India may have dengue vaccine by 2026; Takeda initiates clinical trials

India may have a dengue vaccine by 2026, said a top executive of vaccine manufacturer Indian Immunologicals (IIL), as several players have joined the race to develop the country’s first vaccine against the mosquito-borne disease that claimed 485 lives last year.

Dengue has become a major public health concern in India with 289,235 cases reported last year. According to data from the National Center for Vector Borne Diseases Control, there were 19,447 cases of dengue which resulted in 19 deaths till April 2024. Close to 3 lakh people get dengue a year, and cases have been rising.

Speaking to Business Standard, K Anand Kumar, managing director, IIL, a wholly-owned subsidiary of the National Dairy Development Board, said they had finished the phase 1 clinical trials.

“We will apply for approvals for the phase 2 clinical trials soon. We can expect the vaccine to be commercially available in 2026-27 or so if things go according to plan,” Kumar said.

Phase 1 clinical trials are done on a small group of people to determine the safety of the vaccine, while phase 2 and phase 3 trials are conducted to test a vaccine’s efficacy. IIL’s phase 1 trials have been successful and there have been no adverse reports.
The company aims to start phase 2 and phase 3 trials soon.

Japanese pharmaceutical company Takeda has also initiated local clinical trials in the country. A Takeda India spokesperson told Business Standard they had received the no-objection certification (NoC) for clinical trials from Indian health authorities.

“We have received the NOC for clinical trials from health authorities and have initiated the clinical trial activity as per the local regulation in India and are committed to completing the trial at the earliest, followed by submission to Indian health authorities,” the spokesperson said, adding they were currently engaging with the regulator for appropriate approvals and will launch vaccine after that in compliance with all regulatory requirements.

“We are currently working on the launch of vaccine in India after getting approval from Indian regulatory authorities. As soon as we get clearance, we will launch the vaccine. We are committed to working with national authorities to find ways to support access to our vaccine when it is approved,” the company said.

Takeda has developed Qdenga, a tetravalent vaccine for dengue. It is already available for children and adults in the private market in Europe, Indonesia and Thailand, and in private, in some public programmes in Argentina and Brazil. Takeda follows a dual pricing strategy in both private and public markets, and as such prices in the private market are higher in Europe than in Asian markets.

It has also forged a manufacturing partnership with Hyderabad’s Biological E (BE) where the latter will ramp up capacity to 50 million doses a year, accelerating Takeda’s plans to make 100 million doses a year within a decade. The partnership will build upon existing manufacturing capacity for the vaccine at Takeda’s facility in Singen, Germany and Takeda’s long-term partnership with IDT Biologika GmbH.

The doses made by BE will ultimately be made available for procurement by the governments in endemic countries by 2030 at the latest to support National Immunization Programmes.

Qdenga is a tetravalent, live, attenuated, dengue vaccine in multi-dose vials. BE would produce a multi-dose vial for this vaccine, something they currently do not have. It added that multi-dose vials offer economic and logistical advantages for National Immunisation Programmes by minimising packaging and storage expenses, while also reducing medical and environmental waste.

Gary Dubin, President, Global Vaccine Business Unit, Takeda told Business Standard in February that the global clinical development of this vaccine had covered over 28,000 individuals across dengue endemic and non-endemic countries, and shown an efficacy of around 84 per cent against hospitalised dengue. This was irrespective of whether the individual was exposed to dengue previously or not. Besides Takeda and IIL, the Serum Institute of India and Panacea Biotec are working to develop a dengue vaccine.