Washington Report

Manufacturers Face New Challenges Battling Global Threats (continued)

Fragile vaccine production system A major obstacle in preparing for an influenza pandemic is 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 United States, according to a report from Congress' Government Accountability Office (GAO), (GAO-05-760T, May 26, 2005). At the House Energy and Commerce Committee hearing in May, Julie Gerberding, CDC director, described the US vaccine manufacturing system as "fragile" and noted that pandemic flu vaccine produced in other countries probably will not be available in the United States 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 into new vaccine production methods as well as disease analysis, and FDA is developing policies to facilitate new vaccine approval and ensure that manufacturing facilities meet all quality standards. Although vaccine manufacturing is a tricky process in any situation, fast production of a vaccine for a novel virulent influenza strain raises additional challenges. For seasonal flu vaccine, it usually takes six to eight months to identify prevalent flu strains, to develop effective vaccines, and to ramp up production of millions of doses. Policymakers 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. This past year's shortages, to some extent, may help improve the process by boosting funding for new programs and reducing regulatory and legal obstacles to vaccine development. NIH and CDC are providing funds for manufacturers to develop cell-based vaccine production methods. Such methods eliminate the need for using eggs, which are the basis of traditional vaccines in the United States and Europe. Additional support is available to improve vaccine manufacturing processes at existing facilities through the development of more-efficient methods for viral master seed production; egg inoculation; growing, purifying, and harvesting vaccine; formulating the vaccine product; and filling vials or syringes. Sanofi-Pasteur has received grants from HHS to test cellular and recombinant vaccine production methods, as well as to develop a year-round supply of eggs suitable for full-capacity flu vaccine production under current systems. Sanofi has committed to expanding its current manufacturing operation to produce as many as 300 million doses of monovalent pandemic vaccine, a process that will take at least five years. To move forward now in developing a vaccine against the existing avian flu viral strain (H5N1), Sanofi has produced pilot lots of the new vaccine for testing in clinical trials and has a contract to produce 2 million doses of the vaccine, an unusual move to ensure that manufacturing techniques and conditions that would be used for large-scale production are satisfactory. (continued)