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. 2025 Jul 7;31(7):1789-1796.
doi: 10.1093/ibd/izae220.

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

Trevor L Schell  1 , Lucas Fass  2 , Mary E Hitchcock  3 , Francis A Farraye  4 , Mary S Hayney  5 , Sumona Saha  1 , Freddy Caldera  1
Affiliations

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

Trevor L Schell et al. Inflamm Bowel Dis. .

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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