Sanofi seeks India licence for world’s first dengue vaccine

New Delhi: A vaccine tested against dengue with "very encouraging" results is to be submitted for licensing in India and other dengue-endemic countries next year, said a division of the French drug maker Sanofi Aventis Group on Tuesday.

Sanofi Pasteur, the group's vaccine division, made the announcement after having declared the drug's overall efficacy against dengue in the final phase III clinical trial in Latin America. The vaccine that was used in the Latin America trials is known as CYD15.

"India is part of Sanofi Pasteur's global development strategy for dengue vaccine; the results of CYD15 are very encouraging and in line with the results of the phase III study results in Asia and the Phase II study results in India," said Stephan Barth, country head of Sanofi Pasteur India, Sri Lanka and Nepal, in a statement issued on Tuesday.

"Dengue is a serious health concern in India, causing a significant but under reported burden. Over recent months, we have seen a worrying increase in cases in many parts of the country, putting a huge strain on healthcare systems," Barth added.

The vaccine's overall efficacy against any symptomatic dengue disease was 60.8% in children aged 9-16 years who received three doses of the vaccine, according to detailed results of clinical trials published in The New England Journal of Medicine on Monday.

The vaccine showed 95.5% protection against severe dengue and an 80.3% reduction in the risk of hospitalization. A total of 20,869 children from dengue-endemic countries including Brazil, Colombia, Mexico, Honduras and Puerto Rico participated in the study and were randomized to either receive three injections of the dengue vaccine or a placebo.

The results were consistent with those from an efficacy study in Asia after a 25-month active surveillance period.

Sanofi Pasteur's phase III efficacy clinical study programme for its dengue vaccine candidate was conducted in over 31,000 participants across 10 endemic countries in Asia and Latin America. The Asian countries include Indonesia, Malaysia, Philippines, Thailand and Vietnam.

"We are committed to supporting countries' ambitions to significantly impact the human and economic burden of dengue through comprehensive vaccination programmes. Our goal is to help meet the World Health Organization's (WHO) objectives to reduce dengue mortality by 50% and morbidity by 25% by 2020," said Olivier Charmeil, president and chief executive of Sanofi Pasteur.

Dengue cases have spiked in India from more than 18,000 in 2011 to more that 74,000 cases in 2013, according to health ministry estimates. According to the WHO, 40% of the world's population is at risk from dengue and 100 countries are endemic. There is currently no licensed dengue vaccine available, but several vaccines are in clinical or pre-clinical development.

"A dengue vaccine is terribly important, especially in India. However, there are some reservations regarding the Sanofi vaccine as its efficacy against one of the four virus serotypes is quite poor as seen in the results. A person affected by that particular serotype could get severe dengue," said S. Swaminathan, professor, department of biological sciences at the Birla Institute of Technology and Science in Hyderabad.

"It is the best we have, but it is not the ideal vaccine," added Swaminathan.

Dengue is transmitted by the bite of a mosquito infected with one of four dengue virus serotypes.

Sanofi Pasteur is already producing the vaccine in a newly dedicated production facility in Neuville-sur-Saône, France, targeting to meet global demand.

A study funded by the firm says the direct medical cost to India from dengue was about $548 million per year, or about $94.85 per patient.

Disclaimer: This information has been collected through secondary research and IBEF is not responsible for any errors in the same.