Fast-Tracking a CoV-19 Vaccine: Why Should We Worry?
Richard Gale and Gary Null PhD
Progressive Radio Network, May 21, 2020
The CoV-19 pandemic is now exposing the hidden agendas and motives of the powers that be in government, in the pharmaceutical industry and Wall Street, and in the media. Despairingly opponents of vaccine mandates are largely divided. Many Trump supporters in the so-called anti-vaccination community believed he would be their savior to protect vaccine exemptions and avert compulsory mandates. Nevertheless, during his watch draconian mandate laws to ban religious exemption for children to attend public schools have been signed by the governors of California and New York.
Throughout the CoV-19 pandemic, Trump has waffled wildly, jumping on and off the vaccine band wagon depending upon his daily whims. Early he stated there was no need for a vaccine since the virus would magically disappear and no longer be a threat. It was his gut feeling and not surprisingly he was wrong. Yet during a press conference on March 14th, Trump announced the unveiling of his Operation Warp Speed agenda to accelerate development of a CoV-19 vaccine and have it ready this year. Trump is now fully on board with the pro-vaccination agenda. Moreover, he ordered that the military will be "mobilized so at the end of the year, we're going to be able to give it to a lot people very, very rapidly." His newly appointed Warp Speed advisor is a venture capitalist and a former chairman of GlaxoSmithKline's vaccine division, Moncel Slaoui.
Often in order to understand Trump's strategies, follow the money trail, especially if the money trails leads to sealing loyalty to the president. However, his probable immediate motivation is for reelection and to increase the profits of pharmaceutical and investor profiles as repayment for those loyalties. We can therefore reasonably expect, despite what has already been stated, that Trump may nationally mandate a CoV-19 vaccine. There are voices in Trump's camp who favor mandates. One of Trump's leading attorneys is Harvard law professor Alan Dershowitz who recently went on record saying,
"Let me put it very clearly, you have no constitutional right to endanger the public and spread disease.... You have no right not to be vaccinated, you have no right not to wear a mask, you have no right to open up your business.... if you refuse to be vaccinated, the state has the power to literally take you to a doctor's office and plunge a needle into your arm."
What might be the downside if a vaccine pushed on the public en masse is discovered to not work or is found unsafe in the long-term? Worse, what might be the consequences of a flawed vaccine that becomes mandated and required as policy to attend schools, work or even to leave the home to shop? We might be faced with an epidemic of vaccine-related illnesses and death on a scale that could dwarf the current CoV-19 pandemic.
There would be a greater rationale to push forward a fast-tracked vaccine if the private vaccine manufacturers were held legally liable for vaccine-related injuries and deaths. However, this was laid to rest by the Reagan administration after the passage of the Vaccine Injury Compensation Act in 1986, which freed the pharmaceutical industry from personal injury lawsuits. Consequently, there is no incentive whatsoever for the vaccine industry to perform thorough due diligence analyses and reviews and to adopt gold standard scientific measures to create a safe and effective vaccine. In effect, they have free rein to develop vaccines according to their own rules.
According to German oncologist Claus Kohnlein, we may well be in the era of "virus mania." The prevailing medical establishment has become dominated by a rapidly expanding private industry obsessed with viruses and the invention of pandemics for enormous profit. This obsession has hijacked not only medical practice and legislators who are determined to mandate vaccination, but has also infiltrated the entire mainstream media. This is despite consensual confirmatory evidence that some of these viruses may not be dangerous enough to warrant a vaccine nor demand mass screening to monitor potential infection. For example, University of Toronto professor emeritus of pathology, Dr. Etienne de Harven would have us ask: do molecular markers for retroviruses truly confirm the presence of a virus, or is this a human invention that substitutes the absence of identifiable viral proteins and particles? Embedded in all of the confusion over CoV-19 and the heated debates and uncertainty over life returning to normal, the mainstream chorus chants that stability will only resume after a vaccine is launched on the public. At this moment, Kohnlein's 2007 book Virus Mania: Avian Flu, Cervical Cancer, SARS, BSE, Hepatitis C, AIDS, Polio is essential reading to expose the life-threatening failures in modern medical science's efforts to tackle viral threats. And what Kohnlein outlines is being repeated again with CoV-19.
The need for a vaccine in order for society and the economy to return to normal was clearly stated by Trump's Federal Reserve Chairman Jerome Powell. ".. for the economy to fully recover," he stated, "that may have to await the arrival of a vaccine." Unfortunately, besides the White House and nation being impatient and placing high hopes in a vaccine, we are also witnessing a careless zeal to cut regulatory corners. And this atmosphere could potentially end in a serious medical disaster on the not-too-distant horizon. Virus mania is morphing into vaccine mania. That vaccine mania has become a reality is evidenced in the 133 vaccines currently in development worldwide targeted against CoV-19 according to the Milken Institute.
