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Johnson & Johnson asks FDA to authorize COVID vaccine booster shots

2 years 6 months 2 weeks ago Tuesday, October 05 2021 Oct 5, 2021 October 05, 2021 6:29 AM October 05, 2021 in News
Source: CNN

Pharmaceutical giant Johnson & Johnson has requested the US Food and Drug Administration for authorization of its COVID-19 booster shots.

According to CNN, the company announced news of its request Tuesday, adding that it is leaving the decision of who should get the boosters and when in the hands of the FDA and the US Centers for Disease Control and Prevention.

Dr. Mathai Mammen, head of global research and development for J&J's COVID vaccination development, said, "We're describing the data to them. The process is not that we asked for a very specific interval- we're providing them data and we're going to be presenting to the committee. They'll take all that into consideration when they ultimately decide on an appropriate interval."

The FDA's Vaccine and Related Biological Products Advisory Committee will meet October 14 and 15 to officially review requests from both Moderna and Johnson & Johnson to add booster doses for their COVID-19 vaccines.

In August, Janssen released data from three studies, each revealing that its single-shot vaccine boosted immune protection at two months and at six months.

"We announced that the six month data are a very strong, very strong boost, like an amazingly strong boost," Mammen said. "And that two months is a good boost, and the two month good boost was associated with 94% vaccine efficacy, right across the board, all ages."

Increasing Janssen's vaccine two months after the first shot triggered an uptick in antibody response fourfold, the company said. It was also associated in real life with 94 percent effectiveness.

Waiting until six months to get the shot increased antibody protection 12-fold, the company said last month.

So, while either interval is considered acceptable by J&J researchers, they suggest that waiting six months is the better option.

Interestingly, Janssen says its vaccine offers protection that remains stable over time, meaning the purpose of the boosters is not to replenish protection that has faded over the course of time. Instead, the J&J booster would provide individuals with an even higher level of protection against the virus. 

J&J's request for authorization follows the FDA's August approval of Pfizer's booster for certain individuals who were vaccinated with their first two doses six months ago or longer.  



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