Wednesday, December 23, 2020

How long will Americans put up with faked COVID case and death statistics?/ CBS News

There is no need for me to comment on this story.  The fraud is all too obvious.--Nass

"Grand County Coroner Raises Concern On Deaths Among COVID Cases

By Danielle Chavira

December 15, 2020 at 8:28 pm

KREMMLING, Colo. (CBS4) – Grand County isn’t the first to report a data discrepancy with COVID-19 deaths, but following a murder-suicide in the region the coroner is talking about the impact it may have.

“These two people had tested positive for COVID, but that’s not what killed them. The gunshot wound killed them and it’s very misleading for you to put numbers out there saying these people died from COVID when that’s not what they died from,” said Coroner Brenda Bock.

Bock said her investigation wasn’t finalized when the State of Colorado listed the two victims as dying with COVID-19.

“I realize yes, you’re trying to keep count of the numbers, but you need to do it right, and these people did not die of COVID, they died of gunshot wounds and that’s how it needs to be listed,” she said.

The state classifies COVID deaths in two ways:

·       Deaths caused by COVID-19:

·       The vital records death data is based on CDC coding of death certificates, and it reflects the number of deaths due to COVID-19, based on the expert judgment of health care providers and coroners.

·       The number comes from death certificates where COVID-19 is listed as the cause of death or a significant condition contributing to death.

·       This number is determined by the CDC and is updated daily for dates through the previous Saturday.

·       Deaths among people who died with COVID-19:

·       The epidemiological death data reflects people who died with COVID-19, but COVID-19 may not have been the cause of death listed on the death certificate. It comes from two sources:

·       From health care providers and laboratories that report cases to the state using a national case definition.

·       From state-reviewed death certificates where COVID-19 is listed as the cause of death or a significant condition contributing to death. These death certificates may not yet have been coded by the CDC.

·       This information is required by the CDC and is crucial for public health surveillance, as it provides more information about disease transmission and can help identify risk factors among all deaths across populations.

The state’s website states, “The number of deaths due to COVID-19 are not necessarily included in the number of deaths among people with COVID-19. After review, at either the state or national level, some deaths may not be counted as COVID-19 deaths. This is rare, and the expectation is that in the end the numbers will closely align.” [sic]

The state will often collect data before the death certificates are signed, because that process can take weeks. This gives epidemiologists a faster and better picture of how serious the spread is and how it’s impacting the general population.

“Today, Colorado’s reporting 4,156 COVID deaths, these are actually deaths among cases. Then they show 3,230 deaths due to COVID, and so they’re differentiating that, but I think it can maybe go a little further and I think the policy could be changed,” said Richard Cimino, Grand County Commissioner for District 1.

Cimino says while the state is doing a decent job at making a discrepancy, he agrees with Bock. It could be done better, and while the death count won’t impact where Grand County sits on the states dial, for a rural community, just one death from COVID impacts public perception.

“If they could let the coroners weigh in and take a little bit of time and make that determination early on you won’t have those big swings in numbers that might really alarm our population.”

Currently, the state has five deaths from COVID-19 listed in Grand County, while the Grand County website shows one.

Bock says she reached out to other coroners across the state with questions, “And I got replies back from 80% of the coroners in the state all stating the same thing. They’ve all had the same problems, and these are in small counties, so it’s easy for us to keep track of our numbers.”

She said she reached out to the state asking for the recent deaths to be discounted from the COVID-19 death toll, but hasn’t heard back. She hopes other counties speak up and help influence change in the way deaths are counted.

“I can’t do it alone they need to step up to the plate, too, they need to back me on this; they need to fix the way that they’re reporting the numbers,” she said.

CBS4 reached out to the CDPHE for comment, and was directed to classification information on its website. More information can be found here:"

Monday, December 21, 2020

Explosion Yesterday at World's 2nd largest Hydroxychloroquine supplier

Is someone trying to reduce the supply of hydroxychloroquine? According to the Taiwan English News:

An explosion at a pharmaceutical factory in Taoyuan City left two injured and caused a fire early this afternoon, December 20...

Liberty Times reported that the factory produces hydroxychloroquine APIs, and is the world’s second largest HCQ raw material supplier.

Another source tells the same tale.  The Pharmaceutical company is named Sci Pharmtech Inc. The explosion was huge and spread to five other companies.

