Johnson & Johnson FDA

Johnson & Johnson Asks FDA To Authorize Covid-19 Vaccine Boosters

Johnson & Johnson said Tuesday that it has asked the U.S. Food and Drug Administration (FDA) to authorize booster shots of its COVID-19 vaccine. 

However, it has left it up to the FDA and the US Centers for Disease Control and Prevention (CDC) to decide who should get boosters and when.

Dr. Mathai Mammen, director of global research and development for J & J’s vaccine arm, Janssen, told CNN that “we are describing the data to you.”

“The process is not that we have asked for a very specific interval: we are providing you with data and we are going to present it to the committee. They will take all of that into account when they finally decide on an appropriate interval, ”he explained.

The FDA’s Advisory Committee on Vaccines and Related Biologics is scheduled to meet on October 14-15 to review requests from Moderna and Johnson & Johnson to add booster doses to their COVID-19 vaccines.

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Last month, Janssen released some data from three different studies showing that boosting his single-dose vaccine at two to six months increased immune protection.

“We announce that the six-month data is a very strong, very strong reinforcement, like an incredibly strong reinforcement,” Mammen said. “And that the two months are a good booster, and the good booster at two months was associated with a 94% efficacy of the vaccine, in all areas, at all ages,” he said.

Side effects of booster doses of the vaccine were similar to those of the second dose, brief and mild, according to a study

Boosting the Janssen vaccine two months after the first injection quadrupled the antibody response, according to the company, and was associated in real life with an efficacy of 94%.

Waiting up to six months to increase antibody protection increased 12-fold, the company said last month. “So any of those intervals can make sense. We think six months, immunologically, is even better, ”Mammen said.

The authorization for Pfizer

Pfizer received clearance from the FDA last month for booster doses for certain people who received the original two doses six months or more ago.

Janssen maintains that the protection of his vaccine remains stable over time. In requesting FDA clearance for a booster dose, Pfizer submitted data showing that the efficacy of the vaccine was decreasing over time. Mammen said that is not the case with the Janssen vaccine.

“Our main justification for the reinforcement is very different,” Mammen said.

“We have multiple data sets, but, for example, a real-world efficacy study, the largest of its kind ever conducted, shows a vaccine efficacy of around 80%, protection against infection, which it is maintained, month after month after month, so it is very stable ”, he added.

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“So our argument is not that the efficacy of the vaccine is fading or decreasing, but that, from a personal point of view, an even higher level of protection can be achieved with a booster. So there is a bit more latitude at the exact moment, because you are not up again, you are not fighting a clock, ”he said.

Janssen claims that their 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. “This is why we have a long-lasting response,” Mammen said.

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

Mammen said there is enough supply in the United States so that everyone who received the Janssen vaccine and wants a booster can get it.