COVID-19 Vaccines and Children: A Scientist’s Guide for Parents

 COVID-19  Vaccines  and  Children: A Scientist’s  Guide  for  Parents

 by Dr.  Byram  W.  Bridle,  PhD Associate  Professor  of  Viral  Immunology June  15,  2021

 https://www.canadiancovidcarealliance.org/ 

EXECUTIVE SUMMARY 

Pfizer BioNTech’s COVID-19 mRNA vaccine has been Authorized under an Interim Order by Health Canada for use in Canadians as young as 12 years old, with mandatory commitments for the monitoring of long-term safety and efficacy. Authorization under an Interim Order means additional information is needed on the safety, efficacy, and quality of the vaccine, including in children and adolescents, to support the future full market approval and licensing of the vaccine. 

 There is some uncertainty regarding the long-term safety of Pfizer BioNTech’s COVID-19 vaccine in all individuals, and especially in children, youth, and younger adults of child-bearing age. Indeed, some key safety studies appear to have been missed in the rush to roll out the vaccines, and more is being learned about the vaccines every day. For example, there was a previously wide-held assumption that vaccination with the mRNA vaccines is safe because it is a localized event in the body, with the vaccine remaining limited to the shoulder muscle following injection and triggering an immune response in the local lymph nodes. However, there is evidence that Pfizer’s COVID-19 vaccine does not remain at the injection site. In fact, once injected, the vaccine contents appear to travel extensively throughout the body, to the brain and other sensitive tissues, such as bone marrow, spleen, liver, adrenal glands, ovaries etc. Whether these body sites are involved in producing the spike protein is not known, as this was never studied. Nonetheless, new data have been published that, following vaccination with the Moderna vaccine (an mRNA vaccine very similar to Pfizer’s mRNA vaccine), the spike protein can enter the circulatory system. Presumably, this means the spike protein can travel extensively throughout the body. It is important to understand which organs are producing the spike protein, what factors result in the spike protein entering the circulation, how long the spike protein circulates, and in which body fluids (e.g., semen, saliva, breast milk, urine) the spike protein is present. This information is incredibly important because recent data have come to light that the spike protein is “biologically active”. This means that the spike protein is not just an antigen that is recognized by the immune system as being foreign. It means that the spike protein, itself, can interact with receptors throughout the body, called ACE2 receptors, potentially causing undesirable effects such as damage to the heart and cardiovascular system, blood clots, bleeding, and neurological effects. Although some might argue that the risk of the spike protein causing this type of damage is only a theoretical risk, when we are mass vaccinating a population of predominantly healthy people, including children, adolescents, and adults of child-bearing age, there is absolutely no room for avoidable error. 

 The current scientific uncertainties demand that the administration of Pfizer’s COVID-19 vaccine to children, adolescents, and young adults of child-bearing age be paused until proper scientific studies that focus on the safety and pharmacokinetics and biodistribution of the vaccines and the vaccineencoded spike protein can be conducted. Halting the vaccination can be done safely because: 

 • The risk of severe and potentially lethal COVID-19 in these specific populations is so low that we need to be very certain that risks associated with mass vaccination are not higher; 

• Asymptomatic members of this population are not a substantial risk for passing COVID-19 to others; and 

• There  are  effective  early-treatment  strategies  for  the  very  few  children,  adolescents,  and young adults  of child-bearing  age  who  may  be  at  risk  of  developing  severe  COVID-19,  such  as ivermectin, fluvoxamine,  and  budesonide. 

It  is  not  appropriate  to  use  an  “experimental”  vaccine  in  a  population group  unless  the  benefit  of vaccination  exceeds  the  risk  of  vaccination  in  that  population  group.    With  risk  of  severe  COVID-19  in children,  adolescents,  and young  adults  of  child-bearing  age  already  so  low,  the  benefit  of  vaccinating these  population  groups  with  a  vaccine  for  which  neither  the  long-term  safety  nor  efficacy  is  known cannot be concluded  to  exceed the  risk.  In other  words,  the  risk  of  serious  COVID-19 is  so  low  in  children, adolescents,  and young adults  of  child-bearing  age  that  the  standards  for  safety  must be  set  much  higher for  them. [Page  3  of  37] .

Contents 

EXECUTIVE SUMMARY ............. 2 

Who is Dr. Bridle? .............. 5 

What is the Canadian COVID Care Alliance (CCCA)? ....................... 5 Disclaimer .................. 6

The problem: COVID-19 ........ 7 

How do vaccines works.......... 8 

How do Canada’s COVID-19 vaccines work?................... 9 

What are the known serious adverse events that are associated with COVID-19 vaccines? ........... 12 

Are there other serious adverse events associated with COVID-19 vaccines that are being investigated? 12 

Why weren’t serious adverse events identified before vaccines were rolled out? ................ 14 

A clinical trial was conducted to justify using the Pfizer vaccine in Canadian children and adolescents; was it flawed as well?................. 15 

But we have been told that adolescents and children can: (a) die from COVID-19, (b) suffer severe disease, and (c) be asymptomatic spreaders of SARS-CoV-2 and, therefore, kill others. Don’t these risks suggest that children, youth, and young adults of child-bearing age should be vaccinated?...... 15 

Why was the spike protein from SARS-CoV-2 chosen as a target for the immune system? ........... 19 

What should we know about the SARS-CoV2 spike protein?...... 20 

The spike protein from SARS-CoV-2 has the potential to damage cells in the body ............... 20

 Back to the vaccines............ 22

 Evidence that mRNA-based COVID-19 vaccines can get distributed throughout the body.............. 22 

A concern beyond circulating spike proteins: the potential for induction of autoimmunity ........... 26 

Why doesn’t everyone who gets vaccinated experience a severe side-effect? .................. 27 

Is the Pfizer BioNTech vaccine losing its effectiveness? .................... 29 

The Pfizer BioNTech vaccine might cause an excessive number of serious side-effects in young Canadians .................... 29 

A side note about blood donations ... 30 

What options are we left with if we pause the vaccination roll-out for children, adolescents, and young adults of child-bearing age? ....... 31 

Concluding remarks ................... 32

 What to do next? ..................... 32 

References ............................... 33 

Appendix 1 ............................... 37 

Who is Dr. Bridle? 

I  am an  Associate  Professor of  Viral Immunology  in  the  Department  of  Pathobiology  at the  University  of Guelph  in Canada.  My  research program  focuses  on  the  development of vaccines  to  prevent infectious  diseases  and  treat cancers,  as  well  as  studying  the  body’s  immune response  to  viruses.  I  teach several  courses  at  the  undergraduate  and  graduate  levels  on the topics  of  immunology,  virology,  and  cancer biology.  The  overall aim of  my  research  efforts  is  to develop safe  and  effective  new therapies for people.  Indeed, one of my previous  cancer therapies progressed into  four  human  clinical  trials.  I  am also  involved  in  training  Canada’s  next  generation of  multidisciplinary  researchers,  especially  in  vaccinology.  I  received  funding  from  the  Ontario Government (COVID-19  Rapid  Research  Fund,  Ministry  of  Colleges  and  Universities)  and Government of Canada  (Pandemic  Response  Challenge  Program,  National Research  Council of Canada)  to  develop  vaccines  against  COVID-19.  The  scope  of  this  research  is  limited  to  the  preclinical realm  and  is  years  away  from  being  ready  for  testing  in  a  clinical  trial.  Since  I  do  not  hold any  commercial interests,  this  is  not considered  a  conflict  of interest  that would  preclude  me from  publishing  my  research findings.  If that  were  the  case,  most  researchers  could  never comment on topics  relevant  to  their  area  of  expertise,  because  they  receive  funding  in  that  area. Further,  my  laboratory’s  vaccine  vectors  also  express  the  spike  protein  of  SARS-CoV-2.  As  such, what  I  am  presenting  here  affects  my  vaccines  as  much  as  anyone  else’s.    I  also  hold numerous grants in  support  of  my  cancer  research  and  basic viral immunology  research  programs, including, but not limited,  to  the  Canadian  Institutes  for Health  Research,  Natural  Sciences  and  Engineering Research  Council  of  Canada,  Canadian  Cancer Society,  and  Cancer Research  Society.  Since  the COVID-19  pandemic  was  declared,  I  have  been  actively  involved  in  providing  fact-based, balanced,  scientific  answers  to  questions  posed  by  the  public  to  help  them  make  fully  informed decisions.  This  has  included  ~150  media  engagements  ranging  from  radio  shows,  published articles,  and  appearances  on  televised  news  programs,  spanning  the  local  to  international  scope. I  was  also  an  invited  keynote  speaker  for  two  international  conferences  that  focused  on COVID19  and  served  as  an  invited  member of  several COVID-19-focused discussion  panels.  Vaccinology is a  sub-discipline  of immunology.  I  teach  the  value  of high-quality,  well-validated,  robustly safety-tested  vaccines  and  promote  their  use.  I  consider  vaccines  that  have been  developed  on a  foundation  of  sound  science  to  be  the  most  efficient  type  of  medicine;  they  have  costeffectively  saved  millions  of  people  from sickness  and/or  death.  However,  I  am  concerned  that the  risk-benefit profile  of  SARS-CoV-2  vaccines  currently  being  used  in  Canada  and  elsewhere may not be  appropriate  for  the  mass  immunization  of  children,  youth,  and  young  adults  of childbearing  age.  My  scientific  reasoning  substantiated by  the  peer-reviewed literature  is  contained within this  guide. What  is  the  Canadian COVID  Care  Alliance  (CCCA)? The  CCCA  is  an  alliance  of  independent  Canadian  scientists,  physicians  and other  health professionals,  committed to  providing  top-quality  and  balanced  evidence-based information  to [Page  5  of  37] the Canadian public about COVID-19 so that hospitalizations can be reduced, lives can be saved, and our country can be safely restored as quickly as possible. 

 Disclaimer 

The comments in this guide are mine alone and do not necessarily reflect the opinions held by my academic institution or the agencies funding my research program. Nevertheless, these comments have been vetted and supported by many like-minded researchers and physicians associated with the CCCA. 

Preamble 

Although I have tried to be reasonably comprehensive in my presentation of relevant facts about COVID-19 vaccines, I could have written much more; hundreds of pages, in fact. However, I feel that the current content represents the most important information that parents will need to make informed decisions about vaccinating their children. As children in Canada who are 12 and older can be vaccinated without parental consent, this guide also serves to share information and encourage open discussions between parents and their older children, so that the choice to consent or not consent is truly “informed”. There will be many people who will challenge the content of this guide. I respect others’ opinions and decisions. I simply ask for similar respect in return. I am a public servant providing information for which I have substantial expertise. It is being done from the perspective of having a genuine concern for the well-being of Canadian youth. I urge everyone to follow the weight of validated scientific data. I ask you to challenge information that is accompanied by loose claims of being ‘data from on the ground’ or ‘data from the front lines’, which often lack scientific rigor and a ‘big picture’ perspective, especially in an era of extensive social media censorship. Follow the weight of the validated data when deciding which evidence is relevant and reliable in your decision-making process.

Important note: many treasured colleagues from within and outside Canada have helped me piece together this story. Without them, we would not have made all the scientific links that are described in this guide. As such, I can take only partial credit for this work. Instead, I am fronting a larger group of physicians and researchers; consolidating our conversations and sharing of scientific articles into my own words. Sadly, many of these experts and professionals currently feel the need to remain anonymous to protect themselves from potentially careerending reprisals when objective scientific evidence is presented publicly. 

 I have included some citations and links for important statements to show that they are backed by sound science. In many cases, there are other scientific articles that could have been referenced. However, the purpose of this document is not to provide an exhaustive list of references, but rather to provide sufficient evidence to support my concerns. My goal is not to prove that Canada’s COVID-19 vaccines are unsafe, but to highlight the substantial uncertainties that exist in the current base of safety evidence and my consequent discomfort with the mass [ Page  6  of  37 ] vaccination of our youth. The proper scientific process dictates that the burden of proof of safety is on vaccine manufacturers and health protection agencies. Most importantly, a lack of proof of harm is not proof of safety. I first presented some of the information that is in this guide during a radio interview on May 27, 2021. This was a truncated ~five-minute sound bite that triggered a public smear campaign, including a slanderous website, a fake Twitter account, and harassment in the workplace. Nobody involved in the establishment of the smear campaign reached out to me to respectfully discuss the science. As a result, I wrote, along with collaborators, a brief two-page ‘guide’ to provide some key scientific references. Here, I have assembled a much more comprehensive guide, written with the goal of trying to communicate complex scientific principles to a lay person, yet with sufficient scientific rigour to also address experts. As I have often done with presentations and articles over the past year, I have set up this guide to answer the most common questions that I have received from the public. It is with sincere concern, and with the best interests of my fellow Canadians in mind, that I present you with the information that follows. 

