On November 24, 2009, Novartis officially opened its first, large-scale vaccine manufacturing facility in the U.S. Located in Holly Springs, North Carolina. The project is a collaborative effort between Novartis and the U.S. Department of Health and Human Services, which contributed $457M for the design, construction, and licensing of the facility.
For its part in the deal, Novartis is required to provide two commercial-scale lots of "pre-pandemic" vaccine annually for a minimum of three years. In addition, the government has the right to exercise options to purchase influenza vaccine over the next 17 years. (1) Currently, 191 employees work at the plant but that will increase to 350 persons when fully operational, anticipated to be sometime in 2011. The Holly Springs facility will be able to roll out 150 million flu shots per year.
Even though its use has not been approved by U.S. regulators, the plant will be producing MF59 as early as December 2009.(2) MF59 is Novartis' proprietary and controversial adjuvant composed of squalene and a surfactant called Tween80, also known as polysorbate 80. Back in July, 2009, the department of HHS purchased over $343.8M of "oil-in-water" adjuvant from Norvartis.(3) It looks like the government may want to take delivery on its purchase some time soon.
All flu shots used in the U.S. are made from eggs, a time- and labor-intensive process. But the new plant will provide something different. Vaccines will be brewed from animal cells mixed with viruses in six 1,320 gallon fermenters which are owned by the U.S. government and the Department of HHS, as identified by a bright yellow, plastic plaque on the sides of the giant vats. (4)
The use of human and animal cells for biological and pharmaceutical research is big business, particularly in Europe. For example, the European Collection of Cell Cultures (ECACC), established in 1984, is an international depository of cell culture collections. The ECACC describes itself as having one of the "premier collections of authenticated cell cultures in the world." It holds more than 40,000 cell lines representing 45 different species and 50 different tissue types. (5) Many of these lines are used in cancer research; some are specifically made for use with vaccines.
To replicate, influenza viruses need to be mixed with living cells and several types of mammalian cells have been used for this purpose since the 1950s. Examples include calf lymph for smallpox vaccines, African green monkey cells (AGMK cells and VERO cells) for polio vaccines, and mouse brain cells for Japanese encephalitis vaccines. In the 1960s, tissues from aborted human fetal tissue, called MRC-5 and WI-38 cells, were developed and are still used for the manufacture of rubella, hepatitis A, chickenpox, and shingles vaccines. Since 2000, new cells under investigation for making flu shots include cells derived from retinas of aborted fetuses (PER.C6), cells from ovaries of Chinese hamsters, and even cells from insects.
Perhaps even the FDA agrees that a vaccine made from infected caterpillar eggs is just a little too weird. On November 19, an FDA panel voted 6 to 11 against the approval of FluBlok, flu shots made from bugs, citing "lack of safety data" as the reason. Made by Protein Sciences Corp. of Meriden, Connecticut, FluBlok would have been the first cell-line influenza vaccine licensed in the U.S. (6) Novartis must have been thrilled that its closest U.S. cell-line competitor was knocked out of the running days before it officially announced the launch of its Holly Springs plant.
Novartis still needs approval of its cell line, MDCK cells originating from dog kidneys, before it can ramp up flu shot production. Novartis has been using MDCK cells for several years to make its European-approved influenza vaccines: Optaflu, for seasonal flu, and Celtura, for swine flu. I find it interesting that the plant has been built, the vats are in place and the opening ceremony has been announced...and yet, flu shots made from dog cells have not been approved by U.S. regulators.
