Disconnect between evidence & CDC claims Re: childhood vaccination schedule

A report from the World Health Organization Product Development for Vaccine Advisory Committee (PDVAC)

There are approximately 600 vaccine candidates in development against an estimated 110 pathogensas the routine immunization schedule expands, it becomes increasingly important to have strong, evidence-based justification for investing in the development of new vaccines with a high likelihood of success.” (VACCINE, 2016; )

Vaccines are universally promoted as “safe and effective” and millions of infants are administered multiple doses of vaccine combinations every year in accordance with the Recommended Childhood Vaccination Schedule by the Centers for Disease Control (CDC); which is the most aggressive vaccine schedule in the world. Babies in the U.S. receive 36 vaccine doses before they are 18 months old. Following the 2016 schedule, a child can receive up to 72 vaccinations if they have all the doses of the vaccines, all the boosters, and a double-dose of the annual flu shot done. The CDC website leaves no room for doubt:

“The Centers for Disease Control and Prevention, American Academy of Family Physicians, and American Academy of Pediatrics strongly recommend children receive all vaccines according to the recommended schedule.”

Parents and treating doctors are expected to trust the CDC declaration without independent confirmation. That’s because documents about vaccine safety and efficacy test results are secret. Independent scientists are prevented from verifying that the “safe and effective” claim is true. Parents are understandably concerned about the ever increasing, high number of children affected by developmental neurological disorders, said to be about 15% of children.

Some have described it as a “silent pandemic” that includes learning disability, sensory deficits, and developmental delays and autism. CDC first began to record the autism prevalence data in 2000. At that time, the number of children diagnosed with autism spectrum disorder (ASD) was one in 150 children. In 2007, one in 86 children was diagnosed. 

In 2014, the autism prevalence rate spiked again: 1 in 45 children in the U.S. were diagnosed with autism; in children aged 3 to 17, the autism prevalence rate increased by 80% from 2011-2013.  (Source: CDC, Washington Post, November 2015) 

In 1985 the autism prevalence rate was 1 in 2,500; in 1995 it was 1 in 500; in 2014 the rate was 1 in 45

A report by EPA scientists  “Timing of Increased Autism Disorder Cumulative Incidence,” who analyzed the cumulative incidence of autistic disorder during a 10-year period (1987 – 1996) pinpointed a sharp “changepoint” year (1988) when the incidence of autism sharply increased. The “changepoint” year is concomitant with the year childhood vaccination schedules expanded. In the US, between 1988 and 1996, the following vaccines were added to the CDC vaccination schedule for children in the first 15 months of life.  The review concluded:

 “The design and reporting of safety outcomes in MMR vaccine studies, both pre- and post-marketing, are largely inadequate…lack of clarity in reporting and systematic bias made comparability across studies and quantitative synthesis of data impossible.

HiB – Improved Hib conjugate vaccine added in 1988.
*DTaP – Additional dose at younger age added around 1990.
*HiB – Three additional doses added to schedule in 1991.
*Hep B – Three doses – Added to childhood schedule in 1992.
*Chicken Pox – Approved in 1995, added to schedule in 1996

In the Danish, California, and worldwide data sets, we found that an increase in autism disorder cumulative incidence began about (the birth cohort years) 1988-1989.”(McDonald, ME, Pau, JF.  Environmental Science & Technology, 2010)

Can we in good conscience ignore the evidence that for a minority of children CDC’s Childhood Vaccination Schedule poses serious risks of harm?
Clearly, public health authorities have a public responsibility to obtain scientific data from tests evaluating the combined effect of toxic components (called synergistic toxicity studies) of all the combinations of vaccines that millions of infants are likely to receive – including the timing at which vaccines are given. The fact is that CDC has failed to initiate such studies.  Indeed, the safety of the cumulative effect of CDC’s childhood vaccination schedule – with its multiple vaccines simultaneously administered – has never undergone scientific tests.

No field trials have compared the effectiveness and harms of all vaccines used according to various schedules listed in the recent BMJ infographic.6 12 The time for such studies is ethically and logistically past.

