Johnson & Johnson asks FDA to authorize Covid-19 vaccine booster shots

CNN

By Maggie Fox, CNN

Johnson & Johnson said Tuesday it has asked the US Food and Drug Administration to authorize booster shots for its coronavirus vaccine, but has left it up to the FDA and the US Centers for Disease Control and Prevention to decide just who should get their boosters and when.

“We’re describing the data to them,” Dr. Mathai Mammen, head of global research and development for J&J’s vaccine arm, Janssen, told CNN.

“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 is scheduled to meet October 14 and 15 to consider requests from Moderna and Johnson & Johnson to add booster doses for their Covid-19 vaccines.

Last month, Janssen released some data from three different studies that showed boosting its single-shot vaccine at two months or at six months increased immune protection.

“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.”

Boosting Janssen’s vaccine two months after the first shot increased antibody response fourfold, the company said, and was associated in real life with 94% effectiveness. Waiting until six months to boost increase antibody protection 12-fold, the company said last month. “So either of those intervals can make sense. We think six months, immunologically, is even better,” Mammen said.

Pfizer received the FDA’s OK last month for booster doses for certain people who got the original two doses six months ago or longer.

Janssen maintains that protection from its vaccine remains stable over time. In asking for FDA authorization for a booster, Pfizer presented data showing vaccine efficacy was waning over time. Mammen said that doesn’t happen with Janssen’s shot.

“Our core rationale for boosting is very different,” Mammen said.

“We have multiple data sets, but for example a real-world efficacy study, the largest of its kind that was done, shows about an 80% vaccine efficacy, protection against infection, that goes, month after month after month after month, so it’s a very stable,” he added.

“So our argument is not that our vaccine efficacy is fading or waning, but rather that from a personal standpoint, one can get to an even higher level of protection with a boost. So therefore there’s some more latitude on the exact time because you’re not up again, you’re not fighting a clock.”

Janssen says its vaccine is designed to elicit a strong cellular response. Vaccines stimulate the production of both antibodies — the first line of defense against invaders — and immune cells known as B cells and T cells. “It is the reason we have a long-lived response,” Mammen said.

According to the CDC, about 15 million people in the US have received a J&J Covid-19 vaccine.

Mammen said there’s plenty of supply in the United States for everyone who got the Janssen vaccine and wants a booster to get one.

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