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FDA Continues Important Steps to Ensure Quality, Safety and Effectiveness of Authorized COVID-19 Vaccines
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FDA Continues Important Steps to Ensure Quality, Safety and Effectiveness of Authorized COVID-19 Vaccines
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FDA Media Briefing: Janssen COVID-19 Vaccine | CDC Online Newsroom
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SILVER SPRING, Md., April 13, 2021 /PRNewswire/
The following statement is attributed to Dr. Peter Marks, director of the FDA s Center for Biologics Evaluation and Research and Dr. Anne Schuchat, Principal Deputy Director of the CDC
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 blo
Joint CDC and FDA Statement on Johnson & Johnson COVID-19 Vaccine
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