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Pause Lifted on Johnson & Johnson COVID-19 Vaccine Use

Reports of adverse events following use of the Janssen COVID-19 Vaccine under emergency use authorization suggest an increased risk of thrombosis involving the cerebral venous sinuses and other sites(including but not limited to the large blood vessels of the abdomen and the veins of the lower extremities) combined with thrombocytopenia and with onset of symptoms approximately one to two weeks after vaccination.1

Most cases of thrombosis with thrombocytopenia reported following the Janssen COVID-19 Vaccine have occurred in females ages 18 through 49 years; some have been fatal. The clinical course of these events shares features with autoimmune heparin-induced thrombocytopenia. In individuals with suspected thrombosis with thrombocytopenia following the Janssen COVID-19 Vaccine, the use of heparin may be harmful and alternative treatments may be needed. Consultation with hematology specialists is strongly recommended.1

During the pause, medical and scientific teams at the FDA and CDC examined available data to assess the risk of thrombosis involving the cerebral venous sinuses, or CVST (large blood vessels in the brain), and other sites in the body (including but not limited to the large blood vessels of the abdomen and the veins of the legs) along with thrombocytopenia, or low blood platelet counts. The teams at FDA and CDC also conducted extensive outreach to providers and clinicians to ensure they were made aware of the potential for these adverse events and could properly manage and recognize these events due to the unique treatment required for these blood clots and low platelets, also known as thrombosis-thrombocytopenia syndrome (TTS).1

As described in the Indian Health Manual, report all significant or unusual Adverse Vaccine Events (AVE) to the VAERS program.

Instructions for reporting can be found online at the NPTC Pharmacovigilance website. Please ensure that you document "IHS" in field #26 of the form.

References

  1. FDA and CDC Lift Recommended Pause on Johnson & Johnson (Janssen) COVID-19 Vaccine Use Following Thorough Safety Review Exit Disclaimer: You Are Leaving www.ihs.gov  (CDC website).
  2. Janssen COVID-19 Vaccine Fact Sheet for Healthcare Providers Administering Vaccine Exit Disclaimer: You Are Leaving www.ihs.gov  (FDA website).
  3. Advisory Committee on Immunization Practices (ACIP) Exit Disclaimer: You Are Leaving www.ihs.gov . ACIP Presentation Sides. Retrieved April 23, 2021 from CDC website.