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Biotech Stocks Facing FDA Decision In December 2020

Pfizer
Pfizer

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) is scheduled to review Pfizer (PFE) and BioNTech’s COVID-19 vaccine candidate BNT162b2 on December 10, and make recommendations regarding its authorization.

BNT162b2 is based on BioNTech's proprietary mRNA technology and supported by Pfizer's global vaccine development and manufacturing capabilities. This vaccine is being tested at a 30 micrograms (mcg) dose level in a two-dose regimen, given 21 days apart. BNT162b2 demonstrated an efficacy of 95% in preventing COVID-19 in a phase III study.

The companies filed their application with the FDA seeking Emergency Use Authorization for BNT162b2 on November 20.

The FDA Commissioner Stephen Hahn has said, “While we cannot predict how long the FDA’s review will take, the FDA will review the request as expeditiously as possible, while still doing so in a thorough and science-based manner, so that we can help make available a vaccine that the American people deserve as soon as possible”.

If all goes well, and BNT162b2 is rolled out, the vaccine is expected to cost $19.50 per dose.

PFE closed Friday’s (Nov.27, 2020) trading at $37.23, up 1.92%.