A Centers for Disease Control and Prevention (CDC) advisory committee is recommending that the Johnson & Johnson COVID-19 vaccine resume rollout, but include new language on the product’s emergency use authorization (EUA) warning remote risks of serious blood clots. The Advisory Committee on Immunization Practices held the vote Friday after the FDA and CDC had recommended a pause in the Johnson & Johnson COVID-19 vaccine rollout last week due to several instances of a rare, severe blood clot amid a backdrop of over 7 million recipients.
The vote was 10 to 4.
One committee member abstained.
The recommendation will now go before CDC Director Dr. Rochelle Walensky for approval.
Committee members were tasked with discussing the following question:
Given the review of the benefits and risks, what recommendation does ACIP feel is appropriate for use of the Janssen COVID-19 vaccine?
The committee met on Friday to review safety data surrounding the vaccine after there were 15 cases of so-called thrombosis with thrombocytopenia syndrome (TTS) amid a backdrop of nearly 8 million J&J COVID-19 vaccinations, as of April 21. TTS is a broad term including the rare but potentially deadly cerebral venous sinus thrombosis (CVST), but also deep vein thrombosis and pulmonary thromboembolism.
All of the reported cases were among women aged 18-59, with a median age of 37. Of the 15 total, 12 were identified as CVST with thrombocytopenia; other cases occurred in locations like the portal vein and pulmonary artery. Other potential cases under review include males. Officials excluded one female with a "complex and unique" case history.
There is a reporting rate of 7 TTS cases per million J&J doses administered among women aged 18 to 49 (approximately one in 142,000), compared with 0.9 cases per million doses among women above 50. The greatest risks were reported among women aged 30 to 39 at a reporting rate of 11.8 TTS cases per million doses administered.
The committee delayed a vote last week because members felt there was not enough information at the time to issue policy recommendations. The committee learned last Wednesday of a seventh woman (following six reported cases at the time) who developed a rare and severe type of blood clot after receiving the Johnson & Johnson COVID-19 vaccine, not occurring in the brain as the others did, and an additional incident involving a man which occurred during a clinical trial but could not be linked to the jab at the time.
While the CVST and low platelet count instances have been described as "extremely rare" by the FDA, the agencies recommended a pause "out of an abundance of caution" partly due to how the blood clots must be treated.
Fox News' Alexandria Hein and Madeline Farber contributed to this report.