Takeda’s two-dose QDENGA can be administered without prior dengue screening, says The Hindu
India has approved its first dengue vaccine for people aged between four and 60 years, The Hindu reported.
The Drug Controller General of India (DCGI) has granted market authorisation to Takeda Biopharmaceuticals India’s QDENGA (TAK-003), making it the country’s first approved vaccine against dengue, the newspaper said, citing a company statement.
QDENGA is a live-attenuated tetravalent vaccine designed to protect against all four dengue virus serotypes. It is administered in two doses, three months apart.
According to The Hindu, the vaccine can be given regardless of whether a person has previously been infected with dengue and does not require pre-vaccination screening.
The approval comes as India continues to grapple with a rising dengue burden. Reported cases have increased nearly 11-fold over the past two decades, with the country accounting for almost one-third of the global disease burden, although the actual number of infections is believed to be much higher than official figures.
The newspaper said the approval was based on Takeda’s global clinical development programme, which included 19 Phase I, II and III trials involving more than 28,000 participants in dengue-endemic and non-endemic regions.
The company’s pivotal Phase III TIDES (DEN-301) trial, involving more than 20,000 participants across eight dengue-endemic countries, found the vaccine to be 80.2 percent effective against laboratory-confirmed dengue 12 months after the second dose. It also demonstrated 90.4 percent efficacy against dengue-related hospitalisation after 18 months, according to the report.
Long-term follow-up data showed the vaccine maintained 84.1 percent efficacy against dengue-related hospitalisation after 4.5 years, while seven-year data indicated sustained protection against dengue disease and dengue-related hospitalisation across all four virus serotypes.
The Indian approval was also supported by a Phase III clinical trial involving participants aged four to 60 years, which found the vaccine to be safe, well tolerated and capable of generating a strong immune response in children, adolescents and adults.
The Hindu reported that QDENGA has already been approved in 43 countries across Asia, Latin America and Europe, with more than 32 million doses distributed through public and private immunisation programmes.
The vaccine has received World Health Organization (WHO) prequalification and is recommended by the WHO for use in dengue-endemic settings with high transmission. It has also been incorporated into Brazil’s national immunisation programme and is available through public vaccination programmes in Argentina, Colombia and Indonesia.
Takeda said it would work with Indian regulators, public health authorities and healthcare providers to facilitate the rollout of the vaccine across the country.
