U.S. Regulators Fully Approve Pfizer BioNTech’s COVID-19 Vaccine

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 President 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 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.”

Serious Side Effect Continues to 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, the six-month tracking of Pfizer’s original study showed the vaccine remained 97 percent protective against severe COVID-19. Protection against milder infection waned slightly, from a peak of 96 percent two months after the second dose to 84 percent 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 the emergency use of the 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.


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