The U.S. FDA has awarded the first full approval for a COVID-19 vaccine to Pfizer and its German partner BioNTech, a historic decision that comes weeks ahead of its previously expected Labor Day deadline.
Pfizer’s jab, now approved for people aged 16 and older, will remain under an emergency nod for adolescents aged 12 to 15, the FDA said in a statement Monday. The two-dose vaccine, which was also the first to score an emergency OK late last year, and 204.7 million doses have been administered, Centers for Disease Control and Prevention (CDC) data show.
The agency’s full approval for Pfizer’s mRNA shot, now marketed as Comirnaty, is expected to spark a wave of vaccine mandates from companies, universities and organizations awaiting the agency’s final signoff. Some critics have pushed the FDA to accelerate its approval timeline to give greater legal backing for the wave of requirements issued in recent weeks.
Immediately following the FDA's ruling, the Pentagon said it would accelerate its timeline for requiring all U.S. troops to get vaccinated against COVID-19, the Associated Press reports. Meanwhile, all New York City public school workers will have to get vaccinated by September and won't have the ability to opt out through regular testing, Mayor Bill de Blasio announced later on Monday.
It’s also thought that the decision could push hesitant unvaccinated Americans standing by for a full FDA approval, rather than an emergency authorization, to get inoculated. One recent Kaiser Family Foundation poll from June suggests that three in 10 unvaccinated people surveyed would be more likely to get the jab if it were fully approved.
“Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S,” acting FDA Commissioner Janet Woodcock, M.D., said in the FDA’s statement on Monday.
The drug regulator’s decision was based on its safety and efficacy review of about 40,000 clinical trial participants. The FDA said Pfizer’s jab was 91% effective at preventing COVID-19 among those who were aged 16 and older, a slight drop from the 95% effectiveness reported late last year. Overall, about 12,000 people vaccinated with Comirnaty have been examined for side effects for six months.
Since scoring its emergency go-ahead, the mRNA jabs from both Pfizer and Moderna have turned up some safety concerns. That includes rare cases of heart inflammation, occurring mostly among men a week after their second dose, the FDA said.
While regulators added the side effect to the shots’ label in June, it’s still widely thought that their benefits outweigh the risks.
Pfizer’s approval, among the fastest in the FDA's 115-year history, comes just days after the White House laid out its plans to roll out booster shots for vaccinated people, despite not having the official go-ahead from the FDA or the CDC. The rollout is expected to start the week of Sept. 20 as long as they pass muster.
Pfizer has been pushing U.S. officials to authorize a third shot be added to its original two-dose mRNA vaccine regimen, although the drugmaker’s jab has largely held up when it comes to preventing severe COVID-19, hospitalizations and deaths. However, the company and top Biden administration officials point to recent studies suggesting that the shot’s effectiveness has waned over time amid the rapid rise of the troublesome delta variant, first found in India.
"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," Albert Bourla, Ph.D., Pfizer's chairman and CEO, said in an emailed statement.
Regulators have already moved to authorize a third mRNA jab for those with compromised immune systems, who sometimes do not mount a strong enough response to the two-dose regimen. But in a bid to expand that nod to all vaccinated people, Pfizer said last week that it submitted initial data from an early-stage trial to the FDA in a bid to authorize a booster for those aged 16 and older. The drugmaker previously planned to submit its third booster shot for a full FDA nod once its primary two-dose regimen won approval.
Pfizer plans to deliver over 2 billion Comirnaty doses globally this year and manufacture 3 billion, according to its July earnings report. The New York-based drugmaker also raised its expected COVID-19 shot sales from $26 billion this year to a whopping $33.5 billion.
Moderna is still awaiting an FDA decision for its rival mRNA vaccine after applying for a full nod in June. Top FDA officials declined to comment on the progress of Moderna's application when asked during a Monday press briefing.