TOPEKA – The Kansas Department of Health and Environment (KDHE) announces that Kansas will pause administration of the Johnson & Johnson (Janssen) COVID-19 vaccine following an announcement from the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) this morning. There are reports of six recipients in the United States who developed a rare disorder involving blood clots within about two weeks of vaccination. No known cases have been reported in Kansas to date.
“Just as important as getting vaccines into arms — is making sure those vaccines are safe,” Governor Laura Kelly said. “While this appears to have affected six people in the nearly seven million doses administered, out of an abundance of caution, Kansas will suspend Johnson and Johnson until the CDC and FDA clear it for use again. In the meantime, we anticipate our shipments of Pfizer and Moderna to continue and we will build on the one-third of Kansans who have already received their first dose of the COVID-19 vaccine.”
The federal government will further study links between the vaccine and the rare blood clotting disorder. An emergency meeting of the CDC’s advisory committee has been scheduled for Wednesday.
KDHE asks providers with Johnson & Johnson vaccine to pause administration of the vaccine immediately and to place the supply into storage while material is reviewed. After KDHE has reviewed the findings from the federal government, further guidance will be given to providers on next steps.
Those who have received the Johnson & Johnson vaccine should contact their health care provider if they have any symptoms and report any illness to the VAERS Reporting System, https://vaers.hhs.gov.
The week of April 19th, Kansas is anticipated to receive the following doses:
- 39,780 Pfizer Prime
- 38,610 Pfizer Boost
- 29,000 Moderna Prime
- 27,800 Moderna Boost
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 at https://vaers.hhs.gov/
CDC and FDA will provide additional information and answer questions later today at a media briefing. A recording of that media call will be available on the FDA’s YouTube channel.