 April 14, 2021 www.fda.gov/womens Message from the Associate Commissioner Dear Women's Health Colleagues, We are sharing information from a joint CDC and FDA Statement on Johnson & Johnson COVID-19 Vaccine. 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. Today, CDC will convene a meeting of the Advisory Committee on Immunization Practices (ACIP) 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. Please find the joint statement here and answers to questions from a joint media call with FDA and CDC here. We will continue to share updates with you as they become available. Sincerely Kaveeta P. Vasisht, M.D., Pharm.D. Associate Commissioner for Women's Health
Director, Office of Women's Health | 
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