The Integrated Global Action Plan for Pneumonia and Diarrhoea (GAPPD) was launched last month. Now this week we’ve learned that a new rotavirus vaccine from India, Bharat Biotech‘s ROTAVAC, looks promising, and The Lancet featured results from the Global Enteric Multi-Center Study or GEMS, which offers a comprehensive look at the causes of diarrhea in children, such as rotavirus. In light of this recent news and its impact on efforts to prevent and treat diarrheal disease, especially rotavirus, we sat down with Mathu Santosham, MD, MPH. Dr. Santosham co-chairs the ROTA Council and also chaired the Data Safety and Monitoring Board for the ROTAVAC trial established to protect the participating infants’ rights and needs during the trial.

Why is all of this recent news important for children?

Santosham

Mathu Santosham, MD, MPH

We know that pneumonia and diarrhea are the leading killers of children under 5 worldwide, and we know that we need an integrated approach that uses all proven tools to tackle these two illnesses and prevent unnecessary suffering and death. GAPPD is important because it provides a framework, designed to inform global and national programs and policies, for integrating efforts against these two child killers. It sets ambitious but achievable goals including reducing under-five pneumonia and diarrhea deaths to 3 per 1,000 live births and 1 per 1,000 live births, respectively. A big part of the strategy for tackling both illnesses is vaccination.

For diarrhea, we know rotavirus – a pathogen for which there is a vaccine – is the leading cause of severe diarrhea among infants and children. In fact, the active surveillance results announced from the seven sites in GEMS reaffirmed this understanding, and offered important insights that will help better target interventions to the pathogens like rotavirus that are causing the most diarrhea. We also know that rotavirus contributes significantly to child mortality. According to the most recent estimates, more than 450,000 children died from rotavirus diarrhea in 2008. Rotavirus vaccine is critical to protecting children from rotavirus and preventing illness and death.

There are currently two licensed rotavirus vaccines, and they are saving lives and improving health today in the countries where they are in use. Having an additional vaccine from an Indian manufacturer will expand the market, which will offer more options to protect children in India and around the world. If licensed, Bharat has committed to offering the initial frozen formulation at $1 per dose, which will increase market competition for countries and organizations procuring vaccine. Also, it is especially encouraging to see India making so much progress toward a vaccine because nearly one-quarter of rotavirus deaths occur in India.

Why is rotavirus such a large concern?

Rotavirus is highly contagious and can last for long periods of times on hands and surfaces. It is not adequately prevented by proper hygiene or improvements in water and sanitation, like other pathogens that cause diarrhea. So even children in developed countries are susceptible to contracting rotavirus. In fact, nearly every child will be infected at least once by the age of 5. Once infected, a child often experiences symptoms that include fever, vomiting, and diarrhea. In developed countries where access to care is more reliable, children are unlikely to die from this infection, but in developing countries, children are less likely to have quick access to oral rehydration, making them at risk to suffer severe dehydration. This can lead to hospitalization and even death. In addition, children who suffer from malnutrition are more vulnerable to diarrhea, and diarrhea in turn worsens their malnutrition, resulting in a vicious cycle. For these reasons, rotavirus is a concern worldwide, but especially in developing countries.

What can we do about rotavirus?

Rotavirus cannot be treated with antibiotics or other drugs. However, its symptoms can be alleviated by prompt use of oral rehydration therapy (ORT), which includes home available fluids, oral rehydration salts (ORS), and, in cases of severe dehydration, IV fluids. ORT can effectively treat most rotavirus infections, but when the treatment is received too late, rotavirus can be deadly. In India, only about 4 in 10 children receive ORT when they have diarrhea. Vaccination, on the other hand, can actually prevent rotavirus diarrhea from happening in the first place. The two currently licensed vaccines, Rotarix and RotaTeq, have been demonstrated to be safe and effective and have been introduced in more than 45 countries. When combined with ORT, zinc supplementation, breastfeeding, and improvements in nutrition, hygiene, and water quality, vaccines contribute to the comprehensive approach required to effectively prevent severe illness and deaths caused by rotavirus diarrhea. 

What is ROTA Council doing about this problem?

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Dr. Santosham with other members of the ROTA Council at the International Rotavirus Symposium in Bangkok, September 2012.

The ROTA Council, which I co-chair with Dr. Ciro de Quadros of Sabin Vaccine Institute, is a dedicated team of technical experts with the mission of saving children’s lives by accelerating the introduction of rotavirus vaccines. We work at the global and country level to ensure that policy makers have the latest evidence-based information to inform their decisions about introducing and scaling up rotavirus vaccines as part of broader diarrhea control efforts. At the same time, many of our Council members are on the frontlines of research, conducting the studies needed to demonstrate vaccine efficacy, safety, and impact. We are pleased to see that more than 45 countries have introduced rotavirus vaccines, but many more are still leaving their children unprotected, particularly in Asia, where countries have been slow to introduce the vaccine.

Why should India and other low- and middle-income countries introduce rotavirus vaccine?

Rotavirus diarrhea is a ubiquitous problem that can have some very serious consequences. In India, and other countries where access to care can be quite unequal, prevention becomes even more critical. If left untreated, rotavirus infection can lead to unnecessary illness, hospitalization, and even death, which is not only concerning from a health standpoint, but also takes a very serious toll from a social and economic standpoint. Hospitalization for one child with rotavirus costs nearly the entire amount of an average Indian household’s spending in a month. Diarrhea related healthcare needs are also costly for the country and stretch its already burdened state healthcare system. Beyond direct costs, vaccination could avoid productivity losses and help children grow into healthy, educated, productive adults.

The vaccine has the potential to make a big difference in the lives of families around the developing world. In India alone, we could prevent tens of thousands of deaths, not to mention nearly 300,000 hospitalizations and more than 300,000 doctor visits, which amounts to savings of over US$20 million in medical costs.

Based on your experiences, what is your hope for India and the rotavirus vaccination?

As a medical student in India in the 60s I saw children dying of diarrhea every day. Over the years, we were fortunate enough to develop powerful treatments like ORT, which helped to reduce the number of diarrheal deaths per year from 5 million in 1980 to less than a million now. However, more than 700,000 children continue to die from diarrhea annually because they don’t get the necessary treatment on time. Rotavirus is the leading cause of these diarrheal deaths, and it is a tragedy to see a child die from rotavirus when we have such a powerful weapon to combat this disease. It is my sincere hope that every child in India will soon have access to this life-saving vaccine.

 

Mathuram Santosham, MD, MPH, is Co-Chair of the ROTA Council and Professor of Pediatrics and International Health at Johns Hopkins University. He also serves as Director of the Center for American Indian Health, Director of the International Center for Maternal and Neonatal Health, and a Senior Advisor at IVAC.