Pfizer-BioNTech Has Requested Full Approval of Their COVID-19 Vaccine From the FDA

Pfizer-BioNTech announced on May 7 that they have requested that the U.S. Food and Drug Administration (FDA) start the process of fully approving their COVID-19 vaccine. The companies will continue to supply the agency with additional data on vaccination safety and effectiveness on a rolling basis over coming weeks. The FDA issued an emergency use authorization for the shot in December, based on short-term data on safety and efficacy.

Now, the companies have the required six-month data on the vaccine to support a biologics license application, which the FDA will review over the next several weeks before making a decision.

What difference would approval of the vaccine make over the current authorization? “It would be a total game changer for two reasons,” says Dr. Leana Wen, visiting professor of health policy and management at George Washington University’s Milken School of Public Health and former health commissioner for Baltimore City. “First, legal questions raised about whether employers can require it, or whether schools can mandate vaccination, are put to rest if the FDA gives it full approval because there is precedent for requiring other vaccines that are approved, like childhood vaccinations.

“Second, one of the arguments perpetuated by anti-vaccine activists, and some who are hesitant, has to do with the idea that these are still ‘experimental vaccines’ since they have not received approval,” says Wen. “Full approval would put those concerns and disinformation to rest.”

For people who have already been vaccinated, the filing and anticipated approval doesn’t make much difference. And for doctors and health care professionals, there likely won’t be any surprises in the longer-term data since the companies have already released reports showing strong responses up to six months after vaccination.

But for those who feel the vaccines were released before adequate data was gathered and analyzed, the request for approval should be reassuring, as the new filing includes follow-up safety and efficacy data for up to six months, compared to the two-month data the FDA relied on to issue emergency use.

Dr. Kirsten Lyke, associate professor of medicine at the University of Maryland, says that the approval could be important for Pfizer-BioNTech if, as many experts believe, people will need to receive regular booster shots of the vaccine to maintain immunity—similar to flu shots. “An emergency use authorization allows companies to issue their product during the time of emergency. But at some point when it’s not deemed to be an emergency, then companies cannot continue to distribute their product,” says Lyke.

Having an approved product also lets the companies sell their vaccine directly to doctors, hospitals, pharmacies, schools and other places that provide immunizations. Under the EUA, the government has purchased these doses and is distributing them free to the public, but it’s not clear if that practice will continue with booster doses if they’re needed. If the federal government is no longer providing the shots, then people might start to see fees associated with getting vaccinated, which insurers may cover.

If the FDA decides to approve the vaccine, then people getting immunized would also no longer need to sign the form acknowledging that they are receiving a product that has not been approved yet.