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).
Item Type: | Journal article |
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Faculties: | Medicine |
Subjects: | 600 Technology > 610 Medicine and health |
ISSN: | 1866-0452 |
Language: | English |
Item ID: | 52706 |
Date Deposited: | 14. Jun 2018, 09:51 |
Last Modified: | 04. Nov 2020, 13:31 |