Pfizer and BioNTech Announce Preclinical Data Supporting Efficacy for Phase 2/3 COVID-19 Vaccine

Pfizer Inc. (New York, NY, USA) and Biopharmaceutical New Technologies (BioNTech Mainz, Germany) have announced that in a non-human primate preclinical study, immunization with the BNT162b2, a nucleoside-modified messenger RNA (modRNA) candidate, protected rhesus macaques against SARS-CoV-2 infection.

The companies have published preliminary preclinical data in mouse and non-human primate models from their BNT162b2 mRNA-based vaccine program against SARS-CoV-2. In the preclinical study, BNT162b2 demonstrated protective anti-viral effects in rhesus macaques, with concomitant high neutralizing antibody titers and a TH1-biased cellular response in rhesus macaques and mice. These preclinical data and the Phase 1 clinical results contributed to the decision by Pfizer and BioNTech to commence the global (except for China) Phase 2/3 safety and efficacy portion of the clinical study to evaluate potential prevention of COVID-19 disease by BNT162b2. The Phase 2/3 study has enrolled over 25,000 participants 18 to 85 years of age in the US, Argentina and Brazil. Additional enrollment is planned in Germany, Turkey and South Africa.

“Collectively, these preclinical results, combined with our clinical data collected to date, continue to support the promise and validity of our mRNA-based vaccine program against SARS-CoV-2 and selection of the BNT162b2 candidate, which we believe has the potential to prevent many millions of COVID-19 cases,” said Kathrin U. Jansen, Ph.D., Senior Vice President and Head of Vaccine Research & Development, Pfizer. “We are encouraged by the data thus far and confident in our progress towards developing a safe and effective vaccine candidate to help address this current pandemic.”

“The data we have shared today include the characterization of our lead candidate BNT162b2, as well as key animal studies that were the basis for our clinical programs. They have enabled us to advance BNT162b2 into Phase 3 evaluation,” said Ugur Sahin, M.D., CEO and Co-founder of BioNTech. “This is another development milestone for providing a safe and effective potential vaccine to the global community to help end this pandemic.”

Separately, Pfizer and BioNTech have concluded exploratory talks with the European Commission for a proposed supply of 200 million doses of their investigational BNT162 mRNA-based vaccine candidate against SARS-CoV-2 to European Union (EU) Member States, with an option for further 100 million doses. 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.

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