Johnson & Johnson is planning to ask U.S. federal regulators this week to authorize a booster shot of its COVID-19 vaccine, the New York Instances reported on Monday, citing officers acquainted with the corporate’s plans.
Whereas scientists are divided over the necessity for booster pictures when so many individuals in the USA and different nations stay unvaccinated, the Biden administration introduced the push for an additional dose in August as a part of an effort to shore up safety in opposition to the extremely transmissible Delta variant.
The U.S. Meals and Drug Administration (FDA) final week scheduled an Oct. 15 assembly of its professional advisory committee to debate whether or not to grant emergency use authorization for a booster shot of J&J’s vaccine.
Over 15 million People have obtained J&J’s vaccine, which is run as a single dose, in line with the most recent knowledge from the Facilities for Illness Management and Prevention.
The healthcare conglomerate final month stated a further second shot of its vaccine given about two months after the primary elevated its effectiveness to 94%, in contrast with 70% safety with the only dose.
J&J declined to touch upon the NYT report and pointed to its press launch dated Sept. 21, saying the corporate has submitted accessible knowledge to the U.S. well being regulator and intends to submit the info to different regulators.
The FDA has already licensed a booster dose of the Pfizer Inc and accomplice BioNTech vaccine for these 65 and older, individuals at excessive danger of extreme illness and others who’re frequently uncovered to the virus.
Rival Moderna Inc additionally submitted its software in search of authorization for a booster shot of its two-dose vaccine final month and FDA’s Vaccines and Associated Organic Merchandise Advisory Committee panel will maintain a gathering on Oct. 14 to debate the extra dose. (Reporting by Aakriti Bhalla and Manojna Maddipatla in Bengaluru; Modifying by Ramakrishnan M, Uttaresh.V and Anil D’Silva)
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