The US Food and Drug Administration (FDA) amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine to allow for use of a single booster dose, to be administered at least six months after the second dose in persons 65 years of age and older and individuals at high risk from the virus.
The FDA said in a statement late Wednesday that boosters are to be administered also to “individuals 18 through 64 years of age whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19 including severe COVID-19.” “After considering the totality of the available scientific evidence and the deliberations of our advisory committee of independent, external experts, the FDA amended the EUA for the Pfizer-BioNTech COVID-19 Vaccine to allow for a booster dose in certain populations such as health care workers, teachers, and daycare staff, grocery workers and those in homeless shelters or prisons, among others,” said Acting FDA Commissioner Janet Woodcock.
For his part, director of FDA’s Center for Biologics Evaluation and Research Peter Marks said that the FDA “considered the (advisory) committee’s input and conducted its own thorough review of the submitted data to reach today’s decision.” “We will continue to analyze data submitted to the FDA pertaining to the use of booster doses of COVID-19 vaccines and we will make further decisions as appropriate based on the data,” he added. The Centers for Disease Control and Prevention (CDC) and its advisers must give final approval for any booster doses.
Source- KUNA
