At home, the Department of Health and Human Services (HHS) is developing a Pandemic Influenza Preparedness and Response Plan, issued in draft form last August. Members of Congress now want a final plan and evidence of progress in developing vaccines and treatments to cope with a major flu pandemic. Coming in the wake of last year's devastating flu vaccine shortage, plus regular supply problems with routine children's vaccines, policymakers are very nervous about how the nation will deal with a global health crisis.
FRAGILE SYSTEM In preparing for a serious flu outbreak, an important challenge is to ensure an adequate and timely supply of influenza vaccine, according to Congress' Government Accountability Office (GAO), [GAO-05-760T, May 26, 2005]. However, US preparedness efforts are hampered by a lack of domestic vaccine manufacturing capacity. Only five manufacturers produce vaccines for the US market, and only one company makes conventional seasonal flu vaccine entirely in the US. At a hearing on pandemic flu preparedness before the House Energy and Commerce Committee in May, Julie Gerberding, director of the Centers for Disease Control and Prevention (CDC), described the US vaccine manufacturing system as "fragile." She noted that pandemic flu vaccine produced in other countries probably will not be available in the US because other governments "may prohibit export of the vaccines produced in their countries until their domestic needs are met."The National Institutes of Health (NIH) are supporting research efforts geared toward new vaccine production methods as well as disease analysis. FDA is developing policies to facilitate new vaccine approval and ensure that manufacturing facilities meet all quality standards. While vaccine manufacturing is a tricky business in any situation, fast production of a vaccine for a novel virulent influenza strain raises additional challenges. It now takes six to eight months to identify prevalent flu strains each season, to develop effective vaccines, and to ramp up production of millions of doses.
Policy makers recognize that efforts to expand the nation's vaccine manufacturing infrastructure and to stabilize the market for routine and seasonal vaccines will lay a foundation for responding to a national or global pandemic. Last year's shortages, to some extent, may help improve the process by boosting funding for new programs and removing regulatory and legal obstacles to vaccine development. A number of NIH and CDC initiatives have been launched that support vaccine R&D and expanded production capacity: