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Rotavirus Update - News from the PATH Rotavirus Vaccine Program



Promising trial results add to evidence on rotavirus vaccination in Asia
Results released this week from a clinical trial of GlaxoSmithKline’s Rotarix™ revealed significant immune responses among Bangladeshi infants given the vaccine. In a study conducted at the International Center for Diarrheal Disease Research, Bangladesh (ICDDR,B), and supported by PATH, 57 to 67 percent of participants receiving the live, oral vaccine developed an immune response, providing critical evidence of the potential impact of rotavirus vaccine introduction in the region. The Phase 2, double-blind, randomized, placebo-controlled study of 300 children was conducted from June 2005 through January 2006.

In addition to testing the immunogenicity of Rotarix™ in this setting, investigators at ICDDR,B also evaluated the co-administration of the vaccine with oral polio vaccine (OPV) and found that coadministration did not lower the polio immune response and that Rotarix™ may be administered concomitantly with OPV. Because the performance of oral vaccines can vary in different regions, WHO’s Strategic Advisory Group of Experts (SAGE) has called for appropriately designed clinical trials of rotavirus vaccines among infants in Asia and Africa as a prerequisite to recommending global use. 

To learn more about additional clinical studies PATH is supporting in Africa and Asia, please see the summary below. Click here to read PATH’s press release on the new study results.


WHO releases updated estimates of global rotavirus disease burden
WHO recently announced updated estimates on the number of child deaths worldwide in 2004 that were associated with rotavirus infection:

  • 527,000 children under five years old died due to rotavirus infection, comprising 29 percent of all diarrhea-related mortality in this age group.
  • Nearly 85 percent of child rotavirus deaths occurred in Africa and Asia.                                 
  • 23 percent of all rotavirus deaths under five years of age occurred in India; six countries (India, Nigeria, Democratic Republic of the Congo, Ethiopia, China, and Pakistan) accounted for more than half of under-five rotavirus deaths.

An extended summary of the new estimates is available on the WHO website. Check back for future updates to this web page, including country-specific estimates of rotavirus disease burden.


Update on clinical trials in Africa and Asia
PATH is working in partnership with Merck & Co., Inc. and GlaxoSmithKline to evaluate the safety and efficacy of their respective rotavirus vaccines in developing countries of Africa and Asia. A Phase 3 study of Merck’s RotaTeq® vaccine began in Bangladesh in early April, with enrollment of the study’s first infant at ICDDR,B. Additional trials with RotaTeq® will begin later this year in Mali, Ghana, Kenya, and Vietnam.

A Phase 3 trial of GSK’s Rotarix™ vaccine is ongoing in South Africa and Malawi. At the end of March, investigators in Malawi enrolled the one-thousandth child, bringing the total number of children enrolled at all sites in both countries to more than 4,000. Full participation is anticipated to top 5,000 by the time enrollment is completed on June 30, 2007.


European network established with surveillance initiated in four countries
The CDC’s latest issue of Rotavirus Surveillance News outlines activities of the European regional surveillance network. Data on the burden of rotavirus in Eastern Europe is particularly important, as the region includes several countries that may be early introducers of rotavirus vaccines subsidized by the GAVI Alliance. With technical assistance from CDC and PATH, surveillance began in December 2006 in Azerbaijan, Georgia, Tajikistan, and Ukraine. Activities in these countries enabled the establishment of a regional network that also incorporates data collected in Kyrgyzstan and Uzbekistan, which had previously initiated rotavirus surveillance. To read more about the European regional rotavirus surveillance network, click here.


Learn more about advisory committee review of RotaTeq® vaccine safety in US

Presentations from February’s meeting of the CDC’s Advisory Committee on Immunization Practice are now available online. The committee reviewed post-marketing safety surveillance data on RotaTeq®, the rotavirus vaccine by Merck & Co., Inc. Because of a suspected association between intussusception and the RotaShield® vaccine that was withdrawn from the US market in 1999, the CDC is taking particular care to monitor adverse event reports associated with RotaTeq®. The data reveal that cases of intussusception reported since its introduction in early 2006 did not exceed the expected background rate. For a detailed report of the meeting and the committee’s data review, please see the March 16 issue of the Morbidity and Mortality Weekly Report.


GlaxoSmithKline’s Rotarix® vaccine earns WHO prequalification
On January 30, 2007, WHO announced prequalification of the Rotarix® vaccine manufactured by GlaxoSmithKline (GSK), marking the first time in history that a rotavirus vaccine has been prequalified. This designation of “acceptability in principle” will allow for purchase of the vaccine by United Nations agencies and is a significant advance in the accessibility of rotavirus vaccine for developing countries that depend on agencies like UNICEF for drug procurement.

In issuing its decision, WHO noted the need for data on the vaccine’s safety and efficacy in Africa and Asia before the product will be prequalified for use in these regions. GSK is partnering with PATH to generate important clinical data in trials conducted in Bangladesh, Malawi, and South Africa.

For further details, including provisions on Rotarix® packaging and presentation, please see the notes on Rotarix® within WHO’s list of prequalified vaccines.


FDA updates prescribing information on RotaTeq® vaccine
In a public health notification issued February 13, the US Food and Drug Administration (FDA) provided updated prescribing information for the RotaTeq® vaccine manufactured by Merck & Co., Inc. The update noted 28 reported cases of intussusception identified through the US Vaccine Adverse Event Reporting System, but clarified that “the number of intussusception cases reported to date after RotaTeq administration does not exceed expected background rates among unvaccinated children of the same age.”

In an update to its website posted February 14, the US CDC affirmed its continued support for use of the vaccine: “This notice does not mean there is a problem with the RotaTeq® vaccine. CDC is not changing its policy at this time. CDC continues to support the Advisory Committee on Immunization Practices’ [ACIP] recommendation for routine immunization of all U.S. infants with three doses of RotaTeq® administered orally at ages 2, 4 and 6 months.” The ACIP will conduct a regularly-scheduled review of the safety tracking data during its upcoming meeting on February 21, and the CDC stated that it will continue to monitor reports of possible adverse effects of the vaccine in partnership with the FDA.

