Sanofi Gets Approval for World’s First Dengue Vaccine

Mexico has granted marketing authorization to Sanofi Pasteur for its dengue vaccine, Dengvaxia. The vaccine is the world’s first to be approved for preventing the disease which is transmitted by mosquitoes.

Dengvaxia has been developed to protect against all four dengue virus serotypes in people from nine to 45 years of age living in endemic areas. According to the World Health Organization (WHO), dengue is the world’s fastest growing mosquito-borne disease, infecting nearly 400 million people every year and causing severe bone and joint pain. The WHO has asked endemic countries to reduce dengue mortality by 50% and morbidity by 25% by 2020.

“Dengue is a growing health threat in Mexico and many other tropic and subtropical countries in Latin America and Asia. The first vaccine approved to prevent dengue fever is a major innovation and a public health breakthrough,” said Jose Luis Arredondo Garcia, associate director of clinical research in Mexico’s National Institute of Pediatrics.

The vaccine’s approval is based on results from an extensive clinical development program involving more than 40,000 people in 15 countries, including Mexico.

First doses of Dengvaxia have been produced at Sanofi’s facility in France and full-scale capacity will reach 100 million vaccine doses annually.

Regulatory reviews are ongoing in other endemic countries.