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

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

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

“The procedure is not that we asked for a very precise interval – we’re providing them data and we’re going to be offering to the agency. They’ll yield all that into deliberation when they eventually elect on a suitable intermission.”

The FDA’s Vaccine and Related Biological Products Advisory Committee is planned to meet on October 14 and 15 to deliberate appeals from Moderna and Johnson & Johnson to include booster doses for their Covid-19 vaccines.

Last month, Janssen released out some data from three dissimilar studies that displayed improving its single-shot vaccine at two months or at six months improved immune safeguard.


What Mammen said regarding the Covid-19 vaccine booster shots

Mammen said “They proclaimed that the six-month data are a very resilient, very solid boost, like an incredibly solid boost,” “And that two months is a good boost, and the two-month good boost was related with 94% vaccine effectiveness, right across the panel, for all ages.”

Boosting Janssen’s vaccine two months after the first shot improved antibody reaction fourfold, the firm said and was related in real life with 94% efficiency. Waiting until six months to lift upsurge antibody protection 12-fold, the firm said last month. “So either of those intermissions can make logic. Mammen said that “They think six months, immunologically, is even better,”.

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

Janssen upholds that safety from its vaccine residues steady over time. In requesting FDA approval for a booster, Pfizer offered data presenting vaccine effectiveness was weakening over time. Mammen said that doesn’t occur with Janssen’s shot.

Mammen further added, “Their core justification for boosting is very different,”.

“We have manifold data sets, but for sample a practical effectiveness study, the prevalence of its kind that was done, displays about an 80% vaccine usefulness, safety alongside contagion, that goes, month after month, he further added that “it’s a very steady,”

“So our dispute is not that our vaccine efficiency is vanishing or weakening, but rather that from an individual stance, one can get to an even greater level of safety with a boost. So consequently there’s some more freedom on the particular time since you’re not up again, you’re not fighting a clock.”

Janssen says its vaccine is deliberated to stimulate a strong cellular reaction. Vaccines provoke the making of both antibodies — the first line of defense against invaders and immune cells known as B cells and T cells. Mammen said that “This is the intention we have a long-lasting response,”.

According to the CDC, a J&J Covid-19 vaccine has been taken by 15 million people in the US. Mammen said there’s a huge supply in the United States for everybody who got the Janssen vaccine and needs a booster to get one.

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