WHO

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.

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 IVA 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 WorldSave 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.

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

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.

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

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

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.

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.

2021 – how quickly will COVID-19 vaccines bring the pandemic under control?

News accounts report many countries starting to receive at least some doses of vaccines. In the United States, two vaccines have received emergency use authorization (“EUA”)(the Pfizer/BioNTech and the Moderna vaccines). The Pfizer/BioNTech vaccine has received approval (emergency use or other) in a number of countries (EU, Canada, United Kingdom, Bahrain) and was the first vaccine to receive an EUA from the World Health Organization. See WHO press release, WHO issues its first emergency use validation for a COVID-19 vaccine and emphasizes need for equitable global access, December 31, 2020, https://www.who.int/news/item/31-12-2020-who-issues-its-first-emergency-use-validation-for-a-covid-19-vaccine-and-emphasizes-need-for-equitable-global-access. As the WHO press releases indicates, “The WHO’s Emergency Use Listing (EUL) opens the door for countries to expedite their own regulatory approval processes to import and administer the vaccine. It also enables UNICEF and the Pan-American Health Organization to procure the vaccine for distribution to countries in need.”

AstraZeneca will likely seek emergency use authorization in the United States in January and Johnson & Johnson in February. AstraZeneca has received an emergency use authorization in the United Kingdom. It has also been given EUA by India (along with a vaccine from Bharat Biotech). See New York Times, India Approves Oxford-AstraZeneca Covid-19 Vaccine and 1 other, January 3, 2021, https://www.nytimes.com/2021/01/03/world/asia/india-covid-19-vaccine.html.

A recent Financial Times article includes a graph showing the number of citizens in various countries who have received a first vaccination shot. See Financial Times, European leaders under pressure to speed up mass vaccination, January 1, 2021, https://www.ft.com/content/c45e5d1c-a9ea-4838-824c-413236190e7e. The countries shown as having started vaccinations include China, the U.S., the U.K., Kuwait, Mexico, Canada, Chile, Russia, Argentina, Iceland, Bahrain, Oman, Israel, and fourteen of the 27 members of the EU).

Similarly an article from CGTN on January 1, 2021 shows a number of countries who are buying COVID-19 vaccines from China including Hungary and a number of others while vaccines from China are in stage 3 trials in a number of countries. CGTN, 1 January 2021, Hungary to focus on EU, Chinese coronavirus vaccine purchases, https://news.cgtn.com/news/2021-01-01/Hungary-to-focus-on-EU-Chinese-coronavirus-vaccine-purchases-WHm11NYjni/index.html. “By the end of 2020, UAE became the first country to roll out a Chinese vaccine to the public. Pakistan also announced on Thursday that they will purchase 1.2 million COVID-19 vaccine doses from China’s Sinopharm after China officially approved the vaccine for general public use. Sinovac’s CoronaVac shot, another candidate vaccine in China, has been signed up for purchase deals with Brazil, Indonesia, Turkey, Chile, and Singapore. The company is also in supply talks with Malaysia and the Philippines.”

So the good news at the beginning of 2021 is that effective vaccines are starting to be distributed. Many others are in late stages of trials, giving hope to a significant number of vaccines approved for use in the coming months. The WHO’s list of vaccines in development and their status can be found on the WHO website at this cite. https://www.who.int/publications/m/item/draft-landscape-of-covid-19-candidate-vaccines. How quickly approved vaccines can be produced, distributed and vaccinations given globally will determine when the pandemic will be brought under control. There are many challenges that the world faces in getting to the hoped for situation of a pandemic that is in the past.

For example, even in developed countries, governments are finding that there are significant hurdles in getting production volumes up to promised levels, and much greater challenges in going from production to distribution to vaccinations. In the United States, the Trump Administration had aimed at having 20 million vaccinations accomplished by the end of 2020. Only 13.071 million doses were distributed by the end of the year according to the US CDC and only 4.2 million vaccinations (first shot of two shots) occurred. See Center for Disease Prevention and Control, COVID-19 Vaccinations in the United States, https://covid.cdc.gov/covid-data-tracker/#vaccinations (viewed Jan. 3, 2021). President-elect Biden is talking about an aggressive program to get 100 million vaccinations (as the current vaccines require 2 shots, this means 50 million people) vaccinated in the first 100 days of his Administration (by the end of April). To achieve this objective will require cooperation from Congress in providing sufficient funding to build up the capabilities at the state and local levels. Health care infrastructure has been reduced over the last dozen years with a reduction of some 50,000 health care workers in the U.S. The huge COVID-19 case load in the United States and record hospitalizations also have health care operations across the United States overextended. So despite having sufficient vaccines on order from four companies where EUAs have been or will likely be granted in the near future to permit vaccination of all Americans by fall, there are enormous practical challenges to making the vaccinations happen in fact. And that is before the challenges of convincing portions of the population of the safety of the vaccines and the need for the vast majority of people to be vaccinated to achieve herd immunity.

Similar challenges exist in many other parts of the world as well. For example, in both the EU and India the roll out of vaccines is proceeding slower than desired. See, e.g., The Guardian, BioNTech criticises EU failure to order enough Covid vaccine, January 1, 2021, https://www.theguardian.com/world/2021/jan/01/france-to-step-up-covid-jabs-after-claims-of-bowing-to-anti-vaxxers; Politico, France under pressure to speed up coronavirus vaccine rollout, January 3, 2021, https://www.politico.eu/article/france-under-pressure-to-speed-up-coronavirus-vaccine-rollout/; New York Times, India Approves Oxford-AstraZeneca Covid-19 Vaccine and 1 other, January 3, 2021, https://www.nytimes.com/2021/01/03/world/asia/india-covid-19-vaccine.html (“The Serum Institute, an Indian drug maker that struck a deal to produce the Oxford vaccine even before its effectiveness had been proven, has managed to make only about one-tenth of the 400 million doses it had committed to manufacturing before the end of the year.”).

The WHO/GAVI/CEPI effort to get vaccines to the world on a equitable basis has much of its vaccine commitments in products still in the testing stage although roughly one billion doses can be available for a vaccine currently approved on an emergency use basis in the U.K. and India (the AstraZeneca vaccine) through COVAX agreements with AstraZeneca directly and with an Indian producer who can be asked to produce one of two potential vaccines, including the AstraZeneca one. See WHO, COVAX Announces additional deals to access promising COVID-19 vaccine candidates; plans global rollout starting Q1 2021, 18 December 2020, https://www.who.int/news/item/18-12-2020-covax-announces-additional-deals-to-access-promising-covid-19-vaccine-candidates-plans-global-rollout-starting-q1-2021.

“Geneva/Oslo, 18 December 2020

“COVAX, the global initiative to ensure rapid and equitable access to COVID-19 vaccines for all countries, regardless of income level, today announced that it had arrangements in place to access nearly two billion doses of COVID-19 vaccine candidates, on behalf of 190 participating economies. For the vast majority of these deals, COVAX has guaranteed access to a portion of the first wave of production, followed by volume scales as further supply becomes available. The arrangements announced today will enable all participating economies to have access to doses in the first half of 2021, with first deliveries anticipated to begin in the first quarter of 2021 – contingent upon regulatory approvals and countries’ readiness for delivery.

