FDA Approves First Seasonal Influenza Vaccine Containing an Adjuvant

Infection Control Today ^ | 11/25/2015 | staff

[catnipman]

The Food and Drug Administration (FDA) announces that it has approved Fluad, the first seasonal influenza vaccine containing an adjuvant.

Fluad, which is manufactured using an egg-based process, is formulated with the adjuvant MF59, an oil-in-water emulsion of squalene oil.

The study showed that Fluad induced antibody levels that were comparable to the levels induced by Agriflu [i.e., no better.]

Fluad was approved using the accelerated approval regulatory pathway, which allows the FDA to approve products for serious or life-threatening diseases based on evidence that the product has an effect on an outcome that is reasonably likely to predict clinical benefit

[catnipman]

Watch out for this one folks.

1. First flu vaccine with an adjuvant. (Adjuvants are extremely bad news for the immune system as the function by hyper-accelerating the immune system, sometimes phrased as "irritating" the immune system.)

2. FDA "approved" using the accelerated approval regulatory pathway, which allows the FDA to approve products for serious or life-threatening diseases based on evidence that the product has an effect on an outcome that is reasonably likely to predict clinical benefit. In other words, approve now, and prove later it doesn't kill or maim people.

3. Number two above is totally bogus because this was not proven to be more efficacious than existing flu vaccines.

4. Sqaulene in cat vaccines has caused an epidemic in feline hyperthyroidism and fatal injection site sarcoma.

4. They're targeting old folks with this one.

5. Below is the discussion about this vaccine in medscape.com (which isn't otherwise viewable without a login account):

Dr. Randall Fisher 2 hours ago

I find it somewhat amusing that everybody is touting this as the first adjuvanted flu vaccine.

Alum is an adjuvant. Therefore, all inactivated injectable flu vaccines are already adjuvanted, and have been for decades. Fluad is just a flu vaccine with a DIFFERENT adjuvant.

Vinu Arumugham 18 minutes ago

@Dr. Randall Fisher

No. Inactivated injectable flu vaccines currently approved for use in the United States do NOT contain alum as an adjuvant.

Teri W 2 hours ago

I agree with the others who've asked, if the antibody response is similar to the non-adjuvant vaccine, the adjuvant isn't really doing anything, so what's the point of having this extra substance in the mix to cause potential problems?

N C 3 hours ago

Another approved under accelerated review with a clinical study aftermath....God protect me from "science" when I can't speak for myself any longer!

DR. GERALD GAMBALE 3 hours ago

ASIDE FROM THE MINIMAL SIDE EFFECTS, THIS VACCINE SOUNDS LIKE A GOOD IDEA, ESPECALLY FOR THOSE

IN THE 65 Y/O AND GREATER AGE GROUP.

Dr. Chagai Dubrawsky 4 hours ago

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.

Dr. Randall Fisher 2 hours ago

@Dr. Chagai Dubrawsky This vaccine does not contain an attenuated virus, it contains a killed (inactivated) virus. An adjuvant can't result in the demise of the virus because the virus is already dead.

Teleta White 4 hours ago

Thanks for the information, need further information.

S J 6 hours ago

I totally agree with Vinu Arumugham. As a researcher studying autoimmunity, adding this chemical to flu vaccine seems to be "asking for trouble" or even stupidity. I had no problems with Pen v. k. until they add additional allergen and made amoxicillin. Now, I am allergic to it. FDA must have nothing else to do.

Dr. B I summed it correctly "it's utter insanity to allow this stuff to be injected into humans."

Dr. Randall Fisher 2 hours ago

@S J 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.

Dr. Juan Torres 10 hours ago

Good Info

c j 11 hours ago

Relevant industry comparison/review:

http://www.biopharminternational.com/new-age-vaccine-adjuvants-friend-or-foe

"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"

Elene Gusch 8 hours ago

@c j Thank you so much for this clarifying info.

My immediate reaction to the headline of this article was, "Oh, joy, MORE toxicity!"

L H 11 hours ago

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.

Dr. Chagai Dubrawsky 11 hours ago

Finally the FDA admit that adjuvant, given concomitantly with the flu vaccine is essential. What is the adjuvant?

Did you know that the best adjuvant is:Niacin-nicotinic acid?

