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J&J will seek US FDA approval for a booster shot this week


Reuters File Photo: COVID1 This illustration, taken on October 1, 2020, shows a sticker in front of the Johnson & Johnson logo, a vial with “Covid-1 / / coronavirus vaccine / injection” and a medical syringe.

(Reuters) – Johnson & Johnson plans to talk to U.S. federal regulators this week about approving a booster shot of its COVID-19 vaccine, according to the New York Times https://www.nytimes.com/live/2021/10/04/world/covid -delta-variant-vacc # johnson-johnson-will-see-fda-authorization-for-a-booster-shot Monday quoting officials familiar with the company’s plans.

Although scientists are divided over the need for booster shots when many people in the United States and other countries remain unvaccinated, the Biden administration announced additional doses early in the month as part of efforts to increase protection against highly contagious Delta. Optional

The U.S. Food and Drug Administration (FDA) was scheduled for a meeting of its expert advisory committee last week, Oct. 15, to discuss whether to allow emergency use for J&J (NYSE 🙂 vaccine booster shots.

More than 15 million Americans have received the J&J vaccine, which is administered as a single dose, according to the latest data from https://covid.cdc.gov/covid-data-tracker/#vaccinations_vacc-total-admin-rate-total And prevention center.

The Healthcare Association said last month that an additional second shot of its vaccine was given about two months after the first increased its effectiveness by 94% compared to 70% protection with a single dose.

J&J declined to comment on the NYT report and pointed to its Sept. 21 press release stating that the company had submitted data available to U.S. health regulators and wanted to submit data to other regulators.

The FDA has already approved a booster dose of it Pfizer Inc. (NYSE 🙂 and biotech vaccines for people 655 years of age or older, at high risk of serious disease, and others who are regularly exposed to the virus.

Rival Modern (NASDAQ 🙂 Inc. also filed an application last month seeking approval of a booster shot of its two-dose vaccine, and a panel of the FDA’s Vaccine and Related Organic Products Advisory Committee will meet on Oct. 1 to discuss the additional dose.

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