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WHO has recommended that rotavirus vaccination be included in all national
immunization programmes to provide protection against a virus that is responsible
for more than 500 000 diarrhoeal deaths and 2 million hospitalizations every
year among children. More than 85% of these deaths occur in developing countries
in Africa and Asia. This new policy will help ensure access to rotavirus vaccines
in the world’s poorest countries.
The new recommendation by WHO's Strategic Advisory Group of Experts (SAGE) extends
an earlier recommendation made in 2005 on vaccination in the Americas and Europe,
where clinical trials had demonstrated safety and efficacy in populations with
low and intermediate mortality. New data from clinical trials, which evaluated
vaccine efficacy in countries with high child mortality, has led to the recommendation
for global use of the vaccine. This is reported in the Weekly Epidemiological
Record published on 5 June 2009.
“This is a tremendous milestone in ensuring that vaccines against
the most common cause of lethal diarrhoea reach the children who need them
most,” noted Dr Thomas Cherian, Coordinator of the Expanded Programme
on Immunization in the WHO Department of Immunization, Vaccines and Biologicals.
“This WHO recommendation clears the way for vaccines that will
protect children in the developing world from one of the most deadly diseases
they face," said Dr Tachi Yamada, President of the Global Health
Program at the Bill & Melinda Gates Foundation. “We need to
act now to deliver vaccines to children in Africa and Asia, where most rotavirus
deaths occur.”
Clinical trials
The GAVI Alliance, vaccine manufacturers, and the public health community made
an unprecedented commitment to understand how these vaccines would work in developing-world
conditions. The clinical trial, funded in part by GAVI and conducted by PATH,
WHO, GlaxoSmithKline (GSK) and research institutions in high-mortality, low-socioeconomic
settings of South Africa and Malawi, found that the vaccine significantly reduced
severe diarrhoea episodes due to rotavirus.
In 2006, the GAVI Alliance added rotavirus vaccines to its portfolio of vaccines
for which it provides financial support to developing countries, underscoring
GAVI’s commitment to reduce the traditional 15-year to 20-year lag between
the introduction of new vaccines in developed countries and their availability
in the developing world. WHO’s global recommendation now paves the way
for low-income countries in Africa and Asia to apply to GAVI for introduction
of rotavirus vaccines— just three years after new rotavirus vaccines became
available in the United States of America, Europe and Latin America.
“The GAVI Alliance welcomes this exciting recommendation,”
said GAVI CEO Dr Julian Lob-Levyt. “It represents another important
step in our ability to achieve significant impact on under-five deaths in
the world’s poorest communities and make progress towards the Millennium
Development Goals. We are extremely excited about the potential to offer African
and Asian countries funding to introduce rotavirus vaccines.”
Because oral vaccines can have variable efficacy in different populations,
it was important to demonstrate vaccine performance in high-mortality settings.
The studies in Africa were conducted among populations with high infant and
child mortality, poor sanitary conditions, high diarrhoeal disease mortality
and high maternal HIV prevalence.
“The new evidence and the WHO recommendation are major breakthroughs
for the health of our children,” said Dr Oyewale Tomori, Vice-Chancellor
of Redeemer's University, Nigeria, who has served as Regional Laboratory Coordinator
for WHO in the African Region. “Too many of our children are dying
from rotavirus and other causes of diarrhoea. We urgently need these lifesaving
vaccines against rotavirus.”
Vaccine efficacy valid for all regions
The clinical trial investigators from Malawi and South Africa will present
and publish their data on the GSK RotarixTM vaccine later this summer. Clinical
trial sites in Bangladesh and Viet Nam -- along with sites in Ghana, Mali, and
Kenya -- evaluated the performance of Merck’s rotavirus vaccine, RotaTeq®,
and data are expected in the fall of 2009. While efficacy data from Asian countries
are forthcoming, SAGE recommended rotavirus vaccines for all populations, including
Asia, since available evidence indicates that efficacy data can be extrapolated
to populations with similar mortality patterns regardless of geographic location.
Because there are many causes of diarrhoeal disease, SAGE emphasized the importance
of providing rotavirus vaccination in the context of a comprehensive diarrhoeal
disease control strategy, including improvement of water quality, hygiene, and
sanitation; provision of oral rehydration solution and zinc supplements; and
overall improved case management.
WHO, UNICEF and other GAVI partners are working together in a new accelerated
and integrated approach to combat rotavirus diarrhoea and pneumonia, the two
biggest vaccine-preventable diseases which together account for more than 35%
of all child deaths every year, the majority of which are in the developing
world.
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Ltd.. Material in this news item was released by the World Health Organization
(WHO) on 5 June 2009
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