Sanofi Pasteur, the French drugmaker's vaccine unit, will file for registration of its vaccine candidate and subject to regulatory approval the world's first dengue vaccine could be available by the second half of 2015, the company said in a statement.
Results of the last stage of the clinical study showed that the vaccine gives a 95.5 per cent protection against severe dengue and an 80.3 per cent reduction in the risk of hospitalisation, it said.
Dengue has been a serious challenge to public health as it affects lakhs of people annually in India, Sanofi said.
The company added that its phase III efficacy clinical study programme for the dengue vaccine candidate was conducted in over 31,000 participants across 10 endemic countries in Asia and Latin America.
"We plan to submit the vaccine for licences in 2015 in endemic countries where dengue is a public health priority," Sanofi Pasteur President and CEO Olivier Charmeil said.
Country Head, Sanofi Pasteur, Stephan Barth, said 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. India is part of Sanofi Pasteur's global development strategy for dengue vaccine.
"Results of CYD 15 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," he said.
Committed to dengue vaccine research for more than 20 years, Sanofi Pasteur aims to make the tropical ailment the next vaccine-preventable disease, Barth said.
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