Scientific, technological, and regulatory challenges must be addressed to facilitate the development of effective pandemic
influenza vaccines. The FDA is actively developing pathways and using current regulatory processes such as fast track, priority
review, and accelerated approval to facilitate the availability of vaccines against pandemic influenza. The agency has made
significant strides, as evidenced by the April 2007 approval of the first US vaccine for humans against the H5N1 influenza
virus. The approval of this vaccine is an important step in enhancing the nation's readiness against a possible pandemic.
The vaccine is included in the national stockpile for distribution by public health officials, if required. The agency continues
to work closely with its partners in the industry, academia, and other NRAs to diversify and strengthen influenza vaccine
manufacturing and supply to aid the US in pandemic preparedness.
Norman W. Baylor, PhD, is the director of Office of Vaccines Research and Review at Center for Biologics Evaluation and Research, FDA, Rockville,
1. US Food and Drug Administration. Draft guidance for industry. Clinical data needed to support the licensure of pandemic
influenza vaccines. Rockville, MD; May 2007.
2. US Food and Drug Administration. Draft guidance for industry. Clinical data needed to support the licensure of seasonal
inactivated influenza vaccines. Rockville, MD; May 2007.
3. World Health Organization. Global pandemic influenza action plan to increase vaccine supply. WHO/CDS/EPR/GIP/2006.1. Geneva;
4. Rowe T, et al. Detection of antibody to avian influenza A (H5N1) virus in human serum by using a combination of serologic
assays. J Clin Microbiol. 1999;37:937–943.
5. Wadman M. Race is on for flu vaccine. Nature 2005;438:23.
6. Testimony of Anthony S. Fauci, MD, director, National Institute of Allergy and Infectious Diseases, National Institutes
of Health, on "Pandemic Influenza: The Road to Preparedness" before the Committee on Foreign Relations, United States Senate,
2005; Nov 9.
7. US Food and Drug Administration. Draft guidance for industry. Characterization and qualification of cell substrates and
other biological starting materials used in the production of viral vaccines for the prevention and treatment of infectious
diseases. Rockville, MD; Sept. 2006.