India approves its first dengue vaccine

• The Central Drugs Standard Control Organisation (CDSCO), under the Ministry of Health and Family Welfare, has granted marketing authorisation for dengue vaccine — Qdenga.

• This is the first dengue vaccine approved in the country for the prevention of dengue disease.

• The vaccine is manufactured by Takeda GmbH, Germany and will be imported by Takeda Biopharmaceuticals India Pvt Ltd. 

• The approval has been granted after a comprehensive scientific evaluation of the vaccine’s quality, safety and efficacy in accordance with the provisions of the Drugs and Cosmetics Act, 1940 and the Drugs Rules, 1945.

• 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 Organisation (WHO) prequalification.

Key features of the vaccine:

• Qdenga is a tetravalent live-attenuated dengue vaccine developed using recombinant DNA technology. 

• The vaccine is produced in Vero cells, with genes encoding serotype-specific surface proteins engineered into a dengue virus type-2 backbone. 

• The product contains genetically modified organisms (GMOs). 

• It is supplied as a freeze-dried powder for reconstitution and is administered as a subcutaneous injection.

• The vaccine is indicated for the prevention of dengue disease in individuals 4 to 60 years of age. 

• The recommended immunisation schedule consists of two doses of 0.5 ml each, administered at an interval of three months (0 and 3 months).

• The approval 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.

• 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.

• The approval of the country’s first dengue vaccine is expected to complement the ongoing vector control, surveillance, early diagnosis and case management measures being implemented under the National Vector Borne Disease Control Programme.

Dengue

• Dengue is a mosquito-borne viral infection, found in tropical and sub-tropical climates worldwide, mostly in urban and semi-urban areas.

• It is estimated that there are over 100-400 million cases of dengue worldwide each year and 3.8 billion people living in dengue endemic countries, most of which are in Asia, Africa, and the Americas. 

• Dengue cases are likely to increase and expand geographically due to climate change and urbanisation.

• The virus responsible for causing dengue, is called dengue virus (DENV). It is a virus of the Flaviviridae family and there are four distinct, but closely related, serotypes of the virus that cause dengue (DENV-1, DENV-2, DENV-3 and DENV-4). 

• Recovery from infection is believed to provide lifelong immunity against that serotype. Subsequent infections (secondary infection) by other serotypes increase the risk of developing severe dengue.

• Dengue virus is transmitted by female mosquitoes mainly of the species Aedes aegypti and, to a lesser extent, Ae. albopictus. These mosquitoes are also vectors of chikungunya, yellow fever and Zika viruses.

• Aedes aegypti mosquito bites during daylight hours.

• While many DENV infections produce only mild illness, DENV can cause an acute flu-like illness. Occasionally this develops into a potentially lethal complication, called severe dengue.

• Severe dengue is a leading cause of serious illness and death in some Asian and Latin American countries.