The Food and Drug Administration has granted emergency use authorization to Pfizer (NYSE: PFE) and BioNtech for its Covid-19 booster shots in people 65 years and older as well as other vulnerable Americans. The booster shot is to be used six month after citizens complete their initial two doses.
“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 day care staff, grocery workers and those in homeless shelters or prisons, among others,” acting FDA Commissioner Dr. Janet Woodcock said in a statement.
The FDA’s decision must still be reviewed by the Centers for Disease Control and Prevention. However, on Friday all of the agency’s vaccine advisors recommended emergency use authorization for Pfizer’s booster dose in eligible Americans.
“The FDA considered the committee’s input and conducted its own thorough review of the submitted data to reach today’s decision,” Dr. Peter Marks, who directs the FDA’s vaccine arm, the Center for Biologics Evaluation and Research, said in a statement.
“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.”
The CDC’s advisory committee is anticipated to take a vote Thursday afternoon regarding the FDA’s recommendation. Depending on the outcome, booster shots may be available immediately.