CDC advisory group recommends resuming use of J&J COVID-19 vaccine
On Friday, the Advisory Committee on Immunization Practices voted to recommend resuming the use of the one-shot Johnson & Johnson COVID-19 vaccine in Americans aged 18 years and older.
They said the benefits of the vaccine outweigh the risks for blood clots associated with its use.
The final vote was 10 in favor, four opposed and one abstention. However, committee members said women aged 50 years or younger should be made aware of the risks for blood clots.
“I think that under an emergency use authorization, where there is no informed consent, that it could be that ACIP recommendations might need to reflect some more nuanced concerns than under the usual procedure. Nonetheless, I say I voted yes, but I am concerned that the consumers and women in this age group, in particular, will not be adequately informed just by the FDA/EUA fact sheets,” said Beth Bell, MD, MPH, member of the ACIP and a clinical professor in the department of global health at the University of Washington School of Public Health. “So, we’re really depending on the public health agencies and the partner organizations to make sure that people are actually informed and empowered and that they actually get a balanced perspective.”
On April 13, the CDC and FDA recommended to pause the rollout of Johnson & Johnson’s COVID-19 vaccine so experts could review six reported cases of rare clotting in people who received it.
The six cases of cerebral venous sinus thrombosis (CVST) were seen in combination with thrombocytopenia, or low levels of blood platelets, according to health officials. The six cases occurred out of 6.8 million doses of the vaccine that were administered as of April 12. There was one death, and one patient was reported to be in critical condition. All cases occurred in women aged 18 to 48 years who experienced symptoms 6 to 13 days after vaccination.
On April 14, the ACIP said it needed more information before it could recommend for or against resuming the use of the vaccine, choosing instead to reconvene on April 23.
On Thursday, the ACIP vaccine safety technical subgroup found that the incidence of thrombosis with thrombocytopenia after receiving the Johnson & Johnson vaccine was seven per 1 million doses among women aged younger than 50 years.
The European Medicines Agency said its safety committee reviewed the small number of cases of CVST associated with the vaccine and “concluded that these events should be listed as a very rare side effect,” but the agency also said the benefits of the vaccine outweigh the risks.
“I think this pause was essential to our ability to inform the public, inform the physicians and to acquire more data for presentation and for analysis,” said José Romero, MD, FAAP, chair of the ACIP, secretary of the Arkansas Department of Health and professor of pediatrics and pediatric infectious diseases at the University of Arkansas for Medical Sciences.
The FDA and Janssen have agreed to update the label of the vaccine to indicate the risk for thrombosis with thrombocytopenia.
“I absolutely think this is a serious adverse event. We need to continue to ensure that awareness is raised. I think that the only choices that we really had were to recommend or not recommend, to share the clinical decision-making, and I think that the emphasis and the vote itself reflect the challenge that was before us today,” Grace M. Lee, MD, MPH, member of the ACIP, associate chief medical officer for practice innovation at Lucile Packard Children’s Hospital and professor of pediatrics at Stanford University School of Medicine, said during the committee meeting. “We need to be able to reflect the importance of this specific adverse event and elevate it, but I also think that we have to come out with a clear recommendation.”