India may soon have access to the dengue vaccine Qdenga from Japan’s Takeda Pharmaceutical Company, as the patient-focused, research and development (R&D)-driven global biopharmaceutical company has recently received a no-objection certificate from the Indian regulator to conduct local clinical trials, according to senior company executives.
Qdenga is presently available for children and adults in the private market in European countries, Indonesia, and Thailand, as well as in private and some public programmes in Argentina and Brazil.
Meanwhile, Japan’s Takeda will scale up the manufacturing capacity of its dengue vaccine, Qdenga, in partnership with India’s Biological E., said a joint statement released on Tuesday.
Biological E. will increase manufacturing capacity to up to 50 million doses a year, accelerating Takeda’s plans to manufacture 100 million doses annually within the decade. This collaboration 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.
Dion Warren, head of India and Southeast Asia multi-country organisation at Takeda, told Business Standard, “We are in active dialogue with regulators in India. We recently received a no-objection certificate to conduct local clinical trials here in India, and we are working towards initiating local clinical studies.”
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The global clinical trials did not include an Indian arm, prompting the company to conduct local clinical trials in India.
Warren highlighted the high sense of urgency regarding dengue in India, citing government data that reported over 230,000 cases in 2022, compared to just over 12,000 cases in 2006. He emphasised the high disease burden in India and other Asian countries, expressing the company’s commitment to local clinical trials with a sense of urgency.
Regarding pricing strategy, Takeda mentioned that prices in the private market in Europe are higher than those in Asian markets. They plan to follow a dual strategy of being present in both the private and public markets in India as well. Warren said that it was too early to comment on potential pricing for India.
The doses manufactured by Biological E. will be available for procurement by governments in endemic countries by 2030, at the latest, to support national immunisation programmes.
Qdenga is a tetravalent, live, attenuated dengue vaccine in multi-dose vials. Takeda said that Biological E. would produce a multi-dose vial for this vaccine, which they currently do not have. They 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 of the global vaccine business unit at Takeda, informed Business Standard that the global clinical development of this vaccine has covered over 28,000 individuals across dengue-endemic and non-endemic countries. He mentioned a pivotal efficacy study involving around 20,000 children between the ages of four and 16, demonstrating high efficacy of around 84 per cent against hospitalised dengue.
This data has supported regulatory approvals in 20 countries and vaccine recommendations, including the recent endorsement by the World Health Organization (WHO) for countries with high dengue endemicity.
Dengue fever is among the most common mosquito-borne viral diseases globally, with incidence rates increasing thirtyfold over the past 50 years.
Dengue is currently endemic in more than 100 countries, causing an estimated 390 million infections each year.
The Americas, Southeast Asia, and Western Pacific regions are the most seriously affected, with Asia alone representing around 70 per cent of the global burden of the disease. The WHO has set a disease-specific target to achieve a zero case-fatality rate due to dengue by 2030.
Mahima Datla, managing director at Biological E., said, “Takeda’s commitment to patient-focused, value-based R&D aligns extremely well with our dedication to advancing health care. We are fortunate to have created an institute that attracts such strong global partners for complex vaccines and underscores our shared mission of shaping a healthier future for all. With Takeda’s esteemed history and global presence, we are honoured to advance our vision of delivering highly innovative medicines and transformative care worldwide.”
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