Sanofi awaits govt approval to launch dengue vaccine in India

Mumbai : After receiving authorization in 11 countries, Sanofi Pasteur is still awaiting for approval from the government to launch its dengue vaccine Dengvaxia in India.

"The need for dengue prevention in India is urgent, and the Indian population is at risk for this debilitating disease, for which there is no cure or treatment and deserves to have a choice to be protected against the disease with a well-tested vaccine proven effective against dengue," Sanofi Pasteur India Country Head Jean Pierre Baylet told here.

"As soon as the government approves the use of the Sanofi Pasteur dengue vaccine, it will take minimally 6-8 months to complete the remaining regulatory requirements and make the vaccine available to the Indian population," Baylet said.

However, in a scenario where the government asks us to conduct more clinical trials in India before granting license, the vaccine will not be available to the Indian population before 2020, he said.

On the current approval status, Baylet said that as per the minutes published on 6th October 2016, the Technical Committee of the Ministry of Health and Family Welfare has recommended that Sanofi Pasteur's dengue vaccine be approved to protect adults in the 18-45 years of age in India, on the strength of the published documentation from the clinical studies on the vaccine that included more than 40,000 participants worldwide, including India.

For the last decade, it is estimated that an average of 5.7 million cases of dengue have been occurring in India every year, with related annual costs of over USD 1 billion.

The company has submitted the vaccine regulatory file to the Indian authorities last year in October, based on its worldwide clinical programme, including India. Since the submission, the vaccine has been approved for use in quick succession in 11 endemic countries of which two countries, Brazil and the Philippines, have introduced the dengue vaccine in their public immunization programme.

In July 2016, based on the public clinical documentation, as well as on a set of mathematical modelled outcomes of the potential public health impact of the dengue vaccine's implementation in endemic settings, the WHO recommended the use of the vaccine in highly dengue endemic countries.

The regulatory review process is ongoing in endemic countries. The vaccine's regulatory file has already been submitted in more than 20 countries, in Asia and Latin America, reflecting the global burden of dengue. Singapore is the 11th country to approve the vaccine and we expect more to follow, he said.