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European Society for Paediatric Infectious Diseases consensus recommendations for rotavirus vaccination in Europe:
Timo Vesikari1, Pierre Van Damme, Carlo Giaquinto
1From the *Vaccine Research Centre, University of Tampere Medical School, Tampere, Finland; †Centre for the Evaluation of Vaccination, Vaccine and Infectious Disease Institute, Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium; ‡Department of Paediatrics, University of Padova, Padova, Italy; §Soroka University Medical Center, The Faculty of Health Sciences, Ben-Gurion University of Negev, Beer Sheva, Israel; ¶Departments of Paediatrics, University Federico II, Naples, Italy; ‖Department of Paediatrics, The Medical University of Warsaw, Poland; and **Centre of Paediatrics, Vilnius University, Vilnius, Lithuania.
Insights
Updated European rotavirus (RV) vaccination guidelines emphasize early first-dose administration to minimize intussusception risk. Recommendations now strongly support vaccinating premature and HIV-exposed infants, while excluding those with severe combined immunodeficiency.
Area of Science:
- Pediatric Infectious Diseases
- Vaccinology
- Public Health
Background:
- European rotavirus (RV) vaccination recommendations were first established in 2008 following the licensure of two oral RV vaccines.
- Universal RV vaccination has been adopted by many European countries, generating extensive post-introduction effectiveness data.
- While pre-licensure trials showed no intussusception risk, post-marketing surveillance identified a potential risk of 1:50,000-1:80,000 after the first dose for both vaccines.
Purpose of the Study:
- To update evidence-based recommendations for rotavirus vaccination in Europe.
- To address safety concerns, particularly intussusception risk, and optimize vaccine administration strategies.
- To provide guidance on vaccinating special infant populations, including premature and immunocompromised infants.
Main Methods:
- Review of post-introduction effectiveness data from national immunization programs (NIPs).
- Analysis of pre-licensure efficacy and safety trial data.
- Evaluation of post-vaccination surveillance data on intussusception risk.
- Consideration of data on RV vaccination in premature infants and other special populations.
Main Results:
- Post-introduction data strongly support the benefits of RV vaccination.
- Surveillance data indicate a potential intussusception risk of 1:50,000-1:80,000 after the first dose.
- Early administration of the first RV vaccine dose, preferably between 6-8 weeks of age, may reduce intussusception risk.
- Premature infants should be vaccinated according to calendar age.
- HIV-infected or HIV-exposed infants are strongly recommended for RV vaccination.
Conclusions:
- RV vaccination offers significant benefits, and efforts to mitigate intussusception risk are crucial.
- Optimizing the timing of the first vaccine dose is recommended to enhance safety.
- RV vaccination is recommended for premature and HIV-exposed infants.
- Live oral RV vaccines are contraindicated in infants with known severe combined immunodeficiency.
Abstract:
The first evidence-based recommendations for rotavirus (RV) vaccination in Europe were prepared at the time of licensure of 2 live oral RV vaccines (Rotarix, GlaxoSmithKline Biologicals, and RotaTeq, Sanofi Pasteur MSD) in 2006 and published in 2008. Since then several countries in Europe and more globally have adopted universal RV vaccination of all healthy infants as part of their national immunization programs (NIPs). The experience from these NIPs has produced a wealth of post-introduction effectiveness data that, together with the evidence from prelicensure efficacy trials presented in the 2008 Recommendations, support the case of RV vaccination in Europe. The prelicensure safety trials of Rotarix and RotaTeq, each in populations of more than 60,000 infants, did not reveal risk of intussusception (IS), but postvaccination surveillance in several countries, particularly Australia and Mexico, has established that the risk of IS for both vaccines after the first dose might be between 1:50,000 and 1:80,000. Although it may be argued that the risk is acceptable vis-à-vis the great benefits of RV vaccination, this argument alone may not suffice, and every effort should be made to reduce the risk of IS. Considerable evidence, including postvaccination surveillance data from Germany, suggests that the risk of IS can be reduced by early administration of the first dose of oral RV vaccine. The previous European Society for Paediatric Infectious Diseases/European Society for Paediatric Gastroenterology, Hepatology and Nutrition recommendations held that the first dose of oral RV vaccine should be given between 6 and 12 weeks of age; this recommendation is sustained but with an emphasis toward the lower range of the recommended age, that is, preferably between 6 and 8 weeks of age. At the time of the earlier recommendations, experience of RV vaccination in premature infants and other special target groups was limited. It is now recommended with greater confidence than before that prematurely born infants should be vaccinated according to their calendar age as recommended for full-term infants. It is now strongly recommended that all HIV-infected or HIV-exposed infants should be vaccinated with oral RV vaccine. Although specific information on many immunodeficiencies is lacking, infants with known severe combined immunodeficiency should not receive live RV vaccine.
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