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

“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.

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9 Responses to "NVIC Opposes FDA Fast-Tracking of Flu Vaccine Licensing "

teri

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.

Heather

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.

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.

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?

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.

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!!

Rebeka

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.

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 .

appliance repair

Posted: 4/18/2022 9:01:54 AM

Someday this vaccine not be needed anymore and the virus will be gone!