Concerns about Injected Animal Cells
When viruses are combined with animal and human cells in culture, the new, "immortalized" cells can replicate in perpetuity. By their very design, the cells are neoplastic (i.e. abnormal). If these abnormal clumps cause tumors when injected into experimental animals, the cell line is called tumorigenic. If the tumors are cancerous, the cell line is labeled as oncogenic. (7)
No matter how careful manufacturers try to be, animal cells, animal DNA and culture-contaminating viruses end up in the final vials. While dog kidney cells have reportedly fewer stray viral contaminants than eggs, the injection of animal DNA could have untoward results in humans. The FDA is aware of this and is rightfully concerned. These stray proteins can be incorporated into vaccine recipient's own DNA, leading to the risk of abnormal genetic transcription. To minimize that possibility, the FDA has set manufacturing guidelines: The final vaccine product should have less than 1 million residual [animal] cells and less than 10 ng of DNA. (8) The FDA trusts that vaccine manufacturers will comply with these standards. I wonder who will be responsible for quality control and batch checking?
I find it disturbing that the FDA has been discussing cell-line concerns since 1998. Couldn't manufacturers develop something better? Less risky? Less disgusting? An even bigger question is, knowing the potential cancer-causing risks of animal cell lines, why have government regulators allowed this technology to evolve and be used at all?
Concerns about the adjuvant, MF59
An adjuvant is molecule added to a vaccine so that less antigen (virus) is needed to achieve an antibody response. This reduces vaccine production costs and when the amount of virus is in short supply, adding an adjuvant stretches the available vaccine supply. With a few exceptions, adjuvants are foreign to the body and can cause adverse reactions.
Several types of adjuvants are used today. The most common are aluminum hydroxide, aluminum phosphate and calcium phosphate. There are a number of others under investigation: oil-based emulsions, products from bacteria, liposomes, endotoxins, and aliphatic amines. (9) Of these, oil-in-water adjuvants are at the forefront because they have been added to several of the pandemic swine flu vaccines.
Scientific data in peer-reviewed journals show that ingested squalene, available as shark liver oil in health food stores, passes easily through the digestive tract. It is a very different story when squalene is injected into the arm. Pearson and his associates at UCLA injected dozens of oils, including squalene, into rats and found that all the oils were toxic, inducing arthritis with varying degrees of severity. Based on their ability to cause join pain, the oils were assigned "arthritis scores," ranging from (+), considered to be mildly toxic, to (++++), which was "guaranteed to cripple." Squalene was given a score of (+++). In addition, all rats injected with squalene developed symptoms that, in humans, would look very much like Guillain-Barre syndrome: the animals were crippled and paralyzed, dragging their hindquarters across their cages. (10)
Squalene stimulates an excessive and nonspecific immune response. A study using electron microscopy was undertaken to examine neurological tissue of mice after they had been given 20g/kg of squalene for four days. The devastating effects squalene were seen in both the central and peripheral nervous system. Researchers documented swollen astrocytes (brain cells) and disintegration of myelin sheath throughout the brain. Peripherally, the myelin sheaths were destroyed and the nerves were compressed. It was concluded that squalene "produces characteristic pathological changes in both the central and peripheral nervous systems. (11)
Granted, this is a very large dose of squalene. However, even a trace amount is not harmless. In immunology, parts-per-billion is a substantial dose. A mere 10 ppb concentration of squalene translates into approximately 184 trillion molecules of squalene and an equal number of potentially destructive immune responses. (12) More than two dozen peer-reviewed scientific papers from ten different laboratories throughout the U.S., Europe, Asia, and Australia have published studies documenting autoimmune disease in animals injected with squalene-based adjuvants.
A convincing proposal for how this occurs can be explained through the concept of "molecular mimicry." Squalene is a normally occurring molecule within the body. It is a precursor of cholesterol and it is on the surface of most cells, particularly throughout the nervous system. The squalene droplets from the vaccine are transported by immune cells to the lymphatic system where antibodies against them are formed. Later, the squalene antibodies can cross react with squalene found normally throughout the body, leading to debilitating autoimmune and nervous system diseases.
MF59 - like similar oil-in-water adjuvants - is capable of an accelerated activation of the immune system. Once "turned on," there is no switch to turn it off. The results of long-term reactions are unknown and most likely will remain unknown. Following patients for an extended period to look for the development of serious reactions is not what the vaccine industry is interested in studying.
