwe

“International Organizations, Non-Governmental Organizations, Private Sector, and Philanthropies

“More than 100 International Organizations, non-governmental organizations, private sector, and philanthropies participated in the President Biden’s Global COVID-19 Summit on September 22, 2021.

“Abbott; Access Bio; AdvaMedDX; Africa Centres for Disease Control and Prevention; The World Health Organization Regional Office for Africa (AFRO); African Development Bank; African Union; Alphabet Inc.; American Chamber of Commerce of Mexico; American Chamber of Commerce in South Africa; American Clinical Laboratory Association; American Society of Tropical Medicine and Hygiene; Amref Health Africa; American Public Health Association; Asian Development Bank; Association of Public Health Laboratories; Association of Southeast Asian Nations; Becton, Dickinson and Company; Biotechnology Innovation Organization; Boston Consulting Group; CARE; Caribbean Public Health Agency; The Carter Center; CDC Foundation; Center for Supporting Community; Development Initiatives; Coalition for Epidemic Preparedness Innovations; The Clinton Foundation; Clinton Health Access Initiative; CORE Group; COVID Collaborative; Danaher Corporation; Deloitte; Emory University; European Bank for Reconstruction and Development; Friends of the Global Fight; The Bill & Melinda Gates Foundation; Gavi, The Vaccine Alliance; Ginkgo Bioworks; Global Citizen; Global Communities; The Global Fund; Global Poverty Project; Global Health Council; Global Health Technologies Coalition; Health GAP; Hologic, Inc.; International Federation of Pharmaceutical Manufacturers & Associations; International Monetary Fund; InterAction; International Air Transport Association; International Atomic Energy Agency; International Civil Aviation Organization; International Committee of the Red Cross; International Federation of Red Cross and Red Crescent Societies; International Maritime Organization ; International Organization for Migration; International Vaccine Institute; IntraHealth International; Johnson & Johnson; Jubilee; LEGO Foundation; JustActions; LumiraDx; Management Sciences for Health; Marked by COVID; Mastercard Foundation; Matahari Global Solutions; Mayo Clinic Laboratories; McKinsey & Company; Merck Group; MilliporeSigma; National Nurses Association of Kenya; NETWORK for Catholic Social Justice; Nuclear Threat Initiative; ONE Campaign; One Earth Future Foundation; Open Society Foundations; OraSure Technologies; Oxfam America; Pan American Health Organization; Pandefense Advisory; Pandemic Action Network; PATH; PerkinElmer; Pfizer Inc.; Pharmaceutical Research and Manufacturers of America; Public Citizen; Public Health Foundation of India; QIAGEN; Roche; The Rockefeller Foundation; Sabin Vaccine Institute; SalivaDirect at the Yale School of Public Health; Save the Children; Schmidt Futures; Seed Global Health; The Skoll Foundation; Sustainable Energy for All; Thermo Fisher Scientific; United States Chamber of Commerce; United Nations Foundation; Unitaid; United Nations Children’s Fund; United Nations Environment Programme; United Nations High Commissioner for Refugees; United Parcel Service; The United States Global Leadership Coalition ; World Health Organization; Women in Global Health; World Bank Group; World Food Programme; WOTE Kenya; World Trade Organization.”

Conclusion

The damage from the COVID-19 pandemic is much worse than should have occurred had the world had a robust monitoring system and the global infrastructure to address the problem early on and cooperation among nations in the effort. Developed countries demonstrated a slowness of response. China was not forthcoming early on on developments in their country and has limited the ability of the world to understand the origins of the virus. Leadership in a number of countries downplayed the seriousness of the virus causing untold human suffering from runaway infections. Misinformation and misguided notions of personal choice have slowed the ability to take responsible action where public health care measures would have reduced the human damage and even the willingness to take a life saving vaccine. The world has been set back years or decades in its fight against poverty and other Sustainable Development Goals. While many countries are bouncing back economically and trade wise, it has often been with massive government infusions which reduced the economic collapse of particular economies but which are, of course, not sustainable and which were not available to most countries.

Despite the structures in place to facilitate a rapid development and equitable distribution of vaccines and other medical goods during a pandemic, a host of problems have reduced the success in the acquisition and distribution of vaccines to low- and middle-income countries to date.

The efforts of the United States and the European Union and other countries in recent months are important and will help correct — albeit months late — the issue of equitable access to vaccines. The U.S. and EU push for donations of vaccine doses versus sales with strings attached, working through COVAX for distributions to low- and middle-income countries and the need to address a range of other issues going to reducing death rates around the world (oxygen, therapeutics, PPEs), helping expand vaccine production capacity in low- and middle-income countries, as well as preparing for the next pandemic so the world is better able to respond in a timely manner are all important aspects for ending this pandemic and ensuring a more capable global response in the future. How successful the efforts of the U.S. and EU are will depend on the depth of commitment from other countries, multilateral organizations and the private sector as well as their own ability to deliver and even expand on their own initiatives.

Last week was an important one for the global effort to terminate the pandemic. While the media didn’t pay a lot of attention, the efforts of the U.S. and the EU are critical to a successful conclusion to the health crisis.

WTO’s April 14th virtual meeting to review COVID-19 vaccine availability

Terence P. Stewart · April 18, 2021 · COVID-19 vaccinations · Brazil, China, COVAX, European Centre for Disease Prevention and Control, European Union, GAVI, India, International Federation of Pharmaceutical Manufacturers and Associations, Japan, Republic of Korea, South Africa, United Kingdom, United States, World Health Organization, World Trade Organization, WTO Director-General Ngozi Okonjo-Iweala · No Comments

WTO’s Director-General Ngozi Okonjo-Iweala had indicated when she took office that she would be gathering industry, multilateral groups, and some governments to look at how vaccine production could be expanded and the role the WTO could play in that effort. At the same time, with the proposal from India and South Africa for waiver from most TRIPS obligations on medical products relevant to addressing the COVID-19 pandemic still under consideration in the TRIPS Council, with opposition from a number of important Members, DG Okonjo-Iweala has been seeking an approach that in fact expands production in developing and least developed countries and greater distribution to low- and middle-income countries. without needing an all or nothing resolution to the proposed waiver.

“COVID-19 and Vaccine Equity: What Can the WTO Contribute?”

While the virtual meeting convened by DG Okonjo-Iweala was conducted under Chatham House rules, a number of participants made their prepared comments public and there was some press coverage.

DG Okonjo-Iweala provided a wrap-up at the end of the session which was posted on the WTO website. See WTO news, DG Okonjo-Iweala calls for follow-up action after WTO vaccine equity event, April 14, 2021, https://www.wto.org/english/news_e/news21_e/dgno_14apr21_e.htm (“Director-General Ngozi Okonjo-Iweala today (14 April) called on WTO members, vaccine manufacturers and international organizations to act to address trade-related obstacles to the scale-up of COVID-19 vaccine production to save lives, hasten the end of the pandemic and accelerate the global economic recovery.”). DG Okonjo-Iweala’s summary comments are copied below. See WTO speeches, Chair Summary following “COVID-19 and Vaccine Equity: What Can the WTO Contribute?”, April 14, 2021, https://www.wto.org/english/news_e/spno_e/spno7_e.htm.

“One thing that came out of today’s discussions is that it was only through working together across borders that scientists developed safe and effective vaccines in record time. And it is only by working together, across borders, that we’ll be able to solve the problems [of vaccine scarcity and equitable access] discussed today. This is a problem of the global commons, and we have to solve it together.

“Our purpose today was to contribute to efforts to increase vaccine production and broaden access, starting with the immediate term.

“Specifically we had three goals:

“The first was to pinpoint the obstacles, particularly the trade-related obstacles, to ramping up production, and to equitably distributing and administering vaccines — and we looked at how the WTO could contribute to these solutions.

“The second was to bring together people who are able to increase and to scale up manufacturing, people in a position to share technology and knowhow, and people willing to finance additional manufacturing capacity.

“And third, to think about the road ahead, including on the TRIPS waiver and incentives for research and development, so that we get the medical technologies we need, and no country is left at the back of the line waiting. If there is one refrain we heard continuously from everyone today it is that no one is safe until everyone is safe.

“We heard first-hand from governments and vaccine manufacturers from developed, developing, and least developed countries, as well as a wide range of other stakeholders from international organizations, civil society and development finance institutions.

“And we heard good news: that supplies are ramping up and companies are learning by doing, that there have been major gains in productivity, and that there is still capacity. We also heard that there is a willingness to finance investment in vaccine manufacturing both in the short- and long-term, and there are ideas and energy to do things differently.

“However, we heard from many that we need to do more. It hasn’t really been business as usual, so we may need to move on to ‘business unusual’ to solve the problems before us.

“In the discussions today we heard a great deal of agreement. We agree that it’s not acceptable for people and countries to have to wait indefinitely for vaccines. We do not want to repeat experiences of the past.

“We heard a consensus on the urgent need to scale up production and vaccinate everyone, because every day the shortage continues, scope for dangerous new variants will increase, and the number of prevent preventable deaths will grow. The economic impact of these delays can and has been quantified by many institutions, including the IMF, the World Bank, and the WTO.

“It was agreed that production capacity needs to be expanded, particularly in developing and least developed countries and emerging markets. And that vaccine distribution needs to be more effective and more equitable.

“We heard that open cross-border trade in raw materials, and other inputs, was essential for maintaining and scaling up production, and that supply chains in these inputs must be maintained.

“Also widely shared was the view that innovation, research and development will be vital for dealing with COVID-19 variants and in other health crises.

“We had useful exchanges on issues where some perspectives were different, such as on the future shape of vaccine supply chains, on the appropriate role for intellectual property protections, on issues of vaccine contract transparency — which was pointed to by many as an important factor in appropriate pricing and distribution and a critical part of access and equity.

“Concerns expressed by some about cross-border supply chain operations, including export restrictions and shortages of skilled personnel reinforced my view, and hopefully that of members, that the WTO must and can play a central part in the response to this crisis.

“Various perspectives about the TRIPS Agreement, and whether the existing flexibilities are enough to address developing country needs were put on the table. These echoed the discussions on the waiver proposal going on in the TRIPS Council, and I want to reiterate that today is a way of contributing to that discussion.

“I agree with the view that the WTO is a logical forum for finding a way forward on these issues, and I hope that the ideas raised here will contribute to convergence in the TRIPS Council on meaningful results that can contribute to the goals that we have.

“I hope that the discussion today, listening to each other, seeing that we all share a common goal, and that we may not be so far apart, will lead to the willingness to come to the middle, and work out something that will be acceptable to all.

“Participants were generally of the view that ramping up vaccine manufacturing capacity is a complex process. It requires large, long-term investment and sustainable business models. It relies on open international supply lines for ingredients and equipment. We heard how shortages of even a single piece of equipment, filters, can halt operations at a production facility. Vaccine manufacturing necessitates collaboration, and the movement of skilled labour, to facilitate transfer of technology and knowhow.

“Safety is a paramount consideration, and quality is the other part of safety. This demands effective regulatory capacity and stringent compliance, down to the factory floor. Indeed we heard this is a big risk companies factor in when making decisions as to where to produce, and how to produce. I hope that they’ve heard sufficient encouragement today, to enable us to move towards leveraging the existing capacities in emerging markets and developing countries mentioned repeatedly today, which could actually help to take care of the shortages talked about.

“Turning capacity around to produce COVID-19 vaccines is not only about the physical space alone. We heard repeatedly that it requires transfer of technology and knowhow, together with investment and support for quality assurance.

“We also learned about how existing licensing arrangements have operated — including an example of how skills transfer was carried out in a few as six months. We also heard calls for support to build human capital, and to help build regulatory cooperation.

“Some participants suggested more active matchmaking to connect companies that have the investment capacity with those that have potential for expanding production capacity, even in the short term.

“We also heard about ongoing efforts to build new manufacturing capacity, and the lessons that can be learned from that.

“We also began to see the aspects of the collaboration we need to make things happen. We had many international organizations show they are willing to work together to bring to fruition things like putting in place technical expertise, helping with capacity building and quality control, and investing directly in production.

“I believe that today’s exchanges have advanced our understanding of the challenges we face for scaling up vaccine production, and that working together is the only way ahead.

“In the coming weeks and months, we expect concrete follow-up action. These issues are not easy, but the political will and engagement from the private sector displayed today, suggests it is possible.

“As we move forward, I expect:

“- From WTO members:

“- Action to further reduce export restrictions and supply chain barriers, and to work with other organizations to facilitate logistics and customs procedures. We are monitoring this as part of our regular work, and we’ll continue doing so to increase supplies and maintain robust supply chains. Trade has been underlined as a critical factor in production; it is incumbent upon WTO members to act.

‘- Advance negotiations in the TRIPS Council on the waiver proposal and incentives for research and innovation. I hope that the ideas and the open dialogue heard will move us closer to agreement.

‘- For vaccine manufacturers:

‘- Concrete moves to scale up vaccine manufacturing, both short-term turnaround of existing capacities, milking whatever productivity gains we can from current facilities, and taking steps to invest.

“- Increased technology and knowhow transfer, which many participants stressed would be necessary to make additional production work.

“- We need transparency in contract agreements and product pricing. We hope to continue this dialogue and to help monitoring steps in that direction.

“- For international organisations and financial institutions:

“- We noted your willingness to finance, both existing and new capacity, your willingness to work on capacity building for regulatory issues, not just for vaccines, but also for therapeutics and diagnostics, which are equally important.

“I trust that we have found a good basis to deliver concrete action, and to continue this discussion that we’ve had today.

“This should not be a one-off, we should continue to talk to each other, and make sure that we can deliver.

“I hope that besides concrete action to increase capacity, this discussion has given us elements of a framework on trade and health that we can put together at the WTO, and that can be put before ministers at the 12th Ministerial Conference in mid-December. Such a framework should provide for trade-related preparedness to handle this pandemic, and the next one.”

Press accounts indicate that the United States, European Union, India and South Africa participated. Statements from USTR Katherine Tai and Executive Vice President Dombrovskis are available from government websites. See USTR press release, Ambassador Katherine Tai’s remarks at a WTO virtual conference on Covid-19 vaccine equity, April 14, 2021, https://ustr.gov/about-us/policy-offices/press-office/press-releases/2021/april/ambassador-katherine-tais-remarks-wto-virtual-conference-covid-19-vaccine-equity; European Commission press release, Speech by Executive Vice-President Valdis Dombrovskis at the WTO Webinar “Covid and Vaccine Equity,” 14 April 2021, https://ec.europa.eu/commission/commissioners/2019-2024/dombrovskis/announcements/speech-executive-vice-president-valdis-dombrovskis-wto-webinar-covid-and-vaccine-equity_en.

