Federal health officials on Tuesday called for a pause in the use of Johnson & Johnson's (J&J) single-dose coronavirus vaccine “out of an abundance of caution.”
The recommendation, issued in a joint statement by the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA), comes as the agencies review six cases of a rare but serious type of blood clot, called cerebral venous sinus thrombosis, in individuals after receiving the J&J vaccine. As of April 12, more than 6.8 million doses of the one-shot vaccine have been administered in the U.S.
All six cases occurred in women between the ages of 18 and 48, the agencies said, and symptoms developed six to 13 days after vaccination. One case was fatal, and one person is in critical condition, Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, confirmed during a media briefing.
When to See Your Doctor
Seek medical attention if within three weeks of receiving the J&J vaccine you experience:
- Severe headache
- Abdominal pain
- Leg pain
- Shortness of breath
Blood clot requires unique treatment
The CDC will convene a meeting of its vaccine advisory committee on April 14 to review the cases “and assess their potential significance.” The FDA will also conduct an investigation, and both agencies are recommending that states halt the vaccine's use until the process is complete.
"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,” Anne Schuchat, principal deputy director of the CDC, and the FDA's Marks said in the joint statement.
Blood clots are commonly treated with heparin, an anticoagulant drug often referred to as a blood thinner. A big reason for the J&J pause: Cerebral venous sinus thrombosis can require a different treatment approach. “In this setting, administration of heparin may be dangerous, and alternative treatments need to be given,” Schuchat and Marks said.