Media reports of the FDA notice implied a link between the vaccine and intussusception that is not supported by the current data. To avoid further misperceptions, PATH is reaching out to key audiences, including the investigators with whom we are collaborating to conduct clinical trials of RotaTeq® in Africa and Asia, as well as our partners in the global health community.


Innovative investment accelerates global access to pneumococcal vaccines
The governments of Italy, Canada, Russia, the United Kingdom, and Norway; and the Bill & Melinda Gates Foundation recently announced their decision to financially support an Advance Market Commitment (AMC) for the purchase of pneumococcal vaccines for developing countries. Pneumococcus, a bacterium that is one of the most common causes of pneumonia, kills about one million children under age five each year. By creating incentives for companies to invest in vaccines for diseases that disproportionately affect developing countries, an AMC can help create more predictable markets and accelerate research and development. Click here to learn more.


Investigators’ meeting in London kicks off key clinical trials
At an investigators’ meeting in London last month, PATH and partners met to finalize plans to launch Phase 3 clinical trials of RotaTeq, the rotavirus vaccine manufactured by Merck & Co., Inc. PATH and Merck are partnering with leading researchers in Asia and Africa to conduct efficacy trials in five countries: Bangladesh, Vietnam, Kenya, Ghana, and Mali. Enrollment at some study sites will be initiated as early as this month, and results are anticipated by mid-2009. Meeting participants, including leading rotavirus experts from NIH and WHO, reviewed the study protocol for the study to ensure adherence, scientific rigor, and regulatory compliance.


Update on rotavirus surveillance
Routine surveillance is revealing significant rates of rotavirus among children suffering from diarrheal disease in Pakistan, where two sites recorded rates of 20 and 38 percent, respectively. The data were generated through hospital-based rotavirus surveillance supported by the WHO Eastern Mediterranean Regional Office and were presented at the Third Annual Symposium on Neonatal and Child Health organized by the country’s National Insititute of Child Health.

Sentinel hospital-based surveillance supported by PATH, CDC, and WHO recently begun in several countries of the European (EURO) and African (AFRO) WHO regions. In EURO, surveillance was initiated in December 2006 at six hospitals in Azerbaijan, Republic of Georgia, Tajikistan, and Ukraine. AFRO surveillance is ongoing at six hospitals in Cameroon, Ghana, Kenya, Uganda, and Zambia. Both networks are coordinated by the respective regional WHO offices and follow WHO protocol.

With the launch of these new networks, global rotavirus surveillance is ongoing in a total of 40 countries in all five WHO regions. These surveillance activities will provide valuable data to inform decisions regarding the introduction of rotavirus vaccines. Click here for additional information on the regional rotavirus surveillance networks supported by PATH’s Rotavirus Vaccine Program.


Vaccination may be factor in reduced seasonal rotavirus incidence in El Salvador
The current rotavirus season in El Salvador is providing insight into the real-world impact of vaccine introduction as well as the disease’s epidemiology in the country. Often mislabeled in the local media as a result of “outbreaks,” cases of rotavirus routinely increase in the region during the winter months due to natural epidemiological patterns. But vaccination against rotavirus, initiated in El Salvador last October, is already helping to reduce this burden.

To date, more than 20,000 infants in El Salvador have been fully immunized, and an impact can be seen in the latest surveillance figures. In January 2006, 164 cases including 15 deaths were confirmed among children between 7 and 14 months of age. By comparison, 114 rotavirus cases and four deaths were confirmed among unvaccinated children during the same period this year, and no reports of rotavirus have been recorded among vaccinated children.

El Salvador is one of several countries in Latin America that report monthly rotavirus surveillance data to the Pan American Health Organization. Click here for further details on PAHO’s support of these activities.


PATH featured in BBC series on vaccine innovations and challenges
A new four-part documentary series by the BBC looks at the scientific advances and real-world challenges of delivering life-saving vaccines to children in the developing world. From the hunt within research labs to harness new technologies to the clinics in remote villages where the vaccines are given to children, the series looks at the promise of and the progress on making vaccines affordable and accessible to the countries where they are needed most. PATH’s work on the development of new vaccines and helping to accelerate the use of rotavirus vaccines are featured in this compelling narrative.

BBC World programs may be viewed in more than 200 countries, but do not air in the US or UK. The “Vaccine Hunters” series began airing February 4, 2007, over the BBC World Service; see http://www.bbcworld.com/ for viewing times.


Developing country officials weigh in on GAVI support for rotavirus vaccines
The GAVI Alliance Board’s unanimous decision last month to subsidize funding for rotavirus and pneumococcal vaccines will have a significant impact on the health of children in developing countries, beginning as soon as 2008. Officials in these countries shared their reactions to this landmark advancement:

“The Health Ministry of Uzbekistan applauds GAVI’s funding for the vaccines against rotavirus and pneumococcal diseases. These much needed vaccines will protect our children and allow us to reduce [our country’s] mortality rate.” — Mr. B.I. Niyazmatov, Deputy Minister of Health, Republic of Uzbekistan

“Guyana is determined to introduce these new vaccines into our routine program, and we are grateful that GAVI has included the two vaccines for funding. With GAVI's continued support, further inroads in infant morbidity and mortality can be achieved. Guyana looks forwards to being a pioneer country in this respect.” — Dr. Leslie Ramsammy, Minister of Health, Guyana

“The decision of GAVI to fund rotavirus and pneumococcal vaccines for our country will help to protect Ukrainian children and give them new life.” — Dr. Lyudmila Mukharskaya, Deputy Chief Sanitary Doctor, Ukraine

Click here to learn more about this landmark decision.


