India may require more clinical trials for Sanofi's dengue vaccine
- A top committee at the Indian Ministry of Health rejected Sanofi’s request to waive further late-stage trials for its dengue vaccine dengvaxia, reports The Economic Times. Two lower panels had supported granting a waiver based on Sanofi’s phase 2 studies.
- Dengue is a major public health concern in India. Last year, there were over 90,000 cases of dengue fever in the country, along with 181 deaths.
- Sanofi’s Dengvaxia is the world’s first approved dengue vaccine, and is currently on the market in Brazil, Mexico, and the Philippines. In April, the Philippines launched a public immunization campaign in schools.
Sanofi has conducted phase 3 trials in other countries and sought to waive the requirement for locally conducted trials in India. The so-called apex committee decided evidence was not sufficient to grant an exemption however, according to The Economic Times.
The setback could possibly delay the introduction of Dengvaxia in India, although a Sanofi spokesperson told The Economic Times the company was optimistic it could work with Indian regulators to increase clinical data without impeding access.
Dengue is a debilitating tropical viral disease present in more than 100 countries, with a significant presence in India. It affects a broad spectrum of people, from poorer populations in developing countries to middle-class people in middle-income urban areas. Roughly 2.4 million cases are reported annually, making the introduction of Dengvaxia last December a critical advancement from a global public health perspective.
In 2015, a major outbreak in Delhi, India led to 15,000 cases of dengue, according to the World Health Organization.
Sanofi expects further regulatory decisions for Dengvaxia in 16 other countries.
- Economic Times of India Health Ministry panel rejects Sanofi's clinical waiver plea for dengue vaccine