Last Updated on December 31, 2023 by The Health Master
Japan’s Takeda Pharmaceuticals has asked the Indian drug regulator for permission to carry out Phase III clinical trials for its dengue vaccine, which has already received approval in the European Union and Indonesia.
- Queries have been emailed to the health ministry and the Japanese pharma company did not receive any response.
- 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.
- Scientists say that this year DENV-2 is circulating which is more toxic.
According to the minutes of its meeting on January 23, the subject expert committee (SEC) of the Drugs Controller General of India (DCGI) took up Takeda’s request for authorization to undertake trials of the dengue tetravalent vaccine Qudenga.
“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.
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 are:
DENV-1 which causes classic dengue fever,
DENV-2 which results in hemorrhagic fever with shock,
DENV-3 which causes fever without shock,
DENV-4 which causes fever without relapsing or deep relapsing.
Moreover, the most affected states, as per the NCVBDC data, 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),
- Karnataka (7317 cases, 4 deaths).
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