New support from GAVI enables RVP to gather critical evidence in Africa and Asia
Earlier this year, the GAVI Alliance awarded $15 million to the Rotavirus Vaccine Program (RVP) to advance the clinical trials agenda for rotavirus vaccines produced by GlaxoSmithKline (GSK) and Merck & Co, Inc. Ongoing trials and upcoming studies, conducted in collaboration with GSK and Merck, will evaluate the vaccines’ efficacy and safety among pediatric populations in Africa and Asia and will provide fundamental information regarding the value of rotavirus vaccines in these settings.


Spotlight on reference centers to support global rotavirus surveillance
The latest issue of Rotavirus Surveillance News, published by the US CDC, provides an overview of the Rotavirus Collaborating Centers and Reference Centers supported by RVP. These essential resources provide consultation and training on strain characterization, laboratory diagnostics, and other standard procedures for scientists conducting active rotavirus surveillance around the world. To date, laboratory personnel from more than 35 countries have received training and other support from the five centers. Center directors are also finalizing a unified laboratory manual for use in the field. To learn more, read the latest issue online.


Enrollment begins in trial to determine Rotarix® efficacy and safety in Africa
On October 17, 2006, investigators in Malawi initiated enrollment for a clinical trial supported by RVP and GSK to determine the safety and efficacy of Rotarix®. As part of the same clinical trial, enrollment in South Africa was reinitiated in November 2006, where more than 1,800 infants have been enrolled to date.

Rotarix® is orally administered and, historically, these types of vaccines have performed differently in different regions of the world. Large-scale trials of Rotarix® in North and South America affirmed their safety and efficacy among these populations. However, the WHO’s Strategic Advisory Group of Experts recommended that new rotavirus vaccines should also be studied among infants in Asia and Africa, where the burden of rotavirus disease is very high.


Bond sales to accelerate support for new vaccines and system strengthening
The International Finance Facility for Immunisation (IFFIm) issued its inaugural bonds last month, kicking off an innovative scheme to accelerate funding for vaccination programs in the world’s poorest countries. IFFIm is the latest in groundbreaking strategies spearheaded by the GAVI Alliance to accelerate delivery of lifesaving interventions to benefit the world’s children. Through this new initiative, immediate financing for national immunization programs in developing countries will be raised by selling bonds in the international capital markets, based on legally-binding long term commitments from donors—including the governments of Britain, France, Italy, Norway, Spain, and Sweden. Click here to learn more.


Review of surveillance data in US confirms safety profile of Merck’s rotavirus vaccine
During their meeting on October 25 and 26, 2006, the US Advisory Committee on Immunization Practices reviewed early surveillance data on the safety of RotaTeq®. As of September 30, 2006, nearly 1.8 million doses of the vaccine had been distributed, and the estimated incidence of intussusception (six reported cases total) was lower than the expected background rate, even after accounting for underreporting. CDC will continue to collect data on intussusception and other adverse events through its Vaccine Safety Datalink and Vaccine Adverse Event Reporting System. Click here to view a presentation of surveillance data provided by Penina Haber, epidemiologist of the CDC’s Immunization Safety Office.


Nicaragua demonstration program garners international attention
The landmark collaboration between the Government of Nicaragua and Merck to provide rotavirus vaccines to children reached by the public health system was warmly welcomed in international media. The demonstration program will provide free doses of ROTATEQ®, Merck’s three-dose oral rotavirus vaccine, to all infants in Nicaragua for the next three years.

As Dr. Julian Lob-Levyt, executive secretary of the GAVI Alliance, noted, “This demonstration project is a significant step toward global use of rotavirus vaccines, which have the potential to save hundreds of thousands of lives and help the world achieve the Millennium Development Goals. It is also a good illustration of what can be achieved by combining and integrating political will with private resources and partner support to deliver the outcomes needed to reach the health MDGs.”

The demonstration project announced by the Government of Nicaragua and Merck is an important milestone toward accelerating rotavirus vaccine introduction in GAVI-eligible countries. It will provide valuable lessons as RVP and partners seek to build awareness and replicate such progress in the region and throughout the developing world. In addition to its potential to save thousands of lives, Nicaragua’s experience will help illuminate the benefits and challenges of integrating rotavirus vaccines into routine immunization programs in resource-limited settings.

Merck donating vaccine against diarrheal illness to Nicaragua for 3 years, International Herald Tribune/Associated Press

Merck to donate rotavirus vaccine in Nicaragua, Reuters

Merck and Nicaragua unveil new rotavirus vaccine demonstration project at Clinton Global Initiative, Medical News Today

Rotavirus vaccine demonstration to help accelerate progress against a leading killer of children, GAVI Alliance and PATH


UNICEF cites diarrheal disease control as key element in reducing mortality
The Lancet recently highlighted the role of diarrheal disease control as part of an integrated approach to child survival. Interventions including low-osmolarity oral rehydration solution (ORS), zinc treatment, and promotion of breastfeeding were among five indicators used to define a comprehensive child health policy. The article reviewed the adoption of such interventions by WHO member states as measures of progress toward achieving Millennium Development Goal #4 (to reduce mortality of children under five by two-thirds). Investigators found that, while some countries have successfully implemented the use of low-osmolarity ORS and zinc treatment, many countries reported low rates of diarrheal disease management. This finding emphasizes the urgency of disseminating relevant data among country-level public health officials so that they may make informed decisions on diarrheal disease control measures, including rotavirus vaccines.

A renewed focus on diarrheal disease control has emerged as a priority in global public health, and surveys conducted by RVP among officials and clinicians in developing countries found similar gaps in awareness and implementation. The development and availability of new rotavirus vaccines offers an opportunity to invigorate broader diarrheal disease control efforts. Learn more about what RVP is doing in this arena by visiting our online Enhanced Diarrheal Disease Control Resource Center.

