To: Residential care facilities (Nursing Homes, Assisted Living Facilities, Group Homes, and Intermediate Care Facilities)
From: HFEMS Residential Care Strike Team
Key points
- The FDA and CDC have recommended pausing the use of the Johnson & Johnson (Janssen, J&J) vaccine while they investigate reports of a rare and severe type of clotting syndrome in combination with low platelets (thrombotic thrombocytopenia) in six women, each reported between six to 13 days after J&J vaccination.
- Out of an abundance of caution, the Colorado Department of Public Health and Environment (CDPHE) and the Colorado Joint Vaccine Task Force have directed providers to temporarily pause use of the J&J COVID-19 vaccine.
- Similar rare reports of a thrombotic thrombocytopenic clotting syndrome have been reported in Europe with the AstraZeneca (AZ) vaccine, which uses similar adenovirus-vector DNA-based technology but is not authorized for use in the U.S. The rare syndrome appears similar to heparin-induced thrombocytopenia (HIT).
- Health care providers should maintain a high index of suspicion for symptoms that might represent serious thrombotic events or thrombocytopenia in patients who have recently received the J&J COVID-19 vaccine (or the AZ vaccine in travelers from outside the U.S.) and obtain testing when indicated as recommended below. Clinicians should also be aware that these patients should not be treated with heparin.
- This syndrome has not been observed with the mRNA vaccines (Pfizer, Moderna). The recommended pause in administration of the J&J vaccine does not affect administration of these mRNA vaccines. Health care providers are required to report adverse events to the Vaccine Adverse Event Reporting System at https://vaers.hhs.gov/reportevent.html.
- In addition to reporting to VAERS, CDPHE also requires that health care providers report blood clot events following COVID-19 vaccination directly to the state using this secure, HIPAA-compliant REDCap form: https://redcap.link/9ytrvg22. Health care providers can contact 303-692-2700 with questions.
As of April 12, 2021, approximately 6.85 million doses of the Johnson & Johnson (J&J) COVID-19 vaccine (Janssen) have been administered in the United States. The Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) are reviewing data involving six U.S. cases of a rare type of blood clot in individuals after receiving the J&J COVID-19 vaccine that were reported to the Vaccine Adverse Events Reporting System (VAERS). In these cases, a type of blood clot called cerebral venous sinus thrombosis (CVST) was seen in combination with low levels of blood platelets (thrombocytopenia). All six cases occurred among women aged 18–48 years. The interval from vaccine receipt to symptom onset ranged from 6–13 days. One patient died. 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. When these specific types of blood clots are observed following J&J COVID-19 vaccination, treatment is different from the treatment that might typically be administered for blood clots. 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), a type of protein. Usually, the anticoagulant drug called heparin is used to treat blood clots. In this setting, the use of heparin may be harmful, and alternative treatments need to be given.
CDC will convene an emergency meeting of the Advisory Committee on Immunization Practices (ACIP) on Wednesday, April 14, 2021, to further review these cases and assess potential implications on vaccine policy. FDA will review that analysis as it also investigates these cases. Until that process is complete, CDC and FDA are recommending a pause in the use of the J&J COVID-19 vaccine out of an abundance of caution. The purpose of this Health Alert is, in part, to ensure that the healthcare provider community is aware of the potential for these adverse events and can provide proper management due to the unique treatment required with this type of blood clot.
Recommendations For Clinicians
- Pause the use of the J&J COVID-19 vaccine until the ACIP is able to further review these CVST cases in the context of thrombocytopenia and assess their potential significance. (NOTE: This pause is required by CDPHE for vaccine providers in Colorado)
- 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, including severe headache, backache, new neurologic symptoms, severe abdominal pain, shortness of breath, leg swelling, petechiae (tiny red spots on the skin), or new or easy bruising. Obtain platelet counts and screen for evidence of immune thrombotic thrombocytopenia.
- In patients with a thrombotic event and thrombocytopenia after the J&J COVID-19 vaccine, evaluate initially with a screening PF4 enzyme-linked immunosorbent (ELISA) assay as would be performed for autoimmune HIT. Consultation with a hematologist is strongly recommended.
- Do not treat patients with thrombotic events and thrombocytopenia following receipt of J&J COVID-19 vaccine with heparin, unless HIT testing is negative.
- If HIT testing is positive or unable to be performed in patient with thrombotic events and thrombocytopenia following receipt of J&J COVID-19 vaccine, non-heparin anticoagulants and high-dose intravenous immune globulin should be strongly considered.
- Report adverse events to VAERS, including serious and life-threatening adverse events and deaths in patients following receipt of COVID-19 vaccines as required under the Emergency Use Authorizations for COVID-19 vaccines.
For Public Health
- Pause the use of the J&J COVID-19 vaccine in public health clinics until the ACIP is able to further review these CVST cases in the context of thrombocytopenia and assess their potential significance.
- Encourage healthcare providers and the public to report all serious and life-threatening adverse events and deaths following receipt of COVID-19 vaccines to VAERS as required under the EUAs for COVID-19 vaccines.
- Disseminate this alert to healthcare providers in your jurisdictions.
For the Public
- If you have received the J&J COVID-19 vaccine and develop severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination, contact your healthcare provider, or seek medical care.
- Report adverse events following receipt of any COVID-19 vaccine to VAERS.
- If you are scheduled to receive the J&J vaccine, please contact your healthcare provider, vaccination location, or clinic to learn about additional vaccine availability.
For More Information:
Additional Resources Provided by CDPHE:
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