CDC advisers recommend resuming use of Johnson & Johnson’s coronavirus vaccine
Vaccine advisers to the US Centers for Disease Control and Prevention voted Friday to recommend resuming use of the Johnson & Johnson coronavirus vaccine.
An updated warning will be added to the label.
Members of the CDC’s Advisory Committee for Immunization Practices agreed the benefits of the vaccine outweigh the risks from rare blood clots linked with the vaccine.
The language of the vote: “The Janssen COVID-19 vaccine is recommended for persons 18 years of age and older in the U.S. population under the FDA’s emergency use authorization.”
The vote was 10 in favor, four opposed and one abstention.
The US Food and Drug Administration will update the label for the vaccine, indicating that women under the age of 50 should be aware of the risk of blood clots from the vaccine. Earlier, Johnson & Johnson officials said they had agreed to updated language for the label.
CDC Director Dr. Rochelle Walensky will sign off and then the US Food and Drug Administration will prepare an amended emergency use authorization for the vaccine, Dr. Amanda Cohn, ACIP’s executive secretary, told the meeting earlier.
“We are awaiting and anticipate that the FDA will be putting out a new, a newly approved EUA language,” Cohn said.
“And additionally, we will be taking the input from today, along with this language that FDA will publish and both FDA and CDC will have communication materials and education materials including infographics, patient fact sheets.”