FDA gives green light to Johnson & Johnson booster shot

Silver Spring, Maryland - The advisory panel to the Food and Drug Administration has voted unanimously to recommend a booster dose of Johnson & Johnson's (JNJ) coronavirus vaccine at least two months after people get the first dose.

Johnson & Johnson's Covid-19 booster shot was found to increase protection against moderate to severe Covid-19 to 94%.
Johnson & Johnson's Covid-19 booster shot was found to increase protection against moderate to severe Covid-19 to 94%.  © 123RF/rimidolove

Johnson & Johnson on 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 three findings showing a booster shot increased protection to 94% against moderate to severe Covid-19 in the US.

"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, vice chairman of the executive committee and chief scientific officer, Johnson & Johnson.

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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.

Cover photo: 123RF/rimidolove

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