Experts urge industry and international donors to prepare pneumococcal vaccines

Millions of deaths could be prevented by routine immunisation against a major cause of pneumonia and meningitis in the developing world

London, UK– In today's online edition of The Lancet, a group of leading global health experts have come together to call for vaccine manufacturers and international donors to negotiate affordable pricing of pneumococcal conjugate vaccines and for governments of developing world countries and their partners to establish disease surveillance networks and begin preparations for pneumococcal vaccine introduction.

The experts believe that urgent action to introduce routine childhood pneumococcal vaccination is needed because of the enormous burden of the disease – the World Health Organization (WHO) estimates that about 1.6 million people, including up to one million children under five years old, die every year of pneumococcal pneumonia, meningitis, and sepsis.1 In populations with high child mortality rates, pneumonia is the leading infectious cause of mortality and accounts for about 20-25% of all child deaths.2

This call to action comes on the eve of a meeting of G8 ministers to discuss funding vaccines. This seems to be the latest step in major changes over the last five years in financing of immunization, including the creation of the GAVI Alliance (Global Alliance for Vaccines and Immunization) Fund. Dr Orin Levine, the lead author of the article and Executive Director of PneumoADIP – a non-governmental organization that aims to shorten the time between use of a vaccine in industrialized nations and their introduction in the developing world – commented: "We hope that with such mechanisms in place, all developing countries will begin to consider that millions of children can now be saved by the simple addition of this vaccine to existing immunization programs."

Dr Thomas Cherian, Co-ordinator, Ad Interim, EPI, WHO, and co-author of the article added: "Pneumococcal disease is a major global health issue; what is promising is that a seven-valent vaccine that is effective against seven common strains of the disease is already licensed and in use in over 60 countries and that formulations containing additional serotypes of the organism that are also relevant for developing countries are under development. The WHO considers pneumococcal vaccines to be a priority and recognizes the urgency to make these vaccines available for children in developing countries."

There are other pneumococcal vaccines in development, which contain additional serotypes targeting strains of the disease that commonly cause death and disability in the developing world; however, these will not be available for several years. Introducing the seven-valent vaccine now means that lives can start to be saved immediately. This vaccine, manufactured by Wyeth, is effective, well-tolerated and can be delivered through existing immunization systems. Surveillance data from the U.S.indicate that the herd immunity* effect from routine childhood pneumococcal vaccination prevents twice as many cases as the direct effects of vaccination alone – protecting vulnerable adults as well as children.

Responding to The Lancet paper, Julian Lob-Levyt, Executive Secretary, GAVI Alliance, said, "There is convincing evidence of the benefits of vaccines for major child killers, especially when such a simple health intervention could help in meeting UN Millennium Development Goal no. 4: to reduce child mortality by two thirds by 2015. GAVI will be looking closely at how best to assist countries where pneumococcal disease represents a significant burden on public health."

Jean Stéphenne, President of GlaxoSmithKline Biologicals, the vaccines division of GlaxoSmithKline PLC, also welcomed the call to action in The Lancet and said, "GSK Bio has invested many years in the development of a vaccine that protects against the 10 most important strains of pneumococcus serotypes worldwide, and our candidate is now being studied in a global clinical program. We have a long history of supplying vaccines in developing countries and are committed to working to make our pneumococcal vaccine available worldwide at sustainable prices. We hope that our partners in governments, donor agencies, charities, and international organizations will step up with a firm purchase commitment that will allow us to save as many lives as possible."

James Connolly, Executive Vice President and General Manager of Wyeth Pharmaceuticals vaccine's business unit, concurred with the call to action and stated, "Prevnar has been launched in 60 countries, and has had a significant impact on the health of children where it is in use. In the U.S., three years after the routine use of Prevnar, there has been a 94 percent reduction in invasive pneumococcal disease caused by the disease serotypes included in the vaccine. We are actively working with international agencies to help provide access to Prevnar for children in the developing world.

Meanwhile, Wyeth researchers are continuing to work on new versions of Prevnar, including a version that will address 13 of the most prevalent serotypes of invasive pneumococcal disease, which will expand its usefulness globally for both children and adults."

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* Herd immunity is the resistance of a population to spread of an infectious organism due to the immunity of a high proportion of the population – the US study suggests that the herd immunity effect of pneumococcal vaccination may be particularly strong.

References
1. WHO. Pneumococcal vaccines. Wkly Epidemiol Record 2003; 14: 110-19
2. Williams BG, Gouws E, Boschi-Pinto C et al. Estimates of worldwide distribution of child deaths from acute respiratory infections. Lancet Infect Dis 2002; 2: 25-32
3. Cutts FT, Zaman SM, Enwere G et al. Efficacy of nine-valent pneumococcal conjugate vaccine against pneumonia and invasive pneumococcal disease in The Gambia: randomised, double blind, placebo-controlled trial. Lancet 2005; 365:1139-46

Notes to Editors

Pneumococcal disease is an infection caused by Streptococcus pneumoniae. When these bacteria invade the lungs, they cause the most common kind of bacterial pneumonia. The bacteria can also invade the bloodstream (bacteremia) and/or the tissues and fluids surrounding the brain and spinal cord (meningitis).

According to WHO, pneumococcal pneumonia and meningitis are responsible for 800,000 to one million child deaths each year and more than 90 percent of pneumococcal pneumonia deaths in children occur in developing countries.

The World Health Organization (WHO) is the United Nations specialized agency for health. It was established on 7 April 1948. WHO's objective, as set out in its Constitution, is the attainment by all peoples of the highest possible level of health. Health is defined in WHO's Constitution as a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity.

The goal of the Pneumococcal Vaccines Accelerated Development and Introduction Plan (PneumoADIP) is to shorten the time between the use of a new vaccine in industrialized countries and its introduction in developing countries by reducing demand uncertainty and achieving an affordable, sustainable supply of vaccines. This novel approach is funded by the Global Alliance for Vaccines and Immunization (GAVI) through its partner the Vaccine Fund. PneumoADIP is located at the Johns Hopkins Bloomberg School of Public Health. The mission of PneumoADIP is to improve child survival and health by accelerating the evaluation of and access to new life saving pneumococcal vaccines for the world's children. For more information, please visit: www.preventpneumo.org.

The GAVI Alliance (The Global Alliance for Vaccines and Immunization) was launched in 2000 to increase immunization rates and reverse widening global disparities in access to vaccines. Governments in industrialized and developing countries, UNICEF, WHO, the World Bank, non-governmental organizations, foundations, vaccine manufacturers, and public health and research institutions work together as partners in the Alliance, to achieve common immunization goals, in the recognition that only through a strong and united effort can much higher levels of support for global immunization be generated. Funds channelled through GAVI's financing arm, The GAVI Fund (formerly The Vaccine Fund), are used to help strengthen health and immunization services, accelerate access to selected vaccines and new vaccine technologies - especially vaccines that are new or under-used, and improve injection safety. In addition to substantial funding from the Bill & Melinda Gates Foundation, The Vaccine Fund has been financed by ten governments to date-Canada, Denmark, France, Ireland, Luxembourg, the Netherlands, Norway, Sweden, the United Kingdom, and the United States- as well as the European Union and private contributors.

For further information visit the following website: www.preventpneumo.org or contact:

Hans Kvist
Director, Communications
GAVI's PneumoADIP
Mobile: +1 410 736 8243
Email: hkvist@jhsph.edu

Selina Haylock
Consultant
Ruder Finn Communications
Mobile: +44 (0)7768 823 989
Email: shaylock@ruderfinn.co.uk


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