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Johnson & Johnson asks USFDA to authorize booster vaccine shot

Johnson & Johnson has asked the US Food and Drug Administration for emergency use authorization of its COVID-19 booster shot. The company has announced on Tuesday that it asked the US drug regulators to authorize use of the boosters for people ages 18 and older who have received the company’s vaccine, a one-shot vaccine. The request comes after the FDA authorized a booster shot of the Pfizer vaccine for people over the age of 65, at risk for severe disease, or who are regularly exposed to the coronavirus. Johnson & Johnson submitted data from a late-stage study that found a booster given 56 days after the first dose provided 94% protection against symptomatic COVID-19 in the US and 100% protection against severe disease at least 14 days after the booster shot. It plans to submit the data to other regulators, such as the World Health Organization and National Immunization Technical Advisory Groups.

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