The Lancet article was part of a special issue published to coincide with the Symposium on Child Survival held last month in New York. In outreach regarding the symposium, UNICEF listed rotavirus vaccines among new tools that hold potential in reducing under-five mortality. Click here to learn more.


TIME highlights advances in diarrheal disease control
A feature article in TIME magazine (October 8, Europe edition) provides a comprehensive update on the current use of ORS to treat severe diarrhea, along with other promising interventions including rotavirus vaccines. The article highlights treatment and research efforts of the International Centre for Diarrhoeal Disease Research, Bangladesh (ICDDR,B), the Ethiopian Ministry of Health’s sanitation interventions, and the mission of RVP and partners to accelerate rotavirus vaccine availability in developing countries. Click here to read the complete article.


Shaping new guidelines for evaluating vaccine cost-effectiveness
The WHO’s Weekly Epidemiologic Record (September 15) featured recommendations on assessing the cost-effectiveness of rotavirus vaccines. A March 2006 meeting was convened by WHO, the US CDC, and PATH as a forum for participants to review country-level data as well as global guidelines and a standard protocol for future costing studies. These recommendations are an important component of the evidence that decision-makers will weigh in considering potential rotavirus vaccine introduction.

In an encouraging twist, the meeting’s recommendations to decision-makers in developing countries are providing important guidance to the evaluation of vaccine introduction in the industrialized world. The US Advisory Committee on Immunization Practices (ACIP) looks to follow the lead of RVP and partners in developing standardized methodology for measuring the cost-effectiveness of vaccines. According to Dr. Jean Clare Smith, CDC medical officer and assistant to the director for immunization policy, “Although the focus of the meeting was international, the discussions and recommendations parallel work being done at CDC to develop a standardized approach to economic analyses of vaccines being considered by the ACIP for introduction in the US.”


Lancet article provides update on current rotavirus vaccines
Our CDC partners continue to strengthen the evidence base through surveillance of rotavirus morbidity and mortality and training initiatives. In a recent Lancet review article (July 22), CDC experts detailed the status of rotavirus vaccines and the urgency to make them accessible in the developing world. “Rotavirus vaccines: current prospects and future challenges” provides background on rotavirus disease, historic milestones in vaccine development, and a summary of the obstacles to overcome in accelerating their introduction.


Calendar of events
Upcoming international conferences will offer a forum for discussion of the potential benefits of rotavirus vaccines, as well as broader initiatives for controlling diarrheal disease. Click on the links below for details on registration, abstract submission guidelines, and general information.

Vaccines for Enteric Diseases
April 25 – 27, 2007; Lisbon, Portugal
Sponsored by several vaccine manufacturers, this event will feature discussion of diarrheal disease burden in industrialized and developing countries, as well as updates and research on promising vaccine candidates to protect against enteric infections.

11th Annual Scientific Congress of the International Centre for Diarrhoeal Disease Research, Bangladesh
March 4 – 6, 2007; Dhaka, Bangladesh
The theme of this year’s conference is “Partnership in achieving the Millennium Development Goals.”

 

Online resources

PATH rotavirus resource library

Enhanced Diarrheal Disease Control Resource Center

Presentations from the 7th International Rotavirus Symposium

Journal of Infectious Diseases special supplement: Rotavirus in Asia

PubMed preformatted rotavirus search

PubMed preformatted rotavirus vaccine search


 

PATHKey Facts About Rotavirus Disease and Vaccines
Recent studies demonstrate that crucial gaps exist in the awareness of rotavirus disease among public health providers in developing countries. Yet this missing information is key to designing effective rotavirus control strategies. Here is a summary of the most important facts about rotavirus disease and vaccines.


 

TIME Europe Magazine Oct. 16, 2006 | Vol. 168, No. 17
TIME Europe
 16 October 2006

Diarrhea kills more young children around the world than malaria, AIDS and TB combined. Yet a simple and inexpensive treatment can prevent many of those deaths. Why isn't it more widely used?

A Simple Solution
In the West, it's an inconvenience, but, in the developing world, it can be a death sentence. It kills millions of children every year, yet the treatment is a simple mixture of salt, sugar and water. So why isn't more being done to fight diarrhea?

Most deaths from diarrhea can be prevented by giving the victim oral rehydration. A guide to how it works

Surviving Diarrhea
Most deaths from diarrhea can be prevented by giving the victim oral rehydration. A guide to how it works


 

Dr. David Nalin receiving the Mahidol Medal from His Royal Highness the King of Thailand
click to enlarge

Prince Mahidol Award Foundation under the Royal Patronage

Dr. David Nalin receiving the Mahidol Medal from His Royal Highness the King of Thailand at the 2006 Prince Mahidol Award presentation ceremony, Chakri Throne Hall, Bangkok, Thailand, January 31, 2007. Co-awardees included Dr. Richard A. Cash and Dr. Dilip Mahalanabis (Award for Public Health) and Dr. Stanley Schultz (Award for Medicine).

His Majesty King Bhumibol Adulyadej graciously granted permission for the establishment of the “Prince Mahidol Award” in commemoration of the centenary of the Birthday Anniversary of His Royal Highness Prince Mahidol of Songkla on January 1st, 1992. The Award is administered by the Prince Mahidol Award Foundation under the Royal Patronage of which Her Royal Highness Princess Maha Chakri Sirindhorn is the President. The Foundation confers two international awards each year—one for the exemplary contributions in the field of medicine and the other in the field of public health.


In 2006, there are a total of 59 nominations from 29 countries around the world. The Scientific Advisory Committee carefully screened and submitted the short list to the International Award Committee who scrutinized and made a recommendation for the Award laureates to the Board of Trustees. H.R.H. Princess Maha Chakri Sirindhorn presided over the meeting of the Board of Trustees in which the final decision on the Award laureates was made.

