FDA Approval of Covid Vaccines Must Be Rejected—Here’s Why!

Compelling Case Against COVID ‘Vaccine’ Approval

by Dr. Joel S. Hirschhorn

When I read this headline, I connected to the current struggle by many medical experts urging FDA to hold off granting full approval to COVID vaccines: “US ranks last among 46 countries in trust in media.”

Here are some disturbing details.  The United States ranks last in media trust — at 29% — among 92,000 news consumers surveyed in 46 countries, a report found.  That’s worse than Poland, worse than the Philippines, worse than Peru and far worse that Finland that leads at 65%.  We must use alternative news websites like this one and podcasts to get the truth.

There is no better reason for Americans to distrust mainstream and corporate social media than the combination of propaganda for COVID vaccines and holding back key information on what medical experts for several months have been doing in their fight against full approval of them.  We are in a corrupt world of vaccine fanaticism.

This article lays out the case against granting full approval and why pro-approval shills use big media endlessly.

Understanding the Approval Battle

This is a classic battle between good and evil.  On the good side are medical articles and petitions to FDA to stop the COVID vaccine public health disaster by better assuring safety.  On the evil side are big drug companies and big media arguing that there is no time to waste.  In their world view until full FDA approval happens many people will justify avoiding getting jabbed.  That ignores medical freedom giving people the right to decide what medicine or vaccine to take.

What should greatly trouble Americans is that at least 7,000 deaths have been connected to COVID vaccines and about 500,000 injuries have also resulted.  Sure, compared to millions of vaccinated people these number may not seem critically important.  Unless you or your family have been negatively impacted.  To see reality, you have to read the stories of the many thousands of people who have suffered terrible health impacts from being jabbed.  Often very young people.  None of these nightmares are covered by big media.

There are three things that pro approval articles stay away from mentioning or seriously analyzing that reveal gross bias and dishonesty.

  • First, one word rarely seen in big media stories pushing for full FDA approval is the word “experimental” to describe currently used COVID vaccines allowed under an emergency use authorization.
  • Second, the enormous number of frightful stories of serious health impacts from getting vaccinated are avoided like the proverbial plague.  To see detailed stories, go to Health Impact News.
  • Third, there is no mention of major medical reports and major petitions to FDA by very credible health experts that demand more serious studies by FDA of a multitude of safety issues and concerns.

All three of these should make Americans seriously doubt the integrity of the FDA and its supporters.  All 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.  Left 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.

Below I will briefly indicate what pro-approval people and media are saying.  Then, 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.  For about two months, big media has kept all these hidden from public view.  Keep 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.  These are a legitimate alternative to vaccines.  They are described in detail in Pandemic Blunder and a new review of ivermectin use.

Pro-Approval Propaganda

The most significant big media propaganda was a July 1 opinion article in the New York Times: “It’s Time for the F.D.A. to Fully Approve the mRNA Vaccines” by the biggest shill for approval Dr. Eric Topol of Scripps Research who has served on multiple FDA advisory committees.

Much more was not revealed about him and his objectivity.  In 2016, Topol received $207 million from NIH in addition to other grants of $35 million and $17 million from NIH.  In August 2020 he publicly criticized FDA’s emergency use authorization of hydroxychloroquine.  He has had financial involvement in six companies, including Walgreens and Quest Diagnostics.  He is Editor-in-Chief of Medscape, a publication that has not revealed all the disturbing facts about COVID vaccines, as given below.

Interestingly, in 2020 Topol revealed his “liberal” political position when he was big media’s go-to guy for months for “authoritative” medical objections to Trump’s program to rapidly produce COVID vaccines.  His argument was that, if it is fast — that is, a crash program — it is suspect.  In September, Topol led a campaign accusing FDA head Stephen Hahn of being a tool of Trump in the push for a vaccine, and calling upon him to resign.

Topol is pure “establishment.”  Like Fauci, he is a physician that the public should not trust.

His current biggest claim or assertion is this: “vaccines 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.”  Understand this: a great many medical experts totally disagree with this.  And if you choose to check out what I give below, so will you.

And here is the mainstay of approval proponents.  “Some people…are waiting for full F.D.A. approval before they receive a shot.  Others may not get immunized unless their employers require it, and many organizations —including, reportedly, the military —are waiting for the vaccines to be fully approved before instituting such mandates.”  Meantime everywhere you look there is coercion to get the jab.

