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J&J files for authorization of COVID-19 vaccine booster

October 05, 2021 / 3:47 PM
Sharjah24 – Reuters: Johnson & Johnson said on Tuesday it had submitted data to the U.S. Food and Drug Administration for emergency use authorization of a booster shot of its COVID-19 vaccine in people aged 18 and older.
J&J said its submission includes data from a late-stage study that found a booster given 56 days after the primary dose provided 94% protection against symptomatic COVID-19 in the United States and 100% protection against severe disease, at least 14 days after the booster shot.

While scientists are divided over the need for booster shots when so many people in the United States and other countries remain unvaccinated, the Biden administration announced the push for an extra dose in August to shore up protection against the highly transmissible Delta variant.

J&J's filing comes after the FDA last week scheduled an Oct. 15 meeting of its expert advisory committee to discuss whether to authorize a second shot of the company's single-dose vaccine.

Shares of the healthcare conglomerate rose nearly 1% in trading before the opening bell.
October 05, 2021 / 3:47 PM

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