The Biden Administration has been meeting with various interest groups on the TRIPS wavier proposal (both pro and con) and is receiving pressure from some Members of Congress and prior government officials to agree to a waiver. Ambassador Tai’s statement stresses the need for equity in vaccine availability. “These losses have been disproportionately borne by vulnerable and economically disadvantaged communities within our countries. And the significant inequities we are seeing in access to vaccines between developed and developing countries are completely unacceptable. Extraordinary times require extraordinary leadership, communication, and creativity. Extraordinary crises challenge all of us to break out of our comfortable molds, our in-the-box thinking, our instinctive habits. This is not just a challenge for governments. This challenge applies equally to the industry responsible for developing and manufacturing the vaccines. The desperate needs that our people face in the current pandemic provide these companies with an opportunity to be the heroes they claim to be – and can be. As governments and leaders of international institutions, the highest standards of courage and sacrifice are demanded of us in times of crisis. The same needs to be demanded of industry.”

The EU statement is consistent with their views that equity is necessary and that the EU has been working to contribute to that result through production ramp up and large exports in fact, including to the COVAX facility. The EU summed up what the WTO should be doing. “To sum up, the WTO can support vaccine equity through five sets of actions:
Promoting best practices in terms of trade facilitation and regulatory cooperation to maintain open supply chains; Facilitating cooperation with the private sector, both to ramp up production in the short term, and to enhance manufacturing in global regions with under-capacity, focusing in particular on Africa; Supporting Members’ use of the available TRIPs flexibilities; Continuing to seek joint approaches with the World Health Organisation and the World
Intellectual Property Organisation; and Ensuring transparency and effective monitoring of any temporary export restriction, as proposed by the Ottawa Group.”

I have not found statements from either India or South Africa but at least one publication indicated they stressed the need for a TRIPS waiver for all Members. See Washington Trade Daily, WTO’s Role in Vaccine Equity, April 15, 2021, https://files.constantcontact.com/ef5f8ffe501/63ac7508-8034-44b3-8c3c-045c1bedec43.pdf.

The World Health Organization also participated and the Director-General’s statement is available from the WHO website. See WHO press release, COVID-19 and vaccine equity panel: what can the World Trade Organization contribute?, 14 April 2021, https://www.who.int/director-general/speeches/detail/covid-19-and-vaccine-equity-panel-what-can-the-world-trade-organization-contribute (“COVAX was created, as you know, almost a year ago to avoid the same thing happening again. And although COVAX has distributed almost 40 million doses of vaccine to 110 countries and economies, vaccine nationalism, vaccine diplomacy and severe supply constraints have so far prevented COVAX from realizing its full potential. Global manufacturing capacity and supply chains have not been sufficient to deliver vaccines quickly and equitably where they are needed most. More funding is needed, but that’s only part of the solution. Money doesn’t help if there are no vaccines to buy. We need to dramatically scale up the number of vaccines being produced. To address this challenge, WHO and our partners have established a COVAX manufacturing task force, to increase supply in the short term, but also to build a platform for sustainable vaccine manufacturing to support regional health security. We need to go beyond the traditional modus operandi to provide sustainable and effective solutions to address this extraordinary crisis. Some manufacturers have begun sharing the know-how and technologies to produce more vaccines, but only under restrictive conditions, on a very limited basis. The current company-controlled production sharing agreements are not coming close to meeting the overwhelming public health and socio-economic needs for effective, affordable and equitable access to vaccines, as well as therapeutics and other critical health technologies. This is an unprecedented emergency that demands unprecedented measures.”).

One of the private sector participants, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) included its statement on the IFPMA website. See IFPMA, IFPMA statement at WTO event “COVID-19 and Vaccine Equity: What can the WTO Contribute”, 14 April 2021, https://www.ifpma.org/resource-centre/ifpma-statement-at-wto-event-covid-19-and-vaccine-equity-what-can-the-wto-contribute/. The IFPMA statement is embedded below but highlights the extraordinary effort of the private sector in ramping up production which is expected to be 10 billion doses by the end of 2021 with some 272 partnerships entered into and 200 technology transfer agreements.

IFPMA_WTO_Event_COVID-19_and_Vaccine_Equity_Statement_15April2021

Rising Infections; dramatically ramped up production

Last Thursday’s summary from the European Centre for Disease Prevention and Control (ECDC) shows the world going through a massive ramp up of new infections such that week 14 of 2021 is the second highest week during the pandemic of new infections with the vast majority of the cases and increase in Asia, the Americas and Europe. See ECDC, COVID-19 situation update worldwide, as of week 14, updated 15April 2021, https://www.ecdc.europa.eu/en/geographical-distribution-2019-ncov-cases.

“Distribution of COVID-19 cases worldwide, as of week 14 2021

“Cases reported in accordance with the applied case definition and testing strategies in the affected countries.”

The ECDC data show Africa as accounting for 3.18% of total infections during the pandemic, Asia accounting for 19.50% (India is 9.91%; China is 0.07%), the Americas for 43.18% (United States 22.91% and Brazil 9.90%), Europe 34.08% (the Eu is 20.79%, the UK is 3.20%, Russia is 3.4%), and Oceania 0.05%.

At the same time as new infections are ramping up, vaccinations are also increasing sharply. Bloomberg data through April 17, 2021 shows a global total of 884 million vaccinations having been given globally. See Bloomberg, More Than 884 Million Shots Given: Covid-19 Tracker, updated April 17, 2021, https://www.bloomberg.com/graphics/covid-vaccine-tracker-global-distribution/.

While there are countries who have fewer or more vaccinations as a percent of the global total than their share of infections, considering distribution equity from that vantage point has some surprising results.

Country Percent of infections Percent of vaccinations

United States 22.91% 23.16%

European Union 20.79% 12.36%

United Kingdom 3.20% 4.76%

Japan 0.37% 0.21%

Republic of Korea 0.08% 0.17%

India 9.91% 13.85%

China 0.07% 21.18%

South Africa 1.14% 0.33%

Brazil 9.90% 3.92%

The pharmaceutical industry is projecting that 10 billion doses of COVID-19 vaccine will ship in 2021. That means that in the next eight and a half months, some nine billion doses will ship. If 10 billion doses are shipped in 2021, that is sufficient to fully vaccinate 5-6 billion people in 2021 (depending on number of doses that are for single shot vaccines). That is sufficient doses to vaccinate 63.3-75.9% of the current estimate of the global population (7.9 billion). See Worldometer, Current World Population, https://www.worldometers.info/world-population/#:~:text=The%20current%20world%20population%20is,currently%20living)%20of%20the%20world./ With the continued efforts to expand production and approve additional vaccines, 10 billion doses may be exceeded in fact by the end of the year.

This suggests, just as the COVAX and UNICEF distribution plans indicate, that low- and middle-income countries will see a large increase in supplies in the second half of 2021, just as will be true for the rest of the world.

The U.S.-Gavi event on April 15 talked about increasing funding for COVAX to go from 20% to 30% of populations the COVAX facility is serving. See U.S. Department of State, Video Remarks of Secretary of State Antony Blinken, Launch of GAVI’s COVAX Commitment, April 15, 2021, https://www.state.gov/launch-of-gavis-covax-commitment/. Moreover, the World Bank is committing billions to increases purchases of vaccines for low- and middle-income countries. And many countries are executing their own contracts with vaccine producers.

If there are issues besides assistance in resolving bottlenecks that would appear to be important to speeding up distribution and ensuring access by all, it would be to ensure that all countries with vaccine supplies greater than their internal needs, work to get those vaccines distributed to other countries later this year as their internal needs clarify.

Moreover, there are very exciting developments on the vaccine front with the start up of trials in a number of developing countries of a new vaccine where the potential exists for low costs with a vaccine that can be produced locally by many countries based on technology similar to what is already used for other vaccines. See New York Times, Researchers Are Hatching a Low-Cost Coronavirus Vaccine, A new formulation entering clinical trials in Brazil, Mexico, Thailand and Vietnam could change how the world fights the pandemic, April 5, 2021, updated April 17, 2021, https://www.nytimes.com/2021/04/05/health/hexapro-mclellan-vaccine.html.

All to say, there is considerable reason for optimism with the current efforts and progress. Efforts by governments, multilateral institutions, industry and others are helping identify challenges both to production and distribution but also to the needs for a speedy recovery once the pandemic is brought under control. While everyone needs to continue to focus on resolving bottlenecks, securing cooperation to ensure all are reached, and addressing developments as they arise, 2021 is not a repeat of the HIV situation.

The WTO has an important role in monitoring trade restrictions and looking forward to what actions Members are willing to take to advance trade and health needs and help ensure a next pandemic is handled more quickly than the COVID-19 has been. The effort to obtain a waiver from TRIPS obligations is, in this writer’s view, missing where the challenges are and seeking an outcome that will not advance improved vaccinations in 2021. While it is common for countries to continue to fight yesterday’s problems instead of addressing the current challenges, such an approach will not secure equitable and affordable access to vaccines in 2021-2022.

April 15, 2021 — U.S and Gavi co-host event for additional funding for COVAX amid concerns about two workhorse vaccines for COVAX

Terence P. Stewart · April 13, 2021 · COVID-19 vaccinations · CEPI, COVAX, GAVI, UNICEF, United States, World Health Organization · No Comments

An important part of global efforts to vaccinate the world has been the work of the World Health Organization, Gavi, CEPI and UNICEF to provide an array of vaccines through early support of research and procurement of large quantities of doses for distribution to countries participating in the program including 92 low- and middle-income economies through COVAX. The COVAX objective for 2021 has been distribution of around two billion doses. While a large amount of money has been raised for vaccine purchases, additional needs in 2021 for COVAX are around $2 billion.

This Thursday, the United States and Gavi will co-host an event seeking additional funding for COVAX. The U.S. State Department press release from April 12 is copied below. See U.S. Department of State, United States to Host Event to Launch the 2021 COVAX Investment Opportunity, April 12, 2021, https://www.state.gov/united-states-to-host-event-to-launch-the-2021-covax-investment-opportunity/.

“On Thursday, April 15, 2021 at 8:00 a.m. EDT the United States will co-host the launch of the Investment Opportunity for the Gavi COVAX Advance Market Commitment (COVAX AMC), a virtual convening to galvanize additional resources and commitments to support global COVID-19 vaccination.

“Secretary of State Antony Blinken, USAID Acting Administrator Gloria Steele, and Gavi Board Chair José Manuel Barroso will bring together world leaders, the private sector, civil society, and technical experts to advance and accelerate global access to COVID-19 vaccines. Secretary Antony Blinken will offer opening remarks.

“Equitable access to safe and effective COVID-19 vaccines across the globe is critical for reducing the tragic loss of life, ending the pandemic, bolstering the U.S. and global economy, and keeping Americans safe at home and abroad. By pooling donor resources, the COVAX AMC provides access to safe and effective COVID-19 vaccines for 92 low-and middle-income economies, supporting the delivery of quality, lifesaving vaccines to those most in need and helping to contain the spread of COVID-19 and emerging variants.

“Thanks to Congress and the generosity of the American people, the U.S. government has already contributed $2 billion to support the COVAX AMC, out of a total planned $4 billion through 2022. The United States is currently the largest donor to COVAX, making up nearly forty percent of the COVAX AMC funding commitments announced to date.

“This event will be live-streamed on Gavi’s website, gavi.org and open to the public. For more information email OES_PA_DG@State.gov.”

Gavi’s press release of 29 March 2021 announcing the event is copied below and provides the needs that hopefully will be met by Thurday’s event. See Gavi, United States to host launch event for Gavi COVAX AMC 2021 investment opportunity, 29 March 2021, https://www.gavi.org/news/media-room/united-states-host-launch-event-gavi-covax-amc-2021-investment-opportunity.

“Geneva, 29 March 2021 – The United States government announced today that it will host the launch of the Investment Opportunity for the Gavi COVAX Advance Market Commitment (AMC). The virtual event, which will take place in April, will be co-hosted by José Manuel Barroso, Chair of the Gavi Board, and the Secretary of State and USAID Administrator on behalf of the United States. It will bring together world leaders, the private sector, civil society and key technical partners to present the case for additional resources for the Gavi COVAX AMC.

“Country demand for COVID-19 vaccines has increased significantly in light of new COVID-19 variants, and the need for additional financing has become more urgent. In addition to committing US$ 4 billion to support Gavi’s COVID-19 related work, the United States is a long-standing supporter of the Alliance. It was one of Gavi’s original six donors and has contributed more than US$ 2.7 billion to Gavi’s core work since 2000.

“’We welcome U.S. leadership in hosting the launch of the Gavi COVAX AMC Investment Opportunity,’ said José Manuel Barroso, Gavi Board Chair. ‘The United States has been a key Gavi partner for more than two decades, playing a critical role in helping the Alliance expand access to lifesaving immunisations for the most vulnerable around the world. Its recent contribution of $4 billion for procurement and delivery of COVID-19 vaccines for lower-income countries has made the United States Gavi’s top donor and a leader in the global pandemic response. With U.S. financial and diplomatic support, Gavi is very well positioned to mobilize the funds and the doses we need to end the acute phase of the pandemic.’

“The Gavi COVAX AMC is an innovative mechanism that seeks to provide access to up to 1.8 billion donor-funded doses of COVID-19 vaccines for 92 lower-income economies. In order to achieve that goal and build on the contributions made by donors so far, Gavi will be seeking at least US$ 2 billion in additional funding for the AMC in 2021. The Investment Opportunity will outline how Gavi will use this funding to support equitable access around the world, thus helping end the acute stage of this pandemic. The Investment Opportunity also looks ahead to the future, describing how to address the pandemic as it continues to evolve.

“’As the United States has made clear through its Gavi partnership and commitments to global health security, no one is safe until everyone is safe,’ said Dr Seth Berkley, CEO of Gavi. ‘Gavi is thrilled to co-host the launch of the Investment Opportunity with the United States. With new donor funding, we will be able to procure up to 1.8 billion COVID-19 vaccine doses for lower-income countries. Strong U.S. support for the AMC is a reminder that COVAX offers the fastest, most comprehensive way out of the acute phase of the global pandemic.’

“’The emergence of new, more transmissible COVID-19 variants makes fair global access to vaccines more important than ever to protect the most vulnerable, reduce the prevalence of disease and slow down viral mutation.’ said Dr Richard Hatchett, Chief Executive Officer of the Coalition for Epidemic Preparedness Innovations (CEPI), which manages COVAX vaccine research and development. ‘Equitable access to COVID-19 vaccines will benefit the entire world, so I’m delighted that the U.S. will help COVAX to secure additional donor funding for lower-income countries.’

