FDA Grants Full Approval to Pfizer’s COVID-19 Vaccine

The state set up a mass-vaccination center at Michigan State University. Photo by Rosh Sillars

After months of waiting, the U.S. finally has an approved vaccine for the coronavirus.

The Food and Drug Administration Monday granted full approval of the Pfizer/BioNTech COVID-19 vaccine. It’s the first vaccine to be granted full approval, after previously having been granted emergency use authorization.

Health officials had previously thought it would be closer to the end of August before final approval was granted. According to the FDA, full approval means Pfizer has shown enough effectiveness and safety data to meet the stringent Biologics License Application (BLA) requirements, which includes at least six months of safety data from a majority of the volunteers in a large, final stage clinical trial.

“Based on the longer-term follow-up data that we submitted, today’s approval for those aged 16 and over affirms the efficacy and safety profile of our vaccine at a time when it is urgently needed,” Albert Bourla, Pfizer CEO said in a statement to ABC News. “Hundreds of millions of doses of our vaccine already have been administered in the U.S. since December 2020, and we look forward to continuing to work with the U.S. government to reach more Americans.”

Some expect the formal approval to pave the way for further vaccine mandates in both the public and private sector. In an appearance on CNN Sunday, U.S. Surgeon General Dr. Vivek Murthy said the FDA approval will “help” with such plans.

“For businesses and universities that have been thinking about putting vaccine requirements in place in order to create safer spaces for people to work and learn, I think that this move from the FDA, when it comes, will actually help them to move forward with those kinds of plans,” Murthy told CNN.

Meanwhile, federal, state and local health officials are also hoping full approval will spur those who’ve hesitated to get the vaccine to go ahead and get the shot.

Making the rounds of the Sunday shows, Murthy told ABC’s “This Week” that full approval may “tip” some fence-sitters towards taking the shot and prompt more workplaces and schools to move forward on requirements.

“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,” Bourla said upon Pfizer’s approval.

“Full approval could not come at a more important time, as the highly contagious Delta variant continues to drive up caseloads and deaths across the U.S.,” Dr. Rich Besser, former acting CDC director and president of the Robert Wood Johnson Foundation, told ABC. “I am hopeful that full approval will address any remaining concerns and will move many people to a ‘yes’ on vaccination.”

The Pfizer/BioNTech vaccine has been authorized for emergency use in the United States since mid-December for people age 16 and older. In May, the authorization was extended to those 12 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,” according to the FDA.

Out of more than 170 million people in the United States fully vaccinated against Covid-19, more than 92 million have received the Pfizer/BioNTech vaccine.

Pfizer was the first to request full approval in the U.S.; other Covid vaccine makers are likely to follow suit. All three authorized vaccines – Pfizer, Moderna and Johnson & Johnson — were granted emergency authorization based on massive clinical trials involving tens of thousands of volunteers.