By Gokul Bhagabati

New Delhi, Oct 18 (IANS): The worlds first dengue vaccine, which has already been approved in 11 countries and has got the nod from the Technical Committee of Indias Ministry of Health and Family Welfare, has been shown to be cost-effective, said a top official of Sanofi Pasteur, the vaccine unit of the French pharmaceutical company Sanofi.

"In all the countries where we have conducted cost-effectiveness analysis studies to date, Sanofi Pasteur's dengue vaccine has been shown to be cost-effective and even cost-saving, according to the WHO criteria," Jean-Pierre Baylet, Country Head-Sanofi Pasteur India, Sri Lanka and Nepal, told IANS in an e-mail interview.

"Mathematical modeling shows that the main value of our vaccine in relation to dengue outbreaks is more in terms of its ability to reduce their intensity and frequency based on its capability to significantly lower the dengue burden if implemented in its full three-dose schedule through large-scale vaccination programmes," Baylet noted.

As per minutes published on October 6 this year, the ministry's Technical Committee has recommended that Sanofi Pasteur's dengue vaccine be approved to protect adults in the 18-45 year age-group on the strength of the published documentation from the clinical studies on the vaccine that included more than 40,000 participants worldwide, including India, Baylet said.

Currently, the Sanofi Pasteur dengue vaccine is approved in 11 countries, with 1.5 million having been distributed.

"The Technical Committee's recommendation is now subject to a final evaluation and approval decision by the Indian regulatory authority," Baylet said.

India is endemic for dengue with all four of its serotypes having been found circulating in various parts of the country.

Sanofi Pasteur's vaccine is the culmination of over two decades of scientific innovation and collaboration, as well as 25 clinical studies in over 15 countries around the world, Baylet noted.

More than 40,000 volunteers participated in the clinical study programme (Phases I, II and III), of whom 29,000 volunteers received the vaccine.

Based on the public clinical documentation, as well as on a set of mathematical modeled outcomes of the potential public health impact of the vaccine's implementation, the WHO has also endorsed its use in high dengue-endemic countries as part of a comprehensive prevention and control strategy, Baylet said.