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Diarrheal Disease: The Unfinished Agenda

This post originally appeared in Impatient Optimists on November 9, 2015.

By Dr. Mathuram Santosham

In 1980, the first summer I worked on the White Mountain Apache reservation, a community of fewer than 10,000 people in Arizona, so many babies were dying of diarrhea that we buried one every week.

To combat this major problem, we trained community outreach workers to give oral rehydration solution (ORS)—a mixture of sugar, salt and safe water—to babies and young children sick with severe, dehydrating diarrhea. Over time the practice spread and diarrhea deaths in the community dropped to nearly zero.

Proven solutions like ORS, vaccines and better sanitation and hygiene have dramatically reduced childhood diarrhea deaths around the world—from 5 million deaths in 1980 to 600,000 today.

But it’s not just deaths we have to worry about. Illnesses are a major issue too. As the rate of diarrhea deaths have dramatically come down, incidence has barely decreased at all. Children continue to experience an average of three episodes of diarrhea each year. A case of severe diarrhea, especially during important development stages in a child’s life, can have a lasting impact on physical and cognitive growth. Diarrhea can also make children more susceptible to death from other causes like pneumonia.

Recently, at TropMed in Philadelphia, recent progress in global efforts to protect children from diarrhea was hailed and the unfinished agenda highlighted.

Here are four critical things we need to do to protect children from diarrhea:

1. Expand access to ORS.

Children sick with severe diarrhea can be fully rehydrated within a few hours when provided with ORS. However, only one-third of children in low- and middle-income countries who need ORS get it.

2. Improve nutrition and be sure to feed children suffering from diarrhea to stop the vicious cycle of malnutrition and diarrhea.

Malnutrition weakens immune systems, making children more vulnerable to infections like diarrhea. Diarrhea, in turn, prevents children from absorbing nutrients, contributing to malnutrition. This creates a vicious cycle. Because of malnutrition, one in five children worldwide is moderately to severely stunted. Children with two to three diarrheal disease infections a year suffer an average of 8 cm growth loss and a 10 IQ point loss.

Making the situation worse, many caregivers withhold food from children and babies when they are suffering from diarrhea. It is very important to continue feeding children appropriate food during an episode of diarrhea.

3. Vaccinate all children against rotavirus, the leading cause of severe and deadly diarrhea.

Rotavirus causes 40% of diarrhea hospitalizations—and 200,000 deaths in children under 5 each year. Unlike other forms of diarrhea, rotavirus infections cannot be controlled by hygiene and sanitation alone. Vaccines are essential to prevention.

Two rotavirus vaccines are available and have been internationally licensed since 2006. These vaccines are currently used in the national immunization programs of nearly 80 countries. Despite this, only 15% of the children in Gavi countries—the world’s poorest—have access to this life saving vaccine. Even in countries where rotavirus vaccines are used, the poorest children often do not get vaccinated.

In the US, use of rotavirus vaccines led to a striking decline in rotavirus-related hospitalizations. In some years, there are almost no cases observed. Yet because coverage is still not routinely high (it’s varies geographically from 59-88% now), the accumulation of unvaccinated infants periodically leads to outbreaks. In the US, rotavirus vaccine coverage must be improved.

Worldwide, more than 90 million children still don’t have access to rotavirus vaccines. In countries where the most diarrhea deaths occur, almost none have introduced the rotavirus vaccine, despite considerable evidence of its public health impact, cost saving potential and the prospect of introduction support from Gavi, the Vaccine Alliance.

Public health impact has been dramatic in low- and middle-income countries where rotavirus vaccines have been introduced. In Mexico, the vaccine led to a decrease by 50% in diarrheal deaths in children under 5.

Countries that do not already include the rotavirus vaccine in their national immunization program should consider the striking public health and economic benefits and take steps to introduce it as soon as possible. Countries that do, should work to ensure good coverage.

4. Develop new, low-cost rotavirus vaccines to help reach all children.

New rotavirus vaccines are in the pipeline and could help to accelerate coverage. Companies in China, India, Indonesia and Vietnam are developing new vaccines with prices as low as US$1.00 per dose for governments (such as Bharat Biotech’s ROTAVAC, which India is rolling out soon in four states). There are not yet enough doses of these new vaccines to cover all children in the countries where they are being produced, much less the millions of children around the world who are in need of this vaccine. Yet with new product licensures expected as soon as 2017, the product landscape could be quite different very soon.

One thousand children per day still die from diarrhea—a preventable tragedy. We’ve made progress, but we can do much better.

As Nobel Laurate Gabriela Mistral said:

“We are guilty of many errors and many faults, but our worst crime is abandoning the children, neglecting the fountain of life. Many of the things we need can wait. The child cannot. Right now is the time his bones are being formed, his blood is being made, and his senses are being developed. To him we cannot answer ‘Tomorrow,’ his name is today.”

The Integrated Global Action Plan for the Prevention and Control of Pneumonia and Diarrhea goal is to reduce mortality from diarrhea in children under 5 to fewer than 1 per 1,000 live births. This is a very ambitious goal but we know it is possible as long as the public health community can work together and garner political support. We need to make it happen.

To learn more about how you can get involved, visit this page.

Dr. Mathuram Santosham is Chair for the Rotavirus Organization of Technical Allies (ROTA) Council, Director of the Johns Hopkins Center for American Indian Health, and Senior Advisor for the International Vaccine Access Center (IVAC) at the Johns Hopkins University, where he is also a Professor of International Health and Pediatrics.

Vaccinate Against Rotavirus

This commentary, authored by Drs. Mathuram Santosham, Zulkifli Ismail, and Lee Way Seah, originally appeared in The Star on September 17, 2015.

From Kuala Lumpur to New York, global leaders are gathering this month to discuss the future of health and development. Critical to achieving the health goals launched at the UN General Assembly will be the paediatric issues discussed here in Malaysia this week, because preventable disease in children is still a serious public health – and economic – problem in much of the world.

Take diarrhoea, for example. Diarrhoea is a leading cause of child illness and death, and rotavirus is the most common cause of severe diarrhoea.

Addressing diarrhoeal disease, and rotavirus in particular, is key to improving child health here and in countries around the globe.

Annually, rotavirus results in dozens of deaths and more than 8,500 hospitalisations for gastroenteritis in Malaysian children under the age of five years.

These illnesses can have devastating consequences. Children who recover from a serious case of diarrhoea are more susceptible to the next illness that strikes. And since it takes two months for the intestine to fully repair itself after a bad bout of rotavirus, children cannot absorb nutrients as well, which can slow their growth during crucial stages of development.

In addition, treating rotavirus is expensive for both families and the nation. The typical out-of-pocket cost of hospitalisation for rotavirus in a 2006 study was RM833, and ranged up to RM3,170 – more than one quarter of the average monthly income of households surveyed.

Costs extend beyond hospital fees, since parents would miss many days of work each time their child is hospitalised with rotavirus. Children with rotavirus illnesses are likely to be severely dehydrated upon admission to hospital.

Because children can become infected with rotavirus and other causes of diarrhoea more than once, preventing illness in the first place is critical.

Vaccination is the best way to protect children from rotavirus. While improvements in hygiene, sanitation and drinking water are important to prevent diarrhoea in general, they cannot stop the spread of rotavirus.

Though the World Health Organization has recommended that rotavirus vaccines be introduced into every country’s national immunisation programme, in Malaysia the vaccines are only available in the private market. This means parents have to pay full price for the vaccine, so it can be out of reach for many families.

These vaccines are improving the health of millions of children, reducing healthcare costs and saving lives today in countries where they are in use. In the first four years of use in the United States, rotavirus vaccines prevented more than 176,000 hospitalisations, 242,000 emergency department visits and 1.1 million doctor’s visits among children under five years old, saving nearly US$1bil in healthcare costs. Two years after the introduction of the vaccine in Australia, there were over 6,500 fewer rotavirus-related hospitalisations in children under five years old. And in clinical trials in Asia, rotavirus vaccines were shown to reduce the risk of severe rotavirus diarrhoea by more than half – 51% – in the first year of life when children face the greatest risk of infection.

Globally, 77 countries have introduced rotavirus vaccines into their national immunisation programmes, including Muslim countries like Bahrain, Iraq, Morocco, Qatar, Saudi Arabia, Sudan and Yemen. Yet, not a single Asian country has introduced rotavirus vaccines nationally.

It’s time to protect all children from a disease that places tremendous burden not only on babies and small children who are hospitalised and sick, but also on the parents who worry at bedsides and shoulder the cost of treatment. The illnesses, anguish and hospitalisations can be prevented in the first place through vaccination.

We call on Malaysian and Asian leaders to stand up for our children by introducing rotavirus vaccines into national immunisation programmes. By doing so, we can take significant strides toward achieving the new global health goals.

Millions of children around the world have already benefited from these vaccines. Millions here in Asia depend on us. Let’s not let them down.

This commentary was also highlighted in Global Health Now on September 22, 2015.

For Rotavirus, Prevention is the Best Medicine

This commentary originally appeared in Global Health Now.

World Immunization Week provides a moment to reflect on the tremendous progress in reducing one of the world’s leading killers of children—diarrhea.

While oral rehydration solution has significantly reduced diarrheal disease mortality since its adoption in 1978, diarrhea continues to be a major cause of childhood illness and death globally. Rotavirus, the most common cause of severe diarrhea, is responsible for approximately 40% of all diarrhea hospitalizations and hundreds of thousands of deaths in children under 5.

Rotavirus vaccines offer the best protection for children and are an essential part of comprehensive diarrhea control. While the WHO recommends that all countries introduce rotavirus vaccines, only 77 have done so, 34 of which are Gavi-eligible countries where many of the deaths occur. Unfortunately, some of the most vulnerable children and communities do not have access to the vaccine.