“Given these are arrangements for 2 billion doses of vaccine candidates which are still under development, COVAX will continue developing its portfolio: this will be critical to achieve its goal of securing access to 2 billion doses of safe and effective, approved vaccines that are suitable for all participants’ contexts, and available by the end of 2021. However, today’s announcements offer the clearest pathway yet to end the acute phase of the pandemic by protecting the most vulnerable populations around the world. This includes delivering at least 1.3 billion donor-funded doses of approved vaccines in 2021 to the 92 low- and middle-income economies eligible for the COVAX AMC.

“The new deals announced today include the signing of an advance purchase agreement with AstraZeneca for 170 million doses of the AstraZeneca/Oxford candidate, and a memorandum of understanding (MoU) with Johnson & Johnson for 500 million doses of the Janssen candidate, which is currently being investigated as a single dose vaccine.. These deals are in addition to existing agreements COVAX has with the Serum Institute of India (SII) for 200 million doses – with options for up to 900 million doses more – of either the AstraZeneca/Oxford or Novavax candidates, as well as a statement of intent for 200million doses of the Sanofi/GSK vaccine candidate.

“In addition to this, COVAX also has – through R&D partnership agreements – first right of refusal in 2021 to access potentially more than one billion doses (based on current estimates from the manufacturing processes under development) that will be produced, subject to technical success and regulatory approval, by candidates in the COVAX R&D Portfolio.”

* * *

“The COVAX Facility currently has 190 participating economies. This includes 98 higher-income economies and 92 low- and middle-income economies eligible to have their participation in the Facility supported via the financing mechanism known as the Gavi COVAX AMC. Of the 92 economies eligible to be supported by the COVAX AMC, 86 have now submitted detailed vaccine requests, offering the clearest picture yet on actual global demand for COVID-19 vaccines.

“In addition to gathering detailed information on participating economies’ vaccine requests, COVAX, through Gavi, UNICEF,WHO, the World Bank, and other partners has been working closely with all countries in the Facility, particularly AMC-eligible participants, to help plan and prepare for the widespread roll out of vaccines. Conditions that determine country readiness include regulatory preparedness as well as the availability of infrastructure, appropriate legal frameworks, training, and capacity, among other factors.

“’Securing access to doses of a new vaccine for both higher-income and lower-income countries, at roughly the same time and during a pandemic, is a feat the world has never achieved before – let alone at such unprecedented speed and scale,’ said Dr. Seth Berkley, CEO of Gavi, the Vaccine Alliance, which leads on procurement and delivery for COVAX. ‘COVAX has now built a platform that offers the world the prospect, for the first time, of being able to defeat the pandemic on a global basis, but the work is not done: it’s critical that both governments and industry continue to support our efforts to achieve this goal’.

Early pledges towards 2021 fundraising targets

“To achieve this ambitious goal, COVAX currently estimates it needs to raise an additional US$ 6.8 billion in 2021 – US$ 800 million for research and development, at least US$ 4.6 billion for the COVAX AMC and US$ 1.4 billion for delivery support.

“Support for the COVAX AMC will be critical to ensuring ability to pay is not a barrier to access. Thanks to the generous support of sovereign, private sector, and philanthropic donors, the AMC has met its urgent 2020 fundraising target of US$ 2 billion, but at least US$ 4.6 billion more is needed in 2021 to procure doses of successful candidates as they come through the portfolio.”

In the United States and in the EU, governments are looking to expand volumes of proven vaccines while awaiting approval of other vaccine candidates. See Pfizer press release, PFIZER AND BIONTECH TO SUPPLY THE U.S. WITH100 MILLION ADDITIONAL DOSES OF COVID-19VACCINE, December 23, 2020, https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-supply-us-100-million-additional-doses; Pfizer press release, PFIZER AND BIONTECH TO SUPPLY THEEUROPEAN UNION WITH 100 MILLIONADDITIONAL DOSES OF COMIRNATY®, December 29, 2020, https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-supply-european-union-100-million; HHS, Trump Administration purchases additional 100 million doses of COVID-19 investigational vaccine from Moderna, December 11, 2020, https://www.hhs.gov/about/news/2020/12/11/trump-administration-purchases-additional-100-million-doses-covid-19-investigational-vaccine-moderna.html.

Conclusion

The world is anxiously awaiting the resolution of the pandemic through the approval and distribution of effective vaccines on a global basis in 2021. The good news is that a number of vaccines have been approved in one or more countries and billions of doses of approved vaccines will likely be produced in 2021. The efforts of the WHO, GAVI and CEPI and the generosity of many nations, private and philanthropic organizations will mean people in nearly all countries will receive at least some significant volume of vaccines in 2021. As most vaccines require two shots, the number of people vaccinated in 2021 in an optimistic scenario is probably less than two billion. The world population at the beginning of 2021 is 7.8 billion people. Thus, 2021, even under an optimistic scenario, will not likely result in the eradication of the pandemic around the world.

Even in countries like the United States, the United Kingdom and the 27 members of the European Union where advance purchases should result in sufficient doses being available to vaccinate all eligible members of society, there are massive challenges in terms of distribution and vaccinating the numbers of people involved and educating the populations on the safety and benefits of the vaccines. Thus, even in wealthier countries it will be optimistic to achieve the desired levels of vaccination by the end of 2021.

The Director-General of the WHO in his year-end message laid out the likely situation for the world in 2021, the availability of vaccines but the continued need to be vigilant and adhere to preventive measures to control the pandemic and the need to work collectively to ensure equitable and affordable access to vaccines for all. See WHO,COVID-19: One year later – WHO, Director-General’s new year message, December 30, 2020, https://www.who.int/news/item/30-12-2020-covid-19-anniversary-and-looking-forward-to-2021 (Dr Tedros Adhanom Ghebreyesus, WHO Director-General)

“As people around the world celebrated New Year’s Eve 12 months ago, a new global threat emerged.

“Since that moment, the COVID-19 pandemic has taken so many lives and caused massive disruption to families, societies and economies all over the world.

“But it also triggered the fastest and most wide-reaching response to a global health emergency in human history.

“The hallmarks of this response have been an unparalleled mobilization of science, a search for solutions and a commitment to global solidarity.

“Acts of generosity, large and small, equipped hospitals with the tools that health workers needed to stay safe and care for their patients.

“Outpourings of kindness have helped society’s most vulnerable through troubled times.

“Vaccines, therapeutics and diagnostics have been developed and rolled out, at record speed, thanks to collaborations including the Access to COVID-19 Tools Accelerator.

“Equity is the essence of the ACT Accelerator, and its vaccine arm, COVAX, which has secured access to 2 billion doses of promising vaccine candidates.

“Vaccines offer great hope to turn the tide of the pandemic.

“But to protect the world, we must ensure that all people at risk everywhere – not just in countries who can afford vaccines –are immunized.

“To do this, COVAX needs just over 4 billion US dollars urgently to buy vaccines for low- and lower-middle income countries.

“This is the challenge we must rise to in the new year.

“My brothers and sisters, the events of 2020 have provided telling lessons, and reminders, for us all to take into 2021.

“First and foremost, 2020 has shown that governments must increase investment in public health, from funding access to COVID vaccines for all people, to making our systems better prepared to prevent and respond to the next, inevitable, pandemic.

“At the heart of this is investing in universal health coverage to make health for all a reality.

“Second, as it will take time to vaccinate everyone against COVID, we must keep adhering to tried and tested measures that keep each and all of us safe.

“This means maintaining physical distance, wearing face masks, practicing hand and respiratory hygiene, avoiding crowded indoor places and meeting people outside.

