Johnson & Johnson stated on Tuesday it had submitted knowledge to the U.S. Meals and Drug Administration for emergency use authorization of a booster shot of its Covid-19 vaccine in individuals aged 18 years and older.
The submitting comes after the FDA final week scheduled an Oct. 15 assembly of its knowledgeable 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 supplied 94% safety in opposition to symptomatic Covid-19 in the USA and 100% safety in opposition to extreme illness, a minimum of 14 days after the booster shot.
The FDA has already approved a booster dose of the vaccine developed by Pfizer and accomplice BioNTech for 65-year olds and older, individuals at excessive threat of extreme illness and others who’re recurrently uncovered to the virus.
Moderna additionally submitted its utility in search of authorization for a booster shot of its two-dose vaccine final month.
J&J stated it plans to submit the information to different regulators, the World Well being Group and Nationwide Immunization Technical Advisory Teams to tell decision-making on native vaccine administration methods, as wanted.