“Hon. Kwaku Agyeman-Manu, Minister of Health of Ghana, which took one the first deliveries of COVAX-supported vaccine doses, remarked that ‘this is about fairness, about justice, and about bringing a swift end to the pandemic. COVID-19 has affected all of us, and we must protect at risk populations everywhere if we are ever going to see a return to normal. We will only recover fully if we recover together and with its support for COVAX, the United States is helping set the course for a safer, more resilient world.’

“The Gavi COVAX AMC is a central part of the COVAX Facility, the global pooled procurement mechanism designed and administered by Gavi. Thanks to the support of COVAX AMC donors, coupled with the demand and resources of 191 participating economies, the Facility has already begun to deliver doses – the majority to lower-income countries – as part of the largest and most rapid global vaccine rollout in history.

“COVAX, the vaccines pillar of the Access to COVID-19 Tools (ACT) Accelerator, is co-convened by Gavi, the Coalition for Epidemic Preparedness Innovations (CEPI), and the World Health Organization (WHO) – working in partnership with UNICEF as a key delivery partner, developed and developing country vaccine manufacturers, the World Bank, and others. It is the only global initiative that is working with governments and manufacturers to ensure COVID-19 vaccines are available worldwide to both higher-income and lower-income countries.”

Challenges to COVID vaccines through COVAX from concerns over AstraZeneca and Johnson & Johnson

A large portion of total vaccine doses expected in 2021 through COVAX is from AstraZeneca/Serum Institute of India and from Johnson & Johnson. AstraZeneca has had early production issues and the Serum Institute of India (which licenses the AstraZeneca vaccine for production) has curtailed exports in March and April (and possibly longer) because of the large increases in new COVID-19 infections in India and a redirection of production of vaccine doses for use in India. The AstraZeneca vaccine (from AstraZeneca and from the Serum Institute) constitute the bulk of doses expected in the first half of 2021 by COVAX and the Johnson & Johnson vaccine is expected to be a major supply source in the second half of 2021 as well as Novavax (either produced by Novavax or by license from the Serum Institute. However, both the AstraZeneca vaccine and the Johnson & Johnson vaccine have seen temporary stoppage of use by one or more countries flowing from a number of serious blood cot situations for patients who have taken the vaccine (causation under investigation). The AstraZeneca vaccine, which has been available for longer and under more scrutiny, has been limited in terms of age eligibility in a number of countries at this point. The AstraZeneca vaccine is the lowest priced vaccine (Novavax has an identical price to COVAX of $3.00/dose but is not yet approved). See UNICEF, COVID-19 vaccine market dashboard, https://www.unicef.org/supply/covid-19-vaccine-market-dashboard (prices). COVAX has a $3.00/dose ceiling price, so it is assumed that the Johnson & Johnson vaccine is similarly priced because of the pricing cap used by COVAX. With options, purchase agreements with COVAX have AstraZeneca/Serum Institute supplying some 700 million doses, Johnson & Johnson 500 million doses and Novavax (if approved) 1.1 billion doses. Id (COVID-19 vaccine supply agreements).

The challenge for COVAX and the low- and middle-income countries dependent on supplies from COVAX is the cost and availability of supplies if delays in shipments from the Serum Institute of India are prolonged or if there develops hesitancy in using vaccines which, while approved by many countries, carry some additional risk of serious blood clots. The prices recorded by the UNICEF data base show all other vaccines as significantly higher cost than the three supplying large quantities to COVAX. This suggests much larger financial needs to acquire the doses needed to address the “acute stage” of vaccination — 20% of populations representing health care and those at high risk — if COVAX must change sourcing for the major part of its vaccine doses. It also raises questions about the ability of other vaccines to fill the gap volume-wise in 2021 if major vaccines from AstraZeneca, Johnson & Johnson are not widely accepted or if exports are delayed for months out of India for each of AstraZeneca, Johnson & Johnson and Novavax (if approved).

While the event on Thursday will be focused on raising funds to meet the perceived needs of COVAX at the present time, those needs may be significantly larger in the coming months depending on developments.

Other funding and supply options

While the COVAX effort has been developed to handle the acute phase through contributions, the vaccination needs to get the world fully vaccinated are a multiple of the doses that COVAX is focused on procuring in 2021-2022.

The World Bank has earmarked $12 billion for vaccines and infrastructure for vaccinations for the world’s needy. Many low- and middle-income countries are working with suppliers directly or with Individual countries to obtain doses outside of the volumes expected from COVAX. Suppliers alone or in conjunction with governments have been working to license other producers and to ramp up production so that, depending on approvals of various vaccines, global production by the end of 2021 could be 10-15 billion doses. For example, the Quad countries (United States, Japan, India and Australia) have announced a plan to expand production in India to supply around one billion doses (2021-2022) to countries in the Indo-Pacific region paid for by Quad members and distributed by Australia. The UNICEF vaccine dashboard shows 6.9 billion doses of capacity of all vaccines under development or approved in the first half of 2021 increasing to 14.2 billion doses of capacity in the second half of 2021. See UNICEF, COVID-19 vaccine market dashboard, https://www.unicef.org/supply/covid-19-vaccine-market-dashboard (capacity). Thus, there should be significant additional capacity available later in 2021 for vaccine doses needed for low- and middle-income countries.

Similarly, it is likely that as major countries like the United States, Canada, the European Union, the United Kingdom and others get their populations vaccinated, there will be significant volumes of vaccines that have been bought by these countries that can be distributed to other countries in the last months of 2021 and in 2022.

Some of these efforts may be undertaken in consultation or conjunction with COVAX.

Conclusion

COVAX is an important effort at facilitating vaccinating large parts of the world against the COVID-19 pandemic, including many low- and middle-income countries. Many countries and the EU have led efforts in 2020 to increase funding for the effort. With the Biden Administration rejoining the World Health Organization and reengaging with multilateral organizations, and with the support of the U.S. Congress in funding U.S. contributions to COVAX, this Thursday’s event co-hosted by the United States and Gavi is an important chance to help COVAX receive the additional funding needed for its 2021 objectives.

Because the pandemic continues to be problematic around the world, there are many moving parts to a successful global vaccination effort including availability of vaccines, efficacy of vaccines including against new variants, ability to overcome vaccine hesitancy among portions of the population in many countries and the evolving understanding of human reactions to some of the vaccines available.

Greater cooperation among health administrators and the WHO would seem important to ensure that safe vaccines are not derailed because of discovered risks where the balance of benefits to risks strongly supports continued availability and use of the vaccines (with appropriate warnings). Where restrictions are appropriate, greater cooperation would permit a common approach versus differing restrictions which can only serve to cause confusion to the public and encourage vaccine hesitancy. COVID-19 reported cases globally are presently 137 million with deaths approaching 3 million. Vaccination doses administered globally are 806 million with serious adverse reactions and deaths quite limited (likely in the thousands globally). Serious adverse reactions and deaths if tied to vaccines are obviously a concern that should be addressed appropriately. However, eliminating vaccine availability to large portions of populations where there are not other options available risk far greater damage.

COVAX delivers COVID-19 vaccines to 100th country; India surge in infections likely to reduce product availability for COVAX through May and likely longer

Terence P. Stewart · April 8, 2021 · COVID-19 vaccinations · CEPI, COVAX, GAVI, IMF, India, Serum Institute of India, UNICEF, WHO, World Bank, WTO · No Comments

Apress release from the WHO, Gavi, CEPI and UNICEF on the COVAX facility’s success in getting vaccines to 100 countries by April 8 is impressive news for the efforts of the WHO, GAVI, CEPI, UNICEF and their supporters to get vaccines to low- and middle-income countries as part of the effort to have vaccine distribution done equitably and affordably. See Press Relase from WHO, Gavi, CEPI, UNICEF, COVAX reaches over 100 economies, 42 days after first international delivery, April 8, 2021, https://www.gavi.org/news/media-room/covax-reaches-over-100-economies-42-days-after-first-international-delivery#:~:text=The%20milestone%20comes%2042%20days,Ghana%20on%20February%2024th.&text=Of%20the%20over%20100%20economies,Advance%20Market%20Commitment%20(AMC). The press release is embedded below.

PDF Embedder requires a url attribute COVAX-reaches-over-100-economies-42-days-after-first-international-delivery-_-Gavi-the-Vaccine-Alliance

While the release indicates that there will be delays in deliveries of vaccines in March and April because of increased COVID-19 cases in India, developments in India could mean an even greater delay in supplies than announced in March. For example, the major supplier of vaccines to COVAX in the first half of 2021 is the Serum Institute of India (“SII”) which is licensed by AstraZeneca to produce that vaccine in India for distribution in large part to COVAX. Yesterday, the president of SII indicated that export shipments could resume in June depending on cases levels in India. See Financial Times, India to restart Covid vaccine exports in June if local cases fall, April 7, 2021, https://www.ft.com/content/fcdffb8f-f86e-4bd9-adec-20256aeb0a07. It doesn’t appear that SII has notified COVAX of a further delay past April, but a June resumption, if it occurs, suggests that delays will continue through May at a minimum.

The situation for SII is complicated by a need for expanded capacity. It has sought $400 million from the Indian government to ramp up production from 71 million to 100 million doses per month by May. See Fierce Pharma, ‘Very stressed’ Serum Institute asks government for $400M vaccine production boost, April 8, 2021, https://www.fiercepharma.com/manufacturing/very-stressed-serum-institute-india-asks-government-for-vaccine-production-boost.

Moreover, the refusal of SII to export doses to the United Kingdom, to COFAX and others has become the basis for a legal notice from AstraZeneca. See Times of India, Covid-19: AstraZeneca sends legal notice to SII over delays in vaccine supply, April 8, 2021, https://timesofindia.indiatimes.com/india/astrazeneca-sends-legal-notice-to-sii-over-delays-in-vaccine-supply/articleshow/81960902.cms. SII is also finding itself refunding moneys paid by countries who are not getting supplies. See Reuters, Serum Institute refunds S. Africa for undelivered AstraZeneca doses, April 8, 2021, https://www.reuters.com/article/us-health-coronavirus-safrica/serum-institute-refunds-south-africa-for-undelivered-astrazeneca-doses-idUSKBN2BV1TI.

While COVAX is looking to expand sources of vaccines, SII is the major source through June. Professor Simon Evenett has put out a one page analysis of the implications for supply to COVAX from SII if the resumption of exports is premised on India fully vaccinating all those willing to be vaccinated for whom the government of India has opened up vaccinations. While SII has not stated that resumption of exports is tied to full vaccination of Indians who are 45 years or older, Prof. Evenett’s paper is an interesting analysis of how long a delay could occur in terms of SII becoming a major exporter again. His paper entitled “Vaccine Maths 2: Will India start exporting COVID-19 vaccines again in June 2021?” is embedded below.

Vaccine_Maths_2.pd_

Conclusion

With the spread of the new variants of COVID-19 that have higher rates of transmission and higher rates of serious infection, many countries find themselves facing increased numbers of cases and increased hospitalizations and deaths even as vaccine supplies are increasing and vaccination roll outs starting in many countries. There is a lot of attention within multilateral organizations such as the World Bank, IMF and WTO and by a number of countries on the needs for increased production and distribution to all countries. See, e.g., April 6, 2021, IMF April World Economic Outlook, IMF and World Bank Spring Meetings and U.S. efforts on global access to vaccines, https://currentthoughtsontrade.com/2021/04/06/imf-april-world-economic-outlook-imf-and-world-bank-spring-meetings-and-u-s-efforts-on-global-access-to-vaccines/. COVAX is an important part of the solution but it will need more funding and greater diversity of suppliers to meets its role in the equitable and affordable access to vaccines in 2021 and 2022.

Global vaccinations against COVID-19; developments and challenges in the roll-out for many countries

Terence P. Stewart · April 2, 2021 · Uncategorized · CEPI, COVAX, GAVI, India, Serum Institute of India, UNICEF, United States, World Health Organization, World Trade Organization · No Comments

Globally there have been extraordinary developments of vaccines to help against the COVID-19 vaccine. UNICEF has set up a COVID-19 Vaccine Market Dashboard which notes that at present 14 vaccines have been approved by one or more countries, that the companies in production or testing vaccines report existing or intended capacity in 2021 of 21 billion doses (depends on other vaccines being approved and companies overcoming any bottlenecks in supply), indicates that there are 10.4 billion “secured vaccine doses”, that there are 3.56 billion doses “secured and optioned for the COVAX facility” and that prices in the market range from $2.06/dose to $44.00/dose. See UNICEF, COVID-19 Vaccine Market Dashboard, https://www.unicef.org/supply/covid-19-vaccine-market-dashboard (visited April 2, 2021). The dashboard contains a great deal of information looking at information on products, capacity, agreements, price and delivery.

The COVAX facility, administered by Gavi, put out in early March the first round of allocation of vaccine doses procured for low- and middle-income countries and others choosing to participate in acquiring through COVAX to improve equitable and affordable access for all. 142 of the countries participating in the COVAX facility were identified as allocated delivery of specific quantities of vaccine from a total of 237 million doses that were expected to be available to COVAX during the February – May timeline. See The COVAX Facility, First Round of Allocation: Astra Zeneca/Oxford Vaccine (manufactured by Astra Zeneca & licensed and manufactured by Serum Institute of India), https://www.gavi.org/sites/default/files/covid/covax/COVAX-First-round-allocation-of-AZ-and-SII.pdf . 87 of the 92 countries who will receive doses at no cost or reduced cost are included in the first round allocation (“AMC” countries). The March 2, 2021 document is embedded below.

COVAX-First-round-allocation-of-AZ-and-SII

In an April 1, 2021 update, Gavi notes that to date COVAX has shipped more than 33 million doses to 74 country. See GAVI, COVAX vaccine roll-out, https://www.gavi.org/covax-facility (visited April 2, 2021). While the ramp-up of deliveries to COVAX is scheduled to occur over time, COVAX received notice in late March of delays for shipments from India (Serum Institute of India) in both March and April, which COVAX has estimated could be a delay for as much as 90 million doses and indicated the delays were due to internal needs in India for more doses to support their own vaccination program. See UNICEF, COVAX updates participants on delivery delays for vaccines from Serum Institute of India (SII) and AstraZeneca, 25 March 2021,https://www.unicef.org/press-releases/covax-updates-participants-delivery-delays-vaccines-serum-institute-india-sii-and. The bulk of the press release is copied below.

