Vaccine Approval Cycle - Hard Facts to Consider

The Center for Biologics Evaluation and Research (CBER) is the division at FDA that receives and reviews vaccine applications in the US. The regulation for vaccine products in the US can be found in Section 351 of the Public Health Service Act and specific sections of the Federal Food, Drug and Cosmetic Act.

• The development of a vaccine follows the same general pathway as for drugs and biologics.
• Pharma sponsor must submit an IND - Investigational New Drug application to FDA.

The IND describes:

• the vaccine
• method of manufacture
• quality control tests (70% of a vaccine's production time is dedicated to quality control)
• safety
  
• immunogenicity of the vaccine in animal testing
  
• proposed clinical protocol(s) for human clinical trials.

Clinical Development Phases: (6 - 8 years in humans)

• Phase 1 Clinical Trials - safety and immunogenicity, 10 - 100 subjects
  
• Phase 2 Clinical Trials - dose-ranging, immune response - 100 - 3000 subjects
  
• Phase 3 Clinical Trials - effectiveness, tolerance and safety - 3000 - 40000 subjects.
  

At the end of a successful Clinical Phase 3 development program and if there are no safety concerns or otherwise by FDA, the pharma sponsor files a Biologics License Application (BLA).

The BLA:

• must provide FDA efficacy and safety information
• risk/benefit statements and assessments
• proposed manufacturing facility "actively" in production of the said vaccine when the inspection takes place.

Vaccine Development Cycle:

• Research & Development - 9 - 14 years

1. Exploratory - 2 - 4 years
   
2. Pre-clinical - 1 - 2 years
   
3. Phase 1
4. Phase 2
5. Phase 3

• Registration - 12 - 18 months
  
• Product Launch
• Industrial Operations
  

1. Bulk Production - 1.5 - 2 years
   

Following FDA's review of a BLA for a new indication, the pharma sponsor and the FDA present their findings to FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC). This non-FDA committee provides FDA with advice pertaining to the safety and efficacy of the vaccine for the proposed indication.