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

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

Keywords: vaccination, COVID-19, autoimmune disease

Background:

A large vaccination campaign was initiated worldwide in December 2020 in order to prevent infection with SARS-CoV-2. However, long-term adverse effects of vaccination remain unclear.

Research questions:

We aim to examine the association between vaccination and the incidence of autoimmune diagnoses in the first year after vaccine uptake.

Method:

This retrospective cohort study based on Clalit comprehensive database compared the rates of immune-mediated diagnoses among BNT162b2 vaccinated versus un-vaccinated individuals. 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. Multivariate Cox proportional hazard regression models were applied, followed by a correction for multiple comparisons.

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 rheumatic. These findings should be considered as a part of the risk-benefit assessment when planning future vaccination programs for various population groups.

Points for discussion:

The jouney from clinical observation to study results

Risk benefit of BNT162b2 vaccine

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