Pfizer (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) have reached an agreement with the European Commission to supply 200 million doses of their investigational BNT162b2 mRNA-based vaccine candidate against COVID-19 to European Union (EU) Member States, with an option for the European Commission to request an additional 100 million doses. Deliveries are anticipated to start by the end of 2020, subject to clinical success and regulatory authorization, the parties informed.
Vaccine doses for Europe will be produced in BioNTech’s German manufacturing sites, as well as in Pfizer’s manufacturing site in Belgium. If the BNT162b2 vaccine candidate receives approval from the European Medicines Agency (EMA), then the European Commission will lead the process for allocation of the vaccine doses among the EU Member States who have elected to receive the vaccine as part of this agreement.
Pfizer and BioNTech announced the conclusion of exploratory talks with the European Commission to supply doses of the BNT162b2 vaccine candidate, if approved, on September 9, 2020. The proposed supply agreement is now final.
On November 9, 2020, Pfizer and BioNTech announced their mRNA-based vaccine candidate, BNT162b2, against COVID-19 has demonstrated evidence of efficacy against COVID-19 in participants without prior evidence of SARS-CoV-2 infection, based on the first interim efficacy analysis conducted on November 8, 2020 by an external, independent Data Monitoring Committee (DMC) from the Phase 3 clinical study. The DMC reviewed 94 cases.
Pfizer is focused on applying science and its global resources to bring therapies to people that extend and significantly improve their lives. Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time.
BioNTech is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. The company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals.
