Moderna (NASDAQ:MRNA) reported complete data for its coronavirus vaccine candidate, mRNA-1273, today. It also submitted its application for emergency use authorization to the Food and Drug Administration (FDA). Investors will have to wait a few weeks to see what the agency thinks of the data package. The FDA plans to convene a meeting of its Vaccines and Related Biological Products Advisory Committee on Dec. 17 to review the data.
On Dec. 15, the agency will likely post its review of the data as well as questions it plans to ask the panel of outside experts. At the meeting on Dec. 17, Moderna will present the findings from the clinical trials testing mRNA-1273, and the FDA will present its analysis of the data. The public will also get an opportunity to speak about the application.
Image source: Getty Images.
The meeting isn't on the FDA's calendar yet, but a meeting to review Pfizer (NYSE:PFE) and BioNTech's (NASDAQ:BNTX) coronavirus vaccine, BNT162b2, is an all-day affair, starting at 9 a.m. and ending at 6 p.m. Investors should expect a similarly long day for Moderna.
Pfizer and BioNTech's vaccine review will take place on Dec. 10. Going second could have some advantages for Moderna, as it will get a sense of what the FDA and the committee members see as the most pressing issues.
The agency plans to livestream both meetings on the agency's social media channels as well as on the FDA's website. Biotech investors watching the livestream should remember that the committee members only get an advisory vote. The FDA has the final say in whether the vaccines get authorized.
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December 01, 2020 at 07:15AM
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Moderna's Coronavirus Vaccine to Be Reviewed by FDA Advisory Committee on Dec. 17 - Motley Fool
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