Bengaluru: French pharmaceutical giant Sanofi Pasteur told Deccan Chronicle how the vaccine, Dengvaxia, would be of great help considering the whopping number of dengue cases across the country and city.
“Sanofi’s dengue vaccine is the first such vaccine approved. It has been proved effective against all four serotypes of the disease,” said Jean-Pierre Baylet, Country Head, Sanofi Pasteur India, Sri Lanka and Nepal. He said the vaccine "can prevent more than 80% of hospitalisations and up to 93% of severe dengue cases in the targeted 9-year and older, at-risk population."
It has been eight months since the world’s first dengue vaccine was introduced. Since December 2015, when Sanofi’s dengue vaccine was first approved in Mexico, it was given the nod in Brazil, the Philippines, El Salvador, and Costa Rica. Sadly, the vaccine couldn't see the light of the day in India because there is a three-level approval process for new drugs and vaccines, with applications scrutinised by an expert committee (SEC), a technical committee and an apex committee.
“In India, Sanofi Pasteur is cooperating fully with the Indian regulatory authorities to find the best solution," the spokesperson said.
The spokesperson said that a clinical development programme (Phase I, Phase II and Phase III) involving over 40,000 people of different ages, geographies and epidemiological settings, ethnic and socio-economic backgrounds from 15 countries around the world has been conducted. “Our vaccine was the first to successfully complete phase III clinical efficacy and safety studies in dengue-endemic countries," he added.
In 2015, a pooled efficacy analysis of the two Phase III study results, including 25 months of follow-up, reported that the vaccine is 65.6% effective in preventing dengue irrespective of the serotype and severity. WHO recommends that countries should consider introduction of the dengue vaccine CYD-TDV only in geographic settings where epidemiological data indicate a high burden of disease.
On pricing, he said, “Based on our program-based pricing policy, the public price can differ between countries; i.e, it will decrease with increasing number of age cohorts to encourage large immunisation programmes. Furthermore, in all the countries where we have conducted cost-effectiveness analysis studies to date, Sanofi Pasteur’s dengue vaccine has been shown to be at least cost-effective.”
