J & J submits EUA for COVID-19 booster to the FDA
Booster increases protection to 94% against moderate to severe COVID-19 in the U.S., J&J says.
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Johnson & Johnson has submitted data to the U.S. Food and Drug Administration to support use of a booster shot of the J & J COVID-19 vaccine in individuals 18 years of age and older.
Recent study results show that a booster dose of the single shot Johnson & Johnson COVID-19 vaccine given 56 days after the primary dose provided 94% protection against moderate to severe and critical COVID-19 in the U.S. at least 14 days post-booster vaccination.
When a booster of the Johnson & Johnson COVID-19 vaccine was given six months after the single shot, antibody levels increased nine-fold one week after the booster and continued to climb to 12-fold higher four weeks after the booster.
WHY THIS MATTERS
Last month, the FDA authorized booster shots of Pfizer's vaccine for older Americans and other groups with heightened vulnerability to COVID-19.
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, according to CBS News. If both agencies give the go-ahead, Americans could begin getting J&J and Moderna boosters later this month.
THE LARGER TREND
The Janssen COVID-19 vaccine is authorized for use in the U.S. under an Emergency Use Authorization to prevent COVID-19 in individuals 18 years of age and older.
Blood clots involving blood vessels in the brain, lungs, abdomen and legs, along with low levels of platelets (blood cells that help your body stop bleeding), have occurred in some people who have received the Janssen COVID-19 Vaccine. In people who developed these blood clots and low levels of platelets, symptoms began approximately one to two weeks following vaccination.
Twitter: @SusanJMorse
Email the writer: susan.morse@himssmedia.com
