Expert statement regarding Comirnaty—COVID-19-mRNA-Vaccine for children—-Michael Palmer MD, Sucharit Bhakdi MD, Stefan Hockertz PhD ————doctors4covidethics. This expert statement was submitted by Italian lawyer Renate Holzeisen in conjunction with a lawsuit that challenges the EU’s authorization of the use of Pfizer’s mRNA vaccine on children of 12 years and older. The arguments made here specifically reference the Pfizer vaccine, but they apply similarly to the Moderna mRNA vaccine, and many also apply to the adenovector-based AstraZeneca and Johnson & Johnson vaccines. Permission is hereby granted to freely share and distribute this document in unchanged form. SummaryThis expertise on the use of the Pfizer COVID-19 vaccine (Comirnaty, BNT162b2) in adolescents is divided into three sections, which will deal with the following questions, in order:

Chapter One

  1. Is vaccination of adolescents against COVID-19 necessary? 2. Is the Pfizer COVID-19 vaccine effective?
  2. Is the Pfizer COVID-19 vaccine safe?
    The arguments presented in Section 1 pertain to all COVID-19 vaccines, whereas those in Sections 2 and 3 apply specifically to the Pfizer vaccine.
    Section 1 will show that vaccination of adolescents COVID-19 is unnecessary, because
    • in this age group the disease is almost always mild and benign;
    • for the rare clinical cases that require it, treatment is readily available;
    • immunity to the disease is now widespread, due to prior infection with the virus (SARS-CoV-2) or with other coronavirus strains; and
    • asymptomatic adolescents will not transmit the disease to other individuals who might be at greater risk of infection.
    Section 2 will demonstrate that the claims of efficacy which Pfizer attaches to its vaccine— namely, 95% efficacy in adults, and 100% in adolescents—are
    • misleading,becausethesenumberspertaintorelative,notabsoluteefficacy,thelatter being on the order of only 1%;
    • specious, because they refer to an arbitrarily defined, clinically meaningless eval- uation endpoint, whereas no efficacy at all has been demonstrated against severe disease or mortality;
    • most likely altogether fraudulent.
  3. Section 3 will show that the safety profile of the Pfizer vaccine is catastrophically bad. It will be discussed that
    1

• Pfizer, the EMA, and the FDA have systematically neglected evidence from preclinical animal trials that clearly pointed to grave dangers of adverse events;
• thePfizervaccinehascausedthousandsofdeathswithinfivemonthsofitsintroduc- tion;
• The agencies that granted emergency use authorization for this vaccine committed grave errors and omissions in their assessments of known and possible health risks.
The only possible conclusion from this analysis is that the use of this vaccine in adoles- cents cannot be permitted, and that its ongoing use in any and all age groups ought to be stopped immediately.

1 Vaccination of adolescents against COVID-19 is unnecessary

1.1 What does the available evidence show? There are several lines of evidence that
show vaccination of adolescents against COVID-19 to be unnecessary.

1.1.1 ThecasefatalityrateofCOVID-19inthegeneralpopulationislow. Thevastma- jority of all persons infected with COVID-19 recovers after minor, often uncharacteristic illness. According to world-leading epidemiologist John Ioannidis [1, 2], the infection fa- tality rate of COVID-19 is on the order of 0.15% to 0.2% across all age groups, with a very strong bias towards old people, particularly those with co-morbidities. This rate does not exceed the range commonly observed with influenza, against which a vaccination of adolescents is not considered urgent or necessary.

1.1.2 COVID-19 has a particularly low prevalence and severity in adolescents. In the U.S. and as of April 2020, those younger than 18 years accounted for just 1.7% of all COVID-19 cases [3, 4]. Within this age group, the most severe cases were observed among very young infants [4]. This is consistent with the lack in infants of cross-immunity to COVID-19, which in other age groups is conferred by preceding exposure to regular respitory human coronaviruses (see Section 1.2.1). Among slightly older children, a peculiar multisystem inflammatory syndrome was observed in early 2020 [5]; conceivably, these patients, too, were still lacking cross-immunity.
Essentially no severe cases of COVID-19 were observed in those above 10 but below 18 years of age

[4]. This group accounted for just 1% of reported cases, almost all of which were very mild. Thus, adolescents are at particularly low risk of harm from COVID-19 infection. Vaccination of this age group is therefore unnecessary.

