Abstract

Background: In 2013, the German Standing Committee on Vaccination (Standige Impfkommission, STIKO) recommended rotavirus (RV) vaccination for all infants while stating that this mildly increased the risk of intussusception, a potentially life-threatening event. Since this recommendation was issued, multiple observational studies on this topic designed as self-controlled case series (SCCS) have been published. The SCCS design is particularly suitable for the study of rare adverse effects of medications. Methods: We systematically searched the literature for SCCS studies on the risk of intussusception after RV vaccination. Relative risks (RR) corresponding to different doses of vaccine were summarized in a meta-analysis, and attributable risks (AR) were calculated. Results: Of the 16 initially identified studies, 10 with a predominantly low risk of bias were considered in the analysis. The RR for intussusception was 5.71 (95% confidence interval [4.50; 7.25]) 1-7 days after the first dose, 1.69 [1.33; 2.14] after the second, and 1.14 [0.75; 1.74] after the third. The AR for children of the age at which RV vaccination is recommended was 1.7 [1.1; 2.7] additional intussusceptions per 100 000 vaccinated children after the first dose and 0.25 [0.16; 0.40] after the second. If >3-month-old infants are vaccinated, the AR is higher: 5.6 [4.3; 7.2] per 100 000 after the first dose and 0.81 [0.63; 1.06] per 100 000 after the second. Conclusion: RV vaccination is associated with a markedly elevated RR and a mildly elevated AR for intussusception 1-7 days after the first dose. Physicians should begin the series of vaccinations at age 6-12 weeks, as recommended by the STIKO, because the risk of intussusception is higher afterward. Current health insurance company claim data indicate that 11.2% of infants are still receiving the first dose of the vaccine at ages above 3 months. The parents of vaccinated children should be informed about the possible signs of intussusception (colicky pain, bilious vomiting, and red "currant jelly" stool).
Newborn (0-1 years) Safety Rotavirus