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FDA Report Is Inconclusive on Johnson & Johnson Booster

Outside advisers are meeting this week to consider approval and interval
By Bob Cronin,  Newser Staff
Posted Oct 13, 2021 5:35 PM CUT

(Newser) – It's not clear yet whether people who received the one-shot Johnson & Johnson coronavirus vaccine will be cleared to get a booster shot or will be told to switch brands. A Food and Drug Administration staff report released Wednesday said that there's evidence the J&J booster strengthened the immune system's response in study participants, but that the company didn't provide enough of the evidence. In addition, the Wall Street Journal reports, the agency partly had to accept the company's analysis instead of doing its own. The report did not offer a recommendation on whether the J&J booster should be approved.

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The FDA's committee of outside experts is to meet on Friday about the company's request for approval of its booster shot for the 15 million people in the US who have had the single-shot vaccination, per the New York Times. The company had said Tuesday that the booster should be administered, at six months or more past the initial shot, "based on the strength of the immune responses." Part of the problem is that the FDA had already scheduled the outside advisers' meeting and didn't have time to verify Johnson & Johnson's data. That was unusual scheduling, experts said.

There also wasn't much information provided about the booster's effectiveness against the delta variant, Wednesday's report said, adding that no conclusion could be reached about its usefulness. The advisory committee also is to consider Moderna's booster shot this week, per the AP. For consistency across products, Moderna had proposed a booster at six months. But J&J also tested its booster at two months and provided those results, complicating the issue. The FDA report said the company's data appear to show the one-shot vaccine is less effective than the Pfizer and Moderna two-shot regimens. The advisers' recommendation would precede the FDA's decision. (Read more Johnson & Johnson stories.)

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