In particular, Asia has lagged in introducing rotavirus vaccines, even though it accounts for more than 40% of global rotavirus deaths. To date, no country in the region has introduced the vaccine into its national immunization program.

While dramatic reductions in deaths from childhood diarrheal disease have been achieved in Bangladesh, there are still more than 2.4 million rotavirus cases each year. It causes 2 out of every 3 diarrhea-related hospitalizations among children under 5. There are also serious economic consequences. One episode of rotavirus costs the average Bangladeshi family about USD $80 in direct hospital costs, a significant portion of average monthly income.

In neighboring India, where rotavirus is equally ubiquitous, the disease poses a significant financial burden to families and the country’s economy. Studies have shown that a hospitalization for rotavirus could potentially push a family into poverty or keep them there. Depending on the level of care, the total cost of a rotavirus hospitalization could range anywhere from nearly $32 to more than $135, equal to up to 2 months of income for an average Indian family. Rotavirus also burdens the healthcare system with the high cost of hospitalizations and outpatient visits. One study estimated that hospitalizations and outpatient visits cost India approximately $78 million and $86 million each year, respectively—each more than the estimated $72 million it would cost to fund a rotavirus immunization program.

For fast-growing countries like India and Bangladesh, tackling rotavirus—which cheats children and the nation of productivity, well-being and development—should be a priority. However, the available and effective rotavirus vaccines are not yet available in the national immunization programs of either country.

Many of my scientific colleagues in Bangladesh are making a good case to their leaders for national introduction of rotavirus vaccines. And, I’m inspired by the strides being made in India. Last July, Prime Minister Narendra Modi announced that rotavirus will be included in the Universal Immunization Programme; and just last month, the first India-made rotavirus vaccine, ROTAVAC, was launched. Now is the time to get to the finish line—the cost of delaying access to rotavirus vaccines continues to mount. Together we can close this immunization gap and virtually eliminate rotavirus.

Dr. Mathuram Santosham is the Director of the Center for American Indian Health, Chair of the ROTA Council, and Senior Advisor at the International Vaccine Access Center at Johns Hopkins Bloomberg School of Public Health. Dr. Santosham and his colleagues won an Honorable Mention in GHN’s Untold Global Health Stories Contest for their submission of rotavirus in Bangladesh and India. GHN will feature one Honorable Mention story per month from now until the next contest in early 2016.

Global Buzz for Rotavirus Vaccines

This post originally appeared on Impatient Optimists.

By: Mathuram Santosham

Heading to New Delhi, India recently for the Eleventh International Rotavirus Symposium, I knew that this meeting would be different. Over the past couple of years, notable advancements against rotavirus disease have occurred, including the development of a new indigenously developed vaccine in India, an enormous mass of studies with positive safety and effectiveness results, and many introductions of vaccines into national immunization programs, giving promise that we can beat this leading killer of children.

In the very first moments of my arrival, I learned that my expectations were right.

Never before have more people gathered at this symposium. An astounding 650 experts from 56 countries — more than 16 times as many people who attended our first meeting thirty years ago — came to the conference, themed,“Building on evidence: the case for rotavirus immunization.”

The sheer number and diversity of people are true testaments to the increasing awareness of rotavirus and the essential role of vaccines in reducing the suffering this disease causes.

Pediatricians, epidemiologists, researchers, policy makers, immunization program implementers, government officials and pharmaceutical representatives presented on and heard about a number of important topics. Panels ranged from the Latin American and African experience with vaccines and post-licensure impact and safety of vaccination, to immunity and new insights in strain diversity.

In addition, we discussed the critical policy challenges remaining and advocacy efforts needed to help overcome them. Advocacy among policy-makers, championed by my dear colleague and friend, the late Dr. Ciro de Quadros, along with groundbreaking vaccine development efforts and public-private partnerships are leading to greater prioritization of rotavirus; however, more must be done.

But what also stood out was the excitement of convening this biannual event in India. The new government has made laudable commitments to tackling the burden of rotavirus, and other leading childhood diseases, that will save lives and give all Indian children a chance at being healthy and productive.

Just two months ago, Indian Prime Minister Narendra Modi announced that the Government of India would provide a rotavirus vaccine to all Indian children through the Universal Immunization Program. At the same time, the government has redoubled efforts to improve access to oral rehydration solution (ORS) and other key diarrhea control interventions through its Intensified Diarrhea Control Fortnight. All of these efforts are positive signs for the children of India.

At the symposium, Dr. Harsh Vardhan, India’s Union Minister of State for Health and Family Welfare, spoke about the importance of delivering vaccines to all those in need. Too many children have lost their lives, and too many families are bearing tremendous economic consequences as a result of hospitalizations due to rotavirus. In India, rotavirus is estimated to cause more than 78,000 deaths, 800,000 hospitalizations and three million outpatient visits each year.

However, even with this momentum, we must not become complacent in addressing rotavirus disease, the leading cause of severe and fatal diarrhea in children under five years of age worldwide, killing between a quarter and a half million children each year. While children everywhere are at risk of infection, the majority of deaths occur in South Asia and Sub-Saharan Africa, where children do not have good access to care.

