Johnson & Johnson Asks FDA for Emergency Authorization of COVID Booster Shot

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

The FDA’s Vaccine and Related Biological Products Advisory Committee is scheduled to meet on October 14th and 15th to consider requests from Moderna and Johnson & Johnson to add booster doses for their Covid-19 vaccines. According to the CDC, about 15 million people in the US have received a J&J Covid-19 vaccine. [Writer’s disclosure: I am one of those 15 million]

HINES, ILLINOIS – SEPTEMBER 24: Lalain Reyeg administers a COVID-19 booster vaccine and an influenza vaccine to Army veteran Gary Nasakaitis at the Edward Hines Jr. VA Hospital on September 24, 2021 in Hines, Illinois. Today, CDC Director Rochelle Walensky endorsed a booster shot of the Pfizer-BioNTech COVID-19 vaccine for people 65 years and older, those with underlying medical conditions or those who work in high-risk situations. (Photo by Scott Olson/Getty Images)

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. J&J’s vaccine division, known as Janssen, also released some data last month 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, according to their study.

Johnson & Johnson said in their request to the FDA that 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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