India this week authorized its first vaccine in opposition to dengue, a milestone within the nation’s decades-long wrestle with a mosquito-borne illness that infects hundreds and kills a whole bunch yearly.
The Medicine Controller Common of India (DCGI) has granted market authorisation to Qdenga, the tetravalent dengue vaccine developed by Japanese pharmaceutical firm Takeda, its Indian arm introduced on Monday.
The clearance permits the vaccine for use to stop dengue in people aged 4 to 60, no matter whether or not they have been beforehand uncovered to the virus.
Takeda Biopharmaceuticals India mentioned it expects Qdenga to change into obtainable within the nation within the first half of 2027, initially by personal healthcare services. The corporate has partnered with Hyderabad-based vaccine maker Organic E since 2024 to develop manufacturing.
The approval lands forward of the monsoon-linked surge in instances that India — and far of South and Southeast Asia — braces for yearly. In keeping with India’s Nationwide Centre for Vector Borne Ailments Management (NCVBDC), India had reported 6,927 dengue instances and 10 deaths until February this 12 months.
The World Well being Group (WHO) recorded 232,425 instances and 233 deaths in India in 2024, a part of a report world tally of 14.4 million instances and 11,201 deaths that 12 months.
India accounts for practically one-third of the worldwide dengue burden, and reported instances within the nation have risen 11-fold up to now 20 years, in accordance with Takeda Biopharmaceuticals India.
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What’s Qdenga and the way does it work?
Qdenga, also called TAK-003, is a live-attenuated tetravalent vaccine — which means it comprises weakened however dwell variations of the dengue virus. “Reside-attenuated” means the virus is undamaged, however has been attenuated to be too weak to trigger the illness. Generally recognized vaccines primarily based on live-attenuated viruses embody these for measles, mumps, rubella (MMR), yellow fever and the oral polio vaccine (OPV).
Qdenga is designed to guard in opposition to all 4 dengue virus serotypes (DENV-1, DENV-2, DENV-3 and DENV-4) — every of which might independently trigger dengue in people.
In keeping with the European Medicines Company (EMA), which cleared the vaccine to be used within the European Union in December 2022, Qdenga makes use of the DENV-2 serotype as its genetic spine.
Different parts are “chimeric” or recombinant viruses — created by taking the DENV-2 spine and swapping within the pre-membrane and envelope genes from DENV-1, DENV-3 and DENV-4, in accordance with a 2025 evaluation within the journal Vaccines (MDPI) [https://www.mdpi.com/2076-393X/13/5/532]. The envelope proteins are what the immune system additionally recognises and responds to, so this design successfully presents the physique with signatures of all 4 serotypes.
When the vaccine is run, the physique’s immune system identifies the weakened viruses as international and produces antibodies in opposition to them, which might then neutralise the precise virus if there’s publicity to the dengue-causing virus in a while.
This design issues as a result of dengue is uniquely troublesome to vaccinate in opposition to. An individual contaminated with one serotype develops lifelong immunity to that particular sort however solely short-lived cross-protection in opposition to the opposite three. A second an infection with a distinct serotype can set off a phenomenon known as antibody-dependent enhancement, through which pre-existing antibodies paradoxically worsen the sickness — a danger that has formed the complete area of dengue vaccine growth.
Qdenga makes an attempt to handle this problem by inducing what researchers name “balanced” immunity to all 4 serotypes concurrently in a single course, extra carefully mimicking the immune profile of somebody who has recovered from pure an infection.
However it isn’t an absolute repair. Within the section 3 trial, efficacy different by serotype. TAK-003 demonstrated sustained efficacy in opposition to all 4 serotypes in folks already uncovered to dengue earlier than vaccination, however in dengue-naïve (seronegative) recipients, clear efficacy was proven primarily in opposition to DENV-1 and DENV-2, with much less certainty round DENV-3 and DENV-4, in accordance with a 2025 evaluation in Professional Overview of Vaccines.
