WASHINGTON — The U.S. Food and Drug Administration gave full approval to Pfizer's COVID-19 vaccine Monday.
The formula made by Pfizer and its German partner BioNTech now carries the strongest endorsement from the agency, which has never before had so much evidence to judge a shot’s safety.
More than 200 million Pfizer doses have been administered in the U.S. — and hundreds of millions more worldwide — since December. But up to now, they were dispensed in this country under what is known as emergency use authorization from the FDA.
Below is everything you need to know about the vaccine's approval:
What does the FDA approval mean?
Full approval means Pfizer's COVID-19 vaccine meets the same “very high standards required of all the approved vaccines we rely on every day,” said Dr. Jesse Goodman of Georgetown University, a former FDA vaccine chief. That should help “anyone who still has concerns gain confidence” in the shots.
Approved vaccines undergo the agency’s standard process for reviewing the quality, safety and effectiveness of medical products, according to the FDA. For all vaccines, the agency evaluates data and information included in the manufacturer’s submission of a biologics license application (BLA).
The FDA conducts its own analyses of the information in the BLA to make sure the vaccine is safe and effective and meets the FDA’s standards for approval.
What will the vaccine be called?
The vaccine has been known as the Pfizer-BioNTech COVID-19 vaccine, and will now be marketed as Comirnaty (koe-mir’-na-tee).
Which age group has been approved?
The U.S. Food and Drug Administration approved the first COVID-19 vaccine for individuals 16 years of age and older.
The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.
Will COVID-19 vaccines be mandatory now?
Earlier this month, Defense Secretary Lloyd Austin said he would seek the president’s OK to make the vaccine mandatory for military personnel by mid-September or once the FDA issues final approval, whichever came first. On Monday, after the FDA acted, Pentagon spokesman John Kirby said a timeline for vaccinations will be provided in the coming days.
The FDA’s action may also lead to more vaccine mandates covering students, employees and customers.
“Mandating becomes much easier when you have full approval,” said Dr. Carlos del Rio of Emory University. “I think a lot of businesses have been waiting for it.”
This month, New York City, New Orleans and San Francisco all imposed proof-of-vaccination requirements at restaurants, bars and other indoor venues. At the federal level, President Joe Biden is requiring government workers to sign forms attesting that they have been vaccinated or else submit to regular testing and other requirements.
When will the Moderna and Johnson & Johnson vaccines be approved?
Pfizer is the only fully FDA-approved COVID-19 vaccine.
Moderna applied to the FDA for full approval of its vaccine a month after Pfizer, and J&J said it hopes to do so later this year. So, it will take time for the agency to fully approve both.
Where to get the Pfizer vaccine?
The U.S. Centers for Disease Control and Prevention created the website vaccines.gov for anyone to find a vaccination location. The tool allows individuals to select which vaccine they're looking for.
Also, anyone can text their ZIP code to 438829, or call 1-800-232-0233 to find locations around the U.S.
How effective is the Pfizer vaccine?
Six months into Pfizer’s original study, the vaccine remained 97% protective against severe COVID-19. Protection against milder infection waned slightly, from a peak of 96% two months after the second dose to 84% by six months.
That data came before the extra-contagious delta variant began spreading, but other data from the Centers for Disease Control and Prevention shows the vaccine is still doing a good job preventing severe disease caused by that mutant.