“GENEVA/NEW YORK/OSLO, 25 March 2021 – Deliveries of COVID-19 vaccines produced by the Serum Institute of India (SII) to lower-income economies participating in the COVAX Facility will face delays during March and April as the Government of India battles a new wave of COVID-19 infections. COVAX and the Government of India remain in discussions to ensure some supplies are completed during March and April.

“According to the agreement between Gavi and the Serum Institute of India (SII), which included funding to support an increase in manufacturing capacity, SII is contracted to provide COVAX with the SII-licensed and manufactured AstraZeneca (AZ)-Oxford vaccine (known as COVISHIELD) to 64 lower-income economies participating in the Gavi COVAX AMC (including India), alongside its commitments to the Government of India.

“To date, COVAX has been supplied with 28 million COVISHIELD doses and was expecting an additional 40 million doses to be available in March, and up to 50 million doses in April.

“COVAX has notified all affected economies of potential delays. SII has pledged that, alongside supplying India, it will prioritize the COVAX multilateral solution for equitable distribution.

“Participating economies have also received WHO guidance on optimizing the national deployment doses of the AstraZeneca-Oxford vaccine in a constrained supply environment.

“Separately, the COVAX Facility has informed participants allocated AstraZeneca-manufactured doses of the AstraZeneca-Oxford vaccine that some of the first deliveries due in March are now set to take place in April.

“In this early phase of COVID-19 vaccine roll-out, vaccine manufacturers require time to scale and optimize their production processes. AstraZeneca, which uses a novel supply chain network with sites across multiple continents, is working to enable initial supply to 82 countries through COVAX in the coming weeks.

“COVAX retains its objective of supplying initial doses of vaccines to all participating economies in the first half of the year before ramping up significantly in the second half of 2021. To date, COVAX has shipped vaccines to over 50 countries and economies.”

While there have been various manufacturing challenges in the early months of vaccine roll-outs, the decision by India to slow distribution of vaccine doses purchased by COVAX will clearly slow distribution to many least developed and developing countries dependent on COVAX for their vaccine doses. Since as much as a third of vaccine doses that COVAX has distributed have gone to India, the Indian government has what is at least a public relations challenge at the present time. See India Today, India received one-third of vaccines made for poor countries by India under COVAX programme: Report, 30 March 2021, https://www.indiatoday.in/coronavirus-outbreak/vaccine-updates/story/india-received-one-third-of-vaccines-made-for-poor-countries-by-india-under-covax-programme-report-1785242-2021-03-30. However, with a number of variants of the virus circulating widely and with infections increasing in many countries around the world, the delays are of concern to many governments with anxious populations looking for a path past the pandemic.

In a paper from Airfinity and the St. Gallen Endowment for Prosperity through Trade on March 31, 2021, an effort is made to look at the likely damage to low income countries from the announced delays in shipments to COVAX. See Simon J. Evenett and Matt Linley, Halting India’s Vaccine Exports: The Fallout, 31 March 2021. The paper estimates that the delays in shipments will push back achieving even minimum vaccinations by 60-90 days for many of the COVAX recipient countries. The paper is embedded below.

AF-SGEPT-TL1-31-March-2021-finalised

While there is a lot of positive news being reported (e.g., expansion of capacities and expected shipments in 2021, effectiveness of some of the existing vaccines against some of the new variants, agreement between the United States, Japan, India and Australia to generate one billion doses of a vaccine in India for distribution in the Indo-Pacific area in 2021 and 2022, and the United States hosting a funding effort for COVAX later in April to help close the funding needs for 2021 (after the U.S.’s $4 billion contribution)), delays for up to 90 million doses ( 37.97% of the total doses expected in the February – May 2021 time period by COVAX) to those dependent on COVAX is a significant challenge. See, e.g., Gavi, United States to host launch event for Gavi COVAX AMC 2021 investment opportunity, 29 March 2021, https://www.gavi.org/news/media-room/united-states-host-launch-event-gavi-covax-amc-2021-investment-opportunity; March 25, 2021, Global vaccinations for COVID-19 — continued supply chain and production issues and a new wave of infections in many countries delay greater ramp up for some until late in the second quarter of 2021, https://currentthoughtsontrade.com/2021/03/25/global-vaccinations-for-covid-19-continued-supply-chain-and-production-issues-and-a-new-wave-of-infections-in-many-countries-delay-greater-ramp-up-for-some-until-late-in-the-second-quarter-of-2021/; March 12, 2021, COVID-19 vaccines – U.S., Japan, India and Australia agree to one billion doses for Indo-Pacific countries, https://currentthoughtsontrade.com/2021/03/12/covid-19-vaccines-u-s-japan-india-and-australia-agree-to-one-billion-doses-for-indo-pacific-countries/; March 12, 2021, The 8-9 March “Global C19 Vaccine Supply Chain and Manufacturing Summit” – efforts to ramp-up production, https://currentthoughtsontrade.com/2021/03/12/the-8-9-march-global-c19-vaccine-supply-chain-and-manufacturing-summit-efforts-to-ramp-up-production/.

The WTO Director-General Ngozi Okonjo-Iweala is planning a meeting on vaccines later in April that was described in a WTO press release as follows.

“DG Okonjo-Iweala also said that she plans to convene an event in mid-April to discuss ramping up COVID-19 vaccine production and how the WTO can contribute to a more rapid and equitable distribution of vaccines.

“The event, to be held under Chatham House rules, will include all regional member groups, representatives from vaccine manufacturers from developing and developed countries, civil society groups working on access to medicine, and other relevant stakeholders.

“’The idea is to move us along on our quest to solve this unacceptable inequitable access of poor countries to vaccines,’ she said. ‘At the bottom of this is a very serious scarcity in supply. And how to solve it is to look at how we expand manufacturing in all its ways.’

“She stressed that the event would help advance global discussions on access to vaccines. She expressed hope both for increased vaccine manufacturing in the short- to medium-term, and a longer-term framework agreement that would provide for automatic access to vaccines and other medical products for developing countries in future health crises, including a way forward on the TRIPS waiver proposal many of them support.

“’We also need to look to the future and agree a framework where countries do not need to stand in the queue in order to get access to life-saving vaccines, therapeutics, and diagnostics,’ she said, emphasizing that this can be done while still incentivizing research and development.”

WTO, Director-General urges WTO members to deliver concrete results this year, 30 March 2021, https://www.wto.org/english/news_e/news21_e/dgno_30mar21_e.htm.

Conclusion

Governments are understandably focused on trying to end the pandemic at home as a first priority. The efforts of the WHO, Gavi, CEPI and UNICEF through the COVAX facility in recent years has provided a welcome source of hope for many nations for greater equity in distribution and in affordability of vaccines, including in the last year addressing the enormous challenge presented by the COVID-19 pandemic. Many countries and private groups have stepped up with major funding contributions to make vaccine available. Individual governments are also working to increase supplies globally. Many bottlenecks have arisen with the large number of inputs and the enormous increase in demand that has arisen over the last year. There is a need for continued efforts by governments and businesses to address the challenges and to see that the needs of the low- and middle-income countries can be met in a timely manner as well. While there will be a lot more production in the second half of 2021, there are and will continue to be challenges in the second quarter. Focus on identifying challenges and global cooperation to solve bottlenecks will do a lot to ensure greater global success in the remainder of 2021.

COVID-19 vaccines — U.S., Japan, India and Australia agree to one billion doses for Indo-Pacific countries

Terence P. Stewart · March 12, 2021 · Uncategorized · Australia, COVAX, India, Japan, United States, WHO · No Comments

In a post earlier today, I reviewed a Chatham House event which looked at issues surrounding ramping-up production, dealing with supply chain issues and other matters affecting production and distribution of COVID-19 vaccines. See March 12, 2021, The 8-9 March “Global C19 Vaccine Supply Chain and Manufacturing Summit” – efforts to ramp-up production, https://currentthoughtsontrade.com/2021/03/12/the-8-9-march-global-c19-vaccine-supply-chain-and-manufacturing-summit-efforts-to-ramp-up-production/

Today, the U.S., Japan, India and Australia held a head of government remote Quad meeting. One of the outcomes being reported in the press was agreement that the United States and Japan would pay for, India would produce and Australia would distribute one billion doses of COVID vaccine for the Indo-Pacific region. See Financial Times, US and Asia allies launch major vaccine drive to counter China, The 1bn Covid jabs will be funded by US and Japan, made in India and distributed by Australia, March 12, 2021, https://www.ft.com/content/bcf5ff42-ac7f-4533-8fc2-b3e50a5e13ba.

The White House fact sheet on the quad meeting is available on the White House webpage. The portion dealing with the COVID-19 vaccines is copied below. See White House, Fact Sheet: Quad Summit, March 12, 2021, https://www.whitehouse.gov/briefing-room/statements-releases/2021/03/12/fact-sheet-quad-summit/. The one billion doses will be made available in 2021 and will be done in consultation with WHO, COVAX and others.

“The Quad Vaccine Partnership

“While ensuring that vaccines have been made available to our people, “Quad” partners will launch a landmark partnership to further accelerate the end of the COVID-19 pandemic. Together, Quad leaders are taking shared action necessary to expand safe and effective COVID-19 vaccine manufacturing in 2021, and will work together to strengthen and assist countries in the Indo-Pacific with vaccination, in close coordination with the existing relevant multilateral mechanisms including WHO and COVAX.

“o Drawing on each of our strengths, we will tackle this complex issue with multi-sectoral cooperation across many stages of action, starting with ensuring global availability of safe and effective vaccines.

“o Quad partners are working collaboratively to achieve expanded manufacturing of safe and effective COVID-19 vaccines at facilities in India, prioritizing increased capacity for vaccines authorized by Stringent Regulatory Authorities (SRA). Quad partners will address financing and logistical demands for production, procurement, and delivery of safe and effective vaccines. Quad partners will work to use our shared tools and expertise, through mechanisms at institutions including the United States Development Finance Corporation (DFC), Japan International Cooperation Agency (JICA), and, as appropriate, Japan Bank of International Cooperation (JBIC), as well as others.

“o The United States, through the DFC, will work with Biological E Ltd., to finance increased capacity to support Biological E’s effort to produce at least 1 billion doses of COVID-19 vaccines by the end of 2022 with Stringent Regulatory Authorization (SRA) and/or World Health Organization (WHO) Emergency Use Listing (EUL), including the Johnson & Johnson vaccine.

“o Japan, through JICA, is in discussions to provide concessional yen loans for the Government of India to expand manufacturing for COVID-19 vaccines for export, with a priority on producing vaccines that have received authorization from WHO Emergency Use Listing (EUL) or Stringent Regulatory Authorities.

“o Quad partners will ensure expanded manufacturing will be exported for global benefit, to be procured through key multilateral initiatives, such as COVAX, that provide life-saving vaccines for low-income countries, and by countries in need.

“o Quad partners will also cooperate to strengthen ‘last-mile’ vaccination, building on existing health-security and development programs, and across our governments to coordinate and strengthen our programs in the Indo-Pacific.

“o This includes supporting countries with vaccine readiness and delivery, vaccine procurement, health workforce preparedness, responses to vaccine misinformation, community engagement, immunization capacity, and more.

“o Australia will contribute US$77 million for the provision of vaccines and “last-mile” delivery support with a focus on Southeast Asia, in addition to its existing commitment of US$407 million for regional vaccine access and health security which will provide full vaccine coverage to nine Pacific Island countries and Timor-Leste, and support procurement, prepare for vaccine delivery, and strengthen health systems in Southeast Asia.

“o Japan will assist vaccination programs of developing countries such as the purchase of vaccines and cold-chain support including through provision of grant aid of $41 million and new concessional yen loans, ensuring alignment with and support of COVAX.

“o The United States will leverage existing programs to further boost vaccination capability, drawing on at least $100 million in regional efforts focused on immunization.”

Conclusion

The solution to the COVID-19 pandemic involves greater cooperation among governments, international organizations, manufacturers, suppliers and others. The Quad’s announcement today is an important step in helping bring the pandemic to a close.

The EU’s response to challenges to its actions on COVID-19 vaccine exports

Terence P. Stewart · March 4, 2021 · COVID-19, EU COVID-19 vaccine export authorization, TRIPS waiver proposal from India and South Africa · AstraZeneca, Bayer, CEPI, COVAX, CureVac, Director-General Ngozi Okonjo-Iweala, EU Ambassador João Aguiar Machado, GAVI, India, Johnson & Johnson, Mabion, Moderna, Novartis, Novavax, Pfizer/BioNTech, South Africa, U.S. Chamber of Commerce, UNICEF, WHO · No Comments

At the WTO General Council meeting held on March 1-2 this week, agenda item 9 was aimed at the European Union. The agenda item, entitled “Call to Prevent Export Restrictions on COVID-19,” was put on the agenda by Colombia, Costa Rica, Ecuador, Panama and Paraguay. I had reviewed this agenda item as one of 16 agenda items that was likely to draw a fair amount of attention. See February 26, 2021, WTO Director-General Ngozi Okonjo-Iweala’s first week on the job starts with a two day General Council meeting, https://currentthoughtsontrade.com/2021/02/26/wto-director-general-ngozi-okonjo-iwealas-first-week-on-the-job-starts-with-a-two-day-general-council-meeting/ (Agenda item 9 was added by Colombia, Costa Rica, Ecuador, Panama and Paraguay reflecting concerns by them (and presumably many other trading partners) about actions taken by the European Union to exert control over exports of vaccines from the EU in light of EU concerns about its own access to vaccines from manufacturers. See CALL TO PREVENT EXPORT RESTRICTIONS ON COVID-19 VACCINES, WT/GC/818 (18 February 2021)).

