India has approved its first dengue vaccine for the prevention of the disease in individuals aged between 4 and 60, the Health Ministry announced today.

The Central Drugs Standard Control Organisation (CDSCO), under the Ministry of Health, has granted marketing authorisation for the Dengue Tetravalent Vaccine manufactured by Takeda GmbH, Germany, and to be imported by the Indian unit of Japan’s Takeda Biopharmaceuticals Ltd.

“This is the first dengue vaccine approved in the country for the prevention of dengue,” an official statement said.

The recommended immunisation schedule for the vaccine consists of two doses of 0.5 ml each, administered at an interval of three months, it said.

The statement said the approval of the dengue vaccine is supported by evidence generated through an extensive global clinical development programme evaluating the vaccine’s safety, immunogenicity and efficacy across both dengue-endemic and non-endemic regions.

Clinical studies were conducted in participants from more than eight countries, including Brazil, Thailand and Sri Lanka. The evaluation also included a pivotal Phase III safety and immunogenicity study conducted in the Indian population covering individuals aged 4 to 60 years.

The vaccine has already received regulatory approval in 42 countries, including the European Union, the United Kingdom, Switzerland, Indonesia, Malaysia and Thailand, and has also received World Health Organization (WHO) prequalification. Globally, more than 24 million doses of the vaccine have been distributed.

Post-marketing surveillance data from countries where the vaccine is in use have demonstrated a favourable safety profile, with no significant safety concerns identified.