Shingles Vaccine Dangers Exposed In FDA Letter to Merck

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Shingles Vaccine Dangers Exposed In FDA Letter to Merck

The CDC claims the shingles vaccine is safe, but a letter the FDA wote to Merck paints a different picture.

I recently wrote about the news of a suit against Merck over damage from the shingles vaccine.  There are claims of serious side effects, including death associated with this vaccine.

The Zostavax vaccine is recommended for every adult “fifty years of age and older” in the Merck TV ad, yet the CDC says people 60 years of age or older should get shingles vaccine.” [1]
 
On the CDC website it also states that the shingles vaccine is safe. “No serious problems have been identified with shingles vaccine.”
Despite the CDC claim that the shingles vaccine carries no real risks, the FDA wrote to Merck in February 2016 telling them to add, Eye Disorders: necrotizing retinitis (patients on immunosuppressive therapy)’ to their product information.' [2]
 
KP Stoller, a physician in San Francisco and author of the book, Incurable Me (Skyhorse 2016), is a strong critic of the current vaccine program because of its lack of safety science and oversight. He has coined the word Adversonomics to describe this neglected area of vacinology. I asked him about the safety of this vaccine.
 
Q. Dr. Stoller, what concerns do you have about the way this vaccine is being sold to the public, especially with regard to what Merck says about it in their product information sheet? [3]
 
A. There is ZERO credible safety data on "vaccines" [defined as (adjuvants etc. + antigen)] when there are no saline vs. vaccine comparisons have been done. Vaccines are not tested for safety against a saline placebo, they are tested against a solution that contains all the adjuvants, metals, DNA, and other toxins etc. but just minus the infectious disease antigen itself - in this case the varicella virus. So, the safety data and adverse event data Merck cites in their package insert does not have a lot of meaning.
 
It would be the same as if Monsanto tested RoundUp for safety and compared it not to water but to RoundUp sans Glyphosate (the reported active ingredient). Even without Glyphosate, RoundUp is very toxic... one of the ingredients is 10,000 times more toxic than Glyphosate itself. Would comparing those two substances RoundUp with Glyphosate vs RoundUp without Glyphosate be a fair comparison for safety purposes?
Yet that is exactly what the vaccine manufacturers are allowed to pass off as an adequate safety comparison. RoundUp without Glyphosate isn't anymore a placebo than the varicella vaccine without the varicella.
 
Q. What is the connection between the live virus chicken pox vaccine, now universally recommended for every child, and shingles in the adult population, which Merck claims will affect one in three adults in their lifetime.?
 
A. It has been two decades since the USA implemented Universal Varicella (Chicken Pox) vaccination. And we now know a whole lot more information about what this program has caused because what happened when children are no longer circulating wild Chicken pox virus (varicella or VZV) in the population is that adults who once had VZV as children but were unable to eradicate the virus completely from their bodies are no longer exposed to the wild virus and their own immunity drops.
 
When these adults lose their immunity to the virus, it comes out of its hiding places (the body’s dorsal-root ganglia) and that adult develops herpes zoster (HZ).  Before VZV vaccination there were about 4 million cases per year and 1 million cases of HZ. Fifty children would die each year from complications (90 people die each year from lightening sticks just as a point of reference).
 
Now, initially the vaccine was found to be very effective but that was because not everyone was vaccinated so those that were vaccinated kept getting their vaccine induced immunity boosted by the wild virus just like the adults were keeping the HZ at bay for the same reason. Ten years after its introduction the efficacy of the vaccine had dropped to less than 60%, because there were almost no unvaccinated kids circulating the wild virus. At the same time HZ cases among adults went up 90%. 

Big Pharma's ever ready answer was to vaccinate the adults to replace the natural immune boosting presence of circulating wild virus.
 
The cost of vaccinating adults with a VZV vaccine to achieve protection close to that which occurs naturally when VZV incidence could cost as much as $40 billion dollars – that is a lot a chicken scratch to Big Pharma for a vaccine that wasn’t really needed in the first place.

Essentially, the VZV vaccine shifted the disease from children to an older age group and the vaccine lost efficacy in the childhood age group as well for the same reason - vaccinated children benefited from exposure to their peers who caught wild chicken pox.

In other words, while it would not be in Big Pharma's interest to let kids opt out of the VZV vaccine it would benefit those who did get vaccinated if there were a lot of other kids who weren't vaccinated.

But to Big Pharma this isn't about disease control this is about money only. The cost-benefit of universal VZV vaccination needs to take into account the risk of off-setting the natural balance that results in continual disease and expensive remediation’s for illnesses that would never have taken place without the vaccination being given in the first place. With the meningitis vaccine is it worth killing three children and making 1000 more seriously ill to prevent one case of the disease?

This is a perfect example to demonstrate that vaccinology is far more nuanced than physicians and the public understand. It is not that vaccines are bad, it is you don't force them on everyone, because you end up working against public health interests. The goal should not be to vaccinate everyone, the goal should be to protect the public health and in this case we get better disease control if everyone isn't vaccinated. Additionally, most people think that most vaccines control the spread of disease, but they don't. Many control how sick any one person gets should they come down with the disease, but the vaccine does not control the spread of that disease.