Thursday, December 17, 2020

Bell's Palsy: 7 cases in subjects who received a COVID mRNA vaccine--Yes, it is a Vaccine Adverse Reaction

Four cases of Bell's (facial) palsy occurred in subjects in the Pfizer vaccine clinical trial of its mRNA vaccine, none in placebo recipients.  FDA's briefing document mentioned 3 cases, but 4 were discussed at the VRBPAC advisory meeting on December 10.  The briefing document claimed, "This observed frequency of reported Bell’s palsy is consistent with the expected background rate in the general population." (page 43)

Three cases of Bell's palsy occurred in subjects who received Moderna's mRNA vaccine, and one in a plecebo recipient.

One case of Transverse Myelitis occurred in a subject in the Astra-Zeneca Covid vaccine trial.  This is a rare and usually devastating complication.  According to the Mayo Clinic, transverse myelitis "can cause pain, muscle weakness, paralysis, sensory problems, or bladder and bowel dysfunction... Other conditions, such as a stroke of the spinal cord, are often confused with transverse myelitis."

FDA has failed to warn Americans now being vaccinated about the possibility of Bell's Palsy in its "fact sheet" for the Pfizer vaccine, which is the only printed information patients receive when they are vaccinated.  However, Bell's Palsy is known to be a serious neuro-immune reaction to vaccination.  

How do I know?  Because both Bell's palsy and transverse myelitis were listed on the package insert (the label) for anthrax vaccine, which you can read right here.  Luckily, the label was reproduced in the National Academy of Sciences' report on anthrax vaccine, because it is hard to find online... since FDA removed the warnings from a later version of the label.

So far, there is no label for any Covid vaccine, since none have been given a license.  There is only a fact sheet for the Pfizer vaccine.  Once the Moderna vaccine gets an Emergency Use Authorization, FDA, along with the manufacturer, will craft a fact sheet for it.  How much will they tell the public?

UPDATE Dec. 24:  In an article on the Countermeasures Injury Compensation Program (CICP), USA Today discussed the case of a high school student who in 2009 received the swine flu vaccine.  He developed transverse myelitis a month later, and has been paralyzed from the waist down ever since.  He applied to the program for this vaccine injury, and was denied.  This is the same, and only, program available to those who may be injured by Covid vaccines. There is no appeal to any court allowed. 

I discussed the CICP here.  It is the only program available to soldiers who routinely receive anthrax and smallpox vaccines.  Yet it has denied benefits to every single person who has applied for anthrax vaccine injuries.  

Wednesday, December 16, 2020

Follow the Money to California's draconian vaccine mandates

California has some of the most stringent vaccine mandate laws in the United States.  Why is that?  At first, it seemed that extreme vaccination laws were introduced in 2015 in response to a measles outbreak that began in Disneyland in 2014.  But then, long after the measles threat had evaporated, the ability to obtain or to grant vaccine exemptions for medical contraindications was taken up by the legislature. The right to determine whether a child was clinically fit for vaccination was being taken out of the hands of their physicians. Doctors were threatened with loss of license for issuing medical exemptions to vaccination; some are currently in litigation over this. 

Homeschooled kindergartners grew from around 2,000 to almost 7,000, according to the LA Times. 

The draconian measures to impose all vaccines on every child came as a shock. California's mandate-imposing Senator Pan, himself a pediatrician, had promised this would never occur.

While everyone is familiar with Big Pharma's lobby and campaign contributions to politicians in Washington, few know that Pharma has given more than twice as much money to politicians and party committees at the state level as they gave at the federal level. Perhaps it should have come as no surprise; after all, the practice of medicine is regulated at the state level.  For example, fraud committed by Big Pharma opioid companies is being litigated at the state level. Vaccine mandates are voted in or out at the state level.  Some healthcare price controls are too.

How much money are we talking about?  During the twenty years from January 1, 1999 through December 31, 2018, the pharmaceutical and health products industry spent $877 million dollars on contributions to state candidates and party committees in the US.

Of this amount, $399 Million, or 45.5% went to candidates and committees in California.  The other 54.5% went to the other 49 states and the District of Columbia.

Candidates for state office face legal limits on what they can accept from each donor.  But in many states, California and Ohio included, ballot measure committees are not subject to contribution limits.  A whopping 75.4% of the money Pharma spent on state candidates and committees nationwide went to ballot measure committees.

Only two states received contributions of over $50 million dollars in total during the entire twenty-year period:  California and Ohio.  Ohio received $74 million total, and California $399 million.

Now I am rethinking the California legislature's votes to impose extremely strict vaccine mandates on its citizens.  Had Big Pharma already purchased California's electoral machinery?  Was the industry just wringing more profit from its investment in the Golden State?

