Dengue prevention vaccine ‘QDENGA’ has received approval from the Drugs Controller General of India (DCGI) to launch it in the market. Takeda Biopharmaceuticals India Private Limited, the company manufacturing QDENGA, gave this information on Monday. This is the first dengue vaccine to be approved in India. It is used to prevent dengue in people aged 4 to 60 years. The Indian unit of Japanese biopharmaceutical company Takeda said that this vaccine can be given both whether a person has had dengue infection before or not and no test is required before administering the vaccine.
**QDENGA, launched in 2022, has been approved in 43 countries**
Mahendra Naik, Head of Intercontinental Markets at Takeda, said, “Since its launch in 2022, QDENGA has been approved in 43 countries and more than 32 million doses have been distributed worldwide. This approval is an important step towards strengthening dengue prevention in India.” He added that new seven-year data from QDENGA shows that it provides sustained protection against dengue infection and hospitalization. This protection works against all four serotypes of dengue virus.
**19 clinical trials conducted on more than 28,000 people**
The company said the approval in India is based on the results of Takeda’s global clinical development program. In this program, 19 clinical trials (Phase 1, 2 and 3) were conducted on more than 28,000 people in areas with different levels of dengue. The company said that this approval has also been supported by the data of Phase 3 clinical trial (DEN-302) conducted on the Indian population. In this trial, the safety and immunogenicity (ability to generate immune response) of the vaccine was examined in people aged 4 to 60 years.
Dengue is a matter of great concern in India.
Dengue is a major challenge in India, as all four serotypes of dengue virus are spreading simultaneously in many areas. The company said WHO recommends the use of QDENGA in areas where dengue is prevalent and supports its inclusion in public vaccination programs in areas with high prevalence, with no testing required before administering the vaccine. It was also told that the vaccine has received pre-qualification from WHO, which confirms that this anti-dengue vaccine meets global standards in terms of quality, safety and efficacy.