Evaluation of the Intussusception Risk after Pentavalent Rotavirus Vaccination in Finnish Infants.

Abstract

BACKGROUND: An association between rotavirus immunisation and intussusception (IS) has been suggested with present rotavirus vaccines in post-licensure studies. In Finland, rotavirus vaccination programme was implemented in September 2009 using a 2, 3, and 5 months schedule with the pentavalent rotavirus vaccine. By the end of 2013, it is estimated that 719 000 rotavirus vaccine doses have been given in the national programme of which 240 000 were first doses. Nationwide register allows us to evaluate the association between rotavirus vaccination and IS. METHODS AND MATERIALS: Cases of IS diagnosed during 1999-2013 were identified from National Hospital Discharge Register. All cases under 250 days of age diagnosed during 2009-2013 were confirmed by reviewing medical charts. Self-controlled case-series method was used to assess the risk of IS during 1-21 days compared to 22-42 days post vaccination. FINDINGS: In register data the relative incidence of IS at 2 months of age between the post and pre vaccination era was 9.1 (95%CI 2.0-84.3). We identified 22 verified cases with date of admission less than 43 days after any of the three rotavirus vaccine doses. The incidence of IS in the risk period after the 1st dose relative to the control period was 2.0 (95% CI 0.5-8.4; p = 0.34.) Number of excess IS cases per 100 000 first vaccine doses was therefore estimated to be 1.04 (95% CI 0.0-2.5), i.e. one additional IS case per 96 000 first doses of rotavirus vaccine (95% CI 54 600 to ∞). There was no risk detected after 2nd and 3rd doses. CONCLUSION: The finding is in line with the recent published estimates. The benefits of rotavirus immunisation programme outweigh possible small risks of intussusception.