A U.S. Food and Drug Administration advisory committee voted in favor of a booster shot of the Pfizer, now formally called Comirnaty, COVID-19 vaccine for vaccinated people age 65 and older and anyone at increased risk for severe COVID-19.
The booster shot would be the same Pfizer vaccine people received for their first two doses and would be given at least six months after receipt of their initial shots. It’s unclear exactly which medical conditions or occupations would be included in the group at high risk for severe COVID-19, but some panel members mentioned health care workers and people with obesity in an earlier discussion.
The recommendation for booster shot emergency use authorization came shortly after the committee voted against Pfizer COVID-19 booster shots for all vaccinated people age 16 and older, citing safety concerns due to a lack of data, particularly for younger people.
The FDA still has to formally authorize third doses for the specific groups. A separate recommendation from a committee within the Centers for Disease Control and Prevention is expected next week when it meets to discuss booster shots.
Friday’s vote is at slight odds with the White House’s August recommendation that all adult Americans will be eligible for COVID-19 booster shots beginning the week of Sept. 20, at least eight months after receipt of their second dose.
Still, some members of the FDA advisory group say there is not enough data to fully conclude third doses of the Pfizer vaccine are safe and effective for people younger than 65 years old.
Some experts said breakthrough infections — those that occur two or more weeks after receiving two doses of a COVID-19 vaccine — are less common among younger people than older people, so boosters may not be necessary for this age group yet, pending more data.
Most concerns surrounded reported cases of myocarditis — inflammation in the heart muscle — after two doses of the Pfizer or Moderna COVID-19 vaccine, particularly among male teens and young men. However, Pfizer officials attending the virtual meeting argued myocarditis is a relatively short-term consequence of the vaccine, whereas long-term consequences following a coronavirus breakthrough infection may outweigh the risks of a third dose.