The Food and Drug Administration said Wednesday it will grant emergency-use authorization for a booster shot of Pfizer’s two-dose coronavirus vaccine for people 65 and older, those at high risk of severe disease and people with high-risk jobs.
“Today’s action demonstrated that science and the currently available data continue to guide the FDA’s decision-making for COVID-19 vaccines during this pandemic,” acting FDA Commissioner Janet Woodcock said in a statement. “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.”
Pfizer had sought full approval for a booster for everyone 16 and older, citing evidence of waning efficacy.
The FDA’s vaccine advisers met Friday and voted to recommend emergency-use authorization — not full approval — for a booster dose for people 65 and older, those at high risk of severe coronavirus and people at high risk of infection due to their employment.
The Centers for Disease Control and Prevention’s vaccine advisory committee will meet Thursday to consider the FDA’s decision and formulate their own recommendations. Once the CDC director approves the committee’s recommendation, the administration of booster shots can get underway, CNN reported.