Development of Vaccines

Process

Vaccine research is long, complex and costly. Because a vaccine is a biological product made from living microorganisms, its development cycle is quite different from that of a pharmaceutical product:

• Exploratory stage: to understand the disease, its epidemiological data and the right proteins (antigens) to use in preventing or treating the disease
• Pre-clinical stage: to assess antigen safety and select the best candidate vaccine
• Clinical development: from 10 (Phase I) to 1,000 people (Phase III) are involved in clinical trials and the first batches are produced (clinical batches and industrial batches for compliance)
• Regulatory approval: all the data collected through the preceding stages are submitted to the relevant health authorities for approval
• Manufacturing process: takes up to 22 months to produce a single batch of vaccine
• Quality control: approximately 70% of production time is dedicated to quality control