GSK and Pfizer sign $450 million vaccine contract for developing countries
This article was originally published in Scrip
GlaxoSmithKline and Pfizer will both supply their respective pneumococcal conjugate vaccines (PCV) at a massive discount to the prices charged in industrialised markets to a scheme that aims to save the lives of 900,000 children in the world's poorest countries by 2015.
The firms will receive $225 million apiece for supplying 300 million doses each over a 10-year period, meaning each company will receive 15% of the $1.5 billion funds earmarked for the advanced market commitment scheme (AMC), vaccine-funder the GAVI Alliance told Scrip. This means that "70% of the AMC incentive funds are still unallocated and will be available for successive rounds of calls for offers", GAVI said.
The AMC, which was officially launched last year and has the support of donor countries and the Bill & Melinda Gates Foundation, was set up to stimulate the development and uptake of affordable vaccines for developing countries (scripnews.com, 16 June 2009). Donors can commit money to guarantee the price of vaccines once they have been developed.
The R&D industry will be pleased to see that it was two of its members that signed the first agreements, but two Indian firms have also registered interest in the scheme – Panacea Biotec and Serum Institute of India – as have others. Scrip had predicted GSK as the top contender for the scheme last year (scripnews.com, 11 November 2009). GAVI hopes that more firms joining the scheme will further drive down the price of the vaccine in developing countries.
The two vaccines – GSK's 10-valent Synflorix and Pfizer's 13-valent Prevenar – are expected to be made available this year at $3.50 per dose to be paid by GAVI and the developing governments that introduce the vaccines. For about 20% of the vaccine doses, firms will receive a further payment of $3.50 for each dose provided, which will be paid with AMC funds. The price of the vaccine represents a huge discount to those paid by rich countries: For example, PCV-13 is sold in the US (CDC list) at $108 per dose while PCV-10 is sold in Europe at $54 per dose. Children generally need three doses of the vaccine.
To date only GSK's PCV-10 is pre-qualified by the World Health Organization (WHO), a requirement for the scheme, while Pfizer is awaiting a decision, possibly this year.
GSK received worldwide WHO prequalification for a one-dose vial of Synflorix in November 2009 – the first prequalification of a vaccine against pneumococcal disease – and gained prequalification on 19 March 2010 for a two-dose vial presentation.
It hopes that a two-dose vial "will enable more efficient use of limited refrigeration resources in developing countries", it told Scrip. But Tido von Schoen-Angerer, director of Médecins Sans Frontières's Campaign for Access to Essential Medicines, told Scrip: "Unfortunately, GSK is offering the vaccine only as a two-dose vial to least developing countries, although a one-dose vial exists, [which] is more practical and safer in low-resource settings."
GSK's Synflorix saw sales of £73 million for 2009 (made up of £23 million in Europe and £41 million in the rest of the world), which reflected launches in several markets and the beginning of shipments to the Brazilian government as part of the 10-year $1.5 billion agreement signed in August 2009.
As Pfizer's Prevenar 13 vaccine was only approved in the US in February 2010 and in the EU in December 2009 there are little available public sales data. (Its predecessor, the older 7-valent Prevnar vaccine (originally a Wyeth product) – which saw 2009 sales of $287 million – was used in Gambia last year through GAVI after the firm made donations of the product; scripnews.com, 20 August 2009.)
MSF view on the deal
Dr von Schoen-Angerer told Scrip that: "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."
He believes that there is "still a long way to go to make this vaccine cheaper". At a cost of $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, he adds.
MSF is concerned that some countries will not benefit from the scheme as they do not fall into the category of the poorest countries supported by GAVI, like many in Latin America, where the vaccine will be "even more expensive and likely be unaffordable". GAVI has not named all the countries that will eligible for the vaccine, only 13 countries have been approved so far. "We'll make an announcement in the coming weeks," it told Scrip.
While accepting that the scheme may make new pneumococcal vaccines available in developing countries, MSF believes limited production capacity means that the number of vaccinations will remain limited this year, and fall far short of the needs. "GAVI's latest estimate of demand for pneumo-vaccines shows 19 million doses are needed in 2010, when GSK is proposing to supply around one million this year, and the figure for Pfizer is not yet known," Dr von Schoen-Angerer says.
GSK has invested more than $400 million in a plant it opened in June 2009 in Singapore to meet demand, which it says will produce several hundred million doses of the vaccine annually in the coming months.
Pfizer says it is increasing its manufacturing capabilities to meet growing global demand for its vaccine. "We are excited to be part of it [the scheme] as it is groundbreaking and will make a difference to developing countries," it said. Pneumococcal disease is the leading cause of death in children under five years of age, killing some 800,000 each year, the majority in developing countries
more AMC schemes?
The AMC idea could be extended to other vaccine-preventable diseases affecting developing countries, but MSF is wary. Dr von Schoen-Angerer said: "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."