Postvaccination Symptoms After SARS-CoV-2 mRNA Vaccination Among Patients With Inflammatory Bowel Disease: A Prospective, Comparative Study

Abstract

Background Vaccine hesitancy is prevalent among people with IBD, in part due to insufficient evidence regarding comparative safety of vaccines in this population. Methods We conducted a nationwide comparative study of postvaccination symptoms among those with IBD and health care workers (HCWs) without IBD. Symptom frequency, severity, and duration were measured. Continuous and categorical data were analyzed using Wilcoxon rank-sum and Fisher’s exact test. Regression analysis was used to adjust for confounding variables. Results We had 2910 and 2746 subjects who completed a survey after dose 1 (D1) and dose 2 (D2) respectively (D1: HCW = 933, IBD = 1977; D2: HCW = 884, IBD = 1862). Mean age was 43 years, 67% were female, and 23% were nonwhite; 73% received BNT162b2 (Pfizer) including almost all HCWs and 60% of IBD patients. Most postvaccine symptoms were mild and lasted ≤2 days after both doses in both groups. Health care workers experienced more postvaccination symptoms overall than IBD patients after each dose (D1: 57% vs 35%, P < .001; D2: 73% vs 50%, P < .001). Gastrointestinal symptoms were noted in IBD more frequently after D1 (5.5% vs 3%, P = .003) but not after D2 (10% vs 13%, P = .07). Inflammatory bowel disease subjects who received mRNA-1273 (Moderna) reported more overall symptoms compared with BNT162b2 (57% vs 46%, P < .001) including gastrointestinal symptoms (12% vs 8%, P = .002) after D2. Conclusions People with IBD had fewer postvaccination symptoms following the first 2 doses of SARS-CoV-2 mRNA vaccines than HCWs. Among those with symptoms, most symptoms were mild and of short duration.

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“…IBD cohort plasma samples consisted of IBD subjects (n=205) collected as outline in Kumar et al . 50 along with age and sex matched controls (n=287) from the relatively healthy health care worker cohort, Corale 51,52 . Supplemental table 4 lists the sex, age and race characteristics of IBDs and controls.…”

“…Both cohorts were initially designed to study the effect of SARS-COVID-2 vaccines and received two doses of mRNA vaccine as per local department of health guidelines and institutional policies, and the samples were collected 16 weeks after the 2nd dose of COVID vaccine in both cohorts. IBD cohort plasma samples consisted of IBD subjects (n=205) collected as outline in Kumar et al 50 along with age and sex matched controls (n=287) from the relatively healthy health care worker cohort, Corale 51,52 . Supplemental table 4 lists the sex, age and race characteristics of IBDs and controls.…”