“These simple, yet effective measures will save lives and reduce the suffering that so many people encountered in 2020.

“Third, and above all, we must commit to working together in solidarity, as a global community, to promote and protect health today, and in the future.

“We have seen how divisions in politics and communities feed the virus and foment the crisis.

“But collaboration and partnership save lives and safeguard societies.

“In 2020, a health crisis of historic proportions showed us just how closely connected we all are.

“We saw how acts of kindness and care helped neighbors through times of great struggle.

“But we also witnessed how acts of malice, and misinformation, caused avoidable harm.

“Going into 2021, we have a simple, yet profound, choice to make:

“Do we ignore the lessons of 2020 and allow insular, partisan approaches, conspiracy theories and attacks on science to prevail, resulting in unnecessary suffering to people’s health and society at large?

“Or do we walk the last miles of this crisis together, helping each other along the way, from sharing vaccines fairly, to offering accurate advice, compassion and care to all who need, as one global family.

“The choice is easy.

“There is light at the end of the tunnel, and we will get there by taking the path together.

“WHO stands with you – We Are Family and we are In This Together.

“I wish you and your loved ones a peaceful, safe and healthy new year.”

We all want to have the COVID-19 pandemic in the rearview mirror as 2021 progresses. There is hope for significant progress this year. How much progress will depend on the will of governments and peoples to focus on the eradication of the pandemic and to support the dramatic ramp up of production, distribution and vaccination of the world’s people.

India and South Africa Seek Waiver from WTO Intellectual Property Obligations to Address COVID-19 — Issues Presented

India and South Africa submitted a communication to the WTO Council for Trade-Related Aspects of Intellectual Property Rights entitled “Waiver from Certain Provisions of the TRIPS Agreement for the Prevention,
Containment and Treatment of COVID-19.” IP/C/W/699 (October 2, 2020). The document and correction are embedded below.

W669

W669C1

The waiver request was made part of the agenda of the Council for TRIPS agenda for its meeting on October 15-16. The WTO Secretariat provided a short press release on the TRIPS Council meeting. The discussion on the waiver proposal is quoted below.

“Some 40 members engaged in a substantive discussion on a proposal submitted by India and South Africa for a temporary waiver of certain TRIPS obligations they said would facilitate an appropriate response to COVID-19. The proposal suggests a waiver for all WTO members on the implementation, application and enforcement of certain provisions of the TRIPS Agreement in relation to the “prevention, containment or treatment” of COVID-19. The proponents argued this would avoid barriers to the timely access to affordable medical products including vaccines and
medicines or to scaling-up of research, development, manufacturing and supply of essential medical products.

“The waiver would cover obligations in four sections of Part II of the TRIPS Agreement (https://www.wto.org/english/docs_e/legal_e/27-trips_04_e.htm) — Section 1 on copyright and related rights, Section 4 on industrial designs, Section 5 on patents and Section 7 on the protection of undisclosed information. It would last for a specific number of years, as agreed by the General Council, and until widespread vaccination is in place globally and the majority of the world’s population is immune. Members would review the waiver annually until its termination.

“According to the proponents, an effective response to the COVID-19 pandemic requires rapid access to affordable medical products such as diagnostic kits, medical masks, other personal protective equipment and ventilators as well as vaccines and medicines. The outbreak has led to a swift increase in global demand, with many countries facing shortages, constraining the ability to effectively respond to the outbreak. As new diagnostics, therapeutics and vaccines for COVID-19 are developed, there were significant concerns about how these will be made available
promptly in sufficient quantities and at affordable prices to meet global demand.

“The proponents argued that many countries — especially developing countries — may face institutional and legal difficulties when using TRIPS flexibilities, including the special compulsory licensing mechanism provided for in Article 31bis (https://www.wto.org/english/res_e/publications_e/ai17_e/trips_art31_bis_oth.pdf), which they saw as a cumbersome process for the import and export of pharmaceutical products. Now was the time for the WTO as an organization to rise up to the collective call for defeating the pandemic. The WTO would not succeed in its efforts to rebuild the COVID-19 affected economies unless it acts now to first save those lives that are going to build these economies. It is time for members to take collective responsibility and put people’s lives before anything else, they concluded.

“While a number of developing and least developed country members welcomed the proposal as a contribution to the discussion, many were still studying it in their capitals and asked for clarification on certain points, particularly regarding its practical implementation and the possible economic and legal impact of the waiver at national level. A number of developing and developed country members opposed the waiver proposal, noting that there is no indication that intellectual property rights (IPRs) have been a genuine barrier to accessing COVID-19 related medicines and technologies.

“While acknowledging that the sustained and continued supply of such medicines and technologies is a difficult task, they observed that non-efficient and underfunded health care and procurement systems, spiking demand and lack of manufacturing capacity are much more likely to impede access to these materials. In the view of these members, solutions can be legitimately sought within the existing IP system as the TRIPS Agreement provides enough tools and sufficient policy space for members to take measures to protect public health. The suspension of IPRs,
even for a limited period of time, was not only unnecessary but it would also undermine the collaborative efforts to fight the pandemic that are already under way.

“Given this range of positions, the Council chair, Ambassador Xolelwa Mlumbi-Peter of South Africa, said that the item would remain suspended as members continue to consider the proposal. Requests for waivers concerning WTO agreements must be submitted initially to the relevant council for consideration. After 90 days, the TRIPS Council has to submit a report to the Ministerial Conference. Given that the proposal was submitted on 2 October, the 90-day time-period expires on 31 December 2020. The TRIPS Council meeting will be reconvened on the item of the waiver proposal as appropriate before that date, the chair said.”

WTO, 20 October 2020, Members discuss intellectual property response to the COVID-19 pandemic, https://www.wto.org/english/news_e/news20_e/trip_20oct20_e.htm.

Waiver provisions in the WTO

Article IX:3 and 4 of the Marrakesh Agreement Establishing the World Trde Organization deal with waivers from obligations WTO Members have assumed.

“Article IX

“Decision-Making

” * * *

“3.   In exceptional circumstances, the Ministerial Conference may decide to waive an obligation imposed on a Member by this Agreement or any of the Multilateral Trade Agreements, provided that any such decision shall be taken by three fourths of the Members unless otherwise provided for in this paragraph.

“(a)    A request for a waiver concerning this Agreement shall be submitted to the Ministerial Conference for consideration pursuant to the practice of decision-making by consensus. The Ministerial Conference shall establish a time-period, which shall not exceed 90 days, to consider the request. If consensus is not reached during the time-period, any decision to grant a waiver shall be taken by three fourths of the Members.
 

“(b)    A request for a waiver concerning the Multilateral Trade Agreements in Annexes 1A or 1B or 1C and their annexes shall be submitted initially to the Council for Trade in Goods, the Council for Trade in Services or the Council for TRIPS, respectively, for consideration during a time-period which shall not exceed 90 days. At the end of the time-period, the relevant Council shall submit a report to the Ministerial Conference.

“4.   A decision by the Ministerial Conference granting a waiver shall state the exceptional circumstances justifying the decision, the terms and conditions governing the application of the waiver, and the date on which the waiver shall terminate. Any waiver granted for a period of more than one year shall be reviewed by the Ministerial Conference not later than one year after it is granted, and thereafter annually until the waiver terminates. In each review, the Ministerial Conference shall examine whether the exceptional circumstances justifying the waiver still exist and whether the terms and conditions attached to the waiver have been met. The Ministerial Conference, on the basis of the annual review, may extend, modify or terminate the waiver.”

