Wednesday, November 11, 2009

Vaccine Essentials

The development cycle of a vaccine is laborious, time-consuming, costly and long. A vaccine is a biologic and is made from living microorganisms. The development cycle is different that a pharmaceutical product, a drug, but does share a similar Clinical Phase Program, Phase 1,2,3 and 4 (post-approval). The Clinical Trial Protocols for each Phase share safety, efficacy and tolerance in a broad sense, but protocol designs are very different in design, objectives and outcomes.

The essentials:
  • Exploratory - in preventing a disease or treating the disease:
  1. to understand the disease
  2. to understand the epidemiological data
  3. to understand the correct antigens to use.
  • Pre-clinical stage:
  1. to assess antigen safety
  2. to select the best candidate vaccine.
  • Clinical Development - all Phases are involved in clinical trials and the 1st lots/batches are produced (clinical batches for trials and industrial batches for compliance):
  1. Phase 1
  2. Phase 2
  3. Phase 3
  • Regulatory Approval - all data from previous stages are complied, summarized, quality-controlled and assured and are submitted to regulatory health agencies for approval.
  • Manufacturing - on an average, it takes just less than 2 years to produce a single batch of vaccine.
  • Quality Control - ~70% of the production time is dedicated to quality control of data, process, procedure, R&D, Industrial Operations and Pharmacovigilance.

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