Prescribing information includes warning about risks for myocarditis and pericarditis, particularly in men younger than 40 years
MONDAY, Aug. 23, 2021 (HealthDay News) — The U.S. Food and Drug Administration on Monday granted full approval for the Pfizer-BioNTech COVID-19 vaccine.
The vaccine will now be marketed as Comirnaty and is fully approved for the prevention of COVID-19 in individuals 16 years and older. The vaccine remains under emergency use authorization for individuals ages 12 to 15 years and for administration of a third dose in certain immunocompromised individuals.
“While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated,” Acting FDA Commissioner Janet Woodcock, M.D., said in an agency press release. “Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”
The FDA decision to fully approve Comirnaty was based on a review of updated data from the clinical trial that supported the emergency use authorization. The updated data included a longer follow-up duration and a larger clinical trial population of 20,000 individuals who received the vaccine and 20,000 who received placebo. Based on the updated results, the vaccine was 91 percent effective in preventing COVID-19.
The review also included updated safety data on 22,000 people who received the vaccine and 22,000 who received placebo, more than half of whom were followed for at least four months.
The agency also conducted an evaluation of postauthorization safety surveillance data regarding the risks for myocarditis and pericarditis following receipt of the Pfizer-BioNTech COVID-19 vaccine. They found the data demonstrate increased risks, especially within the seven days following the second dose and with a higher risk among men younger than 40 years, in particular males ages 12 to 17 years. Data have shown symptom resolution in the majority of individuals, but some have required intensive care support.
The Comirnaty Prescribing Information includes a warning about these risks, but the agency notes that information is not yet available on potential long-term health outcomes. The FDA is requiring Pfizer-BioNTech to conduct postmarketing studies to further evaluate these risks.
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