Type 1 diabetes, COVID-19 vaccines and short-term safety: Subgroup analysis from the global COVAD study.
COVID-19
Type 1 diabetes mellitus
Vaccine
Journal
Journal of diabetes investigation
ISSN: 2040-1124
Titre abrégé: J Diabetes Investig
Pays: Japan
ID NLM: 101520702
Informations de publication
Date de publication:
11 Sep 2023
11 Sep 2023
Historique:
revised:
16
08
2023
received:
15
04
2023
accepted:
20
08
2023
medline:
12
9
2023
pubmed:
12
9
2023
entrez:
12
9
2023
Statut:
aheadofprint
Résumé
Coronavirus disease 2019 (COVID-19) vaccinations have been proven to be generally safe in healthy populations. However, the data on vaccine safety in patients with type 1 diabetes are scarce. This study aimed to evaluate the frequency and severity of short-term (<7-day) adverse vaccination events (AEs) and their risk factors among type 1 diabetes patients. This study analyzed data from the COVID-19 vaccination in Autoimmune Diseases (COVAD) survey database (May to December 2021; 110 collaborators, 94 countries), comparing <7-day COVID-19 vaccine AE among type 1 diabetes patients and healthy controls (HCs). Descriptive statistics; propensity score matching (1:4) using the variables age, sex and ethnicity; and multivariate analyses were carried out. This study analyzed 5,480 completed survey responses. Of all responses, 5,408 were HCs, 72 were type 1 diabetes patients (43 females, 48.0% white European ancestry) and Pfizer was the most administered vaccine (39%). A total of 4,052 (73.9%) respondents had received two vaccine doses. Patients with type 1 diabetes had a comparable risk of injection site pain, minor and major vaccine AEs, as well as associated hospitalizations to HCs. However, type 1 diabetes patients had a higher risk of severe rashes (3% vs 0.4%, OR 8.0, 95% confidence interval 1.7-36), P = 0.007), although reassuringly, these were rare (n = 2 among type 1 diabetes patients). COVID-19 vaccination was safe and well tolerated in patients with type 1 diabetes with similar AE profiles compared with HCs, although severe rashes were more common in type 1 diabetes patients.
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Investigateurs
Elena Nikiphorou
(E)
James B Lilleker
(JB)
Hector Chinoy
(H)
Jessica Day
(J)
Nelly Ziade
(N)
Babur Salim
(B)
Miguel A Saavedra
(MA)
Lorenzo Cavagna
(L)
Marcin Milchert
(M)
Johannes Knitza
(J)
Masataka Kuwana
(M)
Oliver Distler
(O)
Sinan Kardes
(S)
Minchul Kim
(M)
Tamer A Gheita
(TA)
Yogesh Preet Singh
(YP)
Rajiv Ranjan
(R)
Avinash Jain
(A)
Sapan C Pandya
(SC)
Rakesh Kumar Pilania
(RK)
Aman Sharma
(A)
Manesh Manoj M
(M)
Vikas Gupta
(V)
Chengappa G Kavadichanda
(CG)
Pradeepta Sekhar Patro
(PS)
Sajal Ajmani
(S)
Sanat Phatak
(S)
Rudra Prosad Goswami
(RP)
Abhra Chandra Chowdhury
(AC)
Ashish Jacob Mathew
(AJ)
Padnamabha Shenoy
(P)
Ajay Asranna
(A)
Keerthi Talari Bommakanti
(KT)
Anuj Shukla
(A)
Kunal Chandwar
(K)
Vishwesh Agarwal
(V)
Kshitij Jagtap
(K)
Döndü Üsküdar Cansu
(DÜ)
John D Pauling
(JD)
Chris Wincup
(C)
Ashima Makol
(A)
Nicoletta Del Papa
(N)
Gianluca Sambataro
(G)
Atzeni Fabiola
(A)
Marcello Govoni
(M)
Simone Parisi
(S)
Elena Bartoloni Bocci
(EB)
Gian Domenico Sebastiani
(GD)
Enrico Fusaro
(E)
Marco Sebastiani
(M)
Luca Quartuccio
(L)
Franco Franceschini
(F)
Pier Paolo Sainaghi
(PP)
Giovanni Orsolini
(G)
Rossella De Angelis
(R)
Maria Giovanna Danielli
(MG)
Vincenzo Venerito
(V)
Lisa S Traboco
(LS)
Suryo Anggoro Kusumo Wibowo
(SAK)
Jorge Rojas Serrano
(JR)
Ignacio García-De La Torre
(I)
Erick Adrian Zamora Tehozol
(EAZ)
Jesús Loarce-Martos
(J)
Sergio Prieto-González
(S)
Raquel Aranega Gonzalez
(RA)
Akira Yoshida
(A)
Ran Nakashima
(R)
Shinji Sato
(S)
Naoki Kimura
(N)
Yuko Kaneko
(Y)
Stylianos Tomaras
(S)
Margarita Aleksandrovna Gromova
(MA)
Or Aharonov
(O)
Ihsane Hmamouchi
(I)
Leonardo Santos Hoff
(LS)
Margherita Giannini
(M)
François Maurier
(F)
Julien Campagne
(J)
Alain Meyer
(A)
Melinda Nagy-Vincze
(M)
Daman Langguth
(D)
Vidya Limaye
(V)
Merrilee Needham
(M)
Nilesh Srivastav
(N)
Marie Hudson
(M)
Océane Landon-Cardinal
(O)
Syahrul Sazliyana Shaharir
(SS)
Wilmer Gerardo Rojas Zuleta
(WGR)
José António Pereira Silva
(JA)
João Eurico Fonseca
(JE)
Olena Zimba
(O)
Informations de copyright
© 2023 The Authors. Journal of Diabetes Investigation published by Asian Association for the Study of Diabetes (AASD) and John Wiley & Sons Australia, Ltd.
