India Develops Its First Indigenous Malaria Vaccine "Edfalcyvacs"; Public Rollout May Take Up to 7 Years
New Delhi(The Uttam Hindu): In a significant breakthrough in India's fight against malaria, the Indian Council of Medical Research (ICMR), in collaboration with the Department of Biotechnology (DBT), has successfully developed the country’s first indigenous malaria vaccine named Edfalcyvacs. The government is now inviting private pharmaceutical companies to apply for the production and commercial distribution of the vaccine. However, health experts caution that despite this achievement, the vaccine may take another 6–7 years before it becomes publicly available due to the rigorous regulatory and testing protocols it must undergo.
According to reports, Edfalcyvacs will first need to pass Good Manufacturing Practice (GMP) certifications and toxicology studies, which could take around two years. Following this, it must undergo multiple phases of clinical trials, including regulatory approvals. Phase 1 and 2 trials may take an additional two years, while large-scale Phase 2b and 3 trials could require another 2–3 years. Post-trial evaluations and licensing would further extend the timeline by at least six months.
Edfalcyvacs works by targeting two critical stages in the life cycle of Plasmodium falciparum—the deadliest malaria-causing parasite. Developed using Lactococcus lactis, a safe, food-grade bacterium, the vaccine is classified as chimeric, meaning it incorporates multiple genetic components to trigger a strong immune response. Experts believe this novel approach can offer effective protection against one of the world's most life-threatening diseases.
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