Some questions from the waiver proposal

The waiver proposal put forward by India and South Africa is extraordinarily broad – covering all WTO Members for a broad range of products not clearly delineated, with the waiver of a broad array of TRIPS obligations without a demonstration of the relevance of the requests for some (e.g., copyright) for a potentially lengthy period of time.

The proposal raises a series of questions that should be addressed to understand whether the waiver is appropriate. These questions include whether such a broad waiver request is appropriate or envisioned by Article IX:3 and 4 of the Marrakesh Agreement? Shouldn’t those requesting a waiver be required to demonstrate that the existing flexibilities within the TRIPS Agreement are inadequate to address concerns they may have? Can two Members request a waiver of obligations for all WTO Members? Can a waiver request be considered where the product scope is lacking clarity, and the uses/needs of the waiver are very broad and potentially open to differing views? To what extent is there a need for those seeking a waiver to present a factual record of actions being taken by governments, companies and international organizations to provide access to medical goods during the pandemic including to developing and least developed countries? Shouldn’t those seeking a waiver identify the extent of existing licenses by major pharmaceutical companies with them or other WTO Members for the production of vaccines or therapeutics to address COVID-19?

Historical usage of waivers have not been as broad as that requested by India and South Africa

Waivers are exceptional by their nature and Article IX:3 talks in terms of a waiver of some obligation for a particular Member, not the waiver of many parts of an agreement for all members. When one looks at waivers granted previously by the WTO, one sees a range of topics — many relate to time for Members to implement changes from updates of the harmonized tariff systems (for individual countries who sought the temporary waiver), some pertain to preferential arrangements between one Member and another or a group of Members and some pertain to waiver of deadlines or specific obligations for least developed countries. Two documents prepared by the WTO Secretariat show waivers granted or continuing in existence in 2019 and all waivers between 1995 AND 2015. The two documents are embedded below.

W795

W718

Thus, the present request for a waiver by India and South Africa doesn’t seem to comply with the literal terms of Article IX:3 of the Marrakesh Agreement or with the much more narrow scope of waivers typically considered. As reviewed above, the request would apply to all members, not just India and South Africa. The request also seems overly broad both in terms of products (not clearly defined), uses and provisions to be waived.

Existing flexibilities within the TRIPs Agreement

Because of the importance to all WTO Members of the health of their citizens, there has been a lot of focus and discussion within the WTO on the interface between intellectual property and public health. Under the original TRIPs Agreement and the subsequent amendment to the Agreement in 2005 that took effect as Article 31bis to the TRIPs Agreement in 2017, there is flexibility within the TRIPs Agreement for Members to deal with health emergencies including through compulsory licensing which can include the right to manufacture and export to developing and least developed countries who don’t have pharmaceutical manufacturing capabilities in-country. See TRIPs Agreement Article 31, Article 31bis and WT/L/641. The current language of Articles 31 and 31bis from the patent portion of the TRIPS Agreement are presented below.

Article 31 Other Use Without Authorization of the Right Holder

“Where the law of a Member allows for other use (7) of the subject matter of a patent without the authorization of the right holder, including use by the government or third parties authorized by the government, the following provisions shall be respected:

“(a)  authorization of such use shall be considered on its individual merits;
 

“(b)  such use may only be permitted if, prior to such use, the proposed user has made efforts to obtain authorization from the right holder on reasonable commercial terms and conditions and that such efforts have not been successful within a reasonable period of time. This requirement may be waived by a Member in the case of a national emergency or other circumstances of extreme urgency or in cases of public non-commercial use. In situations of national emergency or other circumstances of extreme urgency, the right holder shall, nevertheless, be notified as soon as reasonably practicable. In the case of public non-commercial use, where the government or contractor, without making a patent search, knows or has demonstrable grounds to know that a valid patent is or will be used by or for the government, the right holder shall be informed promptly;
 

“(c)  the scope and duration of such use shall be limited to the purpose for which it was authorized, and in the case of semi-conductor technology shall only be for public non-commercial use or to remedy a practice determined after judicial or administrative process to be anti-competitive;
 

“(d)  such use shall be non-exclusive;
 

“(e)  such use shall be non-assignable, except with that part of the enterprise or goodwill which enjoys such use;
 

“(f)  any such use shall be authorized predominantly for the supply of the domestic market of the Member authorizing such use;
 

 “(g)  authorization for such use shall be liable, subject to adequate protection of the legitimate interests of the persons so authorized, to be terminated if and when the circumstances which led to it cease to exist and are unlikely to recur. The competent authority shall have the authority to review, upon motivated request, the continued existence of these circumstances;
 

“(h)  the right holder shall be paid adequate remuneration in the circumstances of each case, taking into account the economic value of the authorization;
 

“(i)  the legal validity of any decision relating to the authorization of such use shall be subject to judicial review or other independent review by a distinct higher authority in that Member;
 

“(j)  any decision relating to the remuneration provided in respect of such use shall be subject to judicial review or other independent review by a distinct higher authority in that Member;
 

“(k)  Members are not obliged to apply the conditions set forth in subparagraphs (b) and (f) where such use is permitted to remedy a practice determined after judicial or administrative process to be anti-competitive. The need to correct anti-competitive practices may be taken into account in determining the amount of remuneration in such cases. Competent authorities shall have the authority to refuse termination of authorization if and when the conditions which led to such authorization are likely to recur;
 

“(l)  where such use is authorized to permit the exploitation of a patent (“the second patent”) which cannot be exploited without infringing another patent (“the first patent”), the following additional conditions shall apply:
 

“(i)  the invention claimed in the second patent shall involve an important technical advance of considerable economic significance in relation to the invention claimed in the first patent;
 

“(ii) the owner of the first patent shall be entitled to a cross-licence on reasonable terms to use the invention claimed in the second patent; and
 

“(iii)  the use authorized in respect of the first patent shall be non-assignable except with the assignment of the second patent.

Article 31bis

“1. The obligations of an exporting Member under Article 31(f) shall not apply with respect to the grant by it of a compulsory licence to the extent necessary for the purposes of production of a pharmaceutical product(s) and its export to an eligible importing Member(s) in accordance with the terms set out in paragraph 2 of the Annex to this Agreement.

“2. Where a compulsory licence is granted by an exporting Member under the system set out in this Article and the Annex to this Agreement, adequate remuneration pursuant to Article 31(h) shall be paid in that Member taking into account the economic value to the importing Member of the use that has been authorized in the exporting Member. Where a compulsory licence is granted for the same products in the eligible importing Member, the obligation of that Member under Article 31(h) shall not apply in respect of those products for which remuneration in accordance with the first sentence of this paragraph is paid in the exporting Member.

“3. With a view to harnessing economies of scale for the purposes of enhancing purchasing power for, and facilitating the local production of, pharmaceutical products: where a developing or least developed country WTO Member is a party to a regional trade agreement within the meaning of Article XXIV of the GATT 1994 and the Decision of 28 November 1979 on Differential and More Favourable Treatment Reciprocity and Fuller Participation of Developing Countries (L/4903), at least half of the current membership of which is made up of countries presently on the United Nations list of least developed countries, the obligation of that Member under Article 31(f) shall not apply to the extent necessary to enable a pharmaceutical product produced or imported under a compulsory licence in that Member to be exported to the markets of those other developing or least developed country parties to the regional trade agreement that share the health problem in question. It is understood that this will not prejudice the territorial nature of the patent rights in question.

