Conference Background
Assuring a consistently available supply of safe and effective vaccines is critical to maintaining public health. Although vaccine supply depends upon multiple factors, one important consideration is the ability to rapidly develop and manufacture vaccines against emerging organisms. The ability to respond will rest in part on the existing infrastructure for annual production of seasonal influenza vaccine. Recent world-wide events have suggested the increasing possibility of a pandemic influenza outbreak. Previous pandemic outbreaks have resulted in devastating social and economic consequences, often including substantial loss of life above that seen with seasonal influenza. Emergence of an influenza pandemic would likely be caused by a type of influenza for which the human population has no previous exposure.
A comprehensive approach to address pandemic influenza has been taken by the World Health Organization and the United States government. Part of an integrated strategy to prepare for a pandemic outbreak includes the identification of potential viral strain(s) and the rapid production of sufficient vaccine to immunize a significant proportion of the US and world population. Attainment of this goal will be accelerated by facilitating the development and production of "next generation" influenza vaccines, e.g., cell-culture based and recombinant protein influenza vaccines. The US capacity to respond will be advanced by a coordinated effort among regulatory officials, developers and manufacturers of vaccines.
Producing sufficient quantities of vaccines against a pandemic influenza strain faces multiple challenges. Current production relies upon egg-based technology that has changed little since its original development. This technology is labor intensive, cumbersome, time consuming, and yields limited product. Alternative methods of production using cell culture-based technologies, modern manufacturing methodology, and control technologies hold promise for increasing the manufacturing capacity and reliability of the vaccine supply for influenza and other diseases.
The meeting will identify major challenges in the production of influenza vaccines, and will cover potential strategies and manufacturing technologies that could increase the production capability of both the current egg-based and alternative cell culture-based processes. Particular attention will be given to identifying novel approaches, including those currently used in non-pharmaceutical industries for other purposes.
The National Academy of Engineering (NAE) and the Institute of Medicine (IOM) are components of the National Academies, which also include the National Academy of Sciences and the National Research Council. The National Academies are private, nonprofit, nongovernmental organizations chartered by Congress to serve as advisors to the nation on scientific and technical matters. Many of their activities are funded by contracts and grants from federal agencies and foundations. The mission of the NAE is to promote the technological welfare of the nation by marshalling the knowledge and insight of eminent members of the engineering professions. The mission of the IOM is to improve health worldwide.
This workshop is important to the overall mission of the co-sponsoring agencies by addressing the critical public health requirement of an adequate supply of safe and effective influenza vaccines. The meeting should also benefit manufacture of other vaccines, as well as biological and pharmaceutical products.