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

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). ICSRs were retrieved...

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Main Authors: Gabriella di Mauro, Annamaria Mascolo, Miriam Longo, Maria Ida Maiorino, Lorenzo Scappaticcio, Giuseppe Bellastella, Katherine Esposito, Annalisa Capuano
Format: Article
Language:English
Published: MDPI AG 2022-05-01
Series:Pharmaceuticals
Subjects:
Online Access:https://www.mdpi.com/1424-8247/15/6/677
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author Gabriella di Mauro
Annamaria Mascolo
Miriam Longo
Maria Ida Maiorino
Lorenzo Scappaticcio
Giuseppe Bellastella
Katherine Esposito
Annalisa Capuano
author_facet Gabriella di Mauro
Annamaria Mascolo
Miriam Longo
Maria Ida Maiorino
Lorenzo Scappaticcio
Giuseppe Bellastella
Katherine Esposito
Annalisa Capuano
author_sort Gabriella di Mauro
collection DOAJ
description 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). ICSRs 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.
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spelling doaj.art-fa2a59b8dc2e462495a1f7c89e7ab0762023-11-23T18:26:51ZengMDPI AGPharmaceuticals1424-82472022-05-0115667710.3390/ph15060677European Safety Analysis of mRNA and Viral Vector COVID-19 Vaccines on Glucose Metabolism EventsGabriella di Mauro0Annamaria Mascolo1Miriam Longo2Maria Ida Maiorino3Lorenzo Scappaticcio4Giuseppe Bellastella5Katherine Esposito6Annalisa Capuano7Campania Regional Centre for Pharmacovigilance and Pharmacoepidemiology, 80138 Naples, ItalyCampania Regional Centre for Pharmacovigilance and Pharmacoepidemiology, 80138 Naples, ItalyDepartment of Advanced Medical and Surgical Sciences, University of Campania “Luigi Vanvitelli”, 80138 Naples, ItalyDepartment of Advanced Medical and Surgical Sciences, University of Campania “Luigi Vanvitelli”, 80138 Naples, ItalyDepartment of Advanced Medical and Surgical Sciences, University of Campania “Luigi Vanvitelli”, 80138 Naples, ItalyDepartment of Advanced Medical and Surgical Sciences, University of Campania “Luigi Vanvitelli”, 80138 Naples, ItalyDepartment of Advanced Medical and Surgical Sciences, University of Campania “Luigi Vanvitelli”, 80138 Naples, ItalyCampania Regional Centre for Pharmacovigilance and Pharmacoepidemiology, 80138 Naples, ItalyFew 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). ICSRs 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.https://www.mdpi.com/1424-8247/15/6/677COVID-19 vaccinesdiabetes mellitusglucose metabolism eventssafetyEurope
spellingShingle Gabriella di Mauro
Annamaria Mascolo
Miriam Longo
Maria Ida Maiorino
Lorenzo Scappaticcio
Giuseppe Bellastella
Katherine Esposito
Annalisa Capuano
European Safety Analysis of mRNA and Viral Vector COVID-19 Vaccines on Glucose Metabolism Events
Pharmaceuticals
COVID-19 vaccines
diabetes mellitus
glucose metabolism events
safety
Europe
title European Safety Analysis of mRNA and Viral Vector COVID-19 Vaccines on Glucose Metabolism Events
title_full European Safety Analysis of mRNA and Viral Vector COVID-19 Vaccines on Glucose Metabolism Events
title_fullStr European Safety Analysis of mRNA and Viral Vector COVID-19 Vaccines on Glucose Metabolism Events
title_full_unstemmed European Safety Analysis of mRNA and Viral Vector COVID-19 Vaccines on Glucose Metabolism Events
title_short European Safety Analysis of mRNA and Viral Vector COVID-19 Vaccines on Glucose Metabolism Events
title_sort european safety analysis of mrna and viral vector covid 19 vaccines on glucose metabolism events
topic COVID-19 vaccines
diabetes mellitus
glucose metabolism events
safety
Europe
url https://www.mdpi.com/1424-8247/15/6/677
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