Fluzone Quadrivalent Influenza Vaccine Approved by FDA for Elderly

Fluzone Quadrivalent Influenza Vaccine Approved by FDA for Elderly

The U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (BLA) for the Fluzone high-dose quadrivalent influenza vaccine for use by adults 65 years of age and older. Fluzone is manufactured by Sanofi Pasteur, Inc. of France.1 2

The Fluzone high-dose influenza vaccine was approved by the FDA in 2009 as a trivalent influenza vaccine, including two influenza A virus strains and one influenza B virus strain. The quadrivalent version of the vaccine contains an additional influenza B strain.1 2

A BLA is a request  for “permission to introduce, or deliver for introduction, a biologic product into interstate commerce.” It affirms that the product is “safe, pure, and potent” and that the production facilities have been qualified for inspection and each package of the product carries the license number.3 4

According to a Sanofi Pasteur press release, “This approval is the final step toward the company’s complete transition to quadrivalent influenza vaccines in the U.S. Fluzone High-Dose Quadrivalent will be made available for immunization efforts during the 2020-2021 influenza season.”1 

The press release notes that the rates of “local and systemic reactions” to the Fluzone quadrivalent have been “similar” to those caused by Fluzone trivalent and that the “most common reactions occurring after administration were injection-site pain (41.3 percent), myalgia (22.7 percent), headache (14.4 percent), and malaise (13.2 percent).”1 

The onset of adverse reactions to Fluzone quadrivalent usually occur within three days after vaccination.1 

The Fluzone quadrivalent vaccine contains egg protein, octylphenol ethoxylate (Triton X-100), sodium phosphate-buffered isotonic sodium chloride solution, thimerosal (multi-dose vials), and sucrose.5

Numerous studies, including a major one by the U.S. National Institutes of Health (NIH), have provided data showing that flu shots provide no benefit to the elderly and, in most flu seasons during the past 15 years, flu shots were less than 50 percent effective in preventing influenza in children and adults of all ages.6 In an article reprinted in The Vaccine Reaction, investigative report Sharyl Attkisson referenced the NIH study saying that “no matter how they crunched the numbers, the data kept telling the same story: flu shots were of no benefit to the elderly.”7 

“Quite the opposite,” wrote Attkisson. “The death rate had increased markedly since widespread flu vaccination among older Americans. The scientists finally had to acknowledge that decades of public health thought had been mistaken.”8 

The Centers for Disease Control and Prevention (CDC) estimate that the influenza vaccine for last year’s flu season (2018-2019) had an adjusted effectiveness rating of negative 29 to 41 percent for people over 65 years of age—meaning that for this segment of the population getting the flu shot made them more susceptible to infection.8 9 


1 Press Release. FDA approves Fluzone® High-Dose Quadrivalent (Influenza Vaccine) for adults 65 years of age and older. Sanofi Nov. 4, 2019.
Brooks M. FDA OKs Fluzone High-Dose Quadrivalent Influenza Vaccine for Older Adults. Medscape Nov. 5, 2019.
3 U.S. Food and Drug Administration. Biologics License Applications (BLA) Process (CBER). FDA.gov.
4 Biologics license application. Wikipedia.
5 Centers for Disease Control and Prevention. Vaccine Excipient & Media Summary. CDC.gov.
6 National Vaccine Information Center. How Effective Is Influenza Vaccine? NVIC.org 2019.
7 Attkisson S. NIH Research: Flu Shots Not Effective in Elderly. The Vaccine Reaction  Nov. 13, 2015.
8 Mercola J. Flu Shot Fails to Protect Seniors and May Increase Miscarriages. The Vaccine Reaction Oct. 9, 2019.
9 Centers for Disease Control and Prevention. US Flu VE Data for 2018-2019 CDC.gov Sept. 10, 2019.

11 Responses to "Fluzone Quadrivalent Influenza Vaccine Approved by FDA for Elderly"

  1. Mary   November 9, 2019 at 1:51 pm

    Thank you for this information. I recently read a blog post by someone apologising for not getting the post out sooner, but she was down for several days after getting one of the high dose flu shots for the elderly…but, NOT the flu and she was glad to be feeling better and knowing she wouldn’t get the flu, blah blah. Sigh.

    Then I read a study by a university researcher (Cornell?) who wanted to find out if giving pregnant women flu shots would be damaging to their infants when born. The research actually showed that women who had a flu shot the year before had less antibodies against the flu than those who hadn’t taken the shot. However, this didn’t seem of interest to the researcher, because she summarized her findings that giving this flu shot to pregnant women didn’t damage their babies later.

    I really wonder what it’s going to take to break through all this brain washing?

  2. INGRID C DURDEN   November 10, 2019 at 12:03 pm

    I read quite a while ago, that when you once get a flu shot you have to go back every year. I wonder if what Mary writes here, is the cause ? Did anyone ever test the antibodies in vaccinated and non-vaccinated people ? Is any research at all being done to compare vaccinated and non-vaccinated people ? And, of course, sift through all the propaganda of those that benefit from the vaccinations ! The pharmaceutical companies, the doctors, pharmacies, vendors… do we ever get to know how much money is involved in all this, and if this money would not be spent better in other ways, like taking care of healthy food ? I think a healthy person can survive the flu.

  3. JOSEPH MACIAS   November 10, 2019 at 1:21 pm

    Death by complications from lethal injection

  4. CATRYNA WHITE   November 10, 2019 at 1:39 pm

    My husband and I are 70 and 72 and we have never received a flu shot. My parents and grandparents didn’t either and none of our children or grandchildren have either. I remember what happened in 1976 with the Swine Flu shot scam of that year. It was horrifying. I have friends who have suffered stroke, renal disease and death after this damnable superstitious piece of garbage vaccine. There is no going backwards, in my belief, that these shots are nothing more than lethal injection.

