Department of Internal Medicine and Clinical Immunology, Hôpital de La Conception, Assistance Publique-Hôpitaux de Marseille (AP-HM), Marseille, France.
Centre for Cardiovascular and Nutrition Research (C2VN), INRA 1260, INSERM UMR_S1263, Aix-Marseille University, Marseille, France.
Hum Vaccin Immunother. 2024 Dec 31;20(1):2334084. doi: 10.1080/21645515.2024.2334084. Epub 2024 Apr 2.
We conducted a national in-depth analysis including pharmacovigilance reports and clinical study to assess the reporting rate (RR) and to determine the clinical profile of polymyalgia rheumatica (PMR) and giant cell arteritis (GCA) in COVID-19-vaccinated individuals. First, based on the French pharmacovigilance database, we estimated the RR of PMR and GCA cases in individuals aged over 50 who developed their initial symptoms within one month of receiving the BNT162b2 mRNA, mRNA-1273, ChAdOx1 nCoV-19, and Ad26.COV2.S vaccines. We then conducted a nationwide survey to gather clinical profiles, therapeutic management, and follow-up data from individuals registered in the pharmacovigilance study. A total of 70 854 684 COVID-19 vaccine doses were administered to 25 260 485 adults, among which, 179 cases of PMR (RR 7. 1 cases/1 000 000 persons) and 54 cases of GCA (RR 2. 1 cases/1 000 000 persons) have been reported. The nationwide survey allowed the characterization of 60 PMR and 35 GCA cases. Median time to the onset of first symptoms was 10 (range 2-30) and 7 (range 2-25) days for PMR and GCA, respectively. Phenotype, GCA-related ischemic complications and -large vessel vasculitis as well as therapeutic management and follow-up seemed similar according to the number of vaccine shots received and when compared to the literature data of unvaccinated population. Although rare, the short time between immunization and the onset of first symptoms of PMR and GCA suggests a temporal association. Physician should be aware of this potential vaccine-related phenomenon.
我们进行了一项全国性的深入分析,包括药物警戒报告和临床研究,以评估报告率(RR),并确定 COVID-19 疫苗接种者中巨细胞动脉炎(GCA)和多发性肌痛(PMR)的临床特征。首先,根据法国药物警戒数据库,我们估计了在 50 岁以上人群中,在接种 BNT162b2 mRNA、mRNA-1273、ChAdOx1 nCoV-19 和 Ad26.COV2.S 疫苗后一个月内出现首发症状的患者中 PMR 和 GCA 病例的 RR。然后,我们开展了一项全国性调查,收集了药物警戒研究中登记的患者的临床特征、治疗管理和随访数据。共接种了 70854684 剂 COVID-19 疫苗,其中 179 例 PMR(RR 为 7.1 例/100 万例)和 54 例 GCA(RR 为 2.1 例/100 万例)。全国性调查描述了 60 例 PMR 和 35 例 GCA 病例。PMR 和 GCA 的首发症状中位时间分别为 10(范围 2-30)和 7(范围 2-25)天。根据接种疫苗次数和与未接种人群的文献数据相比,表型、与 GCA 相关的缺血性并发症和大血管血管炎以及治疗管理和随访似乎相似。尽管罕见,但 PMR 和 GCA 的首发症状与免疫接种之间的时间间隔较短提示存在时间关联。医生应意识到这种潜在的疫苗相关现象。