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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 Boards 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
GAVIs funding for the vaccines against rotavirus and pneumococcal
diseases. These much needed vaccines will protect our children and allow us
to reduce [our countrys] 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 WHOs
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 worlds poorest
countries. IFFIm is the latest in groundbreaking strategies spearheaded by
the GAVI Alliance to accelerate delivery of lifesaving interventions to
benefit the worlds 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 Mercks 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 CDCs 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
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Key
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. |
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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 |
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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. |
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Sudan
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date and photographer unknown |
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Sudan
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date and photographer unknown |
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
More information:
Why world's taps are running dry
Water Facts: The Big Picture
A statistical view of the world's water - BBC
News
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.
more
info

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."
more
info

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.
more
info


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.
more info

 |
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.
more info

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.
more
info

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 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
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 |