J&J/Janssen COVID vaccine

Today, CDC and FDA recommended a pause in the use of Johnson & Johnson's Janssen COVID-19 vaccine due to reports of adverse events. Pending further notice, the following operational guidance should be implemented:

1. Approximately 220,000 J&J/Janssen doses will be delivered today, Tuesday, April 13, as scheduled. Please receive, inspect, and store these deliveries.
2. Existing J&J/Janssen inventory at your enrolled provider sites should be held between 2°C and 8°C (36°F and 46°F) and labeled “Do not use. Awaiting guidance.”.
3. Follow vaccine storage practices and continue to monitor and document storage unit temperatures.
4. Unfilled orders for J&J/Janssen submitted prior to this guidance will be held until further notice.
5. No new orders for J&J/Janssen will be accepted at this time.
6. No J&J/Janssen doses should be administered at this time.

 

As a COVID-19 Vaccination Provider with Janssen (Johnson & Johnson) vaccine, please immediately implement the following CDC operational guidance until further notice:

 

1. Mark any Janssen/J&J vaccine in your inventory “Do not use. Awaiting guidance.”
2. Continue to store the vaccine in the refrigerator between 2°C and 8°C (36°F and 46°F).
3. Follow vaccine storage practices and continue to monitor and document storage unit temperatures.

 

Thank you in advance for your cooperation. Further guidance will be made available after CDC’s Advisory Committee on Immunization Practices (ACIP) meets on Wednesday, April 14.

 

Additional resources:

 

• Joint CDC and FDA Statement on Johnson & Johnson COVID-19 Vaccine
• Joint Media Call: FDA & CDC to Discuss Janssen COVID-19 Vaccine
• Virtual emergency ACIP meeting will be held on April 14, 2021, 1:30 p.m. to 4:30 p.m. ET
• Webcast: Advisory Committee on Immunization Practices- ACIP (ustream.tv)
• Latest News from CDC’s Health Alert Network