Carina Vigna 12 hours ago

Currently, we are vaccinating adults 65 and older with Fluad, with no complications to the vaccine having been reported.

frederick bomonti 2 minutes ago

@Carina Vigna Question that remains to be answered, has it changed the number of cases of the flu you have seen in the 65 and older population? The statistics since 1980 show no changes in the incidence or mortality rate with increased inoculation rates and so the idea that there is no reaction is nice, but does it do anything.

Dr. B I 12 hours ago

"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.

Travis Irvan 3 hours ago

@Dr. B I I don't believe for one moment you're an actual physician or doctor of any kind

Whitney Morejon 12 hours ago

To the author et al: if a patient 65 or older already received HD flu shot or other flu shot are they able to receive this dose? And is there a allotted time to separate the other vaccines?

Elene Gusch 8 hours ago

@Whitney Morejon If they already received another flu shot, why in the world would you want to add to their risk by giving them this on top of it?

2 Dr. Scott Goff 12 hours ago

To the Author et al: How does this Fluad compare with the current ( and widely used ) FluZone High Dose ( a 4x antigen load compared to the straight FluZone ) ? Any thoughts appreciated.

Vinu Arumugham 11 hours ago

@Dr. Scott Goff

The vaccine trials/results may be complicated by the previous influenza vaccination history of the subjects also.

Many studies may be conducted in third world countries where routine influenza vaccination is absent.

In that case, the trial results will be optimistic compared to actual vaccine performance in the US.

http://cid.oxfordjournals.org/content/early/2014/09/29/cid.ciu680.full

Thomas flamini 13 hours ago

Wow, and I had to settle for Afluria

Vinu Arumugham 13 hours ago

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:10.4172/2329-6631.1000137 http://www.omicsgroup.org/journals/evidence-that-food-proteins-in-vaccines-cause-the-development-of-foodallergies-and-its-implications-for-vaccine-policy-2329-6631-1000137.pdf

Dr. J Z 13 hours ago

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. It doesn't belong to Novartis anyway, as they sold their influenza vaccine business to CBL, I believe.

Marena Arnold 1 hour ago

The only reason I can think of is some other agenda at hand. Why else would you expedite the process with no difference in induced antibodies??

Jerome Schindler 13 hours ago

Just in time for the 2015-16 Flu season . . . NOT

b h 13 hours ago

decrease the excess population!!

Philip Kyles 13 hours ago

Whats the point if response is the same? Please show statistics... Some people know what the mean! Still intriguing, I like seeing new stuff!

Dr. sunil kumar 13 hours ago

When immugenicity is same then why this Fluad which must be costly

Stephanie Bozigian-Merrick 14 hours ago

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.

Elene Gusch 8 hours ago

@Stephanie Bozigian-Merrick 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.

N C 3 hours ago

We don't....another moneymaker with the human guinea pig

Dr. James Ransom 14 hours ago

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.

[Buckeye McFrog]

I’m so glad George W. Bush gave them complete immunity from lawsuits. /s

[ifinnegan]

Spread your liberal claptrap elsewhere.

Pseudo science global warming-like idiocy.

My opinion is no one needs a flu, but you are just spreading nonsense of liberal proportion, a backwards anti western world view.

And again - I don’t think any needs these flue shots but I can’t stand the lying idiocy and ignorant fearmongers pushing this liberal anti-science, anti-western rationality claptrap.

[surroundedbyblue]

My husband & I did NOT receive the flu vaccine this year nor didn’t get one for my child. It’s bogus.

[LucyT]

Check out article ... and # 1 .

.

[Buckeye McFrog]

At the very least the comments section reveals a Keystone Cops mentality.

[LurkingSince'98]

Someone is lying.

They have been trying to slip squalene or one of its derivatives into vaccines for years.

It is bad juju for sure.

Plus many of the vaccines use embryonic stem cells derived frim aborted foetuses - they do that to dirty you up.

[antidisestablishment]

Just damn. I had an arthritic reaction to my last Anthrax vaccine and now I face another likely antagonist in this shot. As a military member, I can’t refuse any immunizations because the government will not admit any correlation.

Pseudo-science or not, when you feel like you’ve aged 20 years from one shot, it sucks!

[Talisker]

Try replying with a declared subject, production of evidence and then discussion. Merely repeating the word “claptrap” is meaningless, unless your goal is simple emotional eruption for vague reasons.

[Don W]

I didn’t see any claptrap, and since when is a group of doctors discussing vaccine efficacy “liberal pseudo science global warming like idiocy”?

