Moderna’s Covid Vaccine Granted Full FDA Approval
Moderna's two-shot mRNA covid vaccine, now branded Spikevax, is no longer being administered under emergency use authorization after the FDA fully approved it Monday for use in all 18 and older.
Stat:
Moderna Wins Full Approval For Its Covid-19 Vaccine
The ever-evolving landscape of Covid-19 vaccines shifted again on Monday, with Moderna winning full approval for its jab from the Food and Drug Administration, and Novavax submitting a long-awaited application to the agency for an emergency use authorization for its vaccine. The approval of Moderna’s vaccine, Spikevax, makes it the country’s second fully licensed vaccine to protect against SARS-CoV-2. It’s also the first product the Cambridge, Mass., biotech has brought through licensure in the United States. The Pfizer and BioNTech vaccine, Comirnaty, became the first to be fully approved in August. (Branswell, 1/31)
The Wall Street Journal:
FDA Fully Approves Moderna’s Covid-19 Vaccine
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. (Loftus, Fidler and Sylvers, 1/31)
Politico:
FDA Gives Full Approval To Moderna's Covid-19 Shot
The approval for people ages 18 and older will make it easier for schools and workplaces to require vaccination against the virus, now that there are two approved products to choose from, including Pfizer-BioNTech's Covid shot. It will also allow Moderna to market its vaccine directly to consumers. (Foley, 1/31)