1.1.3 COVID-19 can be treated. Numerous experienced physicians have collaborated on establishing effective treatment guidelines for clinically manifest COVID-19 [6]. Treatment options are available both for the early stage of the disease, at which emphasis is placed on inhibiting viral replication, and for the later stage, at which anti-inflammatory treatment is paramount. Two drugs that have been used successfully at the early stage are hydroxychloroquine and ivermectin. Both drugs have been, and continue to be, in use against a variety of other diseases. Ivermectin, for example, is considered safe enough to be used not only for treating manifest scabies—a parasite infection of the skin that is unpleasant but not severe—but even prophylactically in asymptomatic contacts of scabies-infected persons [7].

Ivermectin is also widely used in the treatment of tropical parasitic diseases such as onchocerciasis (river blindness), and for this reason it is on the WHO’s list of essential medicines. Yet, with COVID-19, the WHO sees fit to warn against the use of this very same well-known and safe drug outside of clinical trials [8]. This policy cannot be rationally justified, and it has quite appropriately been overridden by national or regional health authorities and ignored by individual physicians worldwide.
The availability of effective treatment voids the rationale for the emergency use of vaccines on any and all age groups, including also adolescents.

1.1.4 Most people, particularly adolescents, are by now immune to SARS-CoV-2. Due to the many inherent flaws and shortcomings of the diagnostic methods in common use (see Section 1.2), it is impossible to accurately determine the proportions of those who have already been infected with SARS-CoV-2 and those who have not. However, there are indications that the proportion of those who have been infected and recovered is high:
• The incidence of multisystem inflammatory syndrome in children (see Section 1.1.2) peaked in early to mid 2020, and then receded, with some slight delay after the initial wave of the COVID-19 respiratory disease itself [9].
• Approximately 60% of randomly selected test persons from British Columbia have detectable antibodies against multiple SARS-CoV-2 proteins (personal communication by Stephen Pelech, University of British Columbia), indicating past infection with the virus—as opposed to vaccination, which would induce antibodies to only one (the spike) protein.
Past COVID-19 infection has been found to protect very reliably from reinfection [10], and strong specific humoral and cellular immunity is detected in almost all recovered individuals, and also in those who remained asymptomatic throughout the infection [11]. Thus, a large proportion of individuals in all age groups, including adolescents, already have specific, reliable immunity to COVID-19. As mentioned above, most of those who do not have such specific immunity nevertheless are protected from severe disease by cross- immunity [12, 13]. This immunity will be particularly effective in healthy adolescents and young adults. Individuals with specific immunity or sufficient cross-immunity cannot possibly derive any benefit from undergoing an experimental vaccination.

1.1.5 Asymptomatic transmission of COVID-19 is not real. An oft-cited rationale for vaccinating individuals who are not themselves at risk of severe disease is the need to induce “herd immunity:” the few who are at high risk should be protected by preventing the spread of the virus in the general population.

A subtext of this rationale is the idea of “asymptomatic spread”—persons who have been infected but who show no signs of it other than a positive PCR test are assumed to transmit this infection to other susceptible individuals. If we accept the idea of such asymptomatic spread, then preventative mass vaccination might indeed appear as the only means of reliable protection of those at risk.
It has, however, been unambiguously determined that such asymptomatic transmis- sion does not occur. In a large-scale study, which involved almost 10 million Chinese residents, no new infections could be traced to persons that had tested positive for SARS- CoV-2 by PCR, but who did not exhibit any other signs of infection [14].

This agrees with several studies that compared PCR to virus isolation in cell culture among patients with acute COVID-19 disease. In all cases, growth of the virus in cell culture ceased as symp- toms subsided, or very shortly thereafter, whereas PCR remained positive for weeks or months afterwards [15, 16]. It was accordingly proposed to use cell culture rather than PCR to assess infectiousness and to determine the duration of isolation [16].

These findings indicate that restricting contact of persons at risk with those who show, or very recently showed, symptoms of acute respiratory disease would be effective and sufficient as a protective measure. Indiscriminate mass vaccinations of persons who are not themselves at risk of severe disease are therefore not required to achieve such protection.

1.2 Missing evidence: use of inaccurate diagnostic methods. A key element that is lacking in the current discussion of the need for vaccination is a reliable diagnostic tool for determining who is or is not currently infected with SARS-CoV-2. The diagnostic procedure most widely used for this purpose is based on the polymerase chain reaction (PCR). The PCR is a very powerful and versatile method that lends itself to numerous ap- plications in molecular biology, and also in the laboratory diagnosis of viral infections. However, exactly because it is so powerful, PCR is very difficult to get right even at the best of times; it will yield accurate results only in the hands of highly trained and disci- plined personnel. The enormous scale on which the method has been deployed during the COVID-19 pandemic has meant that it was entrusted to untrained and insufficiently supervised personnel; in such circumstances, the mass manufacture of false-positive re- sults due to the cross-contamination of samples is a disaster waiting to happen (see for example [17]). While this alone already is reason for grave concern, the problems start even earlier—namely, with the design of the PCR tests and the guidelines used for their interpretation, which would lead to false positive results even in the hands of skilled and diligent workers.

