The COVID-19 pandemic poses unprecedented challenges to the health care community. The Anticoagulation Forum is fully committed to providing clinicians with the most current, relevant, and actionable information available. This AC Forum notice has been produced to provide time- sensitive information important to COVID-19 response efforts.
Following six reported cases of cerebral venous sinus thrombosis (CVST) in individuals after receiving the Johnson & Johnson (J&J) COVID-19 vaccine in the US, the CDC and FDA are recommending a pause in the use of the J&J COVID-19 vaccine pending further review.
Per the CDC Health Alert April 13, 2021 1pm:
- As of April 12, 2021, approximately 6.85 million doses of the J&J COVID-19 vaccine have been administered in the US
- The CDC and FDA are reviewing data six US cases of CVST in individuals after receiving the J&J COVID-19 vaccine. One patient died.
- In these cases, CVST was seen in combination with thrombocytopenia
- All six cases occurred among women aged 18–48 years
- The interval from vaccine receipt to symptom onset ranged from 6-13 days
- Providers should maintain a high index of suspension for symptoms that might represent serious thrombotic events or thrombocytopenia in patients who have recently received the J&J COVID-19 vaccine
- Based on studies conducted among the patients diagnosed with immune thrombotic thrombocytopenia after the AstraZeneca COVID-19 vaccine in Europe, the pathogenesis of these rare and unusual adverse events after vaccination may be associated with platelet-activating antibodies against platelet factor-4 (PF4)
- In this setting, the use of heparin may be harmful, and alternative treatments need to be given (see links to clinical pathways below in ‘Information for Clinicians’)
- On April 13, 2021, the CDC and FDA recommend a pause in the use of the J&J COVID- 19 vaccine out of an abundance of caution.
- The CDC’s Advisory Committee on Immunization Practices (ACIP) has suggested extension of this pause for at least another week as they continue review the data.
To access the complete CDC Health Alert visit: https://emergency.cdc.gov/han/2021/han00442.asp
Additional CDC COVID-19 resources are available at: https://www.cdc.gov/coronavirus/2019-ncov/index.html
INFORMATION FOR CLINICIANS
While evidence regarding the incidence and treatment of thrombosis associated with the J&J COVID-19 vaccine is still preliminary and the situation continues to be quite fluid, similarities exist between reports of thrombosis with the Astra Zeneca COVID-19 vaccine currently in use outside of the US. Clinical recommendations for the identification and treatment of such cases may therefore be informative for clinicians until more definitive guidance becomes available. Available resources include, but are not limited to:
Interim guidance from ISTH for the Diagnosis and Treatment on Vaccine Induced Immune Thrombotic Thrombocytopenia (Updated 20 April, 2021) including diagnostic flow chart:
Guidance produced from the Expert Haematology Panel (EHP, UK) focused on COVID-19 Vaccine induced Thrombosis and Thrombocytopenia (VITT) (Version 1.3; April 7, 2021; Document updated frequently)