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“We describe the data to them,” Dr. Mathai Mammen, global head of research and development for J&J’s vaccine arm, Janssen, told CNN.
“The process isn’t that we asked for a very specific interval – we provide them with data and we’ll present it to the committee. They’ll take all of that into consideration when they finally decide on an appropriate interval.”
The FDA Advisory Committee on Vaccines and Related Biologics is scheduled to meet on October 14 and 15 to consider requests from Moderna and Johnson & Johnson to add booster doses for their Covid-19 vaccines.
Last month, Janssen published data from three different studies which showed that boosting his single-shot vaccine to two months or six months increased immune protection.
“We announced that the six-month data is a very strong, very strong push, like an incredibly strong push,” Mammen said. “And those two months is a good boost, and the good two-month boost has been associated with 94% vaccine effectiveness, at all ages.”
Boosting Janssen’s vaccine two months after the first injection quadrupled the antibody response, the company said, and was associated in real life with 94% effectiveness. Wait up to six months for antibody protection to increase 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 FDA clearance last month for booster doses for certain people who received the initial two doses six months or more ago.
Janssen maintains that the protection of his vaccine remains stable over time. In seeking FDA clearance for a recall, Pfizer presented data showing that the vaccine’s effectiveness worsened over time. Mammen said that didn’t happen with Janssen’s shot.
“Our basic rationale for strengthening is very different,” Mammen said.
“We have several datasets, but for example, a real-world efficacy study, the largest of its kind that has been done, shows about 80% vaccine efficacy, protection against infection, which goes, month after month after month after month, so it’s very stable, “he added.
“So our argument is not that the effectiveness of our vaccine fades or decreases, but rather that from a personal point of view, we can achieve an even higher level of protection with a boost. So you have more leeway over the exact time because you ‘re not up yet, you are not fighting a clock.
Janssen says his 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 called B cells and T cells. “This is why we have a long lasting response,” he said. declared Mammen.
According to the CDC, approximately 15 million people in the United States have received a J&J Covid-19 vaccine.
Mammen said there is plenty of supply in the United States for anyone who has received the Janssen vaccine and wants a booster to get one.
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