CDC, FDA Recommend Resuming Johnson & Johnson COVID-19 Vaccines
Today, the U.S. Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) lifted their recommended temporary pause on the administration of the single-dose Johnson & Johnson COVID-19 vaccine.
The move follows today’s vote by the CDC Advisory Committee on Immunization Practices (ACIP) to recommend the resumption of Johnson and Johnson COVID-19 vaccines. The ACIP concluded the benefits of the vaccine outweigh risks from rare blood clots linked with the vaccine on a 10-4 vote with one member not voting.
Recall, the CDC and FDA on April 13 issued a recommendation to pause administration of the single-dose COVID-19 vaccine amid reports of thrombosis with thrombocytopenia syndrome (TTS) among individuals who recently received the vaccine. The CDC has received reports of 15 cases of TTS, all among women, with 13 of the cases among women under age 50. Three deaths have occurred.
CDC Director Rochelle Walensky has signed off on ACIP’s recommendation to resume vaccinations with a warning for women under age 50 acknowledging the risk of TTS. The FDA has issued an amended emergency use authorization (EUA) for the Johnson & Johnson vaccine and will update the label with an accompanying warning for the vaccine. The CDC and FDA are anticipated to make available communication and education materials on the vaccine, including infographics and patient fact sheets.
Additional information on the modified recommendations for the Johnson & Johnson vaccine from the CDC, as well as the California Department of Public Health (CDPH), is anticipated over the coming days. The presentation slides from today’s CDC ACIP meeting are available here. A joint statement by the CDC and FDA is available here.