After 6 cases of dangerous blood clots in women who received the Johnson & Johnson Covid-19 vaccine, the FDA has called for a temporary halt and the CDC is convening the Advisory Committee on Immunization Practices (ACIP) to investigate. The FDA has issued a health warning to women about the vaccine, referring to a joint CDC / FDA statement which we have included in full below:
Joint CDC and FDA statement on the Johnson & Johnson COVID-19 vaccine
The following statement is attributed to Dr. Peter Marks, director of the FDA’s Center for Biological Product Evaluation and Research, and Dr. Anne Schuchat, senior deputy director of the CDC.
As of April 12, more than 6.8 million doses of the Johnson & Johnson (Janssen) vaccine have been administered to the U.S. CDC and the FDA is reviewing data on six reported cases in the U.S. of a type of rare and severe 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 observed in combination with low levels of blood platelets (thrombocytopenia). All six cases occurred in women aged 18 to 48 years and symptoms occurred 6 to 13 days after vaccination. The treatment of this specific type of blood clot is different from the treatment that can normally be given. Typically, an anticoagulant drug called heparin is used to treat blood clots. In this context, the administration of heparin can be dangerous and alternative treatments need to be done.
The CDC will convene a meeting of the Advisory Committee on Immunization Practices (ACIP) on Wednesday to review these cases and assess their potential importance. The FDA will review this analysis as it also investigates these cases. Until this process is complete, we recommend a pause in the use of this vaccine with great caution. This is important, in part, to ensure that the medical provider community is aware of the potential for these adverse events and can plan for appropriate recognition and management due to the unique treatment required with this type of blood clot.
Right now, these adverse events seem extremely rare. The safety of the COVID-19 vaccine is a top priority for the federal government and we take all reports of health problems after the COVID-19 vaccination very seriously. People who have received the J&J vaccine and who have severe headache, abdominal pain, leg pain, or shortness of breath three weeks after vaccination should contact their doctor. Healthcare providers are asked to report adverse events to the vaccine adverse event information system at https://vaers.hhs.gov/reportevent.html.
CDC and FDA will provide additional information and answer questions later today in a media briefing. A recording Exemption from liability for external link of this multimedia call is available on the FDA’s YouTube channel.
The FDA, an agency of the U.S. Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and security of human and veterinary drugs, vaccines, and other biological products for human use and medical devices. The agency is also responsible for the security of our nation’s food supply, cosmetics, dietary supplements, products that emit electronic radiation, and the regulation of tobacco products.