Johnson & Johnson asks FDA for emergency use authorization of booster dose

Health officials expected to make decision in coming weeks

DETROITJohnson and Johnson is formally asking the FDA to authorize a booster for its COVID-19 vaccine.

The focus now shifts to the FDA and CDC to determine if a booster is needed and if so, who should get it. Unlike Pfizer, Johnson and Johnson is not designating when a booster might be recommended for recipients. They said they will leave that decision up to the FDA and CDC.

Read: Johnson & Johnson says a second dose of its COVID vaccine offers a major boost in protection from virus

Johnson and Johnson said their data shows a second dose two months after the first boosts antibodies fourfold. That raised the “real life” effectiveness from around 70% or 80% up to 94%. Giving the booster six months after the first dose boosted the antibodies twelvefold. So there’s an argument to be made for waiting.

Johnson and Johnson said protection from its vaccine appears to remain stable from month to month. That’s in contrast to Pfizer, which told officials its vaccine’s efficacy decreases over time.

The FDA already authorized Pfizer’s booster, but only for specific groups. Those groups include people ages 65 and older, those with underlying health problems, and those who work in higher-risk jobs.

The FDA’s advisory panel will meet on Oct. 14 to consider Moderna’s request for a booster and again on Oct. 15 to vote on Johnson and Johnson’s. After the FDA makes its decision it will then be up to the CDC’s advisory panel to consider which groups need a booster dose. That meeting is expected to happen quickly.

As with Pfizer boosters, the CDC director will have the final say. Answers on booster doses are expected for Moderna and Johnson & Johnson in the next two weeks or so.

Read: Complete Michigan COVID coverage

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About the Authors:

Jason anchors Local 4's 5:30 p.m. newscast. He joined WDIV in January 2015 as a general assignment reporter and has a Journalism degree from Michigan State University.

Kayla is a Web Producer for ClickOnDetroit. Before she joined the team in 2018 she worked at WILX in Lansing as a digital producer.