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Nigeria yet to procure vaccine against rotavirus

This article first appeared in The Guardian (Nigeria).

• Disease causing over 160,000 yearly under-five deaths

• Enugu with highest prevalence rate in Africa

THE deadly rotavirus continues to ravage Nigerian children unchecked and remains a leading cause of severe diarrhea and dehydration in infants and young children, according to a recent study, despite the availability of its vaccine worldwide.

Investigations have also revealed that vaccination against rotavirus diarrhea is one of those recommended by the World Health Organisation (WHO) for all children worldwide.

Rotavirus is seen as the primary cause of diarrhea-related illnesses and deaths, and according to experts, is responsible for 160,000 deaths in under-five Nigerian children each year.

However, a new study published in the Pediatric Infectious Disease Journal revealed that the vaccines are available, but Nigeria was yet to introduce them. The publication stressed: “This study found a relatively high incidence of severe rotavirus-associated diarrhea disease in Nigeria and infants were the most affected.

“It highlights the urgent need for introduction of rotavirus vaccine into the national immunisation programme and the need to adequately equip health facilities to enable them administer intravenous fluids to severe diarrhea patients to reduce morbidity and mortality.”

The researchers found that rotavirus is responsible for close to 56 per cent of cases of diarrhea in children and that more cases occur in the cool dry months of the year, a finding now regarded as one of the highest rates of diarrhea caused by rotavirus.

Reports indicate that vaccines are known to offer the best protection, and have been proved in different studies to be safe and effective in Africa and around the world.

Unfortunately, however, rotavirus vaccines are not yet included in Nigeria’s immunisation programme.

“If Nigerian leaders take action, these life-saving vaccines could be introduced as early as 2015. Every child is vulnerable regardless of where they live, and for those in places without medical care, it can be a death sentence,” the report noted.

 

As a WHO factsheet on the virus indicates, “most symptomatic episodes occur in young children between three months and two years. The virus spreads rapidly, presumably through person-to-person contact, airborne droplets, or possibly contact with contaminated toys.

“Symptoms usually appear approximately two to three days after infection, and include projectile vomiting and very watery diarrhoea, often with fever and abdominal pain. The first infection is usually the worst one.

“There is no specific drug treatment for rotavirus infection, though oral rehydration therapy is recommended. There are now two new rotavirus vaccines to prevent severe rotavirus disease.”

Meanwhile, the study, “Epidemiology of Rotavirus Diarrhea Among Children Younger Than Five Years in Enugu, South-East Nigeria” was recently conducted and the results published in Pediatric Infectious Disease Journal – an official publication of the European Society for Paediatric Infectious Diseases.

The Guardian learnt that researchers from the Ministry of Health, Institute for Child Health, University of Nigeria Teaching Hospital, and WHO recently examined the prevalence of rotavirus in hospitalised children under-five.

The study was conducted in Enugu and found that the percentage of positive cases reported was the highest level observed to date by the WHO Regional Office for Africa in Africa. Among others, it also found that over half (56 per cent) of children under five hospitalised with diarrhea had rotavirus, while almost all (96 per cent) were less than two years old.

It also describes January as the peak month for the infections, as 95 per cent of cases occurred between December and April. It particularly drew attention to the urgent need to protect Nigerian children from the virus.

When contacted, officials of the Ministry of Health referred The Guardian to the National Primary Healthcare Development Agency (NPHCDA), which had the mandate for vaccination, which Executive Director, Dr. Ado Mohammed, was not forthcoming.

However, President of the Nigerian Academy of Science, Prof. Oyewale Tomori, confirmed that the vaccines had not been introduced in Nigeria and stressed the urgent need for government to introduce it into the nation’s vaccination programme.

According to him, many of the countries that have introduced Rota vaccine no longer contend with polio, while measles is a minor problem. He noted: “The government has introduced new vaccines and plans to introduce more between now and 2015.

“The vaccines include Penta, Pneumococcal conjugate vaccine (PCV), Human Papilloma Virus Vaccine (HPV), Tetanus and fractional diphtheria (Td), measles-rubella vaccine (MRV) and rotavirus vaccine”.

Financing options can make rotavirus vaccines affordable

This article, on the affordability of rotavirus vaccines in Asia, first appeared on SciDev.net.