The new Director-General, Ngozi Okonjo-Iweala, has stressed the importance of the WTO doing more to address the COVID-19 pandemic and help Members recover. Equitable and affordable access to vaccines is an issue of importance to the membership and stressed by the Director-General. See, e.g., March 3, 2021, WTO Director-General opinion piece in the Financial Times and recent actions by the U.S., https://currentthoughtsontrade.com/2021/03/03/wto-director-general-opinion-piece-in-the-financial-times-and-recent-actions-by-the-u-s/; March 1, 2021, WTO Director-General Ngozi Okonjo-Iweala’s opening statement at the March 1 General Council meeting, https://currentthoughtsontrade.com/2021/03/01/wto-director-general-ngozi-okonjo-iwealas-opening-statement-at-the-march-1-general-council-meeting/

While the EU Ambassador provided comments on various agenda items, agenda item 9 was obviously one of importance to the EU. See EU Statement at the General Council of 2 March 2021 on the “Call to Prevent Export Restrictions on Covid-19Vaccines,” 02 March 2021, https://eeas.europa.eu/delegations/world-trade-organization-wto/94083/eu-statement-general-council-2-march-2021-%E2%80%9Ccall-prevent-export-restrictions-covid-19-vaccines%E2%80%9D_en. EU Ambassador João Aguiar Machado provided a detailed justification for the EU actions in imposing an export licensing/authorization regime on COVID-19 vaccines claiming lack of transparency by pharmaceutical companies and the need to ensure “fair” distribution. The EU program does not affect vaccines for COVAX low- and middle-income countries nor for various neighboring countries. Of note, for countries covered by the export licensing/authorization scheme, there have been 150 export requests all of which have been granted. The statement is embedded below.

EU-Statement-at-the-General-Council-of-2-March-2021-on-the-Call-to-Prevent-Export-Restrictions-on-Covid-19-Vaccines-–-02-March-2021-European-External-Action-Service

The EU stressed that the major problem facing the world was global capacity far below global demand. The EU is working to identify production bottlenecks and to encourage producers to license their products to maximize global production and expressed a willingness to work with other WTO Members and with the Director-General. The part of the statement covering the demand/supply imbalance is copied below.

“However, the root causes of the problem lie elsewhere: the exploding global demand is well above the global production today. As long as this global industrial challenge is not met, and the world population is not vaccinated quickly enough, we will all face a risk of a continuing health emergency including new Covid-19 variants and a prolonged economic crisis.

“The European Union believes there is an important role for public authorities to play and to drive the increase of production, and to facilitate access to the vaccines and other treatments that are in need today. Cooperation must be promoted amongst the different participants along the value chains where necessary to enhance production capacities. A closer, more integrated and more strategic public-private cooperation with the industry is needed. In this spirit, the EU has set-up a Task Force for Industrial Scale-up of COVID-19 vaccines to detect and help respond to issues in real-time. In order to ramp up production, we will, amongst others, work closely with manufacturers to help monitor supply chains and address identified production bottlenecks. Since EU vaccine production is critical for global supply, the benefits of this initiative will extend beyond the EU’s borders.

“Scaling-up of production on a global level requires further actions. It will not happen without increased global collaboration with the pharmaceutical industry, which should facilitate the transfer of the right know-how and technology for the highly complex vaccine production process. We should facilitate this collaboration, while also recognising that intellectual property provides the necessary platform for it to take place. Waiving intellectual property rights would disrupt this collaboration and the transfer of know-how. In conclusion, Mr Chairman, we believe it is legitimate to engage the sector in order to ensure that all complementary production facilities across companies and continents are actively contributing to ramp up production. Companies that have tried and failed to develop a vaccine of their own, for example, should actively consider making their facilities available for the production of vaccines of successful companies. Companies with new vaccines should consider whether they have checked all options for licensing agreements to increase production. The objective should be to ensure they enter into licence agreements with companies around the world that have the necessary production capacities and could export the vaccines to any low middle-income countries without production capacities. At the same time, we should be mindful that the manufacturing campaigns for covid-19 vaccines do not crowd out the production of other life-saving vaccines and therapeutics.

“The EU, working together with other WTO Members and under the leadership of the Director-General Dr. Ngozi Okonjo-Iweala is ready to facilitate a dialogue between the vaccine developers and companies with the production facilities that are ready to step in to help out with the production of vaccines and their delivery to the countries in need. We welcome the DG’s proposal to focus on collaboration among companies to enhance licensing in order to use all the adequate manufacturing capacity, including in developing countries. The EU is ready to facilitate this dialogue and contribute to the efforts on expanding these partnerships.

“The EU remains open to a dialogue with all WTO Members on how to facilitate the collaboration with the pharmaceutical industry on the transfer of know-how and technology. In the same manner, the EU remains open to a dialogue on how to facilitate the use of the TRIPS flexibilities, should the voluntary solutions fail or not be available. The flexibilities offered by the TRIPs Agreement are absolutely legitimate tools for Members in need, as many are in the midst of this pandemic. This includes fast track compulsory licences for export to countries without manufacturing capacity. Administrative burdens should not stand in the way of manufacturing and delivering vaccines to where they are needed.

“We believe that a successful contribution of the WTO to the current pandemic will require all WTO Members to agree on actions that will not only encompass the elements enshrined in the Ottawa Group’s proposal on Trade and Health, such as export restrictions or transparency, but also address the problem of insufficient manufacturing capacity. The EU stands ready to engage in such a dialogue.”

In my post yesterday, I reviewed some of the efforts that have already occurred where pharmaceutical companies are working with other companies to expand production and availability worldwide. See March 3, 2021: WTO Director-General opinion piece in the Financial Times and recent actions by the U.S., https://currentthoughtsontrade.com/2021/03/03/wto-director-general-opinion-piece-in-the-financial-times-and-recent-actions-by-the-u-s/. But the articles referenced yesterday are just some of the collaborations going on as manufacturers with existing capacity work with companies with COVID-19 vaccines to help expand capacity and production and vaccine manufacturers work with contract producers to expand supply chain capabilities. An additional cooperation agreement was announced today in the press. In addition, some governments, including the U.S. and EU have also worked with manufacturers to ramp up production. See, e.g., Wall Street Journal, Novartis to Help Make CureVac Covid-19 Vaccine, March 4, 2021, https://www.wsj.com/articles/novartis-to-help-make-curevac-covid-19-vaccine-11614859271; Reuters, Poland strikes deal to produce Novavax COVID-19 vaccine, March 3, 2021, https://www.reuters.com/article/us-health-coronavirus-poland-mabion/poland-strikes-deal-to-produce-novavax-covid-19-vaccine-idUSKBN2AV19O (“Polish biotech firm Mabion has signed a preliminary agreement to manufacture Novavax’s COVID-19 vaccine with financial support from a state-run fund, as the government strives to accelerate its vaccination programme.”); PMLive, Novartis, Bayer announce separate agreements to bolster COVID-19 vaccine manufacturing, February 1, 2021, http://www.pmlive.com/pharma_news/novartis,_bayer_announce_separate_agreements_to_bolster_covid-19_vaccine_manufacturing_1362454#:~:text=Novartis%20and%20Bayer%20have%20announced,vaccine%20and%20CureVac’s%20vaccine%2C%20respectively.&text=Novartis%20will%20aim%20to%20begin,its%20site%20in%20Stein%2C%20Switzerland (“Novartis and Bayer have announced separate agreements to aid the manufacturing of Pfizer/BioNTech’s COVID-19 vaccine and CureVac’s vaccine, respectively.”); Pharmaceutical Technology, Pharmaceutical Technology-02-01-2021, Volume 2021
Supplement, Issue 1, Contract Service Tapped to Produce COVID-19 Vaccines, Page Number: s29-s30, https://www.pharmtech.com/view/contract-service-tapped-to-produce-covid-19-vaccines (reviewing actions by Pfizer/BioNTech, Moderna, Johnson & Johnson, AstraZeneca, Novavax). Expanding supply also requires vaccines being approved by governments for use. The EU recently announced it was beginning review of the Russian vaccine Sputnik V. See The Globe and Mail, Europe starts review of Russia’s Sputnik V vaccine to try to overcome shortages as new variants appear, March 4, 2021, https://www.theglobeandmail.com/world/article-europe-starts-review-of-russias-sputnik-v-vaccine-to-try-to-overcome/. And, of course, major producers are expanding where they are producing their vaccines using existing or new facilities. See, e.g., The Globe and Mail, Novavax publishes COVID-19 vaccine contract with Canada, March 4, 2021, https://www.theglobeandmail.com/canada/article-novavax-publishes-covid-19-vaccine-contract-with-canada/ (“American pharmaceutical company Novavax has published its vaccine agreement with Canada for 52 million doses of its COVID-19 vaccine. The company expects to eventually produce some of the vaccine in Canada.”).

Thus, a great deal is going on to expand production capacity globally. Strong intellectual property laws are critical to the developments and resource commitments being made. While many developing countries are pushing to start a process of text drafting for a TRIPS waiver at the WTO, such an effort would be counterproductive to global health needs over the longer term. Washington Trade Daily’s March 2, 2021 edition at pages 5-7 has an article entitled “Call for TRIPS Waiver Negotiations” which presents the views of largely developing countries on the desire to move to negotiating text even though there is not agreement on the proposed waiver. See Washington Trade Daily, March 2, 2021, https://files.constantcontact.com/ef5f8ffe501/ed93e180-7dee-4beb-8629-0e73d4d0ea5c.pdf.

The U.S. Chamber of Commerce released a statement on March 2nd characterizing the effort for a TRIPS waiver being promoted by India, South Africa and others as “misguided”. See U.S. Chamber, U.S. Chamber Statement on Proposed WTO IP Rights Waiver, March 2, 2021, https://www.uschamber.com/press-release/us-chamber-statement-proposed-wto-ip-rights-waiver. The statement is copied below (emphasis added to the third paragraph).

“WASHINGTON, D.C. – The U.S. Chamber of Commerce’s Global Innovation Policy Center (GIPC) issued the following statement from Senior Vice President Patrick Kilbride regarding the World Trade Organization (WTO) General Council’s discussion of a proposed waiver of intellectual property (IP) commitments in the Trade Related Aspects of Intellectual Property Rights (TRIPS) Agreement.

“‘Vaccine distribution is critical for ending the pandemic and reviving the global economy. The U.S. Chamber of Commerce welcomes the WTO General Council’s discussion of the role of intellectual property rights in defeating the COVID-19 pandemic. During this time, transparent and predictable intellectual property rights have formed the legal and economic basis for an unprecedented level of highly successful collaborations between government, industry, academia and NGOs.

“‘The Chamber supports decisive and bold action to remove regulatory and trade barriers in order to boost the global distribution of treatments and vaccines, including support of global vaccine programs such as COVAX. Proposals to waive intellectual property rights are misguided and a distraction from the real work of reinforcing supply chains and assisting countries to procure, distribute and administer vaccines to billions of the world’s citizens. Diminishing intellectual property rights would make it more difficult to quickly develop and distribute vaccines or treatments in the future pandemics the world will face.

“’The ‘3rd Way’ proposed by incoming WTO Director General Ngozi Okonjo-Iweala to encourage licensing agreements is worthy of further discussion and consistent with the ongoing success of government-industry efforts to bring an end to COVID-19 as rapidly and as safely as possible.’”

Conclusion

While there has been a lot of concern among trading partners about the EU action in imposing export licensing of COVID-19 vaccines, to date the licensing system does not appear to have caused problems in fact in the distribution of doses ordered by the group of countries covered by the new system. Moreover, with or without government encouragement, vaccine producers have been working to expand production through arrangements with other vaccine producers, through working with contract manufacturers, and by expanding facilities and internal capacities.

There is no doubt that the COVID-19 pandemic presents a once in a century global health pandemic with demand at the beginning far outstripping supply. Governments have a role to play working with producers, suppliers, those involved in distribution and applying the vaccines to address bottlenecks, to provide encouragement and incentives to rapidly expand production and to support the efforts of the WHO, GAVI, CEPI, and UNICEF to fund the needs of COVAX. While concerns in the early days of vaccine rollout are understandable, COVAX has contracts with a number of vaccine producers and others under negotiation or awaiting approval. AstraZeneca, the first vaccine producer with a contract to supply COVAX put out a press release on March 2, 2021 which is copied in part below. See AstraZeneca, AstraZeneca advances mass global rollout of COVID-19 vaccine through COVAX, March 2, 2021, https://www.astrazeneca.com/media-centre/press-releases/2021/astrazeneca-advances-mass-global-rollout-of-covid-19-vaccine-through-covax.html.

“Supply to 142 countries underway as part of the unprecedented effort to bring
broad and equitable access to the vaccine

“AstraZeneca with its partner Serum Institute of India
will be the biggest initial supplier to COVAX

“The first of many millions of doses of AstraZeneca’s COVID-19 vaccine have begun arriving in low and middle-income countries across the world through the multilateral COVAX initiative, the first steps in fulfilling the Company’s efforts to provide broad and equitable access to the vaccine.

“First COVAX shipments were dispatched late last week to Ghana and Cote D’Ivoire, and more are due to begin arriving this week in countries including the Philippines, Indonesia, Fiji, Mongolia and Moldova. This supply represents the first COVID-19 vaccine for many of these countries.

“Further shipments will arrive in the coming weeks with the aim of supplying a total of 142 countries with hundreds of millions of doses of the vaccine in the coming months. The majority of these doses, manufactured by AstraZeneca and its licence partner Serum Institute of India, will go to low and middle-income countries.

“Pascal Soriot, Chief Executive Officer, Astra Zeneca, said: ‘These first steps towards fulfilling our broad, equitable and no-profit emergency response to the pandemic mean millions of people, irrespective of their country’s income level, will soon be protected against this deadly virus. This is a moment of great pride for us at AstraZeneca and I am extremely grateful to our partners including Gavi, CEPI and Oxford University for their hard work and dedication in order to make this humanitarian ideal a reality for many millions of people around the world.’

“Seth Berkley, Chief Executive Officer, Gavi, said: ‘Global, equitable access to COVID-19 vaccines is only possible when the public and private sectors work together. When we launched the Gavi COVAX Advance Market Commitment in June 2020, our first Agreement was with AstraZeneca. Nine months later, the first doses are already being delivered to those that need them most. This is the beginning of COVAX’s effort to end the acute phase of the pandemic, not the end, but we can all take strength from this moment and I thank AstraZeneca and the University of Oxford for their support and partnership at every step of our journey.’

“Vaccine shipments have been allocated according to the COVAX Allocation Framework which determines volume per participating country based on a number of factors, including country readiness, national regulatory authorisations and national vaccination plans in place. The supply through COVAX follows the recent Emergency Use Listing by the World Health Organization (WHO) for active immunisation in individuals 18 years of age and older, which provides a vital and accelerated pathway to enable supply.

“AstraZeneca was the first global pharmaceutical company to join COVAX in June 2020 in line with the Company’s shared commitment to global, equitable access to vaccines.

“The vaccine can be stored, transported and handled at normal refrigerated conditions (2-8 degrees Celsius/36-46 degrees Fahrenheit) for at least six months and administered within existing healthcare settings.”

