NVIC Opposes FDA Fast-Tracking of Flu Vaccine Licensing

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March 15, 2012 Issue

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.

Informed Public Expects High Licensing Standards

" 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. "

" 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

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.

Post a comment on this article

here.

Vermont House To Hold Mar. 21 Vaccine

Exemption Hearing

The bill (S.199) to remove philosophical exemption

to vaccination in Vermont passed the Senate and there will be a House

hearing on the bill on Mar. 21.

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.

Watch a 90 second video PSA sponsored by the National Vaccine

Information Center and

Vermont Coalition for Vaccine

Choice.

Make Your Voice

Heard

If you have been harassed or threatened for

making a vaccine choice, post your story on NVIC's

Vaccine Freedom Wall.

Vaccine exemptions are being threatened in Vermont, California, Arizona

and other states. If you want to fight for the freedom to make informed,

voluntary vaccine choices in your state, sign up to become a user of

the free, online NVIC Advocacy Portal

here.

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

NVIC In the News

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.

More Vaccine

News

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.

Sheri Nakken, former R.N., MA, Hahnemannian

Homeopath

Vaccination Information & Choice Network, Washington State, USA

Vaccines -

http://vaccinationdangers.wordpress.com/ Homeopathy

http://homeopathycures.wordpress.com

Vaccine Dangers, Childhood Disease Classes & Homeopathy

Online/email courses - next classes start March 1 & 8