Pharmaceutical Business review

Pfizer, BioNTech to supply EU with 200 million doses of mRNA-based vaccine candidate against SARS-CoV-2

Pfizer, BioNTech to supply EU with 200 million doses of mRNA-based vaccine candidate against SARS-CoV-2. (Credit: Gerd Altmann from Pixabay)

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.

The proposed supply agreement with the European Commission would represent the largest initial order of vaccine doses for Pfizer and BioNTech to date. 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.

“Pfizer and BioNTech’s anticipated agreement with the European Commission is an important step forward in our shared goal to have millions of doses of a vaccine against COVID-19 available for vulnerable populations before the end of the year. We would like to thank the European Commission for its commitment and confidence in our development efforts,” said Albert Bourla, Chairman and CEO, Pfizer. “We have activated our supply chain, most importantly our site in Belgium, and are starting to manufacture so that our vaccine would be available as soon as possible, if our clinical trials prove successful and regulatory approval is granted.”

“As a company founded in the heart of Europe, we are pleased to have concluded exploratory discussions with the European Commission, which would be our largest initial order to date. Our aim is to develop a safe and effective vaccine to contribute to bringing this pandemic to an end in Europe and across the world. Today’s decision is a further illustration of how collaboration and solidarity can help address a global health crisis as an international community,” said Ugur Sahin, M.D., CEO and Co-founder of BioNTech.

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, the Vaccine Alliance, the Coalition for Epidemic Preparedness Innovations (CEPI) and World Health Organization (WHO) that, using a range of technology platforms, aims to provide governments, including those in the emerging markets, with early access to a large portfolio of COVID-19 candidate vaccines produced by multiple manufacturers across the world.

Source: Company Press Release