January 2008

NVIC Director appointed to FDA vaccine committee

Vicky Debold, RN, PhD has been appointed to represent consumers on the Vaccines and Related Biological Products Advisory Committee (VRBPAC) of the Food and Drug Administration (FDA), which votes on the scientific evidence presented by vaccine manufacturers seeking licenses to market new vaccines in the US.

Dr. Debold, who is Director of Patient Safety for the National Vaccine Information Center (NVIC), was appointed by the FDA after she was selected by an independent consumer's representative nominating group. Her two‑year term can be extended to four years at the discretion of the FDA.

NVIC President and co‑founder Barbara Loe Fisher served as the consumer member of VRBPAC between 1999 and 2003.

Debold has worked as a health policy analyst for the US Congress at the Physician Payment Review Commission; the Michigan Health and Safety Coalition; and the Michigan State Commission on Patient Safety. Additionally, she has served as an Assistant Professor at the University of Michigan and an Associate Professor and Director of the Health Systems Management Program at the University of Detroit, Mercy.

Her doctoral degree is from the University of Michigan, School of Public Health and the School of Nursing. She was a University of Michigan Regent's Fellow and completed her post‑doctoral fellowship in health systems research.

Debold's son, her only child, experienced serious, long‑term health problems following receipt of seven live virus and killed bacterial vaccines at 15 months of age in 1998, including autism spectrum disorder symptoms. She has been involved in research and advocacy for autism‑focused non‑profit organizations, including SafeMinds, National Autism Association, US Autism and Asperger Association and the Oakland County Chapter, Autism Society of America.

VRBPAC meetings are open to the public and members of the public may speak during public comment times. Debold's first meeting as consumer representative will be February 20‑21, 2008 at the Hilton Gaithersburg Hotel, Gaithersburg, Maryland.

Online transcripts and background material for VRBPAC meetings held between 1998 and 2008, which contain discussions of the pre‑licensure scientific evidence for safety and efficacy presented by vaccine manufacturers for experimental and previously licensed vaccines, can be accessed at www.fda.gov/cber/advisory/vrbp/vrbpmain.htm .