In India, a health ministry committee recently rejected a Dengvaxia large-scale trial waiver from pharmaceutical giant, Sanofi SA (ADR) (NYSE:SNY). According to the Indian panel, the evidence shown by the dengue vaccine is not enough to waive a clinical trial.
Brazil, El Salvador, Mexico, and Philippines are among the pioneer countries to approve the vaccine that counteracts dengue fever manufactured by Sanofi Pasteur, the company’s global vaccines subsidiary. The Philippines was the first to launch a Dengvaxia vaccination campaign last April.
The pharmaceutical giant has already submitted phase III clinical trial results from other Asian and Latin American regions.
India’s Drug Approval Procedure
The country presently observes a drug approval process with three levels. The subject expert committee (SEC), technical committee, and the apex committee carefully review applications for approval.
Dengvaxia may not have qualified for a waiver but the Indian SEC suggested a market authorization. In line with this, the committee has required that the phase IV clinical trial be carried out in accordance with an organized timetable.
The market for dengue vaccines continues to grow and sustain its momentum. Leading Indian pharmaceutical company Sun Pharmaceuticals Industries Ltd., for example, has teamed up with the International Center for Genetic Engineering and Biotechnology (ICGEB) to work on a botanical drug that fights the mosquito-borne illness.
A Sanofi India spokesperson said that the company is optimistic about working things out with the Indian regulators given that dengue cases in the country are becoming worse. The spokesperson said that Sanofi’s dengue vaccine is safe and efficient, as seen from clinical trials involving more than 40,000 people of different cultural, ethnic, and socio-economic backgrounds in more than 10 countries.
Sanofi Pasteur has already submitted regulatory requirements in more than 20 countries. The Sanofi subordinate hopes to submit regulatory files in 15 more countries by the end of the year.
According to Olivier Brandicourt, Sanofi CEO, Dengvaxia sales for the first quarter topped at €19 million.