On November 1st, 2006, the Board of Trustees made a unanimous decision to confer the Prince Mahidol Award for 2006 to a group of medical professionals who, during the 1960s and the 1970s, had dedicated their lives to the discovery, the introduction, and the widespread use of “Oral Rehydration Solution (ORS) or Oral Rehydration Therapy (ORT).” This simple, inexpensive, but effective treatment of severe diarrhea can be practiced by patients and their household members themselves. The treatment has been used worldwide, both in the developed and in the developing countries alike. It is estimated that the introduction of the ORT has saved more than 40 million lives in the past 30 years.

The discovery and introduction of Oral Rehydration Therapy is a major achievement in the human health service by applying “appropriate technology” based on scientifically-proven clinical research. The Lancet, a very prestigious medical journal, has recognized the ORT as “the most important medical discovery of the 20th century”.

Four of the most distinguished scholars and scientists are conferred the Prince Mahidol Awards for 2006:

In the Field of Medicine:

Professor Stanley G. Schultz, MD. is the former Dean of the University of Texas Medical School at Houston in Texas, USA. He is now Professor of the Department of Integrative Biology Pharmacology, University of Texas Medical School at Houston, Texas, U.S.A. In the 1960s, Dr. Schultz and his team demonstrated that glucose and sodium absorption in the small intestine was intimately coupled, and glucose could facilitate the absorption of sodium and water.

This pioneering work provided the scientific foundation for the use of the oral rehydration solution consisting of salt, sugar and water in the treatment of dehydration in diarrhea patients. Since the early 1970s, the ORT has continuously benefited the lives of millions of children each year all over the world. Dr. Schultz is also known to be a great teacher, receiving several teaching awards including Teacher of the Year award from the American Physiological Society.

In the Field of Public Health:

David R. Nalin, MD. Is the former Director of Vaccine Scientific Affairs. Merck Vaccine Division, Merck&Co. Inc., West Point, Pennsylvania, U.S.A. Dr. David R. Nalin, was assigned, in the 1960s, to the Pakistan-SEATO Cholera Research Laboratory (CRL) in Dhaka, East Pakistan (presently, the capital city of Bangladesh) as a research associate at the US National Institutes of Health (NIH). Dr Nalin, Dr Richard Cash, and their colleagues successfully tested the efficacy of an oral glucose-electrolyte solution, later known as oral rehydration therapy (ORT), to be used instead of intravenous fluid for the treatment of patients with severe cholera.

This new treatment was tested in Matlab and then used by the Johns Hopkins University International Center for Medical Research and Training (ICMRT) in Calcutta in the refugee camps during the Liberation War of Bangladesh in 1971. Later as a WHO consultant, Dr Nalin has helped establish a number of highly successful national programs on the oral rehydration therapy for diarrhea diseases in Costa Rica, Jamaica, Jordan, and Pakistan.

Richard A. Cash, MD, MPH. is Senior Lecturer on International Health at the Department of Population and International Health, Harvard University School of Public Health, Boston, U.S.A.

As a young clinician, right after finishing his internship in New York City, working at the Pakistan-SEATO Cholera Research Laboratory (CRL) in Dhaka in 1960s, Dr Cash had been involved in the first scientifically-proven successful clinical trial of testing the oral rehydration therapy on severe diarrhea patients. The trial has become a landmark for subsequently applying this treatment around the world.

Dilip Mahalanabis, MD. is the Director of the Society for Applied Studies, a non-governmental research organization, in Kolkata, India.

Dr. Dilip Mahalanabis started his work on oral rehydration therapy in 1966 as a research investigator for Johns Hopkins University International Center for Medical Research and Training in Calcutta. During the Liberation War of Bangladesh in 1971, Dr. Mahalanabis used the ORT in the refugee camps which accommodated 350,000 refugees, in West Bengal.

Dr. Dilip Mahalanabis instructed his staff to distribute the ORT for the treatment of over 3,000 patients. With the ORT, the death rate dropped to only 3% in comparison with 20 – 30% using only intravenous fluid therapy. This was the first large – scale use of oral rehydration solution in a disaster situation. As a result, it gained the International health Organizations’ recognition and its application was spread worldwide.

The research works conducted by Dr. David R. Nalin, Dr. Richard A. Cash, and Dr. Dilip Mahalanabis have sequentially contributed to the application of the oral rehydration solution in the treatment of severe diarrhea worldwide, including Thailand. It is estimated that each year around 500 million packs of the oral rehydration solution is used in more than 60 developing countries, saving millions of lives around the world.

Supat Vanichakarn MD., Worawut Smuthkalin, Ph.D.


 

Progress For Children: A Child Survival Report Card (Volume 1, 2004)

A UNICEF Report
Progress For Children: A Child Survival Report Card (Volume 1, 2004)
Download the full publication   Progress For Children: A Child Survival Report Card (Volume 1, 2004)pdf 1.2 mb

This first issue of Progress For Children addresses the child survival Millennium Development Goal, graphically depicting the world's advances in the lead up to 2015. Despite global gains in child survival since 1990, 11 million children still die needlessly each year. By ensuring access to basic services and continued use of simple, cost-effective interventions, these deaths can be averted and the goal of a two-thirds reduction in under-five mortality from 1990 to 2015 achieved.

World Falling Short on Promise to Reduce Child Deaths
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Indian scientists develop anti-diarrhoea vaccine
Indo-Asian News Service - New Delhi
November 5, 2004

The first Indian vaccine to prevent a virulent form of diarrhoea that kills hundreds of children every year is ready for clinical trial.

Developed over 10 years by researchers at the All India Institute of Medical Sciences here and the Indian Institute of Science in Bangalore, the vaccine, isolated from the bodies of newborn babies, has passed laboratory tests and will now be tested on humans.