The key conclusion from this section will be that the PCR tests which have been used throughout the pandemic, and which continue to be used, lack accuracy and specificity and cannot be relied on for diagnostic or epidemiological purposes. In order to ade- quately justify these conclusions, we must first consider the basics of the method in some detail.

1.2.1 Coronaviruses and SARS-CoV-2. Coronaviruses are a large family of enveloped, positive strand RNA viruses. In humans and a variety of animal species, they cause res- piratory tract infections that can range from mild to lethal in severity. The vast majority of coronavirus infections in humans cause mild illness (common cold), although in very young children, who lack immunity from previous exposure, respiratory disease can be more severe. Note that the same clinical picture is also caused by viruses from several other families, predominantly rhinoviruses. Three clinical syndromes—SARS, MERS, and COVID-19—are associated with specific coronavirus strains that have “emerged” only within the last 20 years.

The virus that causes COVID-19 is known as Severe acute respiratory syndrome coro- navirus 2 (SARS-CoV-2). The World Health Organization (WHO) declared the outbreak a Public Health Emergency of International Concern on January 30th, 2020, and a pandemic on March 11th, 2020. While it has been maintained that SARS-CoV-2 arose naturally in a species of bats [18], a thorough analysis of the genome sequences of SARS-CoV-2 and of related virus strains indicates unambiguously that the virus is in fact of artificial ori- gin [19–22]. Initially decried as a “conspiracy theory,” this explanation has recently and belatedly been gaining acceptance in the mainstream.

1.2.2 The polymerase chain reaction. The polymerase chain reaction (PCR) is a ver- satile method for the biochemical replication of deoxyribonucleic acid (DNA) in vitro. Immediately after its invention by Kary Mullis in the 1980s, PCR took the world of molec- ular biology by storm, finding application for creating DNA mutations, DNA sequencing, for shuffling and merging nucleic acids of different origin (recombinant DNA technol- ogy), and for the creation of novel nucleic acids or even whole genomes from scratch (“synthetic biology”). PCR also soon found its way into the field of diagnostic medical microbiology [23]. Particularly with respect to viral pathogens, PCR is now one of the mainstay diagnostic methods. Against this background, it is not surprising that PCR methods should also have been adopted in the laboratory diagnostics of SARS-CoV-2.

1.2.2.1 The principle. To understand how PCR works, it is best to start with a piece of double-stranded DNA (the well-known double helix). In such a molecule, each of the paired single strands consists of four different building blocks (nucleotides), which will here be referred to as A, C, G, and T for short. Within each single strand, these building blocks are arranged like pearls on a string; the biological activity and identity of the nucleic acid will be dictated by its characteristic nucleotide sequence.

In a DNA double helix, the two strands are held together by the proper pairing of the nucleotides, such that an A in one strand is always found opposite to a T in the other, and likewise C is always found opposite G. Thus, the nucleotide sequence of one strand implies that of the other—the two sequences are complementary.

The first step in PCR consists in the separation of the two strands, which can be ef- fected by heating the DNA sample past its “melting point.” Each strand can now be used as a template for synthesizing a new copy of its opposite strand. To this end, two short, synthetic single-stranded DNA molecules (“primers”) are added; their sequences are cho- sen such that one will bind to each of the DNA template strands, based on sequence complementarity. For this binding to occur, the temperature of the reaction must be lowered.

Once the primers have bound, each is extended by the repeated incorporation of free nucleotide precursors to one of its two free ends. This is accomplished using a thermostable DNA polymerase—a bacterial enzyme that synthesizes DNA. The extension is carried out at a temperature which is intermediate between those used for double strand separation and primer binding (“annealing”). After this step has extended each of the primers into a new DNA strand, we will have created two double-stranded DNA molecules from one. We can now repeat the process—separate the two double strands and convert them into four, then eight, and so on. After 10 cycles, the initial amount of double-stranded DNA will have increased by a factor of approximately one thousand, after 20 cycles by a million, and so on—amplification proceeds exponentially with the number of reaction cycles, until the reaction finally runs out of primers and/or nucleotide precursors.

1.2.2.2 PCR and RNA templates. While the above discussion referred to DNA only, PCR can also be used with RNA templates; this is important with SARS-CoV-2, since this virus has RNA rather than DNA as its genetic material. To this end, the RNA is first converted (“reversely transcribed”) into DNA, using a reverse transcriptase enzyme. The DNA copy of the viral RNA genome is referred to as complementary DNA (cDNA).

1.2.3 Potential pitfalls of PCR in diagnostic applications. We just saw that PCR allows us to take a very small sample of DNA and amplify it with extraordinary efficiency. How- ever, this very efficiency of amplification creates a number of problems that must be carefully addressed in order to make the result meaningful, particularly in a diagnostic context.

  1. If we use too high a number of repeated reaction cycles, minuscule amounts of nucleic acids will be detected that have no diagnostic significance.
  2. The various temperatures used in the reaction must be carefully calibrated, and they must match the length and nucleotide sequence of the two DNA primers. If in par-
    5

ticular the temperature for primer annealing is too low, then the primers may bind to the template DNA in a non-specific manner—in spite of one or more mismatched nucleotides—and DNA molecules other than the intended ones may be amplified. In the context of COVID diagnostics, this could mean that for example the nucleic acids of coronaviruses other than SARS-CoV-2 are amplified and mistaken for the latter.

  1. Apart from the temperature, other conditions must likewise be carefully calibrated in order to ensure specificity. These include in particular the concentrations of magne- sium ions and of free nucleotides; excessively high concentrations favour non-specific amplification.
    There is a further problem that results not from the efficiency of the amplification, but rather from a technical limitation: PCR is most efficient if the amplified DNA molecule is no more than several hundred nucleotides in length; however, a full-length coronavirus genome is approximately 30,000 nucleotides long. Successful amplification of a segment of several hundred nucleotides only thus does not prove that the template nucleic acid itself was indeed complete and intact, and therefore that it was part of an infectious virus particle.
    1.2.4 Technical precautions in diagnostic PCR. Non-specific or overly sensitive ampli- fication can be guarded against in a number of ways:
  2. All primers that are part of the same reaction mixture must be designed in such a manner that they anneal to their template DNA at the same temperature. As may be intuitively clear, a longer primer will begin to anneal to its template at a higher temperature than a shorter one; and since the bond which forms between C and G on opposite strands is tighter than that between A and T, the nucleotide composition of each primer must also be taken into account. If the primers are mismatched in this regard, then the more avidly binding primer will start to bind non-specifically when the temperature is low enough for allowing the other primer to bind specifically. The original Corman-Drosten PCR protocol [24] that was rapidly endorsed by the WHO has been criticized for exactly this mistake [25].
  3. Instead of amplifying only a single piece of the template DNA, one can simultaneously amplify several pieces, using the appropriate number of DNA primer pairs, and stipu- late that all pieces, or a suitable minimal number, must be successfully amplified for the test to evaluate as positive.
  4. One must keep track of the “cycle threshold” or Ct value for short, that is, the num- ber of amplification cycles that were necessary to produce a detectable amount of amplified product; the lower the number of cycles, the greater the initial amount of template nucleic acid that must have been present.
  5. Confirming the identity—the exact nucleotide sequence—of the nucleic acid mole- cules that were amplified. DNA sequencing has been feasible in diagnostic routine laboratories for a considerable time, and there is no good reason not to use it, partic- ularly when decisions pertaining to public health depend on these laboratory results.
    1.2.5 Real-time PCR. The third point above, and to a degree the fourth, can be ad- dressed using real-time PCR. In this method, the accumulation of amplified DNA is moni- tored as the reaction progresses, in real time, with product quantification after each cycle (quantitative PCR; qPCR for short). Real-time detection can be achieved by the inclusion of a third DNA primer, which binds to either of the template DNA strands, at a location between the two other primers which drive the DNA synthesis. Downstream of the binding of that third primer, a light signal will be emitted, and the intensity of this signal is proportional to the amount of amplified DNA present. Since binding of this primer, too, requires a complementary target sequence on the DNA template, this method does provide some confirmation of the nucleotide sequence of the target DNA.
  6. A second, simpler variety of real-time PCR uses a simple organic dye molecule that binds to double-stranded DNA. The dye displays weak background fluorescence that increases dramatically upon DNA binding. The measured fluorescence increase is then proportional to the total amount of amplified DNA; but since the dye binds regardless of DNA sequence, in this case the signal does not give evidence that the correct template DNA has been amplified.
  7. 1.2.6 Shortcomings of commercial COVID-19 PCR tests. Unfortunately, the number of amplification cycles (the Ct value) needed to find the genetic material in question is rarely included in the results sent to authorities, doctors and those tested. Most commercially available RT-qPCR tests set the limit of amplification cycles up to which an amplification signal should be considered positive at 35 or higher. Multiple studies have indicated that Ct values above 30 have a very low predictive value for positive virus cultures, and thus for infectiousness or the presence of acute disease [15, 26–28]. Considering that in many clinical trials—including the ones conducted by Pfizer (see later)—a “COVID-19 case”, or an “endpoint” amounts to no more than a positive PCR test, regardless of Ct value, in combination with one or a few non-specific symptoms of respiratory disease, the significance of the use of improperly high Ct cut-off values cannot be overstated. This systematic and widespread error alone has sufficed to gravely distort the diagnoses conferred on individual patients, as well as the epidemiology of the pandemic as a whole.
  8. Further systematic negligence concerns the verification of the identity of the ampli- fied DNA fragments. While Sanger DNA sequencing of such fragments, the gold standard, is feasible on a large scale in principle, it has not been routinely used in the ongoing mass PCR testing campaigns. The error is compounded by the very low number of independent PCR amplifications considered sufficient for a positive test—as few as two, or even only one have been considered sufficient in various jurisdictions—as well as by various other technical faults in the widely adopted and commercialized Corman-Drosten protocol, which have been discussed in detail elsewhere [25].
  9. In summary, a positive RT-qPCR test result cannot be accepted as proof that the per- son in question is currently infected and infectious—even if there is reasonable clinical plausibility of actual COVID-19 infection, as well as a significant community prevalence of the disease. Firstly, the RNA material containing the target sequences could very well be from nonviable/inactive virus; this is particularly likely if the patient in question has already recovered from the infection. Secondly, there needs to be a minimum amount of viable virus for onward transmission; but tests carried out with excessively high (yet unreported) Ct values will detect minuscule amounts of genetic material that pose no threat at all .

