Takeda said India’s Drug Controller General of India has granted marketing authorization for Qdenga (TAK-003; dengue tetravalent vaccine, live, attenuated), making TAK-003 the country’s first authorized dengue vaccine.
The clearance covers individuals aged 4 to 60 regardless of prior dengue exposure, without requiring pre-vaccination testing.
The India approval draws on DEN-302, a local Phase III study, alongside the global pivotal Phase III Tetravalent Immunization against Dengue Efficacy Study (TIDES), described by Takeda as the largest and longest efficacy trial conducted for a dengue vaccine.
Seven-year follow-up from TIDES showed sustained protection against virologically confirmed dengue and dengue-related hospitalization, although efficacy varied by serotype and participants’ baseline serostatus.
In terms of the dengue space, Sanofi’s Dengvaxia, a chimeric yellow fever-backbone tetravalent vaccine, remains regulatorily approved in the US and EU for people with confirmed previous dengue infection, although Sanofi is discontinuing global distribution because of low demand.
Takeda said India’s Drug Controller General of India has granted marketing authorization for Qdenga (TAK-003; dengue tetravalent vaccine, live, attenuated), making TAK-003 the country’s first authorized dengue vaccine. The clearance covers individuals aged 4 to 60 regardless of prior dengue exposure, without requiring pre-vaccination testing. The approval comes as India’s reported annual dengue case count has increased more than elevenfold over the past two decades, reaching more than 233,000 cases in 2024, although modeling indicates that the true disease burden is substantially higher.
Qdenga is a live-attenuated tetravalent vaccine built on a dengue serotype 2 genetic backbone, into which envelope and pre-membrane genes from the other three serotypes have been substituted, generating four chimeric viruses intended to elicit immunity against all four circulating strains. Unlike Dengvaxia, Qdenga is authorized without requiring confirmation of previous dengue infection.
The India approval draws on DEN-302, a local Phase III study, alongside the global pivotal Phase III Tetravalent Immunization against Dengue Efficacy Study (TIDES), described by Takeda as the largest and longest efficacy trial conducted for a dengue vaccine. Seven-year follow-up from TIDES showed sustained protection against virologically confirmed dengue and dengue-related hospitalization, although efficacy varied by serotype and participants’ baseline serostatus.
In terms of the dengue space, Sanofi’s Dengvaxia, a chimeric yellow fever-backbone tetravalent vaccine, remains regulatorily approved in the US and EU for people with confirmed previous dengue infection, although Sanofi is discontinuing global distribution because of low demand. Brazil’s Instituto Butantan has also advanced a live-attenuated tetravalent candidate approved domestically for a similar serostatus-agnostic population. TAK-003’s broader label — usable without pre-vaccination screening — is the principal point of differentiation in this landscape, simplifying deployment logistics in high-transmission settings where serological testing is impractical at scale.
Since its 2022 launch, TAK-003 has been authorized in 43 countries, including Indonesia, Thailand, Malaysia and Vietnam, with more than 32 million doses distributed through public and private programs in Asia, Latin America and Europe. The World Health Organization’s Strategic Advisory Group of Experts on Immunization has recommended the vaccine without pre-vaccination screening since 2023, and it holds WHO prequalification, enabling procurement through UNICEF and PAHO. Takeda said it will now work with Indian regulators and health authorities on rollout planning, though the company has not disclosed pricing, launch timing, or whether the vaccine will enter India’s public immunization program rather than remaining limited to private-market distribution.
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