FDA approves Moderna’s COVID-19 vaccine
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The FDA on Monday approved Moderna’s COVID-19 vaccine, making it the second fully approved COVID-19 vaccine in the United States.
The vaccine, which will be branded as Spikevax, is approved for people aged 18 years or older. More than 200 million doses of the vaccine have already been administered under an emergency use authorization since December 2020, according to CDC data.
Acting FDA Commissioner Janet Woodcock, MD, called the approval “a significant step in the fight against the COVID-19 pandemic.”
“While hundreds of millions of doses of Moderna’s COVID-19 vaccine have been administered to individuals under emergency use authorization, we understand that for some individuals, FDA approval of this vaccine may instill additional confidence in making the decision to get vaccinated,” Woodcock said in a press release.
The FDA said the approval was based on follow-up clinical trial data from before the emergence of the omicron variant that showed the vaccine was 93% effective in preventing COVID-19 and 98% effective in preventing severe disease. Moderna and other manufacturers have begun testing omicron-specific vaccines.
In its own analysis, the FDA said it found that the benefits of the Moderna vaccine outweighed the risk for myocarditis or pericarditis, which it said was increased among recipients of the vaccine — particularly within 7 days after the second dose. The risk is highest among males aged 18 to through 24 years, the FDA said.
“Available data from short-term follow-up suggest that most individuals have had resolution of symptoms,” the agency said. “However, some individuals required intensive care support. Information is not yet available about potential long-term health outcomes.”
The FDA has delayed its decision on whether to issue an EUA for the vaccine in adolescents aged 12 to 17 years in order to further evaluate the heart risks in this age group.
The agency’s risk-benefit analysis for adult recipients used modeling to predict how many symptomatic COVID-19 cases, hospitalizations, ICU admissions and deaths the vaccine would prevent vs. the number of potential myocarditis or pericarditis cases, hospitalizations, ICU admissions and deaths that might be associated with the vaccine.
Peter Marks, MD, PhD, who heads the FDA’s Center for Biologics Evaluation and Research, said the agency’s scientists “conducted a thorough evaluation of the scientific data and information included in the application pertaining to the safety, effectiveness, and manufacturing quality of Spikevax.”
“This includes the agency’s independent verification of analyses submitted by the company, our own analyses of the data, along with a detailed assessment of the manufacturing processes, test methods and manufacturing facilities,” Marks said. “Safe and effective vaccines are our best defense against the COVID-19 pandemic, including currently circulating variants. The public can be assured that this vaccine was approved in keeping with the FDA’s rigorous scientific standards.”
Pfizer and BioNTech’s COVID-19 vaccine received full approval in late August 2021.
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