Of the 31% of unvaccinated U.S. adults who claim they are waiting for the COVID-19 vaccinations to be approved by the FDA, one-third of these individuals believe this to be for religious reasons. The FDA has approved Pfizer and BioNTech’s vaccine for ages 16 and up on August 23, 2021. The FDA requires safety studies on a few persons for the temporary use of medications and medications that have received full approval from the FDA. Approximately 43,000 adults participated in the safety studies’ early phases. As Pfizer and Moderna launched their rolling submission for approval in the FDA’s “Fast Track” procedure, which expedites review, Moderna and Pfizer started that process off with a rolling submission in the FDA’s “Fast Track” program.
Initial FDA approval will be granted limited to the same age groups studied under the emergency use authorization issued previously. In Pfizer’s case, the vaccine was initially only licensed for those ages 16 and above and was anticipated to be approved for those ages 18 and up shortly afterward for Moderna.
Reference
What Does Full FDA Approval of the Pfizer COVID-19 Vaccine Mean?, https://heavy.com/news/pfizer-covid-vaccine-fda-approval/