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Impfen => Impfen wissenschaftlich => Topic started by: ama on February 22, 2007, 02:09:40 PM
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http://www.gsk.com/media/pressreleases.htm
http://www.gsk.com/ControllerServlet?appId=4&pageId=402&newsid=975
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WHO awards prequalification status to GSK rotavirus vaccine
Rotarix™ is the first Rotavirus Vaccine to obtain the prequalification status by WHO
Issued — Tuesday 13 February 2007, London, UK and Rixensart, Belgium
- GlaxoSmithKline announced today that the company’s rotavirus
vaccine has been awarded prequalification status by the World Health
Organization (WHO). It is the first time a vaccine against rotavirus
gastroenteritis has received such clearance.
The WHO prequalification endorses the vaccine’s quality, safety and
efficacy, and its ability to fulfill tender specifications. This allows UN
agencies, such as the Pan American Health Organization (PAHO), UNICEF and
others to make large purchases and to use the vaccine in mass vaccination
programs.
Rotavirus infects virtually every child in the world within the first five
years of life and it is the most common cause of severe diarrhea in
children worldwide1. This virus is the single greatest cause of
diarrhea-related deaths among children2.
“The WHO prequalification is good news for millions of children
worldwide, particularly in developing countries,” said Jean
Stéphenne, president of GSK Biologicals. “GSK has a long-standing
commitment to combating disease in developing countries. In keeping with
our practice, we intend to offer the vaccine at tiered prices, with lowest
prices reserved for the public sector in the world’s poorest
countries.”
Dr. Jon Andrus, Lead Technical Adviser for Immunization Unit, Pan-American
Health Organization (PAHO) said: “This decision signals the
importance of rotavirus immunization as a top public health priority. On a
concrete level, it will immediately allow PAHO and other multilateral
organizations to purchase rotavirus vaccines on behalf of resource-poor
and middle-income countries in the region.
This will speed their delivery of these vaccines to the children who need
them most and start saving more lives now.”
Dr. Ciro de Quadros, president and chief executive officer of the Albert
V. Sabin Vaccine Institute, added: “WHO’s decision is
especially good news for developing countries, where 90% of the 600,000
annual deaths from rotavirus infection occur.
Widespread immunization has the potential to offer protection to millions
of children. Prequalification will allow UN agencies to purchase and meet
an ambitious goal of immunizing 80% of the world’s children against
rotavirus by 2015.”
WHO prequalification is an established mechanism to facilitate the supply
of new vaccines to regions where they are most urgently needed. GSK will
be the first company to be able to offer their rotavirus vaccine to those
organizations for use in mass vaccination programs. The WHO endorsement
complements the recent decision by the GAVI board to finance rotavirus
vaccines for use in developing countries.
GSK has played a key role in the prevention of rotavirus diseases by
pioneering a unique global vaccine model,designed to provide the earliest
access to life-saving vaccines to those who need them most. RotarixTM was
first approved in Mexicoin July 12th 2004, and was launched there in
January, 2005. It is a two-dose, oral vaccine that offers early protection
to infants, indicated from the age of 6 weeks for prevention of Rotavirus
Gastroenteritis (RVGE) before the peak incidence of disease at 6-24 months
of age 3,4. The global clinical development program has proven that
RotarixTM protects against the most common circulating strains (G1 and
non-G1 rotavirus strains) including the globally emerging G9 strain3. As
of today Rotarix™ has been approved in 90 countries world-wide and
children in about 50 countries are already benefiting from the vaccine. It
is part of national immunization programs in Brazil, El Salvador, Mexico,
Panamaand Venezuela. Belgiumand Luxembourghave also decided in 2006 to
reimburse the vaccine.
GSK has decades of commitment to the developing world. Its vaccines unit,
GSK Biologicals, has pioneered a price differentiation policy, by which
price levels are adapted to a countries’ financial capabilities,
ordered volumes and long-term contracts. This facilitates the availability
of vaccines in economically weaker parts of the world. About 30 percent of
GSK’s vaccine pipeline is aimed at diseases that affect
predominantly the developing world. GSK is the only major pharmaceutical
company developing vaccines and drugs for all three diseases that are
currently prioritized by WHO: AIDS, TB and Malaria.
GlaxoSmithKline Biologicals
GSK Biologicals, one of the world’s leading vaccine manufacturers,
is located in Rixensart, Belgium, where the majority of GlaxoSmithKline’s activities in the field of vaccine research,
development and production are conducted. GSK Bio employs more than 1,500
research scientists, who are devoted to discovering new vaccines and
developing more cost-effective and convenient combination products to
prevent infections that cause serious medical problems worldwide.
In 2005, GSK Bio distributed more than 1.2 billion doses of vaccines to
165 countries in both the developed and the developing world, an average
of more than 3 million doses per day.
In the next five years, GSK expects to launch more major new vaccines: an
HPV vaccine targeting cervical cancer, a vaccine to prevent pneumococcal
diseases, an improved flu vaccine for the elderly, and a meningitis
combination vaccine for infants in the US.
GlaxoSmithKline — one of the world's leading research-based
pharmaceutical and healthcare companies — is committed to improving
the quality of human life by enabling people to do more, feel better and
live longer.
References
1. Parashar UD, et al. Rotavirus. Emerg Infect Dis 1998;4(4)
2. Bresee J, et al. Rotavirus in Asia: The Value of Surveillance for
Informing Decisions about the Introduction of New Vaccines. J Infect
Dis. 2005; 192 (Suppl 1): S1-S5
3. Ruiz-Palacios GM, et al. Safety and Efficacy of an Attenuated Vaccine
against Severe Rotavirus Gastroenteritis. N Engl J Med 2006;354(1):11-22
4. Linhares AC et al. Rotavirus vaccines and vaccination in Latin America.
Pan Am J Public Health 2000;8(5):305-331
Enquiries:
UK Media enquiries:
Philip Thomson
Alice Hunt
Gwenan White
(020) 8047 5502
(020) 8047 5502
(020) 8047 5502
US Media enquiries:
Nancy Pekarek
Mary Anne Rhyne
Patricia Seif
(215) 751 7709
(919) 483 2839
(215) 751 7709
European Analyst/
Investor enquiries:
Anita Kidgell
David Mawdsley
Sally Ferguson
(020) 8047 5542
(020) 8047 5564
(020) 8047 5543
US Analyst/Investor
enquiries:
Frank Murdolo
Tom Curry
(215) 751 7002
(215) 751 5419
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Updated February 13, 2007
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