The problem: COVID-19 

“COVID-19” is a disease that develops in a subset of individuals infected with a virus that is known as ‘severe acute respiratory syndrome-coronavirus-2’ (SARS-CoV-2). In the vast majority of cases of SARS-CoV-2 infections, people remain healthy (i.e. they are ‘asymptomatic’) or develop only mild to moderate symptoms of illness. However, in some cases, severe, and potentially lethal pneumonia, occasionally accompanied by other inflammatory events causing bleeding, clotting and/or neurological impairment, can develop in people in high-risk demographics, which includes the frail elderly and individuals who are immunocompromised (i.e. their immune systems do not function properly). Many people who become infected with SARSCoV-2 do not develop the disease called COVID-19. 

What is ‘herd immunity’? 

The concept of ‘herd immunity’ means that a virus will stop spreading among a population once most of the people in that population acquire a protective immune response. Importantly, this does not require every person to become immune, just a large majority. There are two ways for people to acquire immunity to SARS-CoV-2 and thus avoid the debilitating effects of COVID-19: [Page 7 of 37]

 1.  Natural infection: 

When infected with  SARS-CoV-2,  most  people  clear this  virus  from  their  body  by  mounting  a robust,  long-lasting  immune  response  that  targets  multiple  components  of the  virus1.  These people  will  be  protected from  re-infection  with  the  same  variant  of  SARS-CoV-2  and,  due  to  the breadth  of  a  natural immune  response,  will also  likely  have  some degree of  protection  against emerging  new  variants  of  SARS-CoV-2.  Indeed,  most people  who  have  naturally  acquired immunity  should  not  be  at  risk  of  developing  severe  disease  even  if  variants  arise  that  can effectively  bypass  the  narrower  immunity  conferred  by  COVID-19  vaccines  that  are  focused  on  a single  component  of  SARS-CoV-2,  such as  the  spike  protein2.  Interestingly,  a landmark  study  in Canada  suggested  that a  majority  of healthy  adults  in British Columbia  have  evidence  of  preexisting  or naturally  acquired  immunity  to  SARS-CoV-23.

 2.  Vaccination: 

Vaccines  that  have  undergone  properly  conducted  preclinical  studies  and the  full  suite  of clinical trials  to  ensure  they  are  (i)  effective;  and  (ii)  have  excellent  short-term and  long-term  (i.e. a minimum  of  two  years;  preferably  longer)  safety  profiles,  can  allow  an  individual to  become immune to  a  virus  without  having  to  be  naturally  infected. 

How do vaccines  work? 

A successful  vaccine  must provide  two  things: 

Thing  1:  The  virus  or  a  piece(s)  of  the  virus  (i.e.  a target  for  the  immune system). 

Thing 2:  A  danger signal (i.e.  something  that  tells  the  person’s  immune system  that  the  target it  is  seeing  is  dangerous  and,  therefore, worth  responding  to). 

An effective  vaccine  simulates  just enough of a  natural infection,  to trigger  a  person’s  body  to  develop  an  appropriate  immune  response  without causing disease. Then, when the person  becomes infected  the first  time  by the  natural  virus,  their body’s  immune  system  senses  it is  seeing  the  virus  for  the  second  time.  This  is  because  an immune  response  triggered  by  successful  vaccination  involves  the  body’s  development of ‘immunological memory’.  Therefore,  the  person’s  vaccine-primed  immune  response  to  the natural  viral  exposure  will be  faster  and  more  robust,  and  the  virus  will  be  cleared without the person  experiencing  disease.  Mass  vaccination  can  accelerate  progress  of  a population  towards herd  immunity. [Page  8  of  37] 

How do  Canada’s  COVID-19  vaccines  work? 

Canada  currently  has  four COVID-19  vaccines  that  Health  Canada  has “Authorized  by  Interim  Order”.  The  Interim Orders  enable  the  widespread deployment of  the  vaccines  while  the  Phase  3  clinical studies  (experiments in  people)  are  being  conducted.  In  the  Phase  3  studies,  all vaccine  recipients must be  followed  for  two  years  following  the  administration  of  the  second vaccine  dose.  As  long-term  effects  of  the  vaccine  have  yet  to  be  understood, the  vaccine  is  largely  investigational.  This  is  why  the  authorizations  are "interim" and continued  use  is  contingent on  the  collection of additional  data from  the  Phase  3  studies,  as  well as  other surveillance  systems to  assess  the safety  and  effectiveness  of  the  vaccines.  Because  the  COVID-19  vaccines  are being  administered  in  Canada  under  experimental  trial  conditions,  people receiving  these  vaccines  should  provide  informed  consent  prior  to  being  immunized.  Informed consent  demands  that  people  be  provided  with  all  the  known  pros  and cons,  in  an  objective fashion  and without undue  pressure  or  coercion.  This  is  a  basic  tenet of bioethics.  Anyone administering  a  COVID-19  vaccine  should be  able  to  explain  the  benefits  and risks  based on the weight of the  evidence  provided in  peer-reviewed,  published scientific  papers.  Lay  persons  are encouraged  to  ask  public  health  officials  to  explain  the  rationale  for  any  statements  made regarding  COVID-19  vaccines  and  to  have  the  sources  of  this  information  identified.  Numbers  in printed  documents  that  do  not  contain  citations  do  not  necessarily  reflect  the  robustness  of the scientific  literature. 

The  four  COVID-19  vaccines  currently  being  used  in Canada  include: 

1.  AstraZeneca/COVISHIELD  vaccine  (ChAdOx1-S): 

These  are  two  different  names  for  the  same  vaccine  (COVISHIELD  is  the  brand  name  of AstraZeneca’s  vaccine  that  is  manufactured  by  Verity  Pharmaceuticals  Inc.  with  the  Serum Institute  of  India).  Developed by  AstraZeneca  and  Oxford University,  the  backbone  of  this  vaccine is  an  adenovirus  that  does  not  cause  disease  in  people.  This  adenovirus  virus  carries  genetic material  that provides  instructions  for  a  cell  to  manufacture  a piece  of  SARS-CoV-2  (i.e.,  the  spike protein).  When this  adenovirus-based vaccine  gets  injected into  the  shoulder  muscle,  it  is intended to  infect  cells  and  use  the  ‘machinery’  in  these  cells  to  manufacture  small amounts  of the  SARS-CoV-2  spike  protein.  The  SARS-CoV-2  spike  protein  and the  adenovirus  backbone provide  the  ‘thing  1’  and  ‘thing  2’,  respectively,  that are  needed  to  trigger  an immune  response.   

Unfortunately,  the  rollout of the  AstraZeneca  vaccine  in Canada  proved  to  be  a  frustrating and  complicated  series  of  ever-changing,  safety-triggered,  recommendations  given  to  a  growing number  of  confused  and  distrusting  members  of  the  public.  While  many  other  countries  paused their  AstraZeneca vaccination  programs  to  investigate  safety  issues  related  to  potentially  fatal blood clots,  Canadians  were  told the AstraZeneca vaccine  was safe for  some  population segments [ Page  9  of  37 ] and vaccinations with the AstraZeneca vaccine were initiated. After other countries practiced due diligence and confirmed that blood clotting was an adverse event associated with this vaccine, Canadians were then told that it was too unsafe for those under 55 years of age. Then Canadians between 40-55 years of age were told it was safe enough for them to use. Several weeks later, the message changed again, and the current messaging is that it is too unsafe to use as a first does in much of Canada. Millions of Canadians who received a single dose of this vaccine have since been wondering what to do. This highlights why the scientific method exists and why it should not be over-ridden by zealous public health officials. Safety testing should never be cut short. In many parts of Canada, the AstraZeneca vaccine is generally being used only for second doses for individuals who have had a first dose of the AstraZeneca vaccine and do not wish to have a second dose of another vaccine. The vaccine is irrelevant to Canadian children, youth, and young adults of child-bearing age, as it was never authorized for use in these population groups. 

2. Janssen vaccine (Ad26.COV2.S): 

This vaccine is made by Johnson & Johnson. Like the AstraZeneca vaccine, the Johnson & Johnson vaccine uses an adenovirus, albeit a different one. The way this vaccine works is similar to the AstraZeneca vaccine. After injection, cells infected with the adenovirus start to manufacture a spike protein that is very similar to that of the SARS-CoV-2 spike protein. There has been some public acknowledgement that this vaccine might also be associated with blood clots, and Health Canada has noted in their website notices of April 26th 2021 to healthcare professionals that “[v]ery rare cases of thrombosis in combination with thrombocytopenia, in some cases accompanied by bleeding, have been observed following vaccination with Janssen COVID-19 vaccine. A causal relationship with the vaccine is considered plausible.” In considering the request for the Janssen vaccine to be Authorized Under Interim Order, Health Canada yet again acknowledged that “[i]mportant limitations of the data at this time include the lack of information on the long-term safety and effectiveness of the vaccine, interactions with other vaccines, and the lack of data in sub-populations (e.g. pregnant/breastfeeding women, pediatric population <18 years of age, patients with autoimmune or inflammatory disorders, immunocompromised patients and frail patients with comorbidities).” At the timing of writing this article, this vaccine has not been authorized for use in Canadian children, youth, and young adults of child-bearing age. 

3. Pfizer BioNTech vaccine (BNT162b2): 

This vaccine relies on technology that, prior to the COVID-19 pandemic, was not previously used in humans, except in small-scale clinical trials (such as a clinical trial of a rabies mRNA vaccine)4. The backbone of the Pfizer BioNTech vaccine is a lipid nanoparticle (a small bubble of fat). Inside the nanoparticle is a ‘messenger ribonucleic acid’ (mRNA). This is a tiny piece of genetic material that provides the instructions for a cell to manufacture a modified version of the SARS-CoV-2 spike protein. When these nanoparticles are injected into the body, they are [Page  10  of  37] intended to  fuse  with cells  with  which  they  come  into  contact.  When  this  happens,  the  mRNA migrates  from the  lipid  nanoparticle  and  into  the  cell  and  the  cell  ‘machinery’  then  uses  this mRNA  ‘blueprint’  to  manufacture  the  modified  version of  the  SARS-CoV-2  spike  protein.  This protein is  the  ‘thing  1’  that provides  one  of the  two  signals  required  for  the  immune  system to become  activated.  It  is  not  entirely  clear  what  provides  ‘thing  2’.  However,  mRNA vaccines promote inflammation that can  cause  injury to  normal tissue.  When  cells are  injured, they  release ‘danger  signals’.  This  might  be  what  is  providing  the  second signal  (‘thing  2’)  needed  to  induce  an immune response.   

Pfizer’s  vaccine  has  been  associated  with  anaphylactic  reactions  in  a  small subset  of individuals.  These  are  serious  allergic  reactions  that  can  be  life-threatening.  At the  time  of  writing this  guide,  the  Pfizer  vaccine  is  the  only  one  that has  received Authorization  under  Interim Order  for  Canadian  children  and  adolescents  12  to  15  years  of  age.  In  its  decision-making process,  Health  Canada  declared;  “Health  Canada has  conducted a  rigorous  scientific  review  of the  available  medical  evidence  to  assess  the  safety  of  the  Pfizer-BioNTech  COVID-19 vaccine.  No major safety  concerns  have  been  identified  in  the  data  that we  reviewed“  [emphasis  added]. Health  Canada  also  acknowledged  that “One  limitation  of  the  data  at  this  time  is  the  lack  of information  on  the  long-term  safety  and  efficacy  of  the  vaccine.  The  identified  limitations  are managed through labelling  and  the  Risk  Management  Plan.  The  Phase  3  Study  is  ongoing  and  will continue  to  collect  information on the  long-term  safety  and efficacy  of  the  vaccine.  There  are post-authorization  commitments  for  monitoring  the  long-term  safety  and efficacy  of PfizerBioNTech  COVID-19  vaccine.”  Specifically  related  to  the  authorization  for  adolescents  12  to  15 years  of  age,  “Health  Canada  declared,  Health  Canada  has  placed  terms  and  conditions  on  this authorization  requiring  Pfizer-BioNTech  to  continue  providing  information  to  Health  Canada  on the  safety,  efficacy  and  quality  of  the  vaccine  in  this  younger  age  group  to  ensure  its  benefits continue  to  be  demonstrated  once  it  is  on  the  market.”    

