The decision to develop a vaccine is based on analysis of need and, in most cases, potential returns on the significant investment of time and resources required to move a candidate product from initial development through to licensure. The vaccine development pathway encompasses a series of highly regulated milestones designed to assess the safety and efficacy of a candidate vaccine via nonclinical testing, using animal models and in vitro assays, and in phased clinical trials in humans. Regulatory oversight also aims to ensure the consistency of its manufacture during the investigational phases and following its approval and licensure.
- Biologics license application
- Clinical trials
- Investigational new drug
- National regulatory authority
- Nonclinical testing
ASJC Scopus subject areas