This is just not information Big Pharma wants politicians and the public to know. They want to sell their vaccines to everyone and many times over and over... it is all about the money to them. The IPV vaccine for polio is not capable of stopping the spread of polio, so why force it on the population? I could keep listing examples, but I think I made my point.
 
Q. Merck now faces mounting complaints of injuries and a lawsuit over damage from the shingles vaccine. How does the Zostavax controversy relate to the claim that our mandated childhood schedule is linked to epidemic increases in autoimmune disorders and autism in our kids?
 
A. The simple answer is vaccines set off autoimmune reactions in many who receive them - some vaccines more than others and some people are more vulnerable than others because of the makeup of their HLA genes, for example. That would be the area where Adversonomics concerns itself with.
The public doesn't hear about all the weird and often tragic reactions to vaccines because you can't sue anyone if you have a bad vaccine reaction.
The public is hearing about Zostavax lawsuits because that vaccine is currently not protected by the Vaccine Injury Compensation Program (VICP). The National Childhood Vaccine Injury Act (NCVIA) created the Vaccine Injury Compensation Program,  provides a legal mechanism for determining whether vaccine injuries for covered vaccines should be compensated; albeit, an unfair and dysfunctional mechanism. To be a covered vaccine for which compensation is available under the VICP a vaccine must be added to the vaccine Table either by legislation or through administrative rule making by the Secretary of Health and Human Services. This applies to all vaccines, whether for adults or childhood. While the NCVIA includes the term "Childhood" in its title, this is misleading as adult vaccines may be covered under the Vaccine Act. In fact, in recent years most cases that have been compensated have been filed by adults, primarily due to the increased number of doses of the flu shot that have been administered, mostly to adults.

Zostavax is  NOT a covered vaccine under the NCVIA and, therefore, cannot be subject to a claim for compensation for vaccine injury under the VICP. The vaccine could be covered under NCVIA, but it is not yet...that could change. 

The herpes zoster vaccine that is covered under NCVIA/VICP is Varivax, or varicella, also manufactured by Merck. As you know, this is the vaccine that is included in the ACIP/CDC recommended childhood vaccine schedule. (Usually, but not always, when ACIP recommends a vaccine, steps are taken to add the vaccine to the NCVIA/VICP Table of covered vaccines.)  Both Varivax and Zostavax are diploid human cell line manufactured vaccines, manufactured using the MRC-5  (Medical Research Council cell strain 5) cell line. The Varivax has been shown to contain human DNA contamination. Zostavax also likely contains human DNA contamination. It has been theorized that the DNA contamination can cause injury by either DNA insertion or by provoking autoimmunity, although this theory is controversial and unaccepted to date in science or legal venues. There is an Omnibus proceeding pending in the VICP in which claimants allege that the diploid human cell line vaccines cause autism.

Thank you to Dr. Stoller for this explanation.
 
I also contacted Robert Krakow for a response. He was one of the principle authors of "Unanswered Questions", the revelation in 2011 that our federal government had for years been compensating children for vaccine injuries that included autism, and he is a former prosecutor who now specializes in vaccine injury cases.
 
This is what he had to say about Zostavax.
Given the obvious risk of serious injury from the Zostavax vaccine, any person over 50 should proceed with caution regarding the commercially promoted recommendation to get this vaccine. While shingles can sometimes be serious in rare cases, my view is that efforts to maintain good health and a strong immune system will serve us better than obtaining this vaccine, which has the undeniable risk of serious injury. There are almost 5000 reports of adverse events after Zostavax. The vaccine contains substances that can provoke autoimmunity, including human DNA contamination, gelatin, neomycin and other problematic substances. As with many other vaccines, I am not convinced that the vaccine or its components have been properly tested.
The promotion of Zostavax on television and other places is as irresponsible as it is inappropriate. The value of the vaccine is overstated, while the risk of adverse reactions is downplayed. This skews the benefit/cost analysis that all of us must employ when we individually decide to take any vaccine or drug.  
 
The result of all this is that an individual’s right to make informed decisions about his or her health is being overridden by bloated claims of efficacy and safety coupled with risks that are hidden from view. Because of misinformation, our informed consent is, effectively, being overridden. This is not an acceptable situation for any American.
 
Our emerging experience with Zostavax mirrors our experience with childhood vaccines. Benefits are exaggerated while risk is minimized, all in the context of relentless promotion. The difference with Zostavax is that we can more easily see when injury occurs as compared with developmental injuries that are difficult to recognize and diagnose, and are often confused with unrelated disorders. The result is the same for both adults and children: unnecessary injury and suffering, often lifelong.
 
It is the policy of our nation that vaccine injuries do occur and the victims of vaccines should be compensated. For the most part, it is unknown how such injuries occur and how often they occur. Despite this reality, there exists relentless commercial promotion of vaccines. For the sake of the health of our people, this must stop. Public education regarding vaccine risk should be increased, and more rigorous testing of all vaccine brought to market should be applied.  Unless this happens, the disturbing trend of increasing vaccine injury will persist as new and exotic vaccines are introduced into the marketplace with dubious justification, except for the bountiful commercial windfall it confers on vaccine manufacturers.
Our thanks also to Robert for telling the truth about a vaccine being sold as safe and effective. 
 

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