The U.S. Food and Drug Administration granted full approval this week to the first COVID-19 vaccine for people 16 and older. So what does full FDA approval really mean?
The FDA’s approval of Pfizer-BioNTech’s vaccine is based on six months of follow-up data from approximately 20,000 people who received the two-dose vaccine and 20,000 people who received the placebo. The vaccine was found to be safe and 90% to 95% effective in preventing COVID-19, says John Segreti, MD, an infectious disease expert at Rush University Medical Center.
Until Monday, the vaccine was authorized only for emergency use, a status that the FDA can grant to speed access to vaccines and other products during public health emergencies like the coronavirus pandemic. The Pfizer-BioNTech vaccine continues to be available under emergency use authorization for people ages 12 through 15 and for a third dose in people with compromised immune systems.
While millions of Americans have already received COVID-19 vaccines made by various manufacturers, millions remain unvaccinated. Segreti hopes that anyone who was hesitant to have the vaccine because it was under emergency authorization use will decide to get the vaccine now.
“We already knew it was a good vaccine,” Segreti says. “So if the FDA’s full approval convinces some people that the vaccine is not investigational and they now feel comfortable getting the vaccine that’s great, even if it’s a small number.”
Getting vaccinated is the best way to prevent hospitalizations and deaths from COVID-19, especially amid a surge of cases caused by the Delta variant, Segreti says.
He adds: “I think we all have an obligation to protect ourselves but also to protect our families, our friends and our co-workers, and if you get the vaccine, you’re doing that.”