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Home » Moderna vaccine gains FDA adcom support, suggesting EUA likely
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Moderna vaccine gains FDA adcom support, suggesting EUA likely

Dec. 17, 2020
By Michael Fitzhugh
As expected, the FDA's Vaccines and Related Biological Products Advisory Committee voted near-unanimously on Dec. 17, with one abstention, that available evidence shows the benefits of Moderna Inc.'s COVID-19 vaccine, mRNA-1273, outweigh its risks for people 18 and older. The vote bolsters the likelihood that the regulator will grant the vaccine an emergency use authorization (EUA), which could come as soon as Friday. Not the same as an approval, the authorization would allow for the vaccine's use for the prevention of COVID-19 in the U.S. even as further trials and regulatory evaluation remains underway ahead of a company BLA submission.
BioWorld Regulatory Coronavirus Vaccine U.S. FDA

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