Pfizer and BioNTech, a Mainz, Germany-based immunotherapy company, have concluded exploratory talks with the European Commission for a proposed supply of 200 million doses of their COVID-19 vaccine candidate, with an option for a further 100 million doses, to European Union (EU) member states.

The supply would be for BNT162b2, which is now in Phase II/III trials for preventing SARS-CoV-2, the virus that causes COVID-19. Deliveries would be starting by the end of 2020, subject to clinical success and regulatory authorization. The companies will now enter into contract negotiations with the European Commission.

Pfizer and BioNTech say they are on track to seek regulatory review for BNT162b2 as early as October 2020 and, if regulatory authorization or approval is obtained, they currently plan to supply up to 100 million doses worldwide by the end of 2020 and approximately 1.3 billion doses by the end of 2021.

The companies say the proposed supply agreement with the European Commission would represent the largest initial order of vaccine doses for Pfizer and BioNTech to date (as reported on September 9, 2020). Vaccine doses for Europe would be produced in BioNTech’s German manufacturing sites, as well as in Pfizer’s manufacturing site in Belgium. If regulatory approval for the BNT162b2 vaccine candidate is received, the European Commission would lead the process for allocation of the vaccine doses among the 27 EU member states.

In addition to engagements with governments, Pfizer and BioNTech have provided an expression of interest for possible supply to the COVAX Facility, a mechanism established by Gavi, a global public health partnership, the Coalition for Epidemic Preparedness Innovations, a public–private partnership focused on vaccine development against emerging infectious diseases, and the World Health Organization, which aims to provide governments with early access to a large portfolio of COVID-19 candidate vaccines using a range of technology platforms and produced by multiple manufacturers globally.

BNT162b2 was one of two COVID-19 vaccine candidates from Pfizer’s and BioNTech’s mRNA vaccine program for COVID-19 that received fast-track designation from the US Food and Drug Administration (FDA) based on preliminary data from Phase I/II studies that are currently ongoing in the US and Germany as well as animal immunogenicity studies.

The companies are advancing BNT162b2 to Phase II/III trials in Germany after receiving approval this week (September 7, 2020) from the Paul-Ehrlich-Institut, a medical regulatory body in Germany and the German federal institute for vaccines and biomedicines, for Phase II/III clinical trials in Germany. The study in Germany is part of a global (except for China) Phase II/III program that BioNTech and Pfizer initiated in July (July 2020) that will evaluate 30,000 participants between 18 and 85 years of age at approximately 120 sites globally. To date (as of September 9, 2020), the study has enrolled over 25,000 participants in the US, Argentina and Brazil. Additional enrollment is planned in Germany, Turkey, and South Africa. To meet those anticipated quantities and milestones, the companies report that they have produced sufficient supply for their 30,000 participant Phase II/III clinical trial and have begun to produce and stockpile their pandemic supply.

The companies reported positive results of BNT162b2 in preliminary preclinical data in mouse and non-human primate models The manuscript describing these preclinical data is concurrently undergoing scientific peer review for potential publication. The companies say that these preclinical results, combined with its clinical data collected to date (as of September 9, 2020), continue to support the promise and validity of BNT162b2 as a potential COVID-19 vaccine.

Source: Pfizer (supply to the EU), BioNTech (supply to the EU), Pfizer (preclinical data), BioNTech (preclinical data), and BioNTech (Phase II/III trial approval in Germany)