Here are views from two other pro approval shills: “Gigi Gronvall, a senior scholar at the Johns Hopkins Center for Health Security, said that while there should not be “political pressure” on the FDA, “I would be interested in knowing what the holdup is.  It could have a big impact on people getting [vaccinated] if it is FDA approved,” she said. “I think it’s worth asking why it hasn’t happened yet.”  You will get answers below.

Ashish Jha, dean of the Brown University School of Public Health, on the wrong side of all pandemic issues, was more direct. “1 out of 3 American adults still unvaccinated.  Data is in. Vaccines are safe and effective.  It’s time for full approval.”  No, it is not.  This guy has been wrong on all pandemic issues and is a favorite of Democrat media.

The position of approval advocates is explained by this: “A Kaiser Family Foundation poll in May found that about a third of unvaccinated people — 32 percent — said they would be more likely to get the shots if a vaccine received full approval.  That 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.”  I say that if more people became informed about what is given below, they would become even more disinclined.

A Yahoo news story invoked fear about the Delta variant and had this to say: “Now 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.  Vaccine holdouts are potentially at great risk of contracting the Delta variant, which is quickly becoming dominant in the United States.  But Americans who have received the Pfizer or Moderna vaccines are extremely unlikely to get sick from Delta or any other coronavirus variant.”  That last statement ignores considerable data about breakthrough infections in vaccinated people.

It also ignores some important new data on Delta.  Here are the details: “A briefing from Public Health England (PHE) shows that as a hospital patient, you are six times more likely to die of the COVID Delta variant if you are fully vaccinated, than if you are not vaccinated at all.  The information shows up for confirmed Delta cases from February 1, 2021, to June 7, 2021.  Of 33,206 Delta variant cases admitted to the hospital, 19,573 were not vaccinated.  Of those, 23 (or 0.1175%) died.…Of the 1,785 patients who had both vaccine doses 14 days or more before admission, 12 (or 0.6722%) died.  This death rate is 5.72 times higher than that for unvaccinated patients.”

Yahoo also said “billions of people worldwide have now been vaccinated without any complications, a sure sign…that they are ‘incredibly safe.’”  That is a boldface lie.  Hundreds of thousands of deaths and injuries have resulted from vaccinations.

Recently Dr. Peter Marks, the vaccine chief at FDA said this: “But after hundreds of millions of vaccine doses administered around the world — and intense safety monitoring — few serious risks have been identified.”  This is a lie.  At the same time CDC reported to FDA a total of 704 serious adverse events among younger people age 12 to 25 through May 31, defined as death, life-threatening illness, hospitalization or prolongation of hospitalization, permanent disability, congenital anomaly or birth defect.  In fact, there were 14 reports of death and 216 cases of heart inflammation after first dose (age 12 to 94) and 573 (age 14 to 87) after second dose—also known as myocarditis or pericarditis.

Strong Case Against Approval

Now let’s get to the most important information, the case for full approval dissenters.  Unlike the pro side, big media has successfully blocked public access to the following.

In early May the headline was “57 leading scientists, doctors, and public policy experts call for IMMEDIATE HALT to Covid vaccine programs.”  A medical article was published with this title: “SARS-CoV-2 mass vaccination: Urgent questions on vaccine safety that demand answers from international health agencies, regulatory authorities, governments and vaccine developers.”  This was the main perspective: “The 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.”

This too was noted: “Despite calls for caution, the risks of SARS-CoV-2 vaccination have been minimized or ignored by health organizations and government authorities.  We 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.”

On the critical issue of vaccination for children this was emphasized: “There 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.”

This is how the report ends: “We are convinced that humanity deserves a deeper understanding of the risks than what is currently touted as the official position.  An 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.  Returning public health policy to evidence-based medicine, relying on a careful evaluation of the relevant scientific research, is urgent.  It is imperative to follow the science.”  If only Fauci would listen.

Instead, we get the usual garbage talk from him.  Fauci said during a White House Covid-19 briefing recently that it would be “most unusual for the FDA to refuse full approval for coronavirus vaccines being used under emergency use authorization.  You never want to get ahead of the FDA, but it would really be a most unusual situation not to see this … get full approval.  I believe it’s going to happen.”  He clearly is not paying any attention to the many experts fighting full approval.

In early June an urgent British report called for complete cessation of COVID vaccines in humans.  The big conclusion was that the British regulatory agency like the FDA “has more than enough evidence … to declare the COVID-19 vaccines unsafe for use in humans.  It is now apparent that these [vaccine] products in the blood stream are toxic to humans.  An 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).”

