Testing For Vaccines Does Not Include Placebo Controlled Trials
How many parents have checked their State Department of Public Health “guidance” or requirements for “vaccines” for children to enter school or who are attending school? Kudos to you if you have. If you have not, I urge you to do so.
Back in the day when my child started attending school, there was no internet to check regulations. Most of the information was provided by the school system citing the Official Code of Georgia Annotated (OCGA). Moreover, as we were a military family when my child was born, “vaccines” were portrayed to us as “required”. All of this was before the 1986 Act that granted big pharma immunity from harm caused by these injections. Therefore, I shamefully admit that my child was given vaccines per the schedule of that time, which was not that many injections. Also, being a nurse, we were instructed in the pediatric vaccine schedule and that vaccines were safe and effective.
Based on what I now know and what continues to be discovered through research, what was told to me as a parent and nurse is patently false.
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To find the “rules” concerning your state’s requirements for immunization/vaccines for school-age children, use the following search terms “[insert your state name] Public Health law mandating vaccines for children to attend school”. Using GA for the state, the “law” governing required immunizations is OCGA 20-2-771. This is the 2006 version, but a newer version is available. In this “law”, if the requirements are not met, uncompliant individuals “shall be guilty of a misdemeanor and upon conviction shall be punished by a fine of not more than $100.00 or by imprisonment for not more than 12 months.” Then, if that isn’t enough, “The Department of Human Resources and the local board of health, or either of them, may institute a civil action in the superior court of the county in which the defendant resides for injunctive relief to prevent a threatened or continuing violation of any provision of this Code section.”
The rules and regulations that apply based upon this “law”, are found here, R&R, Department 511, Chapter 511-2, Section 511-2-2. It provides in detail the vaccines required and an opt-out for religious beliefs, but not on grounds of personal philosophy. Notice also, the State of Georgia requires parents to affirm in the opt-out for religious beliefs, under the presence of a notary public, they understand the Georgia Department of Public Health “has determined … the required vaccines are safe ….” But, is any information ever provided to parents, opting out or not, detailing how the Georgia Department of Public Health determined the “required vaccines are safe”? Would not being able to affirm the safety of vaccines be grounds to opt out based on personal philosophy that vaccines given to children should be affirmed safe?
In a December 31, 2018 letter from Informed Consent Action Network (ICAN) attorney Aaron Siri to Alex Azar, Secretary of the US Department of Health and Human Services, this chart was found on page 14 of the 88-page letter. [insert screenshot provided here] The letter from ICAN’s Aaron Siri is extensively footnoted with references and sources – 482 to be exact.
According to this chart, only one vaccine on the required immunization schedule has ever been clinical trialed for safety against a placebo, except Gardasil. The letter states:
It is deeply troubling that HHS permits pharmaceutical companies to use “active controls” in clinical trials for new vaccines when none of the “control vaccines” were themselves licensed based on a placebo-controlled trial. This creates layers of assumptions regarding safety that resemble a pyramid scheme. Tracing back the pre-licensure clinical trial for each vaccine used as an active control, one finds that the initial vaccine in the “safety chain” was either licensed without any control group or assessed against another vaccine, including vaccines, such as DTP, which was withdrawn from use due to safety concerns.
By the HHS’s own industry guidance, “using another drug as a so-called ‘active control’ is only appropriate if it is for a similar indication and is a ‘drug whose effect is well defined,’ which means ‘historical placebo-controlled trials are available to define the active control effect’.”
As the FDA explains:
The placebo-controlled trial measures the total pharmacologically mediated effect of treatment. In contrast, an active control trial … measures the effect relative to another treatment. The placebo-controlled trial also allows a distinction between adverse events due to the drug and those due to the underlying disease or background noise.
