{"id":73001,"date":"2021-07-09T16:20:55","date_gmt":"2021-07-09T20:20:55","guid":{"rendered":"http:\/\/stateofthenation.co\/?p=73001"},"modified":"2021-07-09T16:21:41","modified_gmt":"2021-07-09T20:21:41","slug":"this-is-a-classic-battle-between-good-and-evil","status":"publish","type":"post","link":"http:\/\/stateofthenation.co\/?p=73001","title":{"rendered":"

“This is a classic battle between good and evil.”<\/b><\/h3>"},"content":{"rendered":"

COVID Vaccine Approval by FDA: Battle is On<\/strong><\/h1>\n

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\"COVID<\/picture><\/figure>\n
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Note that views expressed in this opinion article are the writer\u2019s personal views and not necessarily those of TrialSite.<\/strong><\/em><\/h4>\n

By Joel S. Hirschhorn<\/p>\n

This is a classic battle between good and evil.\u00a0\u00a0On the good side are medical articles and petitions to FDA to stop the COVID vaccine public health disaster.\u00a0\u00a0On the evil side are big drug companies and big media arguing that there is no time to waste.\u00a0\u00a0In their perverted world view until full FDA approval happens many people will justify avoiding getting jabbed.<\/p>\n

What should greatly trouble people is that at least 7,000 deaths have been connected to COVID vaccines and about 500,000 injuries have also resulted.\u00a0\u00a0Sure, compared to millions of vaccinated people these number may not seem critically important.\u00a0\u00a0Unless you or your family have been negatively impacted.\u00a0\u00a0To see reality, you have to read the stories of the many thousands of people who have suffered terrible health impacts from being jabbed.\u00a0\u00a0Often very young people.\u00a0\u00a0None of these nightmares are covered by big media.<\/p>\n

There are three things that pro approval articles stay away from mentioning or seriously analyzing that reveal gross bias and dishonesty.<\/p>\n

First, one word rarely seen in big media stories pushing for full FDA approval is the word \u201cexperimental\u201d to describe currently used COVID vaccines allowed under an emergency use authorization.<\/p>\n

Second, the enormous number of frightful stories of serious health impacts from getting vaccinated are avoided like the proverbial plague.<\/p>\n

Third, there is no mention of major medical reports and two major petitions to FDA by very credible health experts that demand more serious studies by FDA of a multitude of safety issues and concerns.<\/p>\n

All three of these should make Americans seriously doubt the integrity of the FDA and its supporters.\u00a0\u00a0All that pro approval entities embrace is getting more people vaccinated and the dubious claim that artificial immunity obtained from vaccines gets all the credit for better looking COVID cases and deaths.\u00a0\u00a0Left out is acknowledgement of the benefits of natural immunity for about half the population obtained from being infected by the COVID virus without, in nearly all cases, any serious health harm.<\/p>\n

Below I will briefly indicate what pro approval people and media are saying.\u00a0\u00a0Then, more importantly, I will provide coverage of a number of very important reports and petitions by medical experts trying to inform the public why FDA should seriously examine many safety issues and concerns about the COVID vaccines before giving full approval.\u00a0\u00a0For about two months, big media has kept all these hidden from public view.\u00a0\u00a0Keep in mind that this aspect of the cancel culture is also aimed at preventing attention to the various early home\/outpatient treatments to cure and prevent COVID infection.\u00a0\u00a0These are a legitimate alternative to vaccines.\u00a0\u00a0They are described in detail in\u00a0Pandemic Blunder<\/a>.<\/p>\n

The most significant big media propaganda was a July 1 opinion\u00a0article<\/a>\u00a0in the New York Times: \u201cIt\u2019s Time for the F.D.A. to Fully Approve the mRNA Vaccines\u201d by the biggest shill for approval Dr. Eric Topol of Scripps Research who has served on multiple FDA advisory committees.\u00a0\u00a0His biggest claim or assertion is this: \u201cvaccines have overwhelmingly been proved safe and effective by clinical trials, independent research and the experience of millions of people around the world who received them.\u201d\u00a0\u00a0Understand this: a great many medical experts totally disagree with this.\u00a0\u00a0And if you choose to check out what I give below, so will you.<\/p>\n

And here is the mainstay of approval proponents.\u00a0\u00a0\u201cSome people\u2026are waiting for full F.D.A. approval before they receive a shot.\u00a0\u00a0Others may not get immunized unless their employers require it, and many organizations \u2014including, reportedly, the military \u2014are waiting for the vaccines to be fully approved before instituting such mandates.\u201d\u00a0\u00a0Meantime everywhere you look there is coercion to get the jab.<\/p>\n

Here are\u00a0views<\/a>\u00a0from two other pro approval shills: \u201cGigi Gronvall, a senior scholar at the Johns Hopkins Center for Health Security, said that while there should not be \u201cpolitical pressure\u201d on the FDA, \u201cI would be interested in knowing what the holdup is.\u00a0\u00a0It could have a big impact on people getting [vaccinated] if it is FDA approved,\u201d she said. \u201cI think it\u2019s worth asking why it hasn\u2019t happened yet.\u201d\u00a0\u00a0You will get answer below.<\/p>\n

