Sanofi Pasteur is poised to produce the first validation batches of their dengue vaccine at the company’s state-of-the-art production centre near Lyon, France.
According to Antoine Quin, manager at the site in Neuville-sur-Saone, the plant has a design capacity of 100 million doses of the vaccine, tetravalent CYD-TDV, annually. Starting around 2015, Sanofi Pasteur expects to manufacture one billion doses over the following decade.
Investing 300 million euros in building and staffing the plant was a substantial gamble for Sanofi, said Guillaume Leroy, dengue vaccine head. The Lyon facility got the green light in 2009, when only Phase II data was available. Although promising, this was far from definitive.
Confidence was boosted in September 2011 when researchers based in France and Thailand published data in The Lancet from a trial which recruited more than 4,000 Thai schoolchildren. This showed CYD-TDV to be effective against three of the four types of dengue virus currently circulating. Phase III trials are now underway in Asia and Latin America with results expected next year.
The complete production cycle for the tetravalent vaccine takes two years. If the Phase III results fulfil Sanofi’s hopes, the company will be poised to launch in 2015 and hit the ground running to meet the massive global demand for dengue vaccine. It will also be comfortably ahead of competitors with pipeline candidates, such as GlaxoSmithKline, Merck & Co and Takeda/Inviragen.
Dengue is a potentially fatal viral disease. Worldwide, at least 2.5 billion people are at risk of infection, 975 million of whom live in urban areas in tropical and sub-tropical countries in Southeast Asia, the Pacific and the Americas. Each year, more than 50 million people suffer dengue, of whom more than 500,000 require hospital treatment for dengue haemorrhagic fever, a serious form of this mosquito-transmitted infection.