FDA authorizes Pfizer’s Covid booster shots for people 65 and older and other

Trung Nguyen, 13, gets his second dose of the coronavirus disease (COVID-19) vaccine at the Philadelphia Zoo in Philadelphia, Pennsylvania, September 7, 2021.

Rachel Wisniewski | Reuters

The Food and Drug Administration authorized Pfizer and BioNTech‘s Covid-19 booster shots for people 65 and older and other vulnerable Americans six months after they complete their first two doses, making many Americans eligible to receive the shots now.

The FDA’s decision largely follows recommendations given Friday by its key vaccine advisory committee at a more than 8-hour agency meeting. The Vaccines and Related Biological Products Advisory Committee voted 16-2 against distributing the vaccines to Americans 16 and older, before unanimously embracing an alternate plan to give boosters to older Americans and those at a high risk of suffering from severe illness if they get the virus.

Though Americans 65 and older make up roughly 17% of the U.S. population, they account for more than 77% of all Covid deaths, according to the Centers for Disease Control and Prevention.

The FDA granted emergency use authorization to administer the shots to older Americans, people between 18- and 64-years-old with so-called co-morbidities and front-line health workers and others with jobs that place them at a greater risk of exposure to the virus.

“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, the agency’s top vaccine regulator, 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 nonbinding decision by the vaccine advisory committee was expected to be a controversial one as the Biden administration has said it wants to begin offering booster shots to the general public as early as this week, pending authorization from U.S. health regulators.

While the agency hasn’t always followed the advice of its committee, it often does. Still, Marks reminded the panel after the votes that federal regulators did not have to accept its recommendation as written.

He asked the group for suggestions on what other populations the FDA should consider for boosters, like front-line health workers and other occupations that face more exposure to Covid. “We are not bound at FDA by your vote, just so you understand that. We can tweak this as need be,” he said.

Some health experts speculated the agency could depart at least a little from the advice of its committee. Some scientists, including at least two at the FDA, had said they weren’t entirely convinced every American who has received the Pfizer vaccine needed extra doses at this time. However, the nation’s top health regulators, including CDC Director Dr. Rochelle Walensky, acting FDA Commissioner Dr. Janet Woodcock and White House chief medical advisor Dr. Anthony Fauci, already endorsed Biden’s booster plan in August.

The vote puts the committee in an “awkward position” as the administration has already announced they would begin distributing boosters this month, Northwell Health chief of…

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