J&J files for authorization of Covid-19 vaccine booster shot
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 years and older.
The 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 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 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 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.