The U.S. Food and Drug Administration (FDA) has approved Pfizer-BioNTech COVID vaccine’s booster shots for people aged 65 and above and those who are at a high risk of catching a severe illness, according to CNBC.
The agency’s approval now makes many Americans eligible to receive the third shot.
The FDA’s Vaccines and Related Biological Products Advisory Committee voted 16-2 against distributing the vaccines to Americans 16 and older. In addition, they embraced an alternate plan to give booster doses to older Americans and those at high risk.
Dr. Peter Mark, Director of the FDA’s Center for Biologics Evaluation and Research (CBER), said, “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,” he added. “We are not bound at FDA by your vote, just so you understand that. We can tweak this as need be.”
Some scientists, including two experts of the FDA, had said they were not entirely convinced every American who has received the Pfizer vaccine needed extra doses at this time.
However, the nation’s top health experts, including White House Chief Medical Advisor Dr. Anthony Fauci, CDC Director Dr. Rochelle Walensky, and acting FDA Commissioner Dr. Janet Woodcock, already endorsed the Biden administration’s booster plan in August.
Before the FDA panel’s recommendation, Dr. Bruce Farber, a top infectious disease expert, said Friday’s vote put the panel in an “awkward position” as the Biden administration has already announced they would begin distributing boosters to the general population this month.
However, the FDA’s approval is not the final go-ahead, as the CDC’s vaccine advisory committee held the first day of a two-day meeting Wednesday to discuss the booster shots with a vote on the FDA’s proposal scheduled Thursday afternoon, according to CNBC.
If the CDC approves it, booster shots could begin immediately.
The CDC advisers are also expected to debate on what would happen to people who have received either Moderna or Johnson & Johnson vaccine, according to NBC News.
Dr. Sarah Long, a member of the CDC’s Advisory Committee on Immunization Practices (ACIP), said, “That’s going to leave half of the people immunized being told that they’re at risk now of waning immunity and hospitalization and unable to get a booster dose. That’s a big public health panic that we would like to avoid.”
Meanwhile, Moderna has submitted data about its booster dose to the FDA. Johnson & Johnson is also working on planning the same. The story was published on CNBC and NBC News.