Rotavirus vaccination and risk for intussusception in neonates and infants

Takeaway

• This meta-analysis suggests that rotavirus (RV) vaccination is not associated with an increased risk for intussusception up to 2 years after vaccination among neonates or infants.

Why this matters

• Findings oppose the post-marketing monitoring suggestion about the risk for intussusception after the RV vaccination and suggest that vaccination benefit surpasses the potential risk for intussusception.

Study design

• 25 randomised controlled trials (RCTs) including 200 594 participants (104647 receiving vaccine and 95947 receiving placebo) met eligibility criteria.
• Main outcome: diagnosis of intussusception.
• Funding: None disclosed.

Key results

• No significant difference was observed in the risk for intussusception within 31 days after vaccination between vaccine and placebo group (11 vs 9 cases; risk difference [RD], 0.17 per 10000 infants [95% CI, -1.16 to 1.50 per 10000 infants]; P =.80; relative risk [RR], 1.14; 95% CI, 0.49-2.64; P=.77).
• Vaccine (37 cases) vs placebo (37 cases) group did not differ in the risk for intussusception within 1 year (RD, -0.65 per 10000 infants [95% CI, −2.68 to 1.39 per 10 000 infants]; P=.53; RR, 0.84; 95%CI, 0.53-1.32; P=.45).
• Risk for intussusception within 2 years after vaccination did not differ between vaccine and placebo group (29 vs 30 cases; RD, -0.48 per 10000 infants [95%CI, -3.64 to 2.69 per 10 000 infants]; P=.77; RR, 0.91; 95%CI, 0.55-1.52; P=.73).   

Limitations

• Limited number of trials.