To understand how this chart works, let’s start at the bottom with Menomune. Menomune was used as the “control” for the vaccines Menactra and Menveo. Yet, the chart indicates Menomune was not licensed using a placebo-controlled trial. The Center for Disease Control defines “placebo” as a “substance or treatment that has no effect on human beings.” This could be a saline injection for control against vaccines or a sugar pill as a control against oral medications.
According to the Food and Drug Administration website, Menomune is the Meningococcal Polysaccharide Vaccine, Groups A, C, Y, and W-135 combined. In checking the “package insert” on the FDA website by clicking on the link provided at the FDA, Section 6.1, Data from Clinical Studies, indicated, “In three clinical trials primarily designed to assess the safety and immunogenicity of another vaccine, Menactra, …, participants were randomized to receive Menactra or Menomune, A/C/Y/W-135 vaccine, which was used as a control vaccine.” This same insert stated that participants were followed for six months.
It gets worse. If, like me, you are industrious and investigate each vaccine on this pyramid, you will confirm the results by ICAN attorney Aaron Siri and find that some follow-ups were only 5-7 days, with a phone call follow-up at six months. Some had no follow-up at six months.
The “trial” for Gardasil used a placebo only after the control group received three doses of the Gardasil vaccine.
Here is the information on the Gardasil trial from ICAN. (page 8)
The critical difference between using an inert and non-inert substance as a control can be clearly seen from the trials relied upon to license Gardasil in 2006. The manufacturer’s package insert for Gardasil states that it was licensed based on a clinical trial in which: (i) 10,706 women received Gardasil; (ii) 9,092 women received 225 mcg or 450 mcg of Amorphous Aluminum Hydroxyphosphate Sulfate (AAHS) – the so-called “AAHS Control” (aluminum adjuvant, such as AAHS, is a known cytotoxic and neurotoxic substance used to induce autoimmunity in lab animals, and which numerous peer-reviewed publications implicate in various autoimmune conditions); and (iii) 320 women received a “Saline Placebo. During the six month study follow-up, 2.3% of the women receiving Gardasil (the “test group”) and 2.3% of the women receiving the AAHS Control or Saline Placebo (the “combined control group”) reported developing a systemic autoimmune disorder. Since the rate of systemic autoimmune disorders in the “test group” and the “combined control group” were similar, the vaccine was deemed safe and licensed by HHS.
What the manufacturer’s package insert for Gardasil given to the public failed to disclose is that the Saline Placebo group had zero cases of systemic autoimmune disorder (when 7 cases – 2.3% of 320 subjects – would be expected if autoimmune disorders were equally distributed among the Saline Placebo and AAHS Control recipients). This fact was obfuscated by combining the small Saline Placebo group with the large AAHS Control group into a single control group and reporting their combined systemic autoimmune disorder rate, even though all the cases of autoimmunity came from the AAHS Control group.
See the package insert for Gardasil here, Section 6.1.
We all know vaccines are not safe or effective, and here is the proof, provided by the FDA, on their own website, that no vaccine testing ever used a placebo-control trial group.
The most egregious example of using other vaccines to trial another resulted with Prevnar. Notice that Prevnar was trialed using MnCC. MnCC vaccine was never licensed or approved for use. This is found in the Prevnar 13 clinical studies at Section 14. According to the package insert, MnCC was an “investigational meningococcal group C conjugate vaccine”.
The list goes on and on for these approved and licensed vaccines slated for injection into millions of children and adults.
So, for those who tout that vaccines are tested for safety, the FDA’s own website proves that is not the case since the gold standard testing method for safety is placebo-controlled trials. It also dispels the myth that vaccines are “tested” for years before being approved for public use.
This begs the question – What are State Departments of Public Health using to determine whether vaccines are safe? More than likely, statements by the federal Department of Health and Human Services (HHS), the FDA, and the CDC. As shown, those statements are categorically incorrect and false.
