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Published on: January 28, 2019
Safety of Rotavirus Vaccination in Infants That Were Exposed to Biologics In Utero: A Systematic Review
Trevor L Schell1, Lucas Fass2, Mary E Hitchcock3
1Division of Gastroenterology & Hepatology, Department of Medicine, University of Wisconsin School of Medicine & Public Health, Madison, WI, USA.
Insights
Live rotavirus vaccine administration is safe for infants exposed to biologics in utero. This systematic review found no increased risk of adverse events in biologic-exposed infants receiving the rotavirus vaccine.
Area of Science:
- Immunology
- Pediatric Gastroenterology
- Vaccinology
Background:
- Current guidelines recommend delaying rotavirus vaccination in infants with in utero biologic exposure.
- Concerns exist regarding the safety of live vaccines in this vulnerable population.
Purpose of the Study:
- To systematically review the safety of rotavirus vaccination in infants exposed to biologics during pregnancy.
- To evaluate the risk of adverse events associated with rotavirus vaccination in biologic-exposed infants.
Main Methods:
- A comprehensive literature search was conducted across EMBASE, PubMed, Scopus, and Cochrane databases (2006-2024).
- Studies included original data on rotavirus vaccination safety in infants exposed to anti-tumor necrosis factors (TNFs) and non-TNF biologics in utero.
Main Results:
- Ten studies met inclusion criteria, encompassing over 300 infants exposed to biologics (162 anti-TNF, 142 non-TNF).
- No increased risk of severe adverse events or any-severity adverse events was observed in rotavirus-vaccinated, biologic-exposed infants.
Conclusions:
- Live rotavirus vaccine administration appears safe in infants with in utero biologic exposure.
- Rotavirus vaccination may be considered for this population after careful risk-benefit assessment.
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.
