While 35 high- and middle-income countries, including South Africa, currently provide routine childhood immunisation against pneumococcal disease, the introduction of the vaccine in Rwanda signals a new era in vaccine access and delivery in the developing world. 

Thanks to the partnership between developing countries, donor governments and industry, the GAVI Alliance will be able to offer the same access to life-saving, new-generation vaccines currently utilized throughout the industrialised world.

"We applaud the Rwandan government for taking this step, and we are proud to join them in launching a new era in the delivery of vaccines designed to close the gap between rich and poor countries and improve child mortality throughout the developing world," said Dr. Julian Lob-Levyt, CEO of the GAVI Alliance.

"If fully rolled out in GAVI countries, the pneumococcal vaccine could save the lives of more than 440,000 children by 2015. This would help achieve Millennium Development Goal 4,” he said. 

"This event would not be possible without the commitment of public and private partners who are making vaccines available to the poorest countries," concluded Dr. Lob-Levyt.

"Combating the burden of serious disease globally is an important part of Wyeth’s mission,” said Bernard Poussot, Chairman, President and CEO of Wyeth, which donated Prevenar to Rwanda and the Gambia through the GAVI Alliance. 

"Wyeth is committed to protecting current and future generations from pneumococcal disease and continuing to expand access to Wyeth’s pneumococcal conjugate vaccine around the world," he said. 

"It is in that tradition that Wyeth is honoured to provide GAVI Alliance with more than three million doses of Prevenar to help Rwanda and the Gambia protect its children against the potentially devastating consequences of this disease,” said Mr. Poussot.

The millennium development goal (MDG) related to child health, MDG4, addresses a serious disparity in child mortality, which is much higher in poor versus wealthy nations, and which is significantly driven by lack of access to appropriate health care, including treatment and prevention of serious infections. 

The routine use of new vaccines against the two leading killers of children under age five, pneumonia and diarrheal diseases, could save more than 800,000 lives by 2015 and put low-income countries significantly closer to reaching their MDG4 targets.

To help make this program possible in Rwanda, and in the Gambia in June of this year, Wyeth contributed more than three million doses of the pneumococcal vaccine through GAVI. 

Prevenar, originally introduced by Wyeth Pharmaceuticals in the United States in 2000, is the first new generation vaccine to be introduced to the developing world by the GAVI Alliance. 

The United States Agency for International Development (USAID) has provided extensive technical support and worked closely with the Rwandan Ministry of Health to make the rollout of pneumococcal vaccine a possibility. 

In addition, the World Health Organisation provided technical support and USAID donated cold storage equipment where the vaccine is kept until it is administered.

Pneumococcal disease takes the lives of 1.6 million people each year – including up to one million children under five years of age. More than 90 percent of these deaths occur in developing countries. 

Pneumonia, the most common form of serious pneumococcal disease, accounts for one in every four child deaths, making it the leading cause of death among children younger than 5 years of age.

Since 2000, GAVI Alliance, a global partnership that includes WHO, UNICEF, the World Bank and funded by donor countries and the Bill & Melinda Gates Foundation, has achieved remarkable success in creating and implementing new methods of development assistance for health. 

Its focus has been to provide innovative financial support to accelerate the introduction of basic vaccines and strengthen health systems in developing countries, including in Rwanda. 

As a result, more than 200 million children in 72 countries have been immunised against as many as six common, life-threatening diseases. The GAVI Alliance is now expanding its support for new generation vaccines including against pneumococcal and rotavirus.

To ensure the sustainable supply of pneumococcal vaccines to countries in the future, GAVI Alliance has launched a unique financing mechanism known as the Advance Market Commitment (AMC). 

The governments of Italy, the United Kingdom, Canada, Norway, and Russia, and the Bill & Melinda Gates Foundation launched a pilot AMC against pneumococcal disease with a collective US$ 1.5 billion commitment. 

The pilot is expected to begin implementation in the next few months. New pneumococcal vaccines currently under development may be eligible for AMC funding.

