Humoral Immune Response and Safety of SARS-CoV-2 Vaccination in Pediatric Inflammatory Bowel Disease

Abstract

INTRODUCTION: Children with inflammatory bowel disease (IBD) may respond differently to COVID-19 immunization as compared with healthy children or adults with IBD. Those younger than 12 years receive a lower vaccine dose than adults. We sought to describe the safety and humoral immune response to COVID-19 vaccine in children with IBD. METHODS:We recruited children with IBD, ages 5-17 years, who received ‡ 2 doses of the BNT162b2 vaccine by a direct-to-patient outreach and at select sites. Patient demographics, IBD characteristics, medication use, and vaccine adverse events were collected. A subset of participants had quantitative measurement of anti-receptor binding domain IgG antibodies after 2-part immunization. RESULTS:Our study population included 280 participants. Only 1 participant required an ED visit or hospitalization because of an adverse event. Of 99 participants who underwent anti-receptor binding domain IgG antibody measurement, 98 had a detectable antibody, with a mean antibody level of 43.0 mg/mL (SD 67) and a median of 22 mg/mL (interquartile range 12-38). In adjusted analyses, older age (P 5 0.028) and antitumor necrosis factor monotherapy compared with immunomodulators alone (P 5 0.005) were associated with a decreased antibody level. Antibody response in patients treated with antitumor necrosis factor combination vs monotherapy was numerically lower but not significant.DISCUSSION:Humoral immune response to COVID-19 immunization in children with IBD was robust, despite a high proportion of this pediatric cohort being treated with immunosuppressive agents. Severe vaccinerelated AEs were rare. Overall, these findings provide a high level of reassurance that pediatric patients with IBD respond well and safely to SARS-CoV-2 vaccination.

Humoral immune response and safety of SARS‐CoV‐2 vaccination in very early onset inflammatory bowel disease

“…Other studies have demonstrated that older children with IBD mount a robust antibody response to SARS-CoV-2 vaccination as well. 8,16,17 Moreover, similar to reports in adults with IBD 7 and older children, 8 severe vaccine-related AEs and IBD exacerbation following vaccination were uncommon.…”

“…Data from adults and children >6 years of age have already been published. [4][5][6][7][8] The data herein highlights findings from children who were 6 years of age and younger at the time of enrollment. Recruitment started in March 2021 and ended September 2022.…”

Safety and effectiveness of vaccines against COVID-19 in children aged 5–11 years: a systematic review and meta-analysis

“… 26 , 27 Studies were primarily done in high-income countries (eg, the USA, Canada, and Israel), and assessed a complete primary schedule of BNT162b2 vaccine (n=46 [90%]). Three (6%) studies only assessed the effect of a single dose of either BNT162b2 or mRNA-1273, 28 , 29 , 30 and nine (18%) studies assessed the effect of a monovalent 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 or bivalent (BNT162b2 bivalent [against original strain or omicron BA.4 or BA.5]) 39 booster vaccination ( appendix 1 pp 26–33 ). Participants' age was in line with the authorised age group (ie, 5–11 years for studies on BNT162b2 or BNT162b2 bivalent and 6–11 years for studies on mRNA-1273; appendix 1 pp 26–33 ).…”

SARS-CoV-2 Infection and Outcomes in Children with Inflammatory Bowel Diseases: A Systematic Review

“…Seroconversion rates after vaccination were comparable to the control group. Conversely, neutralizing antibody responses in children receiving combination therapy (anti-TNFa and immunomodulators) were reduced [ 45 ], while in other studies, monotherapy with anti-TNFa was associated with decreased levels of anti-receptor binding domain IgG antibodies compared to immunomodulators alone [ 46 ]. Hence, expert guidelines released by various gastroenterological societies have advised in favor of early administration of mRNA vaccines [ 47 , 48 ].…”