U.S. regulators give full approval to Pfizer-BioNTech's COVID-19 vaccine
Until now, vaccine had been approved under an emergency use authorization
The U.S. gave full approval to Pfizer-BioNTech's COVID-19 vaccine on Monday, a milestone that may help lift public confidence in the shots as the nation battles the most contagious coronavirus variant yet.
The vaccine made by Pfizer and its German partner, BioNTech, now carries the strongest endorsement from the Food and Drug Administration, which has never before had so much evidence to judge a shot's safety.
More than 200 million Pfizer doses already have been administered in the U.S. — and hundreds of millions more worldwide — since emergency use began in December.
"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," said acting FDA Commissioner Janet Woodcock. "Today's milestone puts us one step closer to altering the course of this pandemic in the U.S."
The U.S. becomes the first country to fully approve the shot, according to Pfizer, and CEO Albert Bourla said in a statement he hoped the decision "will help increase confidence in our vaccine, as vaccination remains the best tool we have to help protect lives."
The sentiment was echoed by U.S. President Joe Biden on social media.
"While all three COVID vaccines have met FDA's strict standards for emergency use, this FDA approval should give added confidence that this vaccine is safe and effective," reads a tweet from Biden's account. "If you're not vaccinated yet, now is the time."
What does this mean for Canada?
U.S. approval doesn't necessarily hint at Canadian approval happening imminently.
Earlier this month, a federal spokesperson told CBC News in a statement that while Health Canada "has put in place a fast-tracked review process to assess COVID-19 vaccines," the process is a bit different from what's in place south of the border.
A spokesperson for Pfizer said in mid-August that the company has filed a new drug submission to transition its COVID-19 vaccine from Canada's interim order authorization to a full approval, but would not comment on when the vaccine manufacturer expects to receive a decision from Health Canada.
"We're obviously a different country with different regulatory bodies," but when people hear that Pfizer's vaccine has been granted full approval in the U.S., "I think that's at least enough of a push to nudge many people" to get the shot, said Dr. Isaac Bogoch, an infectious diseases physician and member of Ontario's COVID-19 vaccine task force.
"Obviously, if Health Canada does the same I think it'll also have a similar positive effect — not only will it just nudge people who might have been a little bit indifferent or a little bit hesitant, it also can nudge businesses as well."
Many Canadian businesses and organizations may be holding out on mandating vaccines because there's only interim approval of these vaccines, he added.
"Once [the vaccines are] granted full approval, I think we'll see many other businesses and organizations start to mandate vaccinations."
Approval comes as vaccine uptake rising in U.S.
The U.S. approval comes while the delta variant is filling hospital beds and shots are on the rise again — with a million a day given Thursday, Friday and Saturday — after U.S. vaccinations bottomed out in July.
Just over half of the U.S. population is fully vaccinated with one of the country's three options, from Pfizer, Moderna or Johnson & Johnson.
The FDA's action may spur more vaccine mandates by companies, universities and local governments.
This month, New York City, New Orleans and San Francisco all imposed proof-of-vaccination requirements at restaurants, bars and other indoor venues. At the federal level, President Biden is requiring government workers to sign forms attesting that they've been vaccinated or else submit to regular testing and other requirements.
Nearly six in 10 Americans favour 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. So Pfizer kept that study going, and 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.
WATCH | Biden pushes for mandatory COVID-19 vaccines:
Serious side effects remain rare
Even after hundreds of millions of shots, serious side effects — such as chest pain and heart inflammation in teens and young adults — remain exceedingly rare, the FDA said.
As for effectiveness, six-month tracking of Pfizer's original study showed the vaccine remained 97 per cent protective against severe COVID-19. Protection against milder infection waned slightly, from a peak of 96 per cent two months after the second dose to 84 per cent by six months.
Those data came before the extra-contagious delta variant began spreading, but other data from the Centers for Disease Control and Prevention shows the vaccine is still doing a good job preventing severe disease caused by that mutant.
As for all the talk about booster doses, the FDA's licensure doesn't cover those. The agency will decide that 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, such as organ transplant recipients who don't respond as strongly to the usual two shots. 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.