The “third way” sought by the WTO Director-General has been underway for some time and is picking up speed as vaccines start to be approved. There are an increasing number of announced agreements among producers to work together to expand production of particular vaccines. Thus, collaboration and cooperation among producers has and is occurring. Governments can help by identifying bottlenecks in all areas relevant to raw materials, intermediate products, finished vaccine doses, distribution and resources to apply the vaccines and helping to resolve the bottlenecks; by encouraging increased ramp ups of capacity and production, including through licensing.

A broad waiver of TRIPS obligations as being pursued by India, South Africa and many other developing and least developed countries is unwise, unlikely to be agreed to, and if implemented, will backfire in terms of global cooperation in getting the world’s population vaccinated and will destroy the likelihood of private sector engagement to solve future pandemics. The EU’s approach as laid out in EU Ambassador João Aguiar Machado’s statement on March 2 is likely the best course forward whether through the WTO or otherwise.

WTO Director-General opinion piece in the Financial Times and recent actions by the U.S.

Terence P. Stewart · March 3, 2021 · COVID-19, Director-General Ngozi Okonjo-Iweala · AstraZeneca, CEPI, China, COVAX, GAVI, GSK, India, Johnson & Johnson, Merck, Pfizeer/BioNTech, Russia, Sanofi, United States, WHO · No Comments

WTO Director-General Ngozi Okonjo-Iweala on her second day on the job in Geneva had an opinion piece in the Financial Times taking to the public her message to the WTO membership that “WTO members must intensify co-operation”. Financial Times, Opinion, Ngozi Okonjo-Iweala: WTO members must intensify co-operation, March 2, 2021, https://www.ft.com/content/0654600f-92cc-47ad-bfe6-561db88f7019. To a large extent, the opinion piece reflects her opening statement to the General Council on March 1st. See March 1, 2021, WTO Director-General Ngozi Okonjo-Iweala’s opening statement at the March 1 General Council meeting, https://currentthoughtsontrade.com/2021/03/01/wto-director-general-ngozi-okonjo-iwealas-opening-statement-at-the-march-1-general-council-meeting/. The opinion piece starts with the challenges posed by the COVID-19 pandemic and the need for equitable and affordable access to vaccines and other medical goods. The Director-General (DG) then goes through the reforms and ongoing negotiations that need to be addressed. The topics include completion of the fisheries subsidies negotiations, dispute settlement reform, updating the rule book to include topics like digital trade and other Joint Statement initiatives, restarting negotiations on environmental goods and services, various topics in agriculture (market access, domestic subsidies, removal of export restrictions on farm products purchased for humanitarian purposes by the World Food Programme) and rules to address distortions flowing from industrial subsidies to state-owned enterprises.

For this post, I will focus on the access to vaccines issue and recent actions by the United States (but also others) on this topic.

Two paragraphs from the opinion piece lay out the views of the Director-General on access to vaccines. They are copied below.

“However, for the global economy to return to sustained growth, we must intensify co-operation to ensure equitable and affordable access to vaccines, therapetics and diagnostics. The WTO can and must play a more forceful role in encouraging members to minimise or remove export restrictions and prohibitions that hinder supply chains for medical goods and equipment.

WTO members have a further responsibility to reject vaccine nationalism and protectionism while co-operating on promising new treatments and vaccines. We must find a ‘third way’ on intellectual property that preserves the multilateral rules that encourage research and innovation while promoting licensing agreements to help scale-up manufacturing of medical products. Some pharmaceutical companies such as AstraZeneca, Johnson & Johnson, and the Serum Institute of India are already doing this.”

While India and South Africa have sought a waiver for all WTO Members from most TRIPS Agreement obligations during the pandemic, that proposal has not received the backing from various developed countries with pharmaceutical industries, a fact the new DG saw first hand during the General Council meeting of March 1-2 where the TRIPS Council reported that there was not yet agreement on what to recommend on the proposal. Rather through the WHO, GAVI and CEPI and the creation of COVAX to buy vaccines for low- and middle-income countries and others wishing to participate, the expectation has been that some 2 billion doses would be available through COVAX in 2021 starting in February and ramping up, with 1.3 billion doses going to 92 countries needing assistance.

In her opening statement to the General Council, DG Ngozi Okonjo-Iweala indicated that COVAX would not be enough even though shipments had started. The latest COVAX interim distribution forecast is embedded below and dates from February 3 and shows the number of doses from the AstraZeneca/Serum Institute, from AstraZeneca’s own facilities and from Pfizer/BioNTech.

COVAX-Interim-Distribution-Forecast

Press accounts identify Ghana as the first recipient from COVAX, but other countries have already received the vaccines as well. See, e.g., World health Organization, First COVID-19 COVAX vaccine doses administered in Africa, March 1, 2021,https://www.who.int/news/item/01-03-2021-first-covid-19-covax-vaccine-doses-administered-in-africa; Pan American Health Organization, Colombia receives the first vaccines arriving in the Americas through COVAX, March 1, 2021, https://www.paho.org/en/news/1-3-2021-colombia-receives-first-vaccines-arriving-americas-through-covax. The Financial Times vaccine tracker shows that by March 3, 2021, 268.6 million doses had been administered in 128 locations/countries. Financial Times, Covid-19 vaccine tracker: the global race to vaccinate, March 3, 2021, https://ig.ft.com/coronavirus-vaccine-tracker/?areas=gbr&areas=isr&areas=usa&areas=eue&cumulative=1&populationAdjusted=1.

In recent weeks, the United States confirmed it was contributing $4 billion to COVAX ($2 billion immediately and $2 billion over the rest of 2021 and 2022). Other countries and the EU increased contributions as well and some countries have agreed to send some vaccine doses as well. See February 19, 2021, COVAX’s efforts to distribute COVID-19 vaccines to low- and middle income countries — additional momentum received from G-7 virtual meeting, https://currentthoughtsontrade.com/2021/02/19/covaxs-efforts-to-distribute-covid-19-vaccines-to-low-and-middle-income-countries-additional-momentum-from-g-7-virtual-meeting/

From a recent WHO release it is clear that GAVI and the other COVAX partners are working at expanding available vaccines and seeking additional funding beyond what has already been provided or promised. Vaccines from Johnson & Johnson and potentially from Novavax were identified. See UN News, Equitable vaccine delivery plan needs more support to succeed: COVAX partners, March 2, 2021, https://news.un.org/en/story/2021/03/1086142. The release is embedded below.

Equitable-vaccine-delivery-plan-needs-more-support-to-succeed_-COVAX-partners-_-_-UN-News

“intensify co-operation”

There have been efforts at co-operation from the beginning as AstraZeneca’s licensing of its product to India’s Serum Institute demonstrated.

In the United States, President Biden on March 2 announced co-operation between Merck and Johnson & Johnson where Merck will convert two facilities to help in the production of the Johnson & Johnson vaccine. This has been supported by the United States through use of the Defense Production Act to speed access to equipment needed for the conversion. Merck is a major vaccine producer but doesn’t have a viable COVID-19 vaccine of its own. See NPR, How The White House Got 2 Pharma Rivals To Work Together On COVID-19 Vaccine, March 3, 2021, https://www.npr.org/2021/03/03/973117712/how-the-white-house-got-2-pharma-foes-to-work-together-on-covid-19-vaccine. This is the type of co-operation that DG Okonjo-Iweala referenced in her opinion piece yesterday.

Johnson & Johnson in late February had struck an arrangement with Sanofi in France for similar cooperation at one of Sanofi’s facilities in France. Similarly, Sanofi had earlier struck a deal with Pfizer-BioNTech. See Sanofi, Sanofi to provide manufacturing support to Johnson & Johnson for their COVID-19 vaccine to help address global supply demands, February 22, 2021, https://www.sanofi.com/-/media/Project/One-Sanofi-Web/Websites/Global/Sanofi-COM/Home/media-room/press-releases/2021/20200222-Sanofi-statement-EN.pdf.

The world’s largest vaccine producer, GlaxoSmithKline, has entered an agreement to help produce CureVac produce some of CureVac’s first generation COVID-19 vaccine in 2021 and “to jointly develop next generation mRNA vaccines for COVID-19 with the potential for a multi-valent approach to address multiple emerging variants in one vaccine.” See GSK, GSK and CureVac to develop next generation mRNA COVID-19vaccines, 3 February 2021, https://www.gsk.com/en-gb/media/press-releases/gsk-and-curevac-to-develop-next-generation-mrna-covid-19-vaccines/.

There are, of course, other vaccine producers — China has multiple vaccines developed, Russia, India, Cuba has two in development — including companies who do not have a COVID-19 vaccine in development. Thus, additional opportunities for co-operation should exist for those producers as well.

Conclusion

There is understandably great focus within the WTO and its Members in getting past the COVID-19 pandemic and getting economies back on growth paths. The rapid development of vaccines has been critical and has seen extraordinary success in the 15 months since COVID-19 was first identified. The R&D efforts globally have been stunning and have received some government support which has undoubtedly been important particularly in giving pharmaceutical companies an assist in early efforts to ramp up production. There is no question that the R&D efforts would not have occurred at the level that has taken place without strong intellectual property protections.

There has been great efforts by the WHO along with GAVI and CEPI to prepare to be able to get large quantities of vaccines to low- and middle-income countries when vaccines are available including by contracting with multiple companies pursuing a vaccine, reserving capacity, etc. There have been efforts by many countries to help build support for the COVAX approach and to provide funding for the purchase of vaccines for those in need. The effort is having success and can be more successful as 2021 moves into the second quarter and as countries, NGOs, businesses and individuals contribute to see that there is adequate funding for the effort being undertaken.

In addition to COVAX, a number of countries have been sending some of their production of vaccines to other countries. These include China, Russia and India. The U.S. has been in discussions with Japan, Australia and India for helping in getting vaccines to some countries as well. See Financial Times, US and Asia allies plan Covid vaccine strategy to counter China, March 3, 2021, https://www.ft.com/content/1dc04520-c2fb-4859-9821-c405f51f8586. These efforts are likely to accelerate as 2021 moves into the 3rd and 4th quarters.

Moreover, many of the major Western pharmaceutical companies engaged in vaccine production have partnered with other companies around the world to expand capacity and production of vaccines that have proven successful. So cooperation is already occurring. The Biden Administration’s efforts in recent weeks with Johnson & Johnson and Merck show that government involvement to encourage cooperation for expanding capacity and production and providing assistance in terms of availability of supplies can be an important assist to ramping up production.

Thus, the track record to date does not support a waiver of most TRIPS obligations as has been requested by the world’s largest producer of vaccines (India) and South Africa. Private companies have worked with partners on developments and in a number of cases on producing vaccines. Early success vaccines like Pfizer/BioNTech and Moderna have led to significant increases in plans for production by those companies through their own operations or through partnering with others. A number of other vaccines are now approved in major markets or are close to being approved. Significant funding has been provided or promised to make vaccines available to those in need at no cost.

All of the above is “the third way” sought by the new Director-General. It is already working. The WTO should focus its efforts on export restraints on medical goods and collaborate with other multilateral organizations to understand bottlenecks in capacity expansions, supply chain issues, distribution challenges and other aspects to determine if there are matters requiring WTO attention.

WTO Director-General Ngozi Okonjo-Iweala’s opening statement at the March 1 General Council meeting

Terence P. Stewart · March 1, 2021 · Director-General Ngozi Okonjo-Iweala · access to vaccines, COVAX, COVID-19, General Council, India, South Africa · No Comments

Dr. Ngozi Okonjo-Iweala took the helm of the WTO today, March 1, as Director-General and outlined at the beginning of the first day of a two day General Council meeting the need for change at the organization and how Members address the many challenges before them. In a post last week, I had looked at some of the challenging issues confronting the WTO and the new Director-General (DG), some within the General Council agenda. See February 26, 2021, WTO Director-General Ngozi Okonjo-Iweala’s first week on the job starts with a two day General Council meeting, https://currentthoughtsontrade.com/2021/02/26/wto-director-general-ngozi-okonjo-iwealas-first-week-on-the-job-starts-with-a-two-day-general-council-meeting/.

The statement by DG Okonjo-Iweala can be found on the WTO webpage. See WTO, DG Okonjo-Iweala: WTO can deliver results if members “accept we can do things differently”, 1 March 2021, https://www.wto.org/english/news_e/spno_e/spno1_e.htm. Her comments started with thanks to the Members, to the troika of Chairs that had worked the DG selection process, to the four Deputy Directors-General who had managed the organization since the end of August and to the WTO Secretariat staff. Dr. Okonjo-Iweala reviewed the need for doing things differently, the fact that in a Member driven-organization, movement would require efforts by all, and her view based on discussions that the WTO was viewed as less relevant since it has been unable to deliver results. Her comments on the challenges to relevance are copied below.

“I have said it. It cannot be business as usual. We have to change our approach from debate and rounds of questions to delivering results. Excellencies, many of you put in long hours and a great deal of effort to do good work much of which goes unnoticed. There are excellent people in the capitals doing good work. We have talented staff in the Secretariat. But the world is no longer cognizant of this, does not recognize the effort because we are not delivering results at the pace required by our fast-changing environment. Last week at the TNC, several Ambassadors said that You Excellencies talk past each other. You don’t talk to each other. This approach has to change. We have to be more accountable to the people we came here to serve — the ordinary women and men, our children who hope that our work here to support the MTS, will result in meaningful change in their lives, will improve their standard of living, and create decent jobs for those who seek work.

“Excellencies, coming from the outside I have noticed that the world is leaving the WTO behind. Leaders and decision makers are impatient for change. Several Trade Ministers said to me that if things don’t change, they will no longer attend the Ministerial because it is a waste of their time. I have noticed that more and more of the work and decision making that should be undertaken at the WTO is being done elsewhere because there is an increasing loss of confidence in the ability of the WTO to produce results. But there is hope. If we all accept that we can no longer do business as usual, that will help us create the parameters for success.”

DG Okonjo-Iweala then reviewed the long list of issues of importance to various parts of the WTO Membership and the need to achieve deliverables by the 12th Ministerial Conference. After her speech, the date and venue of the 12th Ministerial Conference were taken up as agenda item 4 and a decision taken to hold the Ministerial Conference the week of November 29 in Geneva with the Kazakhstan trade minister chairing the Ministerial Conference (Kazkhstan had offered to host in 2020 and again in 2021 including in December). See WTO, Twelfth Ministerial Conference to take place in Geneva in late 2021, 1 March 2021, https://www.wto.org/english/news_e/news21_e/minis_01mar21_e.htm.