Also, in early June a very important petition to FDA by 27 medical experts made these critical points in a published article: “Why we petitioned the FDA to refrain from fully approving any covid-19 vaccine this year.”  “We are part of a group of clinicians, scientists, and patient advocates who have lodged a formal “Citizen Petition” with the United States Food and Drug Administration (FDA), asking the agency to delay any consideration of a “full approval” of a covid-19 vaccine.

The message of our petition is “slow down and get the science right—there is no legitimate reason to hurry to grant a license to a coronavirus vaccine.  We believe the existing evidence base—both pre- and post-authorization—is simply not mature enough at this point to adequately judge whether clinical benefits outweigh the risks in all populations.”

“The 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.”

“We also call on FDA to require a more thorough assessment of spike proteins produced in-situ by the body following vaccination—including 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.”

Here is a very important contribution by this petition which is the invalid reason to approve the COVID vaccines.  “To bolster public confidence. Like mandates, approving a medical product in order to bolster public confidence is backward logic and is outside the FDA’s purview.  Approving 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.  An approval may bolster public confidence, but it is not a valid reason to approve.

A key signatory to this petition is the highly regarded Dr. Peter McCullough who said this: “US experts have expressed grave concerns over the safety of the mRNA and adenoviral COVID-19 vaccines.  These products trick the body into an uncontrolled biologic frenzy and produce the dangerous Wuhan spike protein, which is the product of bioterrorism research from the Institute of Virology in Wuhan, China…. the products are not sufficiently safe nor effective for full FDA approval.  Many open, unanswered questions surrounding the efficacy and safety of COVID-19 vaccines must be answered before the FDA considers granting a full approval. “

Yet another petition to FDA was submitted in mid-May by Robert F. Kennedy, Jr. and Dr. Meryl Nass, an esteemed medical expert, on behalf of Children’s Health Defense (CHD), asking the agency to immediately revoke the Emergency Use Authorizations (EUAs) for COVID vaccines and to refrain from licensing [approving] them.

Two of the most respected pandemic experts, UCLA Geffen School of Medicine Dr. Joseph Lapado and Yale School of Public Health Dr. Harvey Risch wrote this in a key Wall Street Journal  article: “Another reversal in thinking may be imminent.  Some scientists have raised concerns that the safety risks of Covid-19 vaccines have been underestimated.  But the politics of vaccination has relegated their concerns to the outskirts of scientific thinking—for now.  The large clustering of certain adverse events immediately after vaccination is concerning, and the silence around these potential signals of harm reflects the politics surrounding Covid-19 vaccines.  Stigmatizing such concerns is bad for scientific integrity and could harm patients,” they continued.

They also noted: “Prior research has shown that only a fraction of adverse events are reported, so the true number of cases is almost certainly higher.  This tendency of underreporting is consistent with our clinical experience.”  And most importantly, they noted: “the risks of a Covid-19 vaccine may outweigh the benefits for certain low-risk populations, such as children, young adults and people who have recovered from Covid-19.”  The latter would have natural immunity.

And on that topic, they emphasized: “While you would never know it from listening to public-health officials, not a single published study has demonstrated that patients with a prior infection benefit from Covid-19 vaccination.  That this isn’t readily acknowledged by the CDC or Anthony Fauci is an indication of how deeply entangled pandemic politics is in science.”  The politics are pushing for approval.  A sign of a corrupt system.

An impressive 2017 analysis found considerable evidence to reach this conclusion about the CDC system reporting ill impacts from vaccine use: “By far, the most dire failure of the VAERS system is the vast underreporting of vaccine adverse effects which leads to a dangerous false security in vaccine safety and an erroneous assumption that the benefits of vaccination far outweigh the risks.”

It found a congressional report that said: “Former FDA commissioner David A. Kessler has estimated that VAERS reports currently represent only a fraction of the serious adverse events.”  Another important revelation: “The IOM [Institute of Medicine of the National Academy of Sciences} has been telling the CDC for over 23 years that they have inadequate information (and none at all in some cases) to advise on the causal relationship between vaccines and adverse events for a majority of adverse events reported.”

