India’s DengiAll vaccine enters crucial Phase 3 testing
In a groundbreaking development, the Indian Council of Medical Research (ICMR) and Panacea Biotec announced on Wednesday the initiation of the first-ever Phase 3 clinical trial for a dengue vaccine in India. This landmark trial aims to evaluate the efficacy of DengiAll, India’s indigenous tetravalent dengue vaccine developed by Panacea Biotec.
The trial, primarily funded by ICMR with partial support from Panacea Biotec, is set to follow up with participants for two years.
At the moment, there is no antiviral treatment or licensed vaccine against dengue in the country.
The trial marks a significant milestone in the fight against dengue fever, a major public health concern in the region. The first participant in this crucial trial was vaccinated at the Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences (PGIMS) in Rohtak, as reported by the Ministry of Health and Family Welfare.
The Phase 3 clinical trial will involve extensive testing to assess the vaccine’s effectiveness and safety in a large population, paving the way for potential widespread use and contributing to India’s efforts to combat dengue fever.
“The initiation of this Phase 3 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,” said J P Nadda, Union Minister of Health and Family Welfare.
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,” said the Minister.
In collaboration with ICMR, Panacea Biotec will conduct the Phase 3 clinical trial across 19 sites in 18 states and union territories, involving more than 10,335 healthy adult participants.
The government has emphasized the complexity of developing an effective dengue vaccine due to the need to cover all four serotypes of the virus, which circulate or co-circulate in various regions of India.
In February, Takeda Pharmaceuticals announced plans to start bridging trials on 500 people in India for its dengue vaccine, currently under discussion with the Indian regulator. Takeda’s vaccine, Qdenga, which was pre-approved by the WHO in May, has demonstrated over 50% efficacy in reducing dengue cases, according to a review in the journal Vaccines.
Panacea Biotec, one of three Indian companies with access to the dengue strains, is at the advanced stage of vaccine development. The company has completed Phase 1 and 2 trials with promising results and holds a process patent for its vaccine formulation.
As of April 30, 2024, India has reported 19,447 dengue cases and 16 deaths, according to the National Centre for Vector Borne Diseases Control.
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