Children in Ghana to be vaccinated against diarrhoeal disease with the introduction of GSK’s Rotarix™ vaccine

Issued:  London UK

• Agreement finalised to supply up to 132 million doses of Rotarix at an affordable price to GAVI* over 5 years 
• Ghana becomes the first African country to introduce simultaneously two new vaccines through GAVI funding 

GlaxoSmithKline (GSK) welcomes today’s GAVI announcement that GSK’s rotavirus vaccine, Rotarix™, will be introduced into the newly started national vaccination programme in Ghana. This follows the finalisation of an agreement which confirms acceptance of the offer made by GSK to GAVI in June 2011, to supply up to 132 million doses of Rotarix at a reduced price over five years. GSK will now begin supplying the vaccine through UNICEF to countries in Africa enabling millions of children in the world’s poorest countries to rec eive vaccination against rotavirus diarrhoeal disease.

Rotavirus-related diarrhoea is one of the leading causes of death in children under five worldwide. It kills almost half a million children each year¹ and leads to hospitalisation of around two million more². While rotavirus infects virtually every child within the first five years of life³, it is far less deadly in more developed countries, where hospitalisation and intravenous rehydration are readily available, and where vaccination is becoming more common. In developing countries, such as Ghana, the picture is very different and children die unnecessarily.

Christophe Weber, President of GSK Biologicals said:  “The introduction of an additional life-saving vaccine funded by the GAVI Alliance can help protect millions of children from yet another deadly infectious disease, hopefully giving them a healthier start to life. At GSK, we are determined to play our part in accelerating access to new medicines and vaccines to help improve the health and well-being of people around the world. We are proud to contribute to the efforts being made to protect children in Africa to reduce death and ill health from diarrhoea.”

GSK has committed to supply 132 million doses of Rotarix to GAVI over the next five years at a 95% reduction of the price to developed Western markets. This will help meet the demand for rotavirus vaccination forecasted by UNICEF. The discounted Rotarix price is in line with GSK’s long-standing tiered pricing policy which enables poorer countries to pay significantly less than higher income countries for the same vaccine, with the lowest prices reserved for agencies such as UNICEF which purchase large volumes of vaccines for the world’s poorest children.

GSK has been a long-standing partner with the GAVI Alliance, and continues to supply more than 70% of its total vaccine volumes to the least developed countries. Rotavirus related diarrhoea is one of the leading causes of death in children in developing countries. ^4,5

Vaccination against rotavirus has so far been successfully introduced in five GAVI eligible countries: Nicaragua, Honduras, Bolivia, Guyana and Sudan. By securing a guaranteed supply of low priced high quality vaccines, GSK’s commitment to supply up to 132 million doses of Rotarix will enable GAVI to expand rotavirus vaccination further, with the aim to cover over 40 countries by 2015.

GSK vaccines are included in immunisation campaigns in 173 countries worldwide and of the 1.1 billion vaccine doses delivered in 2011, 870 million doses (more than 80%), were shipped for use in developing countries which include least developed, low and middle income countries. GSK is the leading vaccine supplier to organisations such as UNICEF and the Pan American Health Organization (PAHO).

Notes

• Diarrhoea is the second leading cause of death in children under five years of age worldwide⁴ and rotavirus is the leading cause of severe diarrhoeal disease in children⁶.
• Rotavirus has a devastating effect. It is estimated that almost half a million children die of rotavirus gastroenteritis each year – the equivalent of a child a minute worldwide⁷ – and it is responsible for the hospitalization of millions more.^6. Most (around 85%) of these deaths occur in Africa and Asia.²
• Growing evidence suggests that the introduction of rotavirus vaccines substantially reduce severe diarrhoea in young children. In Brazil, following the launch of Rotarix, hospitalisations due to rotavirus gastroenteritis decreased by almost 60% just one year after the introduction of universal mass vaccination.⁸
• In April 2009, the World Health Organization’s (WHO) Strategic Advisory Group of Experts (SAGE) recommended that rotavirus vaccination be included in all national immunisation programmes. Based on this decision, the WHO awarded global prequalification to Rotarix. These decisions have opened the door to making rotavirus vaccines available to children worldwide.
• 100 million doses of Rotarix have been delivered since its first launch in 2007 which means that around 50 million children across the world have been vaccinated with Rotarix against rotavirus.
• In 2011 Sudan became the first country in Africa to introduce Rotarix with support from the GAVI Alliance. Rotavirus vaccine was initially accepted for use in 14 countries in the Americas and Europe only, with Nicaragua, Bolivia, Guyana and Honduras becoming the first countries to benefit from GAVI rotavirus funding.

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. For further information please visit www.gsk.com

*GAVI - Global Alliance for Vaccines and Immunisation.   

Cautionary statement regarding forward-looking statements

Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK' s operations are described under 'Risk factors' in the 'Financial review & risk' section in the company's Annual Report 2011 included as exhibit 15.2 to the company's Annual Report on Form 20-F for 2011.

References

• Tate JE, et al. 2008 estimate of worldwide rotavirus-associated mortality in children under 5 years before the introduction of universal vaccination programmes: a systematic review and meta-analysis. Lancet Infectious Diseases. 2012;12:136-41.
• Parashar UD, et al. Global illness and deaths caused by rotavirus disease in children. Emerging Infectious Diseases . 2003;9(5):565-72.
• Parashar UD, et al. Rotavirus. Emerging Infectious Diseases. 1998; 4(4):561-568.
• Black R et al. Global, regional, and national causes of child mortality in 2008: a systematic analysis. Lancet 2010; 375: 1969-1987
• GAVI Alliance (2009). Pneumococcal AMC: Frequently asked questions. Accessed 3 June 2011 from: www.vaccineamc.org/files/FAQs2009.pdf
• Forster J et al. Hospital-based surveillance to estimate the burden of rotavirus gastroenteritis among European children younger than 5 years of age. Pediatrics 2009; 123: e393-e400.
• World Health Organisation. Weekly epidemiological record 2011; 86: 173-176
• Safadi M et al. Hospital-based surveillance to evaluate the impact of rotavirus vaccination in Brazil. Poster presentation at ESPID.www.kenes.com/espid09/posters/abstract660.htm (accessed 9 May 2011)