“Initial supply of dengue vaccine for India will be manufactured at Takeda’s facility in Germany”

How is Takeda’s partnership with Organic E. Restricted taking part in a job in strengthening dengue vaccine entry in India? When are we anticipating the vaccine doses to be shipped?

Our partnership with Organic E. is a vital a part of Takeda’s long-term technique to broaden world manufacturing capability for TAK-003 and assist broader entry in dengue-endemic international locations sooner or later. We’re progressing nicely and stay on monitor towards our aim of reaching a worldwide manufacturing capability of 100 million doses per yr by 2030. As beforehand introduced, the collaboration is anticipated to assist manufacturing of as much as 50 million doses yearly by way of multi-dose vials for procurement in dengue endemic international locations by governments to assist Nationwide Immunisation Programmes.

Following advertising and marketing authorisation, there are a number of vital steps earlier than TAK-003 turns into obtainable in India, together with acquiring the mandatory Registration Certificates and Import License from the native authorities. That is adopted by manufacturing and provide of the vaccine from Takeda’s facility in Singen, Germany, the place the vaccines will bear required processes, earlier than they are often launched for industrial distribution. Primarily based on present timelines and topic to native processes, we count on TAK-003 to change into obtainable in India through the first half of 2027.

How a lot has been invested within the R&D of TAK-003? What’s the price of a single dose?

TAK-003 is at the moment probably the most extensively studied dengue vaccine, evaluated by way of a complete scientific improvement programme involving 19 scientific trials and greater than 28,000 individuals throughout 13 international locations, with long-term follow-up by way of 7 years.

We’re happy that TAK-003 has been accepted in India for people aged 4 to 60 years, and are dedicated to supporting broad, equitable, well timed and sustainable entry at a value that displays the vaccine’s worth and potential well being, societal and financial advantages.

Following India’s advertising and marketing authorisation, our fast precedence is to finish the mandatory native processes with the authorities. It will be untimely to take a position on pricing earlier than these are full.

What steps are being taken to handle the chilly chain logistics for the vaccine shipments? What number of doses are being manufactured in India?

Our strong provide chain utilises a worldwide community of inside and exterior manufacturing websites, with important world manufacturing websites within the US, continental Europe and Japan.

Preliminary provide of dengue vaccine for India will probably be manufactured in Germany at Takeda’s facility in Singen and thru our accomplice IDT Biologika GmbH in Dessau-Rosslau.

Our partnership with Organic E. stays an vital a part of Takeda’s long-term technique to broaden world manufacturing capability for TAK-003 and assist broader entry in dengue-endemic international locations. We’re progressing nicely and stay on monitor towards our aim of reaching a worldwide manufacturing capability of 100 million doses per yr by 2030. As beforehand introduced, Organic E. is anticipated to assist manufacturing of as much as 50 million doses yearly by way of multi-dose vials for procurement in dengue endemic international locations by governments.

Are you partnering with a number of hospitals in India, to make sure higher accessibility?

At this stage, following market authorisation, non-public market is prone to play an vital position in enabling early entry for eligible people whereas broader public pathways are established.

We welcome the latest Indian Parliamentary Committee advice to contemplate the inclusion of TAK-003 within the Common Immunisation Programme (UIP), which displays the rising recognition of dengue as a major public well being problem.

Takeda’s aim is to supply broad entry to as many eligible folks as doable by way of inclusion in Nationwide Immunisation Programmes. We do acknowledge that it will take time, and broader entry, together with by way of public well being channels, relies on impartial selections by well being authorities primarily based on their scientific and coverage assessments. This is the reason Takeda is working in parallel within the non-public, endemic, journey and public markets to make sure well timed entry.

In some elements of Southeast Asia, the variety of dengue circumstances recorded has been constantly decrease than these recorded in earlier years. With a slowing development of dengue, what worth does dengue vaccine carry to those areas?

Dengue transmission is influenced by a number of components, together with mosquito populations, urbanisation, local weather variability, inhabitants motion, and the circulation of various dengue serotypes. Due to this complexity, transmission depth can fluctuate, particularly through the El Niño occasion that’s anticipated to final from June 2026 to early 2027, as hotter, unstable climate patterns can set off dengue outbreaks.

As suggested by WHO, efficient dengue management requires an built-in method combining mosquito management, surveillance, public consciousness, vaccination, early prognosis and applicable scientific administration. Whereas vaccination is just one piece of the puzzle, it gives proactive, sustained safety relatively than a reactive response to surges.

By decreasing extreme illness and hospitalisations, vaccination protects weak populations and prevents healthcare amenities from being overwhelmed when the serotype shifts or local weather variations set off future outbreak cycles. These are the outcomes that matter most as a result of they’ve the best impression on sufferers, households and healthcare programs.

One of many largest hurdles in mass immunisation programmes is operational complexity. What makes the scientific profile of TAK-003, significantly the absence of pre-vaccination testing, so worthwhile for endemic international locations in Asia? 

Primarily based on the latest knowledge, TAK-003 is probably the most extensively studied dengue vaccine to this point, with long-term follow-up by way of 7 years. The trial knowledge demonstrates {that a} two-dose schedule, administered three months aside with no booster, is ample in defending in opposition to dengue. Importantly, TAK-003 is the one accepted dengue vaccine to be used no matter prior illness publicity, offering an vital possibility to assist scale back the rising burden of the illness.

A broad age indication from 4 years of age (as much as 60 years of age in some international locations), plus the absence of want for prior dengue publicity nor pre-vaccination testing are key to driving broad utilization, accessibility, and safety at scale for endemic areas. It allows governments to bypass the advanced logistical and monetary hurdles of diagnostic screening. Implementation then turns into far less complicated for healthcare suppliers, enabling native governments and public well being authorities to roll out vaccination campaigns with a lot higher effectivity. It will assist be sure that safety will be delivered straight and quickly to communities most in want throughout city and rural areas.

Hospital congestion is a persistent problem throughout dengue outbreaks, reported in a number of international locations together with Sri Lanka, the Philippines, and Vietnam. Are you able to inform us extra concerning the scientific knowledge and rising real-world proof that implies how Takeda’s dengue vaccine might ease healthcare infrastructure pressure?

Within the pivotal Part III TIDES examine, TAK-003 demonstrated 80.2% vaccine efficacy in opposition to virologically confirmed dengue at 12 months after the second dose, 90.4% efficacy in opposition to dengue-related hospitalization at 18 months, and 84.1% efficacy in opposition to dengue-related hospitalisation over 4.5 years of follow-up, with the finished seven-year follow-up additional demonstrating sustained safety throughout all 4 dengue virus serotypes.

These scientific findings are additional supported by real-world proof from the 2024 dengue outbreak in Brazil, the place a whole two-dose routine supplied roughly 61.7% efficacy in stopping dengue an infection and a single dose confirmed 67.5% efficacy in stopping dengue-related hospitalisation.

That is significantly vital the place dengue outbreaks can place vital stress on hospital beds, emergency providers and healthcare assets, whereas creating a considerable well being and financial burden for sufferers. Lowering hospitalisations can due to this fact assist reduce the impression of dengue on sufferers and the broader healthcare system.