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

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 are the most at risk of dying from Covid, accounting 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 and people from 18- to 64-years-old with medical conditions that place them at risk of getting severely sick. The agency also included a broad definition of people from 18 to 64 “whose frequent institutional or occupational exposure” to the virus place them at a high risk of developing serious complications from Covid. That leaves enough wiggle room for the CDC to potentially clear third doses for people in nursing homes, prisons, front-line health employees and other essential workers who were among the first Americans who got the initial shots in December.

“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…