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USFDA and CDC recommend pause on J&J vaccine

Our Bureau Mumbai | Updated on April 13, 2021

Authorities reviewing data involving six reported US cases of a rare and severe type of blood clot in individuals

The United States Centers for Disease Control and Prevention (CDC) and the US Food and Drug Administration (FDA) have recommended a pause on the Johnson and Johnson vaccine, “out of abundant caution”, following reports of rare blood clots.

In a statement, the two health authorities said they were reviewing data involving six reported US cases of a rare and severe type of blood clot in individuals after receiving the J&J vaccine.

“In these cases, a type of blood clot called cerebral venous sinus thrombosis (CVST) was seen in combination with low levels of blood platelets (thrombocytopenia),” they said.

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The six cases occurred in women aged between 18 and 48 years, and symptoms occurred 6 to 13 days after vaccination, a note from the CDC and USFDA said. As of April 12, more than 6.8 million doses of the J&J (Janssen) vaccine have been administered in the US.

The latest development comes even as the Oxford-AstraZeneca vaccine saw its use being restricted in several European countries to only older people, as rare blood clots were reported in young people.

Review meetings

The CDC and FDA said that treatment of these specific type of blood clots (as seen in the J&J case) was different from the treatment that might typically be administered. “Usually, an anticoagulant drug called heparin is used to treat blood clots. In this setting, administration of heparin may be dangerous, and alternative treatments need to be given,” they said.

The CDC is set to convene a meeting of the Advisory Committee on Immunization Practices (ACIP) on Wednesday to further review these cases and assess their potential significance. FDA will review the analysis as it also investigates these cases.

“Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution. This is important, in part, to ensure that the healthcare provider community is aware of the potential for these adverse events and can plan for proper recognition and management due to the unique treatment required with this type of blood clot,” the note said.

Published on April 13, 2021

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