FDA & CDC Recommend Pausing Administration of Johnson & Johnson COVID-19 Vaccine

Johnson & Johnson COVID-19 Vaccine Authorized For Emergency Use

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, FDA and CDC 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. 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.

The Tennessee Department of Health is acting upon this recent guidance to pause administration of the Johnson & Johnson COVID-19 vaccine.

“Our vaccine supply continues to surpass demand and we do not anticipate this shift will impact our efforts to vaccinate as many Tennesseans as possible. We continue to monitor the situation closely,” the Department of Health writes in a press release.

TDH is taking necessary precautions and is coordinating with its vaccine providers that may have the Johnson & Johnson vaccine in supply to ensure those in the state who are seeking a vaccine have access to vaccines manufactured by Pfizer or Moderna. Both vaccines are highly effective at preventing COVID-19 after 14 days from the second vaccine dose. Both doses are required to achieve the best protection against the virus that causes COVID-19.

Individuals seeking a COVID-19 vaccine appointment can visit covid19.tn.gov or vaccinefinder.org to schedule an appointment with a local vaccine provider.