This article's data come from "Lobbying Expenditures and Campaign Contributions by the Pharmaceutical and Health Product Industry in the United States, 1999-2018" published in JAMA Internal Medicine on March 3, 2020. It was written by researcher Olivier J. Wouters of the London School of Economics.  The numbers were derived by him from data obtained by the National Institute on Money in Politics.


Tuesday, December 15, 2020

Drs. Tyson and Fareed's protocol for treatment and prevention of Covid-19, as discussed during Nov 19 Senate hearing

Dr. George Fareed and his partner Dr. Brian Tyson have together successfully treated over 1,000 Covid patients.  They have been adjusting their protocol over time, and now use both HCQ and ivermectin.  Why not, for a potentially fatal disease?  Why not maximize the potential benefit?  How many drugs was Trump given when he had Covid?

Here is the protocol provided to the Senate Homeland Security and Government Affairs Committee after Dr. Fareed's Nov 19 testimony. 

Senator Josh Hawley submitted questions to Dr. Fareed to clarify his testimony for the record. Here is the correspondence between the Senator and Fareed on December 10:

Sen. Hawley: In your testimony, you say that timing is everything when it comes to treatment and that the best time for outpatient treatment to prevent hospitalization comes when “the virus is in a period of maximum replication in the upper respiratory tract.” Can you explain what this would mean for a patient? Would this be five days after exposure, or ten days? Or is it based on symptoms?  

Dr. Fareed: The earlier the treatment can be started after the start of the infection, the better and more rapid the recovery (as well as the reduction in the risk of spread/contagious period). This would mean that the patient should optimally start the treatment in the first 4 days of the infection and within five days of exposure. It usually is based on symptoms which start within 1-4 days of viral entry into the upper respiratory system. Even starting the multi-faceted treatment later (7-10 days after infection) is also very worthwhile if severe pneumonia necessitating hospitalization has not yet set in.

Sen. Hawley: In your experience, are patients typically coming in to get treated at this point in their illness? And if not, what do you think we need to do to encourage high-risk individuals to seek outpatient treatment and care? 

Dr. Fareed: More patients are coming in to get treated or contacting me from afar for treatment when they can’t receive the treatment in their local communities. Sadly, many infected people and primary care doctors and doctors in ERs follow the NIH and Dr. Fauci stipulations with no effective treatments offered. We need to have the NIH/FDA/CDC formally acknowledge the importance of early treatment with moderately acting, safe anti-virals so readily available. When (if ever) that happens, everything would improve dramatically. Thank you, Senator Hawley,  for all your efforts and for allowing me to respond to these excellent questions.

The following is the protocol Drs. Fareed and Tyson have jointly developed as most effective for their COVID-19 patients:

Fareed/Tyson COVID-19 Treatment Protocol

HCQ 200 mg tabs #16 (HCQ = hydroxychloroquine)

Zinc sulfate 22O mg (or elemental Zinc 50 mg) # 15

Azithromycin 500 mg # 5 (or Z pack) or

Doxycycline 100 mg # 10)

Ivermectin 3 mg tabs #8

Aspirin 325 mg tabs #30 

Day 1 - HCQ 2 tabs twice a day 

Zinc sulfate tab twice a day

(Azithromycin tab one per day or doxycycline cap twice a day)

Ivermectin 12 mg on day 1 only

Aspirin 325 mg 

Days 2-5 

HCQ tab 3 times a day

Zinc sulfate 3 times a day

(Azithromycin tab daily or doxycycline cap twice a day)

Aspirin 325 mg daily

Ivermectin 12 mg on day 3 if symptoms warrant 

Prednisone 60 mg daily x 5-7 days or

Dexamethasone 4 mg bid if wheezing /SOB

Budesonide 0.5-1mg/2ml vía nebulizer bid 

Vitamin D3 5000 iu daily

Pepcid 20 mg daily

Continue daily Aspirin 325 mg

Over the counter prevention:

Elemental Zinc 25 mg once a day

Vitamin D 4000 iu once a day

Vitamin C 1000 mg once a day 

Quercetin 500 mg once a day 

If Quercetin is unavailable, then use Epigallocatechin-gallate (EGCG) 400mg once a day

Dr. Fareed also included Dr. Zelenko’s (Twitter: @zev_dr) COVID-19 Prophylaxis Protocol: 

Prophylaxis is an action taken to prevent or protect against a specified disease. Greek in origin, from the word "phylax", meaning "to guard" and "watching." 

