View inspirational photography from our landmark campaign in this slideshow. Photo: PATH.
PATH’s work on Japanese encephalitis helps millions get access to a lifesaving vaccine
Communities across Asia are celebrating new hope in the fight against Japanese encephalitis (JE): the arrival of a lifesaving vaccine to protect their children from the incurable disease known as “brain fever.”
PATH and our partners led an 11-year effort to turn a little-known vaccine from China into an internationally approved tool to fight JE. By the end of 2017, the JE vaccine is expected to reach an estimated 305 million people—a turning point in the battle to protect children from this dreaded disease.
This is the story of how PATH and our many partners put the JE vaccine on the fast track, redefining what is possible in global health and saving millions of lives.
“Neither alive nor dead”
Transmitted to humans by mosquitoes, JE begins like the flu, progresses to a brain infection, and ends by killing up to 30 percent of its victims and leaving thousands more with permanent brain injuries.
There is no treatment. The only viable solution is prevention through vaccination. But until PATH launched our work in JE in 2003, tens of thousands of children died or were disabled each year for lack of an accessible, affordable, and reliable vaccine.
Because JE mainly strikes poor rural communities in Southeast Asia and the Western Pacific, it historically received little attention. Yet approximately 3 billion people live in areas at risk for JE, and up to 70,000 cases are reported annually.
Up to half of survivors suffer permanent neurological damage, such as paralysis, recurrent seizures, or the inability to speak. It affects boys like Mahesh, who was once among the brightest in his school in India and now sits in the back of the classroom barely aware of his surroundings, and girls like Shekaramma, described by her grief-stricken mother as “neither alive nor dead.”
A growing awareness
In the early 2000s, PATH began to suspect that JE was a bigger problem than previously realized. Health workers in India routinely voiced concerns about JE, and improved disease surveillance suggested a high incidence.
In 2003, we secured a grant from the Bill & Melinda Gates Foundation to tackle JE. Our goal was to understand the disease, determine the health and economic burden it placed on countries, and prepare the way for a vaccine that would safely and affordably prevent it.
We began by helping private-sector partners develop standard diagnostic tests, and we worked with the World Health Organization (WHO) and governments to set up surveillance systems and a web-based platform for sharing data about JE incidence. These efforts allowed countries to understand the extent of JE, prioritize it, and focus prevention efforts on the regions and people most needing protection.
Hope from a hidden vaccine
Then, in 2005, a devastating JE outbreak killed nearly 2,000 people in India and Nepal, mostly children. Media coverage focused international attention on JE, while governments strengthened their resolve to protect their young people.
However, affected countries didn’t have the resources to develop the needed vaccine, and wealthy countries didn’t have the incentive.
In truth, vaccines against the disease actually existed, and international travelers to Asia were routinely vaccinated against JE. But the commonly used vaccine had significant drawbacks—three doses were required, and it was extremely time-consuming and expensive to produce. There simply wasn’t enough funding or vaccine for all the children who needed it.
In search of a solution, PATH surveyed the field for a better JE vaccine. We discovered that one JE-affected country had already developed an affordable vaccine. China had vaccinated more than 200 million children with its vaccine, known as SA 14-14-2. The vaccine, made from active but weakened virus, was safe, effective, and required only one dose. But it was virtually unknown outside the country—and might have stayed that way had PATH not infused innovative thinking into JE control and played a bridging role between partners around the world.
With the vaccine identified, PATH collaborated with international partners and ministries of health in Asia to accelerate its introduction. Because SA 14-14-2 had not been used widely outside of China, international officials called for specific clinical studies. PATH collaborated with the manufacturer, WHO, and ministries of health on pivotal clinical trials to help prove the vaccine was safe and effective.
We also supported clinical trials to confirm that the vaccine can be given at the same time infants get their measles shots, making it easier to fit into existing immunization programs. To help countries plan for the vaccine’s introduction, we modeled the cost-effectiveness of immunization strategies.
The vaccine also needed to be affordable for use in low-income countries, so PATH negotiated with the vaccine manufacturer—Chengdu Institute of Biological Products (CDIBP)—to establish a special public-sector price.
India and beyond
In the hot summer sun of 2006, just a year after the deadly JE outbreak, millions of Indian children lined up outside village clinics, schools, and community centers for the lifesaving protection of the new vaccine. India and Nepal were the first countries outside of China to introduce the SA 14-14-2 vaccine through mass campaigns and routine immunization services. They were soon followed by Cambodia, Sri Lanka, and the Democratic People’s Republic of Korea (North Korea).
By 2014, PATH helped supply the vaccine to six countries outside China for one-time campaigns and routine use, and the vaccine had reached more than 221 million people. Throughout this period, PATH and our partners provided technical assistance to countries—from developing introduction strategies to implementing and evaluating immunization programs.
A leap forward
We were also helping the vaccine manufacturer, CDIBP, pursue WHO prequalification as the critical next step in expanding access. Both the vaccine and CDIBP underwent rigorous inspections to ensure they met international standards of quality, safety, and efficacy. PATH provided CDIBP with technical and financial support to meet these standards. We also assisted in the design and financing of a new manufacturing facility to ensure high-quality, adequate, stable, and affordable vaccine supply.
WHO gave its critical stamp of approval in 2013. Prequalifying the vaccine allows United Nations procurement agencies to purchase the vaccine. It also opened the door for the vaccine’s inclusion in the portfolio of Gavi, the Vaccine Alliance, which provides vaccine financing for low-income countries where the burden of JE is especially high.
In 2015, Laos became the first country to receive Gavi support to complete a nationwide immunization campaign, building on earlier campaigns supported by PATH and our partners that reached children in eight provinces. The Laotian government plans to include the vaccine in its routine immunization program following the campaign.
The JE vaccine also marks China’s entrance into the global vaccine marketplace. It is the first vaccine ever produced in China to receive WHO prequalification, with the potential to foster a more competitive vaccine manufacturing market and fundamentally shift how vaccines are made, delivered, and priced for the developing world.
Rolling out hope
PATH continues to be intimately involved with JE control, advocating for use of the vaccine and leading a multicountry project that builds on the best practices we developed to introduce and scale up JE vaccination.
The day when all children at risk of JE are protected by a safe, effective, and affordable vaccine is now within reach.