Government may exempt Sanofi’s dengue vaccine from large-scale clinical trials

The economic times reports about the possibility of large-scale CT exemption for Dengue vaccine. 

As India reported a record number of dengue cases during the year, the health ministry is exploring the possibilities to accelerate the marketing authorisation for a preventive vaccine, health industry sources said.

Dengvaxia, the brand name of the vaccine developed by Sanofi Pasteur, a unit of French pharmaceutical giant Sanofi, is being examined by the Indian drug regulatory agency for exemption from large-scale clinical trials on patients, the sources said. If cleared, the step may eventually pave the way for its availability via the wide government distribution system and private channels.

Sanofi filed for the approval of the vaccine in India last month citing widespread prevalence and the high number of dengue cases seen in India, an industry source told ET. This month, Mexico's Federal Commission for the Protection against Sanitary Risks became the first drug regulatory agency globally to allow the tetravalent vaccine for prevention of dengue caused by four virus serotypes. The product is not approved for use in children below the age of nine years.

According to data compiled by India's National Vector Borne Disease Control Programme, until the end of November, 90,040 cases of dengue were reported from 29 states and six union territories with New Delhi leading the chart.

The figure could be higher as a number of cases are not reported due to low detection rates, medical experts say. However, with an improvement in surveillance systems and efficient management, death rates are low compared with the number of cases. This year, 181 dengue-related deaths were reported as of November.

In response to questions from ET, Sanofi, which completed global studies in 40,000 volunteers over the past 20 years, said it is in contact with local Indian authorities to assess the "best registration pathway" for the dengue vaccine candidate. The vaccine has undergone Phase II studies in 189 Indian volunteers aged 18 to 45 years in five sites (New Delhi, Ludhiana, Bengaluru, Pune and Kolkata) and was found to be safe and immunogenic in Indian adults, data from India's clinical trial registry showed.

Jean-Pierre Baylet, country head at Sanofi Pasteur (India, Sri Lanka and Nepal), said the data were consistent with its global dengue vaccine clinical studies (Phase I, II and III) carried out among volunteers in Asia and Latin America, including 31,000 subjects in Phase III.

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