For DG Okonjo-Iweala it is important that the WTO membership have an achievable agenda for the upcoming Ministerial Conference (MC), which means not attempting too much. However, the list of “deliverables” DG Okonjo-Iweala outlined is significant as well as the group of issues on which agreed work programs should be ready for adoption at the MC. Here is what DG Okonjo-Iweala outlined as the hoped-for focus.

“Therefore, we must work hard to complete a few deliverables before MC12 so that Ministers can focus on ratifying agreements and agreeing best methods for implementation. In this regard, we need to prioritize action on COVID-19 both for the immediate and longer term and focus on completing Fisheries Subsidies negotiations before the middle of the year. We must agree the road map for reform of the Dispute Settlement System and prepare a work program to achieve this which can be endorsed at MC12. On Agriculture, let us identify a few things we can deliver such as PSH, SSM, Cotton, and the WFP Humanitarian waiver which is material to our Pacific Island economies as we heard a few days ago. We must put forward a subsidies work program both on domestic support and industrial subsidies which can be agreed on at MC12. We must sharpen our approach to SDT bearing in mind how crucial this is to the policy space of Least Developed Countries in particular. For the rest, let us review the work on e-commerce, investment facilitation, Services Domestic Regulation, MSMEs, Women in Trade, and Trade and Climate to see what aspects of these important work programs we can advance at MC12. So in short, I am suggesting three or four clear deliverables finalized before MC12 and work programs for the rest to be agreed at MC12.”

DG Okonjo-Iweala then turned to the challenges of the COVID-19 pandemic, more specifically getting the world vaccinated. She noted the proposal by India and South Africa (supported by many developing countries) for a waiver from TRIPS obligations for medical goods during the pandemic. A status report from the TRIPS Council on the proposed waiver is agenda item 6. DG Okonjo-Iweala argues that time is of the essence and that while WTO Members deal with the waiver proposal, efforts should be made to ramp up global production and distribution, noting the challenges facing COVAX in delivering vaccines to low- and middle-income countries and the gross shortfall between global vaccine capacities and global vaccine needs. It is not clear what direct role the WTO has or should have in working with companies to expand production or to encourage additional licensing, but certainly there is a role for governments collaborating on the issue and for multilateral organizations to collaborate and develop information on current and planned capacities, existing licensing arrangements (as there are some in existence already). Here is what DG Okonjo-Iweala said.

“Permit me Ladies and Gentlemen to spend just a little time on COVID-19. We have a demand for a TRIPS waiver by a growing number of developing countries and the dialogue is intensifying. Whilst this is happening, I propose that we ‘walk and chew gum’ by also focusing on the immediate needs of dozens of poor countries that have yet to vaccinate a single person. People are dying in poor countries. We just had our first COVAX shipment to Ghana last week and others will follow but it will not be enough. There is serious supply scarcity and some countries are out bidding COVAX and diverting supplies. The world has a normal capacity of production of 3.5 billion doses of vaccines and we now seek to manufacture 10 billion doses. This is just very difficult, so we must focus on working with companies to open up and license more viable manufacturing sites now in emerging markets and developing countries. We must get them to work with us on know how and technology transfer now. There will soon be a world manufacturing convention where we can seek to build this partnership. I also hope we can initiate a dialogue and information exchange between us and representatives of manufacturers associations from developing and developed countries. Excellencies, this should happen soon so we can save lives. As I said at the beginning, this will be an interim solution whilst we continue the dialogue on the TRIPS waiver.”

The General Council meeting runs through tomorrow March 2. While much of a General Council meeting is simply reporting developments in various areas, it is also an opportunity for Members to stake out positions and measure the sense of openness to agenda items by the WTO membership. There is no doubt that WTO Members expressed great enthusiasm and hope for the new Director-General. Whether that will translate into Members working differently to obtain solutions and find compromises is unknown at this point but seems unlikely with the deep divisions and differences of views on objectives for the WTO held by Members. The new DG clearly will be pushing Members to proceed in a more collaborative and solution-finding mode. Her own list of objectives for MC12 is quite ambitious and includes items that are very controversial to many. Her wanting WTO involvement in considering vaccine production and distribution levels is more consistent with her prior role at GAVI and her background as a development economist than her current role as WTO DG. Finding a comfort zone for WTO Members to act within the WTO, other than the consideration of the waiver proposal, on such issues may prove to be challenging. What is clear is that the new DG is looking forward to working with Members to return the WTO to greater relevance. Her opening statement at the General Council meeting says she will be urging Members to get out of their comfort zones. Fingers crossed that she is successful.

WTO Director-General Ngozi Okonjo-Iweala’s first week on the job starts with a two day General Council meeting

Terence P. Stewart · February 26, 2021 · 12th Ministerial Conference, Deputy Director-General Alan Wolff, Director-General Ngozi Okonjo-Iweala, electronic commerce and digital trade, Fisheries Subsidies negotiations, General Council, Waiver of TRIPS Obligations · Accessions, Australia, Brazil, Canada, CEPI, Chile, Colombia, Costa Rica, COVAX, Ecuador, European Union, export restraints, GAVI, India, Japan, Joint Statement Initiatives, Kenya, Mexico, New Zealand, Norway, Panama, Paraguay, Republic of Korea, Singapore, South Africa, Switzerland, United States, World Health Organization · No Comments

While the WTO’s General Council, in special session, appointed Dr. Ngozi Okonjo-Iweala to be the next Director-General on February 15, 2021, her term starts on Monday, March 1. The challenges facing the WTO membership and the incoming Director-General are many and complex. At the same time, there is a lot of useful work that is done within the WTO including efforts of non-members to join the WTO (accessions).

In speaking to an informal Trade Negotiations Committee and Heads of Delegation meeting on February 25, Deputy Director-General Alan Wolff spoke in part on “The Ngozi Okonjo-Iweala Era”. See WTO, DDG Wolff calls on members to work with new Director-General to reform WTO, 25 February 2021, https://www.wto.org/english/news_e/news21_e/ddgaw_25feb21_e.htm. Part of the section of his statement on the new DG’s era is copied below.

“The Ngozi Okonjo-Iweala Era

“The landmark event of the last six months was the appointment of the new Director-General ten days ago after what turned out to be a lengthy process. 91 member delegations spoke last week to congratulate the new Director-General. The DDGs and the Secretariat join you in welcoming Dr Okonjo-Iweala’s appointment with great enthusiasm.

“Of course, member enthusiasm, optimism and hope need to be translated into concrete action.

“There is much that needs to be done at this critical juncture for the WTO. World trade must contribute to a more effective pandemic response as well as a strong and sustainable economic recovery. Climate issues are demanding more urgent attention. WTO reform is overdue, having been called for repeatedly by you, by your ministers and by many heads of government.

“The challenges are many but so are the opportunities. Dr Ngozi’s remarks at the Special General Council meeting last Monday, subsequently circulated to delegations in document JOB/GC/250, presented a worthy and ambitious agenda for the members of this organization.

“What did she say?

“To act with a sense of urgency to assist in controlling the COVID-19 pandemic through the nexus of trade and public health:

“First, by playing a more forceful role in exercising the WTO’s monitoring function. Part of this would involve encouraging members to minimise or remove export restrictions that hinder supply chains for medical goods and equipment. WTO monitoring suggests that as of yesterday, 59 members and 7 observers still had pandemic-related export restrictions or licensing requirements in place, mostly for personal protective equipment, disinfectants and to a lesser extent, for medicines and food. This represents a significant level of rollback compared to the 81 members and 10 observers that had implemented such measures over the past year. A welcome development — but there is much room to improve this record.

“And second, by broadening access to new vaccines, therapeutics, and diagnostics by facilitating technology transfer within the framework of multilateral rules.

“Beyond these immediate responses to the pandemic, Dr Ngozi set out a number of other, also vitally important, challenges:

“To swiftly conclude the fisheries subsidies negotiations, and thus pass a key test of the WTO’s multilateral credibility while contributing to the sustainability of the world’s oceans.

“To build on the new energy in the multilateral trading system from the joint statement initiatives attracting greater support and interest, including from developing countries.

“To address more broadly the nexus between trade and climate change, using trade to create a green and circular economy, to reactivate and broaden negotiations on environmental goods and services, to take the initiative to address the issue of carbon border adjustments as they may affect trade.

“To level the playing field in agricultural trade though improving market access and dealing with trade distorting domestic support, exempting from export restrictions World Food Programme humanitarian purchases.

“To strengthen disciplines on industrial subsidies, including support for state-owned enterprises.

“To defuse the divisions over Special and Differential Treatment (SDT).

“And to develop a work programme for restoring two-tier dispute resolution, to be agreed no later than MC12.

“I sense from my discussions with members that you chose this leader, Ngozi Okonjo-Iweala, because she has shown herself during her career to be fearless in the face of daunting challenges — and is experienced in knowing how to work with others to make progress toward solutions.

“Each of the challenges the WTO faces, I am sure, can be met and overcome. Echoing Dr Ngozi’s words, the trading system that we inherited, now only three-quarters of a century old, is about people. This is inscribed in the opening section of the Marrakech agreement: ‘to raise living standards, ensure full employment, increase incomes, expand the production of and trade in goods and services, and seek the optimal use of the world’s resources in accordance with the objective of sustainable development.”’

DDG Wolff’s summation correctly lays out many of the issues needing to be addressed by the WTO membership. The vast majority of the issues are highly controversial among at least some Members.

The first major order of business is a two day General Council meeting on March 1-2 which has several agenda items that lay out controversies on important potential deliverables by the WTO in 2021. The agenda for the two day meeting contains sixteen items. See WT/GC/W/820 (26 February 2021) embedded below.

W820

General Council meetings deal with updates on ongoing work at the WTO and address issues teed up by particular Members for consideration at the meeting. This post does not take up all agenda items but highlights a few of possible interest. Because DDG Wolff’s statement on February 25 reviews many of the activities of the WTO in the last six months which shows some of the positive developments, the full statement is embedded below.

WTO-_-2021-News-items-Speech-DDG-Alan-Wolff-DDG-Wolff-calls-on-members-to-work-with-new-Director-General-to-reform-WTO

The 12th WTO Ministerial Conference

Agenda item 4 deals with the 12th WTO Ministerial Conference. It is expected that there will be a decision on the timing and location of the twelfth Ministerial Conference at the General Council session on Monday-Tuesday. The 12th MC was postponed from June 2020 because of the COVID-19 pandemic. With the continued challenges from the pandemic the likely date will be the end of 2021. Kazakhstan which had offered to host the conference in 2020 and again in the summer of 2021 has recently indicated a willingness to host in December of this year as well. The ministerial had originally been scheduled for June because of challenging weather conditions in Kazakhstan in December. See TWELFTH SESSION OF THE MINISTERIAL CONFERENCE, COMMUNICATION FROM KAZAKHSTAN, 8 February 2021, WT/GC/229 (24 February 2021)(embedded below).

229

Report on WTO Accessions

Deputy Director-General Wolff will provide a statement on the annual report on WTO accessions. The report is WTO ACCESSIONS, 2020 ANNUAL REPORT BY THE DIRECTOR-GENERAL, WT/ACC/38, WT/GC/228 (18 February 2021). Activity on accessions was challenged by the pandemic and inability to travel/hold in person meetings. More technical assistance and virtual meetings were held. Accessions are important for acceding governments in terms of promoting reforms at home and obtaining increased certainty in their international trade relations. Accessions are also an important benefit of membership for existing Members as acceding Members reduce tariffs and various non-tariff barriers to gain accession. The first eight paragraphs of the report provide an overview of activities in 2020 and are copied below.

“Overview of activities in 2020

“1. 2020 was an unprecedented year in recent history due the COVID-19 pandemic outbreak and its consequences which have touched upon every single aspect of our lives in every corner of the world. It was a challenging year for the WTO, not least because the pandemic disrupted its core activities, especially during the first half of the year, and it also disrupted the international trade of Members, except for supplies of essential goods critical to combatting the health crisis as trade in these goods expanded dramatically. The difficulties and challenges arising from the pandemic were particularly pronounced in acceding governments due to the uncertainties of being outside of the multilateral trading system. In fact, the desire and urgency to be part of the WTO was never felt stronger than in the pandemic year. This was reflected in the level of accession activities in 2020, which was sustained vis-à-vis previous years, with a significant increase in technical assistance and outreach activities.

“2. The year for accessions started with the establishment of a new Working Party for the accession of Curaçao, a constituent country within the Kingdom of the Netherlands (WTO Member), following its application for an independent membership as a separate customs territory pursuant to Article XII of the Marrakesh Agreement. This constituted the 59th request by a state or separate customs territory for membership since the establishment of the Organization in 1995. In July, Turkmenistan was granted observer status in the WTO, with the understanding that it would apply for accession no later than in five years. This brought the total number of observer governments with the intention to accede to the WTO to 24, an increase by five since 2016 when Afghanistan and Liberia became the Organization’s most recent Members. The continuing interest to become part of the multilateral trading system is a testament to the attraction and relevance of its values and principles for all economies, regardless of their size or level of development.

“3. The COVID-19 pandemic undoubtedly hampered or delayed the technical work by acceding governments, Members and the Secretariat to prepare for, engage in and follow up on Working Party meetings. However, thanks to the firm commitment of the acceding governments to advance their work, four Working Parties met, including through the use of virtual platforms that connected the acceding governments which were unable to travel to Geneva. One acceding government had to cancel its already scheduled meeting due to the suspension of all WTO meetings in March. Out of the four accession Working Party meetings held in 2020, three were on LDC accessions (Ethiopia, Comoros and Timor-Leste). In two cases – the Working Parties of Ethiopia and Uzbekistan – this also represented the formal resumption of accession processes after several years of inactivity (8 and 15 years, respectively), signalling their desire to use WTO membership negotiations to drive domestic economic reforms, which have broader implications in the regions where they are located.

“4. When the pandemic halted planned missions, technical assistance, and outreach activities which required air travel, the Secretariat rapidly shifted the mode of operation to virtual format and took advantage of the opportunities provided thereby. In addition to the formal accession Working Party meetings which took place via Interprefy, the Accessions Division organised virtual technical meetings and briefing sessions with acceding governments, Working Party Chairpersons and partners in support of accessions. Moreover, the Division delivered a number of technical assistance, training and outreach activities in response to articulated needs of acceding governments, using various virtual platforms, such as MS Teams, Zoom and WebEx. In fact, the number of activities delivered by the Division and of participants who attended or were trained in 2020 exceeded considerably the numbers in previous years.

