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FDA Fast-Tracks Licensure of MF59 Adjuvanted Influenza Vaccine
Posted: 9/16/2015 9:33:17 AM

During the Sept. 15, 2015 meeting of the FDA's advisory committee on vaccines, Vaccines and Related Biological Products Advisory Committee (VRBPAC), the committee voted to fast-track licensure of the MF59 adjuvanted Fluad influenza vaccine. NVIC's President and Co-Founder, Barbara Loe Fisher gave the following public comment in opposition to licensure of the Fluad vaccine. NVIC has also issued a press release on the VRBPAC decision that may be read here.
 

Public Comment
Barbara Loe Fisher, Co-founder and President
 National Vaccine Information Center
Opposition to Fast Track Licensure of MF59 Adjuvanted Fluad
FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC)
Sept. 15, 2015
 
 
Squalene adjuvants hyper-stimulate the immune system and have been linked with development of autoimmunity, narcolepsy and other chronic disease.1 2 3 Based on the very limited safety and immunogenicity evidence submitted by Novartis,4 MF59 adjuvanted Fluad vaccine should not be fast tracked to licensure for use by seniors over age 65 in the U.S. for the following reasons:  
  1. FDA states there is uncertainty about how MF59 affects immune function but it is “thought” to activate local cells and has been “shown to directly increase phagocytosis” in human immune cells and to induce cytokines.5If MF59 does that, it is an active ingredient and should be proven safe in a placebo controlled trial. 
  2. Influenza vaccines induce immune mediated responses, whether adjuvanted or unadjuvanted. Comparing adverse responses following receipt of one adjuvanted bioactive product to those of an unadjuvanted bioactive product does not prove safety unless both are compared to an inactive placebo.6 7  Novartis did not compare Fluad to an inactive placebo. 
  3. It is well known that responses to vaccination are affected by genetic factors. The Pivotal Study population clearly was not genetically representative of U.S. seniors over age 65, a population that is over 80 percent Caucasian, 9 percent Black, 7 percent Hispanic and 4 percent Asian.8 Fluad was only given to about 1,000 U.S. seniors, while more than 2,400 Fluad recipients were from countries with high majority Asian or Hispanic populations.9 
  4. The trial exclusion criteria is so broad that the health of most of the study participants does not match that of the majority of U.S. seniors over age 65, of whom two-thirds have two or more chronic conditions such as heart, lung and kidney disease,10 11 and will be candidates for receipt of Fluad post-licensure. 
  5. Compared to Agriflu, Fluad produced a much higher number of pain, tenderness, redness and swelling reports; a higher number of systemic adverse event reports and more deaths and cases of new onset chronic disease.12 
  6. The Pivotal Study provides no information about the safety of giving seniors with multiple chronic conditions repeated doses of squalene adjuvanted Fluad every year and no information about how Fluad performs when given simultaneously with other vaccines. 
  7. Using surrogate markers in the Pivotal Study, Novartis was not able to demonstrate that Fluad was superior to Agriflu with regard to immunogenicity, while Novartis was able to demonstrate that squalene adjuvanted Fluad is more reactive.13
Why does Fluad need to be fast tracked to licensure for seniors without additional evidence? There is public concern that fast tracking Fluad is really about fast tracking MF59 to licensure so it can be added to lots of new vaccines targeting infants, pregnant women and every American without adequate evidence for safety or effectiveness.
  
References:

1 Kuroda Y, Nacionales DC et al. Autoimmunity induced by adjuvant hydrocarbon oil components of vaccine. Biomed Pharmacother 2004; 58(5): 325-327.
 
4 Novartis. FDA Advisory Committee Briefing Document: Fluad, Seasonal Adjuvanted Trivalent Influenza Vaccine (aTIV). FDA Vaccines and Related Biological Products Advisory Committee Meeting Sept. 15, 2015.
 
