Chapter 5: Article 4
We're told vaccines are the most thoroughly and rigorously tested drugs on the market. But government documents say otherwise (Ch5: Article 2). Federal agencies have shown us that:
vaccine studies are small, testing the vaccine on a few hundred or few thousand healthy people
vaccines are not tested against a placebo
once licensed, they are then given to the entire population, healthy AND sick (and sometimes even when pregnant - despite NEVER having tested on pregnant women)
after vaccinating the entire population, the CDC never looks back to see if the health of the population is improving, remaining the same, or deteriorating. Remember the CDC informed us that long term health outcomes in a vaccinated population have never been studied.
In Ch5: Article 3, you discovered that researchers don't look for serious adverse effects, and that a lack of data is pointed at as proof of safety. You learned it's critical to ask is, "What types of health outcomes are the focus of vaccine safety clinical trials?" The manufacturers answered this in their package inserts. You learned the focus in testing is to look for minor, short term reactions, things like runny noses, fever, etc. A second critical question to ask is, "How long are trial participants monitored for?" Again the manufacturer answered this. They informed us that trial participants are monitored closely for 1-15 days, following receipt of a dose of vaccine. These events that researchers are monitoring for are called solicited events.
But let's discuss unsolicited events. Unsolicited events are any health observation that differs from the solicited event list, and that occurs outside the solicited event monitoring window. For unsolicited events, the monitoring window is typically longer, ranging from a few weeks, to a few months following receipt of the dose of vaccine. Sometimes the unsolicited event window starts at day one of receipt of the first vaccine and lasts until a couple months after the final dose of vaccine was administered.
In essence, the signs and symptoms that are classified as "unsolicited events" those symptoms might be early indication of a more serious or chronic condition. Unsolicited events or symptoms might appear to occur randomly, out of the blue, they might be vague and confusing because they are a new development that doesn't make sense based on the individual's previous health/behaviour/actions.
In vaccine clinical testing, because the researchers do not ask targeted questions over a long term, questions which broadly cover signs and symptoms of chronic health conditions, such data is left lacking. Remember, "absence of evidence is not evidence of absence." If you don't ask the questions, to gather the information, it doesn't mean the events are not occurring.
So what happens when participants or their parents, tell researchers about their health symptoms, symptoms which don't match the solicited event list.
Well, having read the package inserts, I can say that when serious adverse events, including death, are observed during the safety monitoring period, or unsolicited event window, most package inserts minimize the occurrence of those events by doing 1 of 3 things:
describing the statistics of serious adverse events and deaths as comparable across all trial groups. But remember a genuine saline placebo was omitted from the trial and all trial groups received vaccines or vaccine ingredients
suggesting the side effect or death was only "temporally related," that "a causal relationship has not been established." In previous articles I've explained that in order to determine if the vaccine plays a causal role, they would need to conduct an appropriate study with a control group that either received a placebo or was never vaccinated. Unfortunately, they refuse to conduct such a study.
describing the serious adverse event or death as "considered unrelated to vaccination."These determinations are based upon the researchers personal opinion and bias, not on scientific measurement and comparison to a placebo / unvaccinated group.
Also, in the vaccine package inserts, each time the manufacturers mention a serious adverse event or death, that is their way of covering off their legal liability. By providing this information, it gives them some legal protection. Should a person experience that medical condition or death following vaccination, and should that person or their family try and sue the manufacturer for damages (in many countries like the USA you CANNOT sue the vaccine makers) the manufacturer then points to the package insert, to that specific data or warning, saying, "We provided that information, in warning, and by accepting receipt of this vaccine, they agreed to accept any such risk that they might in fact experience that outcome."
If you read the FDA's drug labeling laws, those laws explain that the manufacturer must NOT list every side effect that was witnessed during the testing, but rather, the label must list ONLY those side effects where there is basis to believe the event was caused by the drug or vaccine. And therefore, if an adverse event is mentioned in the vaccine package insert, it's because the manufacturer recognizes the relationship is potentially causal. This FDA regulations state:
"Adverse Reactions...This definition does not include all adverse events observed during use of a drug, only those adverse events for which there is some basis to believe there is a causal relationship between the drug and the occurrence of the adverse event."
