FDA Panel Recommends Approval of Johnson & Johnson Booster Shot

FRIDAY, Oct. 15, 2021 (HealthDay News) -- In a unanimous vote, the U.S. Food and Drug Administration vaccine advisory panel on Friday recommended that the agency grant emergency use of booster shots of the Johnson & Johnson coronavirus vaccine.

The FDA is expected to make a decision within days that will help guide the 15 million Americans who have received the Johnson & Johnson vaccine. Friday's vote recommends the J&J booster shot for anyone 18 years and older, to be given at least two months after the first dose, The New York Times reported.

Peter Marks, M.D., head of the FDA Center for Biologics Evaluation and Research, said during the meeting that the agency may at some point consider allowing Johnson & Johnson vaccine recipients to get a booster shot of the Moderna or Pfizer COVID-19 vaccines, the Times said. Preliminary research published by the U.S. National Institutes of Health this week showed that booster shots of the Moderna and Pfizer vaccines provided a far greater boost to immunity than a J&J booster did. Moderna won emergency use authorization for its booster shot from the advisory panel on Thursday, though the booster will actually be a half-dose of the original vaccine.

During the advisory panel's Friday meeting, Johnson & Johnson officials argued that a second dose given either two months or six months after the first shot increased antibody levels. They also said that the single dose of the vaccine remained durable, the Times reported. But FDA officials repeatedly pointed out flaws in the company's data. They warned that the two-month booster trial only followed study volunteers for a short period of time after their second shot. They also noted that a key test used by the company to measure the antibodies produced by a booster shot had a low sensitivity, so the results could not be completely trusted, the Times said.

Federal regulators did not see any evidence of serious safety concerns in the booster trial, but they noted they did not have enough time to independently review much of the data that Johnson & Johnson provided in its application for authorization, the Times reported.

The New York Times Article