In a significant development in the field of indigenous vaccine manufacturing, the Indian Council of Medical Research (ICMR) in collaboration with Panacea Biotec has initiated the first-ever phase three clinical trial for developing an indigenous dengue vaccine in India, the Union Health Ministry said on Wednesday.
The maiden participant of the trial was vaccinated on Wednesday at the Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences, Rohtak.
Commenting on the development, Union Health Minister J P Nadda said, "The initiation of this phase three clinical trial for India's first indigenous dengue vaccine marks a critical advancement in our fight against dengue. It reflects our commitment to protecting our citizens from this pervasive disease and underscores India's capabilities in vaccine research and development."
"Through this collaboration between ICMR and Panacea Biotec, we are not only taking a step towards ensuring the health and well-being of our people but also reinforcing our vision of Atmanirbhar Bharat in the healthcare sector."
About the Dengue Vaccine Phase 3 trial
Pharmaceutical company Panacea Biotec has developed the indigenous tetravalent dengue vaccine, DengiAll.
As per reports, the third phase of the clinical trial will be conducted across 19 sites in 18 states and union territories, involving more than 10,335 healthy adult participants.
According to the official statement, phase one and two clinical trials of the indigenous vaccine formulation were completed in 2018-19, yielding promising results.
The trial is primarily funded by the ICMR with partial support from Panacea Biotec. The third phase of the trial is all set to follow up with participants for two years.
About the Dengue vaccine
Panacea Biotec is one of the three Indian companies to receive the tetravalent dengue vaccine strain (TV003/TV005), originally developed by the National Institutes of Health (NIH), USA. In preclinical and clinical trials across the globe, the strain has shown promising results.
After extensive work on the development of a full-fledged vaccine formulation from the strain, Panacea Biotec's vaccine currently is at the most advanced stage of development.
Dengue: A serious health concern in India
Ranking among the top 30 countries in the world with the highest incidence of the disease, Dengue is still considered a major public health concern in India with no anti-viral treatment available in the country as of now.
According to the World Health Organisation (WHO), the global incidence of Dengue has been seeing a steady increase over the past two decades across the globe, with more than 129 countries reporting dengue viral disease by the end of 2023.
In India, approximately 75-80 percent of infections are asymptomatic win while in 20-25 percent of cases are symptomatic. Children are always at a significantly higher risk of hospitalisation and mortality.
