COVID-19 Business Intelligence and Analysis for Clinical Laboratories, Pathology Groups and Hospital Administration

COVID-19 Briefings

Reliable COVID-19 Business Intelligence and analysis for clinical laboratories, pathology groups and Laboratory Diagnostics.

FDA and CDC Pause Use of Johnson and Johnson Vaccine Due to Rare Blood Clotting Disorder

FDA maze of regulations

Johnson and Johnson COVID-19 vaccine suspended as rare blood clotting disorder appears to be associated with the vaccine

The US Food and Drug Administration (FDA) and the US Centers for Disease Control and Prevention (CDC) issued a joint statement recommending a temporary pause of the use of the Johnson and Johnson COVID-19 vaccine. This joint statement was issued on April 13, 2021, and resulted in immediate suspension of the vaccine by federal health systems while recommending the same for state health entities.

The temporary pause was issued due to six known cases of rare blood clotting disorders that appeared to be associated with the use of the vaccine. The AstraZeneca vaccine, which has not yet gained regulatory authorization in the United States and uses technology similar to the Johnson and Johnson vaccine, has been phased or suspended in much of Europe due to similar concerns.

“CDC will convene a meeting of the Advisory Committee on Immunization Practices (ACIP) on [April 14] to further review these cases and assess their potential significance,” Anne Schuchat, MD, Principal Deputy Director of the CDC, and Peter Marks, MD, PhD, Director of the FDAs Center for Biologics Evaluation and Research, said in a joint statement. “FDA will review that 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 health care 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 CDC’s ACIP meeting did not result in an immediate decision, and evaluation of the Johnson and Johnson COVID-19 vaccine continues.

Related Resources: