NVIC Vaccine News

NVIC Opposes FDA Fast-Tracking of Flu Vaccine Licensing

By NVIC Staff
Published March 15, 2012 in Government

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=

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.

Vermont House To Vote Mar. 21 on 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. 

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9 Responses to "NVIC Opposes FDA Fast-Tracking of Flu Vaccine Licensing "
Commenter Name
Posted: 3/15/2012 3:44:20 PM
Interesting, seeing as how there is no science to be found regarding vaccines, and what little there is is laughable at best and ultimately dangerous and inefficient. A hoax, as it were.
Commenter Name
Posted: 3/15/2012 4:31:26 PM
I suffered a huge allergic reaction of Stevens Johnson Syndrome - hot red rashes arms, tummy groin and hives which the itch nearly drove me mad and got infected. Disgusting that a vaccine is allowed to do this to people and worse I could have died.
Commenter Name
Shira Nahari
Posted: 3/15/2012 4:35:54 PM
Re: NVIC Opposes FDA Fast-Tracking of Flu Vaccine Licensing The public is indeed looking for the most rigorous licensing process possible, and that to be based on proper, objective testing. This article has it right on! We the people need to be vocal about this matter and meanwhile shun all vaccinations that are suspect.
Commenter Name
Susan Pearce
Posted: 3/15/2012 8:40:43 PM
I'm so glad Chris Downey advised the committee to license new adjuvants separately. In fact, they should license all adjuvants, even old ones, separately. I don't think they do, do they?
Commenter Name
Bob LaRue
Posted: 3/15/2012 11:18:42 PM
My wife, a healthy, active 53 year old woman, began experiencing a reaction the the 2010 flu vaccine 4-days after receiving the vaccine. Symptoms began as blurred vision, numbness in her left hand and foot and extreme dizziness. Within 3 days, after dramatic health deterioration, she was in a coma and non-responsive. She remained in a coma for nearly 4 weeks until she received her first plasmapharesis treatement. After 5 treatments, she was fully out of the coma and began a 5-month rehab process to learn how to eat, drink, walk, read and perform other normal functions. Fortunately, she has now fully recovered, thanks to her tremendous work ethic and positive attitude combined with her strong faith and supportive family. It is imperative that the FDA mandate complete testing of flu vaccines and that the general public be made aware of the neurological complications that can accompany a flu vaccine.
Commenter Name
Ej Pfluger
Posted: 3/16/2012 3:50:58 PM
The only "person" to benefit from fast tracking is big pharma! Do whats morally correct!!
Commenter Name
Posted: 4/13/2012 7:18:36 PM
Actually I've been on a wait list for 6 weeks to get my infant son the cavcine through our doctor, covered by insurance. Finally they advised me to take him to the clinic because of the shortage they are suffering. They are losing the competition with government health care. I think this is a relevant look at our future under Obama-care. When medical care is in the hands of the government rather than private sources we can expect shortages, rationing, and poor delivery. We can also expect private options to be unavailable as it becomes impossible for them to compete with the government. A safety net is great in theory but what we're seeing in these clinics has nothing to do with a safety net and everything to do with universal health care. I feel sorry for the hundreds of County workers who were laid off this year only to see the County footing the bill for thousands to be vaccinated against a relatively low-risk virus without any oversight whatsoever no proof of income, residency, citizenship, or even qualification of being in a high-risk group. This situation represents incompetent medical care and irresponsible stewardship of resources in the hands of our current leadership. Whichever way you slice it it's time to replace the Board of Supervisors.
Commenter Name
Karen b
Posted: 12/8/2014 2:54:19 PM
after receiving the 2014 flu vaccine, I became sick in 72 hours. Headache ,fatigued, swollen lymph nodes, 4 days later in urgent care facility Bering tested for strep, mono and labs to rule out Hodgkins or lymphoma . 48 hours later I had flashes in my eye and blurred vision. My optomologist said I had a posterior visceral tear of my eye. I was negative for mono , strep and lymphoma. I was healthy before the flu shot and now have blurred vision from the detachment. I blame all my health problems from the flu vaccine and the allergy and hyperinflammation and causing my immune system to be compromised .
Commenter Name
appliance repair
Posted: 4/18/2022 9:01:54 AM
Someday this vaccine not be needed anymore and the virus will be gone!

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