Lesson 5: Plan for the future

Transitioning from an initial vaccination campaign to a sustainable, routine vaccination program within an Expanded Programme on Immunization (EPI) schedule requires planning—and lots of it. When countries plan, the likelihood of successful and sustainable vaccination programs increases. The Japanese encephalitis (JE) project witnessed both the benefits of planning and the challenges faced by countries that had not adequately planned.

Determining the disease burden before the vaccination program starts not only helps with decision-making, but also allows comparison of the disease burden before and after vaccine introduction (vaccine impact), changes in JE epidemiology, and changes in JE vaccine performance. Plans for safety monitoring and how to respond to any safety signals (crisis communication) should also be in place before vaccine introduction. Similarly, evaluating the impact of adding JE vaccine on coverage of other routine vaccines already within the EPI schedule should be planned for. Being able to measure and monitor these outcomes is crucial for JE vaccination program’s long-term success and requires advance planning.

For JE, impact monitoring comes with a set of unique challenges. The JE virus is the most common vaccine-preventable cause of acute encephalitis syndrome (AES) in Asia. However, because many AES cases are caused by other pathogens, JE vaccination programs will not eliminate all AES cases. Proportions of AES cases in Southeast Asian countries due to the JE virus range from 4 to 37%. In the beginning of the JE project, some members of governments, the public, and media were concerned about why their country still had AES cases after introducing JE vaccination. When feasible, PATH helped countries set up surveillance and/or conduct laboratory testing to determine the proportion of AES due to JE both before and after vaccine introduction. Total AES cases typically do decrease following JE vaccine introduction, as seen in countries like Nepal,¹⁰ but will not completely disappear and are still subject to outbreaks and increases due to other, non-JE pathogens. The project team learned the importance of explaining the many etiologies of AES and setting the right expectations for monitoring according to each country’s current surveillance system and capacity.

Safety monitoring is necessary for surveillance of adverse effects following immunization (AEFIs) to ensure the safety of a new vaccine and health worker compliance with proper storage, handling, and administration procedures. For JE vaccines, the availability of AEFI monitoring data from several countries went a long way toward increasing public confidence in CD-JEV and in countries’ immunization programs. Crisis communication planning—including the development of messages, independent investigation teams, and a response plan for how to address potential concerns or misinformation about vaccine safety that could circulate in local or national media—also proved invaluable for maintaining public confidence.

Finally, new vaccine introductions should also monitor the effects of the new vaccine on coverage of other routine vaccines. This is a primary purpose of post-introduction evaluations (PIEs). The JE project team observed the importance of PIEs for monitoring not only the acceptability of new JE vaccine introduction, but also the potential for subsequent new vaccines to affect coverage of JE vaccines.

By planning for the future of vaccination programs and the necessity of measuring impact, safety, and conducting future PIEs before a vaccine is even introduced, programs can enable monitoring of safety and impact in order to build public trust in the program.¹¹ This is true not just for JE vaccination, but for all immunization programs. If countries are not already measuring vaccine impact, programs may want to consider the reasons why—e.g., lack of awareness, lack of prioritization, lack of planning, or lack of capacity or infrastructure—and develop strategies to address these reasons across the EPI as part of a new vaccine introduction.

Planning for vaccine supply, demand, and procurement lays a foundation for vaccine supply security that will be crucial for preventing delayed or interrupted supplies.

Vaccine, device, and cold chain forecasting provides a projection of demand—both now and in the future—for countries, vaccine manufacturers, and procurers like UNICEF and Gavi and is the first step in establishing security for vaccine supply and demand. Having an accurate demand forecast helps ensure adequate immunization supplies free from unexpected shortages or excesses, which can increase costs and result in delays or interruptions in vaccination programs. Because PATH worked directly with the manufacturer of CD-JEV, the team also needed accurate forecasting to provide guidance on how much manufacturing capacity would be needed.

In order to ensure the sustainability of not just one specific vaccine, but of all vaccination programs, planning for surveillance, monitoring, demand forecasting, and vaccine procurement must be a prioritized part of vaccine introduction products.

Procurement, the process of purchasing and shipping the vaccine and related supplies, is another step that requires careful planning to avoid delays or interruptions. For JE vaccine procurement, two main options are available to countries: (1) self-procurement, where a country takes full ownership and responsibility for procuring vaccines; or (2) delegation to a procurement agency, such as UNICEF. Pooled procurement, a third option where countries form a buying group to share supplier and pricing information and have joint tenders and contractors with vaccine manufacturers, does not yet exist in the JE-endemic region. Throughout the course of the JE project, some countries took full ownership of procurement but were not always aware of all the necessary steps involved, leading to delays with national regulatory approvals. Others, like Cambodia and Laos, delegated procurement to UNICEF. Making sure countries are aware of the options and requirements involved with each method was an important lesson learned by the project team. In the future, alternative methods such as pooled procurement for JE vaccines may merit consideration.

