A Facilities for Illness Management and Prevention (CDC) committee didn’t maintain a vote concerning steerage on Johnson & Johnson’s COVID-19 vaccine Wednesday after federal officers really helpful a pause within the rollout. The Advisory Committee on Immunization Practices (ACIP) met sooner or later after the FDA and CDC really helpful the pause over concern of six cases of a uncommon, extreme blood clot in over 6.8 million vaccine recipients.
The ACIP had been tasked with discussing two questions:
Does ACIP have sufficient data to make interim age or threat factor-based suggestions to be used of the Janssen vaccine?
What suggestion does ACIP really feel is suitable at this time given present accessible data to be used of the Janssen vaccine?
Many committee members felt there was inadequate information to make an evidence-based determination on Wednesday. A number of unknowns embody the true background incidence of cerebral venous sinus thrombosis (CVST) with low platelet rely, particular threat components, potential to match thrombotic circumstances post-vaccination between AstraZeneca and J&J vaccines, and true incidence of circumstances particular to J&J vaccine recipients.
Officers emphasised the prolonged pause didn’t point out elevated concern however as an alternative an try to higher characterize the chance.
The circumstances underneath assessment concerned six females between ages 18 and 48, whose severe hostile occasions occurred inside six to 13 days of vaccination. Most of them skilled complications, and one of many girls died whereas one other is in important situation.
The cases have been described as “extraordinarily uncommon” by the FDA, and the companies really helpful the pause Tuesday “out of an abundance of warning” partly resulting from how the blood clots should be handled. There have been no such reported circumstances of CVST with low platelet rely in practically 200 million vaccinations between Moderna and Pfizer.
The committee mentioned that by Friday it might decide when to subsequent meet and focus on the info.
Fox Information’ Alexandria Hein contributed to this report.