The partnership between Japan’s Takeda and India’s Biological E, involving dengue vaccine QDENGA, forms a critical part of the strategy to ramp up supplies in India and globally, said Dr. Gary Dubin, Takeda’s President of the Global Vaccine Business Unit.

Dubin was referring to the partnership with Bio E to accelerate access to QDENGA-Takeda’s (Dengue Tetravalent Vaccine [Live, Attenuated]) (TAK-003) multi-dose vials (MDVs). These doses will be made available for government procurement in endemic countries by 2030, to support national immunisation programmes, a global announcement by the two companies said earlier on Tuesday.

Dengue is a global health problem, and the MDV presentation of the vaccine makes it compatible with nation-wide immunisation programmes, reducing storage space, Dubin told businessline, adding that the manufacturing would support supplies to India (when the approvals are through) and the rest of the world.

BE will ramp up manufacturing up to 50 million doses a year, accelerating Takeda’s efforts to manufacture 100 million doses a year within the decade. The partnership will build on existing manufacturing capacity for the vaccine at Takeda’s facility in Singen, Germany, and Takeda’s long-term partnership with IDT Biologika GmbH.

India trial

Presently, TAK-003 is not approved for use in India. But Dion Warren, Takeda’s Head of India and Southeast Asia multi-country organisation, said the company was working with Indian regulatory authorities towards licensure, and they had already received a “no obection certificate,” he added. A trial would be taken on 500 subjects, he said, in addition to the data available from the global trials.

Dubin said the process for the WHO pre-qualification of this vaccine was at an advanced stage. (Pre-qualification paves the way for easy adoption by vaccine countries, especially those without robust regulatory systems.) Late last year, deliberations by WHO’s advisory group recommended the use of this vaccine after reviewing data from 19 studies and over 28,000 children and adults, the company said last October.

Tiered pricing

The vaccine would be supplied through both public and private channels, the company representatives said. Takeda has an access philosophy and a policy of tiered pricing, allowing it to price the product differently in endemic countries, explained Dubin. While the focus would presently be on the dengue vaccine partnership, he said, future potential partnerships were on the table.

Dengue fever is among the most common mosquito-borne viral diseases worldwide, with global incidence rates increasing 30-fold over the last 50 years due to urbanization, travel, and climate change. It is currently endemic in more than 100 countries and causes an estimated 390 million infections each year.

Qdenga is 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.