NEW DELHI : Japan’s Takeda Pharmaceuticals has sought permission from the Indian drug regulator to conduct phase three clinical trials for its dengue vaccine which has received approval in the European Union and Indonesia.
The Drugs Controller General of India’s (DCGI) subject expert committee (SEC) took up Takeda’s proposal seeking permission for trials of its dengue tetravalent vaccine Qdenga, minutes of its 23 January meeting showed.
“The firm presented its proposal for grant of permission to conduct phase III clinical trial of dengue tetravalent vaccine containing DEN1, DEN2, DEN3, DEN4. The vaccine is approved for marketing in Indonesia, 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 a Phase 3 trials in many countries,” the minutes said.
Queries emailed to the health ministry and Takeda pharma remained unanswered.
Takeda’s proposal gains significance given that dengue cases in India have shot up in the last few years, even as the country lacks any effective vaccine or treatment for the viral disease. Dengue infected over 100,000 and killed 90 in 2022, according to the National Centre for Vector Borne Disease Control (NCVBDC). Dengue virus has four different strains—DENV-1 that causes classic dengue fever, DENV-2 that results in haemorrhagic fever with shock, DENV-3 that causes fever without shock, and DENV-4 that leads to fever without shock or profound shock. Scientists say that DENV-2 circulating this year which is more virulent.
According to the NCVBDC data, the worst hit states are Kerala (3446 cases and 24 deaths), Haryana (4551 cases, 12 deaths), Jammu & 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).
Download The Mint News App to get Daily Market Updates.
More
Less
NEW DELHI : Japan’s Takeda Pharmaceuticals has sought permission from the Indian drug regulator to conduct phase three clinical trials for its dengue vaccine which has received approval in the European Union and Indonesia.
The Drugs Controller General of India’s (DCGI) subject expert committee (SEC) took up Takeda’s proposal seeking permission for trials of its dengue tetravalent vaccine Qdenga, minutes of its 23 January meeting showed.
“The firm presented its proposal for grant of permission to conduct phase III clinical trial of dengue tetravalent vaccine containing DEN1, DEN2, DEN3, DEN4. The vaccine is approved for marketing in Indonesia, 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 a Phase 3 trials in many countries,” the minutes said.
Queries emailed to the health ministry and Takeda pharma remained unanswered.
Takeda’s proposal gains significance given that dengue cases in India have shot up in the last few years, even as the country lacks any effective vaccine or treatment for the viral disease. Dengue infected over 100,000 and killed 90 in 2022, according to the National Centre for Vector Borne Disease Control (NCVBDC). Dengue virus has four different strains—DENV-1 that causes classic dengue fever, DENV-2 that results in haemorrhagic fever with shock, DENV-3 that causes fever without shock, and DENV-4 that leads to fever without shock or profound shock. Scientists say that DENV-2 circulating this year which is more virulent.
According to the NCVBDC data, the worst hit states are Kerala (3446 cases and 24 deaths), Haryana (4551 cases, 12 deaths), Jammu & 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).
Download The Mint News App to get Daily Market Updates.
More
Less