Reassuring safety information for monovalent rotavirus vaccine

Abstract

Rotavirus vaccines (RVs) are remarkably effective in averting this previously inescapable cause of gastroenteritis in young children. The benefit of RVs in developing countries primarily are saving lives, and in developed countries they are preventing hospitalizations. Since the implementation of pentavalent human-bovine reassortant vaccine (RV5) and monovalent human vaccine (RV1) in multiple countries, it has become apparent that both vaccines are associated with a small but measurable increase in cases of intussusception following immunization, especially in the first week and especially after the first dose. The rate of vaccine-associated intussusception has varied by country and likely is related to existing differences in rates of nonvaccine associated intussusception, as well as diet, maternal antibodies, and prevalence of enteropathogens – to name just a few. Young age, when intussusception is uncommon and when some maternal antibody to rotavirus is still present, is thought to be protective against RV-associated intussusception. The vast safety studies leading to licensure of RVs entered only young infants. Recommendation in the US is that the first dose of RV vaccination should be given at 2 months of age routinely and vaccination should be initiated only if the infant is 14 weeks and 6 days of age or younger. The study from Singapore reported in this issue of The Journal adds further data from a geographic area with higher incidence of background intussusception, a slightly older age at first dose, and dominant use of RV1 compared with the US. The analysis of cases and timing of intussusception in infants who received RV1 versus unimmunized infants suggests that a program achieving 90% vaccine coverage would prevent 71% of rotavirus hospitalizations, require 340 infants to be immunized to prevent one hospitalization, and would result in one excess intussusception hospitalization for every 64 668 infants immunized. These data, in this setting, are reassuring to the conclusion that the benefits of RVs far outweigh risk. Article page 163▶ Intussusception and Monovalent Rotavirus Vaccination in Singapore: Self-Controlled Case Series and Risk-Benefit StudyThe Journal of PediatricsVol. 167Issue 1PreviewTo investigate the association between monovalent human rotavirus vaccine (RV1) and intussusception among Asian infants and the impact of older age of vaccination. To perform risk-benefit analysis of RV1 vaccination programs in Singapore. Full-Text PDF