Swine flu hit my neighborhood this weekend. Three schools, including one about a mile from my home, are closed today. Developing a vaccine against the H1N1 virus have dominated industry discussions this past week and has been on the minds of many parents I know. It seems, too, that the rapid and efficient development of vaccines (not specific to any one virus) has been on FDA’s agenda as well, especially in terms of implementing the modern approach well known as its Critical Path Initiative.
FDA’s goals for the initiative include developing better evaluation tools, streamlining clinical trials, harnessing bioinformatics, and developing products to address urgent public health needs. The agency recently posted a report that lists the more than 50 projects that during fiscal year 2008 had received support as a Critical Path Initiative program. Three of the projects described in the report directly relate to vaccines, although from novel and modern technical perspectives.
A two-year FDA project seeks to help in the development of vaccine adjuvants by examining methods for predicting unacceptable immunological reactions and systemic toxicities that are known to be associated with new adjuvants and delivery systems. According to the report, developing rapid in vitro screening trials based on relevant human cells will provide alternatives to traditional assays used for identifying bacterial contaminants in vaccine adjuvants.
Another Critial Path Initiative project involves the use of sponsor-supplied data to estimate the immunogenicity threshold for approval of a vaccine when a large efficacy trial is not possible. Developing a new trial design for testing vaccine efficacy may help alleviate the burden of having to conduct a large-scale trial for a vaccine that is similar (same target pathogen) to an already-approved vaccine.
Many of the projects listed in the report aim to bring the industry out from its dependence on paper-based methods and into electronic systems. Bioinformatics is quickly becoming the preferred data-mining tool for enormous databases. The third vaccine-related project is a collaboration of FDA and industry that uses large healthcare databases (public and private) to create new tools (data sources) to monitor the safety and effectiveness of several biological products, including vaccines.
One hopes that in time this work will bring the objective of efficient vaccine production to fruition.