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NVIC Questions FDA Fast Tracking of Squalene Adjuvanted Flu Vaccine

National Vaccine Information Center

“Novartis failed to demonstrate that squalene adjuvanted Fluad was more effective or safer than an unadjuvanted influenza vaccine in the small clinical trial being used to justify accelerated licensure.” — Barbara Loe Fisher

The non-profit National Vaccine Information Center (NVIC) is questioning the basis for the fast tracked licensure by the U.S. Food and Drug Administration (FDA) of a squalene-adjuvanted influenza vaccine for use in seniors over age 65. The Novartis MF59 adjuvanted Fluad vaccine was approved for accelerated licensure by the FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Sept. 15, 2015 primarily using limited immunogenicity and safety evidence from a small clinical trial in which only about 1,000 healthy Americans over age 65 were given the adjuvanted vaccine.1 2

“Novartis failed to demonstrate that squalene adjuvanted Fluad was more effective or safer than an unadjuvanted influenza vaccine in the small clinical trial being used to justify accelerated licensure. In fact, Fluad was shown to be far more reactive and, in some studies, the vaccine was associated with even more serious reactions in the elderly when given a second time,” said NVIC Co-founder and President Barbara Loe Fisher.

At public comment time, Fisher asked the FDA advisory committee, “Why does Fluad need to be fast tracked to licensure for the elderly 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.”3

Before the FDA advisory committee had taken a vote on whether Novartis had demonstrated the safety and effectiveness of Fluad in seniors, agency officials indicated they would approve accelerated licensure of the vaccine even though fast tracking is supposed to be reserved for instances when there are vaccine shortages. There are nine influenza vaccines licensed by the FDA as safe and effective for seniors, including two high dose options, and the Centers for Disease Control (CDC) estimates more than 170 million doses of influenza vaccine will be delivered to the U.S. market for the 2015-2016 flu season.4

Although MF59 is bioactive and designed to stimulate a strong immune response, FDA does not require that vaccine adjuvants be proven safe in a placebo controlled trial and they are not licensed separately.5 Fluad will be the first influenza vaccine licensed in the U.S. containing squalene, a controversial oil in water adjuvant that has been linked with development of autoimmunity, narcolepsy and other immune and neurological disorders.6

In her Sept. 15 public statement at the FDA advisory committee meeting, Fisher pointed out that the Novartis clinical trial did not provide sufficient evidence for fast track licensure of Fluad when:

  • It is known that responses to vaccination are affected by genetic factors and only 30 percent of the Fluad study population was ethnically representative of U.S. seniors over age 65;
  • The majority of Fluad study participants did not have heart, lung and kidney disease or other chronic health conditions that affect two-thirds of U.S. seniors, although chronically ill seniors will be recipients of Fluad after licensure;
  • Fluad produced a much higher number of pain, tenderness, redness and swelling reports; a higher number of systemic adverse reaction reports and more deaths and cases of new onset chronic disease;
  • The study did not evaluate the safety of giving repeated doses of squalene adjuvanted Fluad year after year to seniors with multiple chronic conditions;
  • There is no information on how Fluad performs when given simultaneously with other vaccines (such as pneumococcal vaccine).

NVIC is a charitable educational organization founded in 1982 to prevent vaccine injuries and deaths through public education. It does not make vaccine use recommendations and advocates for the inclusion of informed consent protections in U.S. vaccine policies and laws. NVIC monitors vaccine science, policy and law and provides public comment at federal vaccine advisory committee meetings.


18 Responses to NVIC Questions FDA Fast Tracking of Squalene Adjuvanted Flu Vaccine

  1. Louise Gallagher Reply

    September 17, 2015 at 9:45 am

    I appreciate the educational info about vaccines. I personally think that big pharmacy and our government is truly killing our young and old. I think money and control is at the root of it all.

    • Carwyn Williams Reply

      September 17, 2015 at 5:31 pm

      There may be something a bit darker than money/greed at the bottom of this, or is that greed corrupts so thoroughly. Very, very scarry.

      • Jenny M Reply

        October 23, 2015 at 3:50 pm

        Read about the Georgia Guidestones, that should help make sense of all this craziness. Also, an excellent book is “The Rockefeller File” by Gary Allen and “None Dare Call it Conspiracy”.

  2. Berne Van Duinwyk Reply

    September 17, 2015 at 10:14 am

    I would like to know how many children who never were vaccinated have Autism today?

