Abstract

Pneumonia is the world's leading killer of children younger than 5 years, and is one of the foremost vaccine-preventable killers of children today. Every year, pneumococcal disease kills about 1 million children worldwide. Children younger than 5 years in low-income countries are 89 times more likely to die from pneumococcal disease than are children in high-income countries. In Nicaragua, 20% of children who get pneumococcal disease die, compared with a global average of 18%. Through introduction of an innovative financing mechanism called advance market commitment (AMC), developed by the GAVI Alliance, Nicaragua became the first developing country to introduce a new 13-valent pneumococcal vaccine in December last year, just months after the vaccine was made available in the USA. The GAVI Alliance was created in 2000 at the World Economic Forum, with the ambition to save children's lives and to protect health in developing countries. The Alliance works in the 72 poorest countries in the world, and in 10 years it has immunised 288 million children, saving more than 5 million lives. Development of a vaccine might take up to 20 years and requires a series of big financial investments. In developed countries, these investments are normally recouped through sales. In developing countries, pharmaceutical companies fear that sales will never be sufficient to recover the costs of vaccine development. Although a vaccine against pneumonia has existed since 2000, no affordable pneumonia vaccine is available in developing countries. The existing vaccine is sold at US$70 per dose in developed countries. The AMC initiative for pneumococcal vaccine was launched in June, 2009, at the G8 Summit in L'Aquila, Italy, with the intention to help prevent pneumonia. With $1·5 billion funding from Canada, Italy, Norway, Russia, the UK, and the Bill & Melinda Gates Foundation, the initiative is aiming to create a market to ensure demand for, and supply of, pneumococcal vaccines for developing countries. Donor organisations will guarantee a price for vaccines once they have been developed, and pharmaceutical companies will sign agreements to supply vaccines at a fixed price of no more than $3·50 per dose for 10 years. The money will be paid mostly by GAVI, with, in the case of Nicaragua, the government contributing a small share (initially $0·30 per dose), which will increase over time. For the first 20% of doses, manufacturers will get an extra $3·50 for each dose they provide, which will be paid from the $1·5 billion of AMC funding. For the remaining 80%, manufacturers will supply vaccines at a lower cost, which cannot exceed the price cap of $3·50. GlaxoSmithKline and Pfizer are the first companies to participate, and both have signed an agreement to provide 30 million doses every year for 10 years. Rollout of the 13-valent pneumococcal conjugate vaccine in Nicaragua is expected to cover 80% of the serotypes causing invasive pneumococcal disease in children in Latin America and the Caribbean, and it is remarkable that this new vaccine has reached children in developing countries in the same year as it reached those in the USA, but at a 90% reduction in price. Nicaragua was the first country to introduce the pneumococcal vaccine, but another 19 countries have been approved by GAVI for rollout of the pneumococcal vaccine by the end of the 2011. Honduras and Guyana also introduced the vaccine in December, 2010, followed by Mali, Sierra Leone, Kenya, and Yemen in January, 2011. Other countries that will be introducing the vaccine in 2011 include Cameroon, the Central African Republic, Congo (Brazzaville), the Democratic Republic of the Congo, Rwanda, and The Gambia. More than 110 million children are expected to be immunised by 2015, and the AMC pneumococcal vaccine scheme could prevent an estimated 700 000 childhood deaths by 2015 and more than 7 million by 2030. The crucial aspect of the AMC scheme is whether $3·50 is the right price. Is it low enough to be sustainable in the poorest nations that need access to the vaccines included in the scheme? But also, is it high enough for the AMC scheme to be attractive to pharmaceutical companies? The launch of pneumococcal vaccination in Nicaragua under AMC has shown that innovative approaches to health financing can benefit both global health and pharmaceutical companies. The involvement of more manufacturers could help such programmes to grow and create a competitive market to provide access to lifesaving vaccinations for more children in the poorest countries.

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