COVID-19 vaccines have been rolled out and administered without full approval from the Food and Drug Administration (FDA) – and while the substances are allowed under emergency use authorizations (EUA), some experts see full approval to encourage those who are reluctant to roll their sleeves.
The FDA accepted Pfizer’s application Friday for full approval of the COVID-19 vaccine more than a year after it was developed with BioNTech, and as the delta variant increases.
The FDA granted the application priority review and will consider full approval of the vaccine in individuals 16 years and older by January, though an FDA spokesman told Fox News last week that the agency expects to conduct the review “well in advance” of the January target date. The application approval could pave the way for the official approval of the other two vaccines, Moderna, which submitted its application last month, and Johnson & Johnson.
More than 182.7 million people in the United States (more than half of the total population) have received at least one dose of the COVID-19 vaccine, according to the Centers for Disease Control and Prevention (CDC), when the FDA issued an emergency authorization in December . And it is urgent to get more Americans vaccinated as the delta variant of coronavirus cases continues to rise across the country.
Pfizer, Moderna, and Johnson & Johnson all received their EUA, which required companies to follow a set of guidelines that required safety data from clinical trials and information about its quality and consistency, according to ScienceMag.org.
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Pharmaceutical companies Pfizer and BioNTech and Moderna have already submitted applications for full approval of their vaccines to the FDA on May 7 and June 1 to begin regulatory review. J&J is also expected to file, but the company had a few setbacks after the FDA issued a warning earlier this month about a possible link to Guillain-Barré, a rare autoimmune nerve disease. The agency revised the vaccine fact sheet to show an increased risk of the disease after inoculation.
The difference between an EUA and full FDA approval involves further review of data over an extended period, Science Mag reported.
After submitting applications, the FDA reviews them to ensure completion for the first 60 days and analyzes additional data related to safety, efficacy and production quality before issuing full approval, according to Science Mag.
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Full FDA approval makes it possible to use and market vaccines directly to consumers in the post-pandemic. FDA approval is likely to encourage more unvaccinated Americans to get their shots. About a third of unvaccinated adults said they would be more likely to be vaccinated if one of the COVID-19 vaccines obtained full FDA approval, according to a June study by the Kaiser Family Foundation (KFF).
Monica Gandhi, an infectious disease doctor at the University of California, San Diego, told Science Mag on Wednesday that full FDA approval “could help win over skeptics.”
“It means something to people that it is being approved,” Gandhi told the outlet. “It just seems like the simplest and easiest thing we could do right now.”
Fox News’ Kayla Rivas contributed to this report.