Sanofi applies for dengue vaccine approval in India
French drugmaker Sanofi has applied for regulatory approval of the world’s first dengue vaccine in India, the company’s spokesperson said on Thursday, raising hopes of its availability in the country where 90,000 people were afflicted by the disease this year.health and fitness Updated: Dec 10, 2015 19:48 IST
French drugmaker Sanofi has applied for regulatory approval of the world’s first dengue vaccine in India, the company’s spokesperson said on Thursday, raising hopes of its availability in the country where 90,000 people were afflicted by the disease this year.
The vaccine, branded as Dengvaxia, was approved for use in Mexico on Wednesday. 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.
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.
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 immunisation.
“Sanofi Pasteur is ready to work with governments and the larger public health community to support financing and implementation of effective dengue vaccination programmes,” the company spokesperson said.
Introducing vaccines in the public health system increases volumes, which brings down prices, as do public funding from international agencies such as the World Health Organisation (WHO).
Caused by the day-biting female aedes mosquito, dengue is one of the biggest challenges for the government in the country’s healthcare front.
This year, India had more than 90,000 confirmed cases and 181 deaths till November 30, shows health ministry data, up from a little over 15,000 cases and 96 deaths in 2009.
The actual numbers are, however, likely to be higher because people with fever are routinely not tested for dengue.
In Delhi alone, where panic drove thousands with fever to get tested this year, recorded 15,000 cases and 38 deaths, which was the highest across all states in India.
Globally, dengue infects an estimated 400 million people across 128 countries and kills 22,000 people per year, the WHO says.