Références
Ahmed AS, Alotaibi WS, Aldubayan MA, et al. Factors affecting the incidence, progression, and severity of COVID-19 in type 1 diabetes mellitus. Biomed Res Int 2021; 2021: 1676914.
Holman N, Knighton P, Kar P, et al. Risk factor or COVID-19-related mortality in people with type 1 and type 2 diabetes in England: a population-based cohort study. Lancet Diabetes Endocrinol 2020; 8: 823-833.
Ebekozien OA, Noor N, Gallagher MP, et al. Type 1 diabetes and COVID-19: preliminary findings from a multicenter surveillance study in the U.S. Diabetes Care 2020; 43: e83-e85.
Wang Y, Duan L, Li M, et al. COVID-19 vaccine hesitancy and associated factors among diabetes patients: a cross-sectional survey in Changzhi, Shanxi, China. Vaccines 2022; 10: 129.
Aldossari KK, Alharbi MB, Alkahtani SM, et al. COVID-19 vaccine hesitancy among patients with diabetes in Saudi Arabia. Diabetes Metab Syndr 2021; 15: 102271.
Scoccimarro D, Panichi L, Ragghianti B, et al. Sars-CoV2 vaccine hesitancy in Italy: a survey on subjects with diabetes. Nutr Metab Cardiovasc Dis 2021; 31: 3243-3246.
Zilbermint M, Demidowich AP. Severe diabetic ketoacidosis after the second dose of mRNA-1273 COVID-19 vaccine. J Diabetes Sci Technol 2022; 16: 248-249.
Wilson C. Vaccine side effects. New Sci 2021; 250: 10.
Gil-Vila A, Ravichandran N, Selva-O'Callaghan A, et al. COVID-19 vaccination in autoimmune diseases (COVAD) study: vaccine safety in idiopathic inflammatory myopathies. Muscle Nerve 2022; 66: 426-437.
Sen P, Gupta L, Lilleker JB, et al. COVID-19 vaccination in autoimmune disease (COVAD) survey protocol. Rheumatol Int 2022; 42: 23-29.
Eysenbach G. Improving the quality of web surveys: the checklist for reporting results of internet E-surveys (CHERRIES). J Med Internet Res 2004; 6: e34.
Gaur PS, Zimba O, Agarwal V, et al. Reporting survey based studies - a primer for authors. J Korean Med Sci 2020; 35: 1-15.
PROMIS, n.d. Available from: https://www.healthmeasures.net/score-and-interpret/interpret-scores/promis Accessed October 20, 2022.
US Centers for Disease Control and Prevention. Possible side effects after getting a COVID-19 vaccine. Published September 28, 2021. Available from: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/expect/after.html Accessed September 29, 2021.
Benedetto U, Head SJ, Angelini GD, et al. Statistical primer: propensity score matching and its alternatives. Eur J Cardiothorac Surg 2018; 53: 1112-1117.
Meo SA, Bukhari IA, Akram J, et al. COVID-19 vaccines: comparison of biological, pharmacological characteristics and adverse effects of Pfizer/BioNTech and Moderna vaccines. Eur Rev Med Pharmacol Sci 2021; 25: 1663-1669.
Modin D, Claggett B, Køber L, et al. Influenza vaccination is associated with reduced cardiovascular mortality in adults with diabetes: a nationwide cohort study. Diabetes Care 2020; 43: 2226-2233.
Gomez CAG, Cosatti M, Coello VVC, et al. Ab1101 prevalence of long covid in rheumatic disease patients: analysis of SAR covid registry. Ann Rheum Dis 2022; 81: 1668-1669.
DiIorio M, Kennedy K, Liew JW, et al. Prolonged COVID-19 symptom duration in people with systemic autoimmune rheumatic diseases: results from the COVID-19 global rheumatology alliance vaccine survey. RMD Open 2022; 8: e002587.
Ganakumar V, Jethwani P, Roy A, et al. Diabetic ketoacidosis (DKA) in type 1 diabetes mellitus (T1DM) temporally related to COVID-19 vaccination. Diabetes Metab Syndr Clin Res Rev 2022; 16: 102371.
Singh A, Khillan R, Mishra Y, et al. The safety profile of COVID-19 vaccinations in the United States. Am J Infect Control 2022; 50: 15-19.
Dicembrini I, Vitale V, Cosentino C, et al. Interstitial glucose monitoring, type 1 diabetes and COVID-19 vaccine: the patient-reported outcomes and vaccine-associated changes in glucose and side effects (PRO-VACS). Acta Diabetol 2022; 59: 435-438.
Sen P, Ravichandran N, Nune A, et al. COVID-19 vaccination-related adverse events among autoimmune disease patients: results from the COVAD study. Rheumatology (Oxford) 2022; 62: 65-76.
Fazal ZZ, Sen P, Joshi M, et al. COVAD survey 2 long-term outcomes: unmet need and protocol. Rheumatol Int 2022; 42: 1-8.
Edwards AE, Vathenen R, Henson SM, et al. Acute hyperglycaemic crisis after vaccination against COVID-19: a case series. Diabet Med 2021; 38: e14631.
Lee HJ, Sajan A, Tomer Y. Hyperglycemic emergencies associated with COVID-19 vaccination: a case series and discussion. J Endocr Soc 2021; 5: bvab141.
D'Onofrio L, Coraggio L, Zurru A, et al. Short-term safety profile of Sars-Cov2 vaccination on glucose control: continuous glucose monitoring data in people with autoimmune diabetes. Diabetes Res Clin Pract 2021; 179: 109022.