Recently, the Vietnamese Ministry of Health has approved Takeda's dengue vaccine. This is the first approved dengue vaccine and is considered an advanced additional preventive tool in the comprehensive strategy for dengue prevention in Vietnam.
During a visit to Asia and Vietnam in September, Dr. Derek Wallace, Global President of Takeda Vaccines, who led the vaccine development project, shared about the challenging, yet rewarding journey of researching and producing the quadrivalent vaccine, which is capable of fighting all four types of dengue virus.
Dr. Derek Wallace, Global President of Takeda Vaccines
1. Takeda has recently been attracting much attention thanks to its groundbreaking efforts in dengue prevention globally, including in Vietnam. As a key person in the journey to develop a dengue vaccine, can you share what inspired you to join and commit to this mission?
I have always believed that vaccines are the cornerstone of public health, with the potential to have a profound impact on the lives of individuals and families for generations to come. After witnessing firsthand the devastating effects of the dengue outbreak in Thailand in 20091 , I was even more determined to find a way to eradicate the disease. That experience inspired me to lead the Takeda team in developing a dengue vaccine, providing a more proactive and sustainable means of prevention.
2. The dengue vaccine is approved for the prevention of dengue fever. Could you share some of the milestones in the development of this vaccine?
Dengue is a complex disease caused by four different virus types (DENV-1, 2, 3 and 4), making vaccine development particularly challenging. Takeda’s dengue vaccine is the culmination of a long and challenging journey that began 60 years ago.
Although efforts to find and research a dengue vaccine began in the 1920s, progress has not been seen for decades due to various obstacles.
Takeda’s journey to develop a dengue vaccine began in 1978 at Mahidol University in Thailand. The World Health Organization (WHO) Regional Office for Southeast Asia proposed a dengue vaccine research project, and Mahidol University was selected as a partner. Since then, the university has been at the forefront of dengue vaccine research and development. In 1986, they discovered a live attenuated vaccine that could prevent DENV-2. This was the foundation for our current quadrivalent vaccine. After 12 years of research, the quadrivalent vaccine was successfully developed, providing broad protection against all four dengue virus serotypes.
Over the past 11 years, Takeda has successfully led the development of a dengue vaccine through 19 clinical trials involving 28,000 people in 13 countries, including endemic and non-endemic countries. Our vaccine has recently been recommended by the WHO Strategic Advisory Group of Experts (SAGE) for use in endemic countries with high levels of infection to provide the best protection for the community. In addition, the vaccine has been prequalified by the World Health Organization, demonstrating that it is a quality vaccine and is trusted as an important dengue prevention tool, suitable for national immunization programs. We are proud that the dengue vaccine has been approved and is being used to protect the community, regardless of whether or not they have had the disease before. The global recommendation marks an important step forward for Takeda in its mission to develop new vaccines to address some of the most difficult public health challenges. The WHO recommendation affirms that dengue vaccines are an important tool in a comprehensive dengue prevention strategy, helping to reduce the global health threat to people.
Vietnam's Ministry of Health has just approved Takeda's dengue vaccine - This is the first approved dengue vaccine and is considered an advanced supplementary prevention tool in the comprehensive strategy for dengue prevention in Vietnam.
3. Sir, what challenges and difficulties did you and your research team encounter when developing the dengue vaccine? And how did Takeda overcome those challenges?
There were many challenges during the development process, one of which was the complex nature of dengue virus with four distinct serotypes. Achieving an immune response that protects against all four serotypes without increasing the risk of severe disease due to antibody-dependent enhancement (ADE) was a major challenge that we overcame. In addition, the vaccine needed to be effective and safe across a wide range of populations.
In addition to research, manufacturing, especially large-scale manufacturing for global commercialization of vaccines, is no small task. The tetravalent dengue vaccine requires sophisticated and complex manufacturing, storage, preservation and transportation processes. Therefore, we have worked closely with partners in Vietnam and other countries to develop transportation and storage strategies that help manage vaccination effectively.
4. Can you share some of Takeda's high quality standards in the production of dengue vaccines, from manufacturing to the supply chain and distribution worldwide?
Takeda’s first dengue vaccine manufacturing facility in Singen, Germany, began operations in November 2019, performing secondary packaging and supporting formulation, vial filling and freeze-drying. In 2023, we will expand the facility to increase production capacity, making Singen the only Takeda facility globally capable of manufacturing both active pharmaceutical ingredients and active pharmaceutical ingredients for dengue vaccines.
WHO’s inclusion of Takeda’s dengue vaccine in the Prequalified Vaccine List demonstrates the quality and suitability of the vaccine for national immunization programs. This is an important step in expanding access to Takeda’s dengue vaccine globally, especially in areas heavily affected by dengue.
Understanding the need for a comprehensive, integrated solution to address the global health threat posed by dengue, Takeda is committed to working closely with partners, governments and health authorities in countries where dengue vaccines have been licensed to provide the best possible prevention. Building on the manufacturing capabilities of its German facility, Takeda entered into a strategic partnership with Biological E. Limited in India last year to enhance access to multi-dose vaccines for national immunization programs in areas where the disease is endemic. We are working to increase supply each year, with a target of 100 million doses per year by 2030, through investments in existing facilities and strategic partnerships, to meet the growing demand for dengue vaccine prevention.
With millions of doses of dengue vaccine distributed globally, we are committed to providing dengue vaccines that meet the highest standards of safety and efficacy. At Takeda, we strive to maintain rigorous quality standards at every stage of the development and manufacturing of our medicines and vaccines.
5. How do you predict the dengue vaccine will impact public health, especially in endemic countries like Vietnam?
We expect that the dengue vaccine will have a positive impact on public health, especially in endemic countries like Vietnam. The vaccine will not only protect people who have never had dengue before, but will also help reduce the number of new cases in those who have already been infected. Furthermore, the vaccine has the potential to reduce hospitalizations, which will have a significant economic benefit by reducing the financial burden on the health care system and households, contributing to overall economic stability.
In its Dengue Vaccines Statement, the World Health Organization also stressed the importance of prioritizing the deployment of all available prevention methods, including vaccination. Accordingly, to effectively prevent dengue and improve public health, we need to implement an integrated solution, including: vector control; case management; community education; and vaccination.
At the same time, WHO also determined that Takeda's dengue vaccine will have a major impact. public health in areas with high transmission rates. Vaccine deployment should be combined with an effective communication strategy and active community participation. In addition, individuals should also take additional measures to protect themselves and their loved ones. This will contribute to increasing the effectiveness of preventive measures, enhancing the effectiveness of public health efforts and minimizing the impact of dengue on the community.
At the end of September 2024, Dr. Derek Wallace - Global President of Takeda Vaccines, and Mr. Dion Warren - General Director in charge of India - Southeast Asia (I-SEA) Takeda visited and worked in Vietnam.
During this visit, the two Takeda leaders will spend time working and supporting the official implementation of Takeda's dengue vaccine in the Vietnamese market, after the vaccine is licensed for circulation by the Ministry of Health in May 2024. Currently, Takeda is the only vaccine manufacturer and importer in Vietnam.
The participation of Takeda leaders affirms the Group's continuous efforts in finding and providing effective solutions to repel dengue fever, contributing to reducing the disease burden in countries with high disease rates such as Vietnam.
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