BioNTech which has partnered with Pfizer in producing an mRNA vaccine to address COVID-19, issued a press release today (February 16, 2022) from Mainz, Germany outlining its development of modular mRNA manufacturing facilities and their intended deployment in Africa. See BioNTech, Press Release, BioNTech introduces first modular mRNA manufacturing facility to promote scalable vaccine production in Africa, 16 February 2022, https://investors.biontech.de/news-releases/news-release-details/biontech-introduces-first-modular-mrna-manufacturing-facility. Part of the press release is copied below.
” BioNTech SE (Nasdaq: BNTX, “BioNTech”) has taken a next step to improve vaccine supply in Africa. The
company has introduced its approach to establishing scalable vaccine production by developing and delivering turnkey mRNA manufacturing facilities based on a container solution. At a high-level meeting at BioNTech’s new manufacturing facility in Marburg and at the invitation of kENUP Foundation, the company presented the container solution named ‘BioNTainer’ to key partners.
“Attendees included President Macky Sall of Senegal, President Nana Akufo-Addo of Ghana, President Paul Kagame of Rwanda, Tedros Adhanom Ghebreyesus, Director General of the World Health Organization, John Nkengasong, Director of the Africa Centers for Disease Control and Prevention
(Africa CDC), and Svenja Schulze, the Federal Minister of Economic Cooperation and Development of Germany. Together with BioNTech’s Co-Founders Prof. Ugur Sahin, CEO, and Prof. Özlem Türeci, CMO, and COO Dr. Sierk Poetting, they jointly discussed the infrastructure, regulatory and technological requirements to establish an end-to-end manufacturing network for mRNA-based vaccines in Africa.
“The manufacturing solution consists of one drug substance and one formulation module, each called a BioNTainer. Each module is built of six ISO sized containers (2.6m x 2.4m x 12m). This allows for mRNA vaccine production in bulk (mRNA manufacturing and formulation), while fill-and-finish will be taken over by local partners. Each BioNTainer is a clean room which BioNTech equips with state-of-the-art manufacturing solutions. Together, two modules require 800 sqm of space and offer an estimated initial capacity of for example up to 50 million doses of the Pfizer-BioNTech COVID-19 vaccine each year. The BioNTainer will be equipped to manufacture a range of mRNA-based vaccines targeted to the needs of the African Union member states, for example the Pfizer-BioNTech COVID-19 vaccine and BioNTech’s investigational malaria and tuberculosis vaccines, if they are successfully developed, approved or authorized by regulatory authorities.
“The capacity can be scaled up by adding further modules and sites to the manufacturing network on the African continent. One of the most critical parts of the manufacturing process is quality control, which includes all necessary tests for each finished vaccine batch. In partnership with local quality control testing labs, BioNTech will help to ensure the identity, composition, strength, purity, absence of product- and process-related impurities, as well as the absence of microbiological contamination of each produced batch.
“The establishment of the first mRNA manufacturing facility by BioNTech in the African Union is expected to start in mid-2022. The first BioNTainer is expected to arrive in Africa in the second half of 2022. Manufacturing in the first BioNTainer is planned to commence approximately 12 months after the delivery of the modules to its final location in Africa. BioNTech expects to ship BioNTainers to Rwanda, Senegal and potentially South Africa in close coordination with the respective country and the African Union. BioNTech will be responsible for the delivery and installation of the modules, while local organizations, authorities and governments will ensure the needed infrastructure. Partners in Ghana and South Africa could support the manufacturing with fill-and-finish capacities. BioNTech will work closely with local authorities to ensure compliance to relevant regulatory procedures of the national regulatory agencies in each partner country, and also coordinate where appropriate with relevant continental and international agencies, including WHO, Africa CDC, the African Medicines Agency (AMA), and the African Union Development Agency (AUDA-NEPAD).
“BioNTech will initially staff and operate the facilities to support the safe and rapid initiation of the production of mRNA-based vaccine doses under stringent good manufacturing processes (“GMP”) to prepare for the transfer of know-how to local partners to enable independent operation. Vaccines
manufactured in these facilities are expected to be dedicated to domestic use and export to other member states of the African Union at a not-for-profit price.”