Yet, despite the World Health Organization’s (WHO) recommendation for all countries to introduce rotavirus vaccines in their national immunization programs, only 35 percent of countries worldwide (69) have done so. The most disappointing statistic for me is that only one country in Asia — The Philippines — has introduced the vaccine nationally.

Additionally, while vaccination is the best way to protect children from rotavirus, a comprehensive approach will best protect child health and boost immunity. Vaccination should be part of a broad strategy that includes improved water, sanitation and hygiene; good nutrition; breastfeeding; ORS; and zinc supplementation.

I am hopeful that when we meet again for the next symposium, two years from now, we’ll have even more scientific and policy progress to celebrate and build on. Thanks to all of the dedicated rotavirus experts who participated and whose work is making a lasting difference in the health and well-being of children everywhere.

Thanks also to the conveners and funders: the Bill & Melinda Gates Foundation, U.S. Centers for Disease Control and Prevention, Christian Medical College Vellore, Indian Council of Medical Research, National Institutes of Health Fogarty International Center, PATH, ROTA Council, Sabin Vaccine Institute, Bharat Biotech, GlaxoSmithKline, Merck Pharmaceuticals, Serum Institute of India, Ltd. and WHO.

Learn more about how rotavirus vaccines can improve health and save lives at

Rotavirus Vaccines – Balancing Intussusception Risks and Health Benefits

This commentary, authored by Dr. Roger Glass and Dr. Umesh Parashar, was originally posted on The New England Journal of Medicine on January 14, 2014.

In January 2006, the Journal published two landmark articles reporting the safety and efficacy of two different vaccines — RotaTeq (Merck), a pentavalent vaccine (RV5) and Rotarix (GlaxoSmithKline), a monovalent vaccine (RV1) — to prevent rotavirus, the most common cause of severe childhood diarrhea worldwide and of deaths from diarrhea in low-income countries. Each trial enrolled more than 60,000 infants to determine whether these live oral vaccines caused intussusception, the rare complication that in 1999 forced the withdrawal of the first licensed rotavirus vaccine, RotaShield (Wyeth Lederle), less than a year after it was recommended for routine immunization of U.S. children. The trials showed no significant risk of intussusception with either RV5 or RV1; however, further postmarketing surveillance was recommended.

Today, these vaccines are recommended by the World Health Organization for immunization of children worldwide, and their introduction into the national immunization programs of more than 50 countries has shown tremendous health benefits. In the United States, where routine rotavirus vaccination began in 2006, hospitalizations and emergency department visits for rotavirus have decreased by more than 80% among immunized children, and herd protection has been documented among nonvaccinated children and even adults. Similar results have been reported in many countries in which vaccine coverage has been high. Furthermore, in Mexico, deaths from diarrhea decreased by 40% after implementation of the vaccination program, providing the first demonstration of the lifesaving potential of these vaccines.

While assessing the huge and immediate impact of these vaccines on children’s health, Australia, Mexico, and Brazil, each of which has high vaccine coverage and well-tuned medical record systems, also detected a small but significant increase in the risk of intussusception, primarily in the 1 to 7 days immediately after administration of the first dose of vaccine. In the United States, the first hint that intussusception might occur after immunization was detected by the national Vaccine Adverse Event Reporting System (VAERS), which passively receives reports of any adverse events from physicians or parents. Two independent postmarketing surveillance studies were then initiated, the Vaccine Safety Datalink (VSD) program of the Centers for Disease Control and Prevention (CDC), which followed a cohort of children enrolled in six national health care organizations, and the Post-Licensure Rapid Immunization Safety Monitoring (PRISM) program of the Food and Drug Administration (FDA), which was based on surveillance of hospital discharge, emergency department, and outpatient clinic data from three large insurance groups.

The results of these studies, now reported in the Journal, provide the most comprehensive description of the risk of intussusception after immunization with each of the rotavirus vaccines in the United States. The two groups used several complementary methods to assess the relative and attributable risks — the self-controlled case-series method and a cohort design that used electronic records and a known population base. Both groups of investigators recognized the need to assiduously adjudicate cases of intussusception and confirm the vaccination status of the infants, and the PRISM group used a detailed sensitivity analysis to show that even if some cases were missed or improperly assigned, the results would remain significant. The very fact that it took more than 7 years to document a significant risk speaks to the relatively low rate of intussusception after immunization with either vaccine and the large populations required to assess this with confidence, as well as the need to have an established system in place to monitor such rare events.

The two studies appear to report contrasting results, but cautious interpretation is required. The VSD study showed a significant association of RV1 with intussusception but no significant increase in the risk of intussusception after vaccination with RV5, whereas the PRISM study was not powered to detect risk after vaccination with RV1 but identified a significant association of RV5 with intussusception.

