Home 
FAQs
FAQs
FAQs
- What is a Vaccine Adjuvant?
Adjuvants are substances that, when added to a vaccine, produce a more effective immune response. Adjuvants such as Vaxine's ADVAX(TM) family of adjuvants, increase the effectiveness of vaccines and thereby prolong vaccine protection and reduce the dose of vaccine needed for protection. The ADVAX(TM) family of adjuvants has been proven in the laboratory and in the clinic to enhance the performance of all vaccines in which they have been tested. - What is the process to get a vaccine approved for sale?
In Australia, the approval of the Therapeutic Goods Administration (TGA) is required for vaccines to be supplied for human use. The TGA is the Australian equivalent of the US FDA. The TGA uses internationally agreed guidelines for the approval of all vaccines for human use. These guidelines cover evaluation of the safety and effectiveness of the vaccine being developed. Following proof of vaccine safety and effectiveness in animal models, a series of clinical trials are conducted to demonstrate the safety and effectiveness of the vaccine in the target human population. Typically, in Phase I clinical trials healthy subjects are studied to investigate safety and tolerability (drug distribution and metabolism). In Phase 2 clinical trials, larger numbers of subjects are studied to demonstrated vaccine effectiveness and collect additional safety data. Optimum dose levels may also be investigated at this time. Finally Phase 3 clinical trials are conducted in large numbers of subjects to generate the final data required for regulatory approval so that the vaccine can be placed on the market. A typical duration of Phase I and Phase 2 trials is one year while Phase 3 trials, being much larger, may take 2-3 years to complete. The total time taken for a vaccine to be developed, from the initial discovery and animal testing phase to final regulatory approval is generally around 15-18 years at a cost of around 800 million dollars.