FDA to hold emergency meeting on COVID vaccine side effects in adolescents
New York Medical College professor Dr. Bob Lahita discusses new concerns about COVID vaccine side effects in children and adolescents
COVID-19 vaccines have been rolled out and administered without full approval from the Food and Drug Administration (FDA) – and while the drugs have been permitted under emergency use authorizations (EUA), some experts eye full approval to encourage those reluctant to roll their sleeves.
The FDA accepted Pfizer's application on Friday for full approval of the COVID-19 vaccine more than a year after it was developed with BioNTech, and as the delta variant surges.
The FDA granted the application priority review, and will weigh full approval for the vaccine in people 16 and up by January, though a spokesperson at the FDA told Fox News last week the agency expects to complete the review "far 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 filed its application last month, and Johnson & Johnson.
The FDA granted Pfizer's application priority review and how it could pave the way for Maderna and Johnson & Johnson. (iStock)
More than 182.7 million people in the U.S. (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), since the FDA granted emergency use authorization in December. And the urgency to get more Americans vaccinated comes as the delta variant of coronavirus cases continues to rise across the country.
Pfizer, Moderna and Johnson & Johnson all received their EUA, which mandated that the companies follow a set of guidelines calling for safety data from clinical trials and information on its quality and consistency, according to ScienceMag.org.
FDA TARGETS JANUARY FOR PFIZER COVID-19 VACCINE FULL APPROVAL DECISION
Pharmaceutical companies Pfizer and BioNTech and Moderna already submitted applications for full approval for their vaccines to the FDA on May 7 and June 1 to begin regulatory review. J&J is expected to also file, however, the company had a few setbacks after the FDA announced a warning earlier this month of a possible link to Guillain-Barré, a rare autoimmune nerve disorder. The agency revised the vaccine's fact sheets to show an increased risk of the disorder following inoculation.
The difference between an EUA and full FDA approval involves further review of data over a longer time period, Science Mag reported.
After applications are filed, FDA then reviews them to ensure completion for the first 60 days and further analyzes data related to safety, effectiveness and manufacturing quality before issuing full approval, according to Science Mag.
PFIZER, BIONTECH SEEK FULL FDA APPROVAL FOR COVID-19 VACCINE
Full FDA approval will allow vaccines to be used and marketed directly to consumers in the post-pandemic. The FDA's approval will likely promote more unvaccinated Americans to get their shots. Around a third of unvaccinated adults said they would be more likely to get vaccinated if one of the COVID-19 vaccines earned full FDA approval, according to a June survey from the Kaiser Family Foundation (KFF).
Monica Gandhi, an infectious disease physician at the University of California, San Diego, told Science Mag Wednesday that full, FDA approval "could help win over skeptics."
"It means something to people for it to be approved," Gandhi told the outlet. "It just seems like the simplest, easiest thing we could be doing right now."
Fox News' Kayla Rivas contributed to this report.