NEW DELHI: French drugmaker Sanofi has applied for regulatory approval of the world’s first dengue vaccine in India, the company’s spokesperson said.

The vaccine, branded as Dengvaxia, has already been approved for use in Mexico.

However, it is yet to be cleared for use on children below nine years.

“Sanofi Pasteur is in contact with the local Indian authorities to assess the best registration pathway for our vaccine. The results of the India study will also support licensure application in India,” the company’s spokesperson said.

The vaccine prevents infection from all four dengue virus serotypes — a medical term used to describe different strains — in people living in endemic countries such as India.

The company was yet to fix the price for Dengvaxia in India but said it will depend on whether it is made part of routine immunization.

“Sanofi Pasteur is ready to work with governments and the larger public health community to support financing and implementation of effective dengue vaccination programs,” the company spokesperson said.

In India, trials for Dengvaxia were carried out in Delhi, Ludhiana, Kolkata, Pune and Bengaluru on adults between 18 to 45 years.

Dr. AP Dubey, director at the Maulana Azad Medical College and Lok Nayak Hospital, who was a principal investigator during the India trials, said the vaccine “after three doses was well tolerated and produced antibodies against all four dengue serotypes” in the patients.

“There were no cases of severe dengue reported, no deaths and no related serious adverse events reported during the trial,” he added.