It also dug out data from a three-year study by a Harvard University medical practice group that found adverse vaccine impacts for 2.6 percent of jabs.  CDC refused to use the Harvard system to update theirs.  Indeed, a Harvard report criticized the CDC system and found “fewer than 1% of vaccine adverse events are reported.”  The Harvard data indicate a possible level of adverse events for the COVID vaccines of close to 3 million, far above official CDC data.

Additionally, a very strong, detailed analysis of vaccine safety has been done.  Here is a big conclusion: “The number of previously healthy Americans killed by the vaccines so far appears to be over 25,000 and the number of Americans who have been significantly injured could well be over 1M.”  Moreover, this too was said: “we can show causality for a variety of very serious neurological and cardiovascular events.  Our methods include methods similar to what the FDA itself used to ascribe excess myocarditis events to the vaccine (i.e., showing an incidence rate significantly above baseline).



The analysis here raises serious issues that are impossible to ignore.  The precautionary principle of medicine says that until more definitive analysis is available, we should assume the current analysis is correct.  This means we should not mandate forced vaccinations for students or employees anywhere in the world until these issues are clearly resolved.”

Another important observation in this paper: “So the vaccine deaths are simply categorized as deaths from the virus.”  If true, this is yet another big government lie.  And most important: “If you believe early treatment works (which it does), nobody should get vaccinated.  Lower risk, higher benefit from early treatment.”  I agree.  Add this nugget of reality: The incredible frontline doctor George Fareed “reports a ratio of 10:1 of vaccine side-effect visits to COVID visits in urgent care.”

Dr. Martin Makary, a public health expert at Johns Hopkins University who has spoken pandemic truth is urging his colleagues to “think twice” before recommending universal COVID-19 vaccination of healthy kids. Given the data in hand, “there’s no compelling case for it right now,” he wrote in MedPage.  He has called for more thorough examination of the safety data.  “We’ve converted now from being pro-vaccine to vaccine fanaticism,” he said.  He has also stressed the importance of natural immunity and questioned the need for vaccination: “Several studies demonstrate that natural immunity should protect those who had Covid-19.”  And, on all the hysteria about the delta variant Makary recently smartly observed: “I think it’s used to manipulate people to get vaccinated.  I’m for vaccines, but this is turned into a tool to try and coax people into it.”  In other words, coercion.

The great Dr. Robert Malone, inventor of mRNA vaccines and a truly honest, ethical expert has spoken out about the downside of the COVID vaccines.  Here are some of his important points that support opposition to full approval of them.  Early on, he advised FDA about potential health risks for them, but he was not taken seriously.  Here are his statements from an extensive interview in early July.

On vaccine ill effects: “So we end up relying on really outdated, antiquated systems that have been set up a decade or more ago for the most part or some systems that are self-reported like V-safe at the CDC. But those typically capture 1 per cent of the events because they’re all self-reported.”

On rapid development of the vaccines: “My fear has been with rushing this through, we would end up with problems. How can you not end up with problems if you cut corners and rush these things, particularly the safety issues?”

On risk and obeying federal law: “if you’re going to be administering experimental products to patients, that falls under clinical research, and medical research.  And so you have to follow the guidance for medical research. [in] the Common Rule [as] codified in the Code of Federal Regulations.  The first clause, importantly, in the Common Rule, is there has to be complete disclosure of risk.”  [But] we are not meeting the criteria for full disclosure of risk.”

On coercion to get vaccinated: “All of this messaging that the vaccine is safe, and all the peer pressure that’s happening around the vaccine is coercion.  ‘We all have to get vaccinated so we will reach herd immunity.’ That’s the logic.  The problem is that this is a fallacy.  We have not even gathered the data to be able to calculate in these clinical trials what would give us herd immunity.”

On medical freedom: “You have the right to accept or not accept a vaccine product, particularly an experimental one. You make your own decision. I can’t advise you, in the end, neither can your physician completely advise you.”

Dr. Mercola wrote about Malone’s views and noted: “He believes the risks outweigh the benefits in children, teens and young adults, and that those who have recovered from natural SARS-CoV-2 infection should not get the injection.”

Bottom line: 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.  More reason than ever for people to reject getting the jab, especially if you have natural immunity or want to use early home/outpatient treatments that cure and prevent COVID infection.  This is very relevant for the 50 percent of working age adults who have not taken any jab.  And vaccinated people should think deeply about getting a booster shot.

Dr. Joel S. Hirschhorn, author of Pandemic Blunder, 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’s Frontline Doctors.

Photo by Artem Podrez from Pexels.


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