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. 2022 Jun:130:102830.
doi: 10.1016/j.jaut.2022.102830. Epub 2022 Apr 14.

Autoimmune conditions following mRNA (BNT162b2) and inactivated (CoronaVac) COVID-19 vaccination: A descriptive cohort study among 1.1 million vaccinated people in Hong Kong

Xue Li  1 , Le Gao  2 , Xinning Tong  3 , Vivien K Y Chan  2 , Celine S L Chui  4 , Francisco T T Lai  5 , Carlos K H Wong  6 , Eric Y F Wan  7 , Esther W Y Chan  5 , Kui Kai Lau  8 , Chak Sing Lau  3 , Ian C K Wong  9
Affiliations

Autoimmune conditions following mRNA (BNT162b2) and inactivated (CoronaVac) COVID-19 vaccination: A descriptive cohort study among 1.1 million vaccinated people in Hong Kong

Xue Li et al. J Autoimmun. 2022 Jun.

Abstract

Background: Concerns regarding the autoimmune safety of COVID-19 vaccines may negatively impact vaccine uptake. We aimed to describe the incidence of autoimmune conditions following BNT162b2 and CoronaVac vaccination and compare these with age-standardized incidence rates in non-vaccinated individuals.

Methods: This is a descriptive cohort study conducted in public healthcare service settings. Territory-wide longitudinal electronic medical records of Hong Kong Hospital Authority users (≥16 years) were linked with COVID-19 vaccination records between February 23, 2021 and June 30, 2021. We classified participants into first/second dose BNT162b2 groups, first/second dose CoronaVac groups and non-vaccinated individuals for incidence comparison. The study outcomes include hospitalized autoimmune diseases (16 types of immune-mediated diseases across six body systems) within 28 days after first and second dose of vaccination. Age-standardized incidence rate ratios (IRRs) with exact 95% confidence intervals (CIs) were estimated using Poisson distribution.

Results: This study included around 3.9 million Hong Kong residents, of which 1,122,793 received at least one dose of vaccine (BNT162b2: 579,998; CoronaVac: 542,795), and 721,588 completed two doses (BNT162b2: 388,881; CoronaVac: 332,707). Within 28 days following vaccination, cumulative incidences for all autoimmune conditions were below 9 per 100,000 persons, for both vaccines and both doses. None of the age-standardized incidence rates were significantly higher than the non-vaccinated individuals, except for an observed increased incidence of hypersomnia following the first dose of BNT162b2 (standardized IRR: 1.47; 95% CI: 1.10-1.94).

Conclusions: Autoimmune conditions requiring hospital care are rare following mRNA and inactivated COVID-19 vaccination with similar incidence to non-vaccinated individuals. The association between first dose BNT162b2 vaccination and immune-related sleeping disorders requires further research. Population-based robust safety surveillance is essential to detect rare and unexpected vaccine safety events.

Keywords: Autoimmune diseases; COVID-19 vaccines; Inactivated virus vaccine; Pharmacovigilance; mRNA vaccine.

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Conflict of interest statement

XL received research grants from Research Fund Secretariat of the Food and Health Bureau (HMRF, HKSAR), Research Grants Council Early Career Scheme RGC/ECS, HKSAR), Janssen and Pfizer; internal funding from the University of Hong Kong; consultancy fee from Merck Sharp & Dohme, unrelated to this work. CSLC has received grants from the Food and Health Bureau of the Hong Kong Government, Hong Kong Research Grant Council, Hong Kong Innovation and Technology Commission, Pfizer, IQVIA, and Amgen; personal fee from Primevigilance Ltd.; outside the submitted work. FTTL has been supported by the RGC Postdoctoral Fellowship under the Hong Kong Research Grants Council and has received research grants from Food and Health Bureau of the Government of the Hong Kong SAR, outside the submitted work. CKHW reports the receipt of Health and Medical Research Fund, Food and Health Bureau, Government of Hong Kong SAR; General Research Fund, Research Grant Council, Government of Hong Kong SAR; EuroQol Research Foundation, all outside the submitted work. EYFW has received research grants from the Food and Health Bureau of the Government of the Hong Kong SAR, and the Hong Kong Research Grant Council, outside the submitted work. EWYC reports honorarium from Hospital Authority, grants from Research Grants Council (RGC, Hong Kong), grants from Research Fund Secretariat of the Food and Health Bureau, grants from National Natural Science Fund of China, grants from Wellcome Trust, grants from Bayer, grants from Bristol-Myers Squibb, grants from Pfizer, grants from Janssen, grants from Amgen, grants from Takeda, grants from Narcotics Division of the Security Bureau of HKSAR, outside the submitted work. KKL reports research funding from the Food and Health Bureau of the Hong Kong Government, Hong Kong Research Grants Council, Hong Kong Innovation and Technology Commission, Boehringer Ingelheim, Eisai and Pfizer, all unrelated to the submitted work. ICKW reports research funding outside the submitted work from Amgen, Bristol-Myers Squibb, Pfizer, Janssen, Bayer, GSK, Novartis, the Hong Kong RGC, and the Hong Kong Health and Medical Research Fund, National Institute for Health Research in England, European Commission, National Health and Medical Research Council in Australia, and also received speaker fees from Janssen and Medice in the previous 3 years. He is also an independent non-executive director of Jacobson Medical in Hong Kong. LG, XT, VKYC, and CSL do not report any competing interests.

Funding Research Grant from the Food and Health Bureau, the Government of the Hong Kong Special Administrative Region (Ref. No. COVID19F01).

Figures

Fig. 1
Fig. 1
Cumulative incidence of hospitalized autoimmune diseases among vaccine recipients and non-vaccinated individuals.
Fig. 2
Fig. 2
Standardized incidence rates of autoimmune conditions among first dose vaccine recipients and non-vaccinated individuals.
Fig. 3
Fig. 3
Standardized incidence rates of autoimmune conditions among second dose vaccine recipients and non-vaccinated individuals.
See this image and copyright information in PMC

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