Abstract:
:At the present time it is estimated that the process of development of a vaccine from discovery to licensure takes approximately 18-20 years and costs in excess of US$500 million. For "routine" vaccines, the case for developing a vaccine is straightforward in terms of economics and large scale public health utilization each year. For vaccines used for biodefense and emerging diseases, the considerations are somewhat different as the vaccine may not be needed every year to control outbreaks and may be stockpiled only as a countermeasure that hopefully may never be needed. Furthermore, efficacy trials are often difficult as the natural disease may be rare or not present. Consequently, animal models will play a critical role in demonstrating efficacy. Nonetheless, the vaccine pathway still requires the same fundamental components of basic science/discovery, preclinical development, clinical trials, registration/licensure, and a plan for implementation.
journal_name
Vaccinejournal_title
Vaccineauthors
Barrett AD,Beasley DWdoi
10.1016/j.vaccine.2009.07.094subject
Has Abstractpub_date
2009-11-05 00:00:00pages
D2-7eissn
0264-410Xissn
1873-2518pii
S0264-410X(09)01136-0journal_volume
27 Suppl 4pub_type
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