An expert advisory committee to the Centers for Disease Control and Prevention meets today to discuss the six cases of a rare blot clotting disorder associated with the Johnson & Johnson COVID-19 vaccine.
The Food and Drug Administration and the CDC on Tuesday recommended a pause in administering the vaccine after reports of blood clots in a small number of people who received it.
The extremely rare blood clots have been reported in six of the 7.2 million Americans who have gotten the Johnson & Johnson vaccine. All were in women ages 18 to 48, and symptoms occurred six to 13 days after vaccination. One woman died, and one was hospitalized in critical condition.
The Advisory Committee on Immunization Practices is an independent expert group. It will review information about the reports and make a recommendation to the CDC and FDA about how, or whether, the Johnson & Johnson vaccine should be used going forward.
The ACIP meeting is broadcast live online on the CDC’s ACIP web page.
The cases were reported to the CDC’s Vaccine Adverse Event Reporting System known as VAERS, which the CDC and FDA co-manage. It serves as an early warning system to monitor the safety of vaccines, CDC director Dr. Rochelle Walensky said in a White House press briefing Wednesday.
One of the reasons for the pause was to alert health care professionals to the possibility of the rare blood clotting problems so they can be properly treated and reported to CDC.
“We believe these events to be extremely rare, but we are also not yet certain we have heard about all possible cases as this syndrome may not be easily recognized as one associated with the vaccine,” Walensky said.
FDA and the CDC made the recommendation to pause use of the Johnson & Johnson vaccine so that it could assess the risk it might pose and decide how to move forward. The ACIP committee, which was told of the emergency meeting on Tuesday, will help with that decision.
While the committee makes only recommendations and does not regulate drugs, its advice is generally considered a gold standard by the agencies.
ACIP consists of 15 voting-member experts who are primarily responsible for vaccine recommendations. The secretary of the U.S. Department of Health and Human Services selects the committee through an application and nomination process.
Fourteen have expertise in vaccinology, immunology, pediatrics, internal medicine, nursing, family medicine, virology, public health, infectious diseases or preventive medicine. One member is a consumer advocate to provide perspective on the social and community aspects of vaccination.
In addition to the voting members, there are 30 non-voting representatives from professional organizations that are highly regarded in the health field. They comment on ACIP’s recommendations and offer the perspectives of groups that will implement the recommendations.
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