On July 21st 2026, Takeda announced that India’s Drug Controller General granted marketing authorization of Qdenga. With this announcement, Qdenga became the country’s first authorized dengue vaccine. The approval follows more than an elevenfold increase in the number of dengue cases recorded annually in India over the last 20 years, with the country logging more than 233,000 cases so far this year, although estimates suggest the true burden is much higher.
Qdenga, a live-attenuated tetravalent vaccine using a dengue serotype 2 genetic background into which envelope and pre-membrane genes from the other three serotypes have been introduced to create four chimeric viruses targeting all four circulating strains, was previously authorized in the European Union without requiring prior dengue infection.
India’s approval of Qdenga leverages the DEN-302 local Phase III study and the global pivotal Phase III Tetravalent Immunization against Dengue Efficacy Study (TIDES), touted by Takeda as the largest and most comprehensive dengue vaccine efficacy trial conducted to date; which recorded more than seven years of protection against virologically confirmed dengue and hospitalization for the disease, although protection varied between serotypes and against baseline infection status.
There is currently only one dengue vaccine approved for use in the U.S. and EU, Sanofi’s chimeric, yellow fever-backbone, tetravalent Dengvaxia vaccine; but this has been largely restricted for use in individuals who have had dengue infection previously, as confirmed by laboratory tests.
Sanofi announced that it was discontinuing its global distribution due to low demand and the difficulties associated with its narrow indication. As Dengvaxia requires laboratory screening to identify patients who have had dengue prior to vaccination, deployment of the vaccine has been limited.
However, a major advance has been seen in Brazil from Instituto Butantan’s tetravalent, live-attenuated dengue vaccine, which has been approved domestically for use across all serostatus groups. This move demonstrates increased efforts in endemic countries to achieve vaccine accessibility through an easier-to-deploy dengue vaccine, regardless of past dengue infection.
This brings Takeda’sTAK-003 (QDENGA), which received approvals without the need for a pre-vaccination serological screen in December 2022, into sharper focus. In countries where laboratory diagnostic infrastructure and affordability at a population scale are limitations, a vaccine like TAK-003 that can be rolled out to all recipients without prior screening offers a much easier vaccination strategy for disease control programmes aiming to lower dengue hospitalizations and transmissions.
TAK-003 was launched in Indonesia, Thailand, Malaysia, Vietnam, Brazil, Argentina, and various European markets in 2022, and has since been approved in 43 countries in total. Over 32 million doses of the vaccine have been supplied and administered via public and private immunization campaigns throughout Asia, Latin America, and Europe. The World Health Organization’s Strategic Advisory Group of Experts on Immunization (SAGE) recommended the vaccine for use in all age groups, without the need for pre-vaccination testing, in 2023.
Following its recent approval in India, Takeda is expected to collaborate with Indian authorities to implement and commercialize the vaccine but has not disclosed the price or timing of the launch, or whether it will be added to the Indian universal immunization program or will be available through private sector routes.
Reference: https://allsci.com/news/approvals/india-approves-takedas-qdenga-as-first-dengue-vaccine/
