There have been a number of misrepresentations made today about what was done; what was said; and who said or did it; in regard to the J&J/Janssen vaccine. A couple of highlighted items in the CDC Reports of cerebral venous sinus thrombosis from the Vaccine Safety Team stand out. These were also contained in the CDC Health Alert published yesterday.
https://emergency.cdc.gov/han/2021/CDC Health Alert Network 00442"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."
In addition to the summary above, specific and important recommendations were made for evaluation, treatment, and reporting for clinicians caring for patients...
RecommendationsFor Clinicians1. 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.
2. 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, 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.
3. 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.
4. Do not treat patients with thrombotic events and thrombocytopenia following receipt of J&J COVID-19 vaccine with heparin, unless HIT testing is negative.
5. 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.
6. 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.