  3. Sheldon Reply

    September 17, 2015 at 11:46 am

    I’m sure that this was an innocent mistake in writing an article about Fluad with MF59 and leaving out any mention of its use in Europe for years and years. People who didn’t know better would think that this was a brand new vaccine.

  4. naomi zuckerman Reply

    September 17, 2015 at 12:25 pm

    why no mention of what the ingredients in this vaccine are? what exactly does “squalene-adjuvanted ” mean?

    • Sheldon Reply

      September 17, 2015 at 1:54 pm

      Vaccines work by presenting themselves to the immune system and getting a reaction which creates antibodies ready to fight off the actual virus or bacteria.

      The problem with the flu vaccine in the elderly is that their immune system may not give a strong enough reaction to the vaccine and thus it is less effective in the elderly.

      One US approved vaccine’s answer is to give a flu vaccine to the elderly that contains 3 times as much stuff as the same vaccine for those who are not elderly and thus get a stronger reaction from the immune system and a more effective result.

      Another approach is to use the standard strength vaccine an add to the vaccine something (an adjuvant) which will create a stronger reaction to the vaccine. The adjuvant MF59 is made up of a specially processed fish oil. MF59 has been used in Europe for years and years.

      • Sheldon Reply

        September 17, 2015 at 5:03 pm


        Fluzone HighDose has 4 times as much of each of the antigens, not 3 times as much.

        According to a study in the New England Journal of Medicine, it “indicated that the high-dose vaccine was 24.2% more effective in preventing flu in adults 65 years of age and older relative to a standard-dose vaccine.”

        So those over 65 bothered by sqaualene (no reason to) can get Fluzone High Dose.

        Fluad with MF59 was found in a major study “Results found
        that FLUAD reduced the risk of hospitalizations caused by influenzaor pneumonia by 23 percent in older adults compared to the nonadjuvanted vaccine

        And since Fluzone High Dose and Fluad with MF59 are only packed as individual doses, there will absolutely be zero Thimerosol in them.

  5. naomi zuckerman Reply

    September 17, 2015 at 12:29 pm

    why no mention about what the ingredients of this vaccine are? what exactly is “squalene-adjuvanted “?

  6. Francis E Aloise Reply

    September 17, 2015 at 9:07 pm

    Why the need for the fast track? I can see a mirid of possibilites, not all of them good. Follow the money.

  7. APV Reply

    September 17, 2015 at 9:27 pm

    The Institute of Medicine has concluded that the egg (ovalbumin) present in current vaccines causes the development of egg allergy in non-allergic people.

    Adding an adjuvant (MF59) to an egg containing vaccine will cause more people to develop severe egg allergies.
    Vaccine trials do not look for development of allergies.


    Document Pg. 65 (pdf pg. 94 ):

    “Adverse events on our list thought to be due to IgE-mediated
    hypersensitivity reactions
    Antigens in the vaccines that the committee is charged with reviewing do
    not typically elicit an immediate hypersensitivity reaction (e.g.,
    hepatitis B surface antigen, toxoids, gelatin, ovalbumin, casamino acids).
    However, as will be discussed in subsequent chapters, the
    above-mentioned antigens do occasionally induce IgE-mediated
    sensitization in some individuals and subsequent hypersensitivity
    reactions, including anaphylaxis.”

  8. Kathy Reply

    September 17, 2015 at 10:09 pm

    The comment by Berne Van Duinwyk was awesome! Is there any study’s on how many have autism when they haven’t received vaccines maybe that needs to be studied and brought to there attention. I get it will probably fall in deaf ears but could be a great argument. Please respond and thank you!

  9. L.H. Reply

    September 18, 2015 at 7:51 pm

    My spouse works in a pharmacy. There is a HUGE push to inoculate the public with the flu vaccine. The cashiers get a bonus for each victim, er, customer that they refer. The pharmacist told my spouse that the CDC is behind this push. That would be the same CDC that holds a patent on ebola. Think about that before you get the flu shot.

  10. Jenny M Reply

    October 23, 2015 at 3:43 pm

    Oh no! I read the book by Gary Matsumoto “Vaccine A, The Covert Government Experiment That’s Killing Our Soldiers…”. In his book he mentions that they used squalene as an adjuvant. Squalene from what I read is made by your liver (a type of cholesterol, I think) and injecting squalene directly into your body can sensitive your immune system to react to your own body’s squalene and cause Lupus and other horrid disorders. He mentioned a soldier who got some sort of skin disease that made his skin fall off his body…pretty gruesome. Especially since the government has already experimented with squalene adjuvants…horrible! Just horrible.

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