The U.S. Food and Drug Administration on Wednesday said it would grant approval for emergency use of the Pfizer COVID-19 vaccine booster shot for Americans 65 and older, people who are at high risk of severe illness, and those who are exposed to the virus because of their jobs.
“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,” acting FDA Commissioner Dr. Janet Woodcock said in a statement cited by CNN.
Vaccine advisers to the FDA on Friday unanimously recommended emergency use authorization for a booster shot of Pfizer’s COVID-19 vaccine for Americans 65 and older and people who are at high risk of severe illness and be administered six months after receiving the first two shots.
According to Dr. Peter Marks, who directs the FDA’s Center for Biologics Evaluation and Research, the agency considered the advisers’ input and did their own careful review of the data submitted.
“The FDA considered the 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.”
Pfizer has previously asked for the agency’s approval to administer its vaccine to everyone 16 and older six months after they have received the first two doses of the vaccine. The company claimed that it provided enough evidence that the vaccine’s immunity starts to diminish after six months and the booster shots will restore the immunity safely.
On Thursday, vaccine advisers to the U.S. Centers for Disease Control and Prevention will meet to act on the recent FDA decision. The CDC must also give its approval for any booster shots before it officially starts to be given to people.
The CDC’s Advisory Committee on Immunization Practices can revise or change recommendations on how vaccine booster shots should be administered.
In a letter sent on Thursday and acquired by news agency CNN, the CDC encouraged local and state health officials to wait before giving booster shots until both agencies had approved it.
Third doses were already authorized for specific immunocompromised people but not for the general population. According to the CDC, over 2.3 million Americans already received their third dose of Pfizer’s COVID-19 vaccine.
Meanwhile, Moderna already asked approval from the FDA to approve its booster shots but the agency has only approved Pfizer’s bid.
Johnson & Johnson also released data earlier this week stating that the single-dose vaccine showed that a booster shot immensely raised immunity, but the company is yet to send an application to the FDA for a booster vaccine dose.
On Wednesday, Dr. Doran Fink of FDA told ACIP that no data is available suggesting that mixing and matching vaccines or boosting with a dose of a brand of vaccine different from the original vaccine received is safe or effective.
Also Read: Johnson & Johnson Says Booster Shot of Its One-Dose Vaccine Makes It 94% Effective Against COVID-19
