"As soon as the government approves the use of the Sanofi Pasteur dengue vaccine, it will take minimally 6-8 months to complete the remaining regulatory requirements and make the vaccine available to the Indian population," Baylet said.
The Philippines' FDA has approved Dengvaxia for the prevention of disease caused by all four dengue types in individuals from 9-45 years of age living in endemic areas, Sanofi said in a statement.
Sanofi is committed to delivering the vaccine to India and is in contact with local authorities in the country for providing the drug, says Dr Anh Wartel, Senior Director, Clinical Development, R&D at Sanofi.
The trial is designed to show non-inferiority against a currently licenced vaccine with the use of three, ready-to-use liquid doses administered orally, starting from six-to-eight weeks of age, with the subsequent doses administered at four weeks intervals, according to Shantha Biotechnics.