June 15, 2021 ~ Canadian Covid Care Alliance ~ by Dr. Byram W. Bridle, PhD

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

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

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
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• 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.

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