NVIC Opposes FDA Fast-Tracking of Flu Vaccine Licensing

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.

 

“The informed American health care consumer expects FDA vaccine licensing standards demonstrating the safety and effectiveness of new vaccines, including those developed for pandemic influenza, to be very high,” said Fisher during public comment time. ”If the regulatory standards are too low and the pre-licensure scientific data is limited because everything is put on an accelerated “fast track,” the informed public will question and resist using those newly licensed vaccines – even if the heel of the boot of the state is used to try to force compliance with federal recommendations and state mandatory vaccination laws.”

 

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.”

 

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.

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If you or a loved one have suffered a vaccine reaction, injury or death, post a description and photo on NVIC’s Memorial for Vaccine Victims.

AZ Moves to Limit Vaccine Exemptions. Arizona Republic News. Feb. 29, 2012.  

More on Vaccines and Their Dangers. New American. Feb. 29, 2012.

 

The Emerging Police State in the United States. Boiling Frogs Radio Blog. March 2, 2012.

 

The Battle to Defend Vaccine Exemptions is Worth Fighting. Age of Autism. March 5, 2012.

 
 

Doctor Wins Fight to Clear His Name: High Court Judge Overturns the GMS’s Ruling. Daily Mail Online. Mar. 7, 2012.
 

VT Senate Moves to Remove Philosophical Exemption to Vaccination. Bennington Banner. Mar. 3, 2012.
 

Goats Genetically Engineered to Carry Vaccine in Milk. Houston Chronicle. Mar. 2, 2012.
 

FDA Approves First 4-Strain Flu Vaccine. CBS News.  Mar. 1, 2012.