Regulatory Issues: Pandemic Preparedness Pacing Up - Challenges and opportunities for facilitating the development and licensure of pandemic influenza vaccines - BioPharm International

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Regulatory Issues: Pandemic Preparedness Pacing Up
Challenges and opportunities for facilitating the development and licensure of pandemic influenza vaccines


BioPharm International


Conclusion

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, MD, 301.827.5105.

References

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 Draft guidance for industry.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. http://www.fda.gov/cber/gdlns/panfluvac.htm.

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 Draft guidance for industry.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. http://www.fda.gov/cber/gdlns/trifluvac.htm.

3. World Health Organization. Global pandemic influenza action plan to increase vaccine supply. WHO/CDS/EPR/GIP/2006.1. Geneva; 2006.

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. http://amedeo.com/lit.php?id=16267526.

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. http://www.fda.gov/cber/gdlns/vaccsubstrates.htm.


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