Archive | News RSS feed for this section

Fresh onslaught against ravaging rotavirus disease

This article originally appeared in The Guardian (Nigeria).

The deadly Rotavirus has over the years ravaged Nigerian children unchecked. EMEKA ANUFORO of our Abuja Bureau writes on the cheery news that help is on the way as Nigeria finally announces plans to introduce a vaccine against the virus.

ROTAVIRUS diarrhea is considered a big threat to Nigerian children, and causes more than 160,000 deaths in children under five each year. A recent research indicates that the percentage of cases found in Enugu as the highest in Africa. Despite the availability of its vaccine worldwide, the deadly Rotavirus is still a leading cause of severe diarrhea disease and dehydration in infants and young children in Nigeria.

The World Health Organization (WHO) estimates that the rotavirus disease causes the death of approximately 527,000 young children yearly. About 85 per cent of these deaths are said to occur in developing countries, mainly in South Asia and sub-Saharan Africa.

Rotavirus, according to the United States Centre for Disease Control and Prevention (CDC), is a contagious virus that can cause inflammation of the stomach and intestines.

“Symptoms include severe watery diarrhea, often with vomiting, fever, and abdominal pain. Infants and young children are most likely to get rotavirus disease. They can become severely dehydrated and need to be hospitalized and can even die.”

Unfortunately, despite the deadly nature of the virus, Nigeria is yet to introduce a vaccine to contain the disease. The Guardian had reported that the country has not introduced a vaccine to curb the ailment.

But the good news is that come next year, the vaccine for Rotavirus would be available in Nigeria, if assurances by officials are anything to go by.

Executive Director of the National Primary Healthcare Development Agency (NPHCDA), Dr Ado Mohammed, whose agency has the mandate for vaccination, told The Guardian that the vaccine would be introduced next year (2015).

He said: “Diarrhea accounts for a major percentage of child mortality in Nigeria. We are working towards introducing rotavirus vaccine as part of other interventions that we are doing. You are aware that we have introduced flavored ORS in Nigeria, you are also aware that we have introduced sinc-surphate treatment regiment for diarrhea in Nigeria.

“We are working towards ensuring that we introduce rotavirus vaccine next year. By 2015, Rotavirus will come on board as part of our vaccine plans so that we can change lives and fast track our attainment of the MDGs goals 4 and 5 and ensure that we reduce to the barest minimum deaths attributable to the virus.”

A recent study indicates that the deadly Rotavirus is still ravaging Nigerian children unchecked.

Checks at the World Health Organization (WHO) indicate that vaccination against rotavirus diarrhea is one of the vaccinations recommended by the global body to be given to 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 (5) Nigerian children each year

A new study published in the Pediatric Infectious Disease Journal reveals that vaccines are available, but Nigeria is yet to introduce the vaccines.

An abstract on 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 immunization program, 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 in their study that rotavirus is responsible for close to 56 per cent of cases of diarrhea in children and that more case 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 indicate that vaccines are known to offer the best protection, and have been proven in study after study to be safe and effective in Africa and around the world.

But unfortunately, Rotavirus vaccines are not yet included in Nigeria’s immunization program.

“If Nigeria’s leaders take action, these lifesaving 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.

A WHO factsheet on the virus indicate that: “Most symptomatic episodes occur in young children between the ages of 3 months and 2 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, although oral rehydration therapy is recommended. There are now two new rotavirus vaccines to prevent severe rotavirus disease.”

The study ‘Epidemiology of Rotavirus Diarrhea among Children Younger than 5 Years in Enugu, South East, Nigeria was recently conducted and the results published in Pediatric Infectious Disease Journal.

The Pediatric Infectious Disease Journal is an official publication of the European Society for Paediatric Infectious Diseases.

The Guardian learnt that researchers from the Nigerian Ministry of Health, Institute for Child Health and University of Nigeria Teaching Hospital, and World Health Organization recently examined the prevalence of rotavirus in hospitalized children under five (5).

The study was conducted in Enugu and found that the percentage of positive cases reported in Enugu was the highest level observed to date by the WHO Regional Office for Africa in Africa

Among other things, the report also found that more than half (56%) of children under 5 hospitalized with diarrhea were found to have rotavirus, while almost all (96%) of these children were under the age of two (2).

A copy of the report obtained by The Guardian describes January as the peak month for rotavirus infections. 95 per cent of rotavirus cases, it stressed, occurred between December and April,

The study particularly drew attention to the urgent need to protect Nigeria’s children from rotavirus.