4.  Moderna vaccine  (mRNA  1273  SARS-CoV-2): 

The  Moderna  vaccine  also  is  an  mRNA-based  vaccine  and,  therefore,  works  the  same  way  as Pfizer’s  COVID-19  vaccine.  This  vaccine  has  also  been  associated  with  anaphylactic  reactions  in  a small subset  of  individuals.  On  June  7th  2021,  Moderna  had  filed an application  to  extend  the Authorization  under  an  Interim Order  to  adolescents  aged 12  to  17  years.  At the  time  of writing this  guide,  Health Canada  had  not  issued  its  decision. 

None of Canada’s  COVID-19  vaccines  can,  in  and  of  themselves,  infect  people  with  the  SARSCoV-2 virus,  per  se.  Rather,  these  vaccines  trigger  the  cells  in  a  person’s  own  body to manufacture one  of  the  proteins  that is  a  component  part  of  SARS-CoV-2,  and  all  the  vaccines  cause  a  person to  make  a  modified  version  of  the  spike  protein from  SARS-CoV-2.  The  AstraZeneca vaccine contains  the  manufacturing  blueprint for  the  exact  same  spike  protein  as  is  found  on  SARS-CoV2.  In  contrast,  the  other  three  vaccines  in  use  in  Canada  contain  the  manufacturing  blueprint for a modified  version  that  scientists  refer  to  as  the  ‘prefusion-stabilized  spike’.  All four vaccines  are [Page  11  of  37] designed to use the body’s internal capability to manufacture the spike protein to then trigger the body’s immune response. What are the known serious adverse events that are associated with COVID-19 vaccines? Using the United States Vaccine Adverse Event Reporting System (U.S. VAERS), as of June 11th 2021, the 20 most frequently reported adverse events (presented in descending order) were headache, pyrexia (fever), fatigue, chills, pain, nausea, dizziness, pain in extremity, injection site pain, myalgia (muscle pain), injection site erythema (redness), arthralgia (joint stiffness), pruritus (itching), rash, dyspnoea (difficulty breathing), injection site swelling, injection site pruritus (itching), vomiting, and asthenia (weakness). These side effects are common side effects and are similar to those reported in the Phase 3 clinical trials. Although these symptoms can be severe in some people and can result in an inability to perform daily activities, they usually subside over one to three days. The mRNA vaccines (Pfizer and Moderna) can, in rare cases, cause anaphylaxis. Since this can be potentially fatal, these vaccines are often administered in special vaccine clinics that are staffed with personnel trained to treat people who may experience anaphylactic shock. The reason this problem is thought to be limited to the mRNA vaccines is likely due to a pre-existing allergy against something present in the liposome nanoparticles (the small bubble of fat) that are the part of the vaccine that envelopes the mRNA material. One of the liposome ingredients that might be the culprit is polyethylene glycol (PEG). Based on data from international regulatory agencies (such as the Norwegian Medicines Agency), the adenovirus-based vaccines (i.e. AstraZeneca and Janssen) have been implicated in causing a very serious type of blood clot (a cerebral venous sinus thrombosis) that is simultaneously associated with a low platelet count and bleeding following vaccination. This is one of the reasons the AstraZeneca vaccine has largely been suspended for use in Canada, with the exception of use for second doses in those who received the AstraZeneca as their first dose and wish to stay with the same vaccine brand. Are there other serious adverse events associated with COVID-19 vaccines that are being investigated? Side effects that are rarer, including those that are serious or life-threatening, are still being learned about. For example, the United States Centers for Disease Control and Prevention (CDC) announced, only on June 11th 2021, that an Emergency Meeting would be held on June 18th 2021 to discuss reports of inflammation of the heart resulting from use of the Pfizer and Moderna vaccines in young males 16 to 24 years of age. It has been approximately six months since the vaccines were authorized under an emergency use in the U.S., and only now is this [Page  12  of  37 ] association  being  recognized.  There  are  many  reasons  why  it  is  difficult to  identify  serious  side effects  that  are  rare  or  that  occur  only  over a longer period  of  time  or in  a specific  population group  or  sex.  These  difficulties  are  described  below.

 Difficulty  #1:  Too Soon  to Tell  for  Sure 

Pfizer  and Moderna  each  initiated  large,  Phase  3  trials  that  were  randomized,  doubleblind,  and  placebo-controlled.  The  placebo  group  is  important  because  it  serves  as  the reference group and helps  in  the  interpretation  of  side  effects  experienced  in  the  vaccine  group.  At the time that the  vaccines  were  granted emergency  use  authorization,  each  company  had  safety  and efficacy  data  for  an  average  of  only  two  months  following  the  administration  of  the  second vaccine  dose;  in  the  study  in adolescents,  most subjects  had safety  and  efficacy  data  for  either one  or  two  months.  According  to  the  original  protocols,  every  individual  in  the  study  is  supposed to  be  followed for  a  total  of  two  years  following  their  second  dose. 

Difficulty  #2:  Abandoning the  Control  Group 

The  vaccines  have  been  authorized  under  emergency  use  in  many  key  countries,  globally; and fear-based  pressures  imposed  by  public  health  agencies  to  vaccinate  everyone  has  triggered study  participants  to  want  to  know which  study  group  they  had been allocated  to,  so  that  those in the  placebo  group could be  vaccinated.  The  studies  have  therefore  been unblinded,  meaning there  is  no  longer  a  placebo  group. This means that a  rigorous  assessment  of safety  in  the  context of a  well-controlled  clinical study  is  no  longer possible,  and  there  must  be  increased  reliance  on vaccine  post-deployment, passive  surveillance  systems.  Of  course,  this,  itself,  is  challenging,  given that there  is  uncertainty  in both  the  numerator  (the  number  of vaccine-related adverse  events) and the  denominator  (the  number  that  is  typical  for  that event,  otherwise  referred  to  as  the “background incidence” of the  event).  Moreover, it is  extremely  difficult  to  prove  definitively  that an event is  caused  by  (and  not  just associated  with)  vaccination  when  using  passive  surveillance systems. 

Difficulty  #3:  Under-Reporting of  Adverse  Events 

The  problem  with  passive  adverse  event  reporting  systems,  which  is  the  type  of  system that  both  Canada and  the U.S.  are  relying  on,  is that there  is  a notorious  problem of  adverse  event under-reporting.  This  is  because  reporting  is  voluntary; people  may  be  unaware  there  are  ways to  report  adverse  events; people  are  often  discouraged  from  reporting  adverse  events;  people (including  attending  physicians)  assume  the  condition  is  not related  to  vaccination;  or  people may  not  be  able  to  report  their  adverse  events  (if  they  are  severely  disabled,  ill,  or  deceased). Most  disconcerting  is  the  situation,  as  we  see  in  Canada,  where  adverse  event  reports  attempted to  be  submitted  by  medical  professionals  are  pre-screened  and  sometimes  rejected  by  prescreening  authorities.  Consequently,  adverse  event  databases  can  easily  fail  to  identify  potential concerns,  or  underestimate  problems  to  an  unknown  degree  and are,  therefore,  not  a source  of [Page  13  of  37] accurate  numbers  to  calculate  true  risk.  For  example,  using  the  U.S.  VAERS,  it  was  estimated  that the  risk  of  anaphylaxis  was  4.7  per  million  for  the  Pfizer  vaccine  and  2.5  per million  for  the Moderna vaccine5;  however,  in  an  active  surveillance  study  of  64,900  healthcare  workers  who had  been  vaccinated,  the  rate  was  actually  216  per million5,  representing  a  potential  rate  of under-reporting  of 46-  to 86-fold.  Despite  these  limitations,  passive  surveillance  systems  are useful  for  identifying  potential  risks  that  could then be  investigated  in  properly  designed  safety studies. 

Difficulty  #4:  Lack  of  Global  Consistency  and Thoroughness  in Defining Events  of  Special  Interest 

Using the  U.S.  VAERS  and  similar  adverse  event  reporting  systems  around  the  world,  there  is continuous  monitoring  of  adverse  events  of  special  interest.  But  each  jurisdiction  is  left  to  their own  discretion  to  decide  which,  if  any,  particular  adverse  events  of  special interest  will  receive closer scrutiny.  For  example,  the  European  Medicines  Agency  has  compiled  a list  of  important medical  events  (IMEs)  which  are  always  to  be  classified  as  serious  (the  IME  list).  The  IMEs  that are  most  frequently  reported  following  COVID-19  vaccination  (in descending  order)  are: •  Fainting  (syncope) 

•  Blood clot(s)  in the  lungs 

•  Anaphylactic  reaction   

•  Deep vein thrombosis 

•  Pneumonia 

•  Low blood platelet  count  (thrombocytopenia) 

•  Blood clot(s)  or  bleeding  in  the  brain 

•  Hallucinations 

•  Cerebral stroke 

•  Loss of  consciousness

 Definitive  cause-and-effect relationships  for  these  events  have  not yet been established;  it is hoped  that with additional  surveillance  and time,  clarity  on  the  role  of  the  vaccines  in the  cause of these  events  will  be  better  understood.  In the  meantime,  given that the  spike  protein is biologically  active  and  there  are  mechanisms  that  could  potentially  explain  some  of  these  IMEs (discussed further  below),  there  is  good  reason  for  genuine  concern.   

Why weren’t  serious  adverse events  identified  before vaccines  were rolled  out? 

Problems  like  anaphylactic  shock  (a severe  allergic  reaction)  and  potentially  fatal  blood clots  were  not  identified  until  most of the  experimental COVID-19  vaccines  were  used  widely among  the  public5,  6.  Janssen’s  study  of  the  Johnson &  Johnson vaccine  did suggest  some propensity for blood  clotting.  As  for anaphylactic  reactions,  people  with  a history  of  allergies  were excluded  from  the  earlier  clinical trials.   [Page  14  of  37] 

Another reason why some problems were not identified earlier is because short-cuts were taken with  the  traditional approach  to  vaccine  research.  Specifically,  the  time  taken to  assess safety  was  too  short.  Instead  of  taking  the  usual  ~4-10  years  to  undergo  thorough  in vitro  (i.e., benchtop)  tests,  pre-clinical (i.e.,  animal)  studies,  and  then  sequential  clinical  testing  (i.e.,  human Phase  1,  2  and  3  trials),  COVID-19  vaccines  were  developed  and  assessed  for  safety  and  efficacy in  less  than  one  year.  This  meant  that  only  very  short-term  safety  scenarios  could be  evaluated. Of equal  concern,  the  number  of  people  that  were  evaluated in clinical  trials  was  too  small  to capture  rare  but  dangerous  side-effects.  This  is  unfortunate,  because  we  have  seen in Canada that rare  but serious  problems  can  lead  to  a vaccine  program  being  suspended.  Indeed,  in Canada,  a  risk  of  blood  clots  for  the  AstraZeneca vaccine  of  1  out  of  every  55,000  people vaccinated was deemed to  be too dangerous,  leading  to its use being halted.  Authorization under Interim  Order  for  COVID-19  vaccines  was  granted after  they  were  evaluated  for  a  short duration in  about  20,000  people.  This  means  these  studies  could,  at best,  detect  serious  side  effects  that would occur  in at least 1  out of every  20,000  people.  In other  words,  the  study  design included a test population that  was  too  small  to  identify  vaccines  that  may  be  too  dangerous  for Canadians.   

A clinical  trial  was  conducted  to  justify  using  the  Pfizer  vaccine  in  Canadian children  and adolescents;  was  it  flawed  as  well? 

