| アブストラクト | BACKGROUND: Acquired haemophilia A (AHA) is a rare autoimmune bleeding disorder commonly associated with autoimmune disorders, malignancies, infections, pregnancy, and certain medications. During the COVID-19 vaccination campaign, several case reports have documented instances of AHA occurring subsequent to SARS-CoV-2 vaccination. In France, enhanced real-time surveillance for adverse drug reactions (ADRs) associated with tozinameran/BNT162b2 (Pfizer-BioNTech, Comirnaty) identified a potential signal for AHA in April 2021. OBJECTIVES: To investigate the potential signal for AHA following tozinameran vaccination by analyzing spontaneous reports recorded in the French Pharmacovigilance Database (FPVD). PATIENTS/METHODS: We conducted pharmacological and medical analyses of AHA cases following tozinameran vaccination registered in the FPVD. A total of 27 cases were included. RESULTS: AHA typically occurred after the second dose with a median onset of 23 days. The most frequent symptom was spontaneous haematoma. Haemorrhagic syndrome was severe in 19 cases due to associated anaemia. Seventeen patients received anti-haemorrhagic agents, and 23 patients were treated with corticosteroids alone or combined with immunosuppressive agents. The mortality rate was 15%. No alternative etiology for AHA was identified in most cases, despite thorough investigations. Two patients experienced worsening of symptoms after re-exposure to tozinameran. CONCLUSIONS: This study supports a potential AHA signal with tozinameran, emphasizing the need for awareness among healthcare professionals. |
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| ジャーナル名 | Haemophilia : the official journal of the World Federation of Hemophilia |
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| Pubmed追加日 | 2026/5/7 |
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| 投稿者 | Laeng, Marine; Lambert, Aude; Gautier, Sophie; Briet, Marie; Piel-Julian, Marie-Lea; Micallef, Joelle |
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| 組織名 | Regional Pharmacovigilance Center of Marseille, CHU de Marseille - Hopital Sainte;Marguerite, INSERM UMR 1106 Institut de Neurosciences des Systemes, Marseille,;France.;Regional Pharmacovigilance Center of Strasbourg, CHU de Strasbourg - Hopital;Civil, Strasbourg, France.;Regional Pharmacovigilance Center of Lille, CHRU de Lille, Lille, France.;Regional Pharmacovigilance Center of Angers, CHRU de Angers, Angers, France.;Internal Medicine Department, Resource and Competence Center for Congenital;Bleeding Disorders, CHU de Toulouse, Toulouse, France. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/42093355/ |
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