Johnson & Johnson to seek FDA booster shot authorization this week, paper says


Johnson & Johnson is planning to ask federal regulators this week to authorize a booster shot of its Covid-19 vaccine, the New York Times reported on Monday, citing officials familiar with the company’s plans.

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 as part of an effort to shore up protection against the highly transmissible Delta variant.

The Food and Drug Administration last week scheduled an Oct. 15 meeting of its expert advisory committee to discuss whether to grant emergency use authorization for a booster shot of Johnson & Johnson’s vaccine.

Over 15 million Americans have received Johnson & Johnson’s vaccine, which is administered as a single dose, according to the latest data from the Centers for Disease Control and Prevention.

The vaccine maker last month said an additional second shot of its vaccine given about two months after the first increased its effectiveness to 94 percent, compared with 70 percent protection with the single dose.

NBC News reached out to Johnson & Johnson for confirmation of the NYT report. The company pointed to its Sept. 21 press release, saying that it has submitted data to the FDA and plans to submit it to other regulators, the World Health Organization and other vaccine advisory groups worldwide.

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Johnson & Johnson also released data at that time showing that a second shot of its vaccine given about two months after the first increased its effectiveness to 94 percent against moderate to severe forms of the disease.

On Friday, NBC News reported that hundreds of thousands of unused Johnson & Johnson vaccine doses were possibly at risk of expiring because the FDA will not further extend the shelf life of the shots. It’s unclear how many J&J doses could be wasted, but the federal government has shipped 22 million doses to states and only 15 million have been administered so far, according to data from the Centers for Disease Control and Prevention.

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Most states stopped ordering new J&J shots a few months ago and demand for the shot has not been strong, according to state health officials.

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

Rival Moderna also submitted its application seeking authorization for a booster shot of its two-dose vaccine last month and FDA’s Vaccines and Related Biological Products Advisory Committee panel will hold a meeting on Oct. 14 to discuss the additional dose.

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