Many challenges must be recognized and surmounted before an effective CoV-19 vaccine can be deemed safe.. The virus has already been shown to mutate rapidly despite beliefs that its RNA is stable. .Mutations of course naturally occur when a virus changes hosts, especially after jumping species. However, RNA viruses mutate more readily than larger DNA viruses such as herpes, HPV and smallpox. University of Cambridge has identified three separate mutations since the Wuhan outbreak. Last month Los Alamos National Laboratory reported a recent mutation that is more contagious and transmittable than the original Wuhan strain. Another strain was identified in India; the South China Morning Post reported that this Indian strain is being viewed as more virulent for the development of severe acute respiratory syndrome. The researchers from National Changhua University in Taiwan and Murdoch University in Australia warned that it "means current vaccine development against Sars-CoV-2 is at risk of becoming futile." The problem with mutations, similar to the challenges to create a universal flu vaccine, is whether or not any CoV-19 vaccine would generate sufficient immunity to combat future mutant strains and whether this is a cross-over of multi-strain immunity.
Furthermore, some reports indicate that natural CoV-19 immunity may wane quickly. This is an additional caution about any promises that a fast-tracked and poorly evaluated vaccine, which will bypass a rigorous regulatory review, will provide much if any long-term immunity. In a preliminary study, Columbia University researchers identified people who were reinfected with the same coronavirus strain within a single year. Twelve individuals tested positive two or three times for the same strain within 18 months. Similar findings were noted in South Korea. The Columbia scientists' conclusion is that coronavirus "immunity seems to wane quickly." Dr. Matthew Frieman at the University of Maryland is an expert in coronaviruses. He states that "we get coronaviruses every winter even though we're seroconverted..... We really don't understand whether it is a change in the virus over time [ie., mutations] or antibodies that don't protect from infection." The consequences are that proposals for issuing immunity certificates or passports would be utterly futile, an extraordinary waste of funding and that would accomplish little.
Since 2003 efforts have been made to develop coronavirus vaccines following the first SARS outbreak in China. All of these efforts failed either because of a lack in funding or because of observable serious adverse effects that necessitated the project to cease. To our knowledge, none of these efforts reached human trials because of serious adverse effects in animal trials.
However, now we are witnessing one company Moderna bypassing animal studies with its new CoV vaccine and commencing with human trials. The company has already reported that its experimental vaccine showed signs of being "safe and provoked a strong immune response" in a first phase clinical trial; the vaccine was administered to a very small number of human participants (N=45) to determine safety and to measure the levels of volunteers' immune response. Just over half of the participants had recognizable antibodies, but these were "binding antibodies." What is critical for protection is neutralizing antibodies; and on this account only 4 of the 45 participants were actually "analyzed" to show promising neutralizing antibody results. Nor did Moderna report any T-cell activity, essential for fighting the virus. In other words, Moderna's premature reports are negligible for guaranteeing an effective and safe CoV-19 vaccine.
We should remember this is only a first phase trial. The vaccine has a ways to go before it can be ruled effective. "If you look at vaccine development," stated Dr. Daniel Salmon, Director of Johns Hopkins' Institute for Vaccine Safety, "[there are] lots of vaccines that look good out of phase one that don't turn out to be good products."
Prof. Michel Chossudovsky, a professor emeritus at the University of Ottawa, has documented NIAID's Dr. Anthony Fauci's support of Moderna's vaccine, and. according to Bobby Kennedy, Faico waved the needs for the company to test the vaccine in ferrets and primates and instead proceed directly into larger human trials. Both Moderna's and its German competitor CureVac's CoV-19 vaccine rely on mRNA technology, which carry strands of mRNA that encode CoV-19-specific proteins intended to stimulate the immune system to produce antibodies. Bill Gates says he is "particularly excited by two new approaches that some of the candidates are taking: RNA and DNA vaccines." But modern medicine has no practical experience with such vaccines being given to entire populations; therefore, there is absolutely no past history to monitor potential long-term risks, such as whether an engineered genetic code of a viral antigen will recombine adversely with the body's own DNA and trigger other life-threatening injuries we have to be aware of.
