• Mon. Nov 29th, 2021


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F.D.A. Panel Recommends J.&J. Boosters at Least Two Months After First Shot

The Food and Drug Administration’s vaccine advisory panel unanimously voted on Friday to recommend authorizing booster shots of Johnson & Johnson’s one-dose coronavirus vaccine for adults, at least two months after the first dose.

The vote paves the way for F.D.A. officials to give the booster shots a green light, which would be followed by review at the Centers for Disease Control and Prevention. The F.D.A. typically follow the panel’s advice but is not bound by it.

The panel of advisers was not asked to make a recommendation on whether Johnson & Johnson recipients should also be allowed to get a booster shot of one of the two other competing vaccines in use in the United States, though the members discussed a study showing the mix-and-match approach gives patients a stronger immune response.

Many panel members said that a second dose of the Johnson & Johnson vaccine was important because the first dose did not provide strong enough protection. Unlike the other vaccines available in the United States, Johnson & Johnson chose to seek authorization for a single dose — a decision that some committee members said was a mistake in hindsight.

“I think this frankly was always a two-dose vaccine,” said Dr. Paul Offit, an infectious disease expert at the Children’s Hospital of Philadelphia.

Representatives from the drug maker made their case to the panel in the morning, arguing that a second dose increased antibodies if given either two months or six months after the first shot. They also maintained that the single dose remained durable.

Federal vaccine experts repeatedly pointed out shortcomings in the company’s data. They warned the two-month trial had followed up with study volunteers for a only short period of time after their second shots. They also raised questions about a key test the company used to measure the antibodies produced by a booster, saying it had a low sensitivity. That concern was raised by panel members as well.

The regulators said they did not see any evidence of serious safety concerns in the booster studies. But they noted they did not have enough time to independently review much of the data that Johnson & Johnson provided, including in its large, two-dose trial that the company maintains makes a clear case for boosters.

One panel member, Dr. Archana Chatterjee, an infectious disease expert at Rosalind Franklin University, asked the F.D.A. why it convened the panel if its own experts had not had time to verify the company’s data.

Dr. Peter Marks, the agency’s top vaccine regulator, responded that it could have taken a month to verify all the data from the company’s largest-scale, two-dose trial and several weeks to review the smaller studies.

Some federal officials expressed skepticism about the claims the company made regarding the efficacy of one dose, and worried that those who received it are not as protected as Moderna or Pfizer-BioNTech recipients.

In the end, the panel voted to recommend authorizing the boosters, with some members saying the move would effectively bring the effectiveness of J.&J.’s vaccine up to the level of the two-dose vaccines made by Moderna and Pfizer-BioNTech.

Dr. Chatterjee said that her concerns about waning immunity and the shot’s efficacy against hospitalization led her to be supportive of offering boosters.