India's first-ever dengue vaccine DengiAll enters Phase 3 clinical trial

The Indian Council of Medical Research (ICMR) and Panacea Biotec have initiated Phase 3 clinical trial for India's first-ever dengue vaccine. The pathbreaking trial will assess the effectiveness of DengiAll, an indigenous tetravalent dengue vaccine developed by Panacea Biotec. The initial participant was vaccinated on Wednesday at the Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences (PGIMS) in Rohtak.

Union Health & Family Welfare Minister JP Nadda said, "The start of this Phase 3 clinical trial for India’s first homegrown dengue vaccine represents a pivotal moment in our battle against dengue. It demonstrates our dedication to safeguarding our citizens from this widespread disease and highlights India's strengths in vaccine research and development. This collaboration between ICMR and Panacea Biotec not only advances our efforts to ensure public health but also supports our vision of an Atmanirbhar Bharat in healthcare."

Dengue remains a major public health challenge in India, ranking among the top 30 countries for disease incidence. 

The global incidence of dengue has been rising steadily over the past 20 years, with over 129 countries reporting dengue by the end of 2023, according to the World Health Organization (WHO). 

In India, approximately 75-80% of dengue infections are asymptomatic, yet these individuals can still transmit the virus through Aedes mosquito bites. 

Among the 20-25% of symptomatic cases, children are particularly vulnerable to hospitalization and severe outcomes. In adults, dengue can progress to severe conditions such as dengue hemorrhagic fever and dengue shock syndrome. With four distinct serotypes (1-4) and limited cross-protection, repeated infections are possible.

Currently, India lacks an antiviral treatment or licensed vaccine for dengue. Developing an effective vaccine is challenging due to the need to provide robust protection against all four dengue virus serotypes, which circulate or co-circulate in various regions of the country.

The tetravalent dengue vaccine strain (TV003/TV005), initially developed by the National Institutes of Health (NIH) in the USA, has shown promising results in global preclinical and clinical trials.