![]() Both vaccines contain replication-incompetent adenoviral vectors (human for J&J and chimpanzee for AstraZeneca) that encode the spike glycoprotein of SARS-CoV-2, the virus that causes COVID-19. These reports following the J&J COVID-19 vaccine are similar to reports of thrombotic events with thrombocytopenia after receipt of the AstraZeneca COVID-19 vaccine in Europe. To date, VAERS has received no reports of CVST with thrombocytopenia among persons who received either of the two mRNA-based COVID-19 vaccines. The Clinical Immunization Safety Assessment (CISA) project which includes experts in infectious disease and hematology are also reviewing these cases. ![]() All data presented in this HAN are preliminary and investigations of these VAERS reports are ongoing. Four patients developed intraparenchymal brain hemorrhage and one subsequently died. Unusual for patients presenting with thrombotic events, all six patients showed evidence of thrombocytopenia (<150,000 platelets per microliter of blood), consistent with a condition known as thrombotic thrombocytopenia, with platelet nadir counts ranging from 10,000 to 127,000 during their hospitalizations. All were eventually diagnosed with CVST by intracranial imaging two patients were also diagnosed with splanchnic* and portal vein thrombosis. The median days from vaccination to hospital admission was 15 days (range = 10–17 days). Four developed focal neurological symptoms (focal weakness, aphasia, visual disturbance) prompting presentation for emergency care. One patient also had abdominal pain, nausea, and vomiting. Initial presenting symptoms were notable for headache in five of six patients, and back pain in the sixth who subsequently developed a headache. ![]() The six patients (after 6.85 million vaccine doses administered) described in these VAERS reports came to attention in the latter half of March and early April of 2021 and developed symptoms a median of 9 days (range = 6–13 days) after receiving the J&J COVID-19 vaccine. VAERS is a national passive surveillance system jointly managed by CDC and FDA that monitors adverse events after vaccinations. 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. 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. FDA will review that analysis as it also investigates these cases. In this setting, the use of heparin may be harmful, and alternative treatments need to be given.ĬDC 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. Usually, the anticoagulant drug called heparin is used to treat 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. 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. 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. The interval from vaccine receipt to symptom onset ranged from 6–13 days. All six cases occurred among women aged 18–48 years. 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). 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 Event Reporting System (VAERS). Food and Drug Administration (FDA) are reviewing data involving six U.S. ![]() The Centers for Disease Control and Prevention (CDC) and the U.S. Distributed via the CDC Health Alert NetworkĪs 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. ![]()
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