The PRISM study showed that there were approximately 1.5 excess cases of intussusception per 100,000 vaccinees after the first dose of RV5, on the basis of 8 cases of intussusception detected among approximately 500,000 vaccinees in the critical 21-day postvaccination window. In contrast, the VSD study showed no increased risk of intussusception with RV5, on the basis of 4 cases of intussusception reported among 493,000 vaccinees within 7 days after the first dose. Of note, the confidence intervals of these two estimates overlap.

Because RV1 was implemented 2 years after RV5 in the United States, the risk assessment of RV1 is based on fewer vaccine doses. The VSD study showed a significantly increased risk of intussusception within 7 days after the first or second dose of RV1, on the basis of 6 cases documented among approximately 200,000 doses administered, results that were similar to those of the underpowered PRISM study, in which 3 cases of intussusception occurred within 7 days after the first or second dose of RV1 among approximately 103,000 doses administered.

The differences between the studies are marginal, and it appears that both vaccines cause intussusception at low rates; therefore, small variations in case detection and in confirmation of vaccination status, as well as chance alone, can introduce considerable uncertainty into the analysis. Furthermore, Australia, which is the only other country to contemporaneously use both rotavirus vaccines in its national immunization program, has found that the risk of intussusception is similar with the two vaccines.

What, then, is the message for the physician or nurse who administers rotavirus vaccines, and what is the implication for vaccine policy in developed countries? Certainly, the abundance of evidence in the United States and beyond indicates that intussusception can occur as a result of vaccination with either RV5 or RV1, but the risk is low, on the order of approximately 1 to 5 cases per 100,000 infants, with wide confidence limits. Given this low risk and the major impact that these vaccines have had on the reduction of hospitalizations, emergency department visits, and in some cases, deaths from diarrhea, policy makers have concluded that rotavirus vaccine remains a valuable addition to the national program for childhood immunizations. For example, in the U.S. cohort of 4.5 million babies born each year, vaccination is estimated to prevent approximately 53,000 hospitalizations and 170,000 emergency department visits for diarrhea, at the expense of causing 45 to 213 cases of intussusception nationwide.

Many questions remain to be resolved: Is the risk of intussusception similar with the two vaccines? What is the mechanism for the event? Can we identify a subgroup of infants who may be at increased risk? And will the findings of the risk of intussusception from high-income and middle-income countries extend to low-income countries, where these vaccines are known to be less efficacious and, thus, may be associated with a lower risk? Answers to these questions will remain for further study. However, despite lower efficacy in low-income countries, the public health benefits of rotavirus vaccines in these settings, where the vast majority of deaths from rotavirus occur, are likely to be substantial and outweigh a small risk of intussusception.

Dr. Umesh Parashar is a ROTA Council member and leads the CDC Division of Viral Diseases Enteric Viruses Epidemiology Team. He is the co-lead of the Advisory Committee on Immunization Practices Working Group, which developed recommendations for rotavirus vaccine use in the US. Dr. Roger Glass is a ROTA Council member, Director of the Fogarty International Center and Associate Director for International Research at the National Institutes of Health (NIH). Dr. Glass’ research focuses on the prevention of gastroenteritis caused by rotavirus and norovirus. 

You can read the original studies here:

Intussusception Risk after Rotavirus Vaccination in US Infants

Risk of Intussusception after Monovalent Rotavirus Vaccination

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

This commentary, authored by Dr. Julie Bines, was originally posted on Impatient Optimists on August 21, 2013 and the Jakarta Post on August 31, 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 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).

Study – Rotavirus Vaccines Work Well in Developing Countries

This commentary, co-authored by Drs. Ciro de Quadros and George Armah, was originally posted on All Africa on June 19, 2013.

Leaders of developing nations take note: a new study shows that rotavirus vaccines will have a powerful public health impact in your country. This pivotal study, just released in the British Medical Journal, shows that children who were vaccinated against rotavirus were 70 percent less likely to be hospitalized for rotavirus diarrhea compared to unvaccinated children. The vaccines also provided broad protection against rotavirus–even against strains of the virus not included in the vaccine–through the first two years of life, when children face the greatest risk of death from the dehydrating diarrhea rotavirus can cause.

The study, funded by the GAVI Alliance, examined the impact of introducing the rotavirus vaccine Rotarix (manufactured by GlaxoSmithKline) into the national immunization program of Bolivia, a lower-middle income country in Latin America. The findings provide the evidence other low and lower-middle income countries, such as those in sub-Saharan Africa, need to evaluate whether rotavirus vaccines are right for their children.

The study was conducted in Bolivia, but its implications are global.

Diarrhea is a leading cause of child death and rotavirus is the most common cause of severe and fatal diarrhea in young children. While unvaccinated children everywhere are at risk, those living in low and lower-middle-income countries with high child mortality due to rotavirus diarrhea, such as in regions of Africa, are more likely to die from rotavirus diarrhea than children in middle- and high-income countries.

In Africa, rotavirus kills more than 600 children each day and thousands more are hospitalized or require clinic visits, straining health care systems and resulting in lost productivity.

