World’s first dengue vaccine approved in Mexico
Sanofi Pasteur, the vaccines division of Sanofi, announced that Mexican authorities approved Dengvaxia, making it the first vaccine to be licensed in the world for the prevention of dengue.
“Today, with this first marketing authorization of Dengvaxia, we have achieved our goal of making dengue the next vaccine-preventable disease. This is a historic milestone for our company, for the global public health community and, most importantly, for half the world’s population who lives at risk of dengue.” said Olivier Brandicourt, MD, Chief Executive Officer, Sanofi.
The approval of Dengvaxia is based on results from an extensive clinical development program involving over 40,000 people of different ages, geographic and epidemiological settings, and ethnic and socio-economic backgrounds living in 15 countries. Dengue-endemic regions of Mexico participated in all three phases of the clinical development program for the vaccine.
“Dengue is a growing health threat in Mexico and many other tropical 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. Dengvaxia will be a critical addition to the integrated dengue prevention and control efforts. It will be an essential tool to boost on-going community efforts to relieve the long-standing suffering that this disease continues to bring to people in endemic countries like ours,” asserts José Luis Arredondo García, Associate Director of Clinical Research in the National Institute of Pediatrics.
Regulatory review processes for Dengvaxia are continuing in other endemic countries. Manufacturing of Dengvaxia has already started at vaccine facilities in France and first doses are already produced. Sanofi Pasteur remains committed to introducing Dengvaxia first in countries where dengue is a major public health priority.
Category: Features, Pharmaceuticals
