Sanofi may get waiver from large-scale dengue vaccine trials in India

A waiver of large-scale clinical trials for Sanofi's ($SNY) dengue vaccine, Dengvaxia, was recommended by a special committee that advises the Drug Controller General of India (DGCI), the Economic Times reports.

Brazil, the Philippines and Mexico have so far approved the vaccine to prevent all four types of dengue fever, though at varied levels of efficacy.

In the case of India, approval would be timely with a recent outbreak of cases there and several other countries in the region, particularly Southeast Asia. The outbreak in India, the Economic Times said, had prompted talk of a clinical trial waiver.

But the stance adopted by the Subject Expert Committee advising the DGCI was to recommend "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."

According to the Economic Times, that decision made on Jan. 12 requires Sanofi to submit its protocol related to the Phase IV trials within three months of marketing approval.

Public health experts have cautioned that a rollout on a large scale is ideal for the vaccine because of the potential to have a major impact in a region with frequent travel between countries and a wide mix of public health spending plans with India, for example, mainly out-of-pocket for many treatments.

The sense of urgency was highlighted in the recommendation.

"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," the Economic Times said, citing the recommendation report.

The Economic Times cited data from India's National Vector Borne Disease Control Programme to show that by the end of November, 90,040 cases of dengue were reported from 29 states and 6 federal territories, including the capital New Delhi at the top spot.

Sanofi CEO Olivier Brandicourt

In November, Sanofi CEO Olivier Brandicourt was upbeat on sales prospects for the vaccine, more so than Olivier Charmeil, executive vice president for vaccines. But the approvals to date since then are even a bit better than expected.

"With regard to dengue, as we had indicated in the previous quarterly calls, we are expecting to get the first license by the end of this year," Charmeil said in response to an analyst query in November. "It could be one, two countries. Difficult to say whether we are going to have sales this quarter for dengue. It will depend on exactly when we get the first license. What you should keep in mind, should we get sales, it's going to be very, very minimal, but we are expecting to get license for dengue this quarter."

Sanofi says millions of doses of the vaccine are ready to ship and the company expects annual production to reach 100 million doses by 2017.

- here's the story from the Economic Times