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FDA Advisory Board Unanimously Recommends Johnson & Johnson Vaccine Booster

FDA Advisory Board Unanimously Recommends Johnson & Johnson Vaccine Booster

A panel of experts unanimously voted 19-0 to recommend Emergency Use Authorization (EUA) for a booster dose of the Johnson & Johnson COVID-19 vaccine for adults aged 18 and older at least two months following initial vaccination with the single-shot vaccine.

A study published by the CDC in September showed the J&J vaccine had an effectiveness of around 68% in keeping people out of the hospital for COVID-19 compared with more than 90% for Moderna’s vaccine and about 77% for the Pfizer-BioNTech after about four months. The panel recommended that the booster dose come at least two months after initial immunization with one shot of the J&J vaccine. It applies to people 18 years and older. During the meeting, J&J presented data that showed the protection of the single-shot remained largely stable over time but that a second dose pushed the protection to a higher level.

HINES, ILLINOIS – SEPTEMBER 24: Lalain Reyeg administers a COVID-19 booster vaccine and an influenza vaccine to Army veteran Gary Nasakaitis at the Edward Hines Jr. VA Hospital on September 24, 2021 in Hines, Illinois. Today, CDC Director Rochelle Walensky endorsed a booster shot of the Pfizer-BioNTech COVID-19 vaccine for people 65 years and older, those with underlying medical conditions or those who work in high-risk situations. (Photo by Scott Olson/Getty Images)

The vote was based on findings from two company clinical trials which evaluated a booster dose of the Johnson & Johnson COVID-19 vaccine administered two months after the single-shot, as well as a large and robust real-world evidence study. The company also presented data that support the increased potential of a booster when administered at six months. Phase 3 clinical data and real-world data both demonstrated the Johnson & Johnson single-shot COVID-19 vaccine was strong and long-lasting.

 

See Also

The FDA panel said that the J&J vaccine’s protection was substantially lower than the mRNA vaccines made by Moderna and Pfizer — even when waning of their protection is taken into account.

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