Am J Gastroenterol. 2022 Oct 28. doi: 10.14309/ajg.0000000000002016. Online ahead of print.

Arthur J Kastl ¹, Kimberly N Weaver ², Xian Zhang ³, Jennifer A Strople ⁴, Jeremy Adler ⁵, Marla C Dubinsky ⁶, Athos Bousvaros ⁷, Runa Watkins ⁸, Xiangfeng Dai ², Wenli Chen ², Raymond K Cross ⁹, Peter D R Higgins ¹⁰, Ryan C Ungaro ¹¹, Meenakshi Bewtra ¹², Emanuelle A Bellaguarda ¹³, Francis A Farraye ¹⁴, Kelly Y Chun ¹⁵, Michael Zikry ¹⁵, Manory Fernando ¹⁵, Monique Bastidas ¹⁵, Cristian G Hernandez ¹⁶, Riley G Craig ¹⁶, Margie E Boccieri ³, Anne Firestine ³, Millie D Long ^2 17, Michael D Kappelman ^3 17

Author information

¹Division of Gastroenterology, Children's Hospital of Philadelphia, Perelman School of Medicine, Philadelphia, Pennsylvania, USA.

²Department of Medicine, Division of Gastroenterology and Hepatology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.

³Department of Pediatrics, Division of Pediatric Gastroenterology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.

⁴Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois, USA.

⁵Susan B. Meister Child Health Evaluation and Research Center and Department of Pediatrics, University of Michigan, Ann Arbor, Michigan, USA.

⁶Department of Pediatrics, Susan and Leonard Feinstein IBD Center, Icahn School of Medicine, Mount Sinai New York, New York, USA.

⁷Division of Gastroenterology, Boston Children's Hospital, Harvard Medical School, Boston, Massachusetts, USA.

⁸University of Maryland School of Medicine, Division of Pediatric Gastroenterology & Nutrition, Baltimore, Maryland, USA.

⁹University of Maryland School of Medicine, Division of Gastroenterology and Hepatology, Baltimore, Maryland, USA.

¹⁰Division of Gastroenterology, University of Michigan, Ann Arbor, Michigan, USA.

¹¹Susan and Leonard Feinstein IBD Center, Icahn School of Medicine, Mount Sinai New York, New York, USA.

¹²Division of Gastroenterology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.

¹³Division of Gastroenterology and Hepatology, Northwestern University, Chicago, Illinois, USA.

¹⁴Division of Gastroenterology and Hepatology, Mayo Clinic, Jacksonville, Florida, USA.

¹⁵Esoterix Specialty Laboratory, LabCorp, Calabasas, California, USA.

¹⁶University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA.

¹⁷Center for Gastrointestinal Biology and Disease, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.

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 μg/mL (SD 67) and a median of 22 μg/mL (interquartile range 12-38). In adjusted analyses, older age ( P = 0.028) and antitumor necrosis factor monotherapy compared with immunomodulators alone ( P = 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 vaccine-related 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.