People who have received the J&J vaccine who develop severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination should contact their health care provider. COVID-19 vaccine safety is a top priority for the federal government, and we take all reports of health problems following COVID-19 vaccination very seriously.
Right now, these adverse events appear to be extremely rare. 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. Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution. FDA will review that analysis as it also investigates these cases. In this setting, administration of heparin may be dangerous, and alternative treatments need to be given.ĬDC will convene a meeting of the Advisory Committee on Immunization Practices (ACIP) on Wednesday to further review these cases and assess their potential significance. Usually, an anticoagulant drug called heparin is used to treat blood clots. Treatment of this specific type of blood clot is different from the treatment that might typically be administered. All six cases occurred among women between the ages of 18 and 48, and symptoms occurred 6 to 13 days after vaccination. 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). cases of a rare and severe type of blood clot in individuals after receiving the J&J vaccine. CDC and FDA are reviewing data involving six reported U.S. Peter Marks, director of the FDA’s Center for Biologics Evaluation and ResearchĪs of April 12, more than 6.8 million doses of the Johnson & Johnson (Janssen ) vaccine have been administered in the U.S. Anne Schuchat, Principal Deputy Director of the CDC, and Dr. The following statement is attributed to Dr. Joint CDC and FDA Statement on Johnson & Johnson COVID-19 Providers should report all adverse events following any vaccination to the Vaccine Adverse Events Reporting System at .ĭSHS will provide updates as they become available. Providers that have or receive the Johnson & Johnson vaccine should continue to store it in the proper conditions. None of the cases of blood clots reported at this time have occurred in Texas, where more than 500,000 doses of the Johnson & Johnson vaccine have been administered.ĭSHS has not been notified of any change in vaccine distribution. People who have received the Johnson & Johnson vaccine who develop severe headache, abdominal pain, leg pain or shortness of breath within three weeks after vaccination should contact their health care provider. Right now, these adverse events appear to be extremely rare and are being further evaluated to ensure vaccine safety. The pause is recommended following reports of blood clots in six individuals 6 to 13 days after receiving the Johnson & Johnson vaccine. News Release, Ap-The Texas Department of State Health Services is asking vaccine providers in Texas to pause all administration of the Johnson & Johnson/Janssen COVID-19 vaccine following today’s recommendation from the Centers for Disease Control and Prevention and the Food and Drug Administration.