“Financial barriers to vaccines have been overcome,” said Dr. Orin Levine, Executive Director of GAVI’s Pneumococcal Accelerated Development and Introduction Plan (PneumoADIP). “The price of action will be measured in dollars. The price of inaction will be measured by the number of children who will lose their lives to a preventable disease.”

Private industry continues its efforts to deliver new vaccines that offer protection against the strains of pneumococcal disease that are most prevalent in the developing world. 

"Wyeth applauds the GAVI Alliance, the World Bank and donors for developing innovative finance instruments such as the Advance Market Commitment to spur the development of new vaccines for countries in need," said Mr. Poussot. "We look forward to working together with the GAVI Alliance and other global partners to help make the AMC pilot a reality." 

Streptococcus pneumoniae, also known as pneumococcus, is a bacterium frequently found in the upper respiratory tract of healthy children and adults. The bacterium, however, cause a range of infections – from relatively mild ear infections to fatal pneumonia, meningitis and sepsis. 

Serious pneumococcal infections are most common in young children (especially those < 2 years old), the elderly and immune compromised individuals such as those who are undernourished or HIV positive.

Pneumococcus is the main cause of pneumonia, which kills more children than any other disease. Pneumonia causes nearly 1 in 5 deaths of children under five worldwide and kills more children than AIDS, malaria and measles combined.

For those children in developing countries who contract and survive pneumococcal meningitis, one in four are left with serious disabilities, including neurological damage, kidney disease, deafness, limb amputations, and developmental delays.

The GAVI Alliance (formerly the Global Alliance for Vaccines and Immunisation) is a public-private partnership of major stakeholders in immunisation and health system support. It includes developing country and donor governments, the World Health Organisation, UNICEF, the World Bank, the vaccine industry in both industrialized and developing countries, research and technical agencies, civil society, the Bill & Melinda Gates Foundation and individuals. WHO projections show that GAVI Alliance support has prevented more than 3.4 million future deaths by the end of 2008. Visit www.gavialliance.org.

Wyeth is one of the world’s largest research-driven pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing and marketing of pharmaceuticals, vaccines, biotechnology products, nutritionals and non-prescription medicines that improve the quality of life for people worldwide. The company’s major divisions include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal Health. Visit www.wyeth.com.

PneumoADIP is a small, dedicated team based at Johns Hopkins Bloomberg School of Public Health – the world’s largest school of public health – and is supported by a grant from the GAVI Alliance (GAVI). PneumoADIP’s mission is to improve child survival and health by accelerating the evaluation of and access to new, lifesaving pneumococcal vaccines for the world's children. 

PneumoADIP coordinates its activities through a strategic alliance with the World Health Organisation and aims to achieve its goals through partnerships with countries, donors, academia, international organisations, and industry. Visit www.preventpneumo.org or www.jhsph.edu.

Prevenar™ (Pneumococcal 7-valent Conjugate Vaccine) is approved by the World Health Organization for active immunisation of infants and children from 6 weeks through 9 years of age against invasive disease, pneumonia and otitis media caused by Streptococcus pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F and 23F. 

Prevenar may be given at the same time as DTP, hepatitis B, measles, mumps, rubella, polio (OPV or IPV) and varicella. The use of Prevenar should be based on official recommendations taking into consideration the impact of invasive disease in different age groups as well as variability of serotype epidemiology in different geographic areas. A PCV7 fact sheet is available upon request.

In clinical trials, the most frequently reported adverse events included injection site reactions, fever (≥38°C/100.4°F), irritability, drowsiness, restless sleep, decreased appetite, vomiting, diarrhea, and rash. 

Risks are associated with all vaccines, including Prevenar. Hypersensitivity to any vaccine component, including diphtheria toxoid, is a contraindication to its use. Prevenar does not provide 100% protection against vaccine serotypes or protect against non-vaccine serotypes.

For more information, please contact:

Fidele Ngabo, Rwanda Ministry of Health, fidele.ngabo@moh.gov.rw

Jeffrey Rowland, GAVI Alliance, jrowland@gavialliance.org

Julie Buss, PneumoADIP, buss@jhsph.edu

Lili Gordon, Wyeth, gordonl2@wyeth.com