The third day of the 4th Postgraduate International Vaccinology Course (PGIVAC 2025), hosted by PGIMER Chandigarh, focused on the complex landscape of regulations, ethics, and methodologies across the phases of vaccine development. Dr. Madhu Gupta, Course Director, opened the day with a recap, setting the stage for discussions on regulatory frameworks and ethical concerns in vaccine trials. Dr. Nusrat Shafiq addressed the ethical considerations in conducting trials, followed by a case study exploring real-world dilemmas in vaccine development. Dr. Rubina Bose, Deputy Drugs Controller, CDSCO, provided insights into the role of national regulatory bodies. Statistical methodologies critical to vaccine trials were unpacked by Ms. Maria Abraham from EMMES, emphasizing practical approaches to sample size calculation and data analysis.
A detailed overview of vaccine trial phases was delivered by Dr. Badri Narayan Patnaik of Bharat Biotech. He covered methodologies for Phase I and II trials, followed by group exercises on trial design, recruitment, and result analysis using SARS-CoV-2 as a case study. Post-lunch, Dr. Temsunaro Rongsen Chandola led the session on Phase III trials with a focus on rotavirus vaccines. Another interactive group session guided participants through planning and evaluating Phase III trials. Discussions on Phase IV trials centred on post-licensure surveillance and pharmacovigilance. The concluding sessions highlighted cutting-edge topics: Dr. John Clemens (IVI, South Korea) spoke on assessing herd protection and vaccine effectiveness. Mr. Sourabh Sobti (CEPI) shared insights on platform technologies for pandemic preparedness. Dr. Raju Sunagar discussed codon deoptimization technology. It was discussed that to meet the objective to be prepared for 100 days to deal with the pandemics, newer vaccine technology should be used like AI based vaccine development and codon deoptimization technology. Dr. Nithya Gogtay, Member of NTAGI, examined ethical issues in human challenge trials. The day ended with a wrap-up and participant feedback session led by Dr. Madhu Gupta. PGIVAC 2025 continues to bridge science, policy, and innovation to strengthen India’s vaccine ecosystem. With a mix of theory, real-world case studies, and hands-on exercises, Day 3 provided a comprehensive understanding of the vaccine development lifecycle, preparing participants to tackle the complex challenges of global immunisation.
