An expert consultative committee of the Indian drug regulatory agency has waived a large-scale clinical trial for a dengue vaccine developed by Sanofi Pasteur. The Subject Expert Committee (SEC), which advises the Drug Controller General of India, said it recommends for market authorisation of the vaccine in the age group of 18-45 years only with the condition to conduct Phase IV clinical trial in time bound manner. If the DCGI finally approves the product for marketing, India will be the fourth nation to approve the product following Mexico, Philippines and Brazil.
Found to work against the four serotypes of the dengue virus, Dengvaxia is recommended for use in age groups 9 to 45 years. According to SEC, Sanofi requested for marketing authorization of the vaccine without conduct of Phase III trial, based on its Phase III trials data from other nations such as Thailand, Brazil and Mexico. Although, the vaccine does not qualify the requirements of waiver of clinical trial, because Dengue is a major health problem in the country, the committee recommends for market authorization of the vaccine.
According to data compiled by India’s National Vector Borne Disease Control Programme (NVDBCP), till November end, 90,040 cases of dengue were reported from 29 states and six union territories with New Delhi leading the chart. Many experts think this an understatement of the problem.