GSK’s Rotarix™ Vaccine Against Rotavirus Granted WHO Global Prequalification

Opens access to Asia and Africa – potential to save hundreds of thousands of lives

June 5, 2009 -- London UK -- The World Health Organisation (WHO) has awarded global prequalification to GlaxoSmithKline Biologicals’ vaccine against rotavirus, Rotarix™.Additionally, the WHO's Strategic Advisory Group of Experts (SAGE) also recommended that rotavirus vaccination be included in all national immunisation programmes. Together, these WHO decisions open the door to making rotavirus vaccines available to children worldwide.

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Rotavirus, a severe diarrhoeal illness, is the second leading killer of children under five years of age. The WHO prequalification will accelerate access to the vaccine in Asia and Africa and expands on the WHO decision taken in 2007 to prequalify the vaccine for Europe and the Americas. The WHO prequalification is necessary for UN agencies and the GAVI Alliance to purchase rotavirus vaccines on behalf of developing countries.

Since 2006, GAVI has provided support for the introduction of rotavirus vaccines and estimates that an immediate, widespread global immunisation campaign against rotavirus could save the lives of 2.5 million children by 2025.[i] Rotavirus kills more than 500,000 children each year and sickens millions more, the vast majority of whom live in developing countries.[ii] Once funding is in place, effective immunisation programmes can help achieve the UN Millennium Development Goal on child mortality.

“Today’s approval is the culmination of a long-standing commitment at GSK to deliver a rotavirus vaccine for the world,” said Jean Stéphenne, CEO of GSK Biologicals. “Five years ago, GSK pursued a different regulatory strategy to speed the availability of Rotarix™ by introducing the vaccine in developing countries first, where the medical needs and mortality rates are highest. In Latin America, we carried out some of the largest clinical trials for a vaccine in history and continued clinical studies of the vaccine in a range of different settings in both rich and poor countries.”

Historically vaccines reach developing countries as long as 15-20 years after their introduction in the U.S. and Europe. As part of an innovative ‘South-first’ access strategy, GSK Biologicals launched Rotarix™ in Latin America. Rotarix™ is registered in more than 100 countries worldwide, and is approved by major regulatory agencies such as the European Medicines Agency and U.S. Food & Drug Administration. Furthermore it is currently the only rotavirus vaccine to receive global prequalification from the World Health Organisation.

To receive WHO prequalification, new vaccines must demonstrate clinical impact in relevant settings as well as meet high international production and safety standards. This is to ensure that vaccines used in U.N. Agency tenders are safe and effective for the target population at the recommended schedules and that they meet particular operational specifications for packaging and presentation. Before prequalification is granted, the WHO conducts quality assurance tests on individual vaccine batches, rigorously inspects manufacturing sites and evaluates the national regulatory agency of the country where the vaccine will be produced.

About Rotarix™ and rotavirus

Rotarix™ is a two-dose, orally-administered vaccine that offers early protection against rotavirus to infants. The WHO recommends that administration of RotarixTM occur between the ages of 6-32 weeks for prevention of Rotavirus Gastroenteritis (RVGE) [iii]. Since 80% of rotavirus infections in developing countries occur in infants less than one year old, early administration of the first dose at six weeks ensures that the most vulnerable population is protected as early as possible.

The global clinical development programme has spanned five continents and demonstrates that RotarixTM protects against the most common circulating strains (G1 and non-G1 rotavirus strains) including the emerging G9 strain. RotarixTM is also able to significantly reduce hospitalisations for all gastroenteritis, regardless of cause. Today, Rotarix™ benefits children in more than 100 countries around the world.

Rotavirus is the most common cause of severe diarrhoea and the single greatest cause of diarrhoea-related deaths in children worldwide[iv] ,[v] . Although the disease is endemic worldwide, more than 90% of these deaths occur in developing countries. The effects of rotavirus are especially severe in Asia and Africa, where a lack of clean water and limited healthcare infrastructure contribute to the spread of the disease.

Source: GlaxoSmithKline