Στις 24-11-2015 το FDA / USA ανακοίνωσε ότι εγκρίθηκε το πρώτο εμβόλιο εποχικής γρίπης που περιέχει ανοσοενισχυτικό. Προορίζεται για άτομα άνω των 65 χρόνων που φυσιολογικά έχουν μειωμένη ανοσολογική απάντηση σε εμβόλια. Το ανοσοενισχυτικό είναι διάλυμα σκουαλενίου.
Το εμβόλιο (Fluad) είναι τριδύναμο περιέχοντας δύο υποτύπους Α και έναν υπότυπο Β.
FDA News Release / 24-11-2015
Μέχρις εδώ καλά. Εξάλλου το εμβόλιο είναι ήδη εγκεκριμένο σε 38 χώρες μεταξύ των οποίων 15 ευρωπαϊκές. Εκείνο που λίγο θορυβεί είναι η ένταση των σχολίων που ακολούθησαν την ανακοίνωση αυτή. Μπορεί να τα βρεί κανείς στο Medscape. Δείχνουν την αντίθεση που υπάρχει για το εμβόλιο γρίπης, δείχνουν αντιεμβολιαστική άποψη και επίσης επικριτική για το πόσο σωστά ή όχι είναι μελετημένα κάποια πράγματα. Τελικά στο εμβόλιο γρίπης γενικώς υπάρχουν πολλές αντιρρήσεις και δεν μπορεί κανείς εύκολα να συμπεράνει ποιοι έχουν δίκιο: οι υποστηρικτές ή οι επικριτές;
You at the FDA and pharma are one big murderous drug kartel.
Squalene!?? This will be a surefire way of kicking the elderly "off the cliff" into polio ... ooops its called Guillaine Barre these days... or just DEATH. This with the new Nazi forced children vaccines nationally, is global depopulation on steroids.
Mr. Rockefeller recently said -" people aren't dying quickly enough.... people are too resilient, despite our efforts"...his words, not mine.... so I guess we are just going to pour a bunch of extra vaccines into people... "double strength" to ensure we meet the UN agenda 21 goal of only 500,000,000 people globally. Yes people we are already at 7 billion so 6.5 billion too many...
More garbage from conventional medicine. Let’s forget for a second about the Cochrane meta-analysis which concluded that flu vaccines as a whole are worthless junk and pretend that this has something to offer, and address this squalene they are obviously so proud of. Squalene adjuvant vaccines create an extremely strong antibody response that may cause death in some people. FLUAD consists of a combination of squalene and Polysorbate 80, a common surfactant used in vaccines, which literally blows up the blood brain barrier allowing aluminum, Thimerasol and other vaccine toxicants to enter the brain. Gee, I wonder if that could cause an issue!? Who’s for dementia and other debilitating neurological diseases? Squalene (MF-59) has been shown to cause severe autoimmune disorders such as MS, rheumatoid arthritis and Lupus. Yes, yes -squalene occurs naturally in the human body in small amounts to assist with vitamin D production, administering synthetic squalene is much different, particularly when it’s injected via a vaccine.
We'll have to ponder a proper name for the new syndrome associated with this new vaccine for seniors. The symptoms of Gulf War Syndrome were: chronic fatigue, muscle pain, cognitive problems and digestive issues.
On second thought, perhaps rather than having to deal with a new syndrome we can simply dismiss the symptoms as typical for this age population. "The vaccine didn't make you sick... You're just old!"
Another approved under accelerated review with a clinical study aftermath....God protect me from science" when I can't speak for myself any longer!
Kudos to you all, for having the courage to add an adjuvant, to the flu vaccine. Is a good move? I doubt , you can not
injected attenuated virus into the individual, with the purpose to initiate an immunologic reaction, and then inject an adjuvant, why? Because this is a self defeating move. Injecting a virus to start an immunologic reaction, ending in antibodies against this specific virus, is target. Giving concomitantly the attenuated virus, will result, instantly in demise of the virus, therefor no antibodies formed. What we need is Flu-gone and not:Fluad.
"it's utter insanity to allow this stuff to be injected into humans."
They didn't "add an additional allergen" to make amoxicillin. They changed the chemical structure of the side chain. This was done to change the antimicrobial spectrum. Pen VK is still available and still works just fine. Amoxicilin and penicillin have different spectra of activity and different indications.
