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J&J seeking clearance for COVID-19 vaccine booster shots

It’s the first step in a review process that also includes sign-off from the leadership of both the FDA and the Centers for Disease Control and Prevention.
Published: Oct. 5, 2021 at 7:46 AM EDT|Updated: Oct. 5, 2021 at 7:48 AM EDT
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NEW BRUNSWICK, N.J. (WBTV/AP) - Johnson & Johnson announced Tuesday it has submitted data to the U.S. Food and Drug Administration to support use of a booster shot of the Johnson & Johnson COVID-19 vaccine in individuals 18 years of age and older.

Company officials said the submission includes recent results from the Phase 3 ENSEMBLE 2 study that found a booster of the Johnson & Johnson COVID-19 vaccine given 56 days after the primary dose provided 94 percent protection against symptomatic COVID-19 in the U.S. and 100 percent protection against severe/critical COVID-19, at least 14 days post-booster vaccination.

Earlier this year, the American Health Research Network in south Charlotte registered participants to take part in the ENSEMBLE 2 trial, which involved two shots.

Related: Behind the scenes of the Johnson & Johnson two-dose COVID-19 vaccine trial in south Charlotte

“Our clinical program has found that a booster of our COVID-19 vaccine increases levels of protection for those who have received our single-shot vaccine to 94 percent. We look forward to our discussions with the FDA and other health authorities to support their decisions regarding boosters,” said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, Johnson & Johnson.

Last month, the FDA authorized booster shots of Pfizer’s vaccine for older Americans and other groups with heightened vulnerability to COVID-19. It’s part of a sweeping effort by the Biden administration to shore up protection amid the delta variant and potential waning vaccine immunity.

Government advisers backed the extra Pfizer shots, but they also worried about creating confusion for tens of millions of other Americans who received the Moderna and J&J shots. U.S. officials don’t recommend mixing and matching different vaccine brands.

The FDA is convening its outside panel of advisers next week to review booster data from both J&J and Moderna. It’s the first step in a review process that also includes sign-off from the leadership of both the FDA and the Centers for Disease Control and Prevention. If both agencies give the go-ahead, Americans could begin getting J&J and Moderna boosters later this month.

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