Following the discovery of six cases of a rare and severe type of blood clot that developed two weeks after the adminstration of the Johnson and Johnson single-dose vaccine for Coronavirus disease (Covid-19) the U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) has temporarily stopped its use.
In a joint statement issued on Tuesday, the CDC and FDA said: “As of April 12, more than 6.8 million doses of the Johnson & Johnson (Janssen) vaccine have been administered in the U.S.
“CDC and FDA are reviewing data involving six reported U.S. 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).
“All six cases occurred among women between the ages of 18 and 48, and symptoms occurred 6 to 13 days after vaccination.
“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.
“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.
“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.
“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”.