First African country introduces GSK’s pneumococcal vaccine through innovative financing mechanism

• Rapid introduction of Synflorix™ in Kenya at around 90% discount to developed markets through first use of AMC in Africa - Enables vaccination of millions of children against pneumococcal disease

Issued: London, UK

GlaxoSmithKline (GSK) announced the incorporation of its pneumococcal vaccine into the Kenyan national immunisation programme.  Kenya is the first African country to receive pneumococcal vaccines through the innovative financing mechanism known as the Advance Market Commitment (AMC), which is designed to bring heavily discounted vaccines to children living in the world’s poorest countries.

At a commemoration ceremony to be held in the capital city of Nairobi on 14 February, government officials will be joined by representatives of the Global Alliance for Vaccines and Immunisation (GAVI), the Bill & Melinda Gates Foundation, UNICEF and GSK, to launch the programme.  Consequently, millions of children will be vaccinated and protected against pneumococcal disease, which is the world’s leading killer of children under five years of age.

GSK’s Synflorix™ is the first vaccine to be rolled out in Africa under the AMC framework and provides protection against 10 strains of the pneumococcus bacteria that are responsible for the large majority of pneumococcal disease in Kenya and worldwide. 

Sierra Leone is also introducing pneumococcal vaccines through the AMC in Africa, and Yemen is doing the same in the Middle East.  Certain countries in Latin America are also eligible to receive pneumococcal vaccines through the AMC. 

Nicaragua began vaccinating children in late 2010 and Guyana is introducing vaccines this year.  In total, GAVI anticipates that more than 40 developing countries will receive pneumococcal vaccines through the AMC by 2015.

The AMC accelerates access to new and innovative vaccines.  By guaranteeing the availability of initial purchase funds, the AMC enables vaccine makers to invest in development and manufacturing capability.  In addition, by contracting significant volumes over the long-term, manufacturers can significantly reduce the cost of their vaccines.

Jean Stéphenne, Chairman and President of GlaxoSmithKline Biologicals said: “The architects of the AMC have delivered on their promise to accelerate access to vaccines for children living in the world’s poorest countries.  Their vision, Kenya’s leadership and the willingness of donors to realise this commitment have resulted in a genuine breakthrough to global public health.”

The AMC is backed by five donor countries – the United Kingdom, Canada, Russia, Norway and Italy – and the Bill & Melinda Gates Foundation. 

In March 2010, GSK and Pfizer signed 10-year contracts through the AMC to provide up to 300 million doses each of their pneumococcal vaccines, at an approximate reduction of 90% of the cost in developed markets. 

GSK has invested more than US$400 million in a plant to manufacture Synflorix in Singapore to meet expected global demand.

Kenya began administering immunisations in early January with Synflorix, which is supplied in a two-dose presentation to help developing countries optimise their storage and transport space.  Kenya rolled out a comprehensive training programme to prepare its healthcare workers and clinics to administer the vaccine alongside the traditional immunisations Kenyan children already receive. 

About Synflorix™

• Synflorix helps protect against diseases due to pneumococcus bacteria.  It contains 10 serotypes, three of which – 1, 5, and 14 – were required to be included in the vaccine for the AMC due to the high burden of invasive diseases caused by these serotypes in the developing world.¹
• It is the most technically sophisticated of GSK’s vaccines and each dose takes a year to make.  It is essentially ten vaccines in one.  Each individual strain is grown and developed separately – it is only at the very end of the process that they are brought together as one vaccine.
• Over the next decade, GSK has committed to provide an average of up to 30 million doses annually under the AMC.
• GSK has invested more than US$400 million in a dedicated manufacturing plant in Singapore that will produce several hundred million doses of the vaccine annually in the coming years.
• Synflorix was the first pneumococcal vaccine to receive World Health Organisation (WHO) ‘prequalification’ for global use, a regulatory endorsement that is a precondition for participation in the AMC.

About pneumococcal disease

• Pneumococcal disease is a global health issue.  Each year, S.pneumoniae infections are estimated to kill one million children under five years of age, mostly in developing countries.^2-3
• Pneumococcal bacteria can cause life-threatening diseases such as meningitis, pneumonia and bacteraemia.⁴ 
• S.pneumoniae can also cause less severe, but considerably more common diseases of the respiratory tract such as middle ear infections, sinusitis and bronchitis.⁴

About GlaxoSmithKline 

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 more information please visit: www.gsk.com. 

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 'Business Review' in the company' s Annual Report on Form 20-F for 2009.

1. Pneumococcal Regional Serotype Distribution for Pneumococcal AMC TPP, PneumoADIP Report, November 2008. Last accessed February 2011.
2. GAVI Alliance 2007. The Pneumococcal AMC: Ready to save lives. Last accessed February 2011.
3. World Health Organization. Immunization,Vaccines and Biologicals. Last accessed February 2011
4. World Health Organization. Weekly epidemiological record. Last accessed February 2011.