A Facilities for Illness Management and Prevention (CDC) advisory committee is recommending that the Johnson & Johnson COVID-19 vaccine resume rollout, however embrace new language on the product’s emergency use authorization (EUA) warning distant dangers of significant blood clots. The Advisory Committee on Immunization Practices held the vote Friday after the FDA and CDC had really useful a pause within the Johnson & Johnson COVID-19 vaccine rollout final week attributable to a number of situations of a uncommon, extreme blood clot amid a backdrop of over 7 million recipients.
The vote was 10 to 4.
One committee member abstained.
The advice will now go earlier than CDC Director Dr. Rochelle Walensky for approval.
Committee members have been tasked with discussing the next query:
Given the overview of the advantages and dangers, what advice does ACIP really feel is acceptable to be used of the Janssen COVID-19 vaccine?
The committee met on Friday to overview security information surrounding the vaccine after there have been 15 instances of so-called thrombosis with thrombocytopenia syndrome (TTS) amid a backdrop of almost 8 million J&J COVID-19 vaccinations, as of April 21. TTS is a broad time period together with the uncommon however probably lethal cerebral venous sinus thrombosis (CVST), but in addition deep vein thrombosis and pulmonary thromboembolism.
The entire reported instances have been amongst ladies aged 18-59, with a median age of 37. Of the 15 complete, 12 have been recognized as CVST with thrombocytopenia; different instances occurred in places just like the portal vein and pulmonary artery. Different potential instances beneath overview embrace males. Officers excluded one feminine with a “advanced and distinctive” case historical past.
There’s a reporting charge of seven TTS instances per million J&J doses administered amongst ladies aged 18 to 49 (roughly one in 142,000), in contrast with 0.9 instances per million doses amongst ladies above 50. The best dangers have been reported amongst ladies aged 30 to 39 at a reporting charge of 11.8 TTS instances per million doses administered.
The committee delayed a vote final week as a result of members felt there was not sufficient data on the time to problem coverage suggestions. The committee discovered final Wednesday of a seventh lady (following six reported instances on the time) who developed a uncommon and extreme sort of blood clot after receiving the Johnson & Johnson COVID-19 vaccine, not occurring within the mind because the others did, and a further incident involving a person which occurred throughout a scientific trial however couldn’t be linked to the jab on the time.
Whereas the CVST and low platelet depend situations have been described as “extraordinarily uncommon” by the FDA, the businesses really useful a pause “out of an abundance of warning” partly attributable to how the blood clots have to be handled.
Fox Information’ Alexandria Hein and Madeline Farber contributed to this report.