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Pfizer and BioNTech plan to seek full regulatory approval, or licensure, for their coronavirus vaccine in the first half of the year.
As of now, Pfizer-BioNTech’s jabs, and another vaccine developed by Moderna, were rolled out in the U.S. under the Food and Drug Administration’s emergency use approval (EUA), or authorization intended to address serious, threatening diseases where there are no other alternatives. Full FDA approval, however, requires a so-called Biologics License Application, or BLA.
"Pfizer and BioNTech are planning to submit a Biologics License Application (BLA) during the first half of 2021 to secure full regulatory approval for BNT162b2," reads a statement emailed to Fox News. "Once filed, we expect the FDA to make a final decision in the second half of 2021."
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The FDA said it expects manufacturers with vaccines under emergency approval to continue on and pursue full approval. (iStock)
Emergency approval from the FDA came after massive clinical trials involving tens of thousands of volunteers, and sufficient data on safety and efficacy, with experts in an independent advisory panel poring over the results.
The panel voted to support that, based on the total scientific evidence available at the time, the benefits of the Pfizer-BioNTech vaccine outweighed its risks for those aged 16 and up. Moderna received emergency approval for those aged 18 and up.
The vaccines met skepticism in the U.S., with many criticizing the speed of development and approval, though experts attribute the record pace to "extraordinary scientific advances," per Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases.
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More specifically, for emergency approval of a vaccine, the FDA required two months’ worth of safety data, a certain number of disease events in order to establish the efficacy of the vaccine compared to a placebo, and a plan for follow-up on safety, among other requirements. In addition, Health and Human Services Secretary Alex Azar recently said that full approval also requires additional safety data and about "four repeated validated runs" on the vaccines’ manufacturing process with FDA inspectors, which was said to take about four months."
While the FDA didn’t require companies developing COVID-19 vaccines to undergo manufacturing site inspections for emergency use authorizations, they did have to submit thorough information about the processes.
Both Pfizer and Moderna previously announced plans to file for full FDA approval through biologics license applications in 2021. Moderna did not return Fox News' requests for comment by time of publication.
Nevertheless, the FDA recently confirmed to Fox News that it expects companies granted emergency approvals to continue on and seek full approval.
"The FDA also expects manufacturers whose COVID-19 vaccines are authorized under an EUA to continue their clinical trials to obtain additional safety and effectiveness information and pursue approval (licensure)," the regulatory agency said in an emailed statement.
According to figures from the Centers for Disease Control and Prevention, over 12 million Americans have received their first dose in a two-shot regimen, with more than 31 million shots rolled out to states. While Americans' resistance to vaccinations appears to be subsiding, per data from the Kaiser Family Foundation, formal approval may help to gain further trust in the vaccines.