New top story from Time: Pfizer-BioNTech’s Vaccine Is the First COVID-19 Shot to Get Full Approval From the U.S. FDA

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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.

“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.
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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.

In the months since the vaccine has been administered around the world, the FDA has also added warnings about rare side effects that can occur among vaccinated people, including the risk of inflammation of the heart muscle and tissues surrounding the heart.

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. The vaccine will therefore 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.

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.