The full evidence base to make such complex decisions as the timing of each vaccination, in conjunction with developmental issues and the effect each vaccine has on the response to the others, is seldom fully available when vaccination schedules are devised…despite concerns about overloading infants’ immune systems we can find no evidence of harm.

However, because detailed reports for most clinical trials of vaccines are not available, and have not been independently reviewed, we cannot be certain of vaccines’ harms profiles. [Emphasis added]

The evidence base used in designing schedules is incomplete We should start by carrying out a more accurate assessment of the magnitude of disease threats. Those vaccines not targeting impending or credible threats should then be phased out or delayed. We also need randomised trials comparing different vaccination schedules to provide good quality data on the potential harms of single or multiple vaccinations. All aspects of vaccination should be monitored and assessed by independent studies.” 
(Is the Timing of Recommended Childhood Vaccines Evidence-Based?  Dr. Tom Jefferson and Dr. Vittorio Demicheli, BMJ (2016)

When did Merck know about the safety hazards of thimerosal, the mercury disinfectant its widely used in its vaccines?

The first “hard evidence” that Merck knew about the hazards posed for children who were exposed to significantly more mercury than the generally accepted dose, is documented in a seven page memo, dated 1991. The memo was addressed to the president of Merck’s vaccine division, and was signed by Dr. Maurice Hilleman, an internationally renowned vaccinologist, who acknowledged that:

6-month-old children who received their shots on schedule would get a mercury dose up to 87 times higher than guidelines for the maximum daily consumption of mercury from fish. When viewed in this way, the mercury load appears rather large.

The key issue is whether thimerosal, in the amount given with the vaccine, does or does not constitute a safety hazard. However, perception of hazard may be equally important.” (This memo was uncovered during the course of litigation; it was publicly disclosed by Myron Levin of the Los Angeles Times in 2005)

However, neither Merck, nor any of the zealous vaccine stakeholders in industry, government, and academia, ever acknowledge a vaccine safety problem. Concern about the safety of thimerosal, led the Scandinavian countries to require its elimination from childhood vaccines in 1992; and Japan followed suit in 1993. The U.S. dragged its feet for another decade. Vaccine idolatry in the U.S. and the U.K. demands total acceptance of the vaccine mantra: “there is no credible evidence of harm from the children’s vaccines.” Above all, the vaccination schedule must be protected at all cost:

CDC Finances, Writes and Helps Publish Danish Research
In 2005, the authors of a series of CDC- contracted Danish study, employed the following written pitch to persuade the editor of the New England Journal of Medicine to publish their study:

“It has been suggested that the measles-mumps-rubella (MMR) vaccine may cause autism. If true, this could jeopardize the MMR vaccine program in children.

The debate was initiated by research in Britain by Wakefield. In addition, Uhlmann recently published a study where they found measles in the gut in patients with developmental disorders but not I controls.

These findings, combined with the more general concern that the introduction of wide-scale use of the MMR coincides with an apparent increase in the incidence of autism, has led WHO and IOM to request further research into the association.”

The authors, one of who is a CDC scientist, assured the editor that their study “gave no support for an association between MMR vaccination and autismWe declare that there is no conflict of itnerest in connection with this paper.” (Edward Yazbak MD, Vaccination News, 2005,” Exhibit II)

The ferocity and underhanded tactics used by vaccine zealots in the autism debate are akin to the battle waged by the Tobacco industry in its long denial that cigarettes cause lung cancer. However, the medical establishment did not promote or defend tobacco.

National Vaccine Injury Compensation Program (NAVIC)
Most people do know that in 1986, in the wake of thousands of vaccine injury lawsuits, congress eliminated liability from vaccine manufacturers and established the National Vaccine Injury Compensation Program (NAVIC) with its own special vaccine court to handle vaccine-related injuries – and to pay compensation. After many years of vehement denial by the US government; by vaccine promoters in industry; and by the medical profession, the media, the scientific literature – that there is no evidence of a link between vaccines with the onset of autism, in November 2008, the US government conceded in the special US vaccine court that a causal effect of autism features, triggered by vaccines had been demonstrated in one child. The government agreed to pay millions of dollars in compensation.