Ashish Jha, dean of the Brown University School of Public Health, was more direct. \u201c1 out of 3 American adults still unvaccinated.\u00a0\u00a0Data is in. Vaccines are safe and effective.\u00a0\u00a0It\u2019s time for full approval.\u201d\u00a0\u00a0No, it is not.<\/p>\n

The position of approval advocates is explained by\u00a0this<\/a>: \u201cA Kaiser Family Foundation poll in May found that about a third of unvaccinated people \u2014 32 percent \u2014 said they would be more likely to get the shots if a vaccine received full approval.\u00a0\u00a0That was a higher percentage than those saying paid time off, a free ride to the vaccination site, or getting $100 from the state would make them more likely to get vaccinated.\u201d\u00a0\u00a0I say that if more people became informed about what is given below, they would become even more disinclined.<\/p>\n

A\u00a0Yahoo news story<\/a>\u00a0invoked fear about the Delta variant and had this to say: \u201cNow that the Delta coronavirus variant is posing a serious risk to unvaccinated Americans, some experts are calling for the Food and Drug Administration to fully approve the Pfizer and Moderna COVID-19 vaccines, which are currently being used under emergency use authorization.\u00a0\u00a0Vaccine holdouts are potentially at great risk of contracting the Delta variant, which is quickly becoming dominant in the United States.\u00a0\u00a0But Americans who have received the Pfizer or Moderna vaccines are extremely unlikely to get sick from Delta or any other coronavirus variant.\u201d\u00a0\u00a0That last statement ignores considerable data about\u00a0breakthrough infections<\/a>\u00a0in vaccinated people.<\/p>\n

Yahoo also said \u201cbillions of people worldwide have now been vaccinated without any complications, a sure sign..that they are \u2018incredibly safe.\u2019\u201d\u00a0\u00a0That is a boldface lie.\u00a0\u00a0Hundreds of thousands of deaths and injuries have resulted from vaccinations.<\/p>\n

Now let\u2019s get to the most important information, the case for full approval dissenters.\u00a0Unlike the pro side, big media has successfully blocked public access to the following.<\/p>\n

In early May, the\u00a0headline<\/a>\u00a0was \u201c57 leading scientists, doctors, and public policy experts call for IMMEDIATE HALT to Covid vaccine programs.\u201d\u00a0\u00a0A medical article was published with this title: \u201cSARS-CoV-2 mass vaccination: Urgent questions on vaccine safety that demand answers from international health agencies, regulatory authorities, governments and vaccine developers.\u201d\u00a0\u00a0This was the main perspective: \u201cThe lack of thorough testing in animals prior to clinical trials, and authorization based on safety data generated during trials that lasted less than 3.5 months, raise questions regarding the safety of these vaccines.\u201d\u00a0\u00a0This too was noted: \u201cDespite calls for caution, the risks of SARS-CoV-2 vaccination have been minimized or ignored by health organizations and government authorities.\u00a0\u00a0We appeal to the need for a pluralistic dialogue in the context of health policies, emphasizing critical questions that require urgent answers if we wish to avoid a global erosion of public confidence in science and public health.\u201d<\/p>\n

On the critical issue of vaccination for children, this was emphasized: \u201cThere is a lack of scientific justification for subjecting healthy children to experimental vaccines, given that the Centers for Disease Control and Prevention estimates that they have a 99.997% survival rate if infected with SARS-CoV-2. Not only is COVID-19 irrelevant as a threat to this age group, but there is no reliable evidence to support vaccine efficacy or effectiveness in this population or to rule out harmful side effects of these experimental vaccines. In this sense, when physicians advise patients on the elective administration of COVID-19 vaccination, there is a great need to better understand the benefits and risk of administration, particularly in understudied groups.\u201d<\/p>\n

This is how the report ends: \u201cWe are convinced that humanity deserves a deeper understanding of the risks than what is currently touted as the official position.\u00a0\u00a0An open scientific dialogue is urgent and indispensable to avoid erosion of public confidence in science and public health and to ensure that the WHO and national health authorities protect the interests of humanity during the current pandemic.\u00a0\u00a0Returning public health policy to evidence-based medicine, relying on a careful evaluation of the relevant scientific research, is urgent.\u00a0\u00a0It is imperative to follow the science.\u201d\u00a0\u00a0If only Fauci would listen.<\/p>\n

In early June, an urgent British\u00a0report<\/a>\u00a0called for complete cessation of COVID vaccines in humans.\u00a0\u00a0The big conclusion was that the British regulatory agency like the FDA \u201chas more than enough evidence \u2026 to declare the COVID-19 vaccines unsafe for use in humans.\u00a0\u00a0It is now apparent that these [vaccine] products in the blood stream are toxic to humans.\u00a0An immediate halt to the vaccination programme is required whilst a full and independent safety analysis is undertaken to investigate the full extent of the harms, which [regulatory] suggest include thromboembolism, multisystem inflammatory disease, immune suppression, autoimmunity and anaphylaxis, as well as Antibody Dependent Enhancement (ADE).\u201d<\/p>\n

