India advances dengue vaccine as Phase III trials proceed

Panacea Biotec has begun Phase III testing of its dengue vaccine candidate DengiAll in India with more than 10,000 volunteers, and results are expected later this year.

Panacea Biotec has moved its dengue vaccine candidate, DengiAll, into final Phase III trials in India. The study enrolled more than 10,000 volunteers and began in 2024. Dengue risk has risen globally and all four virus serotypes circulate in India. The trial results are expected later this year and would be followed by regulatory review. Key details: - DengiAll is in Phase III testing overseen by the Indian Council of Medical Research. - More than 10,000 participants were randomly assigned to receive the vaccine or a placebo. - The candidate is described as a single-dose, tetravalent vaccine based on a strain developed by the US National Institutes of Health. - Panacea Biotec is one of three Indian firms licensed to use the strain and holds a process patent for its formulation. - If trials are favourable, final approval in India would come from the Drug Controller General of India and WHO prequalification would be needed for wider international use. Summary: Officials report that Phase III testing of DengiAll is under way with national oversight and large-scale enrolment. The current status is active trials with results due later this year. The next procedural steps, if results are favourable, are regulatory review by the Drug Controller General of India and possible WHO prequalification for broader use.