Sanofi gets Philippines’ approval to market dengue vaccine

Wednesday, Dec 23, 2015,17:32 IST By Metrovaartha A A A

Mumbai | Sanofi Pasteur, the vaccines division of Sanofi, today said Food and Drug Administration of Philippines has granted marketing approval to its Dengvaxia vaccine to be licensed for the prevention of dengue in Asia.

The Philippines’ FDA has approved Dengvaxia for the prevention of disease caused by all four dengue types in individuals from 9-45 years of age living in endemic areas, Sanofi said in a statement.

Dengvaxia is the first vaccine to be licensed for the prevention of dengue in the world. First doses of the vaccine have been produced at the dedicated production site in France with planned full-scale production capacity of 100 million vaccine doses annually, it added.

Besides the Philippines, it is registered in Mexico and regulatory review processes for the drug are continuing in other countries too where dengue is a public health priority, the firm said, adding that manufacturing (of the vaccine) has already started in France.

Approval of the first dengue vaccine in Asia, which bears 70 per cent of global disease burden, is a major milestone in dengue prevention and public health, Sanofi Pasteur President and CEO Olivier Charmeil said.

Approval of Dengvaxia in the Philippines, following closely the first approval in Mexico, is further evidence of Sanofi Pasteur’s long-standing commitment to introduce this innovative new vaccine first in countries where dengue is a major public health threat, Charmeil added.

Dengue fever burden in Asia continues to be the highest, with an estimated 67 million people being sickened by the disease annually. As an urban disease, dengue attacks populations of Asia in the form of unpredictable outbreaks capable of paralysing healthcare systems, negatively impacting social and economic activity.

Asian endemic countries spend an estimated USD 6.5 billion annually in both direct medical and indirect costs due to the fever.