The study noted:  “Severe rotavirus diarrhea in children is a major cause of morbidity globally and mortality in developing countries. It is estimated to be responsible for 453,000 deaths in children less than 5 years of age globally and 232,000 in the African region. The aim of the current study was to determine the prevalence of rotavirus gastroenteritis among hospitalized children less than 5 years of age in Enugu and to support awareness and advocacy efforts for the introduction of rotavirus vaccines in Nigeria…

“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 immunization program and the need to adequately equip health facilities so as  to enable them administer intravenous fluids to severe diarrhea patients to reduce morbidity and mortality.”

But President of the Nigerian Academy of Science, Prof Oyewale Tomori confirmed that the vaccines had not been introduced in Nigeria and called attention to the urgent need for the Nigerian government to introduce the vaccine into the nation’s vaccination program.

In an interview with The Guardian, he stressed how many of the countries that have introduced Rota vaccine no longer contend with polio, while measles is a minor problem such countries

According to him, “We need to accelerate the introduction of rotavirus vaccine in Nigeria. The vaccine is available for any nation who considers it important enough to give their children.”

On his thoughts on why government was yet o introduce the vaccine, Tomori, who is a virologist, stressed: “I think the government has done a fairly good job, but as we say ‘ water pass gari’.  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

“However, we could do more with the resources we have, if we spend our money wisely and judiciously. We hear of competing interests against vaccinating our children. I wish those competing interests were important things and issues. The things competing against providing our children with vaccines include: wastage, undue process, looting, stealing with conspicuous and obscene life style.”

On the likely implication of non-introduction of the vaccine on Nigerian children, he stressed; “Many of them will die from preventable diseases and we will not meet some of the Millennium Development Goals (MDG).”

He, nevertheless, gave kudos to the efforts of the Nigerian government in introducing vaccines for a number of child killer ailments, but noted:  “The government is trying, but we have too many disease conditions we should have controlled a long time ago.”

The Guardian reached out to a co-author of the study, Dr. George Armah, who noted that there had been several reports on the contribution of rotavirus to the large mortality in children which were in the possession of the Nigerian government.

Armah, Senior Research Fellow and Associate Professor at the University of Ghana, stressed that the introduction of rotavirus vaccines would help avert the risk of the more 41,000 kids dying from this vaccine preventable disease.

“It will reduce considerable the lost time for mothers who have to attend their sick children as well save the economy a lot of Naira from the treatment cost of the disease. “

He said the latest study aimed to determine the prevalence of rotavirus gastroenteritis among hospitalized children less than five years of age in Enugu.

“The data from this study was to augment support awareness and advocacy efforts for the introduction of rotavirus vaccines in Nigeria,” he noted.

He told The Guardian: “The main findings were that more than 50% of children admitted to the hospital with severe diarrhea infected with the human rotavirus. The majority of these unfortunate children (77%) were less than 12 months of age. These are very small and delicate children. The ones who made it to the hospital are the very lucky ones who will survive.

“For an unfortunate child in a hard to reach and inaccessible part of rural Nigeria – it is a death sentence and a lot of anxiety for the parents. The study showed that the incidence of disease, the months at which infection is at its peak (October to February) are very similar to countries in the sub-region and introduction of vaccines will help ameliorate the burden of disease as is being observed in countries that have introduced the vaccines in their Expanded Programme on Immunisation.

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 www.ROTACouncil.org.

Presentations Posted from Eleventh International Rotavirus Symposium

Presentations from the Eleventh International Rotavirus Symposium have been posted.

You can find them, as well as conclusions and findings from the meeting, on the Sabin Vaccine Institute’s website here.

Eleventh International Rotavirus Symposium Held in New Delhi, India

New Delhi, India — September 3, 2014 — The Eleventh International Rotavirus Symposium today began just two months after Indian Prime Minister Narendra Modi announced that the Government of India would provide a rotavirus vaccine to all Indian children, and weeks before the highly anticipated UN General Assembly’s 69th opening session, which will assess progress towards the Millennium Development Goals (MDGs).

At the three-day conference, more than 600 experts from 56 countries will examine new surveillance data and studies demonstrating the effectiveness and impact of vaccination for rotavirus, a leading cause of severe and fatal diarrhea in children under five years of age worldwide. Killing between a quarter and a half a million children each year, rotavirus significantly impedes achieving MDG4: reduce child mortality.

“We cannot reduce death and suffering from rotavirus — as well as its significant economic toll —without vaccines,” said Dr. Mathuram Santosham, chair of ROTA Council and professor of International Health and Pediatrics at Johns Hopkins University in Baltimore, Maryland, United States. “Greater prioritization of rotavirus vaccines will protect children and avoid substantial health costs to families and healthcare systems. India, which has a heavy rotavirus burden but is home to a promising new vaccine, is the perfect setting to evaluate the current scientific evidence on rotavirus vaccines to inform decision-making.”

