The United States will resume use of the Johnson & Johnson Covid-19 vaccine, the Centers for Disease Control and Prevention and the Food and Drug Administration announced Friday, following an 11-day pause.
"With these actions the administration of Johnson & Johnson's Covid-19 vaccine can resume immediately," CDC director Dr. Rochelle Walensky said Friday evening during a media briefing.
The joint announcement came after a CDC advisory committee voted to recommend lifting the pause, but advised adding a warning about the increased risk of very rare but severe blood clots. The vote was 10 to 4, with one abstention for a conflict of interest.
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.
A day later, the CDC's advisory committee, called the Advisory Committee on Immunization Practices, met to review the available data on the cases and make a recommendation on how to proceed. Ultimately, however, the committee felt it didn't have enough information to make a recommendation at that time, and instead decided to reconvene this week.