Yes.  First,  it  was  far too  short  in  duration  to  have  any  chance  of  assessing  anything  other than short-term  harm.  Also,  in  light  of  the  information  provided  above,  one  needs  to  consider the  following:  only  1,131  adolescents  between the  ages  of  12  and 15  received the  vaccine  in this study.  This means  that  the  study  would have  only  been  able  to  detect a  serious  side  effect that occurs  in  1  out  of  every  1,131  adolescents  that  are  vaccinated;  but  a  1  in  55,000  risk  was  deemed to  be  too  dangerous  for  adults  for  whom  SARS-CoV-2  represents  a greater risk.  Furthermore, based on the  recent  observation  of  increased  risk  of  heart  inflammation  following  immunization with  either  the  Pfizer or  Moderna vaccine  in  young  males,  it  appears  serious  side  effects  may  be a  function  of  both age  and  sex.  In this  regard,  the  Pfizer  study  of only  1,131 subjects  provides even less  robust  data…enough to  detect a  serious  gender-differentiating  side  effect that  occurs in  one  out  of approximately  565  (i.e.,  1,131÷2)  males  vaccinated  and  one  out  of  approximately 565  females  vaccinated. 

But we  have  been told  that adolescents  and children can:  (a)  die  from  COVID-19,  (b)  suffer severe disease,  and  (c)  be asymptomatic  spreaders  of  SARS-CoV-2 and,  therefore,  kill  others. Don’t  these  risks  suggest that children,  youth,  and young  adults  of  child-bearing  age  should  be vaccinated? 

No,  they  don’t.  Let’s  break  this  down… [Page 15 of 37] 

(a) Deaths due to COVID-19 are extremely rare in young Canadians. In sixteen months 13 Canadians under the age of 20 have died of 266,852 with confirmed SARS-CoV-2 infection (data from the Government of Canada, as of June 11, 2021). Because many children have asymptomatic infections, the true denominator is likely greater. This loss of 13 lives is indeed a tragedy, but no more so than the ~2,266 Canadians under the age of 20 who die from other causes every 16 months. Basic cost-benefit analyses have been largely ignored during the pandemic. The fear of young people dying from SARS-CoV-2 has reached a point where we seem to have placed a much higher value on lives lost due to COVID-19 than lives lost to any other causes. 

 SARS-CoV-2 is not a problem of pandemic proportions for all demographics. Infection fatality rate (IFR) is a way to assess how dangerous a pathogen is. The IFR is calculated based on the number of people who die, from among the total number infected. Early in the declared COVID-19 pandemic, it was estimated that the IFR for SARS-CoV-2 was ~10-fold higher than for a serious outbreak of an influenza virus, or ~1%; maybe even as high as 10%. Indeed, the IFR for a bad ‘flu’ season can be as high as ~0.1%7. This IFR for influenza is calculated despite the high use of influenza vaccines that are commonly given seasonally to target populations. It is important to note that calculating an accurate IFR requires having accurate data for the denominator in the equation, which is the total number of people that have been infected. 

 Exacerbated by Canada’s lack of testing for evidence of seroconversion (i.e. when virusspecific antibodies are present in an individual, which indicates they were infected) against SARSCoV-2, it has been impossible to ascertain how many Canadians have been infected. However, as data have accumulated in countries that did practice due diligence in this area, the total number of infections that have occurred keeps getting re-adjusted to higher numbers. This is due to phenomena such as the large number of people who were infected but did not realize it, because they never became ill (they never developed COVID-19). As a result, the actual calculated IFR for SARS-CoV-2 has been steadily declining. Remarkably, as the data regarding total infections have become more accurate, the IFR for SARS-CoV-2 has most recently been estimated to be only ~0.15%8. It is likely that this IFR will drop even further as the extent of unnoticed infections is further elucidated.

 Indeed, a recent study found that ~90% of randomly tested healthy adults in British Columbia had evidence of natural immunity to SARS-CoV-29. This indicates that the denominator for determining the true IFR is likely substantially higher than previously appreciated, which would mean the IFR is less than 0.15%9. Further, this IFR includes the high-risk frail elderly, immunocompromised, smokers, highly obese people, and those with diabetes, pulmonary and cardiovascular disease. For Canadians who are outside of these high-risk demographics, the IFR would be much less than 0.15%, especially for children. Therefore, COVID-19 does not represent a substantial risk to children, youth, and young adults of child-bearing age10. [Page 16 of 37] 

(b)  Very  few  children  are  at  risk  of  developing  severe  COVID-19.  It  is  challenging  to  know  how small this  risk  is  because  public  health  officials  have  refused to  differentiate  the  nature  of  the ‘cases’  of  COVID-19  that have  been  reported.  Many  estimates  of children in hospital  with COVID19  include  children  who  were  admitted  for  other  reasons  but  had  tested  positive  with  SARS-CoV2.  The  reality  is  that  most  cases  in  children  and  adolescents  are  mild.  In  fact,  most  children do not  get  sick  at  all after  being  infected  with  SARS-CoV-2.  Children  have  a  lower  risk  of  developing disease,  especially  severe  forms,  compared  to  adults.  This  is  in  large  part  because  they  express in  their  lungs  and  airways  lower  concentrations  of the  “ACE2  receptor”,  a  protein  on  the  surface of various  cells  in  the  body  that  serves  as  a  point  of attachment  for  the  SARS-CoV2 spike  protein, and that when  “docked”  enables  entry  of  the  virus  into  the  cell  for  subsequent  replication  and spread  of  infection. 

(c)  Asymptomatic  transmission  of SARS-CoV-2  is  negligible.  The  definition of  an  asymptomatic individual  is  a  person who  is  known  to  be  infected  with a  microorganism but  fails  to  develop symptoms associated  with  a  disease.  Indeed,  we  are  all  ‘asymptomatic  carriers’  in  the  sense  that we  harbor  trillions  of  bacteria  and viruses  in  and on our  bodies.  However,  these  normal microbiomes  usually  do  not  cause  us  any  disease,  unless  we become  immunosuppressed  or unless  ‘safe’  microbes  get  transferred  to  anatomical locations  where  they  can  potentiate  disease (e.g.  fecal-to-oral transfer of  some  strains  of  Escherichia  coli).  So,  in  the  context of  SARS-CoV-2, an  asymptomatic  carrier  would  be  defined  as  an  individual  who  is  infected  with  the  virus  but fails to  develop  COVID-19.  A  colleague  of  mine  recently  asked  this  rhetorical  question:  “didn’t we previously  call  an  asymptomatic  person  ‘healthy’?” 

A study  of  the  prevalence  of  SARS-CoV-2  in  ~10  million  people  in  Wuhan,  China  found  no evidence  of  asymptomatic  transmission11.  In  the  United Kingdom,  the  ‘Scientific  Advisory  Group for  Emergencies’  recommended  that  “Prioritising  rapid  testing  of  symptomatic  people  is  likely  to have  a  greater  impact  on  identifying  positive  cases  and  reducing  transmission  than  frequent testing  of  asymptomatic  people  in  an  outbreak  area”12.  Consequently,  they  have  asked  their government to  change  their  testing  policy  by  moving  away  from  asymptomatic  testing.  The World  Health  Organization  notes  that  “Most  PCR  assays  are  indicated  as  an  aid  for  diagnosis, therefore,  health  care  providers  must consider  any  result  in  combination  with  timing  of  sampling, specimen  type,  assay  specifics,  clinical observations,  patient  history,  confirmed  status  of any contacts,  and  epidemiological  information”13. 

On its  own,  a  positive  result  on  a  PCR  test  to  detect SARS-CoV-2  is  insufficient  to  diagnose COVID-19,  yet this  has  become  routine  in  Canada.  In  addition  to  the  potential  for  false  positive tests,  true  positive  results  can also  be  obtained  from  genomes  of  SARS-CoV-2  particles  that are no  longer  infectious.  An  example  of  the  latter  would  be  an  individual  who  has  mounted  an effective  immune  response  and  may  have  remnant  replication-incompetent  viral particles  or partially  degraded  viral  genetic  material.  Indeed,  following  clearance  of  SARS-CoV-2 from  the body,  full and/or partial  genomes  of  SARS-CoV-2  can  remain  for up  to  several  weeks.  One  key reason  for  this  is  that  some  phagocytic  cells,  which  are  a  component  of  the  innate  immune [Page  17 of 37] system, can be long-lived. Phagocytosis, which is the engulfment and digestion of SARS-CoV-2, is a mechanism to kill and remove the virus from the body and to activate other white blood cells. As such, these can be a source of SARS-CoV-2 genetic material that could be amplified by a PCR test. However, this genetic material would not have the potential to cause COVID-19. Persistence of whole or partial genetic material that is not associated with infectious particles is well documented for a variety of other viruses, including measles14, Middle East Respiratory Syndrome (MERS)-coronavirus15, and other coronaviruses16. 

Too often, a positive PCR test for the presence of SARS-CoV-2, is being used, on its own, to define positive cases of COVID-19. However, the presence of a portion of the viral genome in an individual, on its own, does not necessarily equate with disease (i.e. COVID-19). To be declared a COVID-19 “case”, the infection would also have to be associated with expected signs such as antibody development and/or symptoms of disease. This is known as a clinical diagnosis and would be based on evaluation by a physician, in conjunction with test results. A gold-standard test for infectivity of a virus is a cell-based functional assay that determines the potential for the virus sample to cause cell death. However, such an assay is not in routine use in Canada. Absence of such an assay further confounds any meaningful interpretation of positive results in asymptomatic people. Drawing conclusions based solely on the results of laboratory tests, would take the diagnosis of diseases out of the hands of physicians, and place the onus for this on technicians employed by testing laboratories. Further confounding this issue is the fact that cases of COVID-19 can be claimed in the absence of confirming infection with SARS-CoV-2 (this is known as “ICD code U07.2 COVID-19, virus not identified”)17. Worse, the definition of a case of COVID19 has changed over time in Canada. Indeed, the government of Canada has stated the following on their website: “Previous versions of the COVID-19 case definition are available upon request. Please email COVID19Surveillance@canada.ca to request a copy or for more information.”17 

Positive PCR tests for SARS-CoV-2 in asymptomatic people are often based on what scientists call ‘high cycle numbers’ (also called “cycle thresholds” or Ct”). PCR tests that only yield a positive result at high cycle numbers brings into question whether or not these individuals actually harbor infectious viral particles. This, combined with the absence of a functional cellbased assay to prove infectivity, renders results of asymptomatic testing nearly impossible to interpret accurately. Indeed, the World Health Organization, agreeing with many health professionals around the world, has emphasized that spreading of SARS-CoV-2 by asymptomatic individuals is rare and an emphasis should be placed, therefore, on testing people with signs or symptoms of illness, not those who are apparently healthy18. Of particular concern is the high cycle numbers being used by labs in Ontario (i.e. up to 38 cycles being defined as ‘positive’ by Public Health Ontario19), to define a COVID-19 positive “case.” Several studies have been conducted to determine the highest number of PCR cycles at which live SARS-CoV-2 from a sample could be successfully cultured in cells. These studies suggest that appropriate cycle thresholds were 2520, 22-2721, and 3022 cycles. This indicates that tests with positive results obtained above 22-30 cycles are not clearly supportive of the presence of live (i.e. replicationcompetent) SARS-CoV-2. The logical conclusion is that it is erroneous to declare samples that test [Page 18 of 37] positive at high cycle numbers, especially those above 30, as being “positive” for infectious SARSCoV-2. Appendix 1 shows results of a published study that depicts the numbers of PCR cycles at which asymptomatic people tested positive for SARS-CoV-2 relative to that observed for people with symptomatic infections23. Remarkably, if the cut-off for positive test results was set to Ct values of 22 or 30 (i.e. the point beyond which samples fail to yield potentially infectious virus particles), the vast majority of ‘positive test results’ would be rendered negative. It was even concluded in a study by La Scola B, et al., that patients testing ‘positive’ at cycle numbers above 33 could likely be discharged from hospitals24. This means that an unknown number of positive cases reported in Ontario were likely not true positives of COVID-19. This is further supported by evidence that asymptomatic people have detectable SARS-CoV-2-specific memory T immune cells after exposure to the virus, which would be inconsistent with a risk of them harboring and spreading the virus to others25. 

