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Sanofi Pasteur's dengue vaccine Dengvaxia gets approval in Philippines

Increase font size  Decrease font size Date:2015-12-25   Views:576

Sanofi Pasteur has received marketing approval from the Philippines' Food and Drug Administration for Dengvaxia to prevent all four dengue types in individuals aged from nine to 45 years and living in endemic areas.

The approval makes dengvaxia the first vaccine to be licensed for the prevention of dengue in Asia, where approximately 67 million people contract the disease annually.

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

Each year, Asian endemic countries spend an estimated $6.5bn in both direct and indirect medical costs due to dengue.

Philippine Foundation for Vaccination president Dr May Book Montellano said: "Prevention of dengue is an urgent and growing medical priority in the Philippines.

"Vaccination is widely accepted as one of the most cost-effective ways to reduce the spread of infectious diseases like dengue.

"The approval of Dengvaxia, the world's first dengue vaccine, in the Philippines will be a critical addition to the ongoing public education and vector control efforts currently directed towards dengue prevention in our country."

Apart from the Philippines, Dengvaxia is also registered in Mexico, while regulatory review processes for the vaccine are continuing in other countries where dengue is a public health priority.

The company has already started manufacturing of the vaccine in France.

Last year, Dengvaxia completed Phase III clinical studies to evaluate the primary objective of vaccine efficacy.

The company noted that the Philippines participated in all three phases of the clinical development of Dengvaxia.

 
 
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