New Delhi : Japan’s Takeda Pharmaceuticals has sought permission from the Indian drug regulator to conduct Phase III clinical trials for its dengue vaccine that has received approval in the European Union and Indonesia.
The subject expert committee (SEC) of the Drugs Controller General of India (DCGI) took up Takeda’s proposal seeking permission to conduct trials of dengue tetravalent vaccine Qudenga, the minutes of its January 23 meeting showed.
“The firm submitted its proposal for permission to conduct Phase III clinical trials of dengue tetravalent vaccine containing DEN1, DEN2, DEN3, DEN4. The vaccine has been approved for marketing in Indonesia, the European Medicines Agency (EMA), for the prevention of dengue disease in individuals from 4 years of age. The efficacy of dengue vaccine in providing protection against dengue infection is currently being evaluated in phase 3 trials in several countries,” the minutes said.
Emailed queries to the health ministry and Takeda Pharma did not elicit any response.
Takeda’s proposal assumes significance considering that dengue cases in India have spiked over the years, even as the country lacks any effective vaccine or treatment for the viral disease. According to the National Center for Vector Borne Disease Control (NCVBDC), dengue is expected to infect over 100,000 and kill 90 people in 2022. There are four different strains of dengue virus- DENV-1 which causes classic dengue fever, DENV-2 which results in hemorrhagic fever with shock, DENV-3 which causes fever without shock, and DENV-4 which causes fever without relapsing or deep relapsing. Scientists say that this year DENV-2 is circulating which is more toxic.
As per NCVBDC data, the most affected states are Kerala (3446 cases and 24 deaths), Haryana (4551 cases, 12 deaths), Jammu and Kashmir (4927 cases, 10 deaths), Bihar (9374 cases and 7 deaths), Telangana . (13091 deaths), Delhi (4609 cases), Rajasthan (9283 cases and 6 deaths), Punjab (5139 cases and 5 deaths), and Karnataka (7317 cases, 4 deaths).
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