Pfizer and BioNTech SE today announced an advance purchase agreement with COVAX for up to 40 million doses of the Pfizer-BioNTech COVID-19 Vaccine. The doses will be delivered throughout 2021.

COVAX is a global initiative coordinated by the Global Alliance for Vaccines and Immunization (GAVI), the Coalition for Epidemic Preparedness Innovations (CEPI) and the World Health Organization (WHO), to ensure equitable access to COVID-19 vaccines for all countries, regardless of income levels. COVAX includes an Advanced Market Commitment (AMC) financial mechanism that aims to ensure that 92 low- and lower-middle-income countries will be able to secure access to COVID-19 vaccines at the same time as higher-income countries.

The first doses are expected to be delivered in the first quarter of 2021, subject to the negotiation and execution of supply agreements under the COVAX Facility structure.For the COVAX Advanced Market Commitment 92 countries, Pfizer and BioNTech will provide the vaccine to COVAX at a not-for-profit price.

"At Pfizer, we believe that every person deserves to be seen, heard and cared for. That's why from the very beginning of our vaccine development program, Pfizer and BioNTech have been firmly committed to working toward equitable and affordable access of COVID-19 vaccines for people around the world," said Pfizer Chairman & CEO Albert Bourla. "We share the mission of COVAX and are proud to work together so that developing countries have the same access as the rest of the world, which will bring us another step closer to ending this global pandemic and proving that Science Will Win for everyone, everywhere."

“SARS-CoV-2 does not differentiate between borders – a global pandemic requires comprehensive solutions and worldwide collaboration. COVAX is a truly global initiative and we are happy to support by making BNT162b2 available in many low- and lower-middle-income countries to help protect vulnerable people worldwide,” said Ugur Sahin, M.D., CEO and Co-founder of BioNTech.

“The urgent and equitable roll-out of vaccines is not just a moral imperative, it is also a strategic and economic imperative,” said Dr Tedros Adhanom Ghebreyesus, Director-General of the World Health Organization. "This agreement with Pfizer and BioNTech will enable COVAX to save lives, stabilize health systems and drive the global economic recovery.”

“Today marks another milestone for COVAX: in addition to securing access to doses, we are now expecting the first deliveries of life-saving COVID-19 vaccines in Q1. This is not just significant for COVAX, it is a major step forward for equitable access to vaccines, and an essential part of the global effort to beat this pandemic. We will only be safe anywhere if we are safe everywhere,” said Dr Seth Berkley, CEO of Gavi, the Vaccine Alliance, which leads COVAX procurement and delivery.

As part of a broader strategy to support developing countries beyond the agreement with COVAX, Pfizer and BioNTech are committed to partnering with other global health stakeholders to provide expertise and resources that can strengthen healthcare systems where greater support may be needed to deploy COVID-19 vaccines. This includes analyzing supply chains and piloting novel approaches in low-income countries to address transportation and storage challenges. Pfizer and BioNTech are also committed to coordinating with international agencies to support supply and distribution in refugee and other vulnerable populations.

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 16 years of age and older. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564 (b) (1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner. Please see Emergency Use Authorization (EUA) Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) including Full EUA Prescribing Information available at www.cvdvaccine-us.com.