An urgent and cautionary note
to all humans on Earth.
We must SLOW DOWN the global rollout of
COVID-19 mRNA vaccines.
There is a message on the way.
A messenger has now entered the world.
On Thursday, December 10th, 2020, or shortly thereafter, the messenger may begin to come forth in the United States.
This messenger speaks a language of code.
The code is made up of four primary building blocks.
The message will be delivered in an envelope.
If successful, the messenger and the message have the promise to change the world, ushering in a new era for humankind.
It will be a miracle.
The vaccines are on the way.
Last winter, almost no one could have imagined that a vaccine would be ready by the end of the year. If you predicted wrong, you are not alone. I got it wrong. Most of the experts also got it wrong.
Initial results from Moderna and Pfizer’s COVID-19 Phase 3 clinical vaccine trials are . . . Wow.
All the brilliant scientists and numerous hardworking people involved in making this happen deserve a big thanks. Those thanks extend to the tens of thousands of clinical-trial volunteers who took a risk for the greater good of humanity.
In the US, we must give our government—both political parties--a lot of credit for bankrolling vaccine development to remove nearly all of the financial risk, and other obstacles to clear the way for pharmaceutical companies to make this a reality.
This may go down as one of science and medicine’s most impressive achievements.
It’s like a miracle.
The basics of how mRNA vaccines work
At the core of both Moderna and Pfizer’s revolutionary COVID-19 vaccines is a synthetic genetic technology using messenger RNA, or mRNA for short.
Messenger RNA is a naturally occurring molecule that carries instructions from our DNA to create the billions of proteins that build, maintain, and repair life.
The synthetic mRNA molecules used in the vaccines must be stabilized and disguised to avoid detection from our immune system.
In developing the vaccine, one or more of the four base codes on the mRNA are altered. The molecule must then be enclosed in an envelope, referred to as a lipid-nanoparticle delivery system.
Once injected into the skin, the vaccine’s synthetic mRNA will penetrate our muscle cells and get picked up by protein-generating machinery called ribosomes.
The ribosomes then translate the coded instructions into a virtually identical segment of the COVID-19 spike protein that coats the virus’s surface.
The newly made spike protein segments are excreted from the cells and begin to trigger an immune response.
Protective antibodies are produced as a result. Those antibodies help to protect us from a natural COVID-19 infection.
We MUST inject caution into vaccine plans.
I am not anti-vaxx. I am pro-facts, pro-critical thinking, and pro-honest discussion.
As soon as one of the COVID-19 vaccines is well established to be very safe and effective, I will likely recommend to my parents--both in their mid-seventies—that they get the shot. Right now, I am not convinced that the vaccines are safe.
I promise that what follows is entirely free of baseless conspiracy theories. There are enough real-world concerns to address that we need not place a single toe in conspiracy-theory land.
. . .
This new genetic messenger RNA (mRNA) technology from both Moderna and Pfizer has NEVER been approved in any human vaccine.
For existing infectious diseases with an approved vaccine available, there is no precedent for one becoming available within ten months. But you already knew that.
Historically, vaccine development and testing have taken, on average, 10 to 15 years to complete.  
From the US Dept of Health & Human Services, vaccines.gov/basics/safety:
“Every licensed and recommended vaccine goes through years of safety testing.”
“Before a vaccine is ever recommended for use, it’s tested in labs. This process can take several years. FDA uses the information from these tests to decide whether to test the vaccine with people.
“During a clinical trial, a vaccine is tested on people who volunteer to get vaccinated.”
“These tests take several years and answer important questions like: Is the vaccine safe; what dose works best; how does the immune system react to it?”
There are valid reasons why vaccines have historically taken a long time to get approved. Vaccines are the ONLY medical intervention given to healthy people to prevent others from getting sick.
The vast majority of people that are projected to receive a COVID-19 mRNA vaccination are not at high risk for developing severe illness or dying from the virus.
And we MUST learn from past mistakes.
All vaccines and pharmaceuticals present a spectrum of risks. Eliminating all safety risks is impossible.
However, the threshold for determining safety and reducing uncertainty needs to be much higher for a vaccine than for a standard pharmaceutical drug. A vaccine is typically injected into millions, and in this case, potentially billions of otherwise “healthy” humans who are not likely to experience severe COVID-19 disease or death.
Standard phase 3 vaccine clinical trials, conducted to establish effectiveness and SAFETY typically last from one to four years.
Both Pfizer and Moderna’s phase 3 clinical trials lasted less than four months.  
