Infectious Disease

The CDC Advisory Group recommends resuming use of the J&J COVID-19 vaccine

April 23, 2021

2 min read

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Disclosure:
Bell, Lee and Romero do not report any relevant financial information.

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On Friday, the Advisory Committee on Immunization Practices approved the recommendation to resume use of the one-time Johnson & Johnson COVID-19 vaccine in Americans aged 18 and over.

They said the vaccine’s benefits outweigh the blood clot risks associated with its use.

Source: Adobe Stock.

The final vote was 10 for, four against and one abstention. However, the committee members said women aged 50 or younger should be made aware of the risks of having blood clots.

“I think that for an emergency clearance that does not have informed consent, the ACIP recommendations may need to reflect more nuanced concerns than the normal process. Nonetheless, I say I voted yes, but I am concerned that consumers and women in particular in this age group are not only being adequately informed through the FDA / EUA data sheets, ”he said Beth Bell, MD, MPH, Member of ACIP and Clinical Professor in the Department of Global Health in the School of Public Health at the University of Washington. “So we really need the public health authorities and partner organizations to make sure that people are genuinely informed, empowered and that they are actually getting a balanced perspective.”

Beth Bell, MD, MPH

On April 13, the CDC and FDA recommended suspending the rollout of Johnson & Johnson’s COVID-19 vaccine to allow experts to review six reported cases of rare clotting in people who received it.

The six cases of cerebral venous sinus thrombosis (CVST) have been seen in combination with thrombocytopenia or low platelet levels, according to health officials. The six cases occurred out of 6.8 million doses of the vaccine given 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 recommending for or against resuming use of the vaccine and instead decided to reunite on April 23.

On Thursday, the ACIP Vaccine Safety Technical Subgroup found that the incidence of thrombosis with thrombocytopenia in women under the age of 50 after receiving the Johnson & Johnson vaccine was seven per 1 million doses.

The European Medicines Agency said its safety committee had looked at the low number of CVST-related cases with the vaccine and “determined that these events should be listed as a very rare side effect,” but the agency also said the benefits of the vaccine the risks outweigh the risks.

“I think this break was essential to our ability to educate the public, the doctors, and the doctors to get more data for presentation and analysis, ”he said IfIt is Romero, MD, FAAP, Chairman of 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 vaccine label to reflect the risk of thrombosis with thrombocytopenia.

“I absolutely think this is a serious adverse event. We must continue to ensure that awareness is raised. I think the only decisions we really had to recommend or not to recommend were to share clinical decision making, and I think the focus and alignment itself reflects the challenge we faced today. ” Grace M. Lee, MD, MPH, A member of ACIP, deputy 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 and raise the importance of this specific adverse event, but I also think we need to make a clear recommendation.”

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