FDA grants full approval for Pfizer COVID-19 vaccines

The Food and Drug Administration on Monday granted full authorization to Pfizer-BioNTech’s COVID-19 vaccine, the Washington Post reports.

The groundbreaking vaccine was previously authorized for people over the age of 12 in the United States under an emergency use authorization.

What are the details?

In a statement on the FDA approval, Pfizer CEO Albert Bourla said, “Based on the longer-term follow-up date 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. 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.”

The vaccine will still be available for children ages 12 to 15 years under the previous emergency authorization.

Pfizer, in light of the new approval, can now directly market shots to consumers, and the approval may also encourage more companies and school districts to mandate vaccinations.

Dr. Peter Marks, director of the Center for Biologics Evaluation and Research at the CDC — which approves vaccines — said that doctors will now be able to prescribe the vaccination on an off-label basis.

“Not that we’re recommending off-label uses, but there is a broader potential use of that product,” he said. “When we give a biologics license, we are really saying that we have a lot of confidence in that product, in the safety, efficacy, manufacturing information, not just when it’s used exactly according to how it’s labeled, but potentially if it were used somewhat differently by physicians.”

“Off-label” also means that physicians will be able to authorize patients to get an extra Pfizer vaccine when necessary and without having to wait until boosters shots are made available to the general public.

The outlet noted that a federal official speaking on the condition of anonymity, however, said, “Many of us are worried that full approval means you don’t get more of the people who should get vaccinated, but instead the worried well [sic] are going to get additional doses.”

Biden administration officials say that they plan to roll out booster shots beginning Sept. 20.

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