Low Risk Patients

Young healthy people do not need prophylaxis against COVID-19. In young and healthy people, this infection causes mild cold-like symptoms. It is advantageous for these patients to be exposed to COVID-19, build up their antibodies and have their immune system clear the virus. This will facilitate the development of herd immunity and help prevent future COVID-19 pandemics. However, if these patients desire prophylaxis against COVID-19, then they should take the protocol noted below. 

Moderate-Risk Patients

Patients from this category are healthy but have high potential viral-load exposure. This group includes medical personnel, caregivers of high-risk patients, people who use public transportation, first responders and other essential personnel who are crucial to the continued functioning of society. These patients should be encouraged to take prophylaxis against COVID-19 in accordance with the protocol noted below.

High-Risk Patients

Patients are considered high risk if they are over the age of 60, or if they are younger than 60 but they have comorbidities, that is, they have other health conditions that put them at risk. These patients have between a 5 to 10 percent mortality rate if they are infected with COVID-19. These patients should be strongly encouraged to take prophylaxis against COVID-19 in accordance with the protocol noted below. 

Protocol for Low and Moderate Risk Patients:

Elemental Zinc 25 mg once a day[1]

Vitamin C 1000 mg once a day[2]

Quercetin 500 mg once a day 

If Quercetin is unavailable, then use Epigallocatechin-gallate (EGCG) 400 mg once a day[3]

Protocol for High-Risk Patients:

Elemental Zinc 25 mg once a day 

Hydroxychloroquine (HCQ[4]) 200 mg once a day for five days, then once a week

If HCQ is unavailable, then use the Protocol for Low and Moderate Risk Patients.





The spike protein of SARS-CoV-2 (what the mRNA vaccines cause our cells to produce) may be responsible for some of Covid's worst symptoms

This is the most thoughtful and erudite response I have seen to the experiment of turning humans into factories to make Covid (mutated) spike (S) protein.  Neither Pfizer, Moderna nor the FDA have commented in any publicly available documents on the serious safety questions this review of the literature raises.

Dr. Patrick Whelan, MD, PhD, formerly of Mass General Hospital and now UCLA, submitted the following letter about the mRNA vaccines to the FDA on December 8:

I am a pediatric specialist caring for children with the multisystem inflammatory syndrome (MIS-C). I am concerned about the possibility that the new vaccines aimed at creating immunity against the SARS-CoV-2 spike protein (including the mRNA vaccines of Moderna and Pfizer) have the potential to cause microvascular injury to the brain, heart, liver, and kidneys in a way that does not currently appear to be assessed in safety trials of these potential drugs.

Puntmann et al. (JAMA Cardiol. 2020;5:1265-1273) showed that the prospective study of 100 German patients who were recently recovered from COVID-19 revealed significant cardiac involvement on cardiac MRI scans in 78% of them, an average 2-1/2 months after their recovery from the acute illness. Two-thirds of these patients were never hospitalized, and there was ongoing myocardial inflammation in 60%. The abnormalities occurred independent of preexisting conditions, severity of the initial disease, and overall course of the acute illness.

Magro et al. showed that there is complement-mediated damage even in grossly normal skin of coronavirus-infected individuals (Human Pathology 2020:106:106-116). They have also shown (Magro et al. Annals of Diagnostic Pathology 2021:50 in press ) that ACE-2 receptor expression is highest in the microvasculature of the brain and subcutaneous fat, and to a lesser degree in the liver, kidney, and heart. They have further demonstrated that the coronavirus replicates almost exclusively in the septal capillary endothelial cells of the lungs and the nasopharynx, and that viral lysis and immune destruction of those cells releases viral capsid proteins (or pseudovirions) that travel through the circulation and bind to ACE2 receptors in these other parts of the body leading to mannan-binding lectin complement pathway activation that not only damages the microvascular endothelium but also induces the production of many pro-inflammatory cytokines. Meinhardt et al. (Nature Neuroscience 2020, in press) show that the spike protein in brain endothelial cells is associated with formation of microthrombi (clots), and like Magro et al. do not find viral RNA in brain endothelium. In other words, viral proteins appear to cause tissue damage without actively replicating virus.

