- Johnson & Johnson has asked the US Food and Drug Administration to authorize booster shots for its coronavirus vaccine
- Boosting Janssen’s vaccine two months after the first shot increased antibody response fourfold
- Janssen maintains that protection from its vaccine remains stable over time.
Johnson & Johnson has asked the US to authorize booster shots for its coronavirus vaccine, reports CNN.
About FDA’s authorization
Johnson & Johnson said Tuesday it has asked the US FDA 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.
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.
“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.
About the booster doses
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.
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.
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.
Janssen maintains that protection from its vaccine remains stable over time.
“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,” Mammen said.
“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.”
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