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 regula...