Johnson & Johnson (NYSE:JNJ) 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.
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.
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 to shore up protection against the highly transmissible Delta variant.
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 (NYSE:PFE) and partner BioNTech (NASDAQ:BNTX) for 65-year olds and older, people at high risk of severe disease and others who are regularly exposed to the virus.
Pfizer had also asked the FDA to expand its vaccine approval to include boosters for all people aged 16 and older, but the regulator decided to limit their use saying evidence showed they were helpful to older people and those at high risk
JNJ opened Tuesday up 76 cents, or to $159.98.
