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An independent advisory committee on Thursday voted 20-0-1 that the benefits of Moderna Inc.’s COVID-19 vaccine candidate outweigh the risks, a recommendation that sets the stage for the likely second FDA authorization of a vaccine during the pandemic.
Shares of Moderna MRNA, +5.09% gained 1.2% in after-hours trading on Thursday after the vote.
The same committee last week voted 17-4-1 in favor of the FDA granting an emergency use authorization to BioNTech SE BNTX, +0.61% and Pfizer Inc.’s PFE, +0.50% COVID-19 vaccine. The regulator then authorized the vaccine on Friday night, and it is now starting to be administered to health care workers and nursing-home residents across the U.S.
While the FDA is not required to follow the advice of advisory committees like the Vaccines and Related Biological Products Advisory Committee, it often does.
Given the similarities in the two vaccine candidates — they are both mRNA vaccines, with efficacy rates above 94% in clinical trials — Wall Street analysts had largely predicted that an emergency use authorization is in the cards.
After an all-day discussion on Thursday, the committee, which is made up of independent medical experts, voted 20-0-1 in response to this question: Based on the totality of scientific evidence available, do the benefits of the Moderna COVID-19 vaccine outweigh its risks for use in individuals 18 years of age and older?
Moderna, which initially announced plans to develop a COVID-19 vaccine in January, was also the first company to release data from a Phase 1 clinical trial for its experimental vaccine back in May.
This is the first FDA authorization or approval ever granted to a product of the biotech, which was founded in 2010.
Moderna’s stock has rallied 636.2% so far this year. The S&P 500 SPX, +0.58% has gained 14.5%.
