The Genetic Engineering Approval Committee (GEAC), which works under the Union Ministry of Environment and Forests, has granted permission to Sanofi Pasteur India Private Ltd to import tetravalent dengue vaccine.
The vaccine division of the global therapeutics solutions major Sanofi approached the GE regulator for the import of dengue vaccine for phase-2 clinical trials from Sanofi Pasteur's headquarters at Lyon in France. While it is referred to as CYD dengue vaccine, it is globally known as tetravalent dengue vaccine.
Dengue, a viral disease that spreads through mosquito bites, kills about 21,000 annually. Currently a major threat in India, dengue starts with flu-like symptoms and drastically reduces platelets that help blood clot. Left untreated, it leads to death.
Sanofi Pasteur, which says dengue poses threat to almost half of world's population, expects the vaccine to be ready for use by 2015. It is working with World Health Organisation and Paediatric Dengue Vaccine Initiative, funded by Gates Foundation, to make dengue a ‘vaccine-preventable disease'.
Immunogenicity
The phase-2 study is aimed at testing immunogenicity, the ability of a substance produce an immune response, and safety in India. The trials will cover healthy subjects between 18 to 45 years.
The GEAC had deferred a decision on the Sanofi application in its September 21, 2011 meeting for want of comments from experts on the issue. The Drugs Controller General of India had recommended the proposal to conduct phase-2 clinical trials to study immunogenicity and safety in India, the GEAC said.
The French firm, with over 13,000 employees, runs 12 production or research and development centres across the globe, including one in India (Hyderabad).