Is it possible the spike protein itself causes the tissue damage associated with Covid-19? Nuovo et al (in press) have shown that in 13/13 brains from patients with fatal COVID-19, pseudovirions (spike, envelope, and membrane proteins) without viral RNA are present in the endothelia of cerebral microvessels. Furthermore, tail vein injection of the full length S1 spike subunit in mice led to neurologic signs (increased thirst, stressed behavior) not evident in those injected with the S2 subunit. The S1 subunit localizes to the endothelia of microvessels in the mouse brain, and is a potent neurotoxin. So the spike S1 subunit of SARS-CoV-2 alone is capable of being endocytosed by ACE2 positive endothelia in both human and mouse brain, with a concomitant pauci-cellular microencephalitis that may be the basis for the neurologic complications of COVID-19. The Pfizer/BioNTech vaccine (BNT162b2) is composed of an mRNA that produces a membrane-anchored full-length spike protein. The mouse studies suggest that an untruncated form of the S1 protein like this may cause a microvasculopathy in tissues that express much ACE2 receptor. A truncated form of S1 was much less damaging in mice.

While there are pieces to this puzzle that have yet to be worked out, it appears that the viral spike protein that is the target of the major SARS-CoV-2 vaccines is also one of the key agents causing the damage to distant organs that may include the brain, heart, lung, and kidney. Before any of these vaccines are approved for widespread use in humans, it is important to assess in vaccinated subjects the effects of vaccination on the heart (perhaps using cardiac MRI, as Puntmann et al. did). Vaccinated patients could also be tested for distant tissue damage in deltoid area skin biopsies, as employed by Magro et al. As important as it is to quickly arrest the spread of the virus by immunizing the population, it would be vastly worse if hundreds of millions of people were to suffer long-lasting or even permanent damage to their brain or heart microvasculature as a result of failing to appreciate in the short-term an unintended effect of full-length spike protein-based vaccines on these other organs.

Particular caution will be required with regard to the potential widespread vaccination of children before there are any real data on the safety or effectiveness of these vaccines in pediatric trials that are only now beginning.

Wednesday, December 9, 2020

Wonderful summary of known and unknown information on Pfizer's BioNTech vaccine, which could be approved for emergency use as early as tomorrow

Here’s Robert F. Kennedy, Jr.’s December 7, 2020 letter to Dr. Peter Marks, head of the Center for Biologics (CBER) at FDA, regarding Emergency Use Approval of the Pfizer-BioNTech vaccine

Dear Dr. Marks,

Transparency and accountability are essential ingredients in the public policy process, helping to engender public trust and promote sound decision-making. As you are undoubtedly aware, many Americans are expressing worries about the lack of transparency and abbreviated timeline governing the experimental COVID-19 vaccines currently under development. Children’s Health Defense shares the public’s concern that the government’s single-minded—and perhaps unrealistic—preoccupation with a vaccine as the only way to end the COVID crisis has given the vaccine enterprise a dangerous urgency that could prompt health officials to take reckless steps to speed one or more vaccines to approval. Children’s Health Defense is writing to respectfully request that you and the FDA slow down the approval process to meet the public’s expectations for deliberations of the utmost rigor and integrity.

Without having to provide “the full data to back up their claims,” executives at Pfizer and Moderna “have made significant amounts of money off their early announcements of [vaccine] success.” In addition, through Operation Warp Speed, Pfizer (in partnership with German company BioNTech) has received $1.95 billion in taxpayer funds for the manufacture and distribution (though not R&D) of 100 million doses of its BNT162b2 mRNA vaccine; Operation Warp Speed has also awarded over $2.4 billion to support the clinical trials, manufacturing and distribution of 100 million doses of Moderna’s mRNA-1273 vaccine developed in partnership with the National Institute of Allergy and Infectious Diseases (NIAID).

Both Pfizer and Moderna have now submitted Emergency Use Authorization (EUA) applications (on November 20 and November 30, respectively) for their vaccines, and Moderna has also directed an application to the European Medicines Agency. News reports indicate that the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet on December 10 to review Pfizer’s application and are speculating that FDA could authorize the company’s vaccine as soon as mid-December. VRBPAC is also apparently hurrying to review Moderna’s vaccine on December 17.

At an October 22 meeting of outside experts convened by VRBPAC to discuss COVID-19 vaccines, one of the attendees described the difficulty—particularly when making a less stringent EUA decision—of striking the proper “balance between looking at people’s rights to take something where it’s determined that the benefit might exceed the risk, while also making sure that. . . people are not taking vaccines that might actually harm them” (p. 348). Recognizing the innumerable uncertainties that surround these novel vaccines, Children’s Health Defense believes that, at a minimum, the American public deserves to have the FDA’s thorough and thoughtful answers to the following questions:

How will the FDA account for potentially biased conclusions about COVID-19 vaccine efficacy?

