Overview
- Vaccine development starts by assessing unmet medical need, often with limited epidemiological data.
- A Target Product Profile (TPP) defines key vaccine characteristics and guides development as a living document.
- Early decisions must consider feasibility, resources, and high failure risk (~90%).
- Development includes platform selection, antigen definition, CMC development, and animal studies, following GLP/GMP and biosafety standards.
- Manufacturing capacity and large-scale production must be planned early, ideally before Phase 3 trials.
- Clinical development evaluates safety, immunogenicity, efficacy, and rare adverse events.
- Paediatric plans (PIP in the EU, iPSP in the US) are required early to ensure access for children.
- Licensure, post-marketing safety monitoring, and real-world use depend on regulatory approval, NITAG recommendations, reimbursement, and public acceptance.