Someone recently told me that pharmaceuticals (all) do not have to be tested against a placebo to determine safety. Another drug that has been proven “safe” can be used. HHS stated in a letter to ICAN attorney Aaron Siri, that “inert placebo controls are not required to understand the safety profile of a new vaccine, and are thus not required.” By their own admission, HHS admits placebo-controlled trials are not required again, but their guidance as previously shown indicates otherwise. So, how does one determine the safety of one vaccine using another vaccine that has never been through a placebo-control trial as the control? The answer is you can’t.
For more information, check out The Highwire on Rumble, Episodes 332 – The Forbidden Debate and 347 -Vaccine Experts Under Oath.
What about doctors? Do they know this data? They should as it is contained in the package insert that is included with the vials of these vaccines. If there is not a package, physicians can check this information on the FDA website. How many actually do that? How many just trust the HHS, FDA, and CDC?
Unfortunately, it is going to be up to us as parents and patients to inform physicians, pediatricians, public health officials, health department officials and workers, State legislators, and local boards of this information and bring the receipts (proof from the FDA and HHS websites). Fortunately, ICAN has done the work for us. But, always verify yourself by checking the sources.
To the same end, questions need to be asked of State Public Health officials. The officials require anyone requesting a religious exemption (one should not have to ask permission from the State to practice one’s beliefs), to verify they understand the Department of Public Health in Georgia has determined vaccines are safe. Georgia has no opt-out based on grounds of personal philosophy, which could be a lack of evidence of safety where the government’s own documents provide evidence that no vaccine has been trialed using a placebo control group. Interestingly enough, the State of Georgia provides for itself an “out” to get around religious exemption – Section 5 of the form.
I understand that, notwithstanding my religious objections, my child may be excluded from childcare facilities or schools during an epidemic or threatened epidemic of any disease preventable by a vaccination required by the Georgia Department of Public Health, and that my child may be required to receive a vaccination in the event that such a disease is in epidemic stages, as provided in Georgia Code Section 31-12-3 and DPH Rule 511-9-1-.03(2)(d).
Isn’t that special?
Let me leave you with another experience. While in elementary school, some of us carried home a blue sheet requesting permission from parents to administer a “measles” vaccine. Being very young at the time, I cannot remember if everyone received a blue sheet or not. I can say that all in my class did. Men in white coats “injected” those who had permission with supposedly a “measles” vaccine using an “air gun”. The same thing happened with the rubella “vaccine”.
Per the history of the measles vaccine:
In 1954, John F. Enders and Dr. Thomas C. Peebles collected blood samples from several ill students during a measles outbreak in Boston, Massachusetts. They wanted to isolate the measles virus in the student’s blood and create a measles vaccine. They succeeded in isolating measles in 13-year-old David Edmonston’s blood.
In 1963, John Enders and colleagues transformed their Edmonston-B strain of measles virus into a vaccine and licensed it in the United States. In 1968, an improved and even weaker measles vaccine, developed by Maurice Hilleman and colleagues, began to be distributed. This vaccine, called the Edmonston-Enders (formerly “Moraten”) strain has been the only measles vaccine used in the United States since 1968. Measles vaccine is usually combined with mumps and rubella (MMR), or combined with mumps, rubella and varicella (MMRV). Learn more about measles vaccine.
The rubella vaccine was licensed in 1969. I can certainly say the measles injection I received in school was before 1968 and the rubella before 1969 since my sister was born that year. In checking with my mother, she could not remember what the paper said or what years it occurred. However, I can remember due to the trauma it created. Could I and members of my class have been being used in clinical trials for the 1968 and 1969 distribution of measles and rubella vaccines respectively? Who knows.
Friends, we are going to have to go to our State Department of Public Health, our State legislators, and our local boards with this information and bring the receipts and proof using the FDA’s own website as evidence that no vaccine is ever tested using the gold standard of placebo-controlled trials to prove safety. We have to demand an end to mandatory vaccines for our children just to enter school or daycare. Anyone questioning safety should not have to ask permission from the State or anyone else to refrain from giving our children, or ourselves, unsafe products.