"If all goes well, the vaccine will be available in the markets in two to three years," M.K. Bhan, secretary of the Department of Science and Technology, told IANS.


 

Diarrhoea vaccine 'a step closer'
Children in the developing world are particularly vulnerable

26 August, 2004

Scientists have discovered how the virus that causes most cases of diarrhoea invades cells.

The Boston Children's Medical School team say the finding could help develop an vaccine to combat the rotavirus.

The virus, the most common cause of severe, dehydrating diarrhoea, kills around 440,000 children a year, mainly in developing countries.

Writing in Nature, the researchers say understanding more about the virus will help them fight it successfully.

The researchers say their work shows how vaccine development can be made "smarter" by looking at the physical make-up of viruses and finding the minimum parts needed to prime the immune system, without having to use a whole virus to make a vaccine.

Almost all children are infected with the rotavirus as toddlers. It can cause gastroenteritis that is sometimes severe enough to require hospital care.

Breaking into cells

Scientists have been working to develop a vaccine which will be effective against the virus for some time.

Two vaccine have been licensed. One was used in the US, but was withdrawn after it was linked to a condition which causes bowel obstruction. The second has only been licensed for use in China.

The researchers in this study examined the geometric structure and behaviour of one of the rotavirus's surface proteins, called VP4, which plays a key role in binding on to the surface of a target cell, and breaking through its membrane.

The key finding for vaccine development is that the "head" and "body" portions of the VP4 protein contain many of the targets that the immune system recognises when it attacks the virus and protects against infection, they say.

"The work is a clear example of the way in which structural studies can contribute to new good ideas about strategies for vaccines," said Dr Stephen Harrison, head of the Children's Medical Hospital Laboratory of Molecular Medicine. 


 

Meeting the MDG Drinking Water and Sanitation Target: 
A mid-term assessment of progress 

26 August, 2004

In adopting the Millennium Development Goals that address the most pressing development issues, countries pledged to halve the proportion of people without access to safe drinking water and basic sanitation. Yet, more than 1 billion people today lack safe drinking water, and some 2.6 billion - half of the developing world - lack improved sanitation. This publication reports on our progress towards the MDG goal of ensuring environmental sustainability. It seeks to encourage countries slow to meet the target to accelerate action, and highlights areas where efforts need to be strengthened in order to meet the goal. 

UN Water Report Meeting the MDG Drinking Water and Sanitation Target
Meeting the MDG Drinking Water and Sanitation Target

More information: 

Why world's taps are running dry

Water Facts: The Big Picture 
Water Facts - The Big picture  A statistical view of the world's water - BBC News 

Water Facts - The Big picture

World's water hot spots
From disappearing lakes and dwindling rivers to military threats over shared resources, water is a cause for deep concern in many parts of the world. Supplies are threatened by overuse, bad management and changing weather patterns. The pressure will only increase as populations grow. 

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Handwashing Program Dramatically Cuts Childhood Diarrhea in Pakistan

1 June, 2004

A household handwashing program in Pakistan substantially reduced the occurrence of diarrhea among children living in a high-risk situation, according to a report in this week's Journal of the American Medical Association.

The results come from a study of more than 4500 children living in 36 low-income neighborhoods in Karachi. In 25 of the neighborhoods, handwashing was promoted to encourage the use of plain or antibacterial soap after defecation, food preparation, eating, and child feeding. The other 11 neighborhoods served as the control group. 

In their report, Dr. Stephen P. Luby, from the Centers for Disease Control and Prevention in Atlanta, and colleagues write: "In these communities in which diarrhea is the leading cause of childhood death, wash water was heavily contaminated with human fecal organisms, and no provisions were made for clean drying of hands, handwashing promotion with soap halved the burden of diarrheal disease." 

Compared with children from control neighborhoods, those from a neighborhood encouraging plain soap use had a 53 percent lower rate of diarrhea. In addition, the plain soap intervention was tied to a 39 percent reduction in the number of days with diarrhea. 

No apparent advantage was seen for using antibacterial soap rather than plain soap, since the antibacterial agent has no effect on many organisms that cause diarrhea.

"Although visiting households weekly to provide free soap and encourage handwashing was effective in reducing diarrhea, this approach is prohibitively expensive for widespread implementation," the authors point out. Therefore, less costly approaches are needed to reach the millions of children living in at-risk households.

SOURCE: Journal of the American Medical Association.


 

The Rotavirus Vaccine Program
Evan Simpson, Program for Appropriate Technology in Health (PATH), 
RVPinfo@path.org 

PATH's Rotavirus Vaccine Program was created in 2003 to reduce child morbidity and mortality from childhood diarrhoeal disease by accelerating the availability of rotavirus vaccines appropriate for use in developing countries. Strategies include:

  • Vaccine demand: providing potential vaccine purchasers at global, national, and local levels with information about disease burden estimates, safety and efficacy; financing and economic data; and immunisation policy analysis.
     
  • Vaccine supply: collecting data needed to conduct demand forecasts and market surveys, and information related to international supply requirements. "The aim is to overcome demand uncertainty, which has been a significant barrier to ensuring vaccine availability in developing countries."

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NIH Attempts To Revive Diarrhea Vaccine 

5 May, 2004
Washington (AP) -- The National Institutes of Health is attempting to revive an anti-diarrhea vaccine that was pulled off the market five years ago after a life-threatening side effect struck some babies.

At issue is rotavirus, an intestinal infection that kills 600,000 children worldwide each year. In the United States, 3 million children get rotavirus annually, but good medical care ensures only about 40 of them die. In developing countries, however, about one child in every 250 dies of rotavirus.

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Resource Centre Manual: How to set up and manage a resource centre

How to Set Up and Manage a Resource Centre

This manual is designed for health and disability workers planning to set up and develop a resource centre within resource-poor communities around the world, and is aimed toward people operating on a limited budget. Healthlink Worldwide uses this manual to support its workshops for organisations setting up resource centres in developing countries.

