Gastrointestinal Adverse Events Following Rotavirus Vaccination in Children: A Systematic Review

Area of Science:

• Pediatric Gastroenterology
• Vaccine Safety Research
• Immunology

Background:

• Rotavirus vaccines (RV1 and RV5) are crucial for preventing severe rotavirus gastroenteritis in children.
• Gastrointestinal adverse events (GI-AEs) following vaccination require ongoing safety surveillance.
• Understanding the specific risks associated with rotavirus vaccines is essential for public health.

Purpose of the Study:

• To systematically review the evidence on GI-AEs after RV1 and RV5 rotavirus vaccine administration in pediatric populations.
• To assess the occurrence, clinical presentation, and management strategies for these events.
• To evaluate the association between rotavirus vaccination and conditions like intussusception and immune-mediated diseases.

Main Methods:

• A systematic literature search was conducted from April to August 2025, including RCTs, meta-analyses, and case reports from 2007 onwards.
• Primary outcomes focused on prolonged diarrhea, intussusception, and immune-mediated diseases.
• Secondary outcomes examined the clinical management of post-vaccination GI events.

Main Results:

• Of 197 studies, 86 met inclusion criteria. Mild, self-limiting GI symptoms were common.
• No increased risk of prolonged diarrhea was found in healthy infants; rare cases occurred in severely immunodeficient children.
• No increased risk of intussusception or immune-mediated diseases (celiac, IBD) was identified. High-risk infants showed higher AE incidence.

Conclusions:

• Rotavirus vaccines RV1 and RV5 demonstrate an excellent safety profile in pediatric populations.
• In high-income settings, prolonged post-vaccination diarrhea should prompt investigation for underlying immunodeficiency.
• The vaccines are not associated with an increased risk of future immune-mediated intestinal disorders.