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Pfizer, BioNTech Say MRNA-based Vaccine Candidate Protected Rhesus Macaques In Preclinical Studies

Pfizer Inc. (PFE) and BioNTech SE (BNTX) on Wednesday announced preliminary preclinical data in mouse and non-human primate models from their BNT162b2 mRNA-based vaccine program against SARS-CoV-2, the virus that causes COVID-19, or the coronavirus disease.

The companies noted 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.

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.

"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 Jansen, Senior Vice President and Head of Vaccine Research & Development, Pfizer.

In a viral infection model, macaques that received two injections with 100 g BNT162b2 and macaques that received saline control injections were challenged 55 days after the second immunization with a very high viral inoculum of about 1 million plaque forming units of SARS-CoV-2, via both intranasal (nose) and intratracheal (lung) routes.

Immunization with BNT162b2 reduced viral infection with no viral RNA detected in the lower respiratory tract of the immunized animals, while in most non-immunized (saline) animals, there was evidence of viral RNA.

Importantly, BNT162b2 induced potent SARS-CoV-2 neutralizing antibodies in vaccinated-macaques, and viral antigen-specific CD4+ and CD8+ T cells.

According to Pfizer and BioNTech, many of these preclinical data and the Phase 1 clinical results contributed to their decision to commence the global 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 U.S., Argentina and Brazil. Additional enrollment is planned in Germany, Turkey and South Africa. The study is an event-driven trial.

Assuming clinical success, Pfizer and BioNTech said they are on track to seek regulatory review for BNT162b2 as early as October 2020. If regulatory authorization or approval is obtained, the companies currently plan to supply up to 100 million doses worldwide by the end of 2020, and about 1.3 billion doses by the end of 2021.

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