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 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.
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.