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Sanofi's dengue vaccine could debut in 2015

End in sight after 20-year wait for first effective vaccine
dengue fever mosquito

Sanofi is edging close to the fruition of a 20-year effort to develop the first effective vaccine against dengue fever, which hospitalises half a million people a year.

Data from the first phase III trial of the vaccine have now been published in The Lancet and indicate that a three-dose course of the vaccine given to children aged two to 14 had an overall efficacy of 57 per cent against symptomatic dengue.

Moreover, Sanofi's shot reduced the risk of a severe form of the disease known as dengue haemorrhagic fever by almost 89 per cent and cut the risk of hospitalisation by two thirds, according to the trial in five Asian countries. The results also indicate the vaccine is safe, said Sanofi, which hopes to make it available next year.

Around half the world's population is at risk of developing dengue fever, and while the burden is most felt in Asia and Latin America, its incidence is on the increase in many other areas of the world as travellers bring the virus back with them from trips abroad.

For example, Public Health England (PHE) recently reported a 58 per cent increase in cases to 541 last year, mainly contracted during visits to countries such as India and Thailand where the disease is endemic.

Dengue is spread by mosquitoes and symptoms include fever, a hammering headache, flu-like symptoms, bone, muscle and joint pain, rash and nausea and vomiting.

Symptoms generally clear within two weeks in fit and healthy people, but it can take months to recover and a minority of patients go on to develop haemorrhagic fever that can lead to organ damage. It kills around 22,000 people a year, according to the World Health Organization (WHO), and puts huge strain on hospitals and healthcare systems during outbreaks.

"The threat of severe dengue disease creates fear in the community," said the trial's principal investigator Dr Maria Rosario Capeding of the Research Institute for Tropical Medicine in the Philippines, who suggested the vaccine's impact on haemorrhagic fever is particularly exciting from a public health perspective.

"A vaccine that is able to avoid the personal suffering and reduce this significant health burden would change the lives of millions," she noted.

Sanofi has a second trial of the vaccine ongoing in Latin America that is due to report data in the third quarter of this year. If those results are similarly positive, analysts have predicted the vaccine will be rolled out quickly and could generate peak sales of around $1.4bn a year, making it one of the brightest prospects in Sanofi's pipeline.

Takeda is also developing a vaccine against dengue fever that was acquired along with other candidates when it took over Inviragen last year in a deal valued at up to $250m. The vaccine - called DENvax - is in phase II testing.

Article by
Phil Taylor

11th July 2014

From: Research, Healthcare

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