Importantly, false positive test results, which have a greater risk of happening among asymptomatic people, have been shown to have numerous negative consequences in terms of physical and mental health, and causes financial losses26. Testing of asymptomatic people for the presence of portions of the SARS-CoV-2 genome makes neither medical nor economic sense. Positive test results from asymptomatic individuals cannot be interpreted in a clinically meaningful way. Although asymptomatic transmission is theoretically possible, it is improbable that it is occurring in substantial numbers and does not represent a significant risk of causing COVID-19-related hospitalizations or deaths in others. 

For all the aforementioned reasons, it is wrong to label children as being asymptomatic spreaders of SARS-CoV-2 that will sicken and kill others. Indeed, as reported by L. T. Brandal et al., “under 14 year olds are not the drivers of SARS-CoV-2 transmission”27. A study in England concluded “SARS-CoV-2 infections and outbreaks were uncommon in educational settings”, with staff (adults), not students (children) being the primary source of infections28. 

Now that the reasons that were used to justify using an experimental COVID-19 vaccine in children have been put into a reasonable perspective, let’s continue talking about the vaccine technology. 

Why was the spike protein from SARS-CoV-2 chosen as a target for the immune system? 

(Electro micrograph of coronavirus)

The spike protein gives SARS-CoV-2 its ‘crown-like’ appearance, which means it looks like it has a ‘corona’. This protein allows the virus to attach to our cells and then infect them. If antibodies can bind to and ‘block’ all the spike proteins on the surface of the virus, then it could not infect our cells. Moreover, the binding of antibodies to even a part of the virus can tag it for attack by cells of our immune system. As such, COVID-19 [Page  19 of 37] vaccines currently being used in Canada instruct our cells to manufacture the spike protein in order to trigger our bodies to mount an immune response against this protein with the hope that the ensuing antibodies will get into our lungs and airways and block the virus, should we be infected in the future. What should we know about the SARS-CoV2 spike protein? Before we go any further with the story about COVID-19 vaccines, there is important information that you need to know about the spike protein from SARS-CoV-2. The spike protein from SARS-CoV-2 has the potential to damage cells in the body In cases of severe COVID-19, problems can extend well beyond pneumonia and the associated inflammation in the lungs. The disease can progress beyond the lungs and into other parts of the body. In severe infections, SARS-CoV-2 can cause damage to the cardiovascular system (i.e. heart and blood vessels). In fact, some have referred to severe COVID19 as largely being a vascular disease29, 30, 31. Blood clots, bleeding and/or damage to the heart have all been linked to severe COVID-19. Severe COVID-19 can also cause neurological problems (i.e. damage in the brain). A series of recent scientific publications provide some evidence that this damage throughout the body may not require an intact SARSCoV-2 particle. Instead, the spike protein from SARS-CoV-2 might be responsible for at least some of the damage that occurs in severe cases of COVID-1932. This is because there are many cells other than those in the lungs and airways that feature the receptor for the spike protein, known as the ACE2 receptor. Most notably, platelets and cells lining blood vessels can express high concentrations of this receptor. Importantly, autopsies performed on patients who died from severe COVID-19 revealed that free spike protein from SARS-CoV-2, not the intact virus, was responsible for substantial damage throughout the body. Notably, blood vessels in the skin, fat, and the brain were found to express high concentrations of the ACE2 receptor that the spike protein binds to. There was a lot of spike protein found in these tissues, with little to no evidence of the intact virus being present. Indeed, the authors of the study that described these autopsies concluded “COVID-19 represents a viral infection with limited sites of infectious virions but deadly sequelae due to the effective manner in which pseudovirions in the context of released viral proteins activate synergistic microvascular pathways of tissue destruction throughout the body.”33 In lay language, proteins like the spike protein, not the intact virus, appear to mediate [Page 20 of  37] much  of  the  damage  in  the  body  in  people  who  suffer  from  severe COVID-19.  When the  spike protein binds  to  these  receptors,  there  are  several  events  that  can  take  place: 1.  Proteins  (called  ‘complement  proteins’)  that are  part  of  our  innate  immune  system  can get  activated,  causing  inflammation  that  can  damage  or destroy  the  cells  lining  blood vessels  and/or  platelets34.  Platelets  that  are  required  for clotting  of  blood  also  express ACE2  receptors  that can  bind  with spike  protein  with  dire  consequences.  Damage  and destruction of platelets  can cause  their  numbers  to  go  down (a  condition  known as "thrombocytopenia"),  and if  platelet counts  get  too  low  and  blood  vessels  are  damaged, bleeding  cannot  be  stopped.  Therefore,  the  spike  protein  can  potentiate  bleeding. 2.  Binding  of the  spike  protein to  platelets  can  also  cause  the  platelets  to  become activated35.  Activated  platelets  tend  to  clump,  which can  lead  to  the  formation  of clots. There  is  evidence  that  the  spike  protein  can  interact  with  other  proteins  in  the  blood  to promote  clotting36.  As such,  the  spike  protein  can promote  blood clotting. 3.  Spike  proteins  binding  to  the  cells  that line  our  blood vessels  can  cause  these  cells  to express  proteins  (known  as  ‘caspases’)  that  can  cause  the  cells  to  die33.  This  is  similar  to findings  from  the  2002-2004  SARS outbreak  where  the  spike  protein  from the  original SARS-CoV could cause cells  to die  when  it  was  being  manufactured  inside  of them37.  Dying cells  that have  been  manufacturing  the  vaccine-encoded spike  protein  would  release free spike  protein or  portions  thereof. 4.  Spike proteins binding to the cells  that  line  our  blood vessels  can  cause  these  cells  to  overproduce  cell-signalling  cytokines  that can  potentially  contribute  to  dangerous  ‘cytokine storms’  (overly  robust  and  severe  inflammation)33, 38. Of additional  concern  is  the  knowledge  that  the  spike  protein  is  capable  of  dissociating  into two  parts  and  these  smaller  subunits  (S1  and  S2)  can cross  the  blood-brain  barrier  where  they can  potentially  cause  damage  in  the  brain39.  Indeed,  people  who  have died  from  severe COVID19  with  neurological  signs  were  found  to  have  the  spike  proteins  but not the  intact virus  in  their brains40.  These  neurological  signs  could  be  seen  in laboratory  studies  when  spike  proteins  were injected into  the  blood  of mice. 

Conclusion:  The  spike  protein,  if it gets  into  circulation,  has  the  potential  to  cause  damage  to  the cardiovascular system and  other  tissues. [Page 21 of 37] 

Back to the vaccines

 Now that there is a clear understanding that the spike protein from SARS-CoV-2 is a dangerous toxin when it gets into the blood and is distributed throughout the body, we can continue with the story about COVID-19 vaccines. 

Evidence that mRNA-based COVID-19 vaccines can get distributed throughout the body 

When the COVID-19 vaccines were designed, it was not appreciated that the spike protein could potentially damage cells in the body. As a consequence, administration of the current COVID-19 vaccines can put people at risk of damaging their cells, especially if expression of the spike protein is not limited to the vaccine injection site. An assumption was made with these vaccines that has proven to be incorrect. The assumption was that mRNA vaccines, which are a new technology, would behave the same as traditional vaccines. It was thought by many that mRNA vaccines would stay at the injection site and the only other place they would go is to the draining lymph nodes in the immediate vicinity of the injection site. More specifically, it was thought that cells of the immune system would come to the site of injection and create pieces of the virus and take these pieces to the lymph nodes where they would be shown to B and T cells (i.e., B and T lymphocytes). The B and T cells would then get activated, multiply to large numbers (this is why lymph nodes swell when a person is mounting an immune response) and then head out into the body to search for the pathogen. Notably, B cells are the source of antibodies. Unfortunately, researchers have come to learn that the mRNA vaccines do not stay in the shoulder muscle. In fact, they have the potential to spread far and wide throughout the body via the blood. Obviously, this is a very serious conclusion to draw, so let’s walk through the solid scientific evidence that demonstrates this potential for biodistribution. 

A report that Pfizer provided to the Japanese government (see Appendix 2) was published as reference #25 in an article41 published in BMJ that can be found at this link. In section 2.6.5.5B of the report to the Japanese government there is a table containing lipid nanoparticle biodistribution data. This table shows where their surrogate “vaccine” (i.e. represented in the laboratory test by little bubbles of surrogate fat containing an analytical detection marker) ended up in the body of immunized rats, used in the laboratory as surrogates for humans. A portion of the table is reproduced below. Please review the data so you can get the full picture. I would like to highlight some observations. First, as shown in the blue rectangle that I added to the table, a lot of the surrogate vaccine dose remained at the injection site, as one would expect. Remarkably, however, most of the vaccine dose had gone elsewhere. The right side of the table (shown in the report to the Japanese government but not below) shows that 50-75% of the vaccine dose failed to remain the site of injection. The big question is, where did it go? Looking at the other tissues shows some of the places it went and accumulated. The red rectangle shows that the surrogate vaccine was circulating in the blood. There is also evidence that a substantial amount of the vaccine went to places like the spleen (green rectangle), liver (brown rectangle), ovaries (yellow rectangle), [Page  22  of  37]adrenal glands (purple rectangle), and bone marrow (orange rectangle). The vaccine went to other places as well, such as testes, lungs, intestines, kidneys, thyroid gland, pituitary gland, uterus, etc. The surrogate vaccine tested in a laboratory setting was widely distributed throughout the laboratory animals’ bodies. 

Based on the results of this biodistribution test, further tests should have been required in order to assess the impacts on more tissues and for a longer time before the vaccine was authorized for use, especially in growing children, adolescents, and young adults of child-bearing age. The vaccine manufacturer, researchers and regulatory authorities alike should have also looked more comprehensively at the potential for the test animals to shed the vaccine by assessing saliva, urine, and feces. Note that there was evidence of some trafficking of the vaccine to the salivary gland and bladder, which indicates there is potential for some degree of shedding of the vaccine from the body. Further, the biodistribution of the spike protein that is created by the body after vaccination should be carefully mapped. Studies such as these should be performed in at least two animal models, with one of these not being a rodent model since rodents have levels of ACE2 receptor binding affinity that is far less than that of humans and may, as a result, underestimate the impact of spike protein on humans. There should also have been an evaluation of where the vaccine and the spike protein were going in humans in a very limited Phase 1 clinical safety trial. This may not have mattered as much if the protein encoded by the mRNA was inert, although the risks of autoimmunity with the deposition of the lipid nanomaterials at different organs are certainly worthy of consideration. But now that we know the spike protein encoded by the mRNA has [Page 23 of  37] its own biological activities of concern, there is even greater potential for damage to organs and tissues arising from circulating vaccine material.

 Although not as detailed as the data in the report to the Japanese government, Pfizer’s report to the European Medicines Agency states similar findings regarding the broad distribution of their vaccine platform throughout the body. The report is in Appendix 3. Of great concern is the following excerpt from section 2.3.2 on page 45: “No traditional pharmacokinetic or biodistribution studies have been performed with the [Pfizer-BioNTech] vaccine candidate BNT162b2”. If this is the first time this vaccine technology platform has been rolled out for wide distribution to humans, and if the Japanese biodistribution data showed evidence of spread of the surrogate vaccine material, one must ask why was this experimental vaccine allowed to be used in people without it having undergone a crucial biodistribution study first? This would have told us where the vaccine was going in the body before its use in people. 

