At a Feb 29, 2012 meeting of the FDA Vaccines & Related Biological Products Advisory Committee, NVIC went on the public record as opposing the fast-tracking licensure of future pandemic influenza vaccines. Vicky Debold, PhD, RN, NVIC’s volunteer Director of Patient Safety and Research, who has served as the Committee's consumer member since 2008, and NVIC President Barbara Loe Fisher both urged the Committee to apply high regulatory standards to the licensing of both seasonal and pandemic influenza vaccines.
Informed Public Expects High Licensing Standards
“Do The Very Best Science Possible”
Dr. Debold stated during the Committee deliberations that “As a general principle, what the public is looking for is the most rigorous [licensing] process possible,” she said. “The public is hearing things like ‘inferred’ efficacy, ‘inferred’ effectiveness, surrogate clinical endpoints [where] the endpoints are not clear, brand new manufacturing processes that involve [new] cell types and genetic engineering…,my advice is to do the very best science possible.”
License New Adjuvants Separately=
Chris Downey, NVIC’s volunteer Director of Database Management, also made a public comment and urged the Committee to license new adjuvants, such as squalene, separately. Pointing out that adjuvants ramp up the immune response and could potentially pose health risks for individuals with sensitive immune systems, he said ” As a parent of a child with a serious food allergy, I really want to see adjuvants licensed separately.”
Read Barbara’s entire public comment statement.
Listen to the audio webcast of the Feb. 29 FDA meeting.
Vermonters, who want to keep the philosophical exemption to vaccination and oppose S. 199, should sign up for the free online NVIC Advocacy Portal and personally contact their representatives today.
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