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The U.S. formally approved 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.
It could also raise concerns that the Food and Drug Administration 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 — as a result of political pressure.
It is the first COVID-19 vaccine to receive a formal FDA approval.
The shots developed by Pfizer/BioNTech, Moderna Inc.
MRNA,
and Johnson & Johnson
JNJ,
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 approval process instead takes into account six months of data.
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 deaths topped 1,000 for a second-straight day, while hospitalizations were up 43% to 92,482, the most since Feb. 6, according to the New York Times tracker.
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.
