India's first dengue vaccine, who can get 'Qdenga' and how it works
New Delhi, July 21
India has approved its first vaccine for the prevention of dengue, a major step in strengthening the country's response to one of its fastest-growing mosquito-borne diseases, an official statement said on Tuesday.
The Central Drugs Standard Control Organisation (CDSCO) -- under the Ministry of Health and Family Welfare -- has granted marketing authorisation for Qdenga, a live, attenuated tetravalent dengue vaccine developed by Takeda GmbH, Germany.
The vaccine will be imported into the country by Takeda Biopharmaceuticals India Pvt. Ltd.
The approval follows a comprehensive scientific evaluation of the vaccine's quality, safety and efficacy under the provisions of the Drugs and Cosmetics Act, 1940, and the Drugs Rules, 1945.
Qdenga is a live, attenuated tetravalent vaccine developed using recombinant DNA technology and it is designed to protect against all four dengue virus serotypes, which are responsible for causing the disease.
The vaccine is supplied as a freeze-dried powder for reconstitution and is administered as a subcutaneous injection.
The vaccine has been approved for people aged 4 to 60 years. The recommended immunisation schedule consists of two doses of 0.5 ml each, administered three months apart.
According to the Health Ministry, the approval is backed by data from an extensive global clinical development programme assessing the vaccine's safety, immunogenicity and efficacy in both dengue-endemic and non-endemic countries.
Clinical studies were conducted in participants across more than eight countries, including Brazil, Thailand and Sri Lanka. The regulatory review also included findings from a pivotal Phase III study conducted in India involving people aged 4 to 60 years.
Qdenga has already received regulatory approval in 42 countries, including the European Union, the United Kingdom, Switzerland, Indonesia, Malaysia and Thailand. It has also received World Health Organization (WHO) prequalification.
More than 24 million doses have been distributed globally.
According to the ministry, post-marketing surveillance has demonstrated a favourable safety profile, with no significant safety concerns reported.
As per officials, the vaccine is expected to complement existing measures such as vector control, disease surveillance, early diagnosis and case management under the National Vector Borne Disease Control Programme.
However, the ministry emphasised that vaccination is intended to strengthen-not replace, ongoing dengue prevention efforts, including eliminating mosquito breeding sites and promoting personal protective measures.
According to the government, the approval reflects its commitment to ensuring timely access to safe, effective and quality-assured vaccines through a robust, science-based regulatory framework.
— IANS
Reader Comments
Finally some good news for public health! As someone who lost a neighbour to dengue hemorrhagic fever last year, I can't stress enough how important this is. But the article mentions it only complements existing measures—please don't throw away your mosquito nets and repellents yet! The real challenge will be distribution in rural areas. Let's see how the rollout goes in states like UP and Bihar where dengue cases spike every year.
Impressive that India is joining 42 other countries in approving this. But I'm curious—why only for ages 4 to 60? My grandmother is 67, and she's had dengue twice already. Also, will this be covered under Ayushman Bharat? The imported vaccine might be expensive for the common man. Hope the government negotiates a good price with Takeda.
I'm cautiously optimistic. The Phase III study in India is reassuring, but I remember the Dengvaxia controversy in the Philippines. Can we be sure Qdenga won't cause similar issues for people who haven't had dengue before? The article says it's tetravalent, but still—transparency about side effects is crucial. Otherwise, rumours will spread faster than the virus itself. 🙏
Great step! But let's not forget that vaccination alone won't solve the problem. Our cities still have open drains and stagnant water everywhere. In Delhi, the MCD does fogging but it's not enough. We need a multi-pronged approach: better urban planning, community awareness, and now this vaccine. Also, 24 million doses globally sounds good, but for India's population, we need much more. Start manufacturing locally soon!
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