Supporting the need to address uncertainties and concerns regarding the biodistribution of the vaccine and the resulting spike protein is a peer-reviewed scientific paper that has just been accepted for publication. It describes a study in which 13 healthcare workers were assessed for the presence of the spike protein in their blood after receiving Moderna’s vaccine (an mRNA vaccine with essentially identical platform technology as the Pfizer-BioNTech vaccine). Notably, the spike protein, (or the portion of it that binds to ACE2 receptor), could be found in the circulation in 3 out of the 13 people (and in 11 out of the 13 people), respectively42. The spike protein could be detected in the blood up to two weeks post-vaccination in most individuals and at 28 days post-vaccination in one individual. Some may argue that the concentration of the protein was low in most of the people studied. However, a protein circulating at a low concentration for up to two or more weeks could accumulate on cells over time as the blood constantly perfuses (i.e., flows through) bodily tissues. Further, the biodistribution studies in the appendices suggest the spike protein could potentially be concentrated in many tissues that would not be evident by looking in blood alone. The possibility also exists that there were spike proteins already bound to ACE2 on the cells lining the blood vessels, but this was not investigated. Regardless, low concentrations of the spike protein in circulation would be expected in this small scale study. High concentrations of a protein that can cause damage to blood vessels in a large number of people would not be consistent with a low incidence of severe adverse events. Remember, the AstraZeneca vaccination program was suspended in Canada due to a 1:55,000 incidence of blood clots. If spike proteins in blood were responsible for a severe side-effect, one would expect to see high concentrations of this protein in only one out of many thousands of people; a phenomenon that would likely not be detected in an analysis of only 13 people. Clearly, more work is needed here to assess the biodistribution of spike proteins in the human body after vaccination. 

In a pre-print article (note: this means the paper has not yet undergone independent scientific peer review), there are data that indicate mRNA can even be detected in breast milk post-vaccination. This aspect of the study was downplayed but provides proof-of-principle that [Page  24  of  37] this can happen. Knowing what we now know, it would not be surprising to have the spike protein in the breast milk of some lactating women if they were to be vaccinated. Proteins circulating in the blood usually get concentrated in breast milk. Notably, there have been some adverse events reported of infants experiencing bleeding in their gastrointestinal tracts after suckling from mothers who had received a COVID-19 vaccine. Here are some examples from the U.S. VAERS (I haven’t checked for more since May 2021): Serious Adverse Events Related to Breastfeeding After Receiving a COVID-19 Vaccine • VAERS ID #945282; a 32-year-old mother had her 2-month-old breastfeeding daughter die 7 days after the mother had received the Pfizer-BioNTech vaccine • VAERS ID #949926; a 34-year-old mother had her 4-month-old breastfeeding boy pass blood and mucous in the stools starting 2 days after the mother had received the Moderna vaccine • VAERS ID #992676; a 30-year-old mother had her 2-month-old breastfeeding boy experience anorexia, spitting up, discoloured bloody feces, vomiting of blood, ulceration of the stomach, and bleeding in the gastrointestinal tract starting 2 days after the mother had received the Moderna vaccine There were also other types of adverse events in infants associated with breastfeeding from mothers who had recently received a COVID-19 vaccine. For the sake of brevity, I have listed the VAERS ID #s here; anyone can look them up in the publicly available VAERS database. • VAERS ID #s: 903355, 911226, 913968, 913971, 918972, 921052, 927664, 936865, 939409, 974519, 978085, 978485, 984448 (mother) - 984602 (infant), 1049482, 1105816, 1168901, 1171284 There is also a pre-print article that describes how an adenovirus-based vaccine can result in spike proteins damaging the vascular system. These types of vaccines are currently not being given to children in Canada. The mechanism is different from the mRNA-based vaccines, but the outcome is similar. The authors of this paper have coined an interesting term to describe the effect of a COVID-19 vaccine causing the same damage to the body that SARS-CoV-2 does; they called it “vaccine-induced COVID-19 mimicry syndrome”. It turns out that the suggested wide distribution of mRNA vaccines throughout the body has a historical precedent, such as for immunizing against influenza for example43. However, many people do not realize that lipid nanoparticles were not designed to function as vaccines. They were designed to serve as gene therapies or carry drug cargo throughout the body44, including into the brain where attempts could be made to treat diseases such as Alzheimer’s disease, Parkinson’s disease, and brain cancers. Of substantial concern is the use of PEG, which has been associated with anaphylactic shock in some people after receiving a mRNA vaccine. PEG was added to lipid nanoparticles in the early days of drug development to promote much wider distribution throughout the body. Specifically, when PEG is added to lipid nanoparticles, it helps [Page  25  of  37] the  particles  avoid  being  consumed  by  cells throughout  the  body,  especially  cells  of  the immune  system,  that  would  limit  the distribution of the  mRNA  cargo45,  46.  Indeed, addition of  PEG  to  lipid  nanoparticles  was  hailed as  a  breakthrough  because  “This  effect is substantially  greater  than that  observed previously  with  conventional liposomes  and  is associated  with  a  more  than  5-fold prolongation  of  liposome  circulation  time  in blood”45.  In  retrospect,  it  seems  that  another mistake  may  have  been  made  in  the  rush  to  get  these  vaccines  into  people:  Arguably,  the  PEG component should have  been removed from the  lipid  nanoparticle  formulation.  This  likely  would have  resulted  in  lipid  nanoparticles  with  a  greater  tendency  to  remain at  the  injection site  and be picked up  by  the  very  cells  of  the  immune  system  that we  want  to  induce  an immune  response. 

 https://healthengine.com.au/info/blood-function-composition

 Conclusion:  The  assumption that  COVID-19  vaccines  remain  at  the  injection  site  (i.e.  the  shoulder muscle)  is  not  borne  by  the  evidence.  Laboratory  studies  have  shown that  the  vaccine  itself,  and the  spike  protein  that  it  encodes,  may  get  into  the  blood,  and  be  distributed  widely  throughout the  body.  Vaccines  targeting  the  spike  protein  from SARS-CoV-2  were  designed  to  induce antibodies  that would bind to  this  protein  to  prevent  the  virus  from  being  able  to  infect our bodies. The  spike  protein  was  supposed  to  be the  ‘first  thing’  that  a  vaccine must  provide;  a target for the  immune  system.  We  did  not  appreciate  the  potential  for  the  spike  protein  alone  to  cause damage to  cells  in  the  body.  We  now  understand  that  the  current  COVID-19  mRNA  vaccines  have the  potential  to  be  distributed  throughout the  body,  thereby  potentially  and  inadvertently inoculating  many  tissues  with a  protein that  is  possibly  harmful.  If  unknown  damage  is  being caused  in  some  organs,  this  might not be  clearly  evident  until  years  after vaccination.  The  data presented here  do  not provide  proof of  long-term harm.  However,  it  provides  the  rationale  for asking  a  number of safety  questions.  These  questions  should  be  thoroughly  investigated in safety studies  prior  to  using  COVID-19  vaccines  in  children,  adolescents,  and  young  adults  of  childbearing  age. 

A concern  beyond  circulating  spike  proteins:  the  potential  for  induction  of  autoimmunity 

Some  scientists  have  proposed that  the  spike  protein  from  SARS-CoV-2  might  have portions  that are  very  similar  to  proteins  in  our  own  bodies47.  If  true,  inducing  immunity  against the  spike  protein could  theoretically  promote  autoimmune  disorders.  Indeed,  two  researchers found  there was  cross-reactivity  between  antibodies  induced against  the  spike  protein  and several  ‘self’  proteins48.  This  led  to  the  recommendation  almost  one  year  ago  to  avoid  targeting the  entire  spike  protein  in vaccines  and  instead  target  only  portions  of  the  protein  that are  not [Page 26 of 37] similar to  proteins  in  our  own  bodies.  Unfortunately,  autoimmune  diseases  can  be  insidious  and take  years  for  symptoms  to  become  apparent. 

The  broad distribution  of an  mRNA  vaccine  throughout  the  body  implicates  other mechanisms  that  could  lead  to  autoimmune  disease.  First,  the  mRNA vaccines  promote  robust inflammation.  This  is  why  many  people  have  sore  shoulders  after  being  immunized.  Promotion of inflammation in critical  tissues,  such as  the  ovaries,  after  being  seeded  with the  vaccine  could have  dire  consequences.  Tissues  like  the  ovaries  are  not  supposed  to  become  inflamed.  This  is because  inflammation  causes  a  lot of bystander  damage  to  normal  tissues,  which  is  unwanted in an organ designed  for  reproduction.  Also,  the  vaccine-encoded  spike  protein is  designed  to remain  anchored  on the  surface  of  the  cell  that  has  manufactured it.  If  antibodies  are  present, such as  would  be  the  case  several  days  after  vaccination  or  natural  infection,  they  could  bind  to the  spike  proteins  on  cells  throughout  our  body,  resulting  in  their  destruction.  Let’s  take  the ovaries,  again,  as  a  theoretical  scenario.  If  they  were  to  undergo  any  type  of  tissue  destruction, there  is  the  possibility  of  proteins  being  released  that  the  immune  system  has  never  seen before. This  is  because  our  immune  systems  learn  to  tolerate  ‘self’  at  a very  young  age.  However,  organs like  the  ovaries  and  testes  start  to  express  new  proteins  during  puberty  that  the  immune  system has  not  been tolerized  against.  If  these  get  released  due  to  tissue  damage,  this  could  provide  the same  two  signals  that  a  vaccine  needs  to  activate  the  immune  system;  signal  1  (target  protein) and  signal  2  (damage-associated  danger  signals).  This could  result in an autoimmune  response against the  organ.  In this  example  (ovaries),  such  damage  might  not  become  apparent  until years later  when attempting  to  have  a  baby.  This  is  speculation  but  is  based on  a  huge  body  of  scientific literature  looking  at  how  autoimmune  diseases  get  started.  Notably,  this  could  potentially happen in any  of the  tissues  seeded  with the  vaccine  if  they  start  to  express  the  spike  protein. This  is  certainly  worthy  of  investigation before  the  mass  vaccination  of  children,  adolescents,  and young  adults  of child-bearing  age. 

Even  the  fact that  the  current COVID-19  vaccines  cause  muscle  cells  in  the  shoulder  to express  the  spike  protein,  is  a  potential  problem.  This  could  potentially  result in immune responses  being  mounted against muscle  tissue.  This  is  of  particular  concern,  because  Israel  has started to  suspect a  link  between COVID-19  vaccines  and  inflammation  in  the  heart  muscle  (a condition  known  as  myocarditis).  Indeed,  this  potential  link  is  being  actively  investigated  by  the European Medicines Agency,  as  well as  by  the  U.S. CDC.  Again,  with  these  kinds  of  concerns  being raised  in  the  global  community,  one  must  wonder  why  these  vaccines  are  pushed  so  hard  upon Canadian  youth  who  are  not  at  high  risk  of  severe  COVID-19.  It will  be  a  tragedy  if  we  repeat something  similar to  or  even worse  than  the  AstraZeneca  vaccine  fiasco  with our  young  people. 

Why doesn’t  everyone  who  gets  vaccinated  experience a  severe side-effect?

 The  spike  protein likely  does  not get into  circulation  in  every  person.  Indeed,  in  the  study of  13  people  vaccinated with the  Moderna  vaccine,  ten  had no  evidence  of the  spike  protein and [Page  27 of 37] two  had no  evidence  of  the  S1  subunit (a  fragment of  the  spike  protein)  in  their blood42.    Also,  it is  important  to  remember that  following  vaccination,  people  manufacture  the  spike  protein in their  own cells.  The  amount  and quality  of  mRNA  in each dose  of the  vaccine  can  vary  from batch to  batch.  The  stability  of  the  mRNA  is  also  dependent on  its  handling  as  it is  very  temperature sensitive.  So  different  people  will  receive  different  amounts  of  the  active  mRNA.  People  that receive  the  same  amount of  mRNA can produce different amounts of the spike protein depending on how metabolically  active  their  cells  are.  And  there  are  likely  numerous  other  factors,  including body  size,  etc.  All  of  this  could  contribute  to  substantial variability  in  the  concentration of spike proteins  that  a  person produces.  Notably,  a  standard  vaccine  injection  might be  expected to  have a different  impact  in  a  75-pound youth than  in  a  200-pound adult.  The  adverse  events  that  we know  about  seem relatively  rare.  Some  adverse  events  may  go  undetected.  For  example, knowing that the  spike  protein  gets  into  circulation and knowing  that it can  kill  platelets,  it would not  be  surprising  if most  people  have  some  loss  of  platelets  after getting  vaccinated.  Also, platelets  could  pick  up  the  mRNA  from  the  circulating  lipid  nanoparticles  and  then  display  the spike  protein  on  their  surface,  which  would  tag  them  for  destruction  by  the  ensuing  antibody response.  However,  platelet counts  are  not  being  routinely  monitored  after  people leave vaccination  clinics,  nor  have  the  vaccine  companies  publicly  released  their  data  showing  platelet counts  post-immunization.  Indeed,  in a  first-in-human study  of BNT162b1,  an earlier  prototype of  the  Pfizer  BioNTech  BNT162b2  vaccine  in  use  today,  that encoded  the  S1  subunit  of  the  spike protein  (which  contains  the  portion  of  the  spike  protein  that  binds  to  ACE2  receptors,  called  the receptor  binding  domain),  platelet  numbers  dropped  following  vaccination in both the  young  and older  adults  studied49.  Unfortunately,  clinical chemistry  and  haematology  values  following vaccination with the  BNT162b2  vaccine,  which is  the  one  currently  being  used to  vaccinate people,  were  not published  in  Pfizer’s  first-in-human study50.

