FDA Panel Unanimously Recommends J&J Covid Booster Shot

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The advisory panel to the U.S. Food and Drug Administration has voted unanimously recommending a booster dose of Johnson & Johnson's (JNJ) vaccine at least two months after people get the first dose.

Johnson & Johnson Friday announced that the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously voted 19-0 to recommend Emergency Use Authorization for a booster dose of its COVID-19 vaccine for adults aged 18 and older at least two months following initial vaccination with the single-shot vaccine.

The panel's decision was based on by phase 3 findings showing a booster shot increased protection to 94 percent against moderate to severe/critical COVID-19 in the U.S.

"Today's recommendation is based on the totality of evidence, with clinical and real-world data showing that while a single shot offers strong and long-lasting protection against COVID-19, a booster given after the single-dose primary vaccination increases protection, in particular against symptomatic COVID-19," said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson.

This same committee on Thursday had recommended Moderna (MRNA) booster shots to people ages 65 and older and other high-risk adults.

Meanwhile, the panel's recommendation is not final and FDA will decide whether to authorize the EUA. However, the FDA usually follows the advice of the committee.

J&J had received authorization for its vaccine in late February. The company had submitted a request to FDA to approve a booster shot of its one-dose vaccine for people ages 18 and older on October 5.

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