The U.S. formally approved BioNTech and Pfizer’s COVID-19 vaccine in a move that could sway some of the unvaccinated to get a shot.
The approval, announced Monday morning, applies to people who are at least 16 years old. The emergency-use authorization still stands for those between the ages of 12 and 15 years old and the immuno-compromised individuals who qualify for a third shot.
It is the first COVID-19 vaccine to receive a formal FDA approval.
“I am hopeful this approval will help increase confidence in our vaccine, as vaccination remains the best tool we have to help protect lives and achieve herd immunity,” Pfizer CEO Albert Bourla said in a statement.
The FDA cited new data from the clinical trial that found the vaccine, which is now called Comirnaty and was tested in 22,000 people, is 91% effective at preventing the disease caused by SARS-CoV-2. (An additional 22,000 people in the study received the placebo.)
The shots developed by Pfizer Inc.
and Johnson & Johnson
have all received emergency authorization from the FDA, a type of less stringent but speedier “approval” that helped bring the vaccines to Americans sooner during the pandemic.
This kind of authorization relied on two months of follow-up safety and efficacy data from the people who participated in the clinical trials. The full approval process instead takes into account six months of data from 12,000 participants.
“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,” acting FDA Commissioner Janet Woodcock said in a statement.
Some experts including FDA officials have previously said a quick approval could raise concerns that the FDA sped up the regulatory process — it was not required to make a decision about approving the vaccine until January, six months after accepting BioNTech SE BNTX and Pfizer Inc.’s PFE application.
Here’s what the numbers say
The seven-day moving average is 137,188 cases per day and 738 deaths per day, as of Aug. 20, according to the latest data from the Centers for Disease Control and Prevention. The daily average for cases was the highest since Feb. 1 and the daily average for deaths the highest since March 25.
About 170.8 million people in the U.S., or 51.5% of the total population, are now fully vaccinated, as of Aug. 22, and 201.2 million, or 71%, of those who qualify for the vaccine, have received at least one shot.
Here’s what else is happening in the news
• The average cost of a COVID-19 hospitalization is $20,000, according to the Kaiser Family Foundation. The organization put together a new analysis that found there were 37,000 preventable COVID-19 hospitalizations in June and 76,000 preventable hospitalizations in July, which could cost the U.S. health care system $2.3 billion for those two months alone.
• Maryland Gov. Larry Hogan got a third dose of a COVID-19 vaccine, saying that because he is a cancer survivor it was recommended by his doctor, the Associated Press reported. The FDA has already authorized a third dose of the mRNA vaccines to those with weakened immune systems, though there are concerns among public-health experts about the Biden administration’s plans to offer booster shots to the general public. “It just doesn’t make sense on the surface,” Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, told MarketWatch.