“4. Members shall not challenge any measures taken in conformity with the provisions of this Article and the Annex to this Agreement under subparagraphs 1(b) and 1(c) of Article XXIII of GATT 1994.

“5. This Article and the Annex to this Agreement are without prejudice to the rights, obligations and flexibilities that Members have under the provisions of this Agreement other than paragraphs (f) and (h) of Article 31, including those reaffirmed by the Declaration on the TRIPS Agreement and Public Health (WT/MIN(01)/DEC/2), and to their interpretation. They are also without prejudice to the extent to which pharmaceutical products produced under a compulsory licence can be exported under the provisions of Article 31(f).”

The WTO Secretariat has a page on its website that discusses intellectual property and the public interest, https://www.wto.org/english/tratop_e/trips_e/trips_and_public_interest_e.htm, which reviews both flexibilities for Members in addressing public interest needs as well as current topics being discussed within the TRIPS Council. There also have been publications by the WTO Secretariat, WIPO and WHO on flexibilities in accessing medical technologies. See, e.g., WTO, WIPO and WHO, Promoting Access to Medical Technologies and Innovation, SECOND EDITION, https://www.wto.org/english/res_e/booksp_e/who-wipo-wto_2020_e.pdf. And on October 21, 2020 the WTO held a technical workshop on health, trade and intellectual property in addressing COVID-19. See 21 October 2020, WTO workshop on health, trade and intellectual property: an integrated approach to COVID-19; https://www.wto.org/english/news_e/news20_e/heal_21oct20_e.htm. There is a lengthy combined powerpoint presentation available from the webpage which was used in the workshop.

Thus, there can be no doubt that the WTO TRIPS Agreement provides significant flexibilities to Members to address health emergencies. The waiver proposal from India and South Africa doesn’t review any actual efforts to utilize the flexibilities but just opines that Members won’t be able to effectively utilize them. Such an approach should not be acceptable for such far reaching requests as the proposal from India and South Africa.

Ongoing efforts by governments, companies and organizations to make medical goods available to developing and least developed countries

Strangely missing from the waiver request submitted by India and South Africa is any mention of the global efforts underway to ensure access to medical goods and vaccines and therapeutics as approved.

There have been various fund raising efforts in 2020 to provide the necessary wherewithal to organizations focused on developing vaccines for global distribution or focused on the distribution of medical goods, vaccines and therapeutics globally.

CEPI and GAVI in coordination with the WHO have extensive efforts underway, including access to large manufacturing capacity for approved vaccines within the pool of vaccines being developed and included in the CEPI portfolio.

In addition, some private companies involved in manufacturing vaccines under development have licensing arrangements with certain producers for distribution to developing and least developing countries. Some companies have made access to the drawings of their medical equipment available to any company wishing to produce the equipment.

Thus, it is hard to understand a need for a broad waiver when there is considerable international cooperation and substantial vaccine capacity available for some of the vaccines in late stage testing. The WTO membership deserves to have a full compilation of developments and existing actions to facilitate access to medical supplies for developing and least developed countries. The India and South Africa waiver proposal provides none of the relevant information.

While it is not the purpose of this post to develop the full factual record, I provide below some links which supply some information on ongoing developments. See The Guardian, October 20, 2020, India at heart of global efforts to produce Covid vaccine, Country plays central role in development, manufacture, and possible distribution of potential vaccines, https://www.theguardian.com/world/2020/oct/20/india-at-heart-of-global-efforts-to-produce-covid-vaccine (“A deal has already been struck for the Serum Institute of India, based in the city of Pune, to produce 1bn doses of the the Oxford/AstraZeneca vaccine, seen as the forerunner in the vaccine race.” “Johnson and Johnson, whose Covid-19 vaccine is also in phase 3 clinical trials, has struck a deal with the Indian pharmaceutical company Biological E to produce up to 500m doses if successful.” “Bharat Biotech, a Hyderabad-based pharmaceutical company, has a deal to manufacture 1bn doses of Washington University’s intranasal vaccine, now in clinical trials, and Indian pharmaceutical giant Dr Reddy’s has a deal to do a phase 2/3 human trials in India of Russia’s controversial Sputnik vaccine and then produce 100m doses. There are also at least a dozen indigenous vaccines being developed within India. ” “Poonawalla of the Serum Institute said that ‘50% of whatever quantity we manufacture will be kept for India and the remaining will go to low- and middle-income countries.'”).

GAVI, the Vaccine Alliance, October 15, 2020, COVID-19 SITUATION REPORT #19, https://www.gavi.org/sites/default/files/covid/Gavi-COVID-19-Situation-Report-19-20201015.pdf (“COVAX is the vaccines pillar of the Access to COVID-19 Tools (ACT) Accelerator, co-led by Gavi, the Coalition
for Epidemic Preparedness Innovations (CEPI) and WHO. Gavi is coordinating the development and implementation of the COVAX Facility, the global procurement mechanism of COVAX. The COVAX Facility will make investments across a broad portfolio of promising vaccine candidates (including those being supported by CEPI) to make sure at-risk investment in manufacturing happens now. Gavi is also coordinating the development and implementation of the Gavi COVAX Advance Market Commitment (AMC), the financing instrument that will support the participation of 92 low- and middle-income countries and economies in the COVAX Facility.
The goals of the COVAX Facility and AMC include:
“❖ to support the largest actively managed portfolio of vaccine candidates globally
“❖ to deliver 2 billion doses by the end of 2021
“❖ to offer a compelling return on investment by delivering COVID-19 vaccines as quickly as possible
“❖ to guarantee fair and equitable access to COVID-19 vaccines for all participants
“❖ to end the acute phase of the pandemic by the end of 2021”).

CEPI, October 21, 2020, CEPI expands global manufacturing network, reserving manufacturing capacity for more than 1billion doses of COVID-19 vaccines, https://www.gavi.org/vaccineswork/cepi-expands-global-manufacturing-network-reserving-manufacturing-capacity-over-1-billion-doses (“CEPI signs agreements with Biofabri (Spain) and GC Pharma (Republic of Korea) to reserve vaccine manufacturing capacity for more than 1 billion doses of COVID-19 vaccines designated by CEPI.
CEPI’s strategic investments in vaccine manufacturing at facilities around the world will support the COVAX goal to produce 2 billion doses of safe and effective vaccine by the end of 2021.”).

Conclusion

There is no doubt that the COVID-19 pandemic presents a global health crisis. In response to the crisis there have been activities within the WTO to minimize restrictions on the movement of medical goods and a workshop looking at the interface of trade, intellectual property and public health to help Members address internal needs. The TRIPS Agreement has various flexibilities to permit Members to address health challenges. At the same time there have been extraordinary efforts by many governments, companies and international organizations to cooperate both to develop vaccines and therapeutics but also to speed up manufacturing and work towards equitable distribution of medical goods. Leading pharmaceutical companies have already entered into licensing arrangements to provide billions of doses of vaccines when approved to developing and least developing countries. GAVI and CEPI in coordination with the WHO are working on supporting various vaccine development, securing manufacturing capacity and raising funds to permit broad distribution of vaccines and other products to countries in need and others who have contributed to the group effort.

