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A man receives his first dose of Pfizer’s coronavirus vaccine in Valley Stream, New York on 23 February 2021.Photograph: Brendan McDermid/Reuters
The US Food and Drug Administration (FDA) has given full approval to the Pfizer vaccine for Covid-19. The vaccine and others have been in use for months under emergency use authorisation.
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President Joe Biden hailed the announcement as “another milestone, a key milestone, in our fight against Covid”.
The decision is likely to trigger a wave of formal vaccine requirements from government departments, businesses, schools and other bodies.
On Monday a Pentagon spokesman said: “Now that the Pfizer vaccine has been approved, the Department [of Defense] is prepared to issue updated guidance requiring all service members to be vaccinated.”
In New York, city authorities announced that all public school teachers and other staffers will have to get vaccinated.
Many observers hope formal approval will also spur an increase in vaccine take-up among sections of the population, particularly in Republican-led states, so far resistant to government advice.
Delivering remarks in Washington, Biden said: “If you’re one of the millions of Americans who’ve said that they will not get the shot until it has full and final approval of the FDA: it has now happened. The moment you’ve been waiting for is here. It is time for you to go get your vaccination. And get it today.”
More than 200m Pfizer doses have been administered in the US since emergency use began in December, and hundreds of millions more worldwide.
Janet Woodcock, the acting FDA commissioner, said: “The public can be very confident that this vaccine meets the high standards for safety, effectiveness and manufacturing quality the FDA requires of an approved product.
“While millions of people have already safely received Covid-19 vaccines, we recognise that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated. Today’s milestone puts us one step closer to altering the course of this pandemic in the US.”
Biden praised Woodcock for “ensuring the team followed the science above all”.
“The FDA approval is the gold standard,” he said, stressing: “Those who have been waiting for full approval should go get your shot now. The vaccination is free, it’s easy, it’s safe, and it’s effective.”
The US is struggling with a wave of cases, hospitalisations and deaths from the infectious Delta variant of the coronavirus. The overwhelming majorityof hospitalisations and deaths are among unvaccinated people.
According to Johns Hopkins University, nearly 630,000 people have died in the US of Covid-19.
US vaccinations bottomed out in July. But as Delta patients fill hospital beds, shots are on the rise again – with a million a day given Thursday, Friday and Saturday. Just over half of the US population is fully vaccinated with one of three options, from Pfizer, Moderna or Johnson & Johnson.
In a statement, the FDA said: “Today, the US Food and Drug Administration approved the first Covid-19 vaccine. The vaccine has been known as the Pfizer-BioNTech Covid-19 Vaccine, and will now be marketed as Comirnaty, for the prevention of Covid-19 disease in individuals 16 years of age and older.
“The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.”
In New York, the new vaccine policy for the largest US school system was the city’s first flat-out vaccination mandate, with no alternative for regular testing. The city did not immediately say what the penalty will be for refusing, or if there will be exemptions.
This month, New York, New Orleans and San Francisco all imposed proof-of-vaccination requirements at restaurants, bars and other indoor venues. At the federal level, Joe Biden is requiring government workers to sign forms attesting that they have been vaccinated or else submit to regular testing and other requirements.
Americans increasingly are on board with such mandates: close to six in 10 favor requiring people to be fully vaccinated to travel on airplanes or attend crowded public events, according to a recent poll by the Associated Press-NORC Center for Public Affairs Research.
“Mandating becomes much easier when you have full approval,” said Dr Carlos del Rio of Emory University. “I think a lot of businesses have been waiting for it.”
The FDA, like regulators in Europe and much 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. Pfizer therefore kept the study going. The FDA also examined real-world safety evidence in deciding to fully license the vaccine for people 16 and older, those studied the longest. Pfizer’s shot still has emergency authorization for 12- to 15-year-olds.
Serious side effects – such as chest pain and heart inflammation in teens and young adults – remain exceedingly rare, the FDA said.
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As for effectiveness, six-month tracking of Pfizer’s original study showed the vaccine remained 97% protective against severe Covid-19. Protection against milder infection waned slightly, from a peak of 96% two months after the second dose to 84% by six months.
That data came before the extra-contagious Delta variant began spreading, but other data from the Centers for Disease Control and Prevention (CDC) shows the vaccine is still doing a good job preventing severe disease caused by the mutation.
The FDA licensure doesn’t cover booster shots. The agency will decide that issue separately. The FDA already is allowing emergency use of a third dose of either the Pfizer or Moderna vaccine for people with severely weakened immune systems. For everyone else who got those vaccinations, the Biden administration is planning ahead for boosters starting in the fall – if the FDA and CDC agree.
Also still to be decided is vaccination of children under 12. Both Pfizer and Moderna are studying youngsters, with data expected in the fall.
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