FDA and CDC are reviewing six cases of a rare and severe type of blood clot
LANSING, MI – Based on recommendations from Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC), the Michigan Department of Health and Human Services is asking that all Michigan providers temporarily pause the administration of Johnson & Johnson (J&J) vaccine in Michigan.
This temporary recommendation is based on the identification of six reported U.S. cases of a rare and severe type of blood clot in individuals after receiving the Johnson & Johnson vaccine. In these cases, a type of blood clot called cerebral venous sinus thrombosis was seen in combination with low levels of blood platelets (thrombocytopenia). These adverse reactions appear to be extremely rare, as more than 6.8 million doses of the Johnson & Johnson vaccine have been administered in the United States as of April 12, with nearly 200,000 of those doses administered in Michigan.
Vaccine providers across the state have been instructed not to administer this vaccine at this time, while the CDC and FDA review further data and assure that clinicians are identifying and reporting any potential adverse reaction. Clinics that are scheduled to administer Johnson & Johnson vaccine will either reschedule or use a different vaccine.
“More than 6.8 million doses of the Johnson & Johnson vaccine have been administered in the U.S., and these adverse events appear to be extremely rare. However, out of an abundance of caution, we are following recommendations from FDA and CDC and pausing the use of the Johnson & Johnson vaccine in Michigan,” said Dr. Joneigh Khaldun, chief medical executive and chief deputy for health. “As we learn more about this from our federal partners, we will update vaccine providers and Michiganders across the state. We encourage everyone to continue making appointments to be vaccinated with the safe and effective Pfizer and Moderna COVID-19 vaccines at this time. These vaccines are the way we are going to end this pandemic as quickly as possible and move toward a sense of normalcy.”
All six cases occurred among women between the ages of 18 and 48, and symptoms occurred six 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 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, CDC and FDA are recommending a pause in the use of this vaccine. 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.
People who have received the Johnson & Johnson 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/reportevent.html.
Safety is the first priority in vaccine authorization or approval. The FDA has authorized the emergency use of COVID-19 vaccines after determining the vaccines meet FDA requirements. All of the authorized COVID-19 vaccines were found to be safe and effective in reducing the risk of severe illness, hospitalizations and death as caused by the virus. A robust process is in place to ensure the safety of any vaccine authorized or approved for use. More information about the safety of the COVID-19 vaccine is available at the CDC Vaccine Benefits website and the CDC Vaccine Safety website.
Michigan residents seeking more information about the COVID-19 vaccine can visit Michigan.gov/COVIDvaccine. Information around this outbreak is changing rapidly. The latest information is available at Michigan.gov/Coronavirus and CDC.gov/Coronavirus.