The Indian government has rejected a waiver request from Sanofi, which wants to market its dengue vaccine in the country.
Setback for Sanofi in India. The French laboratory, which seeks to market its vaccine against dengue Dengvaxia in the country, suffered a first failure in the marketing process, reports the Indian economic daily The Economic Times.
The Indian government thus refused the waiver request formulated by Sanofi, which wished to waive additional clinical studies in India. The laboratory considered that the results obtained in other countries were sufficiently convincing to allow marketing in India.
WHO recommended
“Given the urgency of dengue fever in India, we are optimistic about our ability to work with Indian regulatory authorities to find the best solution that will allow us to increase the clinical data of our dengue vaccine in the Indian population without delaying access, ”said a spokesperson for Sanofi India quoted by The Economic Times.
Dengvaxia is the first authorized vaccine against dengue fever, a viral infection transmitted by the tiger mosquito. As Sanofi announced last month, a group of experts convened by the World Health Organization (WHO) recommends the use of its vaccine in countries affected by the epidemic. It is currently authorized in Mexico, the Philippines, Brazil and El Salvador.
The recommendations of this Strategic Advisory Group of Experts (SAGE) communicated to WHO are based on a review of clinical data from 25 studies, conducted on more than 40,000 participants in 15 endemic and non-endemic countries around the world, specifies the French pharmaceutical laboratory.
Dengue fever affects nearly 400 million people worldwide, 100 million of whom suffer from the symptomatic form. In fact, in 50 to 80% of cases, the disease remains silent. The incidence of dengue has increased 30-fold over the past 50 years.
.
