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Pfizer’s COVID-19 vaccine gets full FDA approval

It could help some elements of the vaccination process

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The Food and Drug Administration granted full approval to the Pfizer / BioNTech COVID-19 vaccine, another landmark in the historic immunization campaign. The vaccine was previously available to people over the age of 12 in the United States under an emergency use authorization. Now, it’s officially licensed in the United States.

With full approval, Pfizer and BioNTech can directly market the shot to consumers. The vaccine will be marketed under the name Comirnaty to people over 16. It will still be available to people 12-15 years old under an emergency use authorization.

“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 approval may push more companies and schools to mandate vaccinations. While it’s legal for them to require vaccinations under an emergency authorization, some have been reluctant to do so. Public health officials hope that full approval may encourage more people to get vaccinated. “Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.,” Woodcock said.

The companies needed to provide six months of safety and efficacy data on their vaccine to the FDA in order to submit their application for what’s called a Biological License. The agency only asked companies to collect two months of data before applying for an emergency use authorization. The shortened timeline allowed the agency to sidestep some of the more lengthy regulatory steps and get vaccines to people quickly during the crisis.

This approval is based on mountains of data, including a clinical trial that looked at 20,000 patients who received the vaccine, and 20,000 people who received a placebo. That trial found that the vaccine was 91 percent effective at preventing symptomatic COVID after six months.

“Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine,” Peter Marks, director of FDA’s Center for Biologics Evaluation and Research said in a statement. As part of the evaluation, the agency reviewed hundreds of thousands of pages of data, conducted new analyses of the vaccines’ effectiveness, and inspected manufacturing facilities, Marks said.

FDA approval may help some people who were on the fence about getting vaccinated feel more comfortable taking the shot. One May survey found that one-third of unvaccinated adults would be more likely to get a COVID-19 vaccine that was fully approved.

Now that one COVID-19 vaccine has full approval, other pharmaceutical companies will not be able to ask the FDA for new emergency use authorizations. Emergency authorizations can only be issued for drugs or vaccines when there are no approved options available — now that the Pfizer / BioNTech shot is licensed, that’s no longer the case. If AstraZeneca, for example, wanted to make its shot available in the US, it would have to start with the longer formal approval process.