Both Pfizer and Moderna recently issued press releases citing preliminary evidence that their COVID-19 vaccines are 95% effective in preventing symptoms of mild coronavirus infection; they are banking on these early results to obtain the FDA’s emergency use authorization. However, the clinical trials’ reliance on PCR testing to ascertain study participants’ SARS-CoV-2 infection status raises important questions. These prompted world-renowned diagnostics expert Dr. Sin Hang Lee, founder of the Connecticut-based Milford Molecular Diagnostics Laboratory, to file an Administrative Stay of Action petition with the FDA (Docket No. FDA-2020-P-2225) on November 25. The petition focuses on the Pfizer study but is just as relevant to the Moderna study. In the petition, Dr. Lee asserts that Pfizer’s study design is “inadequate to accurately assess efficacy” and asks the FDA to conduct a more appropriate efficacy review before proceeding to an EUA determination, stating that PCR testing—prone to generating a high rate of false-positives—should not serve as the primary evidence of SARS-CoV-2 infection in trial participants. As Dr. Lee spells out, “a higher number of false-positive test results in the participants receiving placebo will artificially raise the efficacy of the vaccine.” He argues that it is “absolutely necessary” that all positive test results be verified using gold-standard DNA sequencing.

Will the FDA factor into its EUA deliberations the fact that neither clinical trial has a primary objective of assessing whether the vaccines prevent severe outcomes?

The pre-specified endpoints forming the basis of Pfizer’s and Moderna’s preliminary conclusions about effectiveness—the endpoints upon which the FDA’s potentially momentous decision to grant EUA rests—focus on a trivial difference in COVID-19 symptomatology between a tiny subset of 164 or fewer trial participants in the vaccinated and control groups. In late October, internationally esteemed British Medical Journal (BMJ) Associate Editor Dr. Peter Doshi, who is also a University of Maryland professor, wrote in the BMJ, “The world has bet the farm on vaccines as the solution to the pandemic, but the trials are not focused on answering the questions many might assume they are.” Dr. Doshi continued, “None of the trials currently under way are designed to detect a reduction in any serious outcome such as hospital admissions, use of intensive care, or deaths.” According to Dr. Doshi, Moderna’s chief medical officer is well aware of this design shortcoming, having explained that to capture endpoints such as hospitalization or death, the trials would need to be “10 times the size” and run for a much longer time frame. Scientist and former Harvard Medical School professor Dr. William A. Haseltine agrees that the trials’ narrow focus on mild cold-like symptoms makes the study protocols “far from adequate”; Dr. Haseltine has argued that the trials seem “intended to pass the lowest possible barrier of success,” allowing manufacturers to quickly petition for vaccine approval.

Experts at the late-October VRBPAC meeting made similar remarks about the limitations of using mild infection as the primary endpoint. Noting that there could be “limited and, in some instances, no information about some of the secondary endpoints” (such as more severe illness), one panelist stated that “This would be particularly true in the instance of an early EUA” (p. 100). Another attendee pointed out that a vaccine could be “effective in avoiding mild cases but actually [do] very little to address what we really care about, which is serious disease and deaths” (p. 308). A third participant made the critical point that “many of the groups at risk for severe disease don’t respond well to vaccines in the first place” (pp. 346-347). 

Messenger RNA technology has previously faced significant safety hurdles; what evidence can the FDA share with the public supporting the short-term and long-term safety of mRNA vaccines?

Until very recently, concerns about mRNA instability bedeviled efforts to develop mRNA vaccines. The apparent technological solutions for overcoming these challenges—including nanoparticle carrier systems and, in the case of the Pfizer vaccine, extreme freezing—remain unproven. To our knowledge, Pfizer has not provided detailed information about the reasons for its mRNA vaccine’s unprecedented minus-94-degree freezing requirements, which specify that the cool boxes may only be opened briefly twice a day, must have their dry ice replenished every five days, and that the vaccine can only be stored at refrigerator temperatures for 24 hours. Why are the Pfizer vaccine’s storage conditions so different from those of the Moderna mRNA vaccine, which apparently can be refrigerated for 30 days? Many members of the public and scientific community would like to know more about the two vaccines’ real-world stability and safety.

Discussing Pfizer’s vaccine, Professor Allan Cheng, acting chief health officer in the Australian state of Victoria, describes safety as a “key unknown,” characterizing mRNA vaccines as “pretty reactogenic” and prone to “lots of side effects.” During the Phase II/III trials, 50% of Pfizer participants aged 18-55 experienced systemic adverse events within a month of their second dose of vaccine, as did 100% of those injected with two doses of Moderna’s vaccine.