"Mechanism of action. Originally, Syntex adjuvant (containing squalene oil, a non-ionic surfactant, poloxamer L121, and threonyl muramyl dipeptide) was developed as a replacement for CFA.39 However, this adjuvant proved too toxic for human use40 and Chiron subsequently developed MF59 adjuvant as an alternative.41 MF59 is a submicron oil-in-water emulsion which contains 4–5% w/v squalene, 0.5% w/v Tween 80, 0.5% Span 85, and optionally, varying amounts of muramyl tripeptide phosphatidyl-ethanolamine (MTP-PE), which activates non-TLR sensing receptors known as NOD-LRRs (reviewed in Akira42 ). Because of excessive reactogenicity and/or toxicity, the current version of MF59 used in an adjuvanted influenza vaccine (FLUAD) registered in Italy does not contain MTP but instead just squalene oil and surfactants.43,44 Published data suggests addition of MF59 only induces a modest (about 25%) increase in antibody levels in the elderly and no difference in younger individuals when compared to unadjuvanted influenza vaccine.4,45 Furthermore, there was little evidence that MF59 is antigen-sparing for influenza vaccines, since the same antigen dose is required for MF59 as for the unadjuvanted vaccine.4,45 MF59 has been shown to be superior to alum in inducing antibody responses to hepatitis B vaccine in baboons46 and humans.47"
"Limitations of MF59. On the negative side, MF59, like all other oil-in-water adjuvants, is associated with major increases in injection site pain and reactogenicity.4 Another concern with squalene oil is its ability to induce chronic inflammatory arthritis in susceptible animal models.48 Susceptibility to squalene arthritis is genetically determined, raising the risk that adjuvants based on squalene oil may also induce or exacerbate inflammatory arthritis in genetically susceptible humans.48"
Thank you so much for this clarifying info.
My immediate reaction to the headline of this article was, "Oh, joy, MORE toxicity!"
I am over 65 and I had the high dose flu vaccine last year. Within an hour or so I became ill with fever, aching and a very sore arm--I could barely lift my arm. I filed a report. This year I got the regular vaccine. No problems. I continue to work as a clinician and I am exposed to a lot of infectious disease. I intend to stick with the regular flu vaccine.
"the adjuvant is an oil-in-water emulsion of squalene oil, a naturally occurring substance in humans, animals, and plants that is highly purified for making vaccines."
this is the stuff in feline vaccines that's caused an epidemic of hyperthyroidism in house cats and probably what causes fatal injection site sarcoma in same.
https://www.google.com/search?q=cat+vaccines+adjuvants+squalene&ie=utf-8&oe=utf-8
it's utter insanity to allow this stuff to be injected into humans.
Squalene can be derived from shark liver oil or from plant sources such as
amaranth seed, rice bran, wheat germ, olives, etc.
There are no specifications for residual allergen content in vaccines. So Fluad can be contaminated with any of the above food proteins along with chicken egg proteins from the influenza virus growth media.
Squalene is an adjuvant that produces stronger Th1 and Th2 (allergic) responses, making it dangerous to even have trace quantities of residual allergen proteins in the vaccine.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3876261/
As I show in my paper below, this increases the risk of patients developing new food allergies.
In vaccine clinical trials, food allergy is not a solicited adverse event. So new food allergies will rarely, if ever, be detected/reported.
Arumugham V (2015) Evidence that Food Proteins in Vaccines Cause the Development of Food Allergies and Its Implications for Vaccine Policy. J Develop Drugs 4: 137. doi:10.4172/2329-6631.1000137http://www.omicsgroup.org/journals/evidence-that-food-proteins-in-vaccines-cause-the-development-of-foodallergies-and-its-implications-for-vaccine-policy-2329-6631-1000137.pdfThere are no specifications for residual allergen content in vaccines. So Fluad can be contaminated with any of the above food proteins along with chicken egg proteins from the influenza virus growth media.
Squalene is an adjuvant that produces stronger Th1 and Th2 (allergic) responses, making it dangerous to even have trace quantities of residual allergen proteins in the vaccine.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3876261/
As I show in my paper below, this increases the risk of patients developing new food allergies.
In vaccine clinical trials, food allergy is not a solicited adverse event. So new food allergies will rarely, if ever, be detected/reported.
Certainly the contents of this review fails to point out WHY this vaccine was given a prioritized license by the FDA if indeed, the immunogenicity with and without the adjuvant is similar or identical (not statistically different). Perhaps there is no WHY, but I hope this is not the case and all we have is another me-too vaccine.
When immugenicity is same then why this Fluad which must be costly
So... according to the FDA website (http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm474295.htm), Fluad demonstrated immunogenicity in 7000 subjects over 65 "comparable to the levels induced by Agriflu." That's comparable to, not superior to. Agriflu contains no adjuvant. So what is the advantage of including squalene or other additional substances as adjuvants if they don't improve the immunogenicity of the vaccine in the target population?
Somebody help me understand why we need this.
Seriously. Why add toxicity for no benefit? All I can think of is that this is an admission of the poor effectiveness of previous flu vaccines in the older population. Adding hazardous material isn't going to make a bad strategy better, it seems to me.
A word of caution: Vaccines with oily adjuvants in the past have occasionally produced sterile abscesses that may need to be drained. The "local reactions" referred to in this summary article may have included some such, but this is not made clear. More information on this point should be made available.
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