Due to the markedly shortened trial times, we will not know about any long-term health effects from this new mRNA technology, even as short as six months from the time of vaccination.
By drastically condensing the vaccine trial times for the COVID-19 vaccines, researchers can not determine the long-term effects of these novel genetic mRNA vaccines on varied immune responses across vulnerable populations--the elderly and those with compromised immune systems, metabolic disorders, impaired detoxification pathways, hyper-inflammatory responses, or severe allergic reactions. 
There will not be adequate time to assess how the vaccine may interfere with other future viral infections or unwanted immune enhancement against subtypes of COVID-19. 
Real-world results from previous vaccine development efforts on RSV, Dengue Fever, and SARS (SARS-CoV-1) have shown that some people who received a trial vaccination and were later exposed to the virus developed more severe disease than those who were not vaccinated. This type of immune enhancement is called antibody-dependent enhancement. 
“Because of this issue with immune enhancement that’s seen in experimental coronavirus vaccines, where, depending on the formulation, and how you deliver it, and the technology used to deliver it, you could actually make things worse instead of making things better . . . This was a phenomenon that was initially described in the 1960s when they developed a formalin-inactivated RSV vaccine . . . The vaccine actually made kids worse.”
– Peter Hotez, MD, Ph.D., professor of molecular virology at Baylor College of Medicine. 
In 1966, a significant number of children vaccinated during clinical trials against RSV had an increase in the severity of lung disease. Eighty-percent of those who received the RSV vaccination were hospitalized after being exposed to the natural RSV infection, compared with only 5% of those that did not receive the vaccine. Two vaccinated infants later died as toddlers after natural infection of RSV.  
In 2016, one million Filipino schoolchildren were vaccinated against the Dengue virus. Some children who developed protective antibodies to a particular Dengue strain (serotype) experienced severe disease when subsequently infected by one of the other three strains. One year later, the campaign was halted due to safety concerns. It took three years of follow-up data from clinical trials to reveal serious problems with the vaccine.  
A study of laboratory animals vaccinated against SARS-CoV-1 was shown to have a high risk of a life-threatening overreactive T-helper cell response (cell-based enhancement). 
In both Moderna’s and Pfizer’s phase 3 COVID-19 clinical trials based on the clinical protocols that have been made public, participants were excluded if they had:
“Known history of SARS-COV-2 [COVID-19] infection”
“Previous clinical or microbiological diagnosis of COVID-19”
Once the vaccines are approved by the FDA for emergency use, they will then be given to untold millions of people who may have already had a COVID-19 infection. What, if any, serious immune-enhancement problems may surface?
We also will not know if any side effects may impact pregnancy or fertility.
Hopefully, there won’t be issues, but we don’t know because there is no data available. Sadly, I guess we’ll have to wait and see.
In 1998, there was RotaShield, the first vaccine approved for rotavirus, an infection that causes fever, vomiting, and diarrhea in small children. This vaccine took about 20 or so years from start to finish. 
Potential safety problems with the vaccine were identified during phase 3 trials, yet a decision was made to greenlight it.
An estimated 1.5 million doses of RotaShield were given to 900,000 children during the year following approval. Depending on whom you ask, it is estimated that between one in every 5000 to 10,000 infants vaccinated developed a severe disorder called intussusception (intestinal blockage) directly attributable to the vaccine.  
Due to safety concerns, RotaShield was withdrawn from the market in October 1999.
If there was any silver lining with RotaShield, it’s that the safety issues were caught before the vaccine was administered to millions more children.
In 2006, RotaTeq, a successor to the RotaShield vaccine, was approved. Initial development efforts took about ten years to create a proof-of-concept.
The following phase 1, 2, and 3 clinical trials lasted a combined 16 years. The phase 3 trial included 72,000 infants across 11 countries and took four years to complete.
RotaTeq was approved after 26 years of rigorous development and testing, learning from the previous vaccine’s failures. To the best of my research, it has since proved to be safe and effective.
“One more thing…”
“One more thing”, as Steve Jobs would say at the end of some of his keynote presentations before rolling out a new Apple product.
In January of 1976, three months before Apple Computer was started, there was a Swine flu scare in the United States.
The US government warned millions of Americans that the Swine flu could spread across the country and potentially be deadly.
In late March of 1976, on national television, President Gerald Ford announced in a press conference the plan to vaccinate “every man, woman, and child in the United States.”  
