Choking BioShield: the Department of Homeland Security's Stranglehold on Biodefense Vaccine Development

Abstract

One of the bright milestones toward the development of a vibrant biodefense vaccine industry was the passage of the Project BioShield Act of 2004. That statute was designed “to provide protections and countermeasures against chemical, radiological, or nuclear agents that may be used in a terrorist attack against the United States.” The most prominent parts of that legislation were its procurement provisions designed to address the key significant impediment to biodefense vaccine production—lack of a significant market. These provisions encourage the development of effective vaccine countermeasures by establishing the Special Reserve Fund of $5.6 billion to be spent over 10 years to purchase for the nation's Strategic National Stockpile (SNS) the “next generation of countermeasures against” a broad array of chemical, biological, radiological, and nuclear (CBRN) agents, all of which were seen by Congress as weapons that could be deployed against the United States. Due to the substantial expense and risk of bringing a vaccine to market, along with the infrequency with which these diseases occur naturally, pharmaceutical manufacturers have claimed they have little to no incentive to invest without BioShield funds.