April 14, 2021 | www.nihb.org
SPECIAL UPDATE FOR INDIAN COUNTRY
Announcement of Pause in Use of Johnson & Johnson/Janssen Vaccine
Yesterday, the Centers for Disease Control and Prevention (CDC) and Food and Drug Administration recommended that all hospitals, clinics, and other providers sites, including Indian Health Service (IHS) and Tribal health facilities and clinics, pause the use of the Johnson & Johnson’s Janssen COVID-19 vaccine due to reports of adverse events. In the United States, there have been six reported cases of a rare and severe type of blood clot known as cerebral venous sinus thrombosis (CVST) along with low levels of blood platelets (thrombocytopenia). These cases have only been observed in women between ages 18 and 48 with symptoms beginning six to 13 days after receiving the J&J/Janssen vaccination. 

The Indian Health Service has confirmed that they will follow this guidance. IHS has three vaccine safety monitoring systems in place. To date, there have been no reported cases of the rare and severe type of blood clot seen in some individuals who have received the Johnson & Johnson/Janssen vaccine.  
By recommendation of the CDC and FDA, IHS and Tribal health facilities and clinics are advised to implement the following guidance until further notice:

  1. Stop or discontinue administering the J&J/Janssen vaccine until further notice.
  2. All J&J/Janssen doses delivered to provider sites today, April 13, should be received, inspected, and stored.
  3. Existing J&J/Janssen inventory at enrolled provider sites should be labeled “Do not use. Awaiting guidance.” and stored between 2°C and 8°C (36°F and 46°F)..
  4. Follow CDC vaccine storage practices and continue to monitor and document storage unit temperatures.
  5. Unfilled orders for J&J/Janssen submitted prior to April 13 will be held until further notice.
  6. No new orders for J&J/Janssen will be accepted at this time.
For Tribal community members and patients:

  1. For those who received the J&J COVID-19 vaccine and develop severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination, should contact a healthcare provider, or seek medical care. If you are unsure which vaccine you have received, please consult your vaccination card or contact your provider.
  2. For those who are scheduled to receive the J&J vaccine, please contact the healthcare provider, vaccination location, or clinic to learn about additional vaccine availability.
Continue to monitor the Centers for Disease Control and Prevention website for updated information and guidance on the J&J/Janssen COVID-19 vaccine.
 
Additional resources:
 

For Questions, please contact Tyler Dougherty, Director of Public Health Policy and Programs at tdougherty@nihb.org.
National Indian Health Board | www.nihb.org | 202-507-4070
Visit the NIHB COVID-19 Tribal Resource Center at:

Reach the NIHB COVID-19 Response Team, contact cwheeler@nihb.org
For media inquiries, contact April Hale at ahale@nihb.org