Globally, diarrhea is one of the most common causes of hospitalizations of children. According to the World Health Organization (WHO), more than one-third (36 percent) of all hospitalizations for severe diarrhea are caused by rotavirus. In some settings around the world, hospitalizations are a tremendous financial burden to already impoverished families and strain health systems. However, rotavirus vaccines could cut hospitalizations of children under five by four to eight percent and substantially improve child health and survival.

If used in all GAVI-eligible countries, rotavirus vaccines could also prevent an estimated 180,000 deaths and avert six million clinic and hospital visits each year, saving US $68 million in annual treatment costs. Yet, despite the WHO’s recommendation for all countries to introduce rotavirus vaccines in their national immunization programs, only 35 percent of countries worldwide (69) have done so. Of those countries, only one is in Asia.

This summer, India announced it would introduce a new vaccine, shown to reduce severe diarrhea caused by rotavirus by 56 percent during the first year of life. Rotavirus is estimated to cause more than 78,000 deaths, 800,000 hospitalizations and three million outpatient visits each year in India.

“Every child deserves the chance to live a long, healthy, productive life,” said Dr. Gagandeep Kang, head of the Wellcome Trust Research Laboratory at the Christian Medical College in Vellore, Tamil Nadu, India. “When rotavirus vaccines are part of a comprehensive strategy including oral rehydration solution (ORS), breastfeeding, good nutrition, and improved water, sanitation and hygiene, we can make this vision a reality.”

Overall, 95 percent of rotavirus deaths occur in developing countries in Asia and Africa. In Asia, rotavirus kills approximately 188,000 children under five each year and in Africa, rotavirus kills 232,000 children under five each year. However, children everywhere are at risk of infection.

The Eleventh International Rotavirus Symposium brings together scientists, clinicians, public health professionals, immunization leaders, vaccine industry representatives and members of the donor community. The Sabin Vaccine Institute serves as the organizing secretariat. The full list of conveners can be found at www.rotavirus2014.org, and the agenda can be found here.

ROTA Council Convenes Leading Experts on Rotavirus Vaccines for Scientific Workshop

 

On July 23 and 24, the ROTA Council, along with its core partners the International Vaccine Access Center at Johns Hopkins Bloomberg School of Public Health, PATH, the Sabin Vaccine Institute and the U.S. Centers for Disease Control and Prevention, gathered a group of rotavirus technical experts and public health officials, leading research and advocacy organizations, funders and vaccine manufacturers for “The Rotavirus Vaccination & Intussusception Workshop: Science, Surveillance & Safety.”

The event, held in Washington, DC, and funded by the Bill & Melinda Gates Foundation, was an important step in helping the global health community understand the benefits and risks of rotavirus vaccines, which offer the best protection against rotavirus and the deadly diarrhea that it causes.

Intussusception is a bowel blockage, which in extremely rare cases is associated with rotavirus vaccines. For every 100,000 children vaccinated, there are an estimated 1-6 extra cases of intussusception. However, numerous studies have demonstrated that the benefits of the vaccine outweigh the risk. Despite this, the lack of understanding about the benefits and risks of rotavirus vaccines can delay introduction of these live-saving vaccines, causing hundreds of thousands of preventable deaths and hospitalizations among young children.

At the workshop, the technical experts in attendance reviewed and evaluated the current evidence on intussusception and rotavirus vaccines, identified and prioritized remaining gaps in the research, discussed challenges and opportunities around new vaccines coming to market or currently in clinical trials, and documented the scientific consensus on best practices for monitoring and communicating the potential risk of intussusception after the introduction of rotavirus vaccines. The meeting outcomes will be published in a peer-reviewed journal and provide a current, reliable source of the latest evidence and scientific consensus on rotavirus vaccine safety and intussusception.

ROTA Council Remembers Ciro de Quadros

“The ROTA Council joins the global health community in celebrating the life of Dr. Ciro de Quadros, a public health hero and our Council co-chair, who passed away peacefully yesterday in his home, surrounded by family. Ciro’s contributions to the field of vaccines are immeasurable, and his legacy will live on in the millions of children’s lives saved each year by vaccines. On a personal note, his boundless energy, sense of humor, and passion were infectious and will be greatly missed.” – Dr. Mathu Santosham, Co-Chair, ROTA Council 

To read additional news of Ciro’s passing, visit the Sabin Vaccine Institute website:

http://www.sabin.org/updates/news/sabin-vaccine-institute-mourns-passing-executive-vice-president-ciro-de-quadros-md.

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