On April 13, 2021, CDC and FDA recommended a pauseexternal icon in the use of Janssen COVID-19 Vaccine (Johnson & Johnson) out of an abundance of caution while they review data involving a small number of U.S. reports of cerebral venous sinus thrombosis (CVST) with thrombocytopenia in individuals after receiving Janssen COVID-19 Vaccine. The Advisory Committee on Immunization Practices (ACIP) met on April 14. After hearing additional data on these reports, ACIP agreed that more information is needed before policy recommendations can be made regarding the continued use of the Janssen COVID-19 vaccine. CDC will collect more information and convene another ACIP meeting on April 23 to review any additional scientific evidence.
At this time, the recommended pause supersedes any other recommendations for use of Janssen COVID-19 Vaccine.
Recommendations for clinicians related to the detection, evaluation, proper management, and reporting of cases of CVST with thrombocytopenia after receipt of Janssen COVID-19 Vaccine are outlined in Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Authorized in the United States. These can also be found in CDC’s Health Alert, issued April 13.
If you are a COVID-19 vaccination provider with Janssen COVID-19 Vaccine:
- Mark any Janssen COVID-19 Vaccine in your inventory “Do not use. Awaiting guidance.”
- Continue to store the vaccine in the refrigerator between 2°C and 8°C (36°F and 46°F).
- Continue to monitor and document storage unit temperatures and follow recommended vaccine storage practices.
Find information for COVID-19 vaccination administration, storage and handing, reporting, and patient education for each specific vaccine
The COVID-19 pandemic is changing rapidly and requires different strategies to maintain clinical preventive services, including immunization. Find up-to-date guidance on routine vaccination and clinical practice.
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