Table 1.

Future Priorities for Rotavirus Vaccines and Intussusception Monitoring - Recommendations from the Rotavirus Vaccination & Intussusception Workshop, July 2014.

Key messages for risk communications •Ensure that stakeholders are aware that robust surveillance has demonstrated consistent, strong benefits of rotavirus vaccination, and that risks associated with rotavirus vaccine, including intussusception, remain very low in all post-licensure safety studies to date. Present information about baseline risk of intussusception. Share information with all levels of decision-makers in countries considering vaccine introduction.

Vaccine introduction and sustainability in low- and middle-income countries • Integrate safety monitoring for rotavirus vaccines into routine vaccine safety monitoring: ○ Ensure that countries have clear risk management and communications plans for adverse events following immunization ˆ Conduct targeted safety monitoring while strengthening capacity for routine vaccine safety monitoring • Ensure that, wherever possible, vaccine impact evaluations occur alongside safety monitoring to allow comprehensive assessment of potential risks within the context of benefits: ˆ Leverage existing surveillance networks to increase efficiency • Understand the regional epidemiology of intussusception to allow accurate interpretation of findings from safety monitoring within the context of comparable data concerning benefit: ˆ Establish background rates and outcomes of intussusception in select areas for each region ˆ Focus on low- and middle-income countries for which there are limited data • Examine the risk of intussusception associated with vaccination in early introducer, regionally representative countries using feasible methods: ˆ Ensure that findings are shared broadly to inform the experiences of other countries •Document use, benefit, and safety of rotavirus vaccines in countries that have implemented the expanded age recommendations for rotavirus vaccine administration.

Gaps in knowledge • Support research to increase understanding of the pathogenesis and etiology of intussusception. This would include the following areas: ˆ Basic science studies to understand better the pathogenesis of and triggers for idiopathic intussusception in young children ˆ Epidemiological studies to understand the occurrence of transient (i.e., self-resolving) and persistent idiopathic intussusception in different regions and settings: – Standardize case definitions and methodologies to allow pooling of data – Share findings with all stakeholders in a timely manner • Explore why some studies have detected an increased risk of intussusception following the first dose of vaccine and other studies have not: ˆ Role of co-administration of inactivated and oral polio vaccines ˆ Differences in immune response and shedding across populations •Support studies to determine risk-benefit assessments for countries with higher baseline rates of intussusception.

Evaluation of new rotavirus vaccines in development •Conduct post-marketing surveillance for intussusception in appropriate representative sites also conducting vaccine impact evaluations. •Continue to monitor the potential association of specific vaccine strains with adverse events following immunization post-licensure.