Despite substantial evidence--and even admissions of concern--the FDA and the government are moving forward with its celebrated relationship with Novartis. If there is any doubt, there should be no doubt. These concerns, and others outside the scope of this article, deserve an in depth investigation prior to proceeding. Let the buyer - and the vaccine recipient - beware.
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(1) "Novartis Partners with U.S. Government for Faster Flu Vaccine Manufacturing," http://seekingalpha.com/article/175396-novartis-partners-with-u-s-government-for-faster-flu-vaccine-manufacturing
(2) Novartis press release. "Novartis inaugurates large-scale US based cell-culture influenza vaccine manufacturing facility." November 24, 2009. http://www.novartis.com/newsroom/media-releases/en/2009/1356789.shtml
(3) "HHS Purchases Additional H1N1 Vaccine Ingredients." July 13, 2009. http://www.hhs.gov/news/press/2009pres/07/20090713b.html
(4) "Novartis 'Cells' Its Flu Vaccine Technology," November 24, 2009. http://www.cnbc.com/id/34130982
(5) The Health Protection Agency Culture Collections of the Health Protection Agency (HPA), UK. http://www.hpacultures.org.uk/aboutus/index.jsp
(6) FDA panel votes against new bug-based flu vaccine. Reuters. Nov. 11, 2009.
(7) FDA: "Use of MDCK Cells for Manufacture of Inactivated Influenza Vaccines" by Philip R. Krause, M.D., FDA. www.fda.gov/OHRMS/DOCKETS/AC/05/slides/5-4188S1_1.PPT
(8) FDA: Use of MDCK Cells for Manufacture of Inactivated Influenza vaccines," by Philip R. Krause, M.D., FDA
www.fda.gov/ohrms/dockets/ac/05/slides/5-4188S1-1draft.PPT
(9) "Adverse Effects of Adjuvants in Vaccines", by Dr Viera Scheibner. http://www.whale.to/vaccine/adjuvants.html#ADJUVANTS,_PRESERVATIVES_AND_TISSUE_FIXATIVES_IN_VACCINES_
(10) Matsumoto, Gary. Vaccine A: The Covert Government Experiment That's Killing
Our Soldiers and Why GIs Are Only the First Victims Vaccine, 54 (New York: Basic
Books). p 54-55.
(11) Gajkowska B, et al. "The experimental squalene encephaloneuropathy in the rat." Exp Toxicol Pathol. 1999 Jan;51(1):75-80. http://www.ncbi.nlm.nih.gov/pubmed/10048717
(12) Ibid. Matsumoto. p 203.
Follow Dr. Sherri Tenpenny on Twitter: www.twitter.com/BusyDrT@twitter
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Top posting because earlier comments didn't appear.
Governments and others are conducting a very large number of studies on the safety of the H1N1 vaccine. Parts of the massive US effort is found here.
http://www.flu.gov/professional/federal/monitor_immunization_safety.html
And there will be studies carried out in other countries.
Why the massive effort? In my opinion, it is primarily to answer the anti-vaccination movement. along the way, some minor issue or another show up.
The (FDA) licensed the first 2009 influenza A (H1N1) monovalent vaccines ("H1N1 vaccines") on September 15, 2009 (1). The H1N1 vaccines are available as a live, attenuated monovalent vaccine (LAMV) for intranasal administration and as monovalent, inactivated, split-virus or subunit vaccines for injection (MIV). The licensure and manufacturing processes for the monovalent H1N1 vaccines were the same as those used for seasonal trivalent inactivated (TIV) or trivalent live, attenuated influenza vaccine (LAIV); none of these vaccines contains an adjuvant (1).
Vaccine safety monitoring is an important component of all vaccination programs. To assess the safety profile of H1N1 vaccines in the United States, CDC reviewed vaccine safety results for the H1N1 vaccines from 3,783 reports received through the U.S. Vaccine Adverse Event Reporting System (VAERS) and electronic data from 438,376 persons vaccinated in managed-care organizations in the Vaccine Safety Datalink (VSD), a large, population-based database with administrative and diagnostic data, in the first 2 months of reporting (as of November 24). VAERS data indicated 82 adverse event reports per 1 million H1N1 vaccine doses distributed, compared with 47 reports per 1 million seasonal influenza vaccine doses distributed. However, no substantial differences between H1N1 and seasonal influenza vaccines were noted in the proportion or types of serious adverse events reported. No increase in any adverse events under surveillance has been seen in VSD data.
