FILE PHOTO: Vials and medical syringe are seen in front of J&J logo in this illustration
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. 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.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.
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.
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