FDA Approves Experimental H1N1 Swine Flu Vaccine Prior to Children Safety Trials Beginning

Jeffry John AufderheideJeffry John Aufderheide

(vactruth.com) In a stunning move, the FDA has approved four monovalent Swine Flu vaccines for the following companies: CSL Limited, MedImmune LLC, Novartis Vaccines and Diagnostics Limited, and Sanofi Pasteur, Inc. Adding to the confusion is the fact that purported ‘safety trials’ for the Swine Flu vaccine haven’t even begun, in some instances.

By example, Novartis is just starting vaccine safety trials for three to eight year old children supposedly as of 09/15/09 as reported in the last article I wrote entitled, “Ingredients Found in Spermicides, Cleaners, and Cosmetics along with Thimerosal, and Squalene Present in Experimental H1N1 Vaccine“. One can only wonder as to what head FDA officials are thinking when they approved the vaccine on the same day. Yet, according to the newly released package inserts, we now know exactly why this decision was made.

The document concerning the Novartis trial becomes a pivotal piece in discerning what is happening behind closed doors. Generally speaking, all four package inserts communicate the same message and are structured similarly. Therefore, we will select quotes from the Novartis insert for the purposes of this article.

—-For the reader’s edification, here are links to information concerning the vaccine by manufacturer—-


How does a vaccine get approved without being properly tested for safety? The press release entitled “FDA Approves Vaccines for 2009 H1N1 Influenza Virus” which can be read here gives us our first clue…

“Based on preliminary data from adults participating in multiple clinical studies, the 2009 H1N1 vaccines induce a robust immune response in most healthy adults eight to 10 days after a single dose, as occurs with the seasonal influenza vaccine.”

“Clinical studies under way will provide additional information about the optimal dose in children. The recommendations for dosing will be updated if indicated by findings from those studies. The findings are expected in the near future.”

Needless to say there is a fair amount of assuming going on by high government officials and those that are practicing ‘evidence based medicine.’ The main assumption of course that this vaccine is perfectly safe. “Where is Novartis and others receiving their information from,” one may ask?  The package insert for Novartis clearly states,

“Safety data were collected in a total of 2768 adult and geriatric subjects (18 years of age and older) who have received FLUVIRIN in 29 clinical studies since 1982.” (pg 6)

“In 9 clinical studies since 1997, among 1261 recipients of FLUVIRIN, 745 (59%) were women; 1211 (96%) were White, 23 (2%) Asian, 15 (1%) Black and 12 (1%) other; 370 (29%) of subjects were elderly (≥65 years of age). All studies have been conducted in the UK, apart from a study run in the US in 2005-2006 where FLUVIRIN was used as a comparator for an unlicensed vaccine.” (pg 6)

“In 1987 a clinical study was carried out in 38 ‘at risk’ children aged between 4 and 12 years (17 females and 21 males)…Three clinical studies were carried out between 1995 and 2004 in a total of 520 pediatric subjects (age range 6 – 47 months).” (pg 10)

Are they implying no testing has been completed for this new experimental H1N1 Swine Flu vaccine? I can see the logic of someone believing that the experimental H1N1 Swine Flu vaccine is safe predicated on the fact it is created with the same ‘technology’ as past shots. Moreover, when official bodies of government reiterate a sound byte, it sure is easier to believe.

If the aforementioned studies in the vaccine insert indicate vaccine safety, it doesn’t make much sense to have safety trials. Even more so, wouldn’t the clinical studies performed would be totally useless if, by example, different formulations were different? It appears what is being said and what is being done are  entirely different matters altogether.


Looking at the CDC’s website for the ingredients of FLUVIRIN, we see it contains the following ingredients:

“Beta-Propiolactone , Egg Protein, Neomycin, Polymyxin B, Polyoxyethylene 9-10 Nonyl Phenol (Triton N-101, Octoxynol 9), Thimerosal (multidose containers), Thimerosal* (single-dose syringes)” (page 2)

Yet if we look at what is being tested in the trial we can abundantly see the two vaccines are not the same. Please look at page 2 of 13 of the experimental swine flu vaccine paperwork.

