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# FDA,CDC Urge Pause in J&J Vaccination
- URL: https://www.fdaweb.com/fda-cdc-urge-pause-in-j-j-vaccination/
- Published: 2021-04-13T12:00:00.000Z
- Updated: 2026-09-14T16:54:45.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5149093

FDA and CDC are recommending a pause in using the Johnson & Johnson (Janssen) Covid-19 vaccine due to concerns about potential blood clots in those getting the vaccine. So far, almost 7 million vaccines have been administered in the U.S. and six cerebral venous sinus thrombosis cases have been reported, according to an [FDA release](https://www.fda.gov/news-events/press-announcements/joint-cdc-and-fda-statement-johnson-johnson-covid-19-vaccine?ref=fdaweb.com). All six occurred among women between the ages of 18 and 48, and symptoms occurred six to 13 days after vaccination. One vaccine recipient died and another is in critical condition, FDA says, adding that treatment with the blood thinner heparin could be dangerous and instead alternative treatments should used.

CDC 4/14 is holding an Advisory Committee on Immunization Practices meeting to further review these cases and assess their potential significance. “FDA will review that analysis as it also investigates these cases,” the release says. “Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution. 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.”

The two health agencies acknowledge that the blood clots are “extremely rare.” They also caution that those receiving the vaccine who develop severe headache, abdominal pain, leg pain, or shortness of breath within three weeks should contact their health care provider.

Johnson & Johnson says it has been reviewing the cases with European health authorities. “We have made the decision to proactively delay the rollout of our vaccine in Europe,” it adds.