Vaccine 27 (2009) D1
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Editorial
Introduction to this supplement
Biodefense has traditionally been associated with defense against biological warfare agents with an emphasis on military applications. However, the events of October 2001 involving envelopes containing anthrax spores sent through the US Postal Service radically changed our thinking about biodefense. Now the need for biodefense to protect both civilian and military populations is evident. It also became apparent that many highly pathogenic microorganisms could be considered as either agents of biological warfare or naturally occurring emerging disease threats. The situation becomes more complicated as we consider bioterrorism from the point of view of public health threats, veterinary threats and agricultural threats. Taken together they can be considered to be “biothreats”. The realization that many of our public health threats are also veterinary threats, has resulted in the “One Health” initiative (http://www.onehealthinitiative.com/). In part this recognizes that 70% of emerging infectious diseases are vectorborne or zoonotic, and in part the realization that human and animal health are intimately linked. Fortunately, there have been no biological attacks since 2001 but other emerging diseases have continued to be a problem, including Ebola, SARS, blue tongue, and most recently pandemic influenza. As research continues to develop biodefense countermeasures, it is clear that vaccines are a critical component of the portfolio to control biothreats. This supplement provides reviews on a number of the major currently recognized biothreats. Developing a vaccine is a complicated and long term process, which currently takes years and costs approximately US$ 500 million. The first section of this supplement discusses the vaccine development pathway, new approaches to immunization, and various scientific, political and economic issues involved in considering the implementation of biodefense vaccines. It is clear that development of biodefense vaccines is not a short term solution for biothreats but is a cost effective long term approach to controlling biothreats. The remaining sections highlight major biothreat agents, including viruses and bacteria of either public health and/or veterinary health. The various reviews emphasize the progress made in developing vaccines and the issues regarding getting the vaccines to the marketplace. The range of pathogens included in this supplement exemplifies the various stages of vaccine development with some candidate vaccines still in the discovery phase, others in preclinical development, while some are in clinical trials, and a few have been licensed or are in investigational new drug status. The supplement also demon-
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strates the challenges in getting a candidate vaccine developed, in particular the difficulty of undertaking efficacy trials and the utilization of studies in two animal species to aid evaluation and hopefully licensure of a vaccine. The progress in development of vaccines for biothreat agents since October 2001 has been remarkable due to the combined efforts of academia, biotechnology companies, large pharma, governments, and regulatory authorities, and we look forward to some of these candidate vaccines being licensed in the future. It is our hope that this supplement may serve as a milestone for this process and a useful reference for people interested in knowing the current status of biodefense vaccine development. Alan D.T. Barrett ∗ Sealy Center for Vaccine Development University of Texas Medical Branch, Galveston, TX 77555-0436, USA Shan Lu 1 Department of Medicine, University of Massachusetts Medical School, 364 Plantation Street, Worcester, MA 01605, USA Gregory A. Poland 2 Mayo Clinic Vaccine Research Group, Mayo Clinic, Guggenheim 611C, 200 1st Street S.W., Rochester, MN 55905, USA ∗ Corresponding
author. Tel.: +1 409 772 6662; fax: +1 409 772 6663. E-mail addresses:
[email protected] (A. Barrett),
[email protected] (S. Lu),
[email protected] (G.A. Poland) 1
Tel.: +1 508 856 6791; fax: +1 508 856 6751.
2
Tel.: +1 507 284 4968; fax: +1 507 266 4716.