FDA Recommends Pausing Use of J&J COVID-19 Vaccine After Reports of Blood Clots

FDA and the Centers for Disease Control (CDC) announced on April 13, 2021 that they are evaluating six cases in the United States of a rare and severe type of blood clot, cerebral venous sinus thrombosis (CVST), that occurred in women after they received the Johnson & Johnson (J&J) vaccine. The CVST clot was seen in combination with low levels of blood platelets and occurred in women ages 18–48. The symptoms appeared 6–13 days after vaccination.

CDC’s Advisory Committee on Immunization Practices (ACIP) will hold a meeting on Wednesday, April 14, 2021 to review the cases. FDA will then review the CDC analysis as a part of its investigation into the matter. “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,” FDA stated in a press release.

FDA’s decision to pause the use of the J&J vaccine is cautionary, stating the rarity of the adverse events. The agency recommends, however, that anyone who develop severe headache, abdominal pain, leg pain, or shortness of breath within three weeks of the J&J COVID-19 vaccination contact their health care provider.