 One  would be  unaware  if they  were  experiencing  a  loss  of  platelets  unless  their  platelet count  became  dangerously  low and  they  suffered  trauma  that would  cause  bleeding.  Of greater concern is  the  potential  for  serious  adverse  events  that we  may  not  know  about  for  quite  some time.  For example,  damage  to  the  ovaries  or  testicles  might  result in infertility  that would not become  apparent until  attempting  to  have  children.  The  oocytes  that are  present in  the  ovaries of newborn  baby  girls  represent  that female’s  life-long  fixed supply  of  oocytes,  which  are  the precursor  of  eggs.  These  oocytes  cannot reproduce  or  regenerate  if damaged or  destroyed. Damage to the uterus  could potentiate  spontaneous  abortions  or  miscarriages  during  pregnancy. The  fact  is,  there  is  a clearly  established  set  of  biological mechanisms  that raise  numerous legitimate  scientific  concerns  about  COVID-19  vaccines.  We  can’t  simply  hope  that  none  of  these concerns  end  up  being  realized.  Instead,  we  must  return to  following  the  scientific  method.  We should stop  the  roll-out of the  vaccination program  for  children,  youth and young  adults  of  childbearing  age,  and  ask  the  manufacturers  of  COVID-19 vaccines  to  take  the  time  to  conduct the proper  biodistribution  and safety  studies  to  answer  these  emerging  questions,  and  then  conduct an  accurate  re-evaluation  of  the  risk  of  COVID-19  versus  the  risks  associated  with  the experimental  COVID-19  vaccines. [Page 28 of  37] 

Is the Pfizer BioNTech vaccine losing its effectiveness? 

The stated purpose of vaccinating children, youth, and young adults of child-bearing age is to protect them from infection and reduce the risk of them transmitting SARS-CoV-2 to older adults. Therefore, it is important to note that the current COVID-19 vaccines fail to induce what we call ‘sterilizing immunity’. This means that vaccinated individuals can still get infected with SARS-CoV-2, potentially become ill, and potentially transmit the virus to others. This is why vaccinated individuals are not exempt from lockdown policies and are still encouraged to wear masks. Importantly, there is evidence that the ‘Delta variant’ of SARS-CoV-2 has changed enough to be able to start evading the immunity conferred by the Pfizer BioNTech vaccine51. Indeed, the earlier ‘South African’ variant rendered AstraZeneca’s vaccine only 10% effective52. With new variants on the horizon that will almost inevitably be able to bypass vaccine-induced immunity, this raises another question about whether the potential risks associated with the current vaccines are worth the minimal protection they will confer in the long-term to children, youth, and young adults of child-bearing age. 

The Pfizer BioNTech vaccine might cause an excessive number of serious side-effects in young Canadians 

As noted previously, Pfizer conducted an extremely small and very short-term clinical trial to test their vaccine in adolescents between the ages of 12-15 years. The results were reported in a fact sheet to the U.S. Food and Drug Administration. In this document, Pfizer defined severe adverse events as follows: 

• Death 

• A life-threatening adverse event 

• Inpatient hospitalization or prolongation of existing hospitalization 

• A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions 

• A congenital anomaly/birth defect 

• An important medical event that based on appropriate medical judgement may jeopardize the individual and may require medical or surgical intervention to prevent one of the outcomes listed above 

No deaths occurred in this small study, but Pfizer did note the following on page 27 of their fact sheet: “Senrious adverse events from Dose 1 through up to 30 days after Dose 2 in ongoing follow-up were reported by 0.4% of Pfizer-BioNTech COVID-19 Vaccine recipients and by 0.1% of placebo recipients.” Much larger numbers of adolescents would have to be studied to provide conclusive evidence, but these limited data suggest the risk of serious adverse events [Page 29 of 37] may have been 0.3% higher in the vaccinated group (not statistically significant in this small study). As discussed previously, adverse events of special interest are being monitored, although the thoroughness is questionable, and the transparency of such activity is spotty at best. For example, the European Medicines Agency has compiled a list of important medical events (IMEs) which are always to be classified as serious (the IME list). The IMEs that are most frequently reported following COVID-19 vaccination include (in descending order): • Fainting (syncope) • Blood clot in the lungs • Anaphylactic reaction • Deep vein thrombosis • Pneumonia • Low blood platelet count (thrombocytopenia) • Blood clots or bleeding in the brain • Hallucinations • Cerebral stroke • Loss of consciousness As the number of adolescents studied in the Pfizer trial was so small, it remains unclear whether adolescents also will experience these IMEs. It is not appropriate or ethical to experiment with youth, especially when their risk of severe COVID-19 is so low. 

A side  note  about blood  donations 

Although  not  directly  related  to  vaccinating children, adolescents, and young adults of child-bearing age, it is important to recognize that if the spike protein, which can cause substantial damage, gets into the blood after vaccination, this could have implications for donating blood. It would be unwise to infuse a blood product into a potentially fragile patient if it is contaminated with the spike protein. Worse, Pfizer’s own biodistribution data demonstrate that the vaccine itself, not the spike protein, circulates in blood for at least two days postimmunization. Intravenous infusion of mRNA that can produce the spike protein in cells of the recipient should not be infused into patients who require blood. Remember, not only is there a risk of free-floating and cell-expressed spike proteins, but the lipid nanoparticles themselves can promote anaphylactic shock in a small subset of people. Of concern, Canadian Blood Services currently states their approval for receiving blood donations from people who have received a COVID-19 vaccine, without deferral. This is based on assumptions made using traditional vaccines that remain at the injection site, not novel mRNA-based vaccines that have been shown in laboratory studies to travel throughout the body. This practice should be halted immediately until it can be determined how long it takes for the lipid nanoparticles, and spike proteins to disappear from the blood. Canadian Blood Services should then recommend deferring blood [Page 30 of 37] donations  from vaccinated  individuals  until  there  is  no  risk  of  transferring  lipid  nanoparticles, mRNA,  or spike  proteins.  The  small-scale  study  that has  looked  at  circulating  levels  of  spike proteins  suggests  that  it  might  not  be  safe  to  use  blood  products  from  a  vaccinated  individual  for at  least  4-5  weeks  post-immunization42. In  the  United Kingdom, the National Health  Service  Blood and  Transplant  has  recommended  that,  “COVID-19  vaccine  –  please  wait  7  full  days  from  your vaccine  before  donating  on  the  8th  day.  If  you  had  side  effects  from  the  vaccine  such  as headache,  temperature,  aches,  and  chills,  please  wait  28  days  from  your recovery”.  It  is unfortunate  that there  is  not international  collaboration  with regards  to  recommendations  for the  donation  of  blood  after  COVID-19  vaccination. 

What  options  are  we  left with if  we  pause  the  vaccination  roll-out  for  children,  adolescents, and young  adults  of  child-bearing age?

 Canada abandoned  the  original goal of  learning  to  live  with  SARS-CoV-2  after  the  initial 23-week  ‘flattening  of  the  curve’  of  daily  cases  of  COVID-19  early  in  the  year  2020.  A massive amount of  scientific  data  about  COVID-19  has  been compiled over  the  past 16  months.  But we have  not  been following  the  accumulating  science.  It can  direct us  towards  what one  of my colleagues  likes  to  call a  ‘rapid  but soft  landing.’  The  purpose  of this  guide  was  not  to  build a detailed  exit  strategy.  However,  I  have  also  been  closely  following  the  scientific  literature  about strategies  that  can  be  used  to  effectively  treat  COVID-19,  especially  if  they  are  implemented  as an  early  out-patient,  at-home  treatment  before  the  disease  progresses  to  a  level  requiring hospitalization.  Some,  but  all  too  few  Canadian  physicians,  are  aware  of,  or  using,  these  early  at home  treatment  protocols.  These  protocols  include  safe  and  highly  effective  drugs  like ivermectin,  fluvoxamine,  budesonide,  zinc,  melatonin,  vitamin  C,  vitamin  D,  and many  others. Several cocktails  of  approved  drugs  have  proven  to  be  particularly  effective  and  are  described  in a variety  of  websites  including  TreatEarly.org,  c19protocols.com,  and  FLCCC.net.  There  is  now  an avalanche  of  scientific  data in  support  of these  treatment options,  but  this  digresses  into  an  area beyond the  scope  of this  guide.  Unfortunately,  the  use  of these  effective  therapies  has  never been  promoted in Canada  even  though  they  could have  prevented a  lot  of sickness  and  deaths and would  have  reduced the  burden  on  intensive  care  units.  Many  people  do  not realize  that  the Interim  Order or  emergency  use  authorization of  COVID-19  vaccines  would  have  been contraindicated  if  there  was  acknowledgement  of effective  treatment  strategies.  This  rule  is  in place  to  protect Canadians  from  being  experimented  on  when  there  are  viable  alternatives  that are  known to  be  safe.  However,  it  is  never too  late  to  do  the  right  thing.  Canada  panicked and threw out pandemic  preparedness  plans  at  all  its  public  institutions.  Sometimes  poor  decisions occur  when being  made  during  a  crisis  and in the  absence  of established guidelines.  It is  time  to move on.  By  promoting  widespread use  of  effective  treatments  for  COVID-19,  Canada  can  safely narrow  its  experimental vaccination  program  and  call for  the  science  to  catch up  before subjecting  our children,  adolescents,  and  young  adults  of child-bearing  age  to  potential  harm. [Page  31 of 37] 

Concluding  remarks

 Looking  back  through  this  report,  it is  clear  that  there  are  too  many  warning  signals  to ignore.  Each  individual  signal  may  present  a  particular  level  of  uncertainty,  but  when  all  the signals  are  considered together,  the  alert is  deafening  and  must  not  be  ignored.  We  must  halt the  vaccination  of  our children,  adolescents,  and  young  adults  of  child-bearing  age.  This  can  be done  safely  and expeditiously  because:   

•  The risk of severe  and  potentially  lethal COVID-19  in these  specific  populations  is  so  low  that we need  to  be  very  certain  that  risks  associated  with  mass  vaccination  are  not  higher; 

•  Asymptomatic members of this population are  not a  substantial  risk  for  passing  COVID-19  to others;  and 

•  There are  effective  early-treatment  strategies  and considerations  for  the  very  few  children, adolescents,  and young  adults  of  child-bearing  age  who  may  be  at  risk  of  developing  severe COVID-19. 

Our younger generations of Canadians are our treasures and our future. Let’s not put their futures  at unnecessary  risk  by  forcing  upon  them experimental vaccines  that present  newly identified and still-to-be-clarified  dangers.  Proof-of-principle  now  exists  to  demonstrate  the current  crop  of  vaccines  may  be  dangerous.  This  risk,  no  matter  how  theoretical,  must  be  further investigated  and all  concerns  put  to  rest  prior  to  the  vaccination  of  our  youth.  It’s  time  to  sort out  the  science  and  reduce  the  pressures  on  parents  and  their  children  so  they  can  make  truly informed  decisions.  It  is  time  to  pass  the  torch  from the  pharmaceutical companies  and hand  it to  the leaders  and innovators  among  our  community  of physicians  and  researchers  who  have  the skills,  knowledge  and  experience  to  optimize  excellent treatment  strategies  encompassing repurposed drugs  that  can  be  deployed to  reduce the future  casualties  of this  war  against  COVID19. 

What to  do  next? 

