In a unanimous vote, the U.S. Food and Drug Administration’s vaccine advisory panel on Friday recommended that the agency grant emergency use of booster shots of Johnson & Johnson’s 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, many of whom have felt left out of the booster shot debate. Friday’s vote recommends the J&J booster shot for anyone 18 and older, to be given at least two months after the first dose, The New York Times reports.
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Mix and Match?
Dr. Peter Marks, head of the FDA’s 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. Preliminary research published by the U.S. National Institutes of Health (NIH) this week found that booster shots of the Moderna and Pfizer vaccines provided a far greater boost to immunity than a J&J booster did.
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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, part of the immune response to vaccines. They also said that the single dose of the vaccine remained durable.
Flaws in the data?
But FDA officials repeatedly pointed out flaws in the company’s data. They warned that the two-month booster trial only followed up with study volunteers for a short period of time after their second shot. They also note 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.
Federal regulators did not see any evidence of serious safety concerns in the booster trial, but they note that they didn’t have enough time to independently review much of the data that Johnson & Johnson provided in its application for authorization, according to the Times. That data included a trial looking at a second shot after six months, not two.
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“The vote was not surprising, but it is interesting that there was some debate about the interval for boosting: two months [which is a de-facto two-dose vaccine] versus the six months that was asked for by J&J,” Dr. Amesh Adalja, a senior scholar with Johns Hopkins Center for Health Security, in Baltimore says. “There is some evidence that the J&J vaccine might be better as a two-dose vaccine and as vaccines are
