Safety of Rotavirus Vaccination in Infants That Were Exposed to Biologics In Utero: A Systematic Review

Trevor L Schell; Lucas Fass; Mary E Hitchcock; Francis A Farraye; Mary S Hayney; Sumona Saha; Freddy Caldera

doi:10.1093/ibd/izae220

Safety of Rotavirus Vaccination in Infants That Were Exposed to Biologics In Utero: A Systematic Review

Inflamm Bowel Dis. 2024 Sep 20:izae220. doi: 10.1093/ibd/izae220. Online ahead of print.

Authors

Trevor L Schell¹, Lucas Fass², Mary E Hitchcock³, Francis A Farraye⁴, Mary S Hayney⁵, Sumona Saha¹, Freddy Caldera¹

Affiliations

¹ Division of Gastroenterology & Hepatology, Department of Medicine, University of Wisconsin School of Medicine & Public Health, Madison, WI, USA.
² Department of Medicine, University of Wisconsin School of Medicine & Public Health, Madison, WI, USA.
³ Department of Health Sciences Library, University of Wisconsin School of Medicine & Public Health, Madison, WI, USA.
⁴ Mayo Clinic, Division of Gastroenterology & Hepatology, Inflammatory Bowel Disease Center, Jacksonville, FL, USA.
⁵ University of Wisconsin-Madison, School of Pharmacy, Madison, WI, USA.

PMID: 39303214
DOI: 10.1093/ibd/izae220

Abstract

Background: In infants that were exposed to biologics in utero, gastroenterology societal guidelines have either recommended against administration of the live rotavirus vaccine until 6-12 months of age or until serum biologic levels are undetectable. We performed a systematic review to evaluate the safety of rotavirus vaccination in biologic-exposed infants.

Methods: EMBASE, PubMed, Scopus, and Cochrane databases were searched from 2006 to 2024 for original data reporting on the safety of rotavirus vaccination in infants that were exposed to anti-tumor necrosis factors (TNFs) (ie, infliximab, adalimumab, golimumab, certolizumab) and non-TNF biologics (ie, vedolizumab, ustekinumab, rizankizumab, mirikizumab) in utero.

Results: A database search yielded 7185 screening results of which 10 studies met inclusion criteria. There were over 300 instances of rotavirus vaccination in biologic-exposed infants (n = 162 exposed to anti-TNFs, n = 142 exposed to non-TNF biologics). Biologic-exposed infants were not at an increased risk of severe adverse events or adverse events of any severity related to rotavirus vaccination.

Conclusions: Administration of the live rotavirus vaccine appears to be safe in biologic-exposed infants. As such, with careful examination of the risks and benefits, there may be a role for rotavirus vaccination in this population.

Keywords: anti-tumor necrosis factor; biologic; infant; rotavirus; vaccine.

Plain language summary

We performed a systematic review evaluating the safety of rotavirus vaccination in infants that were exposed to anti-TNFs and non-TNF biologics in utero. There was no increased risk of adverse events associated with rotavirus vaccination in this population.

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