J&J'S COVID-19 vaccine pause should be lifted, CDC advisers say
(Reuters) -Use of Johnson & Johnson’s COVID-19 vaccine should be resumed in the United States, advisers to U.S. health regulators said on Friday, after weighing evidence of the shot’s link to extremely rare but potentially deadly blood clots.
The recommendation paves the way for J&J’s shot to begin going into arms again in the United States, once they are confirmed by regulators.
The U.S. Centers for Disease Control and Prevention and the U.S. Food and Drug Administration paused its use last week in order to review reports of the blood clot condition accompanied by low blood platelets.
The FDA will update the emergency use authorization for the vaccine to include information about the risk and how to recognize and treat the condition, J&J executives told the panel.
Top U.S. health officials have said they hope for a quick return of the convenient one-shot vaccine following the panel meeting.
“The benefits do clearly outweigh the risk from a population and individual perspective,” said Dr. Beth Bell, a member of the advisory panel and a clinical professor in the department of global health at the University of Washington in Seattle.
“It’s a new risk. It’s admittedly an extremely small risk and smaller than many other risks that we choose to take every day,” she added.
The panel voted 10-4 to reaffirm that the J&J COVID-19 vaccine is recommended for use in people 18 years of age and older. One member abstained from the vote.
Panelists who voted against raised concern that women might not be fully informed of the risks or told that they could choose an alternate vaccine.
“The Committee’s recommendation is an essential step toward continuing urgently needed vaccinations in a safe way for millions of people in the U.S.,” said J&J’s Chief Scientific Officer Paul Stoffels in a statement.
He added that the company will continue to work with the CDC, FDA and health authorities in Europe “to ensure this very rare event can be identified early and treated effectively.”
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