VDH pausing administering Johnson & Johnson COVID-19 vaccine as FDA, CDC investigates rare symptoms of blood clots as symptoms from shot
Virginia state health officials are pausing administering Johnson & Johnson COVID-19 vaccines following a CDC and FDA recommendation to temporarily halt administering that vaccine as rare cases of blood clots as side effects are being investigated.
That directive came Tuesday from Virginia State vaccination coordinator Dr. Danny Avula as federal health officials investigate six cases of reported rare blood clots in women who developed those symptoms between 6 to 13 days after the shot was administered.
Below is the full statement from Dr. Danny Avula:
“We are closely monitoring the actions by the federal government to pause all Johnson & Johnson vaccinations while it investigates an extremely rare possible side effect. In Virginia, we will cease all Johnson &Johnson vaccines until this investigation is complete. If you have an upcoming appointment for the Johnson & Johnson vaccine, you will be contacted to reschedule that appointment.
This pause is reassuring in that it demonstrates that the systems that are in place to monitor vaccine safety are working. We look forward to a thorough review by federal health officials. Meantime, we will continue Virginia’s vaccine rollout at this time with the other two authorized vaccines, developed by Pfizer and Moderna.”
You can read the full statement regarding the CDC and FDA recommendation to pause administering the Johnson & Johnson vaccine below:
“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/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.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.”