President Ford falsely claimed that the same virus was the cause of the 1918 Spanish flu. Never mind that the actual genome of the Spanish flu virus wasn’t fully sequenced until 1997, and the virus wasn’t reconstructed until 2005.  
The Swine flu vaccine was shipped in September of 1976, a mere nine months after the initial scare.
Over 45 million Americans willingly took the vaccine. Four thousand people later claimed Injury damages. Two-thirds of those claims were for neurological damage, including Guillain-Barre Syndrome (GBS), a disorder in which the immune system attacks the nerves and can lead to paralysis. The follow-up research revealed up to an 8-fold increased risk of GBS following the 1976 Swine flu vaccination.   
Those who received the vaccine were given a consent form. The form clearly stated that the vaccine had been tested. However, this was not the vaccine given.
Scientists developed a second vaccine, and that was the one that was given to most of the people that got the shot. Incredibly, this second vaccine never went through any clinical trials.
The vaccination program was suspended three months later, in December of 1976. It was widely looked at as a monumental failure and put a “monkey wrench” into future public-health initiatives.
In 2004, the USA Institute of Medicine (IOM) reviewed the evidence regarding GBS association and the vaccine. They concluded:
“The evidence favors acceptance of a causal relationship between 1976 swine influenza vaccines and GBS in adults.”  
This was mainstream news in the late 1970s. The late, award-winning journalist, Mike Wallace, from 60 Minutes, ran a 15-minute exposé on the findings, which can be viewed on YouTube, HERE:
. . .
Experts may be quick to say that previous vaccine safety problems such as intussusception, antibody-dependent enhancement (ADE), Th2 immune enhancement, and the Swine flu vaccine issue—all previously discussed--are unlikely with this novel vaccine technology.   
And, well, the experts MAY be right! But the critical point is that those safety issues were discovered well into population-wide vaccination programs, long after clinical trials had ended.
We have over a hundred years’ experience with traditional vaccine technology based on inactivated or weakened (attenuated) viruses. Besides short clinical trials from Pfizer and Moderna, we have ZERO years’ experience with this new genetic mRNA technology and the associated nano-particle delivery system.
To restate, mRNA technology has never been approved before in a human vaccine. Billions of people globally are expected to be injected with these vaccines.
What new safety issues have yet to be discovered?
The reason why so many people are anxious about the vaccine is NOT because of a fear that it will be less effective than promised. It is because of the fear that the vaccine will be less safe than promised.
For example, if it turns out that actual real-world vaccine effectiveness rates for preventing moderate to severe COVID-19 illness drop from 90%+ to 70%, I think most people would still consider that a success. I know I would be okay with that.
However, if it turns out that actual real-world vaccine safety rates--severe side effects, long-term health consequences, or loss of life--drop from 99.9999% (1 in a million) to 99.99% (1 in 10,000), it would likely stop the vaccine program in its tracks. In a population of 330 million, that would be 33,000 people experiencing serious health issues.
And if the level of safety dropped to 99.9% (1 in 1000), it would be an unthinkable disaster.
And worse, what then happens if there is a medical-black-swan event--an unexpected, near-impossible-to-predict issue(s) that results in serious long-term health consequences on a global-mass scale?
This feels like an ultra-high-stakes game of Russian roulette, potentially putting billions of people at an untold risk.
One tiny needle with massive consequences for humankind.
Key Dates: December 10th & 17th.
The FDA will meet to review Pfizer’s vaccine candidate on December 10th and Moderna’s on the 17th.
Unless there is a delay, Emergency Use Authorizations (EUA) for the respective vaccines are expected to be granted shortly after the meetings.
There is a delicate balancing act to be had here. We all want to end this pandemic as soon as possible, but NOT at the expense of a significant potential national or global safety disaster.
If any severe safety issues come to light, it will erode the already historically low public confidence in government and regulatory agencies, especially the FDA.
Convincing Americans and the rest of the world to take any future vaccines—adequately tested or not--will be an uphill battle. People may needlessly suffer by not getting other common, and historically proven safe, vaccines that would easily protect them from life threatening-infections.
The reputations of the pharmaceutical companies may be irreversibly destroyed, most especially Moderna. This mRNA vaccine is Moderna’s first commercially viable product. Messenger RNA technology has the potential to revolutionize medicine and change the world, but a significant safety glitch would not bode well for them or the future of this emerging genetic medicine.
Issuing an Emergency Use Authorization and the subsequent mass vaccination of hundreds of millions of people may be among the greatest irreversible blunders in five thousand years of recorded human history.
