En español | Seven months after the U.S. Food and Drug Administration (FDA) first authorized Pfizer-BioNTech's COVID-19 vaccine, more than 160 million people in the United States — 48 percent of the population — have been fully vaccinated against the coronavirus, according to the Centers for Disease Control & Prevention (CDC).
The next milestone: full FDA approval of the COVID-19 vaccines, which are now being given under an emergency use authorization (EUA). Public health experts say they see no reason why the vaccines from Pfizer-BioNTech and Moderna won't receive full approval (Johnson & Johnson, maker of a third vaccine, has yet to apply).
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, 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.”
Editor’s note: This article, originally published on July 15, was updated to reflect new information regarding Pfizer and BioNTech’s request for priority review.
Sarah Elizabeth Adler joined aarp.org as a writer in 2018. Her pieces on science, art and culture have appeared in The Atlantic, where she was previously an editorial fellow, California magazine and elsewhere.