5 FDA. Briefing Document: Influenza Vaccine, Adjuvanted Fluad, Novartis Vaccines and Diagnostics, Inc, Applicant. Vaccines and Related Biological Products Advisory Committee Sept. 15, 2015 Meeting. Page. 6.
 
6 Drugs.com. What is a placebo? Feb. 10, 2013.
 
7  Massachusetts General Hospital. Clinical Trials 101: Placebo Controlled Trials.
 
8 Ortman JM, Velkoff VA, Hogan H. An Aging Nation: The Older Population in the United States. US Census Bureau May 2014. Table 3, page 12.
 
9 FDA. Briefing Document: Influenza Vaccine, Adjuvanted Fluad, Novartis Vaccines and Diagnostics, Inc, Applicant. Vaccines and Related Biological Products Advisory Committee Sept. 15, 2015 Meeting. Table 3, page 11.
 
11 Novartis. . FDA Advisory Committee Briefing Document: Fluad, Seasonal Adjuvanted Trivalent Influenza Vaccine (aTIV). FDA Vaccines and Related Biological Products Advisory Committee Meeting Sept. 15, 2015. Table 29, page 62.
 
12 FDA. Briefing Document: Influenza Vaccine, Adjuvanted Fluad, Novartis Vaccines and Diagnostics, Inc, Applicant. Vaccines and Related Biological Products Advisory Committee Sept. 15, 2015 Meeting. Tables 9 & 10, pages 17 and 18.
 
13 FDA. Briefing Document: Influenza Vaccine, Adjuvanted Fluad, Novartis Vaccines and Diagnostics, Inc, Applicant. Vaccines and Related Biological Products Advisory Committee Sept. 15, 2015 Meeting. Page 5.
 


Posted: 9/16/2015 9:33:17 AM | with 2 comments



  
Comments
Sam
I’m exposed to sick patients all day long. With this year’s flu epidemic, I’m with them more than usual. Some of them ask me,

“Doc, aren’t you sick yet? Did you get flu this year? Did you get vaccinated?”

Yes, the flu season this year is bad. In Boston, at least 18 patients died recently and they declared a medical emergency. New York has also declared an emergency. But you don’t have to be one of the statistics.

I’m living proof that flu can be prevented
In my practice, one patient ended up in the hospital, and countless others are suffering the symptoms. Me? I feel great, no flu symptoms whatsoever. No sick days, no fever, fatigue, runny nose -- nothing! I have not had flu for years and I am not planning to get it. Obviously, this isn’t because I’m not exposed to flu germs --I have plenty of sick people around me. It’s because my immune system is working properly. Here’s how I achieved it. But first, some background…

WHY THE FLU VACCINE IS A LONG SHOT
While doing my residency training, I used to get flu at least 2 to 3 times a year. I felt very bad not only because of the sickness, but also because my flu was almost always complicated by laryngitis—which meant I almost always lost my voice. I couldn’t do my job when I couldn’t speak!

After a few years of suffering I said to myself: that's enough. I have to do something about it. But what? As a resident in the teaching hospital I had done everything that official medicine required us to do: I got a flu shot every year, I washed my hands religiously, and I wore masks when it was appropriate. It didn’t work—I still got sick. Why? According to official medicine, a flu vaccination should prevent flu. How does it work? By exposing you to flu antigens in a vaccine, you’re supposed to produce antibodies that protect you from the real flu. But the vaccination definitely didn't work--not for me, and not for many of my patients. They used to ask me: "Doc, I got a flu vaccine this year. Why am I sick?"

Here’s why. There are lots of strains, or types, of flu that goe around. The vaccine used for flu treatmentcan’t contain all the virus strains that are out there. So even though you are vaccinated, you may still get sick if you catch a flu strain that was not in your vaccine. This happens all the time.

