Safety Records

Benefits Far Outweigh Risks

GSK’s Rotarix and Merck’s RotaTeq have strong safety records and have been studied in every region of the world.

 

  • Side effects are rare, usually mild, and may include fussiness, fever, and diarrhea. In extremely rare cases, intussusception, a bowel blockage where the intestine folds in on itself, can occur.
  • Intussusception (IS) occurs naturally in infants, in the absence of vaccination, between 2 and 9 months of age, and the rates at which it occurs varies from region to region.
  • Based on all of the available evidence, WHO, whose Global Advisory Committee on Vaccine Safety most recently reviewed global intussusception data in February 2014, holds the position that the benefits of rotavirus vaccines outweigh the small risk of intussusception1.
  • The number of naturally occurring cases of IS ranges from 9 to 328 per 100,000 children under age 1, with an average of 74 cases per 100,0002.
  • Studies published after rotavirus vaccine introduction in Australia, Brazil, Mexico, and the US have found the risk of IS for Rotarix & RotaTeq is comparable, and that for every 100,000 children vaccinated, there are an estimated 1 to 6 additional cases of IS3,4.

ROTA Council Recommendation

Countries planning to introduce rotavirus vaccines are encouraged to establish a strong surveillance system to monitor disease burden to evaluate the impact of vaccination on disease and rare adverse events before and after the introduction of the vaccine.

1. WHO, Global Advisory Committee on Vaccine Safety, 11-12 December 2013, in Wkly Epidemiol Rec. 2014. p. 53-60.

2. Jiang, J., et al., Childhood intussusception: a literature review. PLoS One, 2013. 8(7): p. e68482.

3. Carlin, J.B., et al., Intussusception risk and disease prevention associated with rotavirus vaccines in Australia’s National Immunization Program. Clin Infect Dis, 2013. 57(10): p. 1427-34.

4. Cortese, M.M., Advisory Committee on Immunization Practices (ACIP) Summary Report. 2013.