Multi-national pharmaceutical company in talks with govt for registration pathway
A vaccine against dengue may be available in India in near future. Sanofi Pasteur, the vaccines division of multi-national pharmaceutical company Sanofi told dna on Tuesday that it is in contact with the Indian government officials to assess the best registration pathway for its dengue vaccine candidate. The company said that the pricing policy will be sustainable if the vaccine receives market authorisation in the country.
"Once the dengue vaccine candidate receives market authorisation in a given country, the next step will be to discuss the best dengue immunisation programme to address the country's disease burden. Sanofi Pasteur's pricing policy aims to support country goals to effectively reduce dengue burden. Sanofi Pasteur is seeking a fair and sustainable price for both endemic countries and the company," said the spokesperson of Sanofi Pasteur.
By the end of 2015, the vaccine's regulatory file will have been submitted to about 20 countries including India, for market authorisation. The most advanced candidate vaccine against dengue viruses, called CYD-TDV, is now progressing under potential registration and review by the World Health Organization (WHO) in 2016.
In the latest publication of New England Journal of Medicine, results of three-year long studies on dengue vaccine conducted on 31,000 children, between age of 2 to 14 years in Asia Pacific region and 9 to 16 years in Latin America, were published. They were divided into vaccine group and control group. While the vaccine group was administered the dengue vaccine candidate, the control group was not. Three doses of vaccine were administered to children at baseline, at 6 months and 12 months and they were studied over a period of 25 months.
Sanofi Pasteur claimed that two-thirds of these individuals (66%) were protected against dengue and there was prevention of hospitalizations due to dengue. "Which means that amongst the group that had been administered with the vaccine, the children who were virologically infected by dengue, developed milder symptoms," said Dr Hemant Thacker, consultant physician at Breach Candy Hospital.
Dr Altaf Patel, head, department of medicine at Jaslok Hospital, expressed apprehensions on the vaccine trial data. "The vaccine does not show promising results for children under nine years of age. Only in a very small percentage of dengue cases, there are complications and there is no data to show that severe dengue shock syndrome cases are being averted through the vaccine. I would not recommend getting a dengue vaccine administered based on the current findings."
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