Takeda Dengue Vaccine Listing [Clinical trials in Sri Lanka]
The European Medicines Agency’s (EMA) Human Medicines Committee (CHMP) has recommended the use of Takeda’s Dengue Tetravalent Vaccine, to prevent disease caused by dengue virus serotypes 1, 2, 3 and 4 in people from four years of age to 45+. Positive Opinion on the Takeda Dengue vaccine was based on 4.5 years of safety and efficacy data from the pivotal phase 3 trial of over 20,000 children and adolescents across eight Dengue-Endemic countries, including Sri Lanka where the trial was conducted in 2100 children between the ages of 4-16 years across 4 centres. Results from the research showed the vaccine prevents fever, severe disease, and hospitalization for all serotypes of the virus, indicating its ability to help protect a wider pool of patients.
In August, Takeda’s dengue vaccine was approved by the Indonesia National Agency for Drug and Food Control, for the prevention of dengue disease in those age six to 45 years of age. The vaccine has not yet been approved anywhere else in the world. However, it is in the final step to receiving Marketing Authorization from the EMA, which is expected in the coming months. Regulatory reviews are also progressing in dengue-endemic countries in Latin America and Asia.
Dr. Ooi Eng Eong, Professor of Emerging Infectious Diseases at Duke-NUS Medical School in Singapore highlighted that the global health community has been eager for a dengue vaccine that is accessible without the barrier of pre-vaccination testing and the robust clinical data provided by Takeda shows that its dengue vaccine has the potential to help prevent dengue cases and hospitalizations.
Sri Lanka, a Dengue endemic country would be highly benefited by the receipt of marketing authorization of this vaccine since the disease is a key health problem in many parts of the country. So far there have been more than 55,000 cases reported as of 24th November 2022 with a significant patient load comprising of children. Discussions are currently ongoing at a higher level on the registration of the vaccine, and Sri Lanka was prioritized for this purpose mainly due to its involvement in the phase 3 trial, which was pioneered by RemediumOne. Therefore, availability of a proven, safe, and effective dengue vaccine would be instrumental in reducing severe disease and hospitalizations across endemic areas in the country.