While the announcement by BioNTech will not address the short-term 2022 production and distribution needs of COVID-19 vaccines to low and lower-middle income countries (WHO is urging the world to obtain 70% vaccination rates in all countries by summer 2022), the announcement adds to the momentum of creating manufacturing of vaccines (for COVID-19 and other needs) in Africa. See Carnegie Endowment for International Peace, Is there Any COVID-19 Vaccine Production in Africa?, September 13, 2021, https://carnegieendowment.org/2021/09/13/is-there-any-covid-19-vaccine-production-in-africa-pub-85320#:~:text=Africa%20manufactures%20less%20than%20one,have%20faced%20severe%20supply%20shortages (“Efforts are being made to ramp up production of COVID-19 vaccines on the African continent. As of September 2021, there are at least twelve COVID-19production facilities set up or in the pipeline across six African countries (see figure). African COVID-19 vaccine manufacturing in the coming year could range from Pfizer-BioNTech and Johnson & Johnson vaccines to Russia’s Sputnik V and China’s Sinovac vaccines. In South Africa, the U.S. International Development Finance Corporation, along with European partners, announced a 600 million euro ($710 million)financing package for Aspen Pharmacare. Aspen’s facility has already produced millions of doses and will ‘fill-and-finish’ (i.e. package imported vaccine substance) around 500 million Johnson & Johnson doses by the end of 2022. South Africa’s Biovac Institute has also agreed to accelerate fill-and-finish Pfizer vaccine manufacturing in Cape Town from 2022. In Senegal, the government—with Pfizer support from the United States and Europe—is building a $200million COVID-19 vaccine manufacturing facility with the Fondation Institut Pasteur de Dakar. This facility would represent the first on the continent to actually manufacture the substance of vaccines in parallel with fill-and-finish. Starting in November 2021, the Egyptian government will
produce Chinese Sinovac at a new Vacsera facility outside Cairo, with a planned capacity of
1 billion vaccines annually. And with two agreements for drug substance manufacturing and fill-and-finish of Russia’s Sputnik V vaccine, Egypt may soon join Senegal in reducing Africa’s dependency on vaccine imports.”)
The BioNTech press release contains eleven quotes from government and business officials, including EC President Ursula von der Leyen, the Presidents of Senegal, Rwanda, Ghana and the African Union, the WHO Director-General, the Chancellor of the Republic of Germany and others. The full press release is attached below.BioNTech-introduces-first-modular-mRNA-manufacturing-facility-to-promote-scalable-vaccine-production-in-Africa
The announcement by BioNTech is both exciting and important longer term for greater vaccine equity for various purposes. As noted in one of the many news articles on the announcement, Pfizer and BioNTech have also pledged to supply up to two billion COVID-19 vaccine doses to low-income countries during 2022. See Wall Street Journal, BioNTech Unveils Mobile Covid-29 Vaccine Factories for Developing World, February 16, 2022, https://www.wsj.com/articles/biontech-unveils-mobile-covid-19-vaccine-factories-for-developing-world-11645007401; see also Reuters, BioNTech to ship mRNA vaccine factory kits to Africa, February 16, 2022, https://www.reuters.com/business/healthcare-pharmaceuticals/biontech-ship-mrna-vaccine-factory-kits-africa-2022-02-16/; Fortune, Pfizer partner BioNTech unveils container-based COVID vaccine factories that could start manufacturing doses in Africa this year, February 16, 2022, https://fortune.com/2022/02/16/pfizer-biontech-covid-vaccine-biontainers-inequality-africa-afrigen-who/. It is those efforts at getting doses produced in the front half of 2022 to low income and lower-middle income countries that will be most important in meeting the immediate goal of dramatically increasing vaccine rates in Africa and in other countries with current low vaccination rates.
As reviewed in a number of earlier posts, the progress being made in vaccine equity to address COVID-19 in 2022 will not be dependent on the outcome of the ongoing WTO consideration of whether TRIPS obligations should be waived for COVID-19 vaccines. Rather progress is dependent on expanded production, moving product to needed countries, work in countries to ensure the ability to distribute vaccines received and expanded funding of COVAX. See, e.g., January 30, 2022: Recent National Public Radio story, “Africa may have reached the pandemic’s holy grail,” raises interesting questions on a country’s age distribution and ability to get past the pandemic stage with lower vaccination rates, https://currentthoughtsontrade.com/2022/01/30/recent-national-public-radio-story-africa-may-have-reached-the-pandemics-holy-grail-raises-interesting-questions-on-a-countrys-age-distribution-and-ability-to-get-past-the-pandemic-stage-wit/; January 23, 2022: COVID-19 Omicron variant – hopeful signs of peaking in the U.S. and Europe; supply disruptions continue from zero tolerance policy in China, https://currentthoughtsontrade.com/2022/01/23/covid-19-omicron-variant-hopeful-signs-of-peaking-in-the-u-s-and-europe-supply-disruptions-continue-from-zero-tolerance-policy-in-china/; January 11, 2022: WTO efforts to address the COVID-19 pandemic — the January 10, 2022 General Council meeting and some current developments of interest, https://currentthoughtsontrade.com/2022/01/11/wto-efforts-to-address-the-covid-19-pandemic-the-january-10-2022-general-council-meeting-and-some-current-developments-of-interest/.