• Better surrogate animal models are needed for testing vaccines against novel pathogens.

  • Improved vaccines against known agents (like smallpox virus) are necessary if immunocompromised subjects are to be safely protected.

  • A low cost per dose and stability at ambient temperature are important goals if vaccines are to be shipped to troops in remote locations or to populations in developing countries.

  • Antibodies produced for medical use may provide an effective way to ameliorate the effects of a toxin or an infectious agent.

  • The regulatory, legal (liability), and ethical issues associated with new vaccines are complex and must be addressed. Could vaccines developed by certain standard protocols be preapproved by the Food and Drug Administration (FDA) to streamline vaccine deployment, even if only at times when a certain high threshold of infection or mortality had been surpassed?

  • Vaccines must be produced and stored in multiple secure locations, as the vaccine itself could be a target in a terrorist attack to disable our ability to respond.

  • The possibility of using vaccines effective against combinations of antigens from different viral pathogens needs to be investigated.

  • Further work in basic immunology needs to be done to obtain an understanding of whether it will be possible to develop drugs that will up-regulate an immune response to pathogens, including organisms used for bioterrorism (immune modulation).

The application of microbial genomics to the development of a novel meningococcal vaccine is one instructive model to consider here (Pizza et al., 2000). In addition, over the past several decades there has been an explosion of basic knowledge about virus structure, the genetic organization of viral genomes, and the mechanisms of viral replication. This knowledge presents us with many potential targets for antiviral therapy. Only a tiny fraction of such targets has been exploited to date. An informative example of success in this area is development of protease inhibitors, such as anti-HIV drugs. The discovery that processing of certain HIV proteins by the protease is essential for virus multiplication came out of basic research on viral proteins. The demonstration that the protease is essential for infectivity was published in 1988. The first protease inhibitor was approved by FDA in 1995. It is highly likely that similar approaches would result in useful therapeutics to counter viruses that might be used for bioterrorism.

Recommendation 3.9: Increase research and development on therapeutics and vaccines. Support basic and clinical research to discover molecular targets in bacteria and viruses, develop broad-spectrum antivirals and antibiotics, and devise treatments that enhance or stimulate protective host responses (both innate and acquired). Similarly, continue to expand and



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