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 by the Food and Drug Administration, 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 and the immunocompromised individuals who qualify for a third shot.
It is the first COVID-19 vaccine to receive formal approval in the U.S.
“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 COVID-19, the disease caused by the SARS-CoV-2 coronavirus. (An additional 22,000 people in the study received a placebo.)
and by Moderna 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 in hopes of turning the pandemic’s tide. The emergency-use authorization of the Pfizer vaccine was granted in December, and it was extended to include people as young as 12 in May.
Shares of Pfizer shot up 3.7% toward a record in morning trading Monday, and U.S.-listed shares of BioNTech rallied 8.3%. Meanwhile, Moderna’s stock jumped 4.6%. J&J shares slipped 0.4%. In comparison, the S&P 500 index
The emergency authorization relied on two months’ worth of follow-up safety and efficacy data from the people who participated in 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 regulator sped up the regulatory process — it was not required to make a decision about approving the vaccine until January, six months after accepting BioNTech and Pfizer’s application.
Here’s what the numbers say
The seven-day moving average is 137,188 cases per day and 738 deaths per day in the U.S., as of Aug. 20, according to the latest data from the Centers for Disease Control and Prevention. The daily average of cases was the highest since Feb. 1, and the daily deaths average was the highest since March 25.
About 170.8 million people in the U.S., or 51.5% of the total population (including those too young for eligibility), are fully vaccinated, as of Aug. 22, and 201.2 million, or 71%, of those who qualify for vaccination, 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. healthcare system $2.3 billion during 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 for 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.