Sumary of Full FDA approval for COVID-19 vaccines could ease vaccine hesitancy: expert:
- 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 &
- The FDA granted Pfizer’s application priority review and how it could pave the way for Maderna and 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.
- 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.
- 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.