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The American Society for Microbiology (ASM) is pleased to comment in response to the notice in the August 13, 2004 Morbidity and Mortality Weekly Report (MMWR) regarding the current state of the vaccine safety program at the Centers for Disease Control and Prevention (CDC). ASM unequivocally supports immunization programs for children and adults in this country and globally. Such programs have provided and continue to provide enormous benefit in securing health.

ASM recognizes that vaccine programs must have the highest safety standards possible. Traditionally, CDC has been responsible for vaccine safety and for assuring high immunization levels; the insights and expertise of those involved in the administration and evaluation of vaccine programs are invaluable. The ASM supports CDC’s continued role in implementing these activities, but notes that the organizational proximity of both activities within CDC through its National Immunization Program, could lead to a perception of a conflict of interest. ASM recommends that vaccine safety activities should be separate from vaccine promotion within CDC, to avoid any perception of conflict of interest.

The Food and Drug Administration (FDA) also has a critical role in vaccine safety. FDA’s goal of ensuring safe and effective medical products is accomplished through its pre-market review and post-market surveillance processes. The FDA should continue to work on vaccine safety, by accessing and evaluating in a timely and ongoing basis, all pertinent data collected by CDC and available otherwise (e.g., NIH funded research).

ASM appreciates the opportunity to comment on this matter.


Ruth L. Berkelman, M.D., Chair, Public and Scientific Affairs Board
Michael T. Osterholm, Ph.D., M.P.H., Chair, Committee on Public Health