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J&J requests FDA emergency approval for COVID-19 booster shot

Johnson & Johnson requested emergency approval of its COVID-19 vaccine booster shot for people 18 years and older, the company introduced Tuesday.

J&J additionally submitted fresh data from a late-stage trial indicating the booster bolstered insurance plan in opposition t moderate-to-severe COVID-19 disorder to 94% within the U.S., and reported a "enormous enhance in immune response" when the booster turned into administered six months following the initial shot.

further facts suggests a ninefold raise in antibody levels following administration of the booster, ramping as much as twelvefold 4 weeks later, and the shot turned into pronounced as generally smartly-tolerated.

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"Our clinical program has discovered that a booster of our COVID-19 vaccine raises tiers of insurance policy for people that have obtained our single-shot vaccine to ninety four p.c. We appear forward to our discussions with the FDA and other health authorities to aid their selections involving boosters," mentioned Dr. Mathai Mammen, head of research at J&J's Janssen unit, in a press release Tuesday. "on the equal time, we continue to respect that a single-shot COVID-19 vaccine that provides powerful and lengthy-lasting coverage continues to be an important component to vaccinating the global inhabitants."

this is a developing story, please examine lower back for updates.

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