Sanofi's Dengue Vaccine Is World's First Approved
This article was originally published in Scrip
The first vaccine against the world's fastest growing mosquito-borne disease, dengue virus, has been granted marketing authorisation in Mexico. Sanofi Pasteur's Dengvaxia has been approved for prevention against four dengue virus serotypes in adults, adolescents and pre-adolescents, aged 9-45 years, by the COFEPRIS (The Federal Commission for the Protection against Sanitary Risks).
The price of the vaccine has not yet been established; Sanofi said its next steps would involve discussions with the "Mexican health authorities regarding the best immunization program." The company said it was prepared to provide Mexico with the enough of the vaccine to ensure that all those living at risk there are able to receive it.
Sanofi has spent 20 years trying to develop a vaccine against dengue. The WHO has identified the development of an effective dengue vaccine as an essential part of the integrated prevention effort needed to significantly lower the global burden of the disease; itwants to see a reduction of dengue mortality by 50% and morbidity by 25% by 2020. Sanofi says that disease impact modelling indicates that if 20% of the population in the 10 endemic countries that participated in the Dengvaxia Phase III efficacy studies are vaccinated according to the label, this could reduce the dengue burden by 50% in five years.
The approval of Dengvaxia was based on the results from a clinical program that involved over 40,000 individuals from different countries (including Mexico). The latest results to be reported by the French firm were in 2014 from a Phase III trial, which showed a 60.8% reduction in dengue cases and an 80% reduction in the risk of hospitalization due to the virus. In previous Phase III studies, the efficacy rates were slightly lower.
Sanofi said that it had not yet decided where the dengue vaccine will be launched next but by the end of this year it plans to have submitted regulatory applications for the vaccine in nearly 20 countries, filing in Asian and Latin American countries, which are heavily affected by dengue, first. Manufacturing of Dengvaxia has already begun in France and first doses are already produced, the company said.
The live attenuated chimeric vaccine was developed using the ChimeriVax technology which uses yellow fever virus (YF) 17D vaccine strain capsid and non-structural genes to deliver the envelope gene of other flaviviruses such as dengue.
Currently there are a number of other dengue vaccines in development; the most advanced being that developed by Takeda (acquired with Inviragen in 2013) which announced plans to move into Phase III for its dengue vaccine in September 2014. Other companies including GlaxoSmithKline Plc. and Biological E also have vaccines for the virus under development in Phase II.