On February 27, 2021, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the Janssen
COVID-19 (Ad.26.COV2.S)
vaccine (Janssen Biotech, Inc., a Janssen Pharmaceutical company, Johnson & Johnson; New Brunswick, New Jersey), and on February 28, 2021, the Advisory Committee on Immunization Practices (ACIP) issued interim recommendations for its use in persons aged ≥18 years (1,2). On April 13, 2021, CDC and FDA recommended a pause in the use of the Janssen
COVID-19 vaccine after reports of six U.S. cases of cerebral venous
sinus thrombosis (CVST) with
thrombocytopenia, a rare thromboembolic syndrome, among Janssen
COVID-19 vaccine recipients (3). Two emergency ACIP meetings were rapidly convened to review reported cases of
thrombosis with
thrombocytopenia syndrome (TTS) and to consider updated recommendations for use of the Janssen
COVID-19 vaccine in the United States. On April 23, 2021, after a discussion of the benefits and risks of resuming vaccination, ACIP reaffirmed its interim recommendation for use of the Janssen
COVID-19 vaccine in all persons aged ≥18 years under the FDA's EUA, which now includes a warning that rare clotting events might occur after vaccination, primarily among women aged 18-49 years. Patient and provider education about the risk for TTS with the Janssen
COVID-19 vaccine, especially among women aged <50 years, as well as the availability of alternative
COVID-19 vaccines, is required to guide
vaccine decision-making and ensure early recognition and clinical management of TTS.