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Sanofi Begins Manufacturing Dengue Vaccine Ahead of Approval

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Sanofi Begins Manufacturing Dengue Vaccine Ahead of Approval

Related tags: Clinical trial, Sanofi

Sanofi has begun the production of a yet-to-be-approved dengue vaccine in order to stay ahead of competitors and ready a launch in 2015.

Production kicked off because it can take up to two years to manufacture the vaccines, Anthony Quin, head of Sanofi’s Neuville-sur-Saone, France- based manufacturing site told Reuters​. Sanofi invested 300M Euros ($391M) at the facility​.

Guillaume Leroy, who heads the dengue vaccine project at Sanofi Pasteur, also said the company would be able to supply 100 million doses a year once it’s approved.

With up to 100 million people infected with dengue annually, Sanofi is looking to help stave off what the WHO has called a “pandemic threat​.”

Sanofi spokesman Jack Cox told us that the facility is producing the vaccine now because "up to 70% of the time it takes is related to the myriad of quality control measures and tests that must be in place​." He also noted that the decision to begin production now could aid the vaccine's approval since "any approval would require that we show consistency in our production process, hence that we are able to produce batches repeatedly with the same characteristics​." 

Sanofi’s potential vaccine is the only one currently in Phase III clinical trials, though several other live-attenuated vaccines, as well as subunit, DNA and purified inactivated vaccine candidates, are at earlier stages of clinical development, according to the WHO​. Additional technological approaches, such as virus-vectored and VLP-based vaccines, are under evaluation in preclinical studies.

Sanofi still has to wait on the results of its Phase III trials, which are due to be released in late 2013 or early 2014. 

Related topics: Processing, Delivery technologies

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