The Food and Drug Administration and the Centers for Disease Control will stop using the vaccine at federal sites and urge states to do so as well while they investigate safety concerns.
CDC and FDA Joint Statement on the Johnson & Johnson COVID-19 Vaccine
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. The CDC and FDA are reviewing data related to six cases reported in the U.S. - a rare and serious type of blood clot or thrombus reported in people in the United States after they received 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 in women between 18 and 48 years old, and symptoms occurred 6 to 13 days after receiving the vaccine.
Treatment for this specific type of blood clot is different from the treatment normally given. Typically, a blood-thinning medication called heparin is used to treat blood clots. In this case, the administration of heparin can be dangerous and alternative treatments must be administered.
The CDC will convene a meeting of the Advisory Committee on Immunization Practices (ACIP) on Wednesday to further review these cases and evaluate their potential impact. The FDA will review that analysis as it also investigates these cases. Until this process is complete, we recommend pausing the use of this vaccine as a precautionary measure. This is important, in part, to ensure that the healthcare provider community is aware of the potential for these adverse events to occur and can plan for their appropriate recognition and management due to the unique treatment required with this type of blood clot.
At this time, these adverse events appear to be 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 following COVID-19 vaccination very seriously. People who have received the J&J vaccine and develop a severe headache, abdominal pain, leg pain, or difficulty breathing within three weeks of vaccination should contact their healthcare provider. Healthcare providers should report adverse events to the Vaccine Adverse Event Reporting System at https://vaers.hhs.gov/reporteventspan.html.
The CDC and FDA will provide additional information and answer questions later today at a press conference. A recording of that media call will be available on the FDA’s YouTube channel.
The FDA, an agency of the United States Department of Health and Human Services, protects the public health by ensuring the protection, effectiveness, and safety of veterinary and human drugs, vaccines, and other biological products intended for use in humans. humans, as well as medical devices. The agency is also responsible for the protection and safety of our national food supply, cosmetics, dietary supplements, products that emit electronic radiation, as well as the regulation of tobacco products.
WASHINGTON
Federal health agencies on Tuesday called for an immediate pause in the use of Johnson & Johnson’s single-dose coronavirus vaccine after six recipients in the United States developed a rare disorder involving blood clots within two weeks after vaccination, officials briefed on the decision said. .
The six cases were women between 18 and 48 years old.
One woman has died and a second woman in Nebraska has been hospitalized in critical condition, officials said.
Nearly seven million people in the United States have received Johnson & Johnson shots so far, and about nine million more doses have been shipped to states, according to data from the Centers for Disease Control and Prevention.
