New Delhi, July 20 (IANS). India has approved its first dengue vaccine. On Monday, the Drug Controller General of India (DCGI) has approved the launch of Takeda Biopharmaceuticals India’s ‘Qudenga’ in the market.
This vaccine is approved for people aged 4 to 60 years and can be administered to anyone, whether or not they have had dengue before. Unlike some older dengue vaccines, ‘Qudenga’ does not require any testing before administering the vaccine. This allows eligible people to get vaccinated without having to find out whether they have had dengue before or not.
Takeda said the approval will strengthen India’s dengue prevention strategy, at a time when the country has one of the highest incidence of dengue in the world and all four serotypes of dengue virus are circulating in many areas.
Mahendra Nayak, Head of Intercontinental Markets at Takeda, said, “Since its launch in 2022, ‘Qudenga’ has been approved in 43 countries and more than 32 million doses have been distributed worldwide. This approval is an important step towards strengthening dengue prevention in India.”
The company said the approval is supported by evidence from its global clinical development program. In this program, 19 phase one, two and three clinical trials were conducted on more than 28,000 people from dengue-affected and non-affected countries.
The Indian regulator also considered data from the phase three DEN-302 clinical trial conducted in India. In this trial, the safety and immune response of the vaccine was evaluated in people aged 4 to 60 years.
According to Takeda, long-term follow-up data collected for seven years showed that ‘Qudenga’ protects against dengue infection and hospitalization due to dengue caused by all four serotypes of the virus. This vaccine is given as two subcutaneous injections of 0.5 ml, with a gap of three months between them.
Go Chu Beng, head of medical affairs for Takeda’s South-East Asia and India cluster, said the vaccine is designed to provide protection against all four serotypes of dengue virus, regardless of whether or not there has been prior exposure to the virus. “Its approval is an important step towards strengthening India’s comprehensive approach to dengue prevention along with vector control, surveillance, community awareness and other public health measures,” he said.
–IANS
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