J&J seeks approval for a COVID-19 vaccine booster

Johnson & Johnson (JNJ.N) announced on Tuesday that 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 up.

The filing comes after the FDA announced last week that an expert advisory committee meeting on Oct. 15 will be held to discuss whether to authorise a second shot of J&J’s single-dose vaccine.

J&J said its submission includes data from a late-stage study that found a booster of its vaccine 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.

The FDA has already authorized a booster dose of the vaccine developed by Pfizer Inc (PFE.N) 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.

Moderna (MRNA.O) also submitted its application seeking authorization for a booster shot of its two-dose vaccine last month.

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.