FDA grants full approval to Pfizer's COVID-19 vaccine

COVID-19 vaccine
Posted at 7:40 AM, Aug 23, 2021

The Food and Drug Administration on Monday issued full approval to the two-dose Pfizer COVID-19 vaccine.

“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic," acting FDA Commissioner Janet Woodcock said in a statement. "While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, 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.”

The full approval for the vaccine, which will now be marketed under the name "Comirnaty," applies to people 16 and older. The vaccine is still available for kids aged 12 through 15 under emergency use authorization.

In prepared remarks Monday afternoon, President Joe Biden urged those who have been waiting for the vaccine to be granted full approval by the FDA to seek out a shot.

“If you’re one of the millions of Americans who 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,” Biden said.

Full approval also opens the door for more government departments and businesses to issue vaccine mandates. For example, the Pentagon earlier this month said it would require all military members to get vaccinated by Sept. 15, though Sec. of Defense Lloyd Austin said he would issue an order making the shots mandatory "immediately upon licensure" by the FDA.

Biden added in his remarks that he hoped full approval would result in more local governments and private sector businesses adopting their own vaccine mandates, noting that it's been commonplace in the past to adopt vaccine mandates for diseases like polio and mumps.

"It only makes sense to require a vaccine that prevents the spread of COVID-19," Biden said.

Two other COVID-19 vaccines — the two-dose Moderna vaccine and the single-dose Johnson & Johnson shot — are still widely available in the U.S. under emergency use authorization.

The full approval of the Pfizer vaccine comes amid a spike in COVID-19 cases, hospitalizations and deaths caused by the more contagious delta variant. Health experts say that the current spike is driven by those who remain unvaccinated.

All three COVID-19 vaccines have proven to be safe and highly effective in fighting severe and deadly cases of the virus. Earlier this month, the CDC reported that 99.99% of fully vaccinated people had avoided a severe or deadly COVID-19 infection.