The association between BNT162b2 vaccinations and incidence of immune-mediated comorbidities

Michal Shani; Irit Hermesh; Ilan Feldhamer; Orna Reges; Gil Lavie; Ronen Arbel; Yael Wolff Sagy

doi:10.1016/j.vaccine.2024.04.097

The association between BNT162b2 vaccinations and incidence of immune-mediated comorbidities

Vaccine. 2024 May 9:S0264-410X(24)00536-X. doi: 10.1016/j.vaccine.2024.04.097. Online ahead of print.

Authors

Michal Shani¹, Irit Hermesh², Ilan Feldhamer³, Orna Reges⁴, Gil Lavie⁵, Ronen Arbel⁶, Yael Wolff Sagy³

Affiliations

¹ Department of Family Medicine Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel; Department of Family Medicine Central District, Clalit Health Service, Rehovot, Israel. Electronic address: michal.shani@gmail.com.
² Gastroenterology Department Rambam Health Care Campus, Israel.
³ Research and Information Department, Wing of Planning and Strategy, Clalit Health Services, Israel.
⁴ Department of Health Systems Management, Ariel University, Ariel, Israel.
⁵ Branch of Planning and Strategy, Clalit Health Services, Tel Aviv, Israel; Ruth and Bruce Rappaport Faculty of Medicine, Technion-Israel Institute of Technology, Haifa, Israel.
⁶ Community Medical Services Division, Clalit Health Services, Tel Aviv, Israel; Maximizing Health Outcomes Research Lab Sapir College, Sderot, Israel.

PMID: 38729910
DOI: 10.1016/j.vaccine.2024.04.097

Abstract

Background: A large vaccination campaign was initiated worldwide in December 2020 in order to prevent infection with SARS-CoV-2 and severe Covid-19 disease. However, long-term adverse effects of vaccination remain unclear. Therefore, our objective was to examine the association between vaccination and the incidence of autoimmune diagnoses in the first year after vaccine uptake.

Methods: This retrospective cohort study based on Clalit Health Services (CHS) comprehensive database compared the rates of immune-mediated diagnoses among BNT162b2 vaccinated versus unvaccinated individuals. As a reference, a secondary cohort compared individuals infected with Sars-CoV-2 versus uninfected individuals. The minimum follow-up period was 4 months. The cohorts were divided into 4 age groups (12-17, 18-44, 45-64, 65 years or older). Multivariate Cox proportional hazard regression models were applied, followed by a correction for multiple comparisons using the False Discovery Rate (FDR) method, hence accounting for the investigation of multiple clinical outcomes.

Results: Increased risk for immune-mediated diagnoses following vaccination with BNT162b2 was observed for psoriasis in all age groups (HR 1.41-1.69), colitis among patients younger than 65 years (HR 1.38-1.93), vitiligo in patients aged 45-64 (HR 2.82, 95 %CI: 1.57-5.08) and for polymyalgia-rheumatica in patients aged 65 years or older (HR 2.12, 95 % CI: 1.3-3.47). In the reference cohort, patients who were infected by Covid-19 were at increased risk for fibromyalgia (HR 1.72, 95 % CI: 1.36-2.19 in individuals aged 18-44; HR 1.71, 95 % CI: 1.31-2.22 in individuals aged 45-64), and hypothyroidism (HR 1.54, 95 % CI: 1.15-2.07 in individuals aged 65 years or older).

Conclusions: The BNT162b2 vaccine was associated with increased risk (though rare) for psoriasis, colitis and polymyalgia rheumatica. These findings should be considered as a part of the risk-benefit assessment when planning future vaccination programs for various population groups.

Keywords: Adverse effect; BNT162b2 vaccine; Immune mediated disease; SARS-CoV-2 infection.