[ad_1]
COVID-19 vaccines have been deployed and administered without full approval from the Food and Drug Administration (FDA) – and although the drugs have been cleared under Emergency Use Authorizations (EUA), some experts are considering full endorsement to encourage those hesitant to roll up their sleeves.
On Friday, the FDA accepted Pfizer’s request for full approval of the COVID-19 vaccine more than a year after its development with BioNTech, and as the delta variant increases.
The FDA has granted priority review of the application and will assess full approval of the vaccine in people 16 years and older by January, although an FDA spokesperson told Fox News last week. that the agency expects to complete the review “well before” January. target date. Approval of the application could pave the way for formal approval of the other two vaccines, Moderna, which filed its application last month, and Johnson & Johnson.
The FDA has granted priority review of Pfizer’s application and how it could pave the way for Maderna and Johnson & Johnson. (iStock)
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), 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 required companies to 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 FULL APPROVAL DECISION FOR PFIZER COVID-19 VACCINE
Pharmaceutical companies Pfizer and BioNTech and Moderna have 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 also expected to file a case, however, the company has experienced some setbacks after the FDA announced a warning earlier this month regarding a possible link to Guillain-Barré, a rare autoimmune nerve disease. The agency revised the vaccine information sheets to show an increased risk of disease after inoculation.
The difference between an EUA approval and a full FDA approval involves a closer look at the data over a longer period of time, Science Mag reported.
After submissions are filed, the FDA reviews them to ensure completion within the first 60 days and further analyzes data related to safety, efficacy and manufacturing quality before issuing full approval, according to Science Mag.
PFIZER AND BIONTECH REQUEST 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 period. FDA approval will likely encourage more unvaccinated Americans to get vaccinated. About a third of unvaccinated adults said they would be more likely to get vaccinated if any of the COVID-19 vaccines got full FDA approval, according to a June investigation by the Kaiser Family Foundation (KFF) .
Monica Gandhi, an infectious disease physician at the University of California at San Diego, told Science Mag on Wednesday that full FDA approval “may help convince skeptics.”
“It means something to people that this is approved,” Gandhi told the outlet. “It seems like the simplest, easiest thing we can do right now.”
Kayla Rivas of Fox News contributed to this report.
[ad_2]
Source link