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What Full FDA Approval of the COVID-19 Vaccines Will Mean

Vaccine mandates and population hesitancy could be affected

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With more than 51 percent of the U.S. population now fully vaccinated against the coronavirus, another major vaccine milestone has been reached: The Pfizer-BioNTech vaccine has been approved by the U.S. Food and Drug Administration (FDA), making it the first of the COVID-19 vaccines to receive full approval from the agency.

Public health experts say they see no reason why the Moderna vaccine, currently being given under an emergency use authorization (EUA), won't also receive full approval in the months to come. (Johnson & Johnson, maker of a third vaccine, has yet to apply.)

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What's the difference between full approval and an EUA?

"Full approval or licensure of a vaccine means that the Food and Drug Administration has reviewed reams of data regarding the effectiveness of the vaccine, its safety and many issues related to its manufacturing,” says William Schaffner, M.D., medical director of the National Foundation for Infectious Diseases and professor of medicine at the Vanderbilt University School of Medicine. “The difference between an EUA and full licensure is just a matter of degree.”

An EUA permits the COVID-19 vaccines to be administered for the duration of the coronavirus public health emergency. For an EUA to be issued, companies must submit to the FDA at least two months of follow-up safety data from their clinical trials, as well as information about their product's effectiveness and how it is manufactured.

As is necessary for an EUA, full FDA approval requires a team of experts to do an in-depth review of efficacy and manufacturing data. Companies also submit at least six months of follow-up safety data from clinical trials. Even after a vaccine is fully approved, it continues to be monitored for safety.

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; the Pfizer-BioNTech vaccine received full approval on Aug. 23.

Priority review typically means a six-month timeline for the approval process, says Walter Orenstein, M.D., associate director of the Emory Vaccine Center and professor of infectious diseases at the Emory University School of Medicine. The standard approval process takes approximately 10 months, and public health experts say they are confident that the Moderna vaccine will also receive full approval in the months to come.

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What full approval means

The Pfizer-BioNTech vaccine will now be marketed as Comirnaty and is approved for use in people 16 and older. The vaccine will still be given to people 12 to 15 years old under an EUA, as well as to certain immunocompromised people as a third dose.

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Moderna is seeking full approval for use in those 18 and older; if the vaccine receives approval as expected, its manufacturer will be able to distribute and market it for use in the population for which it is approved even after the official public health emergency ends.

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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