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.