Sanofi Pasteur's tetravalent dengue vaccine, Dengvaxia®, was approved for use in individuals 9-45 years of age for the prevention of dengue fever caused by all four serotypes on 22nd December 2015 in the Philippines. The vaccine's anticipated impact on dengue burden is expected to stem from its documented ability to prevent 8 out of 10 dengue hospitalizations and up to 93% of severe dengue that includes hemorrhagic dengue fever that can be fatal in vaccinated study participants 9 years and older.
The public immunization program launched today in the Philippines will begin vaccinating 1 million students from 6,000 public schools this year in three highly dengue-endemic regions of the country. Dengvaxia® was made available for private sector vaccination in the Philippines in February.
Olivier Charmeil, Executive Vice President, Sanofi Pasteur, commends the Philippines on the launch of the first public dengue immunization program in the world: "The Philippines' scientific and healthcare communities have been important collaborators in the development of Dengvaxia®, participating in all three phases of the clinical study program that involved over 40,000 individuals from 15 countries. Ensuring access to this approved vaccine in a public immunization program attests to the Filipino health authority's commitment to add this new dengue prevention tool to their integrated disease management strategy for a disease that continues to represent a major public health threat to their country."
Asia currently bears 70% of the world's dengue burden; in the Philippines alone 200,000 cases of dengue were reported in 2013. A new analysis published in the New England Journal of Medicine on 24th March reports that the Philippines had the highest incidence of confirmed dengue in the 10 endemic countries that participated in the clinical efficacy studies for Dengvaxia®. The analysis also reported that up to 15% of febrile disease in children 9 years and older in the Philippines is due to dengue.
Dr. Cecilia Montalban, President of The Philippine Foundation for Vaccination, said: "This first dengue vaccine has been developed and proven effective in countries like the Philippines where dengue is a major public health priority. As a physician and a mother, I am proud that my country plays a historic role in dengue prevention."
Sanofi Pasteur is committed to working closely with the Philippines government to facilitate successful introduction of the dengue vaccine, as well as monitor the impact of dengue vaccination in the country with an extensive post-marketing communication and surveillance plan, consistent with the recent Call to Action on countries issued by the Asian Dengue Vaccination Advocacy (ADVA) at the Asia Dengue Summit in February.
Besides the Philippines, Dengvaxia® is also registered in Mexico, Brazil and El Salvador to date. Regulatory review processes for Dengvaxia® are continuing in other countries where dengue is a public health priority. Doses have already been shipped and received in the Philippines to support both private and public sector access to dengue vaccination.
Sanofi Pasteur's vaccine is the culmination of over two decades of scientific innovation and collaboration, as well as 25 clinical studies in 15 countries around the world. Over 40,000 volunteers participated in the Sanofi Pasteur dengue vaccine clinical study program (phase I, II and III), of whom, 29,000 volunteers received the vaccine. Dengvaxia® successfully completed phase III clinical studies in 2014 to evaluate the primary objective of vaccine efficacy[5,6]. The Philippines participated in all three phases of the clinical development of Dengvaxia®.
Pooled efficacy and integrated safety analyses from the 25-month Phase III efficacy studies and the ongoing long-term studies, respectively, were published in The New England Journal of Medicine on July 27th 2015 documenting the vaccine's consistent efficacy and longer-term safety profile in study population 9-16 years of age. In the pooled efficacy analysis in this age group, Dengvaxia® was shown to reduce dengue due to all four serotypes in two-thirds of the participants and prevent 8 out of 10 hospitalizations and up to 93% of severe dengue cases.
Dengvaxia® is the first vaccine licensed for the prevention of dengue in the world. The vaccine is produced in a dedicated production site in France with planned full-scale production capacity of 100 million vaccine doses annually.
Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi has core strengths in diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and Genzyme. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
Sanofi Pasteur, the vaccines division of Sanofi, provides more than 1 billion doses of vaccine each year, making it possible to immunize more than 500 million people across the globe. A world leader in the vaccine industry, Sanofi Pasteur produces a portfolio of high quality vaccines that match its areas of expertise and meet public health demand. The company's heritage, to create vaccines that protect life, dates back more than a century. Sanofi Pasteur is the largest company entirely dedicated to vaccines. Every day, the company invests more than EUR 1 million in research and development.
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