The U.S. Health and Human Services’ Operation Warp Speed has pledged to deliver 300 million doses of a COVID-19 vaccine by 2021,1 if not sooner.2 However, developing a safe and effective vaccine normally takes years and begins with animal studies. The COVID-19 vaccines are all being rushed straight into human clinical tests, forgoing lengthy animal trials altogether.
Such fast-tracked vaccines pose unknown risks, which are further magnified since governments are granting COVID-19 vaccine makers immunity from liability for all vaccine injuries and deaths that occur after the vaccines are recommended (or mandated) by public health officials.3
At the end of July 2020, AstraZeneca announced4 most countries it expects to supply with COVID-19 vaccine will grant the pharmaceutical company complete liability protection if people are harmed.
A VOYAGE IN IMAGINATIO…Buy New $9.95(as of 04:21 EDT – Details)In the U.S., vaccine makers already have something of a “free pass” when it comes to vaccine injury liability and lawsuits through the National Childhood Vaccine Injury Act of 19865 and the Public Readiness and Emergency Preparedness (PREP) Act, passed in 2005.6
The main concern is that the combination of COVID-19 vaccines being fast-tracked to market at “warp speed” with minimal testing, together with blanket liability protection against vaccine injuries could be a public health nightmare in the making.
Problems With Moderna’s Vaccine Are Becoming Apparent
Early warning signs that something might be amiss have already started emerging. As detailed in “Gates Tries to Justify Side Effects of Fast-Tracked Vaccine,” results7 from Moderna’s Phase 1 human trial revealed 100% of volunteers in the high-dose group suffered systemic side effects. Side effects included fatigue, chills, headache and myalgia (muscle pain); 21% suffered “one or more severe events.”
According to Bill Gates, those side effects are largely due to the high dosages Moderna had to use in order to achieve desired antibody levels. But, if high dosages are required to create a robust-enough immune response, and higher dosages also cause systemic side effects in nearly all people, just how safe will this vaccination campaign be?
In July, it was reported8 that the 100-mcg dose vaccine — despite its 100% side effect ratio after the second dose — would proceed to Phase 3 trial assessment. In a May 26, 2020, article9 in STAT news, Ian Haydon, one of the Phase 1 study participants who suffered severe side effects requiring hospitalization, stated that while he recovered, the inoculation left him feeling “as sick as he’d ever felt.” As noted by Robert F. Kennedy Jr.:10
“Three of the 15 human guinea pigs in the high dose cohort (250 mcg) suffered a ‘serious adverse event’ within 43 days of receiving Moderna’s jab. Moderna … acknowledged that three volunteers developed Grade 3 systemic events defined by the FDA as ‘Preventing daily activity and requiring medical intervention.’
Moderna allowed only exceptionally healthy volunteers to participate in the study. A vaccine with those reaction rates could cause grave injuries in 1.5 billion humans if administered to ‘every person on earth.’ That is the threshold that Gates has established for ending the global lockdown.
Moderna did not explain why it reported positive antibody tests for only eight participants. These outcomes are particularly disappointing because the most hazardous hurdle for the inoculation is still ahead; challenging participants with wild COVID infection.
Past attempts at developing COVID vaccines have always faltered at this stage as both humans and animals achieved robust antibody response then sickened and died when exposed to the wild virus.”
Moderna Patent Problems
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Other signs of trouble include reports that Moderna has no legal rights to a key patent for its vaccine delivery system, and that company executives are now dumping their stocks. There are also questions emerging as to whether Moderna had some sort of foreknowledge that a coronavirus pandemic might be in the making.
In the video above, independent journalist Ben Swann reports Moderna filed a patent amendment in March 2019, nine months before the COVID-19 pandemic started, stating there was a need for this vaccine technology out of concern for “reemergence or deliberate release of the SARS coronavirus.”
The amendment was done to a patent application that had been repeatedly rejected since its initial filing in 2015. The March 2019 amendment stressed the importance of obtaining this patent due to concerns of a beta coronavirus pandemic. Of all the viruses in the world, why would they suspect a coronavirus pandemic?
In December 2019, the U.S. Patent Office issued a final rejection of Moderna’s patent application, yet when the COVID-19 pandemic broke out in early 2020, Moderna was among the first to state they had the ability to address the problem.
It wasn’t until May 2020, months after it had already entered into partnership with the U.S. National Institutes of Health to develop the vaccine, that Moderna was finally issued the patent for it. And, even then, a key patent for the technology already belonged to another company. The NIH also holds many patents on the core mRNA technology used by Moderna.
