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Joint CDC and FDA Statement on Johnson & Johnson COVID-19 Vaccine

A rare and critical type of blood clot called cerebral venous sinus thrombosis (CVST) has been detected in combination with low levels of blood platelets (thrombocytopenia) in six women between the ages of 18 and 48, 6 to 13 days after they received doses of the Johnson & Johnson (Janssen) vaccine in the U.S. More than 6.8 million doses of the J&J vaccine have been administered in the U.S. as of April 12 th. In these cases of CVST, the administering of an anticoagulant drug called heparin typically used to treat blood clots may prove dangerous, and alternative treatments are required.

The CDC and FDA are reviewing and analyzing data concerning these six cases following a review of their significance by the Advisory Committee on Immunization Practices (ACIP). As a cautionary measure, the administration of the J&J vaccine has, until the completion of this review, been put on hold. This has been done partly in view of ensuring awareness in the health care provider community of these risks, as well as encouraging the planning for their identification and management, considering the unique treatment required for these cases of blood clots.

While these occurrences appear to be extremely rare, the federal government is taking COVID-19 vaccine safety and reports of related health problems seriously. Individuals experiencing severe side effects three weeks after receiving the J&J vaccine are advised to consult their healthcare providers. Additional information provided by the CDC and FDA
during a media, briefing can be found on the FDA’s YouTube channel.

(Source: U.S. FDA, 2021)