CDC, FDA recommend pause for Johnson & Johnson COVID vaccine due to blood clot reports

The U.S. government is recommending a pause in the administration of the single-dose Johnson & Johnson COVID-19 vaccine out of an abundance of caution, and in order to investigate reports of a rare and severe blood clot, the Centers for Disease Control and Prevention and the Food and Drug Administration announced in a joint statement on April 13. More than 6.8 million doses of the J&J vaccine have been administered in the U.S. as of April 12, according to the CDC and FDA.

The CDC and FDA said there are six cases of the rare clot, occurring in women between the ages of 18 and 48, with symptoms occurring 6 to 13 days after they were vaccinated. The clots occurred in veins that drain blood from the brain and occurred along with low platelets, according to The Associated Press.

Shortly after the joint statement, the Indiana State Department of Health announced it would be temporarily removing the J&J vaccine from its clinics. Indiana planned to start a six-day vaccine clinic at the Indianapolis Motor Speedway on April 13. Instead, the clinic will be using the Moderna COVID-19 vaccine, according to The Indianapolis Star.

The University of Indianapolis had planned to use the J&J vaccine as part of a vaccination clinic in partnership with ISDH from April 20-22. The clinic, which was announced on April 7, would have offered 500 doses of the vaccine to students, faculty and staff on a first-come, first-served basis.

In an email to students, faculty and staff on April 13, Vice President for Student and Campus Affairs and Dean of Students Kory Vitangeli said that based on the recommendations of the CDC and the FDA, the university will know more about the clinics next week, and this information will be sent out as soon as possible. 

The J&J vaccine had received an Emergency Use Authorization from the Food and Drug Administration on Feb. 27. The vaccine is allowed to be given to individuals who are 18 years old and older, according to the FDA. 

The CDC announced it will convene a meeting of its Advisory Committee on Immunization Practices on April 14 to further review the case and assess their potential significance, according to the joint statement. The FDA will be reviewing the CDC analysis as it also investigates these cases, according to Anne Schuchat, principal deputy director of the CDC and Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.

“Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution,” Schuchat and Marks said in the joint statement. “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.”

Both the CDC and FDA said that COVID-19 vaccine safety is a top priority for the federal government, and that they take all reports of health problems following COVID-19 vaccination very seriously. Anyone who has received the J&J vaccine and has developed severe headaches, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination should contact their health care provider, according to the joint statement. Health care providers are being asked to report adverse events to the Vaccine Adverse Event Reporting System.

This story will be updated.

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