Bill & Melinda Gates Foundation

After 40 Years, a Rotavirus Vaccine for Newborns Is in Sight

August 21, 2013

The clinic is buzzing with mothers, babies and small children. The babies are weighed and measured, and given vitamins and vaccinations. Outside the gates, the village has gathered, with vendors selling snacks and colorful plastic toys. We’re here for Immunization Day. We’re also here helping Indonesia make history.

Working together with the teams from the Universitas Gadjah Mada and Bio Farma, the Indonesian vaccine manufacturer, as part of the RV3 Rotavirus Vaccine Program, we are studying an innovative rotavirus vaccine that could save thousands of children’s lives and prevent sickness for hundreds of thousands more each year. A vaccine four decades in the making.

It’s a rotavirus vaccine for newborns, and this village is a part of the vaccine trial.

Rotavirus is the most common cause of severe diarrhea. Every year, the disease claims the lives of nearly half a million children globally, and hospitalizes millions more. In Indonesia, rotavirus remains a leading cause of death in children under age 5, and a significant cause of childhood hospitalization. According to recent surveillance efforts, 60 percent of diarrhea-related hospitalizations in children across six Indonesian provinces were for rotavirus.

Improvements in drinking water, sanitation and hand-washing are critical for disease control, but they cannot stop the spread of rotavirus. Rotavirus vaccines are the best tools we have today to protect children from this severe, deadly diarrhea. In fact, the World Health Organization recommended all countries include rotavirus vaccines in their national immunization programs.

Before rotavirus vaccines were available, almost every child in the world, no matter where they lived or how wealthy their parents were, would have contracted rotavirus at some point before their third birthday. Now this is changing, thanks to recent immunization efforts.

Today, there are two rotavirus vaccines on the market, providing good protection against rotavirus. The first dose of these vaccines is typically administered between 6-8 weeks of life. RV3, the new vaccine being tested by our team, is derived from a strain of the virus found in newborn babies that did not cause illness. This vaccine may provide protection against rotavirus even earlier in life. In fact, we are examining whether it is possible to administer the first dose of this new vaccine in the first days of life.

Not only does a rotavirus vaccine for newborns have the potential to begin protecting children from birth, the timing of the first dose may also help to reach more Indonesian babies. The reason is this: some mothers live far from health centers, and may not come in contact with health workers—except to give birth. Administering the first vaccine dose shortly after birth, when a woman and her baby may already be in a health care setting, could help reach those infants whose mothers do not have easy access to health centers.

There is a strong desire to implement rotavirus vaccines in Indonesia and other middle-income countries, which are not eligible for vaccine financing support from organizations like the GAVI Alliance, but so far the costs have been prohibitive—something reflected in the relative slowness in rotavirus vaccine uptake in these countries. The goal of the RV3 Rotavirus Vaccine Program is to develop a safe, effective, affordable vaccine aimed at preventing rotavirus diarrhea from birth.

While the hope is to develop and introduce RV3 for infants within the Indonesian National Immunization Program and then to make it available for global procurement, we are still a few years away from seeing this vaccine on the market. Right now, clinical trials are examining its safety and efficacy—bringing together many partners across the world, including, in Indonesia, two regional hospitals, 23 primary healthcare clinics and more than 35 doctors and 300 midwives.

Preventing rotavirus saves lives. The mothers at the clinic know this, and they are proud of the part they’re playing in the vaccine trial, just as they are relieved that their babies could be protected from rotavirus diarrhea. As my colleagues and I walk back to the car at the end of the day, the mothers press small gifts of food into our hands. All I can think of is the gift they are giving infants across the world: a chance at a healthy life, from the very earliest opportunity.

To learn more about how you can get involved in reducing diarrheal deaths, visit DefeatDD.org or the ROTA Council. 

Dr. Julie Bines is a pediatric gastroenterologist heading the Rotavirus Vaccine Program for RV3 at the Murdoch Children’s Research Institute (MCRI), The University of Melbourne and Royal Children’s Hospital. She is also a member of the Rotavirus Organization of Technical Allies (ROTA) Council. MCRI and Universitas Gadjah Mada are collaborating with Bio Farma to develop the RV3 rotavirus vaccine. Bio Farma manufactures vaccines for Indonesian children and for children around the world, and has WHO prequalification status for a number of vaccines. This longstanding collaboration was recently recognised in Indonesia by the prestigous Innovation award (KIN award).

 
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