J&J information for authorization of COVID-19 vaccine booster

Johnson & Johnson (JNJ.N) stated on Tuesday it had submitted knowledge to the U.S. Food and Drug Administration for emergency use authorization of a booster shot of its COVID-19 vaccine in folks aged 18 years and older.
The submitting comes after the FDA final week scheduled an Oct. 15 assembly of its skilled advisory committee to debate whether or not to authorize a second shot of J&J’s single-dose vaccine.

J&J stated its submission contains knowledge from a late-stage examine that discovered a booster of its vaccine given 56 days after the first dose offered 94% safety towards symptomatic COVID-19 within the United States and 100% safety towards extreme illness, at the very least 14 days after the booster shot.
The FDA has already approved a booster dose of the vaccine developed by Pfizer Inc (PFE.N) and accomplice BioNTech for 65-year olds and older, folks at excessive danger of extreme illness and others who’re often uncovered to the virus.

Moderna (MRNA.O) additionally submitted its utility searching for authorization for a booster shot of its two-dose vaccine final month.
J&J stated it plans to submit the info to different regulators, the World Health Organization and National Immunization Technical Advisory Groups to tell decision-making on native vaccine administration methods, as wanted.