Chapter 4 The Vaccine Industry Flashcards
What are the six (6) main activities of the vaccine industry?
- Research
- Development
- Manufacturing
- Sales
- Marketing
- Distribution
What is the main risk to public health linked to the structure of the vaccine industry?
Vaccine shortages in the event of prolonged supply interruption.
What are the four (4) main reasons for failure of vaccine development?
- Poor understanding of the biology of protection.
- Lack of good animal models to predict vaccine behavior in humans.
- Unpredictability of human immune system reactions to antigens.
- Unpredictability of the impact of combining multiple components in a single vaccine.
What are the four (4) main companies involved in vaccine production and development?
- GlaxoSmithKline
- Pfizer
- Merck
- Sanofi
What are the four (4) types of studies required for vaccine development?
- Phase I study : safety and immunogenicity in small numbers.
- Phase II study : safety, dose ranging and immunogenicity in 200 to 400 individuals.
- Phase III study : safety and efficacy trials in thousands of subjects to permit licensure.
- Phase IV study : post-licensure study for safety and efficacy
What are the eight (8) main processes of vaccine production?
- Cell culture
- Fermentation-based manufacturing
- Separation and purification processes
- Formulation of adjuvant and stabilizer
- Vial and/or syringe filling
- Labeling
- Packaging
- Controlled storage
What are the four (4) keys to a successful phase III trial?
- Accurate estimates of sample size based on disease incidence
- Low dropout rates
- Precise clinical endpoint definitions
- Highest standard of data management
What are the four (4) key elements that support labeled vaccine shelf claims?
- Scale-up and manufacture of consistency lots
- Validation of manufacturing facility
- Demonstration of consistency of the manufacturing process
- Real-time stability analysis
What is the typical elapsed time from vaccine development to population-level distribution?
Between 10 to 15 years, but can be up to 30 years.
Name five (5) types of organizations that can be involved in vaccine development.
- Federal governments
- Public health agencies
- Academic research institutions
- Private companies
- Non-profit and/or non-governmental organizations
What company is the largest vaccine producer by number of doses per year?
Serum Institute of India.
Name four (4) factors that contribute to the vigor of large-companies vaccine industry.
- Active, well-funded research environment
- Patent laws and protection of intellectual property
- Freedom to price products based on value to society
- Well-implemented immunization practices
