India approves first dengue vaccine QDENGA for people aged 4-60 years
New Delhi, July 20
India has approved its first dengue vaccine, with the Drug Controller General of India granting market authorisation to Takeda Biopharmaceuticals India's QDENGA, marking a significant milestone in the country's efforts to combat one of its most widespread mosquito-borne diseases, it was announced on Monday.
The vaccine has been approved for individuals aged between 4 and 60 years and can be administered irrespective of whether a person has previously been infected with dengue.
Unlike some earlier dengue vaccines, QDENGA does not require pre-vaccination screening, allowing eligible individuals to receive the vaccine without undergoing tests to determine prior dengue infection.
Takeda said the approval strengthens India's dengue prevention strategy at a time when the country continues to bear one of the world's highest disease burdens, with all four dengue virus serotypes circulating in several regions.
"Since its launch in 2022, QDENGA has been approved in 43 countries, with more than 32 million doses distributed globally. This approval marks an important step forward in strengthening dengue prevention in India," said Mahender Nayak, Head of Intercontinental Markets at Takeda.
The company said the approval was supported by evidence from its global clinical development programme, comprising 19 Phase I, II and III clinical trials involving more than 28,000 participants across dengue-endemic and non-endemic countries.
The Indian regulator also considered data from the Phase III DEN-302 clinical trial conducted in India, which evaluated the vaccine's safety and immune response among individuals aged 4 to 60 years.
According to Takeda, long-term follow-up data collected over seven years demonstrated that QDENGA continues to provide protection against dengue infection and dengue-related hospitalisation caused by all four virus serotypes.
The vaccine is administered as two subcutaneous injections of 0.5 ml each, given three months apart.
Goh Choo Beng, Medical Affairs Head for Takeda's Southeast Asia and India Cluster, said the vaccine is designed to protect against all four dengue virus serotypes regardless of previous exposure.
"Its approval represents an important step in strengthening India's comprehensive approach to dengue prevention, alongside vector control, surveillance, community awareness and other public health measures," he said.
— IANS
Reader Comments
As someone who works in public health, this is a massive step forward. The fact that it covers all four serotypes and has 7-year follow-up data is impressive. But I'm curious about the pricing structure. In many countries QDENGA is quite expensive. Will it be accessible to rural communities where dengue is most rampant? 🏥
My mother is 58 and has been terrified of dengue every season. This is such a relief! But I hope the DCGI has thoroughly checked all the side effects. Remember the controversy with the earlier dengue vaccine? We need transparency about adverse events before mass rollout. 😊 Still, it's a proud moment for Indian healthcare!
This is great but vector control should still be the priority. No vaccine can replace cleaning our surroundings and preventing mosquito breeding spots. Also, two doses with three months gap means compliance might be an issue in our country. Let's hope the government has a proper distribution plan.
बहुत अच्छा कदम है! 🇮🇳 मेरे घर के आसपास हर साल डेंगू के मामले आते हैं। लेकिन क्या इसकी कीमत आम आदमी के लिए वहनीय होगी? सरकार को इसे निःशुल्क उपलब्ध कराना चाहिए। 32 मिलियन डोज़ दुनिया भर में - ये आंकड़ा भरोसेमंद लगता है।
I'm cautiously optimistic. The
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