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]
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.
NEW: Johnson & Johnson asks FDA to authorize coronavirus vaccine booster shots
— Ana Cabrera (@AnaCabrera) October 5, 2021
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.
People in the recommended booster groups who got the Moderna or Johnson & Johnson’s Janssen #COVID19 vaccine may need a booster shot later. More data on the effectiveness and safety of Moderna and J&J/Janssen booster shots are expected soon.
— CDC (@CDCgov) October 1, 2021
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.