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5848a4.htm
http://www.boston.com/news/health/articles/2009/11/09/swine_flu_monitor/
who was chair the IOM investigation into vaccine and autism, who told the committee in secret when it convened:
“[CDC] wants us to declare, well, these things are pretty safe on a population basis.”
and:
“we are not ever going to come down that it [autism] is a true side effect,”
http://www.nomercury.org/iom.htm
So, this will all be very re-assuring for Sheldon101.
McCormick is not in charge of monitoring swine flu vaccine. That's clear from the article you link to. She's head of an advisory panel that reviews the data from a variety of sources.
She has no authority over VAERS, VSD, the CDC, the FDA or anyone else. In fact, it is hard to say that any one person or any one agency is in charge of monitoring vaccine safety
So stop saying that she is.
The MMWR Vaccine safety report I quoted from is a result of the work of
Reported by: State and local health departments. K Broder, MD, C Vellozzi, MD, CDC Influenza Vaccine Safety Response Team, National Center for Preparedness, Detection, and Control of Infectious Diseases; C Weinbaum, MD, Emergency Operations Center Vaccine Task Force; Y Zheteyeva, MD, P Tosh, MD, A Rao, MD, S Hocevar, MD, D Esposito, MD, EIS officers, CDC.
"A total of 36 pregnant women who received the vaccine had a natural miscarriage, resulting in a miscarriage rate of 0.3%, which is comparatively lower than that among pregnant women who have not received the vaccine."
http://www.cdc.gov.tw/ct.asp?xItem=26759&ctNode=960&mp=5
Getting really sick during pregnancy is not a good idea.
I'm pretty sure that not only does a vaccine need to be approved, but the actual plant and process for making that vaccine must be approved. That is a long process in keeping with the importance of producing the best possible vaccine. This is a vaccine that people of all ages voluntarily decide to take each year, so a slip up can easily erode public confidence.
The overweening power of the vaccine lobby militates against any possible good from it products. A lobby like this creates its own legality - it has exemptions and privileges, the public don't.
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There's no reason why anyone, and especially anyone who believes in freedom of choiceshould object to the news that the plant is finished and is starting testing.
Current US flu vaccine
1. Unadjuvanted egg cultured inactivated vaccine (injected) split/sub unit
2. Unadjuvanted egg cultured attenuated (nasal spray) vaccine.
For a vaccine to be approved for use, it doesn't have to be the best, the most effective. So more effective vaccines don't have to drive others out of the market.
By 2011, the following vaccines may be approved for seasonal, prepandemic (a vaccine made in advance of avian flu H5N1 becoming a human-to-human disease and pandemic use (made against specific H5N1 virus or actual H1N1 virus)
1. Adjuvanted egg cultured inactivated vaccine split (spray, CSL- ISCOMATRIX adjuvant - not squalene) US plant completed
2. Adjuvanted egg cultured inactivated vaccine split (injected, CSL401- aluminum adjuvant) approved in NZ
3.Unadjuvanted egg cultured inactivated vaccine split and subunit
4. Unadjuvanted egg cultured attenuated (nasal spray) vaccine.
5. Adjuvanted egg cultured inactivated split and subunit (AS03 or MF59 squalene adjuvant can be added to any inactivated vaccine)
6. Unadjuvanted whole cell cultured inactivated vaccine (Baxter)
7. Adjuvanted cell cultured inactivated splt/sub unit(Novartis\Sanofi-Pasteur)
What's wrong with letting the market choose?
Flu Vaccination: "Does the Vaccine Matter?" If you're elderly, it does. Expect the elderly to switch to either adjuvanted inactivated splt/subunit vaccines or a whole virus cell cultured vaccines. They are much more effective.
