India’s largest pharmaceutical company, Sun Pharma, has signed a deal with the Delhi unit of the International Centre for Genetic Engineering and Biotechnology (ICGEB) to develop a dengue vaccine, multiple sources confirmed to The Hindu .
An announcement is formally expected in Delhi next month, said a person associated with the deal.
This would be the first time a vaccine developed entirely in India for a vector-borne disease has been advanced for clinical development in India.
Though India is well-known for developing generic versions of drugs and vaccines it rarely develops drugs from scratch, in part due to a regulatory environment that discourages untested drugs and the huge costs and risks associated with early-stage drug development. Rotavac — a vaccine to protect children against infections by the rotavirus — is the only other vaccine developed, tested and commercialised in India.
This year it was integrated into India’s Universal Immunisation Programme.
According to the World Health Organization, 390 million dengue infections are globally recorded annually, of which 96 million manifest clinically. India has recorded one of the worst outbreaks this year with the Union Health Ministry noting 99,913 dengue cases and 220 deaths in 2015 and 33,310 cases and 20 deaths this year as of September 11.
Dengue is transmitted by the Aedes Aegypti mosquito and can be caused by any of four closely-related viruses.
Immunity to one doesn’t confer resistance to the others and while most dengue infections aren’t lethal, a minority of infections can induce bleeding and death.
There is no recommended treatment for dengue so far other than rest, fluids and paracetamol.
Because of the dengue’s provenance in at least 128 countries, several companies and international organisations have developed candidate vaccines that are in various stages of development and commercial release. The most advanced is Dengvaxia, developed by French drug maker Sanofi and recommended for use since December last in Brazil, Mexico, Philippines and El Salvador for those 9-45 years old.
Proposal axedIn April, India’s Health Ministry axed a proposal by Sanofi to skip phase 3 trials and introduce Dengvaxia in the country citing insufficient data about the vaccine’s performance and that it reportedly wasn’t equally protective against all strains of the disease.
Panacea Biotec and the Serum Institute of India have licences to manufacture another vaccine developed by the National Institutes of Health in the United States and Japanese pharmaceutical company Takeda is reportedly beginning phase-2 trials of its dengue vaccine in Singapore.
The ICGEB vaccine candidate, called DSV4, employs an approach different from other vaccines.
