Japanese drugmaker Takeda Pharmaceutical’s dengue vaccine QDENGA has been approved by India’s drug regulator, making it the first such vaccine to be cleared in the country, the company’s India unit said on Monday.
Dengue is a mosquito-borne viral disease and one of the fastest-spreading vector-borne illnesses globally. The World Health Organization reported a record 14.4 million cases and 11,201 deaths worldwide in 2024, including 232,425 cases and 233 deaths in India.
Reported dengue cases in India rose 11-fold in the past two decades, according to Takeda Biopharmaceuticals India.
QDENGA, designed to protect against all four dengue virus serotypes, is indicated for the prevention of disease in children and adults aged 4 to 60 years, the company said.
The vaccine, approved in 43 countries so far, showed in a late-stage trial an efficacy of 80.2% against confirmed dengue cases one year after the second dose.
It also showed 90.4% efficacy against dengue-related hospitalizations after 18 months, meeting the secondary end-point of the study, according to the company.
Takeda India had partnered with Indian vaccine maker Biological E in 2024 to expand the drug’s manufacturing.
LENGTHY PROCESS
QDENGA is administered as a two-dose, 0.5 ml injection given three months apart and can be used regardless of prior dengue exposure, eliminating the need for pre-vaccination testing.
This differs from Sanofi’s Dengvaxia, which is not approved in India and is recommended only for people with prior dengue infection due to concerns about an increased risk of severe dengue in some without previous exposure to the virus, said Divya K.S., an infectious diseases specialist at Apollo Hospitals.
Regulators may have required additional post-marketing safety data before granting approval, according to Divya.
“QDENGA can help reduce disease severity and hospitalizations, but it is unlikely to prevent outbreaks as long as the mosquito vector continues to circulate, she said.
Takeda India did not immediately respond to a Reuters request for comment on the efficacy of preventing outbreaks.
The lengthy development process for dengue vaccines remains a challenge for other vaccine makers as well.
Hyderabad-based Indian Immunologicals Ltd (IIL), which is developing a dengue vaccine candidate of its own, is preparing to begin mid-stage clinical trials, Managing Director K. Anand Kumar told Reuters separately.
“Addressing safety concerns arising from earlier dengue vaccines and identifying trial participants who have not previously been infected with dengue or related viruses takes time,” Kumar said.