Also, in early June a very important petition to FDA by 27 medical experts made these critical points in a published article: \u201cWhy we petitioned the FDA to refrain from fully approving any covid-19 vaccine this year.\u201d\u00a0\u00a0\u201cWe are part of a group of clinicians, scientists, and patient advocates who have lodged a\u00a0formal \u201cCitizen Petition\u201d<\/a>\u00a0with the United States Food and Drug Administration (FDA), asking the agency to delay any consideration of a \u201cfull approval\u201d of a covid-19 vaccine.\u00a0\u00a0The message of our petition is \u201cslow down and get the science right\u2014there is no legitimate reason to hurry to grant a license to a coronavirus vaccine.\u00a0\u00a0We believe the existing evidence base\u2014both pre- and post-authorization\u2014is simply not mature enough at this point to adequately judge whether clinical benefits outweigh the risks in all populations.\u201d<\/p>\n

\u201cThe covid-19 vaccines in widespread use have emergency authorizations (EUA), not actual approvals, a crucial regulatory distinction that reflects major differences in the level of regulatory scrutiny and certainty about the risk-benefit balance.\u201d<\/p>\n

\u201cWe also call on FDA to require a more thorough assessment of spike proteins produced in-situ by the body following vaccination\u2014including studies on their full biodistribution, pharmacokinetics, and tissue-specific toxicities. We ask the FDA to demand manufacturers complete proper biodistribution studies that would be expected of any new drug and request additional studies to better understand the implications of mRNA translation in distant tissues. We call on data demonstrating a thorough investigation of all serious adverse events reported to pharmacovigilance systems, carried out by independent, impartial individuals, and for safety data from individuals receiving more than two vaccine doses, in consideration of plans for future booster shots. We ask the FDA to request necessary studies in specific populations, including those previously infected with SARS-CoV-2, pediatric subjects, and those with immunological or other underlying medical complexities. Given the nature of the novel vaccine platforms, our petition asks for experts in gene therapy to be included among the external committee advising the FDA.\u201d<\/p>\n

Here is a very important contribution by this petition which is the invalid reason to approve the COVID vaccines.\u00a0\u00a0\u201cTo bolster public confidence. Like mandates, approving a medical product in order to bolster public confidence is backward logic and is outside the FDA\u2019s purview.\u00a0\u00a0Approving before substantial evidence that population-based evidence of clinical effectiveness is superior to harms may contribute to public wariness and hesitancy, not only about COVID-19vaccines, but other vaccines and public health authorities more broadly.\u00a0\u00a0An approval may bolster public confidence, but it is not a valid reason to approve.<\/p>\n

Yet another petition to FDA was submitted in mid-May by Robert F. Kennedy, Jr. and Dr. Meryl Nas, on behalf of\u00a0Children\u2019s Health Defense<\/a>\u00a0(CHD), asking the agency to immediately revoke the Emergency Use Authorizations (EUAs) for COVID vaccines and to refrain from licensing [approving] them.<\/p>\n

It should now be clear that there is more than enough reason to reject all the propaganda by big media backing the full approval of COVID vaccines.\u00a0\u00a0More reason than ever for people to reject getting the jab.<\/p>\n

Dr. Joel S. Hirschhorn, author of\u00a0Pandemic Blunder<\/a>, and many articles on the pandemic, worked on health issues for decades. As a full professor at the University of Wisconsin, Madison, he directed a medical research program between the colleges of engineering and medicine. As a senior official at the Congressional Office of Technology Assessment and the National Governors Association, he directed major studies on health-related subjects; he testified at over 50 US Senate and House hearings and authored hundreds of articles and op-ed articles in major newspapers. He has served as an executive volunteer at a major hospital for more than 10 years. He is a member of the Association of American Physicians and Surgeons, and America\u2019s Frontline Doctors.<\/em><\/p>\n

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\nhttps:\/\/trialsitenews.com\/covid-vaccine-approval-by-fda-battle-is-on\/<\/a><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

COVID Vaccine Approval by FDA: Battle is On<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-73001","post","type-post","status-publish","format-standard","hentry","category-uncategorized"],"_links":{"self":[{"href":"http:\/\/stateofthenation.co\/index.php?rest_route=\/wp\/v2\/posts\/73001","targetHints":{"allow":["GET"]}}],"collection":[{"href":"http:\/\/stateofthenation.co\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"http:\/\/stateofthenation.co\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"http:\/\/stateofthenation.co\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"http:\/\/stateofthenation.co\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=73001"}],"version-history":[{"count":0,"href":"http:\/\/stateofthenation.co\/index.php?rest_route=\/wp\/v2\/posts\/73001\/revisions"}],"wp:attachment":[{"href":"http:\/\/stateofthenation.co\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=73001"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"http:\/\/stateofthenation.co\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=73001"},{"taxonomy":"post_tag","embeddable":true,"href":"http:\/\/stateofthenation.co\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=73001"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}