Wall Street Journal (Updated Jan. 31, 2022 6:09 pm ET)
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The Food and Drug Administration on Monday gave its full approval to Moderna Inc.’s Covid-19 vaccine, branded Spikevax, for use in adults 18 and older, making it the second fully approved Covid-19 vaccine after one from Pfizer Inc. and BioNTech SE.
The agency granted full approval to Moderna’s shot after conducting a more thorough review of the evidence for the vaccine’s safety and efficacy.
Previously, the FDA had granted what is known as an emergency-use authorization for Moderna’s vaccine in December 2020, following a shorter-than-normal review of the shot. The FDA may grant such authorizations during public-health emergencies such as the continuing pandemic.
Moderna completed its application for full approval of Spikevax in August 2021, which included results of a 30,000-person clinical trial. A final analysis of that trial found the vaccine, given as two doses 28 days apart, was 93% effective at preventing symptomatic Covid-19 disease, and that efficacy remained durable six months after the second dose.
Another company, Novavax Inc., formally asked the FDA to authorize its Covid-19 vaccine for emergency use, which would bring a fourth shot onto the U.S. market that the company hopes will see strong uptake among the vaccine hesitant.
The Maryland-based company said its request is based on two large clinical trials in which two shots of its vaccine had a 90% protection rate against symptomatic Covid-19 infection compared with a placebo."
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