Vaccine Development Cycle
The process of researching, testing, gaining regulatory approval and manufacturing vaccines is costly, complex and lengthy. Unlike traditional pharmaceuticals, vaccines are biological medicines based on living organisms and therefore must meet specific, extensive regulatory requirements throughout their development, production and distribution cycles. As a result, developing a new vaccine takes on average 18.5 years, costs over $500 million and can require testing in tens of thousands of subjects.
Its development cycle is also quite different from that of traditional pharmaceuticals:
- 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.
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