India Getting Its First Indigenous Vaccine Against Dengue
Serum Institute of India and Panacea Biotec have responded to the Indian Council of Medical Research’s (ICMR) request for an Expression of Interest for cooperative Phase 3 clinical trials for indigenous manufacturers, bringing the development of India’s first dengue vaccine one step closer.
Points to Ponder:
- The first dengue vaccine to be produced in India is being developed by Panacea Biotec and the Serum Institute of India.
- Phase 3 Clinical Trials: In response to an Expression of Interest for joint Phase 3 clinical trials, the firms have provided their submissions to the Indian Council of Medical Research (ICMR). These tests are intended to assess the tetravalent dengue vaccine candidate produced by Indian manufacturers’ efficacy, safety, and immunogenicity.
- The prevalence of the dengue virus is a serious global source of sickness and mortality. Every year, India reports between 2 and 2.5 lakh instances.
- Impact on the World: The incidence of dengue has rapidly increased, putting almost half of the world’s population at risk. One of the top 10 worldwide health hazards, according to the World Health Organisation (WHO), is dengue.
- Lack of Specific Treatment: Dengue or severe dengue does not currently have a specific treatment. It is deemed critical that viable dengue vaccinations be developed.
- The ICMR has listed the qualities that make a good dengue vaccine, including:
- good long-term and short-term safety profile without antibody-dependent improvement.
- generating defence against all four dengue serotypes.
- lowering the danger of deadly diseases.
- triggering an ongoing immunological response.
- being efficient regardless of the person’s age or past serostatus.
- The dengue vaccine developed by the Serum Institute of India is currently the subject of one or two investigations in children.
- Panacea Biotec’s Vaccine: For their dengue vaccine, Panacea Biotec intends to carry out a Phase 3 randomised, double-blind, placebo-controlled experiment. The ICMR-funded experiment will include 10,335 healthy participants between the ages of 18 and 80 at 20 sites.
- Regulatory Approval: In January 2023, India’s Drugs Controller General authorised the Phase 3 protocol for Panacea Biotec’s vaccine.
- Trial Timeline: Around August or September, the companies want to begin Phase 3 studies.
- Scaling Up Vaccine Production: Panacea Biotec is attempting to increase vaccine production to fulfil the needs of the Phase 3 studies.