U.S. regulators give full approval to Pfizer COVID-19 vaccine
WASHINGTON — The U.S. gave full approval to Pfizer’s COVID-19 vaccine Monday, potentially boosting public confidence in the shots and instantly opening the way for more universities, companies and local governments to make vaccinations mandatory.
The Pentagon promptly announced it will press ahead with plans to require members of the military to get vaccinated amid the battle against the extra-contagious delta variant. Louisiana State University likewise said it will demand its students get the shot.
More than 200 million Pfizer doses have been administered in the U.S. under special emergency provisions — and hundreds of millions more worldwide — since December. In going a step further and granting full approval, the Food and Drug Administration cited months of real-world evidence that serious side effects are extremely rare.
President Joe Biden said that for those who hesitated to get the vaccine until it received what he dubbed the “gold standard” of FDA approval, “the moment you’ve been waiting for is here.”
“Please get vaccinated today,” he said.
Pfizer CEO Albert Bourla called the FDA’s action “an important milestone that I think will unlock some of the more skeptical minds.”
Pfizer said the U.S. is the first country to grant full approval of its vaccine, in a process that required a 360,000-page application and rigorous inspections. Never before has the FDA has so much evidence to judge a shot’s safety.
The formula, jointly developed Germany’s BioNTech, will be marketed under the brand name Comirnaty.
Moderna has also applied to the FDA for full approval of its
vaccine. Johnson & Johnson, maker of the third option in the U.S., said it hopes to do so later this year.
Just over half of the U.S. population is fully vaccinated. Vaccinations in this country bottomed out in July at an average of about a half-million shots per day, down from a peak of 3.4 million a day in mid-April. As the delta variant fills hospital beds, shots are on the rise again, with a million a day given Thursday, Friday and Saturday.
Full approval of Pfizer’s COVID-19 vaccine means it 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.
The approval also opened the way for swift action by colleges to require vaccines and solidified the legal ground for hundreds of universities that have already issued mandates for students and staff.
Anxious Americans increasingly are on board: Close to 6 in 10 favor requiring people to be fully vaccinated to fly or attend crowded public events, according to a recent poll by The Associated Press-NORC Center for Public Affairs Research.
The delta variant has sent cases, deaths and hospitalizations soaring in recent weeks in the U.S., erasing months of progress. Deaths are running at about 1,000 a day on average for the first time since mid-March, and new cases are averaging 147,000 a day, a level last seen at the end of January.
“For weeks we have watched cases go up at an alarming pace among individuals who are not vaccinated while the vaccinated are largely protected,” said Dr. Tomas J. Aragon, director of California’s public health department.
“If you are not vaccinated, let this be the milestone that gets you there.”
The FDA, like regulators in Europe and much of the rest of the world, initially allowed emergency use of Pfizer’s vaccine based on a study that tracked 44,000 people 16 and older for at least two months — the time period when serious side effects typically arise.
That’s shorter than the six months of safety data normally required for full approval. So Pfizer kept that study going, and the FDA also examined realworld safety evidence.
Pfizer’s shot will continue to be dispensed to 12- to 15-yearolds under an emergency use authorization, until the company files its its application for full approval.
Both Pfizer and Moderna have vaccine studies underway in youngsters, and they are using lower doses than those available for people 12 and older.