Path-breaking dengue vaccine to hit Mexican markets soon

Sanofi Pasteur, the group’s vaccines division, said Mexico had approved the preventive treatment, called Dengvaxia, for all four dengue virus serotypes, but only for patients aged 9 to 45 who live in areas where the disease is endemic.

However, this means the world’s first dengue vaccine has no approval yet for use on young children, a population considered to be most at risk, or for use by tourists. Dengue fever is a mosquito-borne disease caused by four virus serotypes (1 to 4) as categorised by the World Health Organisation. Overall, the disease is seen as a threat to about half of the world’s population. Some 400 million people are believed to be infected annually.

Guillaume Leroy, who leads the dengue team at Sanofi Pasteur, said the vaccine acted best as an immune booster for patients with some previous exposure. “Health authorities will have to determine (future) recommendations,” he said, adding Sanofi’s first 20 market approval requests were all in South America and Asia. Europe is the target for early next year and the United States in early 2017, he said.

Charmeil said Mexican regulators, approved by WHO, had given their green light based on results from a clinical development program involving over 40,000 people from 15 countries of different ages, geographic and epidemiological settings as well as of varied ethnic and socio-economic backgrounds. The vaccine reduced the risk of hospitalisation by 80 percent and lowered the possibility of developing the severest, haemorrhagic form by 93 percent he said.