FDA Advisory Panel Recommends COVID Booster Dose for People 65 and Older, High-Risk Groups
Panel votes against booster doses for general population, citing need for more evidence
September 17, 2021
Today, the U.S. Food and Drug Administration’s (FDA) advisory panel unanimously recommended a booster dose of the Pfizer-BioNTech COVID-19 vaccine for people 65 and older, as well as those at high risk for severe COVID-19.
The vote came after the committee voted 16–2 against approving a booster dose for everyone 16 and older, citing the need for more evidence and review time.
The booster would be given at least six months after the second dose of the vaccine. In an informal poll, the panel also agreed that health care workers and others at risk for occupational exposure should be recommended for boosters.
Throughout the day, the FDA’s Vaccines and Related Biological Products Advisory Committee met to discuss the potential for booster doses, evaluating real-world data from Israel, as well as Pfizer’s assessment that a booster shot could improve protection for people six months after their second dose.
The advisory panel said it needed more data across age groups to approve booster doses more broadly.
The Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) will meet next week to make its own independent evaluation before the agency makes a recommendation. It is expected ACIP will provide additional recommendations about who would qualify for a booster.
During a press briefing this morning, the nation’s public health leaders provided an update on the plans for COVID-19 booster shots, stressing that the regulatory review was a critical part of the process.
The White House announced its booster plan last month to give providers time to prepare for administration of a potential third dose, said Surgeon General Vivek Murthy. The plan for booster doses has always been contingent on review from the FDA and the CDC, he said.
“Our goal then, and now, is to protect the health and wellbeing of the public,” Dr. Murthy said.
HAP will continue to monitor COVID-19 public health developments and provide updates to members.