[MANILA] Developing Asian countries should consider public financing schemes to make rotavirus vaccines affordable and help reduce the incidence of severe diarrhoea which kills nearly 188,000 Asian children each year, according to a study.

Rotavirus is the most common cause of severe and fatal diarrhoea among young children, accounting for over 40 per cent of the global number of children who die from diarrhoea. The WHO recommended in 2009 that rotavirus vaccines be included in all national immunisation programmes.

But most policy planners in developing Asia-Pacific countries are reluctant to introduce rotavirus vaccines believing that these are too costly, according to Edmund Anthony Nelson, a professor of paediatrics at the Chinese University of Hong Kong.

Nelson, who is the lead author of the study on the issue published inHuman Vaccines & Immunotherapeutics, says that only Fiji, Marshall Islands, Micronesia, Palau, the Philippines and Thailand among the developing countries in the Asia-Pacific region have introduced rotavirus vaccine into their immunisation programmes.

“Most policy planners are not informed of the various pricing options that will make vaccination programmes more affordable. Many countries don’t even try to negotiate prices. They just decide not to try the vaccine which I think is disappointing,” Nelson tells SciDev.Net.

He says that policy planners need to know more about other financing schemes before even deciding to reject the idea of introducing rotavirus vaccines, noting that “governments can actually save money and make more people healthy”.

In Latin America, health officials were able to introduce rotavirus vaccines by using a revolving-fund mechanism that facilitated the bulk purchase of vaccines, syringes, cold chain equipment and related supplies.

This helped reduce the price of vaccines from about US$200 per course (equivalent to two to three doses needed for full vaccination for each child) to roughly US$13-15 per course. Member states contribute three per cent of each net purchase price to the revolving fund that is used as working capital.

Other options are tiered pricing agreements, in which an individual government negotiates prices with vaccine providers. While this may be problematic as it might violate the rules on the tender process of most countries, the study cited Australia’s example which negotiated prices with the industry but at the same time implemented a transparent mechanism by separating technical decisions from economic evaluations.

But Nelson posits that measures such as the revolving-fund mechanism “will require a lot of political commitment”, noting that Asian health and finance officials will have to coordinate and discuss everything before such mechanisms can be established.

Lulu Bravo, professor of paediatric infectious and tropical diseases at the University of the Philippines, Diliman, says: “In the end, the most effective way to cut the mortality rate caused by diarrhoea is for policymakers to be made more aware of the ‘health economics’ of disease prevention and treatment.”

“Vaccination is the most cost-effective way to save children’s lives,” she says, adding that this is true not only for diarrhoea but other diseases as well.

Link to full paper in Human Vaccines & Immunotherapeutics

This article has been produced by SciDev.Net’s South-East Asia & Pacific desk.

New Supplement on Rotavirus Disease Burden in Africa

ROTA Council members Duncan Steele and Umesh Parashar served as two of the guest editors in this month’s The Pediatric Infectious Disease Journal supplement on rotavirus disease burden in Africa. Drs. Parashar and Steele co-authored the introductory article ”Preparing for the Scale-up of Rotavirus Vaccine Introduction in Africa: Establishing Surveillance Platforms to Monitor Disease Burden and Vaccine Impact,” one of several articles they contributed to in the supplement, which appeared in the January 2014 issue of The Pediatric Infectious Disease Journal. Council member George Armah also contributed to a study in the supplement, about rotavirus disease burden in Enugu, Nigeria.

This supplement appeared in The Pediatric Infectious Disease Journal, 2014 Jan 33;1(1) pp: S1-S106. Guest Editors: Mwenda, Jason M.; Tate, Jacqueline E.; Steele, A. Duncan; Parashar, Umesh D.

Read more about the supplement in PATH’s RotaFlash.

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

Overcoming Perceptions of Financial Barriers to Rotavirus Vaccine Introduction in Asia

This paper appeared in Human Vaccines & Immunotherapeutics, 2013 Aug 16;9(11). Authors: Nelson EA, de Quadros CA, Santosham M, Parashar UD, Steele D.

A two-page summary of the paper can be found here.