David E. Martin, Ph.D., a national intelligence analyst featured in Swann’s video report, points out that even though Moderna “very clearly did not have the legal right, and they did not have the contractual rights, they didn’t have the licensing rights” required to enter into a federal contract, they were still somehow pushed to the front of the line by the NIH and Dr. Anthony Fauci.
“This is a situation in which the horse that was being bet on, Moderna, is actually not even qualified to run in the race,” Martin says.
Martin goes on to explain how both Moderna and the NIH are essentially engaged in patent infringement, as a core part of the technology — the lipid nanoparticle technology that is part of the vaccine delivery system — belongs to another company.
Moderna sought to invalidate the patent owned by Arbutus Biopharma, but lost the challenge at the end of July 2020.11,12 As a result, Arbutus might be able to make a royalty claim in the vaccine, and news of the failed patent challenge caused Moderna’s stock to drop by 9.5%.13
Moderna Executives Have Raked in Millions on Dumped Stocks
As reported by NPR14 September 4, 2020, executives at Moderna have also cashed in stock options, raking in tens of millions of dollars of personal profit in the process. Considering the patent problems now emerging and the lingering safety and efficacy questions, this move has raised significant concerns among financial experts:
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“’On a scale of one to 10, one being less concerned and 10 being the most concerned,’ said Daniel Taylor, an associate professor of accounting at the Wharton School, ‘this is an 11.’
Taylor said Moderna’s stock-selling practices appear well outside the norm, and raise questions about the company’s internal controls to prevent insider trading.
Since January, CEO Stéphane Bancel has sold roughly $40 million worth of Moderna stock held by himself or associated investment funds; Chief Medical Officer Tal Zaks has sold around $60 million; and President Stephen Hoge has sold more than $10 million …
Advocates have questioned whether it’s appropriate for executives to privately profit before bringing the vaccine to market, especially when American taxpayers have committed roughly $2.5 billion to the company’s vaccine development and manufacture.”
Importantly, NPR discovered that several of the executives appear to have made “questionable modifications to stock sale plans” shortly before key announcements were made about the vaccine — in some cases just a single day ahead of the announcements.
In order to be legal, prescheduled stock sale plans must be made at a time when no confidential inside information is available that may influence their sales decisions, so the timing of their modifications appears suspicious.
What’s more, as a general rule, corporate best practices call for leadership to maintain stock in the company to ensure they have sufficient incentive to improve company performance. Two Moderna executives, however, have sold all of their stock holdings, and its general counsel has sold “nearly all” of hers, NPR reports.15
What Do Moderna Execs Know That We Don’t?
Why would executives unload their stocks before the vaccine is even launched? Do they suspect or know something has, or is about to go awry? As of right now, there’s no evidence whatsoever that the company’s novel vaccine will actually work, let alone be safe. According to NPR:16
“Friday, March 13, three Moderna executives adopted new 10b5-1 plans, according to records reviewed by NPR: Zaks, Chief Technical Operations and Quality Officer Juan Andres, and then-Chief Financial Officer Lorence H. Kim …
On Monday, March 16 — one business day later — the company announced that it had given a participant the first dose of their vaccine as part of its phase 1 trial. The stock ended that day up 24% compared to the previous day’s close …
’Every company and individual is entitled to the presumption of innocence. That said, from the public’s perspective, this trading behavior looks very problematic,’ said Taylor … who first pointed out the timing of these changes to NPR.
‘If I put on my SEC enforcement hat, I would certainly be asking, ‘What caused you to change the plan on a Friday?’’ said Kurt Wolfe, who works as a defense attorney in securities cases for the firm Troutman Pepper. ‘I don’t think it’s a good fact pattern.’”
Coronavirus Vaccines Have Never Been Successfully Made
As I’ve discussed in several previous articles, COVID-19 vaccine manufacturers have several hurdles to overcome, as coronavirus vaccine development has been notoriously challenging. In the 20 years that vaccine makers have tried to develop a coronavirus vaccine, efforts have failed due to dangerous, many times lethal, side effects.
Adding to the problem is that many of them are relying on novel mRNA technology that has never been used in vaccines before.17 Making matters even worse, the vaccines are not safety tested against inert placebo, as is the gold standard for drug safety research. Oxford University’s mRNA vaccine, ChAdOx1 nCoV-19, for example, is being compared to a meningitis vaccine.18
As discussed in “Dangerous Placebos Used in Medical Trials,” using an active substance such as another vaccine destroys any hope of a valid safety study. This is just one way in which vaccine makers cheat in their safety studies to minimize the appearance of adverse effects.
In the case of a COVID-19 vaccine, establishing safety is of utmost importance, as previous coronavirus vaccines have caused paradoxical immune enhancement — a situation in which the vaccine actually makes you more susceptible to severe illness and death once you’re infected with the actual virus.
