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NIAID Efforts To Strengthen Seasonal Vaccine Supply Bolster Influenza Pandemic Preparedness

"If there were a crisis today similar to the 1918 outbreak of Spanish Flu, in which 50 million lives were lost worldwide, virtually everyone would want to be vaccinated. But the infrastructure and vaccine-production capacity of this nation and the world are not prepared for such demand." - Anthony S. Fauci, M.D. Director of National Institute of Allergy and Infectious Diseases (Source: "Why We Need a Robust Vaccine Market," The Philadelphia Inquirer, February 23, 2006)

The 2004-2005 influenza season brought into sharp focus the fragility of our nation's vaccine industry. At the time, the United States depended on only three manufacturers to produce U.S.-licensed seasonal influenza vaccine for its population. When one of the three manufacturers temporarily ceased production due to a contamination problem, almost half of the anticipated influenza vaccine supply for the 2004-2005 season became unavailable. Each year, seasonal influenza infections cause approximately 36,000 deaths and 200,000 hospitalizations in the United States alone. By undergoing continuous genetic changes, influenza viruses present a perpetual challenge to public health and scientific communities. This interminable evolution allows influenza viruses to avoid the body's previously established influenza-specific immune responses from year to year and, as history has shown, contributes to the intermittent emergence of pandemic influenza viruses. Within the Department of Health and Human Services, the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health devotes almost one-third of its annual budget to vaccine research against many microbes. In addition, NIAID is the principal research entity charged with the conduct of influenza research, including basic research to understand influenza virology, pathogenesis, and immunology, as well as the development of vaccines and therapeutics. Estimated NIAID spending on influenza research in fiscal year 2006 is $154.9 million, up from less than $15 million five years earlier (FIGURE ONE).

The October 2004 discovery that problems within a single vaccine company could so dramatically reduce the U.S. influenza vaccine supply sent a clear message: The number and capacity of manufacturers licensed to distribute seasonal influenza vaccine in the U.S. must be increased to achieve a more reliable supply. With this in mind, NIAID, in consultation with the Food and Drug Administration and the vaccine manufacturer, rapidly implemented a clinical trial to evaluate the safety of and immune response to GlaxoSmithKline's (GSK) seasonal influenza vaccine, Fluarix. At the time, Fluarix was not licensed in the U.S. and therefore was not part of the U.S. influenza vaccine market. The trial began in December 2004 and was carried out in NIAID's network of Vaccine and Treatment Evaluation Units (VTEUs) at research universities across the nation (FIGURE TWO). The safety and immunogenicity data generated from this study helped inform the FDA decision to license Fluarix. The data were reviewed by the FDA on an accelerated track. On August 31, 2005, less than a year after the October 2004 announcement of the influenza vaccine shortage, the FDA approved GSK's seasonal influenza vaccine for immunization of adults in the U.S. The study results were published by Treanor et al. in the November/December 2005 issue of Human Vaccines (1). The NIAID is exploring many other research solutions to strengthen the influenza vaccine supply such as new, more efficient vaccine manufacturing methods, novel vaccine technologies, and strategies to improve existing vaccines. The current challenges associated with seasonal influenza vaccine production will greatly impact the manufacture of pandemic influenza vaccine, should a pandemic occur. Accordingly, solutions to seasonal influenza vaccine deficiencies can only positively influence pandemic influenza preparedness (FIGURE THREE). The Fluarix experience illustrates how successful collaboration between multiple federal agencies, academic institutions and industry can accomplish critical objectives in a time of public health need. 1. Treanor JJ, Campbel JD, Brady RC, Keitel WA, Drame M. Rapid Licensure of a New, Inactivated Influenza Vaccine in the United States. Human Vaccines (2005) 1(6):239-244.