Technical transformation of biodefense vaccines
Section snippets
Changes in manufacturing processes
Anthrax bioterrorism attack that ensued in the U.S. shortly after September 11, 2001 was the key turning point in the history of biodefense vaccine development. Suddenly, the need for biodefense vaccines became eminent and moved from the traditional military market (i.e., protecting soldiers from biological weapons) to one incorporating both military and public use. However, many problems associated with the production of early generations of biodefense vaccines were also exposed. Vaccines for
Correlates of immune protection
Traditionally, it has been postulated that vaccines are effective through the induction of protective antibodies in the host. In recent years, with the availability of more sophisticated biomarker assays that were initially developed for routine human vaccines, the roles of T cell immune responses have been better recognized in biodefense vaccine studies.
One surprising finding came from plague vaccine studies. Smiley and colleagues showed that B cell-deficient mice vaccinated with live
Subunit protein or gene-based vaccination approaches
Traditional biodefense vaccines were designed by using either live attenuated or inactivated vaccine approaches. As discussed in the above sections, live attenuated vaccines have the benefit of normally inducing stronger protective immunity than inactivated vaccines but are not ideal candidates when facing the challenges related to manufacturing processes or more critically, to improve the overall safety profile of biodefense vaccines. Furthermore, regulatory authorities expect to see the
Future outlook
Since 2001, biodefense vaccine development has experienced significant progress in the areas of manufacturing, immunological mechanisms and novel vaccination approaches. There are other unique issues not covered in this technology review but they are equally important for biodefense vaccine development. These include 1) “animal rule” which applies to vaccines unable to conduct a late phase large scale efficacy trial in humans due to the rare natural occurrence of such infections; 2)
Acknowledgement
Authors are supported in part by NIH NIAID grant U01AI078073.
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