“MF59 is an adjuvant which is used in influenza vaccines licensed for adults and/or elderly in many countries worldwide, but it is not contained in any vaccines currently approved in the United States.”

If the MF59 adjuvant is approved for adults and elderly in different countries, but not approved in the United States, and at the same time we are having clinical trials on children now, how valid are those referenced studies in the FDA-approved-vaccine-inserts? That doesn’t appear to be evidence based to many in the scientific communities.

Nonoxynol-9 (which is a spermicide) mentioned on page 8 of the vaccine trial document is not mentioned as an ingredient in FLUVIRIN, according to the CDC’s website. Additionally, just because a vaccine has been manufactured by using the same process as the H1N1 vaccine insert implies, does not mean it has the same ingredients as past vaccines. Therefore, we cannot be presumptuous that all is well in the land of neurology or immunology.

Moreover, it appears that the Novartis Swine Flu vaccine insert is mostly a copied and pasted from the FLUVIRIN insert. Both inserts indicate that the vaccine is not for use for children under four years of age. Yet, Novartis is having a trial as I write this on three year old boys and girls. Even harder to grasp is the CDC’s recommendation that pregnant women and children 6-months of age are being shoved to the front of the line for  being vaccinated.

The cruel irony on page 2 of the Novartis Swine Flu vaccine insert remarks,

“Safety and effectiveness of Influenza A (H1N1) 2009 Monovalent Vaccine have not been established in pregnant women, nursing mothers or children less than 4 years of age. (8.1, 8.3, 8.4)


I seem to recall not too long ago the FDA engaging in a witch hunt to prevent any alternative treatments for the H1N1 Swine Flu. In a press release, “FDA Warns Web Sites against Marketing Fraudulent H1N1 Flu Virus Claims” the FDA boldly declared,

“…the FDA warned consumers regarding products related to the 2009 H1N1 flu virus offered on the Internet. The products involved are those that are promoted and marketed to diagnose, mitigate, prevent, treat, or cure the 2009 H1N1 flu virus but are not approved, cleared, or authorized by the FDA. The agency advised operators of offending Web sites that they must take immediate action to ensure that they are not marketing products intended to diagnose, mitigate, prevent, treat, or cure the 2009 H1N1 flu virus that have not been cleared, approved, or authorized by the FDA.”

“The FDA will consider further civil or criminal enforcement action against those Web sites that fail to resolve the violations cited in warning letters. Actions could include seizure, injunction, and criminal prosecution.”

Let’s get this straight. The powers that be at the FDA asserts unequivocally that the experimental vaccines are safe and effective while some safety trials for the vaccines have not even been started. The formulations are clearly not the same from past flu vaccines although they are being treated as such. Additionally, testing is being conducted on children who are younger than the recommended ages in the vaccine inserts. Lastly, pregnant women and infants are FIRST in line for this vaccine. It almost all seems a bit criminal, doesn’t it?

When the FDA states that it will consider civil or criminal enforcement against blatantly falsified information, perhaps they can look no further than their own backyard.

FDA Warns Web Sites against Marketing Fraudulent H1N1 Flu Virus Claims

VacTRUTH Editor’s Note:

1. A great resource for readers to understand how vaccines are made and information about them can be located at: http://www.trackingvaccinations.com/ (HIGHLY RECOMMENDED!!!)

2. The swine flu vaccine will have 25 mcg of thimerosal. A good read on the topic can be found here: http://katysexposure.wordpress.com/2009/07/30/washington-post-swine-flu-vaccine-will-contain-mercury-toxin-linked-to-autism-and-neurological-disorders/

About the author

Jeffry John Aufderheide

Jeffry John Aufderheide is the father of a child injured as a result of vaccination. As editor of VacTruth.com, he promotes well-educated health professionals, informed consent, and full disclosure and accountability of adverse reactions to vaccines.

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