Below I've provided several quotes from the manufacturers package inserts, from the "Warning and Precautions" sections and the "Adverse Events" section, showing how the manufacturers warn the consumers to provide themselves legal protection. Look for how they try to minimize and dismiss the various concerning outcomes, by saying such outcomes were comparable to other vaccinated groups, that the event was only temporally related to vaccination, or was assessed by investigators as unrelated to vaccination. They can make these vague and inconclusive statements because they don't have to do proper testing against a placebo control. Regardless how they try to dismiss or minimize the relationship, if the adverse event is listed, it's because there is a basis to believe the vaccine caused it.
The statements are as follows (emphasis mine) (Links to all the package inserts can be found here):
Pediacel
Sudden infant death syndrome (SIDS) has occurred in infants following administration of DTaP vaccines. By chance alone, some cases of SIDS can be expected to follow receipt of PEDIACEL.
...Rates of serious adverse events were less than or comparable to the rates in the other acellular pertussis and European [vaccinated] groups in this study.
Infanrix-Hexa
Extremely rare cases of Sudden Unexpected Death (SUD) in close temporal association to vaccination with INFANRIX hexa have been reported in the first year of life. However, a causal relationship has not been established.
Imovax-Polio
Although no causal relationship has been established, deaths have occurred in temporal association after vaccination of infants with IPV.
Menactra
In infants and toddlers who received 2 doses of Menactra alone (at 9 months and 12 months) or the second dose of Menactra with concomitant routine pediatric vaccines, the percentage of subjects with at least one [serious adverse event] SAE after each vaccination was 2.0% to 2.5%. In participants who received one or more pediatric vaccines without the co-administration of Menactra at 12 months of age, SAEs occurred at a rate of 1.6% to 3.6 % depending on the number and type of vaccines received.
In this comparison, all the children received various vaccines, there was no unvaccinated control group. They explain that serious adverse events are occurring in these vaccinated children at rates of 2-2.5% and 1.6-3.6%. If these serious adverse events are vaccine caused, this rate of serious adverse events is significantly higher than the 1 in a million that we are always told about.
Prevnar 13
During the 13 controlled clinical trials, death occurred in 4 (out of 7,489) infants. All 4 cases were attributable to Sudden Infant Death Syndrome (SIDS). Three (out of 4,729 cases receiving 15,739 doses) cases were among Prevnar 13 recipients, and 1 (out of 2,760 cases receiving 9,030 doses) was in the Prevnar (7-valent) group. None of these cases were assessed by the investigator as causally related to vaccination.
In this comparison, they are comparing rates of death in a group of children that received the Prevnar 13 vaccine, vs the number of deaths that occurred in the group that received the Prevnar 7 vaccine. Comparing deaths between vaccinated groups, and assessing those deaths as being not caused by the vaccine, when there is no group that received genuine saline placebo, such conclusion is based upon opinion, not scientific measurement.
Synflorix
In booster studies 8 (out of 19,466 subjects) receiving a booster dose of SYNFLORIX and one (out of the 1011) 7- valent PCV vaccinees reported an SAE with a fatal outcome. None of the fatalities reported in the booster studies was considered by the investigator to be causally related to vaccination.
Again, this is the same as above - they are comparing rates of death in a group of children that received the Synflorix vaccine, vs the number of deaths that occurred in the group that received the Prevnar 7 vaccine. Comparing deaths between vaccinated groups, and assessing those deaths as being not caused by the vaccine, when there is no group that received genuine saline placebo, such conclusion is based upon opinion, not scientific measurement.