Because mRNA vaccines rely on synthetic RNA, they represent a significant departure from other biologically based vaccine technologies. Virologist, Dr. Luc Montagnier (who won the 2008 Nobel Prize for his discovery of HIV) and other scientists even dispute the label of “vaccine,” arguing that these products represent a new form of gene therapy. It is debatable whether a fast-tracked approval schedule is appropriate for an entirely new vaccine technology that, essentially, is intended to turn the body’s cells into viral-protein-making factories. Professor Montagnier, who opposes the use of mRNA vaccines in humans, stated in an interview with Children’s Health Defense, “The human genome contains 7% to 9% of endogenous retrovirus sequences. Some of these sequences code for reverse transcription of RNA into DNA. Therefore, it is possible that the spike protein mRNA of the vaccine could be absorbed by human cells, reverse transcribed, and integrated as a human gene in these cells. This could be a beneficial event protecting the human host from further infection by coronavirus or it could induce a long-term deleterious effect such as cancer. Even if animal testing showed protection, nobody could predict long-term pathologic effects in a human population and the precautionary principle should apply.”

Messenger RNA vaccines will not work without an in-built delivery mechanism that enables the mRNA to make its way into a cell’s cytoplasm. Moderna’s and Pfizer’s chosen solution is to use lipid nanoparticle (LNP) carrier systems. The two mRNA vaccine manufacturers are using LNPs to “encapsulate the mRNA constructs to protect them from degradation and promote cellular uptake,” in addition to taking advantage of what vaccine scientists describe as LNPs’ “inherent adjuvant properties.” However, the LNP formulations in both COVID-19 vaccines are PEGylated, meaning that the vaccine nanoparticles are coated with the synthetic, nondegradable and controversial polyethylene glycol (PEG) polymer. PEG is a potential allergen as well as a suspected carcinogen. Moderna’s 2018 corporate prospectus acknowledges that “there can be no assurance that our LNPs will not have undesired effects,” including reactions that “could lead to significant adverse events.”

How will the FDA evaluate possible risks of pathogenic priming and antibody-dependent enhancement? 

Although Pfizer and Moderna have conducted some experimental animal trials alongside their clinical trials in humans, neither company has released any data addressing the possibility of pathogenic priming. In individuals vaccinated against the SARS-CoV-2 virus, pathogenic priming could potentially trigger autoimmunity against critical human immune system proteins as a result of molecular similarities between SARS-CoV-2 protein components and human protein components (epitopes). A 2020 paper on pathogenic priming discusses these risks, pointing out that “All SARS-CoV-2 immunogenic epitopes have similarity to human proteins except one.” The paper’s author cautions, “These epitopes should be excluded from vaccines under development to minimize autoimmunity due to risk of pathogenic priming.”

Another issue, as yet undiscussed by Pfizer and Moderna, concerns the potential for antibody-dependent enhancement (ADE), a phenomenon documented in humansnon-human primates, and ferrets in connection with the coronaviruses linked to SARS and MERS. In ADE, vaccines can cause idiopathic antibodies to act like a Trojan horse for wild viruses. In the case of individuals receiving COVID-19 vaccines, ADE could not only end up enhancing disease severity but could also lead to organ damage. Of concern, COVID-19 vaccine trials are not designed to detect ADE. It is not known what proportion of the U.S. population might suffer pathogenic priming or ADE after receiving a COVID-19 vaccine, but the estimated 15 to 24 million Americans who already have an autoimmune disease could be particularly susceptible. The CDC has indicated that individuals with high-risk medical conditions—individuals excluded from the Phase I trials—are one of the proposed groups for early vaccination.

What are the FDA’s plans for ensuring transparency of data describing rates and types of adverse events, including information about susceptible subgroups? And how does the FDA plan to monitor adverse events and long-term health outcomes once the clinical trials are unblinded and vaccines are offered to those in the placebo arm? 

The National Vaccine Injury Compensation Program has awarded over $4.4 billion for vaccine injuries and deaths since 1990. These awards, along with the scientific literature, the Vaccine Adverse Event Reporting System (VAERS), and the data compiled in vaccine package inserts, all illustrate that vaccines cause a multitude of serious injuries, many of which have long diagnostic horizons. Unfortunately, conditions such as allergies, autoimmune diseases, neurodevelopmental problems, and cancers are unlikely to be detectable within the short clinical trial follow-up windows. The appallingly low rate of reporting of vaccine injuries (an estimated 1%, according to Harvard researchers) also suggests that, without fully transparent access to data and information, few vaccine recipients or health care providers are likely to connect the dots between vaccination and subsequent adverse events.

