Daijiworld Media Network - New Delhi
New Delhi, Jul 25: India has approved its first dengue vaccine, Qdenga, marking a major milestone in the country's efforts to combat one of its most widespread mosquito-borne diseases.
The Central Drugs Standard Control Organisation (CDSCO) has granted marketing authorisation for Qdenga, a live, attenuated tetravalent dengue vaccine designed to protect against all four dengue virus serotypes—DENV-1, DENV-2, DENV-3 and DENV-4.
The approval comes as dengue continues to pose a major public health challenge in India, particularly during the monsoon and post-monsoon seasons, when thousands of people are hospitalised every year.
Developed using recombinant DNA technology, Qdenga is supplied as a freeze-dried powder that is reconstituted before administration and is given as a subcutaneous injection.
According to the CDSCO approval, the vaccine is indicated for individuals aged between 4 and 60 years. It is administered in two doses of 0.5 ml each, with the second dose given three months after the first.
Medical experts said one of the vaccine's key advantages is that recipients do not require routine testing to determine whether they have previously been infected with dengue before vaccination.
Dr Dinesh Kumar, Director of Internal Medicine at Fortis Greater Noida, described the approval as an important development in dengue prevention. He said the vaccine offers protection against all four dengue virus serotypes and could particularly benefit people living in regions with frequent dengue outbreaks.
However, he noted that vaccination decisions should be made after consultation with a healthcare professional, especially for individuals with underlying medical conditions. As Qdenga is a live-attenuated vaccine, it is generally not recommended for people with severe immune suppression or pregnant women unless future official guidelines advise otherwise.
The vaccine's approval is based on extensive clinical studies evaluating its safety, immune response and effectiveness in both dengue-endemic and non-endemic countries. Trials involved participants from more than eight countries, including Brazil, Thailand and Sri Lanka, while a Phase III study was also conducted in India among people aged 4 to 60 years.
Qdenga has already been approved in 42 countries, including the European Union, the United Kingdom, Switzerland, Indonesia, Malaysia and Thailand. It has also received World Health Organization (WHO) prequalification, enabling procurement by international health agencies. More than 24 million doses have been distributed globally, with post-marketing surveillance indicating a favourable safety profile.
Experts emphasised that while the vaccine significantly reduces the risk of dengue and severe disease, it does not guarantee complete protection against infection.
Dr Vikas Maurya, Senior Director and Head of Respiratory Medicine at Fortis Hospital, Shalimar Bagh, said dengue can range from an asymptomatic infection to life-threatening dengue haemorrhagic fever. He stressed that eliminating mosquito breeding sites remains the most effective preventive measure, while vaccination provides an additional layer of protection.
Public health specialists have also reiterated that vaccination should complement, rather than replace, mosquito control measures. Preventing stagnant water accumulation, using mosquito repellents, installing window screens, wearing full-sleeved clothing, using mosquito nets and supporting local vector-control programmes remain essential in reducing dengue transmission.
Dr Avi Kumar, Senior Consultant in Pulmonology at Fortis Escorts Heart Institute, said the approval of Qdenga represents an important advance in dengue prevention but should form part of a broader strategy that includes mosquito control, environmental sanitation, early diagnosis and timely medical care.
Doctors also advised people to consult qualified healthcare professionals before vaccination to assess their eligibility based on age, medical history, immune status and previous dengue exposure. They stressed that anyone experiencing symptoms such as high fever, severe headache, pain behind the eyes, muscle and joint pain, nausea, vomiting, skin rash or unusual bleeding should seek immediate medical attention.
Health experts said the approval of India's first dengue vaccine marks a significant scientific achievement and provides an important new tool in the country's fight against dengue, while underscoring that vaccination alone cannot eliminate the disease.