Sanofi has received marketing authorisation for its dengue vaccine Dengvaxia from Mexico regulatory body Federal Commission for the Protection against Sanitary Risks (Cofepris).
The company will launch Dengvaxia, the world’s first vaccine for dengue fever, in Mexico early next year.
Also known as breakbone fever, dengue is a mosquito-borne tropical disease caused a virus mainly transmitted by Aedes mosquitoes, particularly A aegypti.
Cofepris has approved Dengvaxia, a tetravalent dengue vaccine, to prevent the disease caused by all four dengue virus serotypes in preadolescents, adolescents and adults aged nine to 45 years living in endemic areas.
Sanofi CEO Olivier Brandicourt said: "When Sanofi set out to develop a dengue vaccine 20 years ago together with local and global public health and scientific communities, it was with the intention of developing an innovative vaccine to tackle this global public health need.
"Today, with this first marketing authorisation of Dengvaxia, we have achieved our goal of making dengue the next vaccine-preventable disease."
Approval was based on results from an extensive clinical development programme that included more than 40,000 people of different ages, geographic and epidemiological settings, as well as ethnic and socio-economic backgrounds living in 15 countries.
The company noted that dengue-endemic regions of Mexico participated in all three phases of the clinical development programme for the vaccine.
The company is continuing regulatory review processes for Dengvaxia in other endemic countries.
Production of Dengvaxia has already started at the company’s facilities in France and the vaccine will initially be introduced in countries where dengue is a major public health priority.
According to the World Health Organization (WHO), dengue is currently the fastest growing mosquito-borne disease in the world, causing nearly 400 million infections every year.
The WHO has called for development of a dengue vaccine as an essential part of the integrated dengue prevention effort needed to reduce the dengue burden across the world.
Image: Dengue virus is transmitted by Aedes mosquitoes, particularly A aegypti. Photo: courtesy of Muhammad Mahdi Karim.