Despite the hype over Moderna's apparent success and a huge 39 percent rise in its stock price, a recent article in Nature warns us not to pop the Champaign corks yet. Moderna's data remains unpublished and many scientists worry the results may be "murky." It is worrisome that the company would make such an announcement before any data is made available for independent review. Seemingly this was solely for financial reasons; Moderna's premature claims were rewarded with a $1.3 million stock offering to bankroll its vaccine. Trump is also throwing his weight behind Moderna's vaccine: it is manufactured in the US, funded by the government, and Warp Speed advisor Slaoui sits on the board of the Lonza Group that is collaborating with Moderna. One caveat is that Moderna has never brought a vaccine nor a therapeutic product to the market and is therefore largely inexperienced. There is also no public release of consent forms that the trial participants are required to sign. And no indication of how much volunteers were paid. Are they being compensated with inordinate amounts beyond the industry's standards to accept high risk? None of this information has been provided.
The Nature article also quotes Baylor University vaccine scientist and coronavirus expert Dr. Peter Hotez's response to Moderna's announcement, "I'm not convinced that this is really a positive result." The article notes that
"... most people who have recovered from COVID-19 without hospitalization did not produce high levels of ‘neutralizing antibodies’, which block the virus from infecting cells. Moderna measured these potent antibodies in eight participants and found their levels to be similar to those of recovered patients."
The most promising vaccine, Hotez believes, is being developed by Sinovac Biotech in China, but it requires three separate inoculations. Sinovac's vaccine after being administered to rhesus monkeys showed no presence of the virus found in the throats, lungs or rectums of the primates.
Another vaccine being developed at Oxford University protected monkeys (only six in the trial) from pneumonia but the primates;' nasal passages contained as much of the virus as those unvaccinated. In other words, all vaccinated monkeys became infected. In addition, the antibody titers were extremely low, which suggests the animals may not be fully protected. Nevertheless, Oxford is interpreting these weak results as a success and will also push forward with recruiting participants for a large human trial.
This sets a very disturbing precedent that will likely be imitated by other vaccine companies either now or during a future infectious pandemic. Still other vaccines in development are entirely experimental and have no predecessor on the market. Noroavx has created a recombinant nanoparticle vaccine -- an artificially engineered fake replica of the actual virus. Since there is no vaccine on the current CDC schedule utilizing this technology, we have no idea of its long-term safety.
So what do earlier efforts at developing a coronovirus vaccine tell us?
In 2012, a vaccine being developed by the University of Texas at Galveston and Baylor University observed pulmonary immunopathology in an animal study with mice. The researchers proposed the vaccine's pathology may be attributed to an adverse cytokine response, an observation a large number of physicians and researchers have made with persons severely affected with CoV-19. A later vaccine effort in 2016 by the same institutions targeted the MERS coronavirus strain and observed lung immunopathology similar to infection with the wild virus.
A year earlier, another vaccine effort led by the University of North Carolina's Vaccine Institute noted an increase in eosinophilic proinflammatory pulmonary responses in a mouse model. Eosinophils are a type of white blood cell that are associated with infections, allergies and cancers. However, an abnormal increase in eos, a condition called eosinophilia, can result in nasal allergies and even cancer. This raises a question whether the North Carolina vaccine could have potentially contributed to lung cancer? The vaccine was also shown to provide poor protection from infection both in the adjuvant and non-adjuvant vaccines.
A later 2018 SARS vaccine trial with rhesus macaques conducted at Wuhan University led to antibody-dependent vaccine induced infections. The project was supposedly discontinued.
Another SARS vaccine trial with ferrets led by researchers at the University of Manitoba observed a promising neutralizing antibody response; however there severe inflammatory responses were observed in the animals' livers. The scientists concluded that the vaccine was "associated with enhanced hepatitis." That vaccine project too seems to have been shelved.
Japanese scientists in 2008 developed a SARS vaccine that utilized a recombinant vaccinia virus that expressed the SARS spike protein. Immunized mice exhibited increased infiltration of esoinophils in the lungs, a thickening of the alveolar epithelium, an uptake in cytokines contributing to abnormal inflammatory storms, and aggravated severe pneumonia.
Clearly, the past history to develop a coronavirus vaccine is not encouraging. Jennifer Sun, a molecular biologist at Princeton, warns that due to past coronavirus vaccine failures, the CoV-19 signatures need to be fully evaluated before any human trials commence in order "to prevent organ damage upon viral challenge." Baylor University, which has attempted to develop a vaccine, knows the problems all too well. According to Dr. Robert Atmar at Baylor's Department of Molecular Virology, coronaviruses "are notoriously difficult when it comes to vaccine development.... the concern is that if these vaccines were used in people, they could end up causing harm."
