Is Vaccine Safety Evidence “Rock Solid”?
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In spite of the widespread notion that vaccines are largely safe and serious adverse complications are extremely rare, a close scrutiny of the scientific literature does not support this view [10-12]. Indeed, it is often assumed that vaccines face a tougher safety standard than most pharmaceutical products. However, according to the U.S. Food and Drug Administration (FDA) transcript of the 2002 Worksop on non-clinical safety evaluation of preventative vaccines: recent advances and regulatory considerations :
“Historically, the non-clinical safety assessment for preventive vaccines has often not included toxicity studies in animal models. This is because vaccines have not been viewed as inherently toxic”
[emphasis In contrast to most drugs and biological products that are predominantly developed to treat ill patients, vaccines primarily are given to large numbers of healthy people, oftentimes predominantly healthy infants and children. And this places significant emphasis on their safety.
This is a startling admission from an Agency which according to its own mission statement is ”responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs” . Essentially, what the FDA workshop  revealed is that not only are vaccines not adequately evaluated for toxicity but also, that the reason for such an oversight rested on a belief rather than scientific evidence. Moreover, it is mind-boggling that inadequately tested products on whose safety FDA “places significant emphasis” are actually licensed by the same Agency for mass use.
Furthermore, the erroneous assumptions of safety, in the absence of actual experimental data, are not only dangerous but have historically hampered serious scrutiny of potential vaccine harms. For example, in responding to numerous criticisms of their study Unexplained cases of sudden infant death shortly after hexavalent vaccination  Zinka et al. (2006) noted :
“(ad 6) The main problem is that vaccination specialists have failed for decades to establish any tests or other criteria to find out if adverse events are linked to vaccinations or not. To our knowledge they did not even try hard—why?!”“(1) A precise description of the mechanism leading to serious adverse events after hexavalent vaccination is not the task of forensic pathology. This would be the job of vaccination specialists, and actually this job should have been done before phase 1 and phase 2 studies in order to get valid data on the drug safety.”
Similarly, in 2006, Ottaviani et al.  in reporting a case of a 3-month-old female infant who died shortly after being given a hexavalent vaccination noted that:
“This case offers a unique insight into the possible role of hexavalent vaccine in triggering a lethal outcome in a vulnerable baby. Any case of sudden unexpected death occurring perinatally and in infancy, especially soon after a vaccination, should always undergo a full necropsy study according to our guidelines…The identification of a possible pathological basis of reflexogenic mechanisms in sudden, unexpected infant death necessarily requires examination of the brainstem nuclei and of the cardiac conduction system on serial sections.”
The senior author of this study, Professor Luigi Matturri is a member of the European Medicines Agency (EMEA) Pathologists Panel for evaluation of SUD (sudden unexpected death) cases reported for hexavalent vaccines. Although a review by EMEA cited in the study concluded that the causes of death following hexavalent vaccination remained unexplained, the following was also emphasized:
“However, to the best of our knowledge, during the mentioned post-mortem investigations, little, if any, attention was paid to examination of the brainstem and the cardiac conduction systems on serial sections, nor was the possibility of a triggering role of the vaccine in the lethal outcome considered” .
It is thus obvious that the real reasons why causality is rarely established by scientific investigations of vaccine-related serious adverse reactions are:
- it is assumed that vaccines cannot cause such reactions (as implied by the FDA workshop) and;
- studies are not designed to detect them 
We have also noted that too often clinical trials of new vaccines conducted by drug companies are fast tracked to licensure but
1) fail to use inactive placebos as controls;
2) include too few children in the age group that will be targeted for universal use;
3) have inadequate periods of time for follow up of safety and effectiveness;
4) only study healthy children without personal or family histories of vaccine reactions, autoimmunity, allergy, neurological disease or concurrent illness (although children with these medical histories are specifically targeted for vaccination post-licensure with very few medical contraindications listed to guide physicians);
5) fail to study large numbers of children given the experimental vaccine simultaneously with all other vaccines routinely administered simultaneously to children in that age group;
6) dismiss serious health problems, injuries and deaths occurring during the trial as not related to the experimental vaccine without adequate research evidence-based support;
7) use questionable surrogate endpoints to demonstrate vaccine effectiveness; and
8) lack adequate post-licensure follow-up [19-22].