About the authors

Michael Palmer MD is Associate Professor in the Department of Chemistry at the University of Waterloo, Ontario, Canada. He studied Medicine and Medical Microbiology in Germany and has taught Biochemistry since 2001 in Canada. His focus is on Pharmacology, metabolism, biological membranes and computer programming, with an experimental research focus on bacterial toxins and antibiotics (Daptomycin). He has written a textbook on Biochemical Pharmacology.

Sucharit Bhakdi MD is Professor Emeritus of Medical Microbiology and Immunology and Former Chair at the Institute of Medical Microbiology and Hygiene, Johannes Gutenberg University of Mainz.

Stefan Hockertz is Professor of Toxicology and Pharmacology, a European registered Toxicologist and Specialist in Immunology and Immunotoxicology. He is CEO of tpi consult GmbH. 

All three are founding signatories of Doctors for Covid Ethics

One thought on “Expert statement regarding Comirnaty—COVID-19-mRNA-Vaccine for children—-Michael Palmer MD, Sucharit Bhakdi MD, Stefan Hockertz PhD ————doctors4covidethics. This expert statement was submitted by Italian lawyer Renate Holzeisen in conjunction with a lawsuit that challenges the EU’s authorization of the use of Pfizer’s mRNA vaccine on children of 12 years and older. The arguments made here specifically reference the Pfizer vaccine, but they apply similarly to the Moderna mRNA vaccine, and many also apply to the adenovector-based AstraZeneca and Johnson & Johnson vaccines. Permission is hereby granted to freely share and distribute this document in unchanged form. SummaryThis expertise on the use of the Pfizer COVID-19 vaccine (Comirnaty, BNT162b2) in adolescents is divided into three sections, which will deal with the following questions, in order:

  1. Is the PR against the vaccines lost now that Fox News is promoting the vaccines ? Only Tucker Carlson of Fox is now critical of CNN, and says any news media promoting vaccines is not news.
    I guess the battles will play out, but when 99% of those being hospitalized don’t have the jab, people take notice, and so it seems FOX has Flipped.
    Not to say that there are no serious side effects of the vaccines, but as to weighing the risks, the courts sometimes gets its right and sometimes not.
    Hindsight is 20/20, and we’ll need the hindsight, which may take a year or more.
    As to whether the RNA vaccines actually prevent the disease or just reduce symptoms, a July 6 th release of a study by Stanford says it does prevent the disease, and close to what Pfizer said, at least for the early variants, but their study did not cover the Delta as to efficacy. Case closed on that?
    Meanwhile I’m not for taking the mixing of Pfizer and Moderna. It may not kill me, but too much risk at present, for me. I’ll wait.
    Winston Adams

    Like

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