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BISMARCK, N.D. — The North Dakota Department of Health (NDDoH) is strongly urging that vaccine providers in the state pause use of the Johnson & Johnson (Janssen) COVID-19 vaccine following a joint statement by the Centers for Disease Control and Prevention (CDC) and Food & Drug Administration (FDA) issued on Tuesday.

“While Janssen use is paused, individuals seeking COVID-19 vaccination should receive Pfizer or Moderna,” said Molly Howell, MPH, NDDoH Immunization Program Director. “Over 180 million doses of the Pfizer and Moderna vaccines have been administered in the United States and the only safety concern that has been identified is anaphylaxis (severe allergic reaction), which is very rare and manageable with immediate treatment. No other concerning safety signals have been associated with either of the mRNA vaccines; vaccination against COVID-19 continues to be safer than risking the disease.”

There are currently no known cases of cerebral venous sinus thrombosis among Janssen COVID-19 vaccine recipients in North Dakota.

Joint CDC and FDA Statement on Johnson & Johnson COVID-19 Vaccine

The following statement is attributed to Dr. Anne Schuchat, Principal Deputy Director of the CDC and Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research

As of April 12, more than 6.8 million doses of the Johnson & Johnson (Janssen) vaccine have been administered in the U.S. CDC and FDA are reviewing data involving six reported U.S. cases of a rare and severe type of blood clot in individuals after receiving 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 among women between the ages of 18 and 48, and symptoms occurred 6 to 13 days after vaccination. Treatment of this specific type of blood clot is different from the treatment that might typically be administered. Usually, an anticoagulant drug called heparin is used to treat blood clots. In this setting, administration of heparin may be dangerous, and alternative treatments need to be given.

CDC will convene a meeting of the Advisory Committee on Immunization Practices (ACIP) on Wednesday to further review these cases and assess their potential significance. FDA will review that analysis as it also investigates these cases. 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.

Right now, these adverse events appear to be extremely rare. COVID-19 vaccine safety 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 who develop severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination should contact their health care provider. Health care providers are asked to report adverse events to the Vaccine Adverse Event Reporting System athttps://vaers.hhs.gov/reportevent.html.

For the most updated and timely information and updates related to COVID-19, visit the NDDoH website at www.health.nd.gov/coronavirus, follow on FacebookTwitter and Instagram and visit the CDC website at www.cdc.gov/coronavirus.  

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