The unpredictable outcomes that may arise from population-wide coronavirus vaccination are a disturbing unknown. Although FDA often requires medicines to continue active monitoring of injuries for up to five years, Pfizer’s approved Phase 3 protocol calls for the company to “actively” collect information about adverse events and serious adverse events only through the second month—the point at which the FDA could decide to award EUA. Although the protocol states that researchers will also collect serious adverse event data “approximately 6 months after the last dose of study intervention,” it implies that it will rely on voluntary rather than “active” reporting of these injuries and illnesses. Moreover, from 24 months on (after the last follow-up visit), Pfizer’s investigators will no longer be “obligated” to pay attention to adverse events.

Following the close of their studies—or even sooner—both Pfizer and Moderna have indicated that they plan to offer their vaccine to every member of the placebo group. This scheme will have the obvious effect of erasing opportunities for long-term comparisons and making future vaccine injuries invisible and deniable. Industry and health officials argue that they will take this action “for ethical reasons,” stating that it would be unethical to deny placebo group members the advantage of an approved vaccine. It would, however, also be highly unethical to give millions of Americans a vaccine with potential long-term adverse effects that have not been properly researched, characterized, and documented.

How will the FDA assess vaccine safety in different age groups, including the elderly and children?

In a recent press release, Pfizer stated that 45% of the participants in the U.S. portion of its vaccine clinical trials were between the ages of 56 and 85. This lumping together of working-age adults and seniors will make it difficult to evaluate subsequent claims about COVID-19 vaccine safety and efficacy specifically in the elderly. This is concerning, given that older adults in assisted living and nursing home populations are one of the proposed groups for early phase vaccination. The elderly and the general public have a right to full transparency concerning the number of seniors, broken down by smaller age ranges and underlying health conditions, who participated in the clinical trials and the rates of infection and adverse events experienced by those trial participants. The published data to date in the Phase I and II trials of both vaccines (Pfizer and Moderna) included only 22 healthy, community-living white seniors (the oldest was 74); none of them were representative of the frail elderly populations in long-term care facilities. Almost two out of five nursing home residents are over age 85 (39%), and Pfizer’s Phase III trial excluded people who were over 85. Many comorbidities found in frail seniors would also have excluded them from both of the Phase III trials. The well-known phenomenon of immunosenescence—the “age-related dysregulation and decline of the immune system”—is linked to poor vaccine responses in older adults. No one, and especially not seniors, will be able to make informed risk-benefit decisions without access to full information and clinical trial data.

At the October 22 expert meeting convened by VRBPAC, participants expressed caution about giving COVID-19 vaccines to children, arguing that the risks could well outweigh the benefits. Leading NIH researcher Dr. Luigi Notarangelo went further, frankly stating that coronavirus vaccines “should not be considered for use” in children “at this point” and adding that the evidence presented at the meeting had been insufficient to answer pressing questions about safety in children (p. 337). Although FDA requires institutions that test drugs and biologics in children to have a pediatric plan in place, in early November, the principal investigator leading Pfizer’s vaccine trials in 12-17-year-olds made the scarcely comforting disclosure to TIME magazine that “The plan can be simply ‘We don’t have a plan,’” stating that the rule “is lenient to the point of being no rule at all.” Bafflingly, these remarks—which one hopes are a mischaracterization of the FDA’s willingness to exercise pediatric oversight—appear to have been intended to reassure parents pondering whether to sign up their children for the trials.

How will the FDA earn the public’s trust? 

While all vaccines require due deliberation about safety and efficacy, the candidate vaccines’ accelerated development and the experimental nature of the never-before-approved mRNA technologies upon which they rely clearly raise even more questions than usual. The fact that racial/ethnic minorities are disproportionately represented among the groups targeted for early phase vaccination (including essential health care workers and individuals with high-risk medical conditions) has also prompted concerns. Focus groups indicate that communities of color do not want to be “first in line,” are reluctant to be “guinea pigs,” and “want to see some data”; vaccine experts concede that ethnic minority groups’ extremely low levels of trust in the vaccines’ safety are “quite rooted in historical reality.”

There are significant differences between the FDA’s standard drug and biologic approval process and the expedited EUA process; as those familiar with drug development procedures acknowledge, an EUA “is not an accepted endpoint for product development.” We urge you, therefore, to take all the time required to carefully assess the full range of unknowns pertaining to the Pfizer and Moderna vaccines. The FDA’s eventual decisions about these vaccines will have major implications not just for 328 million Americans, but potentially for billions worldwide.