So, what does a study from Latin America have to do with Africa? A lot, it turns out. Both regions experience high rates of child mortality due to rotavirus diarrhea. Both have several different rotavirus strains circulating. And both have several countries eligible for vaccine introduction support from the GAVI Alliance. But the difference is, all the GAVI-eligible countries in the Americas are protecting their children with rotavirus vaccines.

Ninety-five percent of rotavirus deaths occur in countries eligible for support from the GAVI Alliance. Though the World Health Organization has recommended that all countries introduce rotavirus vaccines into their national immunization programs, only 45 countries have done so–just eight are in Africa. Twenty-two African nations applied and have received approval or conditional approval from GAVI to introduce rotavirus vaccines. But Benin, Chad, Comoros, Guinea, Ivory Coast, Liberia, Mauritania, Nigeria, São Tomé e Príncipe, Senegal and Somalia have yet to apply for rotavirus vaccine-introduction support, though they are eligible.

The Bolivian study findings provide precisely the kind of scientific evidence African decision-makers need to set priorities and guide smart policies and programs. Policymakers need to know that the interventions they are considering and investing in are proven and effective. As this study clearly demonstrates, rotavirus vaccines are both.

African nations considering whether or not to introduce rotavirus vaccines also need to understand the burden of diarrheal disease in their countries. Diarrhea is the second most common cause of death in children under five, but what does that mean at the country level?

Researchers like those who recently conducted the Global Enteric Multicenter Study (GEMS) of childhood diarrheal diseases in developing country settings are trying to help policymakers better understand the scope of the problem and its impact on child health and mortality.

Rotavirus was found to be the top cause of diarrhea across all of the GEMS sites, including those in Africa. The study concluded that “expanding access to existing tools to prevent and treat diarrhea–particularly rotavirus vaccines–can save a significant number of lives right now.”

Researchers are doing their part–building the evidence base and shining a light on the problem. Now it is time for African policymakers to do theirs. As one of the first lower-middle income countries in the world to introduce rotavirus vaccines, Bolivia has set an example not just for Latin America, but also for the world. African leaders have an opportunity to follow in its path. Who will step up next?

Dr. Ciro A. de Quadros is executive vice president of the Sabin Vaccine Institute and co-chair of the Rotavirus Organization of Technical Allies (ROTA) Council, an organization of technical experts working to save children’s lives and improve health. Dr. George Armah is a senior research fellow and associate professor at Ghana’s Noguchi Memorial Institute for Medical Research at the University of Ghana, and is also a member of the ROTA Council.

How Purchasing Power Can Help Prevent Child Deaths: Lessons for Asia from the Americas

This commentary, co-authored by Drs. Ciro de Quadros and Tony Nelson, was originally posted on on April 26, 2013.

While the recent cholera outbreaks tend to dominate health news coming out of Haiti, there is another dangerous disease that should be on the front page, but isn’t. It’s rotavirus diarrhea. Rotavirus is the most common cause of severe diarrhea in children worldwide, and the devastating dehydration it can cause is responsible for nearly half of all diarrhea deaths in Haitian children under age 5.

In a bold, headline-grabbing move, the Haitian government is taking action by arming its children with the best defense available—rotavirus vaccines. This week, with the support of the GAVI Alliance, Haiti will introduce rotavirus vaccines into its national immunization program, joining 16 other Latin American countries that have already introduced these vaccines. Haiti is the last of five GAVI-eligible countries in the Americas to introduce rotavirus vaccines. Vaccines are an essential tool in the fight against rotavirus because improvements in drinking water, sanitation and hand-washing, which can prevent other forms of diarrhea such as cholera, do not adequately prevent the spread of rotavirus.

As a region, Latin America has taken on rotavirus aggressively and the progress is profound. In Mexico and Brazil, deaths from all causes of diarrhea among children under age 5 declined by approximately 30 percent following the introduction of rotavirus vaccines in these countries’ national immunization programs. Sharp declines have also been observed in child hospitalizations for rotavirus, as well as diarrhea in general, in El Salvador, Nicaragua, Panama, Mexico and Brazil following rotavirus vaccine introduction.

Today, the countries with the greatest rotavirus burden—meaning not only deaths, but also hospitalizations and doctor visits—are found in Africa and Asia. Africa is making progress and vaccines are being introduced, but Asia has a long way to go. Only two Asian countries—the Philippines, which has implemented a targeted vaccine introduction strategy, and Thailand, which has made the vaccines available to an initial single region—have introduced these vaccines. With nearly half of all rotavirus deaths occurring in Asia, there is an urgent need for action in the region. The progress made in Latin America could illustrate a path forward.

One reason so many Latin American nations have been able to introduce rotavirus vaccines (and many other vaccines) is the Pan American Health Organization (PAHO) Revolving Fund for Vaccine Procurement, a mechanism to facilitate the bulk purchase of vaccines, syringes, cold chain equipment and related supplies. It’s had a game-changing impact. Taking advantage of economies of scale, the Fund secures vaccines—prequalified under World Health Organization standards of safety and effectiveness—for Member States at affordable prices. By purchasing through the Revolving Fund instead of directly from producers, countries can save on the purchase price, which quickly adds up when purchasing vaccine doses by the tens of millions.

