India may soon have a dengue vaccine as several players are gearing up for clinical trials of the vaccine candidates. For instance, Japan’s Takeda has started clinical trials of its dengue vaccine with the Indian regulator, while Indian Immunologicals (IIL) is all set to seek approval to start phase 2 clinical trials for its vaccine candidate.
If all goes according to plan, India could have a dengue vaccine on the market by around 2026.
Dengue, a mosquito-borne disease, has become a major public health concern in India with 289,235 cases reported in 2023 and 485 deaths. Data from the National Centre for Vector Borne Diseases Control showed that there have been 19,447 cases of dengue till April 2024, resulting in 19 deaths.
Numbers have risen dramatically in recent years: in 2019 there were 157,315 cases of dengue, which dropped in 2020 (the pandemic year) and has been rising again since then.
Speaking to Business Standard, K Anand Kumar, managing director of IIL, a wholly owned subsidiary of the National Dairy Development Board, said they have completed the phase 1 clinical trials. “We will soon apply for approvals for the phase 2 clinical trials. We can expect the vaccine to be commercially available around 2026-27 if everything goes as planned,” Kumar said.
Phase 1 clinical trials are conducted on a small group of people to determine the safety of the vaccine, while phase 2 and phase 3 clinical trials are conducted to test the effectiveness of a vaccine.
Meanwhile, a Takeda India spokesperson told Business Standard that they have received the NoC for clinical trials from the Indian health authorities. “We have received the no-objection certification (NOC) for clinical trials from the health authorities and have commenced the clinical trial activity as per local regulations in India. We are committed to completing the trial as soon as possible, followed by submission to the Indian health authorities.”
The spokesperson added that they are currently in discussions with the regulator to obtain the appropriate regulatory approvals and will launch the vaccine on the market after all approvals are received, in accordance with all regulatory requirements.
“We are currently working on launching the vaccine in India after receiving approval from Indian regulators. Once we receive approval, we will launch the vaccine. We are committed to working with national authorities to find ways to support access to our vaccine once approved,” the company said.
On the other hand, IIL’s phase 1 trials have been successful and there have been no negative reports. The company aims to start phase 2 and phase 3 trials soon.
Takeda has also entered into a manufacturing partnership with Hyderabad’s Biological E (BE), which will see the latter ramp up capacity to 50 million doses per year, accelerating Takeda’s plans to produce 100 million doses per year within the decade. The partnership will build on existing manufacturing capacity for the vaccine at Takeda’s Singen, Germany facility and Takeda’s long-term partnership with IDT Biologika GmbH.
Qdenga, Takeda’s dengue vaccine, is already available for children and adults in the private market in countries in Europe, Indonesia and Thailand, and in private and some public programs in Argentina and Brazil.
Takeda uses a dual pricing strategy on both the private and public markets. As a result, prices on the private market in Europe are higher than on the Asian markets.
The doses produced by BE will eventually be made available for procurement by governments in countries where the virus is endemic, to support national vaccination programmes, by 2030 at the latest.
Qdenga is a tetravalent, live, attenuated dengue vaccine in multidose vials. BE would produce a multidose vial for this vaccine, something they currently do not have. It added that multidose vials offer economic and logistical advantages for national immunization programs by minimizing packaging and storage costs, 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 has covered more than 28,000 individuals in countries with endemic and non-endemic dengue, and has shown an efficacy of about 84 percent against hospitalized dengue. This was irrespective of whether the person had previously been exposed to dengue or not.
In addition to Takeda and IIL, Serum Institute of India and Panacea Biotec are also working on the development of a dengue vaccine.
First print: Jul 25, 2024 | 6:36 PM IST