So factually, it is hard to understand the waiver request filed by India and South Africa. Against a backdrop of how waivers have been used in the past and the lack of a demonstration that existing flexibilities won’t provide acceptable answers, the waiver proposal also is deficient in terms of legal justification. The proposal is not justified, is too broad both in terms of product coverage, Members who would be given waivers, and the range of
TRIPS provisions that would be waived for some number of years.

These are serious problems with a proposal that requires TRIPS Council action and referral to the General Council by the end of the year. Thus, the TRIPS Council should recommend against acceptance of the waiver proposal put forward by India and South Africa.


Transparency on trade actions surrounding the COVID-19 pandemic

Global confirmed cases of COVID-19 will reach two million today, April 15, with the actual number likely much higher and with deaths over 125,000. Nearly every country on earth has at least some confirmed cases.

Different countries and territories are at different stages in dealing with COVID-19 infections, with China, South Korea and Singapore seemingly well past the worst of the first wave of infections. Countries in Europe and various states within the United States are also seeing the rate of infection flatten or even decline following weeks of stay-at-home orders, social distancing and drastic changes to daily life. Hot spots are shifting both within countries (e.g., the United States) and to different countries.

The economic cost of closing down portions of economies has been unprecedented with the IMF characterizing the hit on global GDP to be the worst since the great depression of the 1930s. https://www.imf.org/en/Publications/WEO/Issues/2020/04/14/weo-april-2020. To avoid even worse economic fallout, countries are pouring huge sums into their economies to prevent massive bankruptcies, limit unemployment and provide expanded social safety nets. Press reports suggest at least $8 trillion has been committed with more being considered in various countries.

For countries who are witnessing likely GDP reductions of as much as 35% in one of the first two quarters of 2020, governments are mapping out scenarios for reopening closed portions of their economies if they have been recent epicenters or engaged in phased reopening if apparently largely past the first phase. Such planning is occurring at the subnational, national or trading bloc level (EU) with little apparent effort to coordinate efforts around the world. Where plans are being discussed publicly, common elements appear to be expanded and harmonized testing (both for the infection and for antibodies), ability to do tracing of individuals who have been in contact with individuals found to have the virus to secure quarantining, capacity of the healthcare system to handle cases, and adequacy of supplies. Concerns about privacy interests are also part of the discussion/needs for democracies. See, e.g., European Commission roadmap released April 15, 2020, https://ec.europa.eu/commission/presscorner/detail/en/ip_20_652; https://ec.europa.eu/info/sites/info/files/communication_-_a_european_roadmap_to_lifting_coronavirus_containment_measures_0.pdf

For most of the developing and least developed countries, the pandemic has yet to show its full force. Many of these countries have inadequate healthcare infrastructure and don’t have the internal manufacturing capabilities or financial resources to handle the pandemic without assistance if they become an epicenter.

The world has seen limited actual coordination of efforts by major players despite commitments by G20 countries although funding for multilateral institutions like the IMF have been increased to facilitate expanded efforts for the weakest countries. There also seems to be an exchange of information and some cooperation in the research efforts underway to find a vaccine.

Many countries who have been hard hit by the pandemic were slow to recognize the extent of the challenge and often slow in implementing comprehensive actions which has exacerbated the challenges, the loss of life and the harm to their economies. This has led to some lack of transparency at least in the early days and perhaps a reluctance for greater cooperation.

The pandemic’s spread has led to extraordinary gaps in supply availability versus short term demand requirements. For example, the OECD indicated that China, which manufactures half of the world supply of masks, found demand for masks at the peak of the crisis in China at ten times the beginning manufacturing capability of the country. Even after ramp up of production, demand in China was twice as large as the dramatically expanded manufacturing capabilities until the country’s infection rate declined. With both the EU and the US going through huge expansions of COVID-19 cases in March and into April, the global shortage problem has been continued and magnified despite additional capacity expansions occurring in other countries.

With no current vaccine to deal with the infections, countries faced with expanding case loads have often shifted to imposing export restraints to prevent loss of scarce supplies, encouraging expanded production, and using other tactics to address domestic demand even if reducing supply to other countries or even if local actions are counterproductive because of global supply chains and similar actions by others. Export restraints have been imposed by close to 70 countries or territories and include actions by China, the EU, the United States and many others, though restraints are arguably temporary and may have exceptions depending on the country applying the restraints. And countries who had export restraints at one point, may be significant exporters later (China) or had been exporters to hard hit countries prior to ramp up of internal demand (e.g., U.S. to China).

Importance of transparency in times of crisis

Each government attempts to provide some level of transparency to its citizens and businesses on actions it is taking. Members of the WTO have committed to providing information on trade measures taken to respond to COVID-19 and groups of countries (G20) have supported that effort. As of April 14th, WTO Members had provided 49 notifications of trade actions related to COVID-19 that either restricted goods or liberalized movement of goods https://www.wto.org/english/tratop_e/covid19_e/covid19_e.htm. While this is a start, there are likely dozens or hundreds of other actions that have not been notified as yet (including actions that may have been withdrawn after a period of time). The lack of full transparency by WTO Members is unfortunate and prevents other Members to understand the reality around the world or to understand potential best practices by other trading partners.

Some business trade associations have put together data bases of actions addressing particular actions important to their members. For example, the Baltic and International Maritime Council (“BiMCO”) has compiled and updates port restrictions/requirements including ability of crew to depart cargo ships in ports, etc. https://www.bimco.org/ships-ports-and-voyage-planning/crew-support/health-and-medical-support/novel-coronavirus—implementation-measures. Similarly, IATA has collected and updates data on requirements for airlines (passenger and air cargo) by country. https://www.iata.org/en/programs/safety/health/diseases/government-measures-related-to-coronavirus/. The data compiled is obviously important for the ships and planes moving cargo internationally. So transparency exists because of efforts of business associations. Unfortunately, one does not see any effort by governments to harmonize requirements across countries to simplify and reduce the costs of moving essential goods.

It does not appear that there are readily accessible data on all suppliers globally of essential medical goods, capacity expansions, current bottlenecks, product availability, etc. It is not clear if such data could be compiled by industry associations or by governments. Presumably such information would be important for a global effort to maximize availability of products to all countries during the pandemic, identify ongoing shortages, prioritize where additional products are needed and so forth. The lack of such information has to be a major shortfall in the transparency needs to effectively deal with the pandemic.

Individual governments, of course, address internal needs on an ongoing basis through notices, regulations, etc. Many of these actions could be notified to international organizations (e.g., to the WTO) in addition to being available domestically. Expanding notifications would improve transparency and potentially encourage other governments to adopt best practices of other countries.

In the United States, many agencies, as well as the White House, are involved in different aspects of keeping goods moving during the pandemic or in restricting the export of such goods. For example, to look just at a few of the agencies involved in the United States, the State Department has made announcements on ensuring H-2 visas for farm workers. https://travel.state.gov/content/travel/en/News/visas-news/important-announcement-on-h2-visas.html. Homeland Security and Customs and Border Protection have taken various actions to expedite clearance of essential goods or implement Administration restrictions on the export of goods. https://www.fema.gov/news-release/2020/04/08/fema-covid-19-supply-chain-task-force-supply-chain-stabilization; https://www.cbp.gov/newsroom/coronavirus. The Department of Agriculture and the Food and Drug Administration have issued various notices addressing special needs for agricultural goods with the collapse of food service sector which supplies restaurants (e.g., temporary waiver of requirements for country of origin information or certain labeling requirements for goods originally destined for food service that are being sold at retail). https://www.usda.gov/coronavirus; https://www.ams.usda.gov/content/usda-announces-labeling-flexibilities-facilitate-distribution-food-retail-locations; https://www.fda.gov/emergency-preparedness-and-response/counterterrorism-and-emerging-threats/coronavirus-disease-2019-covid-19. FEMA, EXIM and others are all playing roles as well.

