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

Johnson & Johnson said on Tuesday it had submitted data to the US 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.

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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.

The FDA has already authorized a booster dose of the vaccine developed by Pfizer Inc and partner BioNTech for 65-year olds and older, people at high risk of severe disease and others who are regularly exposed to the virus.

Pfizer had also asked the FDA to expand its vaccine approval to include boosters for all people aged 16 and older, but the regulator decided to limit their use saying evidence showed they were helpful to older people and those at high risk.

Rival vaccine maker Moderna also submitted an application seeking authorization for a booster shot of its two-dose vaccine last month, and an FDA panel will hold a meeting on Oct. 14 to discuss the extra dose.

J&J said it plans to submit the data to other regulators, the World Health Organization and National Immunization Technical Advisory Groups to inform decision-making on local vaccine administration strategies, as needed.

About 15 million Americans aged 18 and older have received one dose of J&J's vaccine, according to latest data from the Centers for Disease Control and Prevention.