Following a thorough safety review, the U.S. Food and Drug Administration and the U.S. Centers for Disease Control and Prevention have recommended that the pause on the Johnson & Johnson COVID-19 Vaccine be lifted and use of the vaccine should resume.
There will be little delay in the J&J one-dose shots being offered again, officials said. Dr. Peter Marks, director of FDA’s Center for Biologics Evaluation and Research, said shots should be able to resume “shortly after this announcement. … I would expect them to resume probably by tomorrow morning, even.” Dr Marks stated on Saturday. The warnings, in the form of fact sheets that will be distributed to people who receive the vaccines, have already been prepared and approved in anticipation of the vaccinations resuming, the FDA’s Dr. Peter Marks said Friday. “Those are available for use immediately.”
“Today’s presentations and discussions have convinced me that lifting the pause on J&J’s vaccine is in the best public health interest of the U.S. population,” said Dr. Henry Bernstein, a professor of pediatrics at the Zucker School of Medicine at Hofstra/Northwell in New York and a member of the CDC’s advisory committee. The CDC and the FDA recommended the pause April 13, after receiving six reports of dangerous blood clots in the brain among the more than 7 million people who had received the Johnson & Johnson vaccination.
There are now 15 confirmed reports of a rare condition that includes blood clots with low platelet counts following the J&J vaccine, with a dozen of the clots occurring in veins near the surface of the brain, a condition called “cerebral venous sinus thrombosis,” according to the CDC. That’s more than double the cases initially reported that prompted federal regulators to recommend a temporary suspension. Experts caution the reactions are rare. The 15 cases are out of the nearly 8 million J&J shots given. But women under age 50 also seem to be significantly more vulnerable to these abnormal reactions. In debating how to move forward, the committee declined to include a specific warning to women under 50 not to take the vaccine. Several members expressed concern that doing so could deter women from getting vaccinated at all.
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ARTICLE: PAUL MURDOCH
POLITICS EDITOR: CARSON CHOATE
PHOTO CREDITS: DETROIT FREE PRESS