Conclusion

The COVID-19 pandemic has created extraordinary challenges for the health of the world’s peoples and has imposed unimaginable costs to the global and national economies. As countries work through their individual challenges, there are a spectrum of options to pursue that will reduce or expand the human and economic costs of the pandemic. International organizations are only as strong as their member governments permit them to be. Many observers have lamented the lack of global leadership. Such lack of leadership handicaps the ability and likelihood of countries to minimize the damage from the pandemic and to prepare better for future challenges. Transparency should be the bare minimum we receive from the world’s governments. While there is certainly some transparency on COVID-19 and trade actions being taken (better in some countries than others), we are not maximizing the benefits that broad-based transparency would make available for countries individually or acting collectively. There is still time for a better effort. There are real costs for failing to do all that can be done on this issue.

Food security – export restraints and border controls during the COVID-19 pandemic

While COVID-19 is first and foremost a health crisis, efforts to control the fallout from the virus have led to border controls on farm workers and encouraged some countries to impose export restraints on particular agricultural products. While the border control dimension to the problem is new, the world has in recent years gone through a number of situations where large numbers of countries have imposed export restraints on core agricultural products in an effort to ensure adequate supplies at home. The results are never positive for the global community and particularly harm the least developed countries and those dependent on imported food products.

For example, in 2007-2008, there were dozens of countries that imposed export restraints on specific items such as rice or wheat leading to massive price spikes and shortages of product available to countries dependent on imports. The nature and extent of the problem was outlined in a paper I prepared back in 2008 which is embedded below.

GDP

The crisis led to coordinated efforts by the various UN organizations to find solutions and ways of avoiding repeats moving forward. A policy report from multiple UN agencies was released on 2 June 2011, Price Volatility in Food and Agricultural Markets: Policy Responses.

igo_10jun11_report_e

Unfortunately, a number of countries in reacting to the COVID-19 pandemic have introduced export restraints on certain food products. Russia, Ukraine, Kazakhstan, and Vietnam are some of the countries identified so far as introducing export restraints on selected agricultural products. In the past, export restraints by some have led to export restraints by many. The possibility of rapidly expanding restraints by trading nations is obviously a major concern and major complication to the global response to COVID-19.

Equally troubling are the potential challenges to agricultural product availability in countries that rely to some extent on temporary foreign labor to harvest produce and other products where border measures are restricting access of foreigners to reduce the potential spread of COVID-19. Coupled to that are concerns about whether imported agricultural products meet health and quality needs and any changes in approach to those issues during the pandemic.

As one example of the farm labor concern, the United States is a country that relies on temporary farm workers from outside of the country and has significant restrictions on the entry of foreign nationals from many areas at present. U.S. farmers have raised concerns about the availability of sufficient migrant labor to harvest the fields when product is ready. How the issue gets resolved in the United States is not yet clear. But the same or similar challenges will apply in any country where imported farm labor is important to the harvesting, processing or transporting of agricultural products.

That these multiple potential issues on agricultural goods trade are escalating can be seen in yesterday’s joint statement from the WTO, WHO and FAO. The joint statement is available on the WTO webpage, https://www.wto.org/english/news_e/news20_e/igo_26mar20_e.htm, and is reproduced below:

“Joint Statement by QU Dongyu, Tedros Adhanom Ghebreyesus and Roberto Azevêdo, Directors-General of FAO, WHO and WTO

“Millions of people around the world depend on international trade for
their food security and livelihoods. As countries move to enact measures
aiming to halt the accelerating COVID-19 pandemic, care must be taken
to minimise potential impacts on the food supply or unintended
consequences on global trade and food security.

“When acting to protect the health and well-being of their citizens,
countries should ensure that any trade-related measures do not disrupt
the food supply chain. Such disruptions including hampering the
movement of agricultural and food industry workers and extending
border delays for food containers, result in the spoilage of perishables and increasing food waste. Food trade restrictions could also be linked
to unjustified concerns on food safety. If such a scenario were to
materialize, it would disrupt the food supply chain, with particularly
pronounced consequences for the most vulnerable and food insecure
populations.

“Uncertainty about food availability can spark a wave of export
restrictions, creating a shortage on the global market. Such reactions can
alter the balance between food supply and demand, resulting in price
spikes and increased price volatility. We learned from previous crises
that such measures are particularly damaging for low-income, food-deficit
countries and to the efforts of humanitarian organizations to procure food for those in desperate need.

“We must prevent the repeat of such damaging measures. It is at times like this that more, not less, international cooperation becomes vital. In the midst of the COVID-19 lockdowns, every effort must be made to ensure that trade flows as freely as possible, specially to avoid food shortage. Similarly, it is also critical that food producers and food workers at processing and retail level are protected to minimise the spread of the disease within this sector and maintain food supply chains. Consumers, in particular the most vulnerable, must continue to be able to access food within their communities under strict safety requirements.   

“We must also ensure that information on food-related trade measures, levels of food production, consumption and stocks, as well as on food prices, is available to all in real time. This reduces uncertainty and allows producers, consumers and traders to make informed decisions. Above all, it helps contain ‘panic buying’ and the hoarding of food and other essential items.

“Now is the time to show solidarity, act responsibly and adhere to our common goal of enhancing food security, food safety and nutrition and improving the general welfare of people around the world.  We must ensure that our response to COVID-19 does not unintentionally create unwarranted shortages of essential items and exacerbate hunger and malnutrition.”

Conclusion

There is little doubt that COVID-19 is placing extraordinary strains on countries, their peoples, their economies and the ability and willingness to act globally as opposed to locally. The strains and how the world reacts will shape the world going forward and determine the magnitude of the devastation that occurs in specific markets and the broader global community.

The UN report released yesterday, Shared responsibility, global solidarity: Responding to the socio-economic impacts of COVID-19, and the statement from UN Secretary-General Antonio Guterres outline the enormity of the global challenges and a potential path to a better future. See https://news.un.org/en/story/2020/03/1060702; https://reliefweb.int/sites/reliefweb.int/files/resources/sg_report_socio-economic_impact_of_covid19.pdf.

The global health emergency is significantly worsened by the introduction of food security issues. Despite a better understanding of the causes and necessary approaches to minimize food security issues, the world has a poor track record on working for the collective good in agriculture when fears of food availability arise. An eruption of export restraints at the time of the global COVID-19 health crisis could indeed undermine societal stability.

Export restraints vs. trade liberalization during a global pandemic — the reality so far with COVID-19

The number of confirmed coronavirus cases (COVID-19) as of March 26, 2020 was approaching 500,000 globally, with the rate of increase in cases continuing to surge in a number of important countries or regions (e.g., Europe and the United States) with the locations facing the greatest strains shifting over time.

