India has approved a dengue vaccine for the first time. The country’s Drug Controller General (DCGI) has recently granted marketing approval for “QDenga,” a dengue vaccine made by Takeda Biopharmaceuticals India, the company said in a press release.
QDenga is set to become the first dengue vaccine approved for marketing in India. People aged 4 to 60 can take the two-dose vaccine, with the doses given three months apart. It protects against all four serotypes of the dengue virus.
The company says QDenga can be given whether or not a person has previously had dengue, and that no pre-vaccination screening for prior infection is needed.
The approval comes as dengue has become a major public-health problem in India. According to government figures, dengue cases have risen nearly 11-fold over the past two decades, and about one-third of the world’s dengue patients are Indian. Model-based studies suggest actual infections are far higher than official figures.
QDenga’s Indian approval is based on data from Takeda’s global clinical-development program, which ran 19 Phase 1, Phase 2 and Phase 3 clinical trials involving more than 28,000 people in dengue-endemic and non-endemic regions. More than 20,000 people in eight dengue-endemic countries took part in the Phase 3 trial.
According to Takeda, 12 months after the second dose the vaccine was 80.2 percent effective in preventing virologically confirmed dengue, and 18 months on it was 90.4 percent effective in preventing dengue-related hospitalization. Follow-up over up to four and a half years showed 84.1 percent efficacy against hospitalization, and up to seven years of follow-up showed lasting protection against dengue disease and hospitalization for all four serotypes.
A Phase 3 trial in participants aged 4 to 60 was also considered for the Indian approval. The company says the study found the vaccine safe, tolerable and able to generate an immune response in children, adolescents and adults.
Takeda said QDenga has been approved in 43 countries in Asia, Latin America and Europe, with more than 32 million doses distributed so far through public and private immunization programs. The World Health Organization (WHO) has approved QDenga for use in high-transmission, dengue-endemic areas, and the vaccine has received WHO prequalification.
QDenga is currently part of Brazil’s national immunization program and is also available through the public programs of Argentina, Colombia and Indonesia. The company said it would work with India’s regulators, public-health stakeholders and healthcare providers to supply the vaccine in a planned, accessible way.
বাংলায় মূল প্রতিবেদন পড়ুন · Read the original Bengali report