CDC and FDA Recommend Pause in J&J Vaccine

The Centers for Disease Control and Prevention and US Food and Drug Administration is recommending a pause in the use and distribution of the Johnson & Johnson (Janssen) vaccine after six reported US cases of a rare and severe type of blood clot in individuals who had received the vaccine.

In these half dozen cases, a type of blood clot called cerebral venous sinus thrombosis (CVST) was seen in combination with low levels of blood platelets (thrombocytopenia). The CDC reports that all six cases occurred among women between the ages of 18 and 48, and symptoms occurred 6 to 13 days after vaccination.

The CDC will convene a meeting of the Advisory Committee on Immunization Practices (ACIP) on Wednesday to further review these cases and assess their potential significance. The Food and Drug Administration will review that analysis as it also investigates these cases. Until that process is complete, the CDC is 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,” according to a statement issued by Dr. Anne Schuchat, Principal Deputy Director of the CDC and Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.

The CDC advises that treatment of this specific type of blood clot is 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,” said Dr. Schuchat and Dr. Marks.

As of April 12, more than 6.8 million doses of the J&J vaccine have been administered in the US.

“Right now, these adverse events appear to be extremely rare. COVID-19 vaccine safety is a top priority for the federal government, and we take all reports of health problems following COVID-19 vaccination very seriously,” according to the CDC and FDA doctors.

People who have received the J&J vaccine who develop severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination should contact their health care provider. Health care providers are asked to report adverse events to the Vaccine Adverse Event Reporting System at https://vaers.hhs.gov/reportevent.htmlexternal icon.