Other scientists have issued warnings against hastily approving a vaccine without proper large, long-term clinical trials and scrupulous evaluation. For example, Dr. Paul Offit at the Children's Hospital of Philadelphia and one of the nation's most vocal advocates for compulsory vaccination, has criticized the shortened vaccine timelines being stated. In a Philadelphia Inquirer interview, Offit cautioned for the need of "extensive animal model testing" to be certain the vaccine "is safe in animals." This process, Offit says, "takes a lot of time, typically years." "If you're going to be testing this in otherwise healthy people who are very, very unlikely to die from this infection," he continues, "you better make sure it's safe. So you want those regulations in place.... The point being: We're not very good at assessing risk."
Trump is pushing to have a vaccine ready by the end of this year. Offit and others argue two years is more realistic, and the global analytics firm Clarivate estimated that a vaccine "will require at least five years... to complete the development process through full regulatory approval." The good news is that the firm predicts that Moderna's mRNA vaccine has a 5% probability of success. The bad news is that the government and federal health agencies will very likely ram the first promising vaccine through the regulatory channels without having been properly evaluated for its efficacy and safety.
Without serious critical thought, the demand for a vaccine now outweighs the risks. And there is the potential for many risks that remain completely unknown, which is the same for any vaccine. Trump said it will be available "in a fairly quick manner." In an interview with philosophy professor Nicholas Evans at the University of Massachusetts, he raised concerns over the lack of proper animal model vaccine trials before administering it to humans. Unfortunately there are no US laws that require animal trials. Consequently the pharmaceutical companies are taking advantage of this derelict oversight in their race to be the first to get a vaccine approved and distributed. Evans also worries about "the shredding of regulations and regulatory norms as part of their [the federal health agencies] response to this outbreak and this is a very dangerous proposition."
Rarely do politicians, and increasingly more and more scientists, make efforts to learn the lessons history offers. Past efforts to develop a coronavirus vaccine have failed and the adverse effects observed in these efforts are clear indicators for why fast-tracking a CoV-19 vaccine would be frightfully irresponsible. But now this is all being ignored within the Trump White House, the CDC, and across most of the medical establishment, particularly the private vaccine makers. In addition, the media continues to fuel our vaccine mania, priming the public to willingly surrender their bodies to the syringe under a pretext of being protected from future CoV outbreaks.
Perhaps the most disturbing problem our national public health faces is the failure of our leading health agencies -- the CDC, the National Institute of Allergy and Infectious Disease, and the World Health Organization -- to acknowledge the overwhelming evidence that no vaccine developed during the past half century is truly safe and effective for all. Are there any scientific gold standard studies -- double blind, controlled trials using an actual inert placebo -- conducted for any vaccine currently on the market? No? Have meticulous independent studies been performed to compare the quality of health between vaccinated and non-vaccinated participants? Unfortunately there aren't any, and the CDC was forced to acknowledge this during a Congressional subcommittee hearing on autism.
All of the media's vaccine propaganda is stacked with pro-industry scientists who have something to gain. They are always presented as the experts. On the other hand, independent scientists, as well as board certified physicians and pediatricians, who question the official vaccine dogma, are attacked by federal officials and the mainstream media as alarmists, anti-vaxxers and even threats to society if they speak out. Several years ago the World Health Organization listed vaccine opponents among the 10 leading threats to global health.
But no one considers that the many millions of people who either themselves or their children received a vaccine and experienced serious adverse effects were at one time pro-vaccination. It was for that very reason they submitted themselves to be vaccinated in the first place. Now with the dramatic rise in vaccine injuries and deaths as more shots are added to the nation's vaccination schedule, we still await Congressional hearings at the federal and state levels that invite independent scientists, toxicologists and immunologists to explain the actual peer-review literature that would have us conclude there is no such thing as either a safe vaccine or vaccine that creates neutralizing antibodies for any given person. In other words, every vaccine may or not be effective and there is no proof they protect everyone.
There is also the utterly absurd notion that whenever someone receives a vaccine and does not come down with the disease, 100 percent of the credit is given to the vaccine's efficacy.
And where are the real advocates who are speaking on behalf of the victims from vaccine injuries? Certainly not the pharmaceutical industry that profits immensely without any liability for damages. Nor are advocates to be found in federal and state health agencies, in most of the medical community nor across the spectrum of the media. Rather, those who refuse to take unsafe vaccines are blamed for spreading fear, uncertainty, conspiracies and even infectious disease.
But now those who have been injured or their loved ones are speaking out in greater unison. This is becoming increasingly uncomfortable for those who have profited for years from their pain.