The pushing of poorly tested drugs on most vulnerable populations (i.e., infants and children) can hardly be viewed as ethical. Unfortunately it is a frequent occurrence in medical practice when it comes to vaccination. To illustrate the consequences of such practices, in 2010 in Australia, there were a large numbers of serious adverse reactions from seasonal influenza vaccines routinely administered to children.
Subsequently, vaccination with certain influenza vaccines has been suspended in children under five years of age. In a series of Rapid Responses addressing this issue, published in British Medical Journal, titled “Adverse events following influenza vaccination in Australia-should we be surprised?” Peter Collignon (Director of Infectious Diseases & Microbiology at Australian National University) and colleagues from the Cochrane Collaboration review panel concluded [emphasis added] [23, 24]::
Collignon et al. :
“Unlike most drugs, vaccines are used on a population basis triggered by public health policy. As such, evidence of their safety and efficacy needs to be extraordinarily rigorous and evaluation methods and data should be open to independent scrutiny. We need much better and larger studies on both safety and efficacy before we roll out influenza vaccine programs to all populations, especially to children who appear to have much higher rates of adverse reactions.There is poor evidence on how well influenza vaccines prevent any influenza complications in children and other age groups. There is good evidence that influenza vaccines study reports cherry pick results and achieve spurious notoriety. Exposing human beings to uncertain effects is a risky business”
Collignon et al. :
Vaccine policies must ensure they are doing more good than harm. Vaccine must cause far fewer serious adverse events compared to what the disease would have caused in the vaccine’s absence. Evidence suggests this is not the case with influenza. In Australia in 2009, during winter when young children (0-4 years) were first hit with the new H1N1 strain, the admission rate for influenza was 57 per 100,000 (8).
In the US, CDC says that influenza results in hospitalization for approximately 20 per 100,000 children aged 2 to 5 years (9), but vaccine-induced febrile convulsions resulting in hospitalization in US young children, likely occurred at a rate of 114 per 100,000 children vaccinated . According to the FDA, a “serious adverse event” is defined as hospitalization that results from a vaccine adverse event (10). Thus vaccinating young children without risk factors likely caused more serious adverse events than disease from the new “pandemic” itself. There is poor safety data available for other serious adverse events that might occur in young children in addition to febrile seizures (11).
Evidence from systematic reviews show evidence of data suppression of vaccine-associated harms to small children by some pharmaceutical companies (12). Other reports suggest that influenza vaccines put children at higher risk of future influenza infections compared to acquiring natural infection (original antigenic sin) (13). In older children, unexpected adverse events such as narcolepsy have been reported from at least 12 countries (14). In Canada previous immunisation with seasonal influenza vaccine doubled your risk of being infected with “swine flu” (15).
That the influenza vaccine is not an isolated case of poor scrutiny is evident from other literature on vaccines. Indeed, there is a growing number of reports of research misconduct, biased reporting, conflicts of interest, and outright fraudulent activity by pharmaceutical companies who produce the ever growing list of vaccines, bringing into question the accuracy of the vaccine manufacturers claims of safety and efficacy.
For example Merck & Co., Inc., the pharmaceutical company who produces the MMR (measles, mumps, and rubella) vaccine is currently accused in the U.S. of fraudulently lying about the efficacy of its mumps vaccine for the purpose of continuing to secure governmental contracts worth $ millions. In 2012, two former Merck virologists, a group of doctors, and direct payers filed two whistleblower law suits in the Pennsylvania federal court. Merck’s attorneys were unsuccessful in their attempts to block the case from going to trial with U.S. Federal District Judge C. Darnell Jones II, recently clearing the case for trial.
Judge Jones ruled the whistleblowers and direct purchasers produced enough evidence to establish that false statements could have helped give Merck a monopoly. A recent article from Pharma-based website fierce vaccines states :
Merck has been the sole manufacturer with an FDA license to produce mumps vaccine since 1967, the news service points out, and the company has long touted a 95% efficacy rate for the shot. The drugmaker brought in $621 million on mumps vaccine sales last year, between its MMR2 vaccine and ProQuad, a pediatric combo jab.