  5. Sue   November 10, 2019 at 1:59 pm

    I agree Mary. It’s big news on PBS that the current trend of vaping has caused 2000 people to become ill and yet there is never any mention of the 000,000s of those damaged by or dead because of vaccines.

  6. Montana NAR   November 10, 2019 at 2:00 pm

    My motto is: “I’d rather have the flu than a flu shot.”

    During my adulthood, starting in 1970s, I believed that my immune system, overall, was strong and that if I got “sick” every few years, I would build up antibodies by being sick for a week or so. I learned this somewhere; but don’t have a clue where.

    Why are people so AFRAID of being sick? Even for a week? This is marketed fear, which goes back to the Spanish Flu of 1918 (which was neither Spanish nor flu).

    I know seniors who make sure they get their yearly shingles and flu vaccines. They don’t think about why they do it. Or question their actions. Or ask questions about the contents of the vaccines. They don’t even ask themselves: Do I really need this?

    Vaccines transform immune systems and make them weaker, not stronger. The medical model in this era is “managing chronic disease.” It is very lucrative.

    If you get sick with a cold or flu, take 2 grams per hour of Vitamin C. Read Suzanne Humphries’ recommendations. Take 15, 20, 25 grams per day. It will effectively dry up congestion and help your body heal.

  7. Lawrence Greenberg   November 10, 2019 at 2:09 pm

    I am 66 years old and I will say loud and clear that it will be a cold day in the nether regions before I allow myself to be injected with this garbage or any other toxin they call a “vaccine.”

  8. Joy Metcalf   November 10, 2019 at 3:19 pm

    Why don’t the reference links work on TVR articles? For instance, this article referenced studies but clicking on the reference numbers (6, 7) doesn’t access anything–even though they appear to be live links.

  9. DAVID L   November 11, 2019 at 1:06 am

    The influenza vaccine may be less effective in the elderly because their B cells are less capable of producing antibodies that can adapt to protect against new viral strains. While B cells from younger subjects showed a continued recent accumulation of mutations, the elderly appeared to have an essentially fixed B-cell repertoire, lacking recent adaptations that would allow the evolution of B cells to divergent influenza virus strains. antibodies from aged individuals arise from cross-reactive memory B cells generated early in life, with reduced adaptation to recent influenza virus strains. For example, 47% of antibodies generated from the elderly individuals bound to six or more strains of the flu virus compared to only 12% for the young adults. Antibodies from the elderly individuals had higher affinity to historical strains that were circulating during their childhood and lower affinity to more contemporary strains.https://medicalxpress.com/news/2019-02-lack-antibody-diversity-elderly-susceptible.html

    Why the flu vaccine is ineffective – The flu vaccine is effective for preventing influenza if it is matched to the circulating strain. But researchers at The Institute for Genomic Research (TIGR) in Rockville, Md., tracked the evolution of more garden-variety flu strains for five years in New York State, discovering that the virus can re-assort or mutate even during the same flu season. The researchers found at least three distinct subpopulations of the flu virus over the five years, and in some cases, they were circulating at the same time. The variants were even able to swap genetic materials so its constantly changing and can therefore create a mismatch to whats contained in the vaccine. https://www.medpagetoday.org/infectiousdisease/uritheflu/1877?vpass=1
    Even that does not tell the whole story, because vaccination increases the risk for non influenza illnesses and it can increase susceptibility to and severity of non matched strains since vaccination, unlike a natural infection does not produce NA antibody protection which naturally provide robust and broad protection against divergent influenza strains. These NA-reactive antibodies the body produces from natural infection display broad binding activity spanning the entire history of influenza A virus circulation in humans. Priming your immune system with influenza vaccine can make you more susceptible to infection from other viral and bacterial pathogens. This phenomenon is an effect inherent in what’s known as “heterologous immunity.”

    • Colorado   November 11, 2019 at 2:55 pm

      But, shots good, resisting shots bad. The primary body of consumers and medical persons whom continue to participate in vaccination programs remain inadequately educated on the matter.

      Questions: Which educational institute does one turn to for a detailed doctoral education on everything vaccination? What is that persons title called when working in a hospital or medical environment? How many such persons are employed, at what frequency, and where? What roles do they play in both cdc table assimilation and daily administering of such products to patients?

      The questions nobody is asking. Under the illusion of safety and effectivity, the majority of all institutions actually administering these substances does not hire a single individual actually qualified to understand what they’re administering. The policy on these matters is set entirely and completely by those whom have bonafide conflict of interest issues. The administration of these medical products is completed by anyone capable of holding a needle. Does not compute, logical fault.

      We may not be qualified medical professionals, but we know a conflict of interest when we see one. We have therefore opted out on principal. How well do you suppose these mandatory consumption of product programs would fare if people had to pay cash out of their own pocket for these services? It’s not just the manufacturers whom enjoy blanked immunity, it’s the medical insurance companies as well.

  10. Christopher Gamez   November 11, 2019 at 11:17 am

    On my boat with a crew of 9 sailors we had a flu outbreak. 5 of our crew who were vaccinated anywhere from 3 months to 2 weeks prior all got sick as dogs. They could barely move. The 4 of us unvaccinated crew didn’t get sick. They shut the boat down and sent us to the dr who promptly asked if we wanted the flu vaccine. I said “are you crazy?!!” We worked together for 2 weeks and kept our work areas and common areas clean and didn’t touch our faces and we never got sick. This was a perfect container lab experiment and the flu shot lovers failed miserably.


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