What Full FDA Approval of the COVID Vaccines Will Mean

Alonzo Osche

Pfizer and BioNTech submitted their vaccine to the FDA for full approval in early May, as did Moderna on June 1. Both companies requested priority review of their applications, which would mean a six-month timeline for the approval process, says Walter Orenstein, M.D., associate director of Emory Vaccine Center and […]


Pfizer and BioNTech submitted their vaccine to the FDA for full approval in early May, as did Moderna on June 1. Both companies requested priority review of their applications, which would mean a six-month timeline for the approval process, says Walter Orenstein, M.D., associate director of Emory Vaccine Center and professor of infectious diseases at Emory University School of Medicine. The standard approval process takes approximately 10 months.

Pfizer and BioNTech’s request for priority review was granted by the FDA on July 16, and public health experts say they are confident that both the Pfizer-BioNTech and Moderna vaccines will receive full approval in the months to come.

What full approval may mean

If the Pfizer-BioNTech and Moderna vaccines receive full approval as expected, their manufacturers will be able to distribute and market their products for use in the populations for which they are approved even after the official public health emergency ends. Pfizer and BioNTech are seeking approval for their vaccine’s use in people 16 and older; Moderna is seeking approval for those 18 and older.

Experts say full approval could also play a role in shaping vaccine mandates. Employers already can require that workers be vaccinated against COVID-19 (although exceptions apply and workers can seek exemptions on medical and religious grounds), but full FDA approval may prompt additional mandates from employers, schools and other institutions. The U.S. military, for one, has said that it will consider a vaccine mandate once the COVID-19 vaccines receive full approval.

Still, Schaffner says he doesn’t expect an “avalanche” of mandates — and some institutions aren’t waiting for full approval to put vaccine requirements in place. Many colleges and universities have already announced vaccination mandates for the coming school year, as have employers, particularly health care providers.

Impact on vaccine hesitancy

Some polling data suggests that full FDA approval may boost vaccination rates among those yet to receive a COVID-19 shot. According to a June survey from the Kaiser Family Foundation, 31 percent of unvaccinated adults said they would be more likely to get a vaccine if one of the vaccines currently authorized for emergency use received full FDA approval. But both Schaffner and Orenstein note that full agency approval is not likely to mitigate all the reasons for vaccine hesitancy, which include concern about side effects and lack of trust in the government.

Schaffner encourages older adults and anyone who is not yet vaccinated to speak to their health care provider about the vaccines and any concerns they have.

Orenstein points out that the full approval process itself should reassure people that the FDA is not forgoing preexisting standards or procedures when it comes to licensing the COVID-19 vaccines. “The full approval process is a comprehensive one,” he says. “People need to feel … that it’s not rushed.”

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