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Monday, January 18, 2016

An expert consultative committee of the Indian drug regulatory agency has waived a large-scale clinical trial for a dengue vaccine developed by French drug maker Sanofi. The Subject Expert Committee, which advises the Drug Controller General of India, as part of its Jan 12 meeting said it “recommends for market authorization 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.”

ET had first reported the possibility of the clinical trial waiver for Sanofi’s vaccine Dengvaxia in its edition of Dec. 22, given the increased threat of dengue in India. The expert committee has directed Sanofi to submit its protocol related to the Phase IV trials within three months of marketing the product.

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.

A few other nations like Costa Rica and Malaysia, which have a faced increased outbreak of dengue in recent years, are reportedly taking a more cautious and prolonged view in pursuing an approval process for the vaccine.