India waives large-scale clinical trials for Sanofi's dengue vaccine

MUMBAI: 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.

ndia's SEC said it deliberated the proposal of the firm (Sanofi) in detail adding that the company conducted Phase II clinical trial in the age group of 18-45 years in India and the results were accepted by the SEC dated 08.04.15.

SEC further noted that Sanofi requested for marketing authorization of the vaccine without conduct of Phase III trial, based on its Phase III trials data from other nations like Thailand, Brazil and Mexico.

"Although, the vaccine does not qualify the requirements of waiver of clinical trial, considering the fact that Dengue is a health problem of major concern in the country and can be life threatening in certain cases, the committee 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," it said.

If Sanofi's request had been rejected, the company would have been needed to do Phase III trials on a large set of population across age groups. "It's a good move as it would have taken no less than two additional years to get an approval to complete the trials and get a regulatory nod," a specialist in clinical trial for vaccines said.

India figures among the endemic countries for dengue. 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. 181 dengue-related deaths were reported till last November.

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