WHO move helps Merck's Gardasil into poor markets
This article was originally published in Scrip
The World Health Organization has prequalified Merck & Co's cervical cancer vaccine, Gardasil, meaning it is now eligible for procurement by UN agencies, such as the children's fund (UNICEF) and the Pan American Health Organization, for use in national immunisation programmes.
The company says it will offer the vaccine to public sectors of eligible countries of the GAVI Alliance at not-for-profit prices, although it does not reveal prices. Last month, the firm saw first quarter sales of $262 million for the human papillomavirus vaccine, missing analysts' expectations.
The GAVI Alliance, a public-privately funded body that supports vaccination programmes, mostly for children, in 72 poor countries around world, told Scrip: "We are absolutely interested in funding HPV vaccine." Last November, the GAVI board supported the financing of HPV vaccines in theory, but now a cost-plan for a 10-year period would need to be presented at its next board meeting in November, it said.
The vaccine has been approved in 111 countries, 23 of which are GAVI-eligible. One of these, India, makes up about 25% of the world's burden of cervical cancer, and there are two Indian firms already working on cut-price versions of HPV vaccines (Gennova Biopharmaceuticals and Shantha Biotechnics). GAVI said it believed the country would be eligible should it apply for HPV vaccine support.
Merck & Co says it is also looking at other ways of cutting the price of the vaccine to poorer countries, including manufacturing efficiencies and reduction of royalties to licensors on doses sold in developing countries.
The high prices of HPV vaccines – which can cost several hundred dollars, therefore keeping them out of reach for many developing countries – has already been criticised by Nobel winner Professor Harald zur Hausen, who helped make the link between HPV and cervical cancer (scripnews.com, April 6th, 2009).
Cervical cancer is a significant burden in developing countries, where almost 80% of cases occur. The three-jab intramuscular vaccine (0, two, then six months) may help prevent the disease in settings that do not have the resources to undertake cervical cancer screening.
In 2007, Merck & Co promised to help improve access to the vaccine, by committing to donate at least three million doses over five years to developing countries; the first shipment took place in February of this year.
The firm has also signed an agreement with not-for-profit body PATH to run demonstration projects in the developing world by providing vaccine and technical support at no cost; projects are complete in Peru and ongoing in Vietnam and India.
Earlier this month GlaxoSmithKline's cervical cancer vaccine, Cervarix, showed a superior immune response to Gardasil in the first large-scale head-to-head trial of the two rival vaccines, which could potentially mean that Cervarix offers longer lasting protection against cervical cancer (scripnews.com, May 14th, 2009). GSK is also seeking WHO prequalification for its vaccine.
Gardasil is licensed for girls and women aged nine to 26 years of age for the prevention of cervical, vulvar and vaginal cancers caused by HPV types 16 and 18; genital warts caused by HPV types 6 and 11; and precancerous or dysplastic lesions caused by HPV types 6, 11, 16 and 18.