European Safety Analysis of mRNA and Viral Vector COVID-19 Vaccines on Glucose Metabolism Events

被引:10
|
作者
di Mauro, Gabriella [1 ,2 ]
Mascolo, Annamaria [1 ,2 ]
Longo, Miriam [3 ,4 ]
Maiorino, Maria Ida [3 ,4 ]
Scappaticcio, Lorenzo [3 ]
Bellastella, Giuseppe [3 ,4 ]
Esposito, Katherine [3 ,4 ]
Capuano, Annalisa [1 ,2 ]
机构
[1] Campania Reg Ctr Pharmacovigilance & Pharmacoepid, I-80138 Naples, Italy
[2] Univ Campania Luigi Vanvitelli, Dept Expt Med, Sect Pharmacol L Donatelli, I-80138 Naples, Italy
[3] Univ Campania Luigi Vanvitelli, Dept Adv Med & Surg Sci, I-80138 Naples, Italy
[4] Univ Campania Luigi Vanvitelli, Div Endocrinol & Metab Dis, I-80138 Naples, Italy
关键词
COVID-19; vaccines; diabetes mellitus; glucose metabolism events; safety; Europe; VACCINATION; TYPE-1;
D O I
10.3390/ph15060677
中图分类号
R914 [药物化学];
学科分类号
100701 ;
摘要
Few data have been published on the effects of impaired glucose metabolism induced by COVID-19 vaccines. We decided to perform a study to describe Individual Case Safety Reports (ICSRs) of impaired glucose metabolism events reported in the European database (Eudravigilance, EV). IC-SRs were retrieved from the online website of Eudravigilance. The reporting odds ratios (ROR) were computed to assess the reporting frequency for COVID-19 mRNA vaccines compared to COVID-19 viral vector-based vaccines. A total of 3917 ICSRs with a COVID-19 vaccine suspected were retrieved, with a total of 4275 impaired glucose metabolism events. Overall, the most reported events were related to "high glucose levels" (2012; 47.06%). The mRNA vaccines were associated with an increased reporting frequency of "type 1 diabetes mellitus" (ROR 1.86; 95% CI 1.33-2.60), "type 2 diabetes mellitus" (ROR 1.58; 95% CI 1.03-2.42), "high glucose levels" (ROR 1.16; 95% CI 1.06-1.27), "diabetes mellitus inadequate control" (ROR 1.63; 95% CI 1.25-2.11), and "hypoglycemia" (ROR 1.62; 95% CI 1.41-1.86) compared to viral vector-based vaccines. mRNA COVID-19 vaccines were associated with an increased reporting frequency of alterations of glucose homeostasis compared to viral-vector COVID-19 vaccines. Clinicians should be aware of these events to better manage glycemic perturbations. Larger nationwide studies are warranted to verify these findings.
引用
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页数:12
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