Significant time lag to meet an urgent need: The first version of a pneumococcal conjugate vaccine (PCV) reached the market in 2000 - so except in a very few isolated countries that benefited from donations from industry, it has taken over a decade for PCV to reach the children that need it the most. There have been several public launches of the AMC since it was first announced at the G8 in 2006, so we hope pneumococcal vaccines can finally reach children in developing countries this year.

Price still a major issue that threatens the viability of GAVI commitments: There is still a long way to go to make this vaccine cheaper. At a cost of US$21 per child (three doses at $7 per dose), donors and GAVI are paying for a vaccine vastly more expensive than the ones currently used in developing countries.

In addition, for countries that do not fall in the category of the poorest countries supported by GAVI and are therefore outside of the AMC, like many in Latin America, the vaccine will be even more expensive and likely be unaffordable.

By 2015, GAVI plans to spend $2.4bn for the pneumo-vaccine, of which $920 million would come from the AMC, and $1.48bn from GAVI's 'own' funds. It is not surprising that GAVI which has committed to roll out this and other new vaccines is today facing a financing crisis.

Despite this announcement, production remains limited: With the signing of agreements by GSK and Pfizer, new pneumococcal vaccines may become available in developing countries.

But limited production capacity means that the number of vaccines will remain limited this year, and falls far short of the needs. GAVI's latest estimate of demand for pneumo-vaccines shows 19 million doses are needed in 2010, when GSK are proposing to supply around one million this year, and the figure for Pfizer is not yet known. In addition, Pfizer's vaccine will not be able to participate in the AMC until it has been prequalified by WHO.

Access is contingent on registration: So far GSK's vaccine is only registered in one African country (Kenya), so we now urge GSK to quickly register its vaccine in all developing countries.

Adaptability of the vaccine is an issue for developing countries: Unfortunately, GSK is offering the vaccine only as a two doses vial to least developing countries, although a one dose vial exists, is more practical and safer in low-resource settings.

Looking ahead: The pros and cons of the AMC mechanism as a way to roll out new vaccines should be carefully evaluated before any more ambitious AMC (particularly one that seeks to pay for breakthrough innovation and not just building manufacturing capacity) is considered.

Source
Doctors Without Borders / Médecins Sans Frontières
Campaign for Access to Essential Medicines
msfaccess

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