GlaxoSmithKline announced 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 fulfil 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 programmes.
Rotavirus infects virtually every child in the world within the first five years of life and it is the most common cause of severe diarrhoea in children worldwide. This virus is the single greatest cause of diarrhoea-related deaths among children.
"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 per cent 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. Rotarix 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 Rotarix 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. Belgium and Luxembourg have 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.