Pfizer, BioNTech release preclinical data, talk with EU about COVID-19 vaccine

By The Science Advisory Board staff writers

September 9, 2020 -- Preclinical data have demonstrated the ability of BNT162b2, Pfizer and BioNTech's COVID-19 vaccine, to protect against infection. The companies are also in discussions to provide Europe with 200 million doses of the candidate.

The companies released preliminary preclinical data from mouse and nonhuman primate models indicating that BNT162b2, a messenger RNA-based COVID-19 vaccine, protected against SARS-CoV-2 infection. Separately, the companies announced that they have concluded discussions with the European Commission (EC) to provide 200 million doses of the vaccine to European Union (EU) member states.

Preliminary preclinical data was published on the bioRxiv preprint server on September 8. In the preclinical study, BNT162b2 demonstrated antiviral effects in rhesus macaques with high levels of neutralizing antibodies and a TH1-biased cellular response in the macaques and in mice. The macaques received two injections of 30 or 100 µg of BNT162b2.

The data helped the companies decide to initiate the current ongoing phase II/III clinical study of the vaccine. The candidate is on track for regulatory review as early as October 2020. If regulatory authorization is obtained, the companies 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.

Under the proposed supply deal with the EC, 200 million doses of the vaccine would be delivered starting by the end of 2020, with an option to purchase an additional 100 million doses. Vaccine doses would be manufactured at BioNTech's German manufacturing facilities and Pfizer's manufacturing site in Belgium. As exploratory discussions have concluded, the companies will now enter contract negotiations with the EC.

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