The U.S. Food and Drug Administration approved the Pfizer-BioNTech coronavirus vaccine on Monday for people 16 and older, making it the first of three COVID-19 shots available in the U.S. to be upgraded from an emergency use authorization (EUA) to full approval.
For children aged 12 to 15, the vaccine can still be administered under an EUA, as well as third doses for certain immunocompromised individuals. Both the Johnson & Johnson and Moderna COVID-19 vaccines still await FDA approval but remain available for adults under an EUA.
The upgrade means the Pfizer vaccine will still be available to the public even after the “current public health emergency” the original authorization was based on comes to an end. The approval also means employers, local leaders and other businesses may be more willing or likely to mandate COVID-19 vaccination.
For example, the U.S. military said it will mandate vaccines as soon as they became FDA approved, or once the president approved the request, whichever came first. And several colleges and universities have already mandated them for staff and students who wish to return to campus.
However, experts say the approval’s largest impact may be on those who have remained hesitant about the vaccine’s safety, many of whom call them “experimental” shots.
A recent poll by the Kaiser Family Foundation found that 31% of unvaccinated Americans said they would be more likely to get their shots if the FDA officially approved them.
“While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product,” Acting FDA Commissioner Dr. Janet Woodcock said in a statement. “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.”
So, what does the FDA’s approval mean for Americans? And how does it differ from the emergency use authorization?
Here’s everything you need to know.
Does this mean you can get a booster shot now?
White House health officials announced last week they are recommending booster COVID-19 shots for all adult Americans to maximize and prolong protection against severe disease and death.
They are currently recommending that only adults get a booster shot. They said they are leaving it up to the FDA to decide if it’s safe for children between 12 and 17 years old.
The recommendation was based on two main pieces of evidence from the U.S. and around the world: vaccine protection against coronavirus infections decreases over time and vaccine effectiveness generally decreases when put up against the highly contagious delta variant, which is driving infections across the U.S.
But the FDA’s approval does not mean you can rush to your local pharmacy and get a third dose now, officials said. The booster plan is still pending authorization from a special committee within the FDA and a recommendation from the Centers for Disease Control and Prevention.
People could get booster shots beginning the week of Sept. 20, at least eight months after receipt of their second dose.
