The story behind the first dengue vaccine approved in Vietnam

Dr. Derek Wallace, President of Takeda Vaccines Global, led the successful dengue vaccine development project at Takeda.

During his visit to Asia and Vietnam last September, Dr. Derek Wallace - President of Takeda Vaccines Global, who led the project to develop this vaccine - shared about the challenging, yet glorious journey in researching and producing the quadrivalent vaccine, which is capable of fighting all four types of dengue virus.

* 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 across generations.

After witnessing firsthand the devastating effects of the dengue outbreak in Thailand in 2009, I became even more determined to find a way to fight the disease.

It was that experience that inspired me to lead the Takeda team in developing a dengue vaccine, aiming to provide a more proactive and sustainable prevention measure.

* To successfully research a dengue fever vaccine must have been a very long journey. Could you share more about some important milestones in the journey to develop 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 been slow for decades due to various obstacles.

Takeda’s journey to developing 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 types.

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.

Recently, our vaccine has also been recommended by the WHO's Strategic Advisory Group of Experts (SAGE) for use in countries in epidemic areas with high levels of infection to provide the best community protection.

In addition, the fact that the vaccine has been prequalified by WHO shows that it is a quality vaccine and is trusted as an important dengue prevention tool, suitable for national immunization programs.

In particular, WHO's recommendation affirms that dengue vaccine is an important tool in a comprehensive dengue prevention strategy, contributing to repelling the global health threat to people.

We are proud that our dengue vaccine has been approved and is being used to protect people, regardless of whether they have had the disease before. This global recommendation marks an important step forward for Takeda in its mission to develop new vaccines that help address some of the most difficult public health challenges.

Researchers in a laboratory at Takeda's Singen plant (Germany)

* Surely the research team has experienced some challenges and difficulties when developing the dengue vaccine. Can you share about this and how Takeda overcame those challenges?

- There were many challenges throughout the research process, and one of them 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) is a major challenge that we have overcome. In addition, the vaccine needs to be effective and safe in a variety of population groups.

Besides research, production, especially large-scale production for global vaccine commercialization is not a simple task. The tetravalent dengue vaccine requires a modern and complex production, storage, preservation and transportation process.

Therefore, we have worked closely with partners in Vietnam and other countries to develop transportation and storage strategies that help manage vaccinations effectively.

* Can you share some of Takeda's quality standards in the production of dengue vaccines, from production to supply chain and distribution worldwide?

- Takeda's first dengue vaccine manufacturing plant located in Singen, Germany, has been operational since November 2019, performing secondary packaging and supporting the formulation, vial filling and freeze-drying stages.

In 2023, we will expand the plant to increase production capacity, making Singen the only Takeda facility globally capable of producing both active pharmaceutical ingredients and pharmaceutical products for dengue vaccines.

Inside Takeda's Singen vaccine factory in Germany

WHO's inclusion of Takeda's dengue vaccine in its prequalified vaccine list demonstrates its quality and suitability 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 an integrated and comprehensive 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 plant, 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.

Every year, we work to increase supply, aiming to reach 100 million doses per year by 2030, through investment in existing factories 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.

* How do you predict the dengue vaccine will impact public health, especially in endemic countries like Vietnam?

- In its dengue vaccine statement, WHO also stressed the importance of prioritizing the deployment of all available prevention methods, including vaccination.

Accordingly, to effectively prevent dengue fever and improve public health, we need to implement an integrated solution, including: vector control; case management; community education and vaccination.

WHO also identified Takeda’s dengue vaccine as having a major impact on public health in areas with high transmission rates. The vaccine rollout should be coupled with an effective communication strategy and active community participation.

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 people who have already had the disease.

Furthermore, vaccines have the potential to reduce hospitalization rates, thereby bringing major economic benefits by reducing the financial burden on health care systems and households, contributing to overall economic stability.

In addition, each individual should also take additional measures to protect themselves and their loved ones. This will contribute to enhancing the effectiveness of preventive measures, enhancing the effectiveness of public health efforts and minimizing the impact of dengue fever on the community.

At the end of September 2024, Dr. Derek Wallace - President of Takeda Vaccines Global, 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 activities 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.

Source: https://tuoitre.vn/cau-chuyen-phia-sau-vac-xin-sot-xuat-huet-dau-tien-duoc-phe-duet-tai-viet-nam-20240925160311898.htm