  1. Hannah Poling, the government conceded, had a pre-existing mitochondrial disorder that was “aggravated” by the multiple vaccines she received. Two of those vaccines had contained thimerosal. The vaccines ultimately resulted in an autism spectrum (ASD) diagnosis. The court awarded her $900,000 lump sum and approximately $20 million in lifetime compensation. Two other such cases have come to light:
  2. Bailey Banks, the government conceded (2007) developed Pervasive Developmental Disorder (PDD), “a subthreshold” condition with features of autism caused by the MMR vaccine.
  3. Ryan Mojabi, the government conceded (2012) had suffered an MMR vaccine encephalopathy.

A matter of semantics in the vaccine court:
Semantics are important in the Vaccine Court: approximately 5,000 “omnibus autism cases” were dismissed in 2009 –2010. The cases that prevailed – as the Polings had – carefully avoided claiming autism as the primary injury. In 2011, a peer-reviewed study in Pace Environmental Law Review, by Mary Holland, examined the successfully adjudicated cases of vaccine-induced brain injury by the federal Vaccine Injury Compensation Program (VICP). She uncovered 83 cases of autism among those who have been compensated for vaccine-­induced brain damage–most notably, “encephalopathy,” “residual seizure disorder,” “developmental regression.”

After DHHS had conceded the Poling case, CDC Director Dr. Julie Gerberding, acknowledged on CNN that if a child is predisposed with a mitochondrial disorder, vaccines can be the trigger that sets off damage — “symptoms that have characteristics of autism.”

“Well, you know, I don’t have all the facts because I still haven’t been able to review the case files myself. But my understanding is that the child has a — what we think is a rare mitochondrial disorder. And children that have this disease, anything that stresses them creates a situation where their cells just can’t make enough energy to keep their brains functioning normally. Now, we all know that vaccines can occasionally cause fevers in kids.

So if a child was immunized, got a fever, had other complications from the vaccines. And if you’re predisposed with the mitochondrial disorder, it can certainly set off some damage. Some of the symptoms can be symptoms that have characteristics of autism.”(Transcript here)

 An independent review of the VAERS database
The Vaccine Adverse Event Reporting System is an important post-marketing safety surveillance tool. The study confirmed that thousands of VAERS reports are of serious adverse effects resulting in infant hospitalizations and deaths. The reviewers limited their analysis to 38,800 such infants in their first year of life.

“Our findings show a positive correlation between the number of vaccine doses administered and the percentage of hospitalizations and deaths. Infants who receive several vaccines concurrently, as recommended by CDC, are significantly more likely to be hospitalized or die when compared with infants who receive fewer vaccines simultaneously. It also showed that reported adverse effects were more likely to lead to hospitalization or death in younger infants.

Of the 38,801 VAERS reports that we analyzed, 969 infants received two vaccine doses prior to the adverse event and 107 of those infants were hospitalized: a hospitalization rate of 11%.The hospitalization rate increased linearly from 11.0% for two doses to 23.5% for eight doses.

The mortality rate among vaccinated infants stratified by the number of vaccine doses they received. The mortality rate for infants who received five to eight vaccine doses was 5.4%; significantly higher than for infants who received one to four doses (3.6%)

(“Relative Trends In Hospitalizations And Mortality Among Infants By The Number Of Vaccine Doses And Age, Based On VAERS, 1990–2010,”  GS Goldman, NZ Miller, Human Experimental Toxicology, 2012; Journal of American Physicians and Surgeons, 2016 [Free full text of each]

Cochrane Collaboration safety review of the MMR vaccine (2005; 2012)
The Cochrane reviewers determined that none of the studies upon which the safety of the MMR vaccine rests met the Cochrane Collaboration’s methodological criteria.

The design and reporting of safety outcomes in MMR vaccine studies, both pre- and post-marketing, are largely inadequate.”

* no studies had a low risk of bias;* two studies had a moderate/unknown risk of bias;
* eight studies had a High risk of bias.
* All studies suffered from a lack of adequate description of exposure (vaccine content and schedules).
* Another recurring problem was the failure of any study to provide descriptions of all outcomes monitored. In addition, there was an overall attrition rate of 33%.
* “The methodological quality of many of the included studies made it difficult to generalise their results.”

