As of April 12, more than 6.8 million doses of the Johnson & Johnson (Janssen) vaccine have been administered in the United States.
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.
According to the FDA, 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, the FDA is 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; however, the FDA asks that people who have received the J&J vaccine who develop a severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination 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.
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.
Out of an abundance of caution and upon the recommendation of the CDC and FDA, Gov. Jim Justice has announced that all use of the Johnson & Johnson COVID-19 vaccine in West Virginia will be paused immediately until further notice.
Clinics that are scheduled to use the Johnson & Johnson vaccine will substitute with another COVID-19 vaccine manufacturer as supplies allow.
“The safety of West Virginians is always our first and foremost priority,” Gov. Justice said. “This pause will not impact our ability to continue vaccinating West Virginians, and is exactly the reason why we stood up our Joint Interagency Task Force led by our West Virginia National Guard. They were absolutely ready for this scenario.”
The WV DHHR, through the federal Vaccine Adverse Event Reporting System (VAERS), has not received any reports of these extremely rare blood-clotting events in West Virginia residents who have received the Johnson & Johnson vaccine.
The WV DHHR will continue to monitor for instances going forward.