Written in English with illustrations and diagrams, the manual provides readers with tried-and-tested tips, examples, checklists and resource lists. According to Healthlink Worldwide, it can be used for reference, training or to aid the development of information services, and is presented in a ring-binder for ease of reference and updating.

In this second edition, key areas have been updated and extended to include computers and electronic communication, reviews of database software packages, lists of electronic information sources and further reading, and lists of resource suppliers and distributors.

More info on the document  |  View the document in pdf format

Publisher: Healthlink Worldwide, Cityside, 40 Adler Street, London E1 1EE UK
info@healthlink.org.uk 


 

Child survival: a global health challenge - A series of papers - THE LANCET 

26 July, 2003
 

Where and why are 10 million children dying every year? 
How many child deaths can we prevent this year?
Reducing child mortality: can public health deliver?
Applying an equity lens to child health and mortality: more of the same is not enough
 

The series of papers on child survival that have appeared in The Lancet describes a major public health challenge: more than 10 million children dying each year because they have not been reached by known and effective interventions.1 Children are dying because of the neglect of common and preventable childhood illnesses, of health problems in newborn babies, and of the measures needed to protect mothers and infants during pregnancy and childbirth.

The child survival series was written by technical experts who recognised a set of problems, reviewed the evidence, and challenged WHO, UNICEF, other UN agencies, multilateral and bilateral agencies, non-governmental organisations, and health professionals to take appropriate action. Now it is time for policy makers and public-health leaders to respond, and to transform this knowledge into action. Three commitments must be pursued urgently and unremittingly.

Where and why are 10 million children dying every year? 
The first paper in this series on child survival presented an unacceptable picture: more than 10 million children dying every year, almost all in low-income countries or poor areas of middle-income countries. 90% of these deaths occurred in just 42 countries, most from one of a short list of causes: diarrhoea, pneumonia, measles, malaria, HIV/AIDS, and the underlying cause of undernutrition for deaths among children younger than 5 years, and asphyxia, preterm delivery, sepsis, and tetanus for deaths among neonates. The assessment of deaths by cause provides a useful starting point for a stocktaking of available child survival interventions.

http://www.thelancet.com/ 


 

Rotavirus Vaccines, Take Two 

19 August, 2002
Renewed immunization efforts look to avoid pitfalls of failed predecessor | By Bob Beale

excerpts

The optimism however, has reemerged with new vaccines that are in the pipeline. And perhaps within the next five years, the battle against rotavirus can be rejoined. Although public awareness is low, rotavirus is one of the world's worst infectious disease agents, killing up to 2,000 children a day.

"We now have the potential for several other vaccines becoming available in developing nations, made by national producers in China, India, and Indonesia, and by multinational producers within the next three to five years. As a result, we may even achieve our goals faster than we would have before with just one product and one company."

The Scientist  | Volume 16 | Issue 16 | 34


 

New Rehydration Formula to Save Millions of Lives

10 May, 2002 

The World Health Organization, released a new improved formula of Oral Rehydration Salts (ORS) on Wednesday that would save millions of lives and reduce the severity of illness of those suffering from acute diarrhoea, WHO reported.

ORS is a sodium and glucose solution used to treat children with acute diarrhoea. WHO said the new formula would reduce the severity of diarrhoea and vomiting, the number of hospitalisations, the need for costly intravenous fluid treatment and the length of illness.

Use of the new ORS formula would begin later this year in India, WHO said.

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Facts for Life Lifesaving UNICEF Health Guide Gets New Web Site

One of the world's most widely-read books, Facts for Life (FFL), itself gained new life recently with its first major revision in a decade and new PDF and website versions.  

More than 15 million copies of earlier versions of the book are in use, and it has been translated into 215 languages. FFL is a joint effort of UNICEF, WHO, UNESCO, UNFPA, UNDP, UNAIDS, WFP and the World Bank to provide families and communities around the world with essential information on low-cost ways to help prevent child deaths and diseases and to protect women during pregnancy and childbirth.

Everyone has the right to know this life-saving information.
 
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Hypo-Osmolar Oral Rehydration Solution Advantageous In Treating Pediatric Diarrhea 

5 October, 2001

DELHI (Reuters Health) - A modified oral rehydration solution reduces the severity of diarrhea in malnourished children compared with the standard solution currently recommended by the World Health Organization, researchers reported at the recently concluded 9th Asian Conference on Diarrheal Diseases and Nutrition here.

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InteliHealth Professional Network - Professional E-Mails

[InteliHealth Professional Network] InteliHealth is pleased to offer free biweekly specialty e-mails in Neurology and Gastroenterology and a new monthly Dental Professional e-mail. Register today to receive the latest specialty news, meeting information, resources and more! Also, don't forget to register for our free daily e-mail for health professionals and stay on top of the latest health news and research. Register For Professional E-Mail Newsletters.

Sign up for InteliHealth Professional Network Free Member Services  


 

.... the dialogue continues.
The international newsletter on the control of diarrhoeal diseases 

Dialogue on Diarrhoea offers clear, practical advice on preventing and treating diarrhoeal diseases.  Regular features include guidelines on diagnosis and treatment, training tips, information on rational drug use, research updates and feedback from the field. 

In addition to information on clinical management, the newsletter addresses issues which affect health workers' and families' abilities for care for children, such as communication skills, organisation of health centres and hospitals, health education and training.  


 

Interactive Tutorial,
Image Collection and Glossary CD-ROM 
 

Diarrhoeal Diseases CD-ROM Diarrhoeal Diseases 
Interactive Tutorial,
Image Collection and Glossary CD-ROM

 

'Topics in International Health' is an exciting and unique series of educational materials for medical and life sciences students, their teachers and other healthcare professionals. Aspects of international and tropical health are presented on a range of CD-ROMs, each focusing on a disease (or group of diseases) of global significance. 


