FDA Advisory Panel Confirms Moderna’s COVID-19 Vaccine Benefits Outweigh Risks
Thu, 12/17/2020 – 17:06
Following last week’s Pfizer approval, this one just seems a little anti-climactic and yet it is notable as another COVID vaccine is now ready to get final approval by The FDA for Emergency Use Authorization.
U.S. Food and Drug Administration advisory panel voted Thursday to endorse Moderna’s coronavirus vaccine, clearing the way for FDA leaders to authorize emergency mass distribution amid an ongoing surge of COVID-19 cases across the country.
The committee was charged with voting on the following question:
“Based on the totality of scientific evidence available, do the benefits of the Moderna COVID-19 Vaccine outweigh its risk for use in individuals 18 years of age and older?”
The vote was 20-0. One committee member abstained.
As Fox News reports, the highly anticipated meeting included members of the FDA’s Center for Biologics Evaluation and Research advisory committee, outside vaccine experts and Moderna representatives.
FDA committee’s review of Moderna’s coronavirus vaccine emergency use authorization application found “no specific safety concerns” in subgroup analyses by age, race, ethnicity, medical comorbidities, or prior SARS-CoV-2 infection, potentially paving the way for a second COVID-19 jab to enter the scene.
The panel also found that the vaccine reduced the risk of confirmed COVID-19 – including severe cases – occurring at least 14 days after the second dose.
Not unlike Pfizer and BioNTech’s vaccine, the Moderna jab did elicit non-serious adverse reactions such as pain at the injection site, fatigue, headache, muscle pain, joint pain and chills. The reactions were characterized as generally mild to moderate.
The FDA did consider three serious adverse reactions as related to the vaccine, including nausea and vomiting, and facial swelling. An incident of Bell’s palsy also occurred in a vaccine recipient, “for which a causal relationship to vaccination cannot be concluded at this time.”
The FDA panel’s vote to approve the company’s EUA was expected.
Upon formal FDA approval, which would mark the first such approval for Moderna, Americans could see an initial 6 million doses distributed next week.