Over the last 4 consecutive flu seasons what the medical community agreed would be the most likely active variant was in fact NOT correct. They guessed wrong.

I have to get a flu shot every year as a condition of employment. I ALWAYS get it in the middle of my last shift (I work 4 on 4 off) before *MY* long weekend, because I can’t move my arm or mentally focus on anything for 3 full days afterwards. This year’s injection took me out for 5 days, and my arm is still pretty sore today, 7 days after getting back to work.

What this article and the series of comments following is discussing is the addition of an adjunct (irritant/immune system supercharger, if you will) that has NOT been shown to increase the effectiveness of the vaccine, which in and of itself has NOT been shown to help those it is claimed to be targetting.

In plain English: the flu shot is yet another big lie.

[Don W]

adjuvant. my oops.

[Ann Archy]

Amen about them using ABORTED BABIES CELLS for vaccines.....NOTHING good...NOTHING good can come from using those!!

[ifinnegan]

“In plain English: the flu shot is yet another big lie.”

You have no idea that the flu shot is a “big lie”.

I feel you and the antivaxxers use emotional means to spread irrational thought and disinformation.

My opinion is yearly flu shot is not necessary and I never have ever gotten one.

I may actually be more in agreement that they are a “big lie” than they are useful. Yet I maintain objectivity and rationalism and avoid hysteria.

All the marks of the liberal mind are found in the antivax movement and the antivaxxers movement has come out of the left liberal side with all the same world views of evil corporations and capitalists and mistrust of western science and worldview.

As far as this adjuvant and discussion on squalene see:

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1563566/

[MarchonDC09122009]

I Greatly appreciate this post.
I have adult kids who are subject to mandatory flu shots which they hate, due to allegic reactions they get.
This is very helpful information.
Stay an informed critical thinker!

[concerned about politics]

First flu vaccine with an adjuvant. (Adjuvants are extremely bad news for the immune system as the function by hyper-accelerating the immune system, sometimes phrased as "irritating" the immune system.)

Population control. People would die of "natural causes" and no one would know the difference. The immune system would attack the healthy organs and it would be called simple organ failure.
The elites don't like it when their herds get out of control. It must be time for their "Great Culling" to begin.

You might want to tell your friends and loved ones to avoid any government sponsored or advocated medications. Things aren't always what they appear to be. (There's way too many baby boomers using up the socialists financial resources)

[concerned about politics]

They're targeting old folks with this one.

Yep. Bingo. The elderly are interfering with socialized medicine. They're costing too much, and they leave little for the EBT card holders who are suppose benefit from it (because they vote correctly).

After Bush instituted the Welfare to Work Program, millions of welfare freeloaders moved over to Social Security. They claimed a disability, and because of organizations like the ACLU, doctors were afraid to argue about it, and simply agreed to the claimed disability. Because the baby boomers are all in their S.S. age, there's not enough S.S. money left to support both the elderly and those feeding from the public teat.

Baby boomers have to be culled, or the socialists Tower of Babble will fall.

[surroundedbyblue]

The flu shot last year was shown to be only 19% effective, yet it’s marketed as a sure thing. And it does have side effects that are very much downplayed. In other words, it’s a big lie.

[bmwcyle]

My last and final flu shot was 1978.

[hoosiermama]

Don hen teaching I would get the shot and have a similar reaction. Now I’m getting shots through the local pharmacy The pharmacist said the reaction was because of a latex intollerence. Now that they give me the non latex shot I have absolutely no problems. Pharmacies are required to keep both types on hand

[grania]

baby boomers have to be culled

It seems we're evolving from an individual health policy to public health initiatives. Sure, flu (and other vaccinations) will kill off some people, but so what? The goal is to stop people from getting sick or spreading disease, dead or alive. The other goal is for the medical profession to pump our bodies full of profit-making poisons.

We The People have to start using our God-given brains. Take care of our own health and well being through nutrition, exercise, and life style choices. Don't be convinced to take a medicine or get a procedure until you do your own research. Don't be scared into anything by the medical profession.

I just don't get it. I know people who complain about how they're losing control of their bodies and they can't afford their co-pays and premiums. And they take medicines for cholesterol, high blood pressure, irregular sleep patterns, depression, get every flu shot they're told to, get replacement body parts etc etc. It's the multiple odds thing. Eventually, something is going to have a really nasty side effect.