Indigenous Vaccine Development Responding to State Needs
The vaccine development programme was initiated by ICMR under the Department of Health Research, Ministry of Health and Family Welfare, following a request from the Government of Karnataka. Recognising the need for a safer and more effective solution, ICMR partnered with Indian Immunologicals Limited (IIL) and the ICMR–National Institute of Virology (NIV) to develop a fully indigenous formulation.
The candidate vaccine is a two-dose, adjuvanted, inactivated vaccine designed to be administered 28 days apart. Officials involved in the programme have emphasised that the formulation aims to improve immunogenicity while maintaining a strong safety profile suitable for large-scale public health use.
Successful Preclinical Studies Completed
According to information released by ICMR, the vaccine has successfully cleared critical preclinical milestones. Animal challenge studies and toxicity evaluations have been completed, demonstrating promising safety and immune response outcomes.
Following these results, Good Laboratory Practice (GLP)-grade vaccine material was manufactured to meet regulatory standards required for human testing. These developments marked an important transition from laboratory research to clinical evaluation.
Phase I Human Trials Begin with CDSCO Approval
With regulatory clearance from the Central Drugs Standard Control Organization (CDSCO), Phase I human clinical trials of the KFD vaccine have now commenced. These trials will primarily assess the vaccine’s safety profile and its ability to trigger an immune response in healthy volunteers.
Health officials noted that the initiation of human trials represents a crucial milestone, bringing the vaccine closer to potential deployment in endemic regions. If Phase I outcomes are favourable, the vaccine will progress to subsequent trial phases to further evaluate safety and immunogenicity.
Roadmap Toward Regulatory Approval
ICMR has stated that, subject to successful completion of clinical trials, approval will be sought from CDSCO for wider use of the vaccine. Each phase of development will be conducted in accordance with established ethical and scientific protocols to ensure public safety.
Experts believe that an improved KFD vaccine could significantly strengthen disease control strategies in forested districts, where early vaccination is critical to preventing outbreaks during peak transmission seasons.
Strengthening India’s Regional Disease Preparedness
Kyasanur Forest Disease remains a region-specific but serious public health concern, particularly among vulnerable rural and tribal populations. The Government of India has reiterated its commitment to supporting state governments in addressing complex health challenges through scientific innovation and indigenous solutions.
The advancement of the KFD vaccine reflects a broader national strategy to enhance self-reliance in vaccine development and strengthen India’s response to emerging and re-emerging infectious diseases.
As clinical trials progress, public health authorities remain cautiously optimistic that the new vaccine will provide improved protection and contribute to long-term disease control efforts in the Western Ghats.