Kennedy explained this in my interview with him, featured in “Robert F. Kennedy Jr. Explains Well-Known Hazards of Coronavirus Vaccines.”
A short clip of that interview is included below.
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Aside from the possibility of a paradoxical immune response, mRNA vaccines may in and of themselves be problematic. According to researchers at the University of Pennsylvania and Duke University:19,20
“mRNA vaccines have potential safety issues, including local and systemic inflammation and stimulation of auto-reactive antibodies and autoimmunity, as well as development of edema (swelling) and blood clots.”
AstraZeneca Stopped Its Vaccine Trial Due to Side Effects
September 8, 2020, STAT News reported21 that AstraZeneca has temporarily halted its Phase 3 vaccine trials due to “a suspected serious and unexpected adverse reaction” in a British participant.
The company did not divulge the nature of the adverse reaction. The New York Times claims22 “a person familiar with the situation, and who spoke on the condition of anonymity” said the individual ”had been found to have transverse myelitis, an inflammatory syndrome that affects the spinal cord and is often sparked by viral infections.”
AstraZeneca, in collaboration with the University of Oxford, is conducting Phase 2/3 trials for their mRNA COVID-19 vaccine (ChAdOx1 nCoV-19, a chimpanzee adenovirus modified to carry and deliver coronavirus genes into human cells) in the U.K. and India, as well as Phase 3 trials in Brazil, South Africa and the U.S.23 According to STAT News:24
“The [AstraZeneca] spokesperson described the pause as ‘a routine action which has to happen whenever there is a potentially unexplained illness in one of the trials, while it is investigated, ensuring we maintain the integrity of the trials.’ The spokesperson also said that the company is ‘working to expedite the review of the single event to minimize any potential impact on the trial timeline.’”
AstraZeneca Vaccine Has High Rates of Side Effects Too
Like the Moderna vaccine, the AstraZeneca/Oxford University vaccine also appears to come with a shockingly high rate of side effects.
Results25 from one of its Phase 1/2 studies published August 15, 2020, revealed a clear majority of participants experienced side effects.
“Fatigue and headache were the most commonly reported systemic reactions. Fatigue was reported in the ChAdOx1 nCoV-19 group by 340 (70%) participants without paracetamol and 40 (71%) with paracetamol …
Headaches were reported in the ChAdOx1 nCoV-19 group by 331 (68%) participants without paracetamol and 34 (61%) with paracetamol … Other systemic adverse reactions were common in the ChAdOx1 nCoV-19 group:
- muscle ache (294 [60%] participants without paracetamol and 27 [48%] with paracetamol)
- malaise (296 [61%] and 27 [48%])
- chills (272 [56%] and 15 [27%])
- feeling feverish (250 [51%] and 20 [36%]). In the of ChAdOx1 nCoV-19 group, 87 (18%) participants without paracetamol and nine (16%) participants with paracetamol reported a temperature of at least 38°C, and eight (2%) patients without paracetamol had a temperature of at least 39°C”
Prepare by Attending NVIC Online Conference in October
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If you’re concerned about the possibility of COVID-19 vaccine mandates, be sure to attend the Fifth International Public Conference on Vaccination sponsored by the National Vaccine Information Center (NVIC) — an online event held October 16 through 18, 2020.
This year’s theme is “Protecting Health and Autonomy in the 21st Century.” The conference will bring together well-known speakers from around the world — including yours truly — who will present information on vaccine science, policy, law, ethics and civil liberties and will feature formal presentations, panel discussions and live chat rooms.
NVIC has held four previous hotel-based conferences in the Washington, D.C., area but, this time around, the conference will be held online due to the unpredictability of government regulations related to COVID-19, including travel and social distancing restrictions that may still be in play in October.
Sources and References
- 1 HHS June 16, 2020
- 2 Contagion Live September 2, 2020
- 3, 4 Reuters July 30, 2020
- 5 HRSA March 2020
- 6 HHS June 9, 2020
- 7 NEJM July 14, 2020 DOI: 10.1056/NEJMoa2022483
- 8 Contagion Live July 23, 2020
- 9 STAT May 26, 2020
- 10 Fort-Russ.com May 20, 2020
- 11, 13 Reuters July 23, 2020
- 12 Biopharmadive.com July 24, 2020
- 14, 15, 16 NPR September 4, 2020
- 17 Pharmaceutical Technology May 1, 2020
- 18 Daily Mail April 23, 2020
- 19 Nature Reviews Drug Discovery 2018; 17: 261-279
- 20 The Vaccine Reaction May 25, 2020
- 21, 24 STAT News September 8, 2020
- 22, 23 New York Times September 8, 2020 (Archived)
- 25, 26 The Lancet August 15, 2020; 396(10249): 467-478