Johnson & Johnson Will Seek FDA Authorization for a Booster Shot

Posted on

According to a NY Times report, Johnson & Johnson will be seeking U.S. FDA authorization of a booster shot this week of its COVID-19 vaccine.

The New York Times reported on Monday, citing officials familiar with the company’s plans, that J&J would ask U.S. federal regulators this week to green light the booster shot.

The U.S. Food and Drug Administration (FDA) last week scheduled an Oct. 15 meeting of its expert advisory committee to discuss whether to grant emergency use authorization for a booster shot of J&J’s vaccine.

Over 15 million Americans have received J&J’s vaccine, which is administered as a single dose, according to the Centers for Disease Control and Prevention.
J&J said in September that an additional second shot of its vaccine given about two months after the first increased its effectiveness to 94%, compared with 70% protection with the single dose.

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

According to a company press release, new data also showed that protection against COVID-19 increases when a booster shot of the Johnson & Johnson vaccine is administered.

“Our large real-world evidence and Phase 3 studies confirm that the single-shot Johnson & Johnson vaccine provides strong and long-lasting protection against COVID-19-related hospitalizations. Additionally, our Phase 3 trial data further confirm protection against COVID-19-related death,” said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, Johnson & Johnson.

“Our single-shot vaccine generates strong immune responses and long-lasting immune memory. And, when a booster of the Johnson & Johnson COVID-19 vaccine is given, the strength of protection against COVID-19 further increases.”

“It is critical to prioritize protecting as many people as possible against hospitalization and death given the continued spread of COVID-19. A single-shot COVID-19 vaccine that is easy to use, distribute and administer, and that provides strong and long-lasting protection is crucial to vaccinating the global population,” said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer at Johnson & Johnson. “At the same time, we now have generated evidence that a booster shot further increases protection against COVID-19 and is expected to extend the duration of protection significantly.”

Disclaimer: We have no position in any of the companies mentioned and have not been compensated for this article.

Daily updates