 The review concluded: “The design and reporting of safety outcomes in MMR vaccine studies, both pre- and post-marketing, are largely inadequate…lack of clarity in reporting and systematic bias made comparability across studies and quantitative synthesis of data impossible.

In the absence of reliable evidence to support the claimed safety of the MMR vaccine, the Cochrane reviewers resorted to circular reasoning by suggesting that the safety and effectiveness of the MMR vaccine is borne out bycurrent policies of mass immunisation.” If the evidence for Merck’s MMR vaccine safety rests on its widespread use, then by that reasoning the Cochrane would have concluded that the company’s widely used painkiller, Vioxx, was safe.

[Vioxx was withdrawn from the market only after David Graham, MD, FDA safety officer, testified before Congress that Vioxx was probably responsible for 88,000 — 139,000 heart attacks between 1999 and 2004. Hormone replacement therapy was widely and indiscriminately prescribed for millions of menopausal women for decades; until the results of a large clinical trial found that it increased the risk of heart disease, stroke, blood clots, and breast cancer. (Mayo Clinic)]

In November of 2014 the Government Accounting Office (GAO) issued the first report on America’s “Vaccine Court,”(National Vaccine Injury Compensation Program (NVICP). It criticized the government for failure to inform the public about the NVICP existence. Between January 2014 and June 2015, twice as many vaccine-injured victims have won court decisions than in the previous 8 years combined. The plaintiffs provided convincing evidence that persuaded a judge in the special vaccine court [not an easy task] that “vaccines more likely than not” caused their injuries. In one year, government “conceded” vaccine-injury cases rose by 55%. (“What the News Isn’t Saying About Vaccine-Autism Studies” by Sharyl Attkisson, investigative reporter, formerly with CBS) 

CDC officials have shown a lack of interest in developing screening tools to identify individuals who may be “at risk” of catastrophic vaccine injury; and NIH fails to fund that avenue of research. As for the high profile journal gatekeepers of “evidence-based medicine,” they have refused to publish critiques of childhood vaccine mandates; and pretend that a body of research suggesting a link between the onset of regressive autism and intestinal inflammation does not exist.

Dr. Peter Aaby, Director of the Bandim Health Project, a demographic surveillance system (in Guinea-Bissau, West Africa), is affiliated with the Statens Serum Institute. In 1991, Dr. Aaby identified an unexpected finding; non-specific vaccine effects which go beyond the specific protective effects of the targeted disease. These non-specific effects can be beneficial or harmful Dr. Aaby has conducted a series of comparative “natural studies” of vaccinated and unvaccinated children. His most recent study, published in 2017, compared the mortality of children who were vaccinated with the diphtheria, tetanus, pertussis (DTP) vaccine and the oral polio vaccine (OPV) between 3 and 5 months, with those who were unvaccinated.

  •  When DTP and OPV were introduced in Guinea-Bissau in 1981, allocation by birthday resulted in a natural experiment of being vaccinated early or late. 
  • Between 3 and 5 months of age, children who received DTP and OPV early had 5-fold higher mortality than still unvaccinated children.
  • In the only two studies of the introduction of DTP and OPV, co-administration of OPV with DTP may have reduced the negative effects of DTP.

5 Conclusions: DTP was associated with 5-fold higher mortality than being unvaccinated. No prospective study has shown beneficial survival effects of DTP. Unfortunately, DTP is the most widely used vaccine, and the proportion who receives DTP3 is used globally as an indicator of the performance of national vaccination programs.

It should be of concern that the effect of routine vaccinations on all cause mortality was not tested in randomized trials. All currently available evidence suggests that DTP vaccine may kill more children from other causes than it saves from diphtheria, tetanus or pertussis. Though a vaccine protects children against the target disease it may simultaneously increase susceptibility to unrelated infections. [Emphasis aded]

Ultimately, whether people believe that vaccines cause autism or that the theory is all junk science depends largely on which researchers people feel are most trustworthy. The appeal to “authority” is no longer persuasive, given the betrayal of trust.

(Read more: Peer-reviewed scientific reports validate, confirm & expand on “controversial” findings;   HPV vaccine policy & evidence-based medicine: are they at odds?)