CDC and FDA recommend pause on Johnson & Johnson/Janssen COVID-19 vaccine

The U.S. Centers for Disease Control and Prevention and Food and Drug Administration on April 13 recommended a pause in the administration of the Johnson & Johnson/Janssen COVID-19 vaccine. The agencies have made this move as a precaution to gather more information due to the identification of a rare, but serious potential side effect that has occurred in approximately one per one million vaccine recipients. Accordingly, BJC and Washington University School of Medicine are substituting other vaccines if available or canceling any vaccine clinic appointments using the J&J/J vaccine. 

More than 6.8 million doses of the Johnson & Johnson/Janssen vaccine have been administered in the United States and there have been a total of six reported cases of individuals developing blood clots within two weeks of receiving the vaccine. The clots were reported among women aged 18-48. Some cases have been serious, including one death. It is not yet known if these cases are due to the vaccine. BJC and Washington University will follow the investigation closely and determine our next steps based on the findings and federal recommendations.

Anyone who has received the J&J/J COVID-19 vaccine in the last three weeks should pay close attention to potential side effects including:

  • Headache
  • Shortness of breath
  • Leg pain/swelling
  • Abdominal pain 

Individuals who have received the Johnson & Johnson/Janssen vaccine within the last three weeks who develop such symptoms should contact their health care provider. Patients with other clinical questions should contact their health care provider or can call the Missouri COVID-19 hotline at 877-435-8411.

BJC and Washington University will provide updates when more information becomes available. See the joint CDC/FDA statement here.