In this case, if you are a US citizen, you have to pay twice - to subsidise the plant and then for the vaccine: no choice. And President Obama has said he is against exemptions. Shelon101, do you believe it is a matter of choice?
(admittedly misquoted from Hamlet, but accurately reflecting your posts.)
If proven safe, we should expect Dr. Tenpenny to embrace it
http://www.proteinsciences.com/flublock-vaccine.htm
Vaccination: Protecting humans against infection the natural way since the 1600s.
The trouble is, where does it stop? How many pharmaceuticals are we supposed have on preventative basis - hundreds? And how long before we get one that doesn't suit us or doesn't combine well with the others. It now seems part of government policy that we should have more and more pharmaceuticals. This is not being driven by popular demand but by cronyism between industry and government departments, and uses public money on an increasingly subject population.
You may be absolutely delighted with this scenario, but I am not sure most citizens would if they began to see how anomalous it was, and how the fundamentals of good government were being abandoned.
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If my body is working fine and I don't get sick, then I don't need drugs. Because vaccines prevent illness they result in fewer drugs being needed. Vaccines are anti-drug and anti the rest of the health care system.
People who don't get sick don't need doctors and prescription drugs and hospitals.
I live in the province of Ontario. For a few years, Ontario has provided free flu shots to everyone. One of the benefits has been a drop in the number of prescriptions for antibiotics compared to other provinces that didn't have this policy. Fewer rounds of antibiotics means fewer chances for antibiotic resistance. It also means fewer people having side-effects from antibiotics which can sometimes be serious.
And that's great.
VACCINATION: Safer than the drugs from BIG PHARMA or BIG ALTERNATIVE (often made by big alternative)
ddanimal - thanks for posting the link - people need to read it
http://www.ageofautism.com/2009/12/300k-to-banyan-communications-from-advisory-commission-on-childhood-vaccines.html
But it is a start.
Vaccination: Since the 1600s, the natural way to prevent infection.
http://www.ageofautism.com/2009/12/300k-to-banyan-communications-from-advisory-commission-on-childhood-vaccines.html?cid=6a00d8357f3f2969e2012876334505970c#comment-6a00d8357f3f2969e2012876334505970c
There is big money:
"Further analysis of that NIH contracting document...
Holzworth's Constella group was also the recipient of SEVEN $250,000,000 contracts for "Public Information and Communication Services" (9/1/04, 5/14/06, 8/9/04, 7/1/04, 8/9/04, 5/15/06, 9/25/04)...
"The interesting thing is, there are a TON of other firms who received the same amount, or multiple contracts with the same amount, for the same designation of services, with the same contract end dates. I'm going through them now and I'm about halfway through. It's very, very interesting. Let's just say, that if the NIH claims there's no money to fund a little vaxed/unvaxed study, they're a bunch of lying liars [sic]. They're just spending billions of dollars on "Public Informatino and Communication Support" instead of research."
And they pretend that if we take even a few vaccines off the schedule that these awful diseases will come back and kill us all. You know - like what happened when they took the smallpox vaccine off the market???
And just look at how many cases we DON'T see of Polio now that they've taken the OPV off the schedule.
http://www.youtube.com/watch?v=A0JqQyl09zQ
http://www.without-consent.com/media/SqualeneReferences-AnimalToxicology.pdf
It is not uncommon for FDA and CDC employees to work for Pharma when nearing retirement. One could assume that if you do a great job for us at the FDA or CDC we will offer you a cushy PR job at Merck, Baxter, Novartis, Pfizer when your done as a thanks for passing an approval process or the infamous 'If I dont read it, I dont know it and therfore can report it" act which seems to be the norm today.
Far too much corruption and a total lack of transparency. I remember when Merck made Vioxx and one of the drug reps for Merck quit and was hired by the FDA to approve it and then went back to Merck. Combine that with the majority of the advisory board bought and paid by Merck and voila you have 40,000 people dead and 120,000 injured. Julie Gerberding for CDC chief quit and now she works for Pharma. That is ridiculous and should not be allowed.
