6th Global Meeting on Implementing New and Under-utilized Vaccines, 15-17 May 2012
Workshop 1 - Pneumococcal and rotavirus vaccine: experiences with implementation
Pneumococcal & rotavirus vaccines are being used in many high/middle income countries and will soon be widely implemented in developing country settings. Countries have gained valuable early lessons about the introduction of these vaccines, including lessons on monitoring impact and confronting programmatic challenges. The continued monitoring of vaccine impact on disease burden and assessing of vaccine effectiveness are key to sustain vaccine use and to develop the evidence base necessary for adoption decisions in countries where the vaccines are not currently in use. Additionally, the early programmatic lessons from introduction of these vaccines (vaccine product choice, vaccination schedule, cold chain and logistics, and social mobilization) serve to inform introduction plans in other countries. The objectives of this workshop were to:
- Review post-introduction evidence on pneumococcal and rotavirus vaccination
- Share programmatic experiences around vaccine decision-making and implementation
- Understand the rationale and implications of the recent decision of the Strategic Advisory Group of Experts on Immunization (SAGE) to relax rotavirus vaccination age restrictions
Main Topics of Discussion
Effectiveness, impact and safety of rotavirus vaccination in Bolivia
Using a case-control study design, Bolivia evaluated the effectiveness of a 2 dose rotavirus vaccine (rotarix) against severe rotavirus diarrhoea. As a secondary objective, the study evaluated the effectiveness of a reduced schedule of 1 dose, effectiveness by age and by rotavirus strain. Full series vaccination prevented 70-76% of rotavirus hospitalizations in the study population, while the 1 dose series prevented 40-50 percent.
Bolivia implemented sentinel surveillance for rotavirus in six sites three years prior to the introduction of the vaccine. The discussion group agreed that surveillance should be a consideration prior to vaccine adoption, but not a prerequisite. Ideally, surveillance should be implemented two to five years before introduction to allow for vaccine impact monitoring.
Programmatic considerations for new vaccine introduction in Sudan (rotavirus) and Yemen (PCV)
Experiences from the introduction of rotavirus vaccine in Sudan demonstrated how careful planning and implementation of preparatory activities can substantially influence programmatic outcomes. Some of the lessons learned include: outreach sessions should be carefully planned, especially in areas inaccessible due to rains; supervision needs special monitoring for age restrictions; close evaluation improves results; vaccine transport costs are high and should be estimated and provided for from the outset; storage capacity should be reviewed early on in the planning process.
Yemen’s experience with introducing pneumococcal conjugate vaccine showed how political instability can substantially affect early coverage results. However, countries can take several measures to reduce the impact of political instability on vaccination coverage. For example, Yemen leveraged social networks including religious groups to promote PCV vaccination and to reach coverage targets. But, securing funding for social mobilization activities was a challenge, and the relatively short period of 6-8 weeks prior to introduction allocated for social mobilization activities was barely sufficient. Considering Yemen’s experience, advocating internally and externally with the Ministry of Health is important for securing early political buy-in among community members and among the stakeholders that influence allocation of funds.
National decision making in Peru for the introduction of pneumococcal vaccines in childhood
The PAHO ProVac Initiative supported the Ministry of Health in Peru to conduct an economic evaluation of pneumococcal conjugate vaccines. The TRIVAC model was used to compare the cost-effectiveness of vaccination with the 10-valent and the 13-valent pneumococcal conjugate vaccines versus no vaccination. Challenges included the estimation of local disease burden data, incremental EPI costs and vaccine effectiveness. Despite the data limitations, the process of conducting a cost-effectiveness analysis driven by country-specific priorities and local experts proved to be a valuable experience. The country team generated useful information as inputs to the national decision making process and, in parallel, developed recommendations to strengthen information systems, having identified several data gaps and data quality issues.
The PAHO ProVac Initiative has supported 21 national economic evaluations to inform new vaccine introduction decisions in 14 countries. The ProVac framework for supporting evidence-based immunization policy will be piloted in countries in Europe, the Middle East and Africa during a two-year project financed by the Bill and Melinda Gates Foundation. Implementing partners include WHO, Sabin Vaccine Institute, Agence de Médecine Préventive (AMP), PATH and US/CDC.
Evidence behind the SAGE recommendation to relax the age-restrictions for rotavirus vaccination
The evidence behind SAGE’s recent discussion about relaxing the age-restrictions for rotavirus vaccination was reviewed during this session. The risk-benefit analysis that was conducted to compare the potential additional risks and benefits associated with rotavirus vaccination outside the recommended age windows was explained. The results show that the benefits of vaccination beyond the age-restrictions substantially outweigh the potential risks. By loosening the age-restrictions, an estimated 43,100 fewer deaths will occur due to higher absolute coverage (~23-25 percent). The additional benefit associated with loosening the age-restrictions exceeds the potential vaccine-associated risk of 317 intussusception deaths.
Programmatically the regional and national roll out of these revised recommendations may be challenging and effective communication will be key.
- Social mobilization is key to ensuring high coverage with introduction of new vaccines. However, more evidence based communication messages need to be developed and sufficient time for social mobilization should be planned.
- In order to meet the growing need for country relevant data for decision making, the capacity for economic evaluation needs to be increased using existing tools such as those developed by PAHO ProVac Initiative.
- Communication messages need to be developed for each stakeholder (immunization programme managers, health workers and mothers) regarding SAGE’s recommendation to relax age-restrictions for rotavirus vaccination.
- Further evidence is needed from LMIC on the real adverse event risk associated with rotavirus vaccination.