Below is the statement released by the CDC and FDA on April 13 regarding blood clots associated with the Johnson & Johnson Covid-19 vaccine:
Joint CDC and FDA Statement on Johnson & Johnson COVID-19 VaccineThe following statement is attributed to dr. Anne Schuchat, chief deputy director of the CDC, and dr. Peter Marks, director of the FDA’s Center for Biological Evaluation and Research.
On April 12, more than 6.8 million doses of the Johnson & Johnson (Janssen) vaccine were administered in the U.S. CDC and FDA reviewed data related to six reported U.S. cases of a rare and severe type of blood clot in individuals after receipt. of the J&J vaccine. In these cases, a type of blood clot called cerebral venous sinus thrombosis (CVST) has been seen in combination with low platelet counts (thrombocytopenia). All six cases occurred among women between 18 and 48 years of age, and symptoms occurred 6 to 13 days after vaccination. The treatment of this particular type of blood clot differs from the treatment that can usually be administered. Usually an anticoagulant called heparin is used to treat blood clots. In this environment, administration of heparin may be dangerous and alternative treatments should be given.
The CDC will convene a meeting of the Advisory Committee on Immunization Practices (ACIP) on Wednesday to further investigate these issues and assess their potential importance. FDA will review the analysis as it also investigates these matters. Until this process is completed, we recommend that you discontinue the use of this vaccine out of caution. It is partly important to ensure that the healthcare provider community is aware of the potential for these side effects and can plan for proper recognition and management due to the unique treatment required for this type of blood clot.
At the moment, these adverse events seem to be extremely rare. The safety of COVID-19 vaccines is a top priority for the federal government, and we take all reports of health problems after COVID-19 vaccination very seriously. People who have received the J&J vaccine who develop severe headache, abdominal pain, leg pain or shortness of breath within three weeks should contact their healthcare provider. Healthcare providers are asked to report adverse events to the Side Effects Vaccination System at https://vaers.hhs.gov/reportevent.html.
The CDC and FDA will provide additional information and answer questions during a media conference later today. A recording of the media call will be available on the FDA’s YouTube channel.
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US DEPARTMENT OF HEALTH AND HUMAN SERVICES
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