I ask you folks, how well do you trust the drug industry and the FDA and CDC. If these institutions happened to be individuals they would be in jail for life for the stunts they have pulled.
http://eands.caltech.edu/articles/LXIX3/patterson.pdf
Thank you Sherry for sharing this information. Are you aware of this research? It shows that immune activation causes brain damage (e.g. autism and schizophrenia)
http://eands.caltech.edu/articles/LXIX3/patterson.pdf:
I have tried..but..I cannot think of another industry that enjoys a "partnership" with the government regulatory agencies that recommend, approve and promote their product? Do we really want a "partnership" between regulators and the industry they are supposed to be regulating?
In any event...I can understand why the "partnership" exists.
Our public health agencies rely heavily upon vaccines as THEIR main source of "prevention" for communicable diseases...which makes this "partnership" not unlike a "shot gun marriage"..where BOTH parties act out of "convenience" rather than "conviction".
I suspect public health agencies desperate to protect the suppliers of vaccines...encouraged legislators to provide the vaccine industry with "product liability protections". I don't blame vaccine manufacturers who may have demanded protection....because they have been tasked to produce a product that science and public health agencies acknowledge will cause at least a small percentage of users to suffer injuries. However, I do question the wisdom of allowing an industry "product liability protections" that extend to the possibility of choosing "cost effectivness" over "safety" absent any threat of financial losses for having done so.
One can only wonder if the tobacco industry would have suffered such devastating losses had THEY enjoyed the same "partnership" with public health agencies?
No we don't want such partnerships - once the state is tied up with the manufacturers we've had it until such time as this becomes unacceptable to popular opinion.
The interesting thing is that just happens without any questions being asked, but the only mouthpiece they seem to be able to find to defend it is Sheldon Sheps of Toronto (Sheldon101).
The federal government "approves, recommends and promotes" beef the same as they do vaccines? The federal government has legislated "product liability protections" for the beef industry...including creation of their own court....to protect the beef industry from suffering any financial losses due to civil lawsuits arising from tainted beef causing serious injury to customers?
I must admit this is all new to me.
What is exactly 'tested' for vaccine 'safety' then? Because if they don't measure it, they can say anything is safe. A more recent example of this is a patent application by Novartis entitled, "Patent application title: DECREASING POTENTIAL IATROGENIC RISKS ASSOCIATED WITH INFLUENZA VACCINES".
"The inventor has realised that the conditions used for influenza virus 5 culture can increase the risk that pathogens other than influenza virus may grow in the cell lines and have identified specific contamination risks. Suitable tests can thus be performed during manufacture in order to ensure safety and avoid iatrogenic infections."
We have a real problem with vaccines and I'm sitting here left wondering what is going to be denied next? The Earth being round perhaps?
I am one who NEVER gets a flu shot...and never gets the flu.
And all my good buds that get their flu shot every year like clockwork, either because they believe it will work some year (or because their wife nags them into it) tend to come down with the nasty bug about a week or so after their yearly injection. At which point I consider them a risk to be around, and stay clear of the known infected individual. How hard is that? I have just made it a rule of thumb to stay busy and far away when I hear them talking about going to get their injection. Best bet...works for me.
NO fast foods
NO imported foods
NO GMO foods...if you can help it.
and NO fluoridated water of any kind.
My diet...
Plenty of fresh raw milk - fresh eggs - organic foods - and then a nap every afternoon.
That's what works for me. And rather well. I think I]ve been to the doctors office maybe one time in the last fifteen years. And that was to drive the wife in for something if I remember right. She does the same as I do and stays pretty healthy as well.
I don't believe the GOOD Dr. Tenpenny is trying to rake in business by telling us how best to stay healthy. And I applaud her for thinking outside of that box "they" try to make us live in.
THANKS Dr. Tenpenny!
Seriously! Some will stoop to new lows, no matter how ridiculous!