Founded on the principle of equity, PAHO’s Revolving Fund works like this: all participating member states have access to the same products, offered at the lowest price, which is the same regardless of the country’s size or economic situation. Member States all contribute 3 percent of each net purchase price to a common fund used as working capital, so Member States in need can take out lines of credit to purchase their vaccines, repaying within 60 days of vaccine receipt. The Revolving Fund also handles key processes like planning, demand estimates, price negotiations, purchase orders, supply coordination, shipment monitoring and billing.

As a result, Latin American countries have had continuous access to safe and effective vaccines at low, stable prices for over 30 years. Not only does this assist national governments with budget planning, it fosters sustainable immunization programs. Today, the vast majority of vaccines being used in Latin America were acquired through the Revolving Fund. These vaccines reach some 44 million people, protecting them against diseases ranging from rotavirus to polio.

In addition to the Revolving Fund’s efforts, the GAVI Alliance also provides assistance for rotavirus vaccine introduction to the world’s lowest-income countries—those with a gross national income per capita of US $1,500 or below. But for the countries beyond the reach of the Revolving Fund and GAVI, particularly middle-income countries in Asia, more must be done.

That’s why we recommend that Asian governments use PAHO’s experience to establish their own mechanism similar to the Revolving Fund. Currently, policymakers in the region must guess the future price of rotavirus vaccines, making long-term budgeting impossible and vaccine introduction difficult. Just as it has in Latin America, transparency and stability of vaccine pricing would enable policymakers in Asia to expedite their decisions on including rotavirus vaccines in their national immunization programs, improving child health and saving lives.

As we mark World Immunization Week 2013, we call on leaders across Asia to prioritize the fight against rotavirus and to consider every option available to accelerating access to these vaccines. As Latin America has shown, smart buys can save lives.

Dr. Ciro A. de Quadros is executive vice president of the Sabin Vaccine Institute and co-chair of the Rotavirus Organization of Technical Allies (ROTA) Council. Before joining Sabin, he was director of the Division of Vaccines and Immunization at PAHO. Dr. Tony Nelson is a professor in the Chinese University of Hong Kong’s Department of Pediatrics, and a member of the ROTA Council.

Africa: Achieving Prosperity Through Disease Prevention

This commentary, co-authored by Drs. George Armah and Oyewale Tomori, was originally posted in This Day (Nigeria) and on January 28, 2013.

Healthy children grow up to build prosperous nations. A healthy child has the energy to learn more in school, help her parents with their farm or business and become a productive adult. Her parents can focus on their work instead of tending to a sick child. When children are healthy, the positive economic effects are felt not only within their families, but across communities and countries. Child health is the cornerstone of sustainable economic growth, stronger nations and a brighter future for our continent.

To ensure the health of our children, we must protect them from diseases like diarrhea. Despite the fact that it can be prevented and treated, diarrhea continues to take a devastating toll on Africa. It’s a leading cause of child death in Africa and globally, and it is responsible for sickening and hospitalizing millions of children.

In fact, rotavirus, the most common cause of severe, deadly diarrhea, claims the lives of more than 600 African children under age five each day. That’s nearly a quarter of a million of our children each year. In Nigeria alone, over 41,000 rotavirus diarrhea deaths occur annually, the second-highest of any country worldwide.

We can stop illnesses and deaths from diarrheal diseases using a comprehensive approach focused on preventing illness in the first place and treating children if they do become sick. Diarrhea can be prevented with an approach that includes exclusive breastfeeding, access to safe drinking water and improved sanitation and hygiene, as well as by using vaccines, like rotavirus vaccines. When children do become sick with diarrhea, they can be treated with oral rehydration solution (ORS)—a simple mixture containing sugar, salt and safe water and zinc supplements. However, in some cases, the severe dehydration diarrhea can lead to may require intravenous fluids and urgent medical care. For too many of our children this care is out of reach, which makes protecting them through prevention efforts, such as vaccination, essential to ending diarrhea’s deadly toll in Africa.

Today, the most powerful tools to prevent severe diarrhea caused by rotavirus, which causes approximately half of all diarrhea deaths in Africa, are rotavirus vaccines.

As researchers and doctors, we’ve been on the front lines, working to understand the impact vaccines, like rotavirus vaccines, can have in Africa. Today, the existing body of research is robust and demonstrates rotavirus vaccines provide broad protection against severe rotavirus diarrhea, even against strains not included in the vaccines. These vaccines have been shown to significantly reduce the number of diarrhea-related illnesses, hospitalizations and deaths among children.