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Eligibility, dosing and efficacy
Qdenga is run subcutaneously as a 0.5-millilitre injection, given as two doses three months aside. The WHO advises in opposition to shortening this interval. If the second dose is delayed, the schedule needn’t be restarted.
The Indian approval rests on knowledge from Takeda’s world growth programme that concerned medical trials throughout dengue-endemic and non-endemic areas. This included the Section 3 TIDES trial (DEN-301), through which greater than 20,000 contributors throughout eight international locations have been enrolled — 5 in Latin America (Brazil, Colombia, Panama, the Dominican Republic and Nicaragua) and three in Asia (the Philippines, Thailand and Sri Lanka).
India was not among the many trial websites, however they included Asian international locations with dengue epidemiology broadly corresponding to components of India.
In keeping with the trial knowledge cited by Takeda, at 12 months after the second dose, the vaccine confirmed an general efficacy of 80.2% in opposition to virologically confirmed dengue. At 18 months, it demonstrated 90.4% efficacy in opposition to dengue-related hospitalisation. After 4.5 years, two doses continued to supply 84.1% efficacy in opposition to hospitalisation, with sustained security and efficacy documented for as much as seven years in opposition to all 4 serotypes.
The outcomes have been revealed in levels in The Lancet (2020) and The Lancet International Well being (2024), amongst different journals.
New Delhi’s clearance can be supported by a separate section 3 trial (DEN-302) performed amongst Indian contributors. The trial, in accordance with the corporate, concluded that the vaccine was “tolerated, protected and immunogenic” in adults, adolescents and kids aged 4 to 60.
“The newest seven-year knowledge for QDENGA present continued safety in opposition to dengue an infection and hospitalisation throughout all 4 serotypes; an necessary milestone for communities and well being techniques,” mentioned Mahender Nayak, head of intercontinental markets at Takeda, in a press release.
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Frequent unwanted side effects
In keeping with EMA, the commonest unwanted side effects — affecting multiple in 5 folks — are ache and redness on the injection web site, headache, muscle ache, normal malaise and weak point. As much as one in 10 recipients could expertise fever. These results are normally gentle to reasonable, resolve inside a number of days and are much less frequent after the second dose than the primary.
Put up-market surveillance has thrown up some rarer alerts. The WHO place paper on dengue vaccines, up to date in Might 2024, famous that though no instances of anaphylaxis have been noticed within the pivotal medical trial of greater than 20,000 contributors, 16 instances have been reported within the month after the vaccine’s roll-out in Brazil in 2023 — a charge of 4.4 per 100,000 doses. The paper flagged this and famous that the product insert now consists of precautionary measures in opposition to anaphylaxis.
Who ought to — and should not — take it
The WHO recommends Qdenga to be used in youngsters aged six to 16 in areas with high-intensity dengue transmission. The Indian approval spans a wider age band of 4 to 60, monitoring the EMA’s authorisation from age 4 upwards.
WHO doesn’t suggest routine programmatic use in youngsters beneath six as a result of efficacy is decrease in that age group, and seropositivity — the share of individuals exhibiting proof of previous an infection — is usually low even in high-transmission settings.
The vaccine shouldn’t be given to:
- People who find themselves pregnant, planning being pregnant inside a month of vaccination, or breastfeeding
- Folks with congenital or acquired immune deficiencies, together with these on immunosuppressive remedy resembling chemotherapy or high-dose systemic corticosteroids
- Folks with symptomatic HIV an infection, or asymptomatic HIV with proof of impaired immune operate
- Anybody with a historical past of hypersensitivity to a earlier dose of the vaccine
The EMA additionally lists co-administration knowledge supporting using Qdenga alongside yellow fever and hepatitis A vaccines; research on co-administration with HPV vaccines are ongoing.
The place else is it authorized?
In keeping with Takeda, Qdenga has been authorized in 43 international locations since its 2022 launch, with greater than 32 million doses distributed globally.
