After 6 cases of dangerous blood clots in women who received the Johnson & Johnson Covid-19 vaccine, the FDA has requested a temporary cessation and the CDC is convening the Advisory Committee on Immunization Practices (ACIP) to investigate. The FDA has issued a health warning to women regarding the vaccine, referring to a joint statement from the CDC and FDA that we have fully incorporated below:
CDC-FDA joint statement on Johnson & Johnson's COVID-19 vaccine
The following statement is made to Dr. Peter Marks, Director of the FDA Center for the Evaluation and Research of Biologics, and Dr. Attributed to Anne Schuchat, Deputy Chief Executive Officer of the CDC
As of April 12, more than 6.8 million doses of the Johnson & Johnson (Janssen) vaccine had been administered in the US CDC, and the FDA is reviewing data that included six reported US cases of rare and severe blood clots People after receiving the vaccine will affect J&J vaccine. In these cases, a type of blood clot called cerebral venous sinus thrombosis (CVST) has been seen in combination with low blood platelet levels (thrombocytopenia). All six cases occurred in women between the ages of 18 and 48 years, and symptoms appeared 6 to 13 days after vaccination. Treatment for this specific type of blood clot is different from treatment that can typically be given. Usually an anticoagulant called heparin is used to treat blood clots. In this situation, the administration of heparin can be dangerous and alternative treatments must be given.
The CDC will convene a meeting of the Advisory Committee on Immunization Practices (ACIP) on Wednesday to further review these cases and assess their potential relevance. The FDA will review this analysis as it is investigating these cases as well. Until this process is complete, we recommend taking a break from using this vaccine as a precaution. This is important in part to ensure that the healthcare provider community is aware of the potential of these adverse events and can plan for their proper detection and treatment given the unique treatment that is required with this type of blood clot.
At present, these adverse events appear 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 following COVID-19 vaccination very seriously. People who have received the J&J vaccine and develop severe headache, abdominal pain, leg pain, or shortness of breath within three weeks of vaccination should contact their doctor. Healthcare providers are asked to report adverse events to the Vaccine Adverse Event Reporting System at https://vaers.hhs.gov/reportevent.html.
The CDC and FDA will provide additional information and answer questions at a media briefing later today. An external link disclaimer for this media call is available on the FDA's YouTube channel.
The FDA, an agency of the US Department of Health, protects public health by ensuring the safety, efficacy, and safety of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency is also responsible for the safety of our country's food supplies, cosmetics, dietary supplements, products that emit electronic radiation, and tobacco products regulation.