Abstract

Despite a WHO recommendation in 2009, reaffirmed in 2013, that all countries should consider introducing rotavirus vaccines into their National Immunization Programs, as of June 2013 only 45 have done so. One major consideration appears to have been the costs of the vaccine to countries. Of concern, is that Asian countries have been slow to introduce rotavirus vaccines despite having robust data that could inform the decision-making process. Although decisions on new vaccine introduction are very complex and vary by country and region, economic evaluations are often pivotal once vaccine efficacy and safety has been established, and disease burden documented and communicated. Unfortunately, with private sector list prices of vaccines often used in economic evaluations, rather than a potential public health sector pricing structure, policy-makers may defer decisions on rotavirus vaccine introduction based on the belief that “the vaccine price is too high,” even though this might be based on erroneous data. The Pan American Health Organization’s Revolving Fund provides one example of how vaccine price can be made more competitive and transparent through a regional tendering process. Other mechanisms, such as tiered pricing and UNICEF procurement, also exist that could help Asian and other countries move forward more quickly with rotavirus vaccine introduction.

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 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).

Rotavirus Vaccine Proves Itself ‘On the Ground’

This post first appeared on SciDev.Net.

 [LA PAZ] A WHO-recommended vaccine for rotavirus infection has proved effective in Bolivia, the first low-income country to introduce it, researchers have reported.

Rotavirus is the leading cause of diarrhoea-related deaths in most of the developing world. The WHO recommends two vaccines for all children worldwide — RV1, which targets one strain of the virus and is given in two doses, and RV5, a three-dose vaccine targeting five strains.

In 2008, RV1 was added to Bolivia’s routine immunisation schedule, with doses recommended for all children at two and four months. Bolivia was the first country that receives support from the Global Alliance for Vaccines and Immunisation to use the vaccine.

Until now there has been a lack of data on whether RV1 is as effective in the real-life conditions of lower-middle income countries — particularly those with lots of children dying from rotavirus infections — as it has been in clinical trials.

The study, published in The British Medical Journal last month (19 June), analysed hospitalisations at six hospitals in Bolivia between March 2010 and June 2011. It found that RV1 prevented 69-77 per cent of rotavirus hospitalisations.

Manish Patel, lead author of the study and a researcher at the National Center for Immunization and Respiratory Diseases at the US Centers for Disease Control and Prevention (CDC), tells SciDev.Net that the results of the trial were “quite similar to the clinical trial results from lower-mortality middle- and high-income settings in the Americas”.

Other studies have shown that overall the vaccine has performed better in upper-middle income countries than in lower-middle income countries.

Patel says the reasons for this are not fully understood. It may be that malnutrition and co-infections in children in lower-income countries impair the immune response, he says.

What is known is that both rotavirus vaccines are less effective in countries with higher child death rates, making the Bolivian results even more encouraging considering the context in which the vaccine was used, write the study authors.

Patel adds: “This single-strain rotavirus vaccine provided effective protection against a broad range of strains that are different from the vaccine strain.”

The study’s authors write that both RV1 and RV5 should be used in low- and lower-middle income countries. They add that this type of study provides decision-makers with strong evidence to draw upon when faced with challenges — for example funding — that jeopardise vaccine programmes.

“Ongoing monitoring of impact, particularly in Asia and Africa, will be crucial for fully understanding the vaccines and identifying factors that would allow us to realise the full potential of the life-saving benefits of rotavirus vaccines [in these countries],” says Patel.

Another study published in The Journal of Infectious Diseases last month (18 June) showed that RRV-TV, a rotavirus vaccine targeting four strains, had an efficacy of around 60 per cent in Ghana. The next step is to test the vaccine in newborn babies.

Link to full paper in The British Medical Journal
Link to abstract in The Journal of Infectious Diseases

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.

Progress on Rotavirus Prevention – Globally and in India – A Conversation with Dr. Mathu Santosham

This post first appeared on the Johns Hopkins Bloomberg School of Public Health International Vaccine Access Center (IVAC) blog.

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?

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.  

Global Enteric Multicenter Study (GEMS): Rotavirus #1 Cause of Diarrhea in Infants

The Global Enteric Multicenter Study (GEMS), the largest study on diarrheal disease in developing countries to date, confirmed rotavirus is the leading cause of diarrheal diseases among infants. The study involved more than 20,000 children from seven sites across Asia and Africa, and found that approximately one in five children under the age of two suffer from moderate-to-severe diarrhea each year, which greatly increased children’s risk of death and led to stunted growth.

Because more than 90 percent of rotavirus deaths occur in developing countries, where access to treatment for severe diarrhea is out of reach for many children, the GEMS findings highlight the critical role of rotavirus vaccines in preventing child sickness and death.