This exciting new series of CD-ROMs has been developed by the Wellcome Trust, the world's largest medical research charity, for use as an educational resource in tropical and international health.


 

ORS Day in India  

29, July, 2001
 
Over Eight Hundred Thousand people unite on July 29, 2001 - ORS Day 
to spread the message "ORS Saves Lives" 

Indian Academy of Pediatrics, IAP, and Partners Intensify Promotion of ORS to Prevent Childhood Diarrhea Deaths in India

July 29, 2001 declared as ORS Day by the Indian Academy of Pediatrics, is part of a major effort, aimed at reducing childhood diarrhea deaths. 

- more info


 

Maryland Rice-Based ORS Product 
Clinically Superior to Glucose-Based Oral Rehydration Salts

July 2001


STUDY IN SWEDISH PEDIATRIC JOURNAL ACTA PAEDIATRICA

Cost effective - decreased doses compared to World Health Organization ORS

A study of 167 boys with cholera compared the safety and efficacy of CeraLyte, a rice-based oral rehydration solution (ORS) to the standard "World Health Organization formula" glucose ORS, concluding that the CeraLyte ORS, as in other studies with long-chain rice carbohydrate, is more effective than glucose ORS. The boys, ages 5 to 15 years, suffered severe dehydrating diarrhea, with losses equivalent to about 30% of their body weight while hospitalized. On average, these boys were admitted 14 hours after their illness began, by which time they had already lost 14% of their body weight to dehydration. Thus, total average volume lost during illness was about 44%. 

- more info 


 

New Oral Rehydration Solution More Effective for Children with Diarrhea;

2 April, 2001
 

WHO Plans to Make Changes Based on New Research Findings

Multicenter, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of a Reduced Osmolarity Oral Rehydration Salts Solution in Children With Acute Watery Diarrhea

Children who receive a less concentrated (reduced osmolarity) oral rehydration solution for the treatment of dehydration and diarrhea are significantly less likely to need costly intravenous (IV) fluid treatment compared to children treated with the current solution used by the World Health Organization (WHO), according to a new study conducted by the Johns Hopkins School of Public Health and five other institutions around the world. Based on the latest research findings, the WHO plans to conduct a meeting of experts to revise its recommendations on oral rehydration solution formulation for treatment of children with diarrhea. The study is published in April 2001 edition of Pediatrics.

"More than 200,000 children are hospitalized and nearly 300 die from severe diarrhea in the U.S. each year and the problem is worse in other countries. The reduced osmolarity, or less concentrated, oral rehydration solution is a very effective treatment and it will be extremely beneficial to children in developing countries who might not have access to IV's and advanced medical care," says co-author Mathuram Santosham, MD, MPH, professor of international health at the Johns Hopkins School of Public Health.

Since its development in the 1960s, oral rehydration solution has been credited with saving the lives of millions of children throughout the world who suffer from dehydration caused by severe diarrhea. The solution is a mixture of water, glucose, sodium, potassium, and electrolytes, which help children recover and retain vital fluids and nutrients. The United Nations Children's Fund (UNICEF) distributes oral rehydration solution worldwide. Similar solutions are sold in U.S. supermarkets under different brand names such as Pedialyte and Infanlyte.

The new reduced osmolarity solution is a less concentrated formula and contains less sodium than the current WHO solution. The lower osmolarity helps the body absorb water more quickly and reduces the risk of hypernatraemia, which is a rare but deadly disorder caused by too much salt in the body.

For the double-blind study, researchers randomly selected 675 children from health centers in five developing countries who suffered from diarrhea. All of the children selected for the study were between one and 24 months of age. Half of the group was treated with the current rehydration solution while the other half was treated with the new reduced osmolarity solution.

"We found that the children who received the reduced osmolarity solution were 33 percent less likely to need IV treatment when compared to the children treated with the current WHO formula. Also, the new formula was equally effective at reducing diarrhea and vomiting," explains Dr. Santosham.


The study was funded by grants from the World Health Organization (WHO), Division of Child Health and Development, Applied Research on Child Health Project of the Harvard Institute for International Development, and the United Nations Children's Fund (UNICEF).


 

WHO: Soda Bottles, Sunlight Can Save Millions Of Lives A Year 

21 March, 2001

GENEVA (AP) - A do-it-yourself technique of disinfecting water with sunlight and soft-drink bottles could save up to 2.5 million lives a year, the World Health Organization said Thursday. 

In a campaign to reduce water-related deaths in developing countries, the United Nations health agency is promoting Solar Water Disinfection or SODIS. 

Martin Wegelin, a researcher at the Swiss Institute for Environmental Science and Technology, said when transparent bottles are filled with water and placed horizontally on a flat surface for about five hours, the heat and ultraviolet rays of the sun kill illness-causing microorganisms in polluted water. 

The method is even more effective when the bottom half of the bottle is painted black or placed on black-painted corrugated iron or plastic sheets, he said. 

More than one billion people drink unsafe water, WHO said in a report on water and sanitation released to mark World Water Day. Some 3.4 billion people, mostly children, die every year from water-related diseases, which include malaria, diarrhea and guinea worm. 

WHO urged the use of SODIS, chlorination and better hygiene as immediate means of improving people's water supply in developing countries. 

Chlorination is another simple method that costs just a few cents a day, WHO said. 

"Even in conditions of very poor sanitation and hygiene, where people are collecting whatever water is available for their household supply, if the water is chlorinated (it) is improved," said Mark Sobsey, professor of environmental microbiology at the University of North Carolina in Chapel Hill. "And you can find statistically significant decreases in diarrhea disease."

WHO said chlorine could be added to both home and city reservoirs and was essential in refugee camps. 

The International Federation of the Red Cross and Red Crescent said it was redoubling its efforts to provide disa