Moderna Likely To Make Emergency Use Filing With FDA In Early December — Might Have Limited “Ring” Vaccination Authority In Early 2021(?)

Step by step — with solid science as the guide. This is incremental good news, and we will keep a weather eye on it all.

[Yesterday, in describing Merck’s prospects for a multi-billion dollar revenue stream for its Prevar 13 competitor vaccine, I said I thought that would only occur after we had a working COVID-19 vaccine, since gathering kids for shots, across the US will first be focused on that coming vaccine. As expected, that may begin in early 2021 now.] From the Tweet announcing Moderna’s enrollment of the last of 30,000 subjects, in its ongoing study, and a bit:

. . . .Moderna will determine whether to submit a dossier to FDA requesting Emergency Use Authorization based on an assessment of whether the potential benefit of the vaccine outweighs the potential risks once the 2 months of median safety follow-up have accrued.

The Company separately shared its statement at today’s U.S. Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting.

Moderna worked closely with BARDA and the NIH, including NIAID’s COVID-19 Prevention Network (CoVPN), to conduct the Phase 3 COVE study under Operation Warp Speed. Moderna’s partner PPD (Nasdaq: PPD), a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services, has also been essential to the successful execution to date of the COVE study. PPD also supported the Phase 2 study of mRNA-1273. . . .

Onward, to what promises to be a raucous, largely uninformative debate (from the Trump side) in Music City tonight. So it goes. Twelve days left, give or take.


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