It acquired EU advertising and marketing authorisation on December 5, 2022, and WHO prequalification on Might 10, 2024 — a designation that meets world high quality, security and efficacy requirements and allows procurement by worldwide companies resembling UNICEF and PAHO.
Takeda has mentioned it’s on monitor to succeed in a world manufacturing capability of 100 million doses a 12 months by 2030.
The opposite dengue vaccines
Qdenga is one among solely a handful of dengue vaccines to have reached the market.
Dengvaxia (CYD-TDV): Developed by Sanofi Pasteur, Dengvaxia was the primary dengue vaccine to obtain advertising and marketing authorisation, in 2015.
In keeping with the WHO’s International Advisory Committee on Vaccine Security, it makes use of a yellow fever virus spine that expresses envelope proteins of the 4 dengue serotypes. However subsequent evaluation, as documented by the WHO in its 2017 security replace, confirmed that amongst individuals who had by no means beforehand been contaminated with dengue, the vaccine may improve the chance of extreme illness on later an infection — the antibody-dependent enhancement downside.
WHO now recommends Dengvaxia just for folks with confirmed prior dengue an infection. It isn’t authorized in India.
Divya KS, an infectious ailments specialist at Apollo Hospitals, instructed Reuters that regulators could have required extra post-marketing security knowledge earlier than approving it.
Butantan-DV, the single-dose vaccine: Developed in Brazil, it is a single-dose vaccine that Brazilian well being authorities authorized in November 2025, however which the nation quickly suspended after two deaths in June this 12 months.
Of 501,044 folks vaccinated between January and Might, 3,703 — 0.7% — confirmed signs much like dengue, and 42 had extra extreme reactions.
Three extreme instances have been recorded, together with the deaths of a 58-year-old man and a 48-year-old girl. A 38-year-old girl was hospitalised in intensive care and later discharged.
“There’s not sufficient knowledge to determine a cause-and-effect hyperlink between the vaccine and these three critical instances, however it’s a warning sign,” Brazil’s well being minister Alexandre Padilha had mentioned at a press convention.
Padilha described the occasions as “completely surprising” given trial knowledge confirmed 91.6% efficacy in opposition to extreme dengue amongst 16,000 volunteers throughout 14 Brazilian states.
This vaccine has not been authorized in India, and its regulatory standing elsewhere is separate from Qdenga’s. A single-dose routine, if confirmed protected, may considerably simplify mass vaccination — a focal point for public well being techniques, however not but demonstrated at scale.
An indigenous vaccine and different candidates
A number of dengue vaccine candidates stay in growth. In India, the Indian Council of Medical Analysis (ICMR) is working section 3 trials of an indigenous tetravalent dengue vaccine — known as DengiAll and developed in collaboration with New Delhi-based Panacea Biotec — with over 10,000 contributors throughout India.
DengiAll is derived from the identical tetravalent dengue vaccine platform (TV003/TV005) developed by the US Nationwide Institutes of Well being (NIH) that additionally underpins Brazil’s Butantan-DV.
Individually, Hyderabad-based Indian Immunologicals Ltd is getting ready to start mid-stage medical trials of its personal dengue vaccine candidate, managing director Ok. Anand Kumar instructed Reuters.
Dengue’s dangers & burden
Dengue is current in over 125 international locations and is likely one of the fastest-spreading vector-borne sicknesses globally. India reported over 289,000 instances in 2023, although consultants consider the precise burden was doubtless larger due to underreporting and surveillance gaps.
Specialists have persistently cautioned that vaccines alone is not going to remedy the issue. “Qdenga may also help cut back illness severity and hospitalisations, however it’s unlikely to stop outbreaks so long as the mosquito vector continues to flow into,” Divya KS of Apollo Hospitals instructed Reuters.
The WHO makes the identical level, saying that vaccination in opposition to dengue must be seen as a part of an built-in technique, which must contain group consciousness and engagement to cease the illness from spreading.