FDA, withhold the issuance of an Emergency Use Authorization (EAU).
Once an EAU is granted, the first people to be vaccinated are likely to be those volunteers in the placebo group that received a saline injection.
The reasoning behind offering the vaccine to the placebo group is that the volunteers put themselves at considerable risk by participating in the trial. As a reward, so the thinking goes, they should be the first ones eligible to receive the vaccine once it becomes available. I believe that this would be a mistake.
Pfizer and Moderna have only collected a couple of months of safety and effectiveness data. Once the placebo group receives the actual vaccine, the ability to continue to collect accurate safety and effectiveness data, going forward, goes out the window.
Instead, grant a “compassionate use authorization”. Limit it to three million people and six months.
I would only ask the FDA to slow its rollout and withhold the issuance of an Emergency Use Authorization (EUA). Instead, I would ask them to grant an expanded-access authorization, otherwise known as compassionate use.
A compassionate use authorization would grant doctors the ability to give this potentially life-saving vaccine to anyone at a high risk of severe illness or death from COVID-19.
“I never breathe a sigh of relief until the first 3 million doses are out there.”
–Dr. Maurice Hilleman
(as quoted by Paul Offit, MD, key member of the FDA vaccine advisory committee)
Dr. Maurice Hilleman is known as the “father of modern vaccines”. Born during the 1918 Spanish flu, he developed more than 40 vaccines, nine of which are still used today. I believe we would all be well served to heed to Dr. Hilleman’s wise sensibilities.
So that we may all breathe a sigh of relief, I would ask the FDA to limit the compassionate use authorization to three million volunteers and follow them for six months. Let’s watch them closely and then reevaluate.
Based on my sensibilities, if we had six more months of data with three million people, we would not eliminate all potential safety concerns. However, I would feel much more comfortable recommending that those at high risk, like my own parents, get the vaccine.
What we may potentially lose with many fewer people vaccinated over the next six months, we will gain in terms of reducing safety uncertainty and building public trust.
I sense that many others who are hesitant to take a vaccine right now may change their minds if there is more safety data across a much larger diverse population and over a more extended period.
I pray that we don’t sleepwalk into a nightmare of our own making.
And just one more thing …
It is illegal, immoral, and unethical for the FDA to grant an Emergency Use Authorization if there are “adequate, approved, and available alternatives” [FDA]
The following section, Introducing ivermection, has been fully updated as of Aug. 1, 2021, as a stand-alone article. View the update >>
“Ivermectin has high activity against COVID-19. Let me repeat that. Ivermectin, remarkably, has high activity against COVID-19” 
--Paul Marik, MD, FCCM, FCCP, Chief of Pulmonary & Critical Care Medicine at Eastern Virginia Medical School
There is now a pharmaceutical drug widely available that is highly effective in preventing and treating COVID-19. It’s called ivermectin. If you have not yet heard of it, you will, starting now.
Ivermectin is derived from a soil bacterium called Streptomyces avermitilis. It is medicine from the Earth.
The drug has been traditionally used to treat many types of parasite infections in both humans and animals. Many people give it to their dogs once a month to prevent heartworm.
More than 3.5 billion people have used this remarkably safe, inexpensive, and widely available medicine over the last 40 years.
In 2015, Dr. William Campbell and Satoshi Ōmura shared the Nobel Prize in Physiology or Medicine for their discovery of ivermectin. 
23 positive studies on ivermectin and COVID-19
Ivermectin has the potential to stem the global pandemic, and it already appears to be doing so in many parts of the world.
A real-time meta-analysis (last updated Dec 9 2020: version 3) of 23 studies--ten randomized controlled trials and 13 observational studies--on the effects of ivermectin and COVID-19. 
The trials include:
-Five Pre-exposure preventive trials (98% improvement)     
-Two Post-exposure preventive trials (87% improvement)  
-Four Early treatment trials (90% improvement)   
-Twelve Late treatment trials (60% improvement)            
Concerning ivermectin’s early prevention (prophylaxis):
“We now have four large [ivermectin and COVID-19] trials including over 1100 patients, three of them well designed randomized controlled trial . . . we have 100,000 patients in the hospital today and if everyone was on ivermectin, I can guarantee you that would be far far less. And then almost incredibly, a drug [ivermectin] that has antiviral activity is working late phase in the hospital . . . its even working then…it has incredibly potent anti-inflammatory properties.” 