Just months ago Ghana, introduced rotavirus vaccines and already more than 60 percent of eligible children have received the rotavirus vaccine. Six other sub-Saharan African countries—Botswana, Malawi, Rwanda, South Africa, Sudan and Tanzania—have introduced these vaccines into their national immunization programs. Zambia has introduced them regionally, and others—Angola, Burundi, the Central African Republic, Cameroon, the Republic of the Congo, Djibouti, Ethiopia, Guinea Bissau, Madagascar, Niger, Sierra Leone, Togo and Zimbabwe—are planning to include the vaccines in their efforts to control diarrhea. But many more countries need to be reached and there’s more work to be done to protect all of Africa’s children.  If, for example, Nigeria could introduce rotavirus vaccines into the routine immunization, the country would be preventing the deaths of thousands of children each year.

We have seen for ourselves that when children are protected from debilitating illnesses like diarrhea, they can grow up to learn better in school and be more productive, helping to lift their families, communities—and countries—out of poverty.

With this in mind, as our leaders gather at the African Union Summit to discuss the most pressing matters facing the continent, we want to remind them of a core AU objective: the eradication of preventable diseases. This work must start with our children. We must fight diseases that are taking children’s lives with the best tools we have. We know what is needed to stop diarrhea—a comprehensive approach. We urge our leaders to work toward an Africa where every child has access to prevention and treatment tools like vaccines, ORS and zinc that not only improve health, but save lives. Our future depends on it.

Dr. Oyewale Tomori from Nigeria’s Redeemer’s University, and Dr. George Armah from Ghana’s Noguchi Memorial Institute for Medical Research at the University of Ghana, are members of the Rotavirus Organization of Technical Allies (ROTA) Council, an organization of technical experts working to save children’s lives and improve health.

The Case for Childhood Rotavirus Vaccines

This commentary, co-authored by Drs. Ciro de Quadros and Mathuram Santosham, was originally posted in the Impatient Optimist on January 11, 2013.


A mother in Tanzania cradles her week-old son as the nation’s First Lady Salma Kikwete drips a rotavirus vaccine into the tiny “O” of his mouth, helping to protect the infant against severe, and often deadly, rotavirus diarrhea.

It took a lot to arrive at this moment: community education for the mother so she knew to make the difficult journey with her baby for vaccination, the training of hundreds of health workers, new registries and immunization cards, an upgraded cold chain to store the vaccines at the right temperature, a commitment to sustainable vaccine funding—and the decision by the Tanzanian government to introduce rotavirus vaccines into the country’s immunization program.

Just weeks ago, Tanzania became the 8th country in Africa to make rotavirus vaccination part of its childhood immunization program. With the competing priorities of running a nation and keeping its citizens healthy, how did rotavirus vaccines rise to the top for Tanzania’s leaders? In part, it was because of the compelling evidence and the efforts of scientists and medical practitioners who brought it to light.

Diarrhea is one of the world’s leading killers of children, and rotavirus is the most common cause of severe, deadly diarrhea. For every child that dies, many more endure unnecessary suffering and often require hospitalization.

As doctors, we’ve witnessed the anguish of parents who brought in children too late, already limp in their arms, suffering from the life-threatening dehydration caused by rotavirus. As scientists, we know that rotavirus is extremely contagious and nearly every child is vulnerable. Improvements in hygiene, sanitation and drinking water are critical components to preventing diarrhea but do not adequately prevent the spread of rotavirus.

Vaccination offers the best hope for protecting children from rotavirus and is an essential part of comprehensive diarrhea control.

Because ninety-five percent of rotavirus deaths occur in low-income countries, seven years ago, researchers set out to conduct clinical trials in impoverished settings across Africa and Asia to better understand how rotavirus vaccines would work among the infants and children who needed them most urgently. They found that rotavirus vaccines reduced the risk of severe rotavirus in these countries by more than half during the first year of life, when children are at greatest risk. And in June 2009, based in part on the findings from these studies, the World Health Organization recommended that rotavirus vaccines be included in all national immunization programs.

The evidence is compelling and the data are powerful. Countries that have introduced these vaccines have seen major reductions in hospitalizations and deaths from diarrhea. Over the next few decades, millions of unnecessary illnesses and deaths can be prevented by accelerating access to these vaccines. Despite this, today, only 42 countries worldwide have introduced rotavirus vaccines into their national immunization programs.

Advocacy is needed, and scientists and medical practitioners are uniquely suited to step up to the challenge. We conducted the research, and as doctors, we have treated the children in need. We possess firsthand knowledge of the impact of these vaccines, and it is our responsibility to share this information with policymakers so they are fully informed to make decisions that best protect the lives of their youngest citizens.

We must commit to redoubling our efforts to ensure the evidence generated through surveillance, clinical trials and impact studies continues to inform how health programs develop so that, no matter where they are born, every child has access to health interventions that work, like rotavirus vaccines. Millions of children have already benefited from these vaccines—millions more continue to depend on us.

Dr. Mathuram Santosham and Dr. Ciro de Quadros co-chair the Rotavirus Organization of Technical Allies (ROTA) Council, an organization of technical experts working to save children’s lives and improve health by providing the evidence policymakers need to accelerate the introduction of rotavirus vaccines.