The Indian Council of Medical Research (ICMR) and Panacea Biotec announced the commencement of the first-ever Phase 3 clinical trial for developing a dengue vaccine in India. This landmark trial will evaluate the efficacy of India's indigenous tetravalent dengue vaccine, DengiAll, developed by Panacea Biotec. The first participant in this trial was vaccinated at Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences (PGIMS), Rohtak, according to the Ministry of Health and Family Welfare.
The initiation of this Phase 3 clinical trial for India's first indigenous dengue vaccine marks a critical advancement in the country's fight against dengue. It reflects India's commitment to protecting its citizens from this pervasive disease and underscores the nation's capabilities in vaccine research and development. This was stated by J.P. Nadda, Union Minister of Health and Family Welfare.
Through this collaboration between ICMR and Panacea Biotec, India is not only taking a step towards ensuring the health and well-being of its people but also reinforcing its vision of Atmanirbhar Bharat in the healthcare sector. The trial, primarily funded by ICMR with partial support from Panacea Biotec, is set to follow up with participants for two years.
At present, there is no antiviral treatment or licensed vaccine against dengue in the country. The development of an effective vaccine is complex due to the need to achieve good efficacy for all four serotypes. In India, all four serotypes of the Dengue virus are known to circulate or co-circulate in many regions.
In February, Japanese drugmaker Takeda Pharmaceuticals announced that it is in discussions with the Indian regulator and will soon initiate bridging trials on 500 people in India, as it seeks approval of its dengue vaccine. Takeda's dengue vaccine Qdenga, pre-approved by the WHO in May, has shown more than 50 per cent efficacy in reducing the number of cases, with lasting effects and a good safety profile, according to a review of 19 studies published in the journal Vaccines.
The government stated that Panacea Biotec, one of three Indian companies to receive the strain, is at the most advanced stage of development. The company has worked extensively on these strains to develop a full-fledged vaccine formulation and holds a process patent for this work. Phase 1 and 2 clinical trials of the Indian vaccine formulation were completed in 2018-19, yielding promising results.
According to data by the National Centre for Vector Borne Diseases Control, the country recorded 19,447 cases of dengue and 16 deaths till April 30, 2024. This highlights the urgent need for a vaccine to combat the disease.
The Phase 3 clinical trial will be conducted across 19 sites in 18 states and union territories, involving more than 10,335 healthy adult participants. This large-scale trial is a significant step in India's fight against dengue, a disease that has been a major public health concern in the country for several years.
The development of DengiAll, therefore, represents a significant scientific achievement. If successful, the vaccine could potentially protect millions of people in India and other dengue-endemic regions from this debilitating disease.
