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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.
