Pfizer-BioNTech’s Vaccine Is the First COVID-19 Shot to Get Full Approval From the U.S. FDA

On Aug. 23, the U.S. Food and Drug Administration (FDA) approved the first COVID-19 vaccine, one made by Pfizer-BioNTech, for anyone 16 years and older. The vaccine requires two doses and according to company studies, is 91% effective in protecting people from COVID-19 disease, including from severe illness. The vaccine received the FDA’s emergency use authorization (EUA) in December, which allowed the company to distribute and administer the shot due to the urgent public health threat of the pandemic. The approval applies only to the vaccine for adults 16 years or older; teens aged 12 to 15 years will continue to get the vaccine under EUA protocols, and studies on the safety and efficacy of the shot for even younger children are still ongoing.

“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,” said Pfizer chairman and CEO Albert Bourla in a statement.

With full approval, little in the way of how the vaccine is made will change, according to Pfizer. The two companies are discussing with the FDA how the labels on the approved vials will be revised to reflect the full licensure, but the manufacturing process will not change appreciably.

What will change is the quality control requirements for each lot of vaccine. As with any approved vaccine, the FDA must now conduct its own analysis of each lot manufactured and give the green light to release those lots on to the market. Under the EUA, the companies sent samples from each lot they made to the FDA at least 48 hours before distributing, along with their own analysis of the doses’ safety and quality but did not have to wait for the FDA to release them.

What may also change are vaccine mandates from both public and private agencies including governments, schools, and businesses. Having an approved vaccine may provide stronger support for such entities to require vaccination for employees, students and customers. While some already do have such mandates in place, the FDA approval may lead more organizations to adopt similar requirements. The full licensure may also help to sway those who have been reluctant to get vaccinated with a shot that was not approved. “While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated,” acting FDA Commissioner Dr. Janet Woodcock said in a statement. “Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”

Pfizer and BioNTech submitted their request for approval in May, and the agency had eight months to review the 340,000 page package that included data from 44,000 people who participated in clinical trials. Those data showed that overall, the two doses of vaccine are 91% effective in protecting people from COVID-19 disease up to six months after the second dose. The FDA requires follow-up data of at least six months in order to qualify for approval.

Careful monitoring of people who have received the vaccine around the world revealed a side effect that led the FDA to add a warning in June about the rare risk of inflammation of the heart muscle and tissues surrounding the heart that can occur among vaccinated people, particularly young men.

Such data, both from the clinical trials as well as from real world outcomes of people who have been vaccinated, factored into the FDA’s decision to approve the vaccine. Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a briefing that the three months it took for the agency to approve the vaccine is “unprecedented” for such a product. “We don’t just look at summaries of data; we go down to the level of individual patients,” he said. “We monitor a percentage of sites where clinical trials were conducted in order to make sure the data collected was collected accurately, and matches what was submitted to the agency. We go and inspect the facilities making the product to make sure they meet our high quality standards. And doing those inspections in the middle of a pandemic was not trivial.”

With an approved vaccine, Pfizer-BioNTech can also start selling and distributing its shot through its own channels. However, Pfizer said it has an agreement with the U.S. government to provide doses through April 2022, at no cost to Americans, and expects the U.S. government to remain the sole distributor of its vaccine through that time. That means that while the vaccine is approved, it’s unlikely that doctors will be able to prescribe it under off-label conditions, which allows physicians to prescribe any approved drug for any reason — in this case, potentially for a third dose for people eager to get a booster shot or for children under 12 years old. Doctors currently dispensing the Pfizer-BioNTech vaccine are doing so under a provider agreement through the Centers for Disease Control, in which they agree to administer the vaccine under strict conditions that at this point only includes providing two doses, three weeks apart, to anyone 12 years or older. Dr. Janet Woodcock, acting FDA commissioner, said in the briefing that off-label use in children under 12 years “would not be appropriate” since “we do not have data on the proper dose or have full data on safety in children younger that those included in the EUA. We do not recommend that children younger than 12 are vaccinated with this vaccine.”

For people 12 years and up, the vaccine will continue to be offered at the same sites where it has been distributed until now—at federal or state mass vaccination sites, pharmacies, hospitals, doctors’ offices and other health care centers. Health care professionals can continue to use any existing supply they have in their freezers since the formulation of the approved vaccine will be the same as that distributed under the EUA.

Those sites would also be responsible for giving Americans an additional, booster dose of the vaccine which the FDA is currently considering as a way to bolster protection against the more infectious Delta variant. The agency is expected to announce its decision on whether a booster is needed in coming weeks; the FDA has already authorized a booster shot for people with compromised immune systems.