India has got the first dengue vaccine. Takeda Biopharmaceuticals India Private Limited said on Monday that it has received market authorization (approval to launch in the market) from the Drug Controller General of India (DCGI) for its dengue prevention vaccine QDENGA.
QDENGA vaccine is the first dengue vaccine to be approved in India. It can be used to prevent dengue in people between 4 and 60 years of age. This branch of Japan’s big biopharmaceutical company Takeda said in a statement that this vaccine can be given to anyone. In this case, it can be given in both cases whether someone has dengue infection or not. Also, there is no need for any test before administering the vaccine.
Important decision to prevent dengue: Nayak
Mahendra Nayak, Head of Intercontinental Markets, Takeda, said, “Since its launch in 2022, QDENGA vaccine has so far been approved in 43 countries and more than 32 million doses have been distributed worldwide. This approval is a very important step towards strengthening dengue prevention in India.”
He further said that the most recent 7 years of data for QDENGA show that this vaccine consistently protects against dengue infection and hospitalization. This protection is against all 4 serotypes of dengue virus. This is an important achievement for human communities and health systems.
The company further said that this approval in India is based on the results of Takeda’s Global Clinical Development Program. Under this program, 19 clinical trials (Phase 1, 2 and 3) were conducted with more than 28,000 people in areas with high and low incidence of dengue.
The company also said that it has also been supported by the data of the third phase clinical trial (DEN-302) conducted on Indian people. In this trial, the safety and immunogenicity (ability to produce immunity) of the vaccine was assessed in people aged 4 to 60 years.
3 months gap between 2 doses
This vaccine is given subcutaneously in the form of 2 doses in the amount of 0.5 ml, and a gap of at least 3 months is kept between the two doses.
Goh Chu Beng, head of medical affairs of Takeda’s Southeast Asia and India cluster, said that dengue is a big problem in India. In many areas, all four serotypes of dengue virus have been found spreading simultaneously. Beng further said, “This vaccine is designed to provide protection against all four serotypes, whether a person has had dengue before or not. Its approval by the government is an important step towards strengthening the comprehensive approach to dengue prevention in the country. It also includes vector control surveillance, community awareness and other important public health measures.”
The company said that the World Health Organization (WHO) has recommended QDENGA vaccine for use in dengue areas. Also, WHO has said that in areas with high infection, doses will be given publicly under a special immunization program, so that there is no need for screening before vaccination.
Dengue havoc in 125 countries
Dengue is a dangerous viral disease spread by mosquitoes, and it is a major problem in poor countries of the world. Dengue is spread in more than 125 countries. According to the company, about one-third of the total dengue cases worldwide occur in India.
The company said millions of Indians remain at risk every year due to the widespread spread of disease, rapid urbanization and weather-related factors that increase mosquito populations.
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