If interested in  obtaining  more  information  relevant  to  COVID-19,  please  go  to  the Canadian  COVID  Care  Alliance  (CCCA)  website  at  https://www.canadiancovidcarealliance.org/. There  is  an option  to  join  an  e-mail  list  if you are  interested in receiving  news  from  the  CCCA. 

An  example  of  the expertise  represented  within  CCCA’s  membership  and  their  balanced scientific  messaging  with  an  emphasis  on  charting  a  safe  but  rapid  exit  from the  cycles  of lockdowns  can be  found here:  https://trialsitenews.com/covid-19-expert-panel-the-pathforward-for-canadians-trialsite-webinar/.  This  discussion panel  was  set-up after  the governments  of  Alberta,  Saskatchewan,  and  Ontario  failed  to  respond  to  invitations  to  engage scientists  and  physicians  in respectful  public  discussions  of the  scientific  knowledge  that  has accumulated about COVID-19.

 Interviews  that  include  one  of  the  original  inventors  of  mRNA  vaccine  technology  (Dr. Robert  Malone)  opining  on findings  described  in this  guide  can  be  found  here  and  here. [Page 32 of  37] 

References 

1. Dan, J.M. et al. Immunological memory to SARS-CoV-2 assessed for up to 8 months after infection. Science (New York, N.Y.) 371 (2021).

2. Tarke, A. et al. Negligible impact of SARS-CoV-2 variants on CD4 (+) and CD8 (+) T cell reactivity in COVID-19 exposed donors and vaccinees. bioRxiv (2021).

3. Majdoubi, A. et al. A majority of uninfected adults show preexisting antibody reactivity against SARS-CoV-2. JCI insight 6 (2021).

4. Pardi , N., Hogan, M.J., Porter, F.W. & Weissman, D. mRNA vaccines — a new era in vaccinology. Nature Reviews Drug Discovery 17, 261-279 (2018).

5. Blumenthal, K.G. et al. Acute Allergic Reactions to mRNA COVID-19 Vaccines. Jama 325, 15621565 (2021).

6. Selvaraj, G., Kaliamurthi, S., Peslherbe, G.H. & Wei, D.Q. Are the Allergic Reactions of COVID-19 Vaccines Caused by mRNA Constructs or Nanocarriers? Immunological Insights. Interdisciplinary sciences, computational life sciences 13, 344-347 (2021).

7. https://apps.who.int/iris/bitstream/handle/10665/331784/nCoVsitrep15Apr2020-eng.pdf.

8. Ioannidis, J.P.A. Reconciling estimates of global spread and infection fatality rates of COVID-19: An overview of systematic evaluations. European Journal of Clinical Investigation n/a, e13554.

9. Majdoubi, A. et al. A majority of uninfected adults show pre-existing antibody reactivity against SARS-CoV-2. JCI insight (2021).

10. Bhopal, S.S., Bagaria, J., Olabi, B. & Bhopal, R. Children and young people remain at low risk of COVID-19 mortality. The Lancet. Child & adolescent health 5, e12-e13 (2021).

11. Cao, S. et al. Post-lockdown SARS-CoV-2 nucleic acid screening in nearly ten million residents of Wuhan, China. Nature Communications 11, 5917 (2020).

 12. https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file /928699/S0740_Fifty-sixth_SAGE_meeting_on_Covid-19.pdf. 

13. https://www.who.int/news/item/20-01-2021-who-information-notice-for-ivd-users-2020-05

14. Lin, W.H., Kouyos, R.D., Adams, R.J., Grenfell, B.T. & Griffin, D.E. Prolonged persistence of measles virus RNA is characteristic of primary infection dynamics. Proc Natl Acad Sci U S A 109, 14989-14994 (2012).

15. Bin, S.Y. et al. Environmental Contamination and Viral Shedding in MERS Patients During MERSCoV Outbreak in South Korea. Clinical infectious diseases : an official publication of the Infectious Diseases Society of America 62, 755-760 (2016). 

16. Owusu, M. et al. Human coronaviruses associated with upper respiratory tract infections in three rural areas of Ghana. PloS one 9, e99782 (2014).

 [Page 33 of 37]

17. https://www.canada.ca/en/public-health/services/diseases/2019-novel-coronavirusinfection/health-professionals/national-case-definition.html. 

18. https://www.cnbc.com/2020/06/08/asymptomatic-coronavirus-patients-arent-spreading-newinfections-who-says.html. 

19. https://www.publichealthontario.ca/en/about/blog/2021/explained-covid19-pcr-testing-andcycle-thresholds.

20.  Bullard, J. et al. Predicting Infectious Severe Acute Respiratory Syndrome Coronavirus 2 From Diagnostic Samples. Clinical infectious diseases : an official publication of the Infectious Diseases Society of America 71, 2663-2666 (2020).

21.  Corman, V.M. et al. Detection of 2019 novel coronavirus (2019-nCoV) by real-time RT-PCR. Euro surveillance : bulletin Europeen sur les maladies transmissibles = European communicable disease bulletin 25 (2020).

22.  Jansen, R.R. et al. Frequent detection of respiratory viruses without symptoms: toward defining clinically relevant cutoff values. Journal of clinical microbiology 49, 2631-2636 (2011). 

23. Lee, S. et al. Clinical Course and Molecular Viral Shedding Among Asymptomatic and Symptomatic Patients With SARS-CoV-2 Infection in a Community Treatment Center in the Republic of Korea. JAMA internal medicine 180, 1447-1452 (2020). 

24. La Scola, B. et al. Viral RNA load as determined by cell culture as a management tool for discharge of SARS-CoV-2 patients from infectious disease wards. European Journal of Clinical Microbiology & Infectious Diseases 39, 1059-1061 (2020).

25.  Wang, Z. et al. Exposure to SARS-CoV-2 generates T-cell memory in the absence of a detectable viral infection. Nature Communications 12, 1724 (2021). 

26. Surkova, E., Nikolayevskyy, V. & Drobniewski, F. False-positive COVID-19 results: hidden problems and costs. The Lancet. Respiratory medicine 8, 1167-1168 (2020).

27. Brandal, L.T. et al. Minimal transmission of SARS-CoV-2 from paediatric COVID-19 cases in primary schools, Norway, August to November 2020. Euro surveillance : bulletin Europeen sur les maladies transmissibles = European communicable disease bulletin 26 (2021).

28.  Ismail, S.A., Saliba, V., Lopez Bernal, J., Ramsay, M.E. & Ladhani, S.N. SARS-CoV-2 infection and transmission in educational settings: a prospective, cross-sectional analysis of infection clusters and outbreaks in England. The Lancet. Infectious diseases 21, 344-353 (2021). 

29. Lei, Y. et al. SARS-CoV-2 Spike Protein Impairs Endothelial Function via Downregulation of ACE 2. Circulation research 128, 1323-1326 (2021). 

30. Magro, C.M. et al. Severe COVID-19: A multifaceted viral vasculopathy syndrome. Annals of diagnostic pathology 50, 151645 (2021). 

31. Magro, C. et al. Complement associated microvascular injury and thrombosis in the pathogenesis of severe COVID-19 infection: A report of five cases. Translational Research 220, 113 (2020). 

[Page 34 of 37] 

32. Lei, Y. et al. SARS-CoV-2 Spike Protein Impairs Endothelial Function via Downregulation of ACE 2. Circulation research 128, 1323-1326 (2021).

33.  Magro, C.M. et al. Severe COVID-19: A multifaceted viral vasculopathy syndrome. Annals of diagnostic pathology 50, 151645 (2021). 

34. Yu, J. et al. Direct activation of the alternative complement pathway by SARS-CoV-2 spike proteins is blocked by factor D inhibition. Blood 136, 2080-2089 (2020). 

35. Zhang, S. et al. SARS-CoV-2 binds platelet ACE2 to enhance thrombosis in COVID-19. J Hematol Oncol 13, 120 (2020).

36.  Grobbelaar, L.M. et al. SARS-CoV-2 spike protein S1 induces fibrin(ogen) resistant to fibrinolysis: Implications for microclot formation in COVID-19. medRxiv, 2021.2003.2005.21252960 (2021). 

37. Chow, K.Y. et al. Adenovirus-mediated expression of the C-terminal domain of SARS-CoV spike protein is sufficient to induce apoptosis in Vero E6 cells. FEBS letters 579, 6699-6704 (2005). 

38. Hsu, A.C.-Y. et al. SARS-CoV-2 Spike protein promotes hyper-inflammatory response that can be ameliorated by Spike-antagonistic peptide and FDA-approved ER stress and MAP kinase inhibitors <em>in vitro</em>. bioRxiv, 2020.2009.2030.317818 (2020). 

39. Rhea, E.M. et al. The S1 protein of SARS-CoV-2 crosses the blood-brain barrier in mice. Nature neuroscience 24, 368-378 (2021). 

40. Nuovo, G.J. et al. Endothelial cell damage is the central part of COVID-19 and a mouse model induced by injection of the S1 subunit of the spike protein. Annals of diagnostic pathology 51, 151682 (2021). 

41. Doshi, P. Covid-19 vaccines: In the rush for regulatory approval, do we need more data? BMJ 373, n1244 (2021). 

42. Ogata, A.F. et al. Circulating SARS-CoV-2 Vaccine Antigen Detected in the Plasma of mRNA-1273 Vaccine Recipients. Clinical Infectious Diseases (2021). 

43. Bahl, K. et al. Preclinical and Clinical Demonstration of Immunogenicity by mRNA Vaccines against H10N8 and H7N9 Influenza Viruses. Molecular therapy : the journal of the American Society of Gene Therapy 25, 1316-1327 (2017). 

44. Puri, A. et al. Lipid-based nanoparticles as pharmaceutical drug carriers: from concepts to clinic. Critical reviews in therapeutic drug carrier systems 26, 523-580 (2009). 

45. Papahadjopoulos, D. et al. Sterically stabilized liposomes: improvements in pharmacokinetics and antitumor therapeutic efficacy. Proc Natl Acad Sci U S A 88, 11460-11464 (1991). 

46. Gabizon, A. & Martin, F. Polyethylene glycol-coated (pegylated) liposomal doxorubicin. Rationale for use in solid tumours. Drugs 54 Suppl 4, 15-21 (1997). 

47. Kanduc, D. & Shoenfeld, Y. Molecular mimicry between SARS-CoV-2 spike glycoprotein and mammalian proteomes: implications for the vaccine. Immunologic research 68, 310-313 (2020). 

[Page 35 of 37]

48. Vojdani, A. & Kharrazian, D. Potential antigenic cross-reactivity between SARS-CoV-2 and human tissue with a possible link to an increase in autoimmune diseases. Clinical immunology (Orlando, Fla.) 217, 108480 (2020). 

49. Li, J. et al. Safety and immunogenicity of the SARS-CoV-2 BNT162b1 mRNA vaccine in younger and older Chinese adults: a randomized, placebo-controlled, double-blind phase 1 study. Nature Medicine (2021). 

50. Polack, F.P. et al. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. The New England journal of medicine 383, 2603-2615 (2020). 

51. Wall, E.C. et al. Neutralising antibody activity against SARS-CoV-2 VOCs B.1.617.2 and B.1.351 by BNT162b2 vaccination. Lancet (London, England) (2021). 

52. Madhi, S.A. et al. Efficacy of the ChAdOx1 nCoV-19 Covid-19 Vaccine against the B.1.351 Variant. The New England journal of medicine 384, 1885-1898 (2021). 

[Page 36 of 37] 

Appendix 1  

Most ‘positive’ results for the SARS-CoV-2 PCR test are negative based on the gold standard virology assay.  Shown are graphs from Figure 2 of a paper published in the Journal of the American Medical Association (JAMA Intern Med. 2020; 180(11): 1447-1452. doi:10.1001/jamainternmed.2020.3862). The argument being made was that the frequency at which asymptomatic people tested positive for SARS-CoV-2 was like that observed for people with symptomatic infections. However, new cut-offs for a positive test result were placed at 22 (orange line) and 30 (red line) PCR cycles. These are the limits (depending on the laboratory) at which replication-competent SARS-CoV-2 can no longer be recovered from samples according to the gold standard functional virology assay. When this is done, it is apparent that most of the results would be negative (i.e. these samples would fail to transmit infectious SARS-CoV-2).   [Page 37 of 37]