--Pierre Kory, MD, MPA. Pulmonary and Critical Care Specialist. He is an Associate Professor of Medicine at St. Luke’s Medical Center in Milwaukee.
One of the twelve retrospective cohort studies, looking solely at Late treatment, was published in the journal CHEST (the American College of Chest Physicians) in October 2020. The study followed 288 patients hospitalized with confirmed COVID-19 and severe acute respiratory syndrome at four south Florida hospitals, treated with and without ivermectin. Their conclusion:
“Analysis showed statistically significant lower mortality rates in the group treated with ivermectin compared with the group treated with usual care (15.0% vs. 25.2%)”. 
Countries that have initiated ivermectin distribution campaigns
Extensive public awareness and distribution campaigns of ivermectin have been carried out in many countries, including Brazil, Mexico, Paraguay, and Peru.
Epidemiological studies have so far shown that in all areas where ivermectin has been distributed, there have been significant reductions in COVID-19 case counts as compared to either 1) neighboring cities/states that didn’t receive ivermectin and/or 2) compared to the months before distribution. These studies have not yet undergone peer-review.
The epidemiological study data related to Brazil, Paraguay, and Peru may be viewed here. 
In Mexico, as of this writing, the only state distributing ivermectin to treat COVID-19 is Chiapas. The results are stunning. Chiapas has some of the lowest rates of COVID-19 cases per capita in all of Mexico. Distribution started in July 2020. The real-time active, recovered, fatal, and total case counts can be seen on Microsoft's Bing COVID-19 Tracker, HERE.
Vigorous antiviral activity of ivermectin against COVID-19
In an in-vitro study, cells infected with COVID-19 were exposed to 5µM of ivermectin, and a 5000-fold reduction in viral RNA compared with controls. Ivermectin killed almost all viral particles within 48 hours. The drug inhibits the importin (IMP) α/B receptor. At 24 hours, there was a 93% reduction in viral RNA present in samples treated with ivermectin. No toxicity was observed. 
Other studies have demonstrated that ivermectin has antiviral activity against a broad range of viruses, including 14 different single-stranded RNA viruses. 
Ivermectin and anti-inflammatory properties
A growing number of studies show ivermectin’s anti-inflammatory properties, including its ability to inhibit cytokine production and downregulate NF-ĸB, a master regulator of inflammation and immune responses.   
In March 2020, five expert critical care physicians from major academic centers in the US formed the Front Line Covid-19 Critical Care Alliance (FLCCC), including Dr. Paul Marik, Dr. Pierre Kory, and Dr. Joseph Varon.
Their mission was to develop effective COVID-19 treatment protocols. They have recently developed a protocol that they call I-Mask+ The foundation of their protocol is ivermectin. 
“Vaccination is extremely important, but let’s be realistic, there is no way you are going to be able to vaccinate 60% of the global population, which is what you need in order to have some degree of immunity, anytime soon.
I can tell you that my own colleagues are saying they are not going to get the vaccine. My own friends, the Latinx community, the African American community, are very resistant and reluctant to get the vaccine. So we got to do something else.
We’re not going to fight with the vaccination program . . . We want to work with [referring to ivermectin] the vaccination program hand-by-hand.” 
--Joseph Varon, MD, Professor of Acute & Continuing Care at The UT Health Science Center, and Chief of Staff & Chief of Critical Care at UMMC in Houston.
“I don’t think this is a competition. This is a bridge. This is a bridge to vaccination.
People are dying today. . . More people will die tomorrow.
Vaccination is not going to save these people. Ivermectin and vaccination are complementary. They are not competing with one another.
We have to do everything we can to get this pandemic under control so we can open up this country. We can open up the world. And we can develop some kind of normal life.” 
--Paul Marik, MD, FCCM, FCCP, Chief of Pulmonary & Critical Care Medicine at Eastern Virginia Medical School
“We have a solution to this [COVID-19] crisis. There is a drug that is proving to be of miraculous impact. And when I say miracle, I do not use that term lightly . . . it basically obliterates transmission of this virus. If you take it, you will not get sick.”
--Pierre Kory, MD, MPA (Senate testimony on December 8, 2020). It can be viewed on HERE
Yes, it’s like a miracle.
There is another message on the way.
The above section, Introducing ivermection, has been fully updated as of Aug. 1, 2021, as a stand-alone article. View the update >>
FDA. Emergency Use Authorization (illegal EUA issuance)
[Cited Dec 8, 2020] https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization
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