Johnson & Johnson (JNJ.N) stated Tuesday that it had submitted information to the US Food and Drug Administration for emergency use authorization of a booster shot of its COVID-19 vaccine in individuals 18 years of age and older.
The submitting was set by the FDA final week at its October 15 assembly of its professional advisory committee to debate whether or not to authorize a second shot of a single-dose vaccine for Jammu and Kashmir.
J&J stated its presentation contains information from a late-stage research that discovered a vaccine booster given 56 days after the first dose offered 94% safety towards symptomatic COVID-19 within the United States. and gives 100% safety towards severe sickness, not less than 14 days after the booster shot.
The FDA has authorised a vaccine booster already developed by Pfizer Inc. (PFE.N) and companion BioNTech for individuals 65 years and older, individuals at excessive danger of significant sickness, and others who’re recurrently uncovered to the virus. licensed dosage.
Moderna (mRNA.o) additionally submitted its utility final month looking for authorization for a booster shot for its two-dose vaccine.
J&J stated it plans to submit the info to different regulators, the World Health Organization and nationwide immunization technical advisory teams, to tell selections on native vaccine administration methods, if wanted.
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With inputs from TheIndianEXPRESS