“5. One of the novel outreach programs developed in 2020 was two week-long activities which consisted of a series of webinars combining lectures, training and panel discussions. The first Accessions Week was organised from 29 June to 3 July, and the first edition of the Trade for Peace Week took place from 30 November to 4 December. These virtual events brought together a large number of resource persons and panellists from around the world and reached out to a larger number of participants, in a highly cost-effective manner, in comparison with traditional in-person activities. While the full values and benefits of in-person interaction cannot be replaced or replicated, the Accessions Week enabled the Secretariat to remain engaged with acceding governments and Members, experts and partners, beyond Geneva and around the world. The Trade for Peace Week provided an effective networking platform to expand the WTO’s partnership with the peace and humanitarian communities in support of fragile and conflict affected (FCA) countries in accession.

“6. The importance of collaboration and cooperation with partners was never felt more strongly than in 2020. The Secretariat made concerted efforts to enhance and expand the “Trade for Peace through WTO Accession” Initiative to support FCA countries in accession and those recently acceded to the WTO. In 2020, nine acceding governments were identified as being in a FCA situation according to the World Bank’s classification1, while conflicts emerged or resurged in some others. The pandemic hit hardest countries which had already been suffering from years of conflict, political crises, drought and other natural disasters, compounded by declines of the price of oil and other commodities. Nonetheless, some FCA acceding LDCs showed remarkable resilience in sustaining their engagement in accession. The Working Party on the Accession of the Union of Comoros resumed its work with determination to finalise the process as soon as possible. The Working Party on the Accession of Timor-Leste activated the Working Party by holding its first meeting nearly four years after its establishment, despite various challenges faced on the domestic front. Moreover, Somalia submitted its Memorandum on the Foreign Trade Regime, the base document to start its accession engagement with Members. Furthermore, the Secretariat continued to provide support to the g7+ WTO Accessions Group, which was coordinated by Afghanistan.

“7. The year 2020 marked the 25th anniversary of the WTO. The Secretariat used its annual flagship event, the China Round Table on WTO Accessions, to review the contributions made by accessions to the multilateral trading system since 1995. The event also provided an opportunity for an exchange of ideas to explore the future expansion of WTO membership towards universality, including through possible improvements in the accession process. The year also marked a significant anniversary milestone for five Article XII Members2 – Albania, Croatia, Georgia, Jordan and Oman which joined the WTO in 2000, the year with the largest number of new members to date. Other anniversary milestones included the fifth anniversaries of Membership of Kazakhstan and Seychelles and the fifteenth anniversary for the Kingdom of Saudi Arabia. In recent years, membership anniversaries have become an important occasion to reflect on the benefits and values of being part of the Organization.

“8. Finally, the thematic focus of the 2020 Annual Report was on the complementarities and synergies in negotiating WTO membership and regional trade agreements. Almost all acceding governments are involved in regional integration initiatives in parallel with their efforts to achieve WTO membership. The highlight of the year was the implementation of the African Continental Free Trade Area (AfCFTA) to which all African WTO applicants are signatories. The Report’s thematic section builds on the rich discussions held on the topic during the 2020 Regional Dialogues on WTO Accessions for Africa and for the Arab Region, as well as other meetings on Central Asia and Eurasia. It aims to explore key opportunities and challenges that may arise in a simultaneous pursuit of regional and global integration efforts and to provide a checklist of issues for trade negotiators to consider in maximising the benefits from the participation in multiple trade arrangements.”

The full report is embedded below.

WTACC38

Waiver of TRIPS Obligations During COVID-19 Pandemic

The sixth agenda item involves the effort from India and South Africa with a number of other developing or least developed countries to obtain a waiver from most TRIPS obligations on medical goods needed for the COVID-19 pandemic. This has been a very controversial issue with developed countries with pharmaceutical companies involved in the production of vaccines and other items opposing the waiver on the basis of existing flexibilities within the TRIPS Agreement and on the global efforts through the WHO, GAVI and CEPI to provide vaccines to low- and middle-income countries through COVAX with financial contributions from many countries, NGOs and others. See, e.g., February 19, 2021, COVAX’s efforts to distribute COVID-19 vaccines to low- and middle income countries — additional momentum received from G-7 virtual meeting, https://currentthoughtsontrade.com/2021/02/19/covaxs-efforts-to-distribute-covid-19-vaccines-to-low-and-middle-income-countries-additional-momentum-from-g-7-virtual-meeting/

The TRIPS Council received the proposal back in October but has been unable to provide a recommendation to the General Council. A meeting of the TRIPS Council earlier this month continued the lack of agreement. Thus, the agenda item will simply result in the item being continued on the General Council’s future agendas until resolved or dropped. See WTO, Members discuss TRIPS waiver request, exchange views on IP role amid a pandemic, 23 February 2021, https://www.wto.org/english/news_e/news21_e/trip_23feb21_e.htm (” In this context and given the lack of consensus on the waiver request, members agreed to adopt an oral status report to be presented to the General Council at its next meeting on 1-2 March. The report indicates that the TRIPS Council has not yet completed its consideration of the waiver request and therefore will continue discussions and report back to the General Council.”); December 11, 2020, Council for Trade-Related Aspects of Intellectual Property Rights meeting of December 10, 2020 – no resolution on proposed waiver of TRIPS obligations to address the pandemic, https://currentthoughtsontrade.com/2020/12/11/council-for-trade-related-aspects-of-intellectual-property-rights-meeting-of-december-10-2020-no-resolution-on-proposed-waiver-of-trips-obligations-to-address-the-pandemic/; December 6, 2020, Upcoming December 11^th Council for Trade-Related Aspects of Intellectual Property Rights meeting – reaction to proposed waiver from TRIPS obligations to address COVID-19, https://currentthoughtsontrade.com/2020/12/06/upcoming-december-11th-wto-council-for-trade-related-aspects-of-intellectual-property-rights-meeting-reaction-to-proposed-waiver-from-trips-obligations-to-address-covid-19/; November 2, 2020, India and South Africa seek waiver from WTO intellectual property obligations to add COVID-19 – issues presented, https://currentthoughtsontrade.com/2020/11/02/india-and-south-africa-seek-waiver-from-wto-intellectual-property-obligations-to-address-covid-19-issues-presented/.

Fisheries Subsidies negotiations — Draft Ministerial Decision

The WTO has been pursuing negotiations on fisheries subsidies to address sustainable fishing concerns since the end of 2001. Conclusion of the negotiations were supposed to take place in 2020 but WTO Members were unable to get the job completed in part because of disruptions from the COVID-19 pandemic. While completing the negotiations remains a key objective of Members and the incoming Director-General and such completion is needed to fulfill the UN Sustainable Development Goal 14.6, WTO Members continue to face a large number of challenging issues. See, e.g., WTO press release, WTO members hold February cluster of meetings for fisheries subsidies negotiations, 24 February 2021, https://www.wto.org/english/news_e/news21_e/fish_24feb21_e.htm; February 22, 2021, An early test for the incoming WTO Director-General — helping Members get the Fisheries Subsidies negotiations to a conclusion, https://currentthoughtsontrade.com/2021/02/22/an-early-test-for-the-incoming-wto-director-general-helping-members-get-the-fisheries-subsidies-negotiations-to-a-conclusion/.

Agenda item 7 is entitled “Supporting the Conclusion of Fisheries Subsidies Negotiations for the Sustainability of the Ocean and Fishing Communities — Draft Ministerial Decision — Communication from Brazil (WT/GC/W/815. The draft Ministerial Decision is an effort by Brazil to highlight the critical aspect of the negotiations which is to address environmental sustainability and presumably reflects Brazil’s concerns with the efforts of so many Members to protect their subsidies versus ensuring sustainable fishing. The document is embedded below.

WTGCW815

An attack on Joint Statement Initiatives

As reviewed in the incoming Director-General’s statement on February 15 and the summary of her statement by DDG Wolff on February 25, an important aspect of ongoing work at the WTO is a number of Joint Statement Initiatives that were started at the end of the 11th Ministerial Conference in Buenos Aires, including on e-commerce/digital trade.

Agenda item 10 is a frontal attack on such initiatives by India and South Africa through their paper, “Legal Status of Joint Statement Initiatives and Their Negotiated Outcomes”, WT/GC/819. I had reviewed the submission in an earlier post. See February 20, 2021, Will India and South Africa (and others) prevent future relevance of the WTO?, https://currentthoughtsontrade.com/2021/02/20/will-india-and-south-africa-and-others-prevent-future-relevance-of-the-wto/. The agenda item will like see many delegations take the floor to support the use of joint statement initiatives within the WTO or to oppose them. While there won’t be a resolution of the issue, the challenge to the process could significantly handicap some of the efforts envisioned by the incoming Director-General to help developing and least developed countries take advantage of the e-commerce/digital trade world and eventually participate in talks and/or in an agreement. WT/GC/W/819 is embedded below.

WTGCW819-1

Agenda item 8 is viewed as related to agenda item 10. India has been seeking to limit WTO consideration of e-commerce issues to the multilateral efforts over many years within the existing Councils and Committees of the WTO (but where limited progress has been made).

COVID-19 and possible future pandemics — addressing existing trade restrictions and improving the functioning of the WTO to better handle in the future

The incoming Director-General has as a high priority to work with Members to improve monitoring of export restraints on medical goods and agricultural goods during the pandemic and working with Members to see that the WTO helps Members recover and better handle any future pandemics. The Ottawa Group had put forward a trade and health initiative in November 2020. See COVID-19 AND BEYOND: TRADE AND HEALTH, WT/GC/223 (24 November 2020). The communication was made by Australia, Brazil, Canada, Chile, the European Union, Japan, Kenya, Republic of Korea, Mexico, New Zealand, Norway, Singapore and Switzerland. The document contains an annex reviewing the types of actions Members could take to improve the response to the pandemic and improve conditions going forward. Included in the annex to the communication are sections on export restrictions; customs, services and technical regulations; tariffs; transparency and review; cooperation of the WTO with other organizations. Several paragraphs in the communication review the issue of possible export restrictions on vaccines and are copied below.

“9. We realize that the challenges related to the scarcity of essential medical goods, now alleviated to some extent by the response on the supply side, may be repeated at the moment of the development of a vaccine or new medical treatments. In this context, we welcome the COVID-19 Vaccine Global Access Facility (COVAX), a global pooled procurement mechanism for COVID-19 vaccines, managed by Gavi, the Vaccine Alliance, the Coalition for Epidemic Preparedness Innovations (CEPI) and WHO. This mechanism is critical in securing an equitable share of vaccines for all Members of the international community. As we strongly support the objective of this facility, we call on WTO Members to ensure that any export-restricting measures do not pose a barrier to the delivery of necessary supplies under the COVAX facility.

“10. We recognize the collaborative efforts of private and public stakeholders in the research and development of COVID-19 diagnostics, vaccines and treatments. We encourage the industry to take actions to ensure access at affordable prices to COVID-19 diagnostics, vaccines and treatments for vulnerable populations and support voluntary pooling and licensing of IP rights to accelerate the development of such diagnostics, treatments and vaccines and scaling up their production. We recognize the importance of the IP system in promoting R&D and innovation for access to effective treatments. We note that the flexibilities provided by the TRIPS Agreement and reaffirmed in the Doha Declaration on the TRIPS Agreement and Public Health remain available to protect public health and to promote access to medicines for all.”

The full document is embedded below.

WTGC223

Canada will be providing an update on the initiative at the General Council meeting and will likely see many Members provide comments on the agenda item.

Agenda item 9 was added by Colombia, Costa Rica, Ecuador, Panama and Paraguay reflecting concerns by them (and presumably many other trading partners) about actions taken by the European Union to exert control over exports of vaccines from the EU in light of EU concerns about its own access to vaccines from manufacturers. See CALL TO PREVENT EXPORT RESTRICTIONS ON COVID-19 VACCINES, WT/GC/818 (18 February 2021). The document is embedded below.

WTGCW818

Since the EU is one of the Members who has pushed the trade and health initiative, there is concern by some WTO Members that its actions on vaccines run counter to the initiative it is supporting. Presumably the EU will argue that its actions are consistent with its rights under the WTO and is consistent with the language laid out in paragraphs 9 and 10 above.

The two agenda items are likely to show the concerns of many Members on equitable access to medical goods during the pandemic and the reluctance of at least some Members to reduce their flexibilities under the existing WTO rights and obligations.

Conclusion

DDG Wolff indicated that Members selected the incoming Director-General because she is “fearless in the face of daunting challenges”. There is no shortage of daunting challenges facing the WTO and its new Director-General. A few have been reviewed above.

Some good news is that the EU and the United States are supportive of many of the priorities laid out by DG Ngozi Okonjo-Iweala in her February 15 statement to the Special Session of the General Council as seen in the recent EU revised trade policy and the opening statement of USTR nominee Katherine Tai at yesterday’s Senate Finance Committee confirmation hearing See February 18, 2021, The European Commission’s 18 February 2021 Trade Policy Review paper and Annex — WTO reform and much more proposed, https://currentthoughtsontrade.com/2021/02/18/the-european-commissions-18-february-2021-trade-policy-review-paper-wto-reform-and-much-more-proposed/; February 25, 2021, U.S. Trade Representative nominee Katherine Tai confirmation hearing before the U.S. Senate Finance Committee, https://currentthoughtsontrade.com/2021/02/25/u-s-trade-representative-nominee-katherine-tai-confirmation-hearing-before-the-u-s-senate-finance-committee/.

The challenges the new Director-General and the WTO Members face will be made harder by the lack among Members of a common vision and agreed purpose of the WTO, by the current inability of the WTO system to address fundamentally different economic systems, by the structure of decision making, by the failure of obligations to be updated to match level of economic development and role in global trade and by the related issue of how special and differential treatment is used. These challenges have resulted in a negotiating function that is broken, in a dispute settlement system that has no checks on the reviewers for errors or failures to operate within the bounds of authority granted in the Dispute Settlement Understanding and in the underperformance of the monitoring and implementation function.

Hopefully, DG Okonjo-Iweala will develop a strong personal staff and group of DDGs to help her attempt the seemingly impossible — getting meaningful progress and reform from the 164 current WTO Members. See February 13, 2021, Leadership change at the WTO — with Dr. Ngozi Okonjo-Iweala’s arrival next week, what support team and early changes in the role of the Secretariat could help WTO Members move forward?, https://currentthoughtsontrade.com/2021/02/13/leadership-change-at-the-wto-with-dr-ngozi-okonjo-iwealas-arrival-next-week-what-support-team-and-early-changes-in-the-role-of-the-secretariat-could-help-wto-members-move-forward/

Director-General Ngozi Okonjo-Iweala will get her first reality check at the General Council meeting on March 1-2.