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GENEVA
AND SEATTLE, June 5, 2009: The World Health Organization has recommended
that rotavirus vaccination be included in all national immunization
programmes in order to provide protection against a virus that is
responsible for more than 500,000 diarrhoeal deaths and two million
hospitalizations annually among children. More than 85 percent 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 the 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 low and intermediate mortality populations. 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 Review published
on June 5, 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, 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.”
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
to 20 year lag between the introduction of new vaccines in wealthy
countries and their availability in the developing world. Today, WHO’s
global recommendation 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 US,
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 the World Health Organization (African Region). “Too
many of our children are dying from rotavirus and other causes of
diarrhoea. We urgently need these lifesaving vaccines against
rotavirus.”
The clinical trial investigators from Malawi and South Africa will
present and publish their data on the GSK vaccine later this summer.
Clinical trial sites in Bangladesh and Vietnam—along with sites in
Ghana, Mali, and Kenya—evaluated the performance of Merck’s rotavirus
vaccine, and data are expected in Fall 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 percent of all child deaths each year, the
majority of which are in the developing world.(PR) |