A Risk-Benefit Assessment for a Drug is Never Conducted
Back to Ch2: Article 2, in David Graham's interview he made a few statements related to a drug's benefit and risk. On that topic, he had the following to say (emphasis mine):
Another aspect to the culture at the FDA is that it overvalues the benefits of drugs and undervalues the risks of drugs. And so the FDA will always say to you, "Well, we're leaving this drug on the market because the benefits exceed the risks." Well, the FDA has never assessed the benefit of any drug that it's ever approved. It works on what's called efficacy. Does the drug work or not? Does it lower your blood pressure or does it lower your blood sugar? Not: Does it prolong your life? Does it prevent you from having a heart attack? Those are benefits. All they focus on is efficacy.
To frame that statement into the context of vaccines, his statement means that each vaccine has been scientifically tested and measured to demonstrate that it does in fact produce an antibody response within the human body (to various degrees). When he says that "the FDA has never assessed the benefit of any drug that it's ever approved," that statement, in the context of vaccines, means that vaccines have NOT been scientifically tested and measured to determine whether or not having a vaccine induced anti-body level then makes a vaccine recipient immune to the illness. Vaccines have also never been carefully tested to measure whether or not they improve the individual's health (in the short or long term) and a person's longevity.
We regularly hear that vaccines create herd immunity, that vaccines protect vulnerable infants and the immune suppressed. Again, there has never been any testing completed to evaluate the truth of such a claim. And although we regularly hear that vaccines save lives, the manufacturers and health authorities have never tested vaccines in anyway that could prove whether or not that is in fact the case. Each of those proclaimed outcomes are benefits, and as David Graham explained, the FDA has never measured the benefit of any drug they have ever approved.
A recent Ted Talk given by a physician and Global Health Professor Christine Stabell Ben, explains this very fact - her talk is a MUST WATCH! We'll dive deeper into the content of this Ted Talk at a later date, but in her introduction she explains that the overall health of vaccinated populations has never been studied, until she and her team choose to study this themselves. She says:
Allow me to tell you what we discovered in Guinea Bissau. We have a field station where we follow 200,000 people with regular home visits, and we register all deliveries, all vaccinations, all hospitalizations, health centre visits, all child deaths. And with this information, we started doing what no one else had done before, we evaluated the effect of vaccines on overall health. This may come as a surprise, but normally, vaccines are not assessed for their effects on overall health. They're only assessed for their protective effects against the vaccine disease. Everybody has been so convinced that vaccines only had protective effects against the [illness] so it didn't seem necessary to assess their effects on overall health. But when we started looking at the effect of vaccines on overall health, it quickly became clear that there was something wrong, something was clearly missing in this equation.
She goes on to explain:
Our findings can be summarized in one sentence. We discovered vaccines train the immune system in ways that no one expected.
There's much more to say about her Tedx Talk and the research she presented, but I'll save that for another day.
CONTINUE to the next article Ch5: Article 5
Article Sources Here
Must Watch: Tedx Talks with Christine Stabell Ben - Overall Health of the Vaccinated Here
The FDA Website: What is a biological product? Here
Court Documents: BRUESEWITZ vs. WYETH LLC - Vaccines are unavoidably unsafe Here
The CDC: lack of long term health outcome studies in vaccinated populations Here
Standford Medicine - The immune system is poorly understood Here
Interview with David Graham, the FDA whistleblower Here
Transcript of David Graham's Testimony before US Senate Here
Phase I, II, and III vaccine trials are small - medical paper titled FDA Regulation and Evaluation of Vaccines Here
CDC states that vaccines are tested on 1000s Here (some were but many weren't)
FDA legislation - only adverse effects, where there is reason to believe that the reaction could have been caused by the vaccine, are to be listed on the package insert. Here
Harvard Medical School Bio for Dr. Marcia Angell Here
Lecture by Dr. Marcia Angell - A drugs safety profile is discovered after licensing Here
Statement by Dr. Lucija Tomlijenovic that vaccine trials don't look for serious adverse events Here
IOM Report - Adverse Effects of Vaccines Evidence and Causality Here
Canadian Vaccine Package Inserts Here
American Vaccine Package Inserts Here
US Government Table of Vaccine Injuries - explaining the different vaccine injuries that the Government provides immediate financial compensation for Here