ArticleHaemophilia : the official journal of the World Federation of Hemophilia
Acquired Haemophilia A and COVID-19 mRNA Vaccine Tozinameran: Analysis of Cases Registered in the French PharmacoVigilance Database.
Article in Haemophilia : the official journal of the World Federation of Hemophilia. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
backgroundAcquired 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.
objectivesTo investigate the potential signal for AHA following tozinameran vaccination by analyzing spontaneous reports recorded in the French Pharmacovigilance Database (FPVD). PATIENTS/
methodsWe conducted pharmacological and medical analyses of AHA cases following tozinameran vaccination registered in the FPVD. A total of 27 cases were included.
resultsAHA 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.
conclusionsThis study supports a potential AHA signal with tozinameran, emphasizing the need for awareness among healthcare professionals.
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