This is the first COVID-19 vaccine to be subject to a full review by the FDA.
The Food and Drug Administration has officially approved Pfizer's COVID-19 vaccine. It was previously authorized for emergency use (EUA) by the agency last December. Pfizer's vaccine is the first COVID vaccine to undergo a full review by the FDA and to receive approval.
Compared to the emergency use authorization, the formal FDA approval will make it easier for employers, the military, public schools and universities, and other organizations and agencies to mandate vaccination.
With the highly contagious Delta variant already overwhelming hospitals across the country, the FDA and public health experts hope that the formal approval will help convince the 85 million Americans who remain unvaccinated to get the shot.
"While millions of people have already safely received Covid-19 vaccines, we recognize that for some, the F.D.A. approval of a vaccine may now instill additional confidence to get vaccinated," said Dr. Janet Woodcock, the acting F.D.A. commissioner, in a statement. "Today's milestone puts us one step closer to altering the course of this pandemic in the U.S."
Under the emergency use authorization, the COVID vaccine (via Pfizer, Moderna, and Johnson & Johnson) has been considered safe and effective in fighting the virus. Since Dec. 2020, the Pfizer COVID-19 Vaccine has been available under EUA in individuals 16 years of age and older, and the authorization was expanded to include those 12 through 15 years of age in May 2021.
The vaccine has been deemed safe for pregnant and breastfeeding parents to receive as well. The Centers for Disease Control and Prevention recommends that all pregnant women receive the COVID-19 vaccine. The recent increase in cases of the Delta variant of COVID-19 has resulted in many unvaccinated pregnant women becoming seriously ill.
Dr. Phil Dormitzer, chief scientific officer for viral vaccines at Pfizer, told NPR last week that the authorization for children ages 5 to 11 will hopefully be available soon.
"We're hoping to have authorization—depending on both results and, of course, a few decisions—not too long after the school year starts."
The New York Times reports that based on a recent poll by the Kaiser Family Foundation, which has been tracking public attitudes during the pandemic, three of every 10 unvaccinated people said that they would be more likely to get vaccinated once the vaccine had been formally approved.
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