While PATH’s nearly 20 years of working on JE vaccines are largely coming to an end, a new story is beginning. Several challenges lie ahead. Many JE-endemic countries with large populations have yet to fully introduce JE vaccination in all endemic districts. Current efforts must be supported and sustained. Disease, demand, and vaccine supply may change drastically in the face of climate change, urbanization, rice irrigation, and natural disasters. The global community must work together to ensure a sustainable supply of CDJEV and other WHO-prequalified JE vaccines, listening to countries’ concerns and collecting and utilizing new data around long-term protection, safety, and impact monitoring. Having multiple manufacturers and types of JE vaccines will improve sustainability and supply.

Additionally, other new vaccines and global efforts, like the elimination of polio, will affect the demand and uptake of existing vaccines such as JE. Several countries have already seen these competing priorities rising to the surface above JE vaccines, further delaying introduction or expansion of programs.

In order to ensure the sustainability of not just one specific vaccine, but of all vaccination programs, planning for surveillance, monitoring, demand forecasting, and vaccine procurement must be prioritized during vaccine introduction projects. Identifying the end goal and planning the steps needed to reach it are the best way to achieve desired results.

The five lessons outlined in this report—meeting countries where they are; prioritizing public health; working together; deciding with data; and planning for the future—represent the keys to the success of global efforts to combat JE. Through strong partnerships and sharing lessons for others to learn from, new vaccine introductions can achieve unprecedented success for global health.

After widespread JE outbreaks began in 2014 and enhanced surveillance showed wide-spread endemicity, the Myanmar Ministry of Health and Sports (MOHS) committed to introduce JE vaccination. At a 2015 stakeholder meeting organized by MOHS and PATH, Myanmar committed a bold pledge to immunize all children from 9 months to 15 years of age against JE.

Over the next year, the MOHS worked with WHO, UNICEF, and PATH—all of whom became supporting members of the central Expanded Programme on Immunization (cEPI)’s JE Vaccination Technical Task Force—on a comprehensive introduction plan and submitted a successful Gavi application for JE vaccination funding. The plan was to begin with a nationwide JE vaccination campaign of all children between 9 months and 15 years—the ages with the highest risk of contracting JE—and then subsequently integrate the vaccine into routine immunization.

Myanmar’s JE vaccination campaigns took place in November and December 2017 and reached more than 12 million children in all regions, covering 92.5% of the country’s children under the age of 15. School-based campaigns reached older children, and community-based campaigns reached younger children. Then, in January 2018, the cEPI transitioned JE vaccine into Myanmar’s routine immunization schedule. Since then, all children have been scheduled to receive JE vaccine at 9 months of age alongside other routine vaccines.

The success and quick implementation of Myanmar’s JE vaccination program is due to the commitment of its leaders to protecting children, strong support and coordination with partners, and importantly, careful planning. The campaign Technical Task Force worked diligently to develop detailed campaign guidelines, plan and monitor cold chain logistics and financial coordination, develop training and educational materials, roll out social mobilization activities, prepare crisis communications plans, and monitor campaign delivery to provide recommendations for areas in need of strengthening. The MOHS’ existing surveillance program provided crucial evidence for decision-making and enabled ongoing monitoring of the vaccine’s future impact. Finally, a post-introduction evaluation conducted with PATH support in early 2019 helped the National Immunization Program identify strengths and problem areas, providing valuable lessons for future vaccine introductions.

¹⁰ Upreti SR, Janusz KB, Schluter WW, et al. Estimation of the impact of a Japanese encephalitis immunization program with live, attenuated SA 14-14-2 vaccine in Nepal. The American Journal of Tropical Medicine and Hygiene. 2013;88(3):464-468.

¹¹ For additional country guidance on vaccine monitoring, see Module 6: Is My Country’s JE Vaccination Program Working? from Navigating Vaccine Introduction: A Guide for Decision-Makers—Japanese Encephalitis.

This is the fifth lesson in Approaching vaccination from end to end: Five lessons from more than 15 years of advancing Japanese encephalitis vaccination, a report developed by PATH's Center for Vaccine Innovation and Access.

View or download the report as a PDF.