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J&J Will Seek US FDA Clearance For Booster Vaccine This Week


© Reuters. FILE PHOTO: In this illustration, taken on October 31, 2020, vials with a label that reads “COVID-19 / Coronavirus Vaccine / Injection Only” and a medical syringe are seen in front of the Johnson & Johnson logo displayed. REUTERS / Dado Ruvic

(Reuters) -Johnson & Johnson plans to ask US federal regulators this week to authorize a booster injection of its COVID-19 vaccine, the New York Times reported https://www.nytimes.com/live/ 2021/10/04 / world / covid-delta-variant-vaccine # johnson-johnson-will-seek-fda-authorization-for-a-booster-shot on Monday, citing officials familiar with the company’s plans.

While scientists are divided on the need for booster shots when so many people in the United States and other countries remain unvaccinated, the Biden administration announced the push for an additional dose in August as part of an effort to bolster protection against the Highly transmissible delta. variant.

The US Food and Drug Administration (FDA) last week scheduled for October 4. 15 meeting of your expert advisory committee to discuss whether to grant an emergency use authorization for a J&J (NYSE 🙂 vaccine booster injection.

More than 15 million Americans have received the J&J vaccine, which is administered as a single dose, according to the most recent data https://covid.cdc.gov/covid-data-tracker/#vaccinations_vacc-total-admin-rate -total from Centers for Disease Control and Prevention.

Last month, the healthcare conglomerate said an additional second injection of its vaccine given about two months after the first increased its effectiveness to 94%, compared to 70% protection with the single dose.

J&J declined to comment on the NYT report, pointing to its press release dated Sept. 21, saying the company has submitted the available data to the US health regulator and intends to send the data to other regulators.

The FDA has already authorized a booster dose of Pfizer Inc (NYSE 🙂 and its partner’s BioNTech vaccine for people 65 and older, people at high risk of severe disease, and others who are regularly exposed to the virus.

Rival Modern (NASDAQ 🙂 Inc also submitted its application seeking authorization for a booster injection of its two-dose vaccine last month and the FDA’s Vaccines and Related Biologics Advisory Committee panel will meet on October 4. 14 to discuss the additional dose.

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