AN ANTI-VIRUS FOR THE VIRUS?
I needed to find a way to deal with flu. I decided that if a flu vaccine won’t work, I should try anti-viral medications. So I started looking in the medical literature to see what might work. After all, here in the 21st, we should have a reliable flu remedyto escape all those sufferings, right? I was looking, looking, looking…

I couldn't find any. To my surprise, there was no reliable and safe anti-viral medication. So I said to myself: if in all these years they couldn't find a remedy for something as simple as the flu, then maybe the remedy isn’t some magic pill?

GOOD BACTERIA GONE BAD
While sifting through medical literature, I learned a lot about bacteria. I learned that one of the most dangerous bacteria, Staphylococcus aureus, can cause a very serious skin infection. But why does it damage skin? Because it lives there. Another bad bug, Hemophilus influenza, can cause serious sinus infection. Why? Because it lives there. It’s strange that bacteria can cause serious infection where they live--but not anywhere else. In truth, bacteria should not be a threat where they live, since they are natural inhabitants. Or, on the other hand, if they are dangerous bugs, maybe they shouldn't be natural inhabitants of the human body. Something was very wrong there. Unless it was not really a bug that caused the problem... Usually we blame the bug, but could it be something else? Could it be us, who are to blame? Maybe it’s our immune systems that are the problem, not the bugs!

In fact this theory isn’t new. When bacteria were first discovered, there were two points of view: bugs are to blame, and our own defense is the guilty party. The first opinion won—when you’re sick, blame the bacteria. And that's what I was taught in medical school. But is it true? Blaming viruses for my problem didn't work. So I decided to blame myself, especially my immune system.

A SYSTEM FOR STAYING HEALTHY
Rather than going for the flu prevention medicine, I started looking for ways to improve my immune system. And I learned that to strengthen my immune system and improve my ability to cope with stress, I needed to do two things:

1. Give my body everything it needs for my immune system to work properly.
2. Get rid of toxins and unnecessary stress.

So I detoxified myself, did everything possible to reduce my stress level, and normalized my sleeping pattern. I started taking vitamins and micro-elements. I've worked very hard to reduce the stress from processed food and to normalize my bacterial gut flora. It took me a few years to do it. But eventually I achieved what I wanted to: I have not gotten sick with the flu for years. Occasionally I have a very mild runny nose but that's it--no major problem.

HOW TO STAY HEALTHIER THIS FLU SEASON
Make sure you’re getting enough vitamin D. Taking the right level is key.
Get enough vitamin C, but before taking it you should be checked to see if you have a G 6 PD deficiency (the most common human enzyme deficiency). If you don’t have enough of this enzyme, you shouldn’t take vitamin C.

Get enough sleep--at least 8 hours. Keep in mind that getting sleep at inappropriate time doesn’t make any sense. If you want real sleep, you should get to bed at about 9 PM (no late-night talk shows!) and get up at about 6 AM. Otherwise it's not quality sleep.
Get rid of unnecessary stress. Review your daily activities, and eliminate anything that is not really necessary. (No, you don’t have to check your email every 5 minutes!)

Take care with your diet. Stay away from processed food and carbs. Stick with a Paleolithic diet. Eat garlic, but not too much of it. For my patients, I usually do not recommend more than one clove a day. If you are allergic or sensitive to garlic, do not take it.
Avoid crowded places, especially doctors’ offices and hospitals.

Wash your hands often and use a mask if necessary.
Do not make any health decisions unless approved by your doctor.

Good luck!
9/26/2015 12:58:44 AM
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Diane
My daughter is a 19-year-old, healthy, athletic sophomore at a prominent Pennsylvania university nursing school. She was "forced" to have the flu vaccine (i.e. no vaccine, no clinical work!), and within days was suffering from chest pain, shortness of breath, headache, and a cough. After we discerned these were reactions to the vaccine, I told her to report to the school health center. She was persuaded to believe her pain was a simple musculoskeletal response to a rigorous workout...that the reactions had nothing to do with the flu vaccine. We know better. She immediately reported the reactions to the VAERS.
11/22/2015 12:59:50 PM
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