mRNA (BNT162b2) and Inactivated (CoronaVac) COVID-19 Vaccination and Risk of Adverse Events and Acute Diabetic Complications in Patients with Type 2 Diabetes Mellitus: A Population-Based Study

Eric Yuk Fai Wan; Celine Sze Ling Chui; Anna Hoi Ying Mok; Wanchun Xu; Vincent Ka Chun Yan; Francisco Tsz Tsun Lai; Xue Li; Carlos King Ho Wong; Esther Wai Yin Chan; David Tak Wai Lui; Kathryn Choon Beng Tan; Ivan Fan Ngai Hung; Cindy Lo Kuen Lam; Gabriel Matthew Leung; Ian Chi Kei Wong

doi:10.1007/s40264-022-01228-6

mRNA (BNT162b2) and Inactivated (CoronaVac) COVID-19 Vaccination and Risk of Adverse Events and Acute Diabetic Complications in Patients with Type 2 Diabetes Mellitus: A Population-Based Study

Drug Saf. 2022 Dec;45(12):1477-1490. doi: 10.1007/s40264-022-01228-6. Epub 2022 Oct 2.

Authors

Eric Yuk Fai Wan^#^{1

2

3}, Celine Sze Ling Chui^#^{3

4

5}, Anna Hoi Ying Mok², Wanchun Xu², Vincent Ka Chun Yan¹, Francisco Tsz Tsun Lai^{1

3}, Xue Li^{1

3

6}, Carlos King Ho Wong^{1

2

3}, Esther Wai Yin Chan^{1

3

7

8}, David Tak Wai Lui⁶, Kathryn Choon Beng Tan⁶, Ivan Fan Ngai Hung^{6

9}, Cindy Lo Kuen Lam², Gabriel Matthew Leung^{3

5}, Ian Chi Kei Wong^{10

11

12

13

14

15}

Affiliations

¹ Centre for Safe Medication Practice and Research, Department of Pharmacology and Pharmacy, Li Ka Shing Faculty of Medicine, The University of Hong Kong, L2-57, Laboratory Block, 21 Sassoon Road, Pokfulam, Hong Kong Special Administrative Region, China.
² Department of Family Medicine and Primary Care, School of Clinical Medicine, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Pokfulam, Hong Kong Special Administrative Region, China.
³ Laboratory of Data Discovery for Health (D24H), Hong Kong Science and Technology Park, Sha Tin, Hong Kong Special Administrative Region, China.
⁴ School of Nursing, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Pokfulam, Hong Kong Special Administrative Region, China.
⁵ School of Public Health, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Pokfulam, Hong Kong Special Administrative Region, China.
⁶ Department of Medicine, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Pokfulam, Hong Kong Special Administrative Region, China.
⁷ Department of Pharmacy, The University of Hong Kong-Shenzhen Hospital, Shenzhen, China.
⁸ The University of Hong Kong Shenzhen Institute of Research and Innovation, Shenzhen, China.
⁹ Research Department of Practice and Policy, School of Pharmacy, University College London, London, UK.
¹⁰ Centre for Safe Medication Practice and Research, Department of Pharmacology and Pharmacy, Li Ka Shing Faculty of Medicine, The University of Hong Kong, L2-57, Laboratory Block, 21 Sassoon Road, Pokfulam, Hong Kong Special Administrative Region, China. wongick@hku.hk.
¹¹ Laboratory of Data Discovery for Health (D24H), Hong Kong Science and Technology Park, Sha Tin, Hong Kong Special Administrative Region, China. wongick@hku.hk.
¹² Expert Committee on Clinical Events Assessment Following Covid-19 Immunization, Department of Health, The Government of the Hong Kong Special Administrative Region, Pokfulam, Hong Kong Special Administrative Region, China. wongick@hku.hk.
¹³ Research Department of Practice and Policy, School of Pharmacy, University College London, London, UK. wongick@hku.hk.
¹⁴ Aston Pharmacy School, Aston University, Birmingham, UK. wongick@hku.hk.
¹⁵ Department of Pharmacy, The University of Hong Kong-Shenzhen Hospital, Shenzhen, China. wongick@hku.hk.

^# Contributed equally.

Abstract

Introduction: In Hong Kong, CoronaVac and BNT162b2 have been approved for emergency use owing to the coronavirus disease 2019 (COVID-19) pandemic. Reactions towards the vaccine and the risk of post-vaccination adverse events may be different between recipients with and without type 2 diabetes mellitus (T2DM).

Objective: The aim of this study was to evaluate the risk of adverse events of special interest (AESI) and acute diabetic complications in the T2DM population after COVID-19 vaccination in Hong Kong.

Research design and methods: Self-controlled case-series analysis was conducted. Patients with T2DM who received at least one dose of BNT162b2 or CoronaVac between 23 February 2021 and 31 January 2022 from electronic health records in Hong Kong were included. The incidence rates of 29 AESIs and acute diabetic complications (any of severe hypoglycemia, diabetic ketoacidosis or hyperosmolar hyperglycemic syndrome) requiring hospitalization within 21 days after the first or second dose of vaccination were reported. The risks of these outcomes were evaluated using conditional Poisson regression.

Results: Among 141,224 BNT162b2 recipients and 209,739 CoronaVac recipients with T2DM, the incidence per 100,000 doses and incidence per 100,000 person-years of individual AESIs and acute diabetic complications ranged from 0 to 24.4 and 0 to 438.6 in BNT162b2 group, and 0 to 19.5 and 0 to 351.6 in CoronaVac group. We did not observe any significantly increased risk of individual AESIs or acute diabetic complications after first or second doses of BNT162b2 or CoronaVac vaccine. Subgroup analysis based on HbA1c < 7% and ≥ 7% also did not show significantly excess risk after vaccination.

Conclusions: Patients with T2DM do not appear to have higher risks of AESI and acute diabetic complications after BNT162b2 or CoronaVac vaccination. Moreover, given the low incidence of AESIs and acute diabetic complications after vaccination, the absolute risk increment was likely minimal.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

BNT162 Vaccine
COVID-19 Vaccines* / adverse effects
COVID-19* / complications
COVID-19* / epidemiology
Diabetes Complications*
Diabetes Mellitus, Type 2* / complications
Diabetes Mellitus, Type 2* / epidemiology
Humans
RNA, Messenger
Vaccination / adverse effects

Substances

BNT162 Vaccine
COVID-19 Vaccines
RNA, Messenger