In an era of global supply chains, few countries are self-sufficient in all medical supplies and equipment needed to address a pandemic. Capacity constraints can occur in a variety of ways, including from overall demand exceeding the supply (production and inventories), from an inability or unwillingness to manage supplies on a national or global basis in an efficient and time responsive manner, by the reduction of production of components in one or more countries reducing the ability of downstream producers to complete products, by restrictions on modes of transport to move goods internationally or nationally, from the lack of availability of sufficient medical personnel or physical facilities to handle the increased work load and lack of facilities.

The reality of exponential growth of COVID-19 cases over weeks within a given country or region can overwhelm the ability of the local health care system to handle the skyrocketing demand. When that happens, it is a nightmare for all involved as patients can’t be handled properly or at all in some instances, death rates will increase, and health care providers and others are put at risk from a lack of adequate supplies and protective gear. Not surprisingly, shortages of supplies and equipment have been identified in a number of countries over the last three months where the growth in cases has been large. While it is understandable for national governments to seek to safeguard supplies of medical goods and equipment to care for their citizens, studies over time have shown that such inward looking actions can be short sighted, reduce the global ability to handle the crisis, increase the number of deaths and prevent the level of private sector response that open markets would support.

As we approach the end of March, the global community receives mixed grades on their efforts to work jointly and to avoid beggar-thy-neighbor policies. Many countries have imposed one or more restraints on exports of medical supplies and equipment with the number growing rapidly as the spread of COVID-19 outside of China has escalated particularly in March. Indeed, when one or more countries impose export restraints, it often creates a domino effect as countries who may depend in part on supplies from one or more of those countries, decides to impose restraints as well to limit shortages in country.

At the same time, the G-7, G-20 and others have issued statements or other documents indicating their political desire to minimize export restraints and keep trade moving. The WTO is collecting information from Members on actions that have been taken in response to COVID-19 to improve transparency and to enable WTO Members to identify actions where self-restraint or roll back would be useful. And some countries have engaged in unilateral tariff reductions on critical medical supplies and equipment.

Imposition of Export Restraints

The World Customs Organization has developed a list of countries that have imposed some form of export restraint in 2020 on critical medical supplies. In reviewing the WCO website today, the following countries were listed: Argentina, Bulgaria, Brazil, Colombia, Ecuador, European Union, India, Kazakhstan, Kyrgyzstan, Russia, Serbia, Thailand, Ukraine and Vietnam. Today’s listing is copied below.

List-of-Countries-having-adopted-temporary-export-control-measures-Worl.._

While China is not listed on the WCO webpage, it is understood that they have had some restrictions in fact at least during the January-February period of rapid spread of COVID-19 in China.

While it is surprising to see the European Union on the list, the Official Journal notice of the action indicates that the action is both temprary (six weeks – will end around the end of April) and flows in part from the fact that sources of product used by the EU had been restricting exports. The March 15, 2020 Official Journal notice is attached below.

EC-Implementing-Regulation-EU-2020-402-of-14-March-2020-making-the-exportation-of-certain-products-subject-to-the-production-of-an-export-authorisation

Professor Simon Evenett, in a March 19, 2020 posting on VOX, “Sickening thy neighbor: Export restraints on medical supplies during a pandemic,” https://voxeu.org/article/export-restraints-medical-supplies-during-pandemic, reviews the challenges posed and provides examples of European countries preventing exports to neighbors — Germany preventing a shipment of masks to Switzerland and France preventing a shipment to the U.K.

In a webinar today hosted by the Washington International Trade Association and the Asia Society Policy Institute entitled “COVID-19 and Trade – A WTO Agenda,” Prof. Evenett reviewed his analysis and noted that the rate of increase for export restraints was growing with 48 of 63 actions occurring in March and 8 of those occurring in the last forty-eight hours. A total of 57 countries are apparently involved in one or more restraints. And restraints have started to expand from medical supplies and equipment to food with four countries mentioned by Prof. Evenett – Kazakhstan, Ukraine, Russia and Vietnam.

Efforts to keep markets open and liberalize critical medical supplies

Some countries have reduced tariffs on critical medical goods during the pandemic and some countries have also implemented green lane approaches for customs clearance on medical supplies and goods. Such actions are clearly permissible under the WTO, can be undertaken unilaterally and obviously reduce the cost of medical supplies and speed up the delivery of goods that enter from offshore. So it is surprising that more countries don’t help themselves by reducing tariffs temporarily (or permanently) on critical medical supplies and equipment during a pandemic.

Papers generated by others show that there are a large number of countries that apply customs duties on medical supplies, equipment and soaps and disinfectants. See, e.g., Jennifer Hillman, Six Proactive Steps in a Smart Trade Approach to Fighting COVID-19 (graphic from paper reproduced below), https://www.thinkglobalhealth.org/article/six-proactive-steps-smart-trade-approach-fighting-covid-19

Groups of countries have staked out positions of agreeing to work together to handle the pandemic and to keep trade open. For example, the G20 countries had a virtual emergency meeting today to explore the growing pandemic. Their joint statement can be found here and is embedded below, https://www.wto.org/english/news_e/news20_e/dgra_26mar20_e.pdf.

dgra_26mar20_e

There is one section of the joint statement that specifically addresses international trade disruptions during the pandemic. That language is repeated below:

“Addressing International Trade Disruptions

“Consistent with the needs of our citizens, we will work to ensure the flow of vital medical supplies, critical agricultural products, and other goods and services across borders, and work to resolve disruptions to the global supply chains, to support the health and well-being of all people.

“We commit to continue working together to facilitate international trade and coordinate responses in ways that avoid unnecessary interference with international traffic and trade. Emergency measures aimed at protecting health will be targeted, proportionate, transparent, and temporary. We task our Trade Ministers to assess the impact of the pandemic on trade.

“We reiterate our goal to realize a free, fair, non-discriminatory, transparent, predictable and stable trade and investment environment, and to keep our markets open.”

The WTO Director General Roberto Azevedo participated in the virtual meeting with the G20 leaders and expressed strong support for the commitment of the G20 to working on the trade related aspects of the pandemic. https://www.wto.org/english/news_e/news20_e/dgra_26mar20_e.htm.

Separately, New Zealand and Singapore on March 21st issued a Joint Ministerial Statement which stated in part,

“The Covid-19 pandemic is a serious global crisis.

“As part of our collective response to combat the virus, Singapore and New Zealand are committed to maintaining open and connected supply chains. We will also work closely to identify and address trade disruptions with ramifications on the flow of necessities,”

https://www.thestar.com.my/news/regional/2020/03/21/new-zealand-works-closely-with-singapore-to-maintain-key-supply.

The Joint Ministerial Statement was expanded to seven countries (Australia, Brunei Darussalam, Canada, Chile, Myanmar, New Zealand and Singapore), on March 25th and is reportedly open to additional countries joining. See https://www.mti.gov.sg/-/media/MTI/Newsroom/Press-Releases/2020/03/updated-joint-ministerial-statement-25-mar.pdf

Conclusion

When a pandemic strikes, many countries have trouble maintaining open trade policies on critical materials in short supply and/or in working collaboratively to address important supply chain challenges or in taking unilateral actions to make critical supplies available more efficiently and at lower costs.

The current global response to COVID-19 presents the challenges one would expect to see – many countries imposing temporary restrictions on exports — while positive actions in the trade arena are more limited to date with some hopeful signs of a potential effort to act collectively going forward.

Time will tell whether governments handling of the trade dimension of the pandemic contributes to the equitable solution of the pandemic or exacerbates the challenges and harm happening to countries around the world.