But rather than using the “gold standard” approach and testing the vaccine against a wild-type mumps virus, Merck tested it against the attenuated virus strain that had created the vaccine in the 1960s–likely overstating the vaccine’s effectiveness, the whistleblowers claim, according to the judge’s memorandum.
And if Merck “fraudulently misled the government and omitted, concealed, and adulterated material information regarding the efficacy of its mumps vaccine” in violation of the False Claims Act, as they allege, it may have discouraged competition.
“This decision brings us one step closer to shining a light on Merck’s deceptive business practices so that new and more effective vaccines will ultimately be developed in the future,” Robins Kaplan Miller & Ciresi lawyer Kellie Lerner said in a statement.
Furthermore, with regard to the studies which allegedly demonstrably show no link between autism and vaccines, it has to be emphasized that once such studies undergo proper expert scrutiny, the “evidence” against the link becomes rather flimsy. In reviewing the published literature on measles-mumps-rubella (MMR) vaccine (139 studies), the respected Cochrane Collaboration review panel concluded that, “The design and reporting of safety outcomes in MMR vaccine studies, both pre- and post-marketing, are largely inadequate” [emphasis added] .
Moreover, none of the 31 studies that were included in the review met the Cochrane Collaboration’s methodological criteria. More specifically, referring to the 2001 Fombonne and Chakrabarti study  which was widely regarded by medical health authorities as most persuasive in disproving the link between the MMR vaccine and autism, the Cochrane Collaboration commented the following: “The number and possible impact of biases in this study was so high that interpretation of the results is impossible” .
Although the Cochrane Review on the safety of MMR concluded that there was no credible link between MMR vaccination and autism and Crohn’s disease, as pointed out earlier, the majority of the studies included in the evaluation were methodologically inadequate. The question thus is what “credible” evidence can be derived from inadequate and/or methodologically flawed studies?
It important to note that even those in the scientific community who are strong proponents of vaccinations have come to question the scientific legitimacy of “one-size fits all” vaccination practices . For example, Poland (Editor in Chief of the journal Vaccine and co-author of “The age-old struggle against the antivaccinationists” ) and colleagues rightly ask whether “with the advances coming from the new biology of the 21st Century”, it is time to consider “how might new genetic and molecular biology information inform vaccinology practices of the future?” . In light of this question Poland et al. conclude that “one-size fits all” approach for all vaccines and all persons should be abandoned.
According to Poland, this conclusion applies to both vaccine efficacy, as well as safety . Regarding the latter, the widely held view that serious vaccine-related adverse reactions are rare needs revision, as current worldwide vaccination policies indeed operate on “one-size fits all” assumption. This assumption persists despite the fact that historically, vaccine trials have routinely excluded vulnerable individuals with a variety of pre-existing conditions (i.e., premature birth, personal or family history of developmental delay or neurologic disorders including epilepsy/seizures, hypersensitivity to vaccine constituents etc. [30-34]).
Because of such selection bias, the occurrence of serious adverse reactions resulting from vaccinations may be considerably underestimated. As mentioned previously, such an outcome should be of concern in view of documented evidence of permanent neurodevelopmental disabilities and deaths following vaccination in children with underlying genetic and other susceptibilities [2-4]. Poland et al.’s current data may thus have far broader implications for understanding vaccines, not only in terms of efficacy and the desired immune response, but also in terms of safety. Indeed, vulnerable populations will neither have the same antibody response nor the same level of tolerance to serious adverse reactions as non-vulnerable populations [28, 35].
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Herd Immunity: Can Infectious Diseases be Prevented by High-Vaccination Coverage?
Vaccine- or Hygiene-Preventable Diseases?
The prevalent view that vaccines are the sole cause of the disappearance of infectious diseases requires intellectual caution because it has been clearly demonstrated that factors such as clean water and improved sanitation, as well as better nutrition, availability of antibiotics, greater access to health care, and technological advances in maternal and neonatal medicine) have also played a major impact on infectious disease incidence .