Expert opinion on Comirnaty (Pfizer) COVID-19 mRNA vaccine for children

dr Michael Palmer, Dr. Sucharit Bhakdi, Dr. Stephen Hockertz

This opinion was submitted to the European Court of Justice by Italian attorney Renate Holzeisen in connection with a lawsuit challenging the EU approval of Pfizer's mRNA vaccine for children aged 12 and over. The arguments put forward here relate specifically to Pfizer's vaccine, but similarly apply to Moderna's mRNA vaccine, and many also apply to AstraZeneca and Johnson & Johnson (Janssen) adenovirus-based vaccines.

In Section 1 It is shown that vaccinating adolescents against COVID-19 is unnecessary because

• in this age group the disease is almost always mild and benign;
• for the rare clinical cases that require treatment, it is readily available;
• immunity to the disease due to previous infection with the virus (SARS-CoV-2) or with other coronavirus strains is now widespread; and
• asymptomatic adolescents do not pass the disease on to others who may be at greater risk of infection.

In Section 2 shows that Pfizer's claimed effectiveness of its vaccine - 95% in adults and 100% in adolescents - is not true. For the following reasons:

• The figures are misleading because they refer to relative rather than absolute effectiveness, the latter being on the order of only 1%;
• They are flimsy because they relate to an arbitrarily defined, clinically meaningless assessment endpoint, while no efficacy against serious illness or mortality has been demonstrated;
• They are most likely fraudulent overall.

In Section 3 the safety profile of the Pfizer vaccine is shown to be catastrophically poor. It is discussed that

• Pfizer, the EMA, and the FDA systematically neglected evidence from preclinical animal studies that clearly indicated serious adverse event hazards;
• Pfizer's vaccine caused thousands of deaths within five months of its launch;
• The authorities that granted emergency approval for this vaccine made serious errors and omissions in assessing known and potential health risks.

The only possible conclusion from this analysis is that the use of this vaccine is prohibited in adolescents and that its continued use in all age groups should be stopped immediately.

 Most people, especially teenagers, are now immune to SARS-CoV-2.

Due to the many inherent errors and inadequacies of common diagnostic methods (see Section 1.2), it is impossible to accurately determine the proportion of those who have already become infected with SARS-CoV-2 and those who have not. However, there is evidence that the proportion of those who have been infected and have recovered is high:

About 60% of the randomly selected test subjects from British Columbia have detectable antibodies against several SARS-CoV-2 proteins (personal communication from Stephen Pelech, University of British Columbia), which indicates a previous infection with the virus - as opposed to a vaccination that would only raise antibodies against a single protein (the spike).

A previous COVID-19 infection has been shown to be very reliable in protecting against re-infection [10], and strong specific humoral and cellular immunity is demonstrated in almost all cured persons, including those who were asymptomatic throughout the infection remained [11].

• Thus, a large proportion of people of all ages, including adolescents, already have specific, reliable immunity to COVID-19. As mentioned earlier, most people who do not have such specific immunity are nonetheless protected from serious illness by cross-immunity [12, 13].
• This immunity will be especially effective in healthy adolescents and young adults. Individuals with specific immunity or adequate cross immunity cannot possibly benefit from experimental vaccination.

The asymptomatic transmission of COVID-19 is not real.

• A common reason for vaccinating people who are not at risk of developing serious illness is the need to create “herd immunity”: the few who are at high risk should be protected by preventing the spread of the Virus in the general population is prevented. Pfizer has consistently touted the 95% effectiveness of its vaccine, relying on the clinical studies that formed the basis for the emergency approvals granted by the FDA [29] and the European Union [30].
• In a recent study on adolescents [31] the claimed effectiveness was increased to no less than 100%. However, these claims are not to be taken at face value. Based on these numbers - 8/162 ≈ 5% - Pfizer claimed 95% effectiveness. Of course, this effectiveness is only one relative value - In absolute numbers, less than 1% of the placebo group contracted COVID-19, so that less than 1% of the vaccine group was protected from it.

A sudden onset of full immunity on day 12 after the first exposure to the antigen is not a biologically plausible result. Usually immunity develops more slowly and gradually. These two sets of data are impossible to reconcile; one of them must be wrong. Since, as discussed, the sudden onset of immunity in Figure 1B has no biological plausibility whatsoever, it is very likely that this data set was forged.

It is well known that vaccines can at best approximate, but not exceed, the immunity conferred by the corresponding natural infection. Very robust immunity after previous natural infection with SARS-CoV-2 has recently been reported [10]; In this study, not a single case of COVID-1359 was observed among 19 unvaccinated people. A robust immunity after infection is also confirmed by extensive laboratory tests [11].

The above analysis therefore confirms once again that the study results reported by Pfizer cannot be trusted. The fact that neither the FDA nor the EMA became aware of these inconsistencies does not inspire confidence in the thoroughness and integrity of their testing procedures.

• If, in a study of 40.000 people, the number of deaths is too low to determine any benefit from the vaccine, then there is certainly no “emergency” that would justify the very high risks and the now evident harm that comes with the extraordinary hasty adoption of this and other COVID-19 vaccines.

• In the cited study on adolescents [31] there were no deaths at all; and we have already pointed out that no cases of serious illness were reported in this study either. Even in this special age group, neither a useful benefit nor an emergency can be seen

The FDA report's verdict reads: "Additional evaluations are needed to assess the vaccine's effectiveness in preventing the long-term effects of COVID-19, including data from clinical trials and post-approval use of the vaccine." In other words, the clinical studies did not provide such evidence. There is no evidence that transmission is reduced, and the attempts were not even designed to prove or disprove such an effect.

The clinical studies conducted by Pfizer provided no evidence of any benefit of the vaccine in relation to clinically relevant endpoints. This applies to all age groups examined, especially also to young people.

• The clinical trials for Comirnaty (BNT162b2), as well as the other COVID-19 vaccines, have been completed in a very short period of time, which means that adequate precautions have not been taken to ensure safety. Animal experiments carried out before the start of the clinical trial, however, indicated severe toxicity. Unfortunately, this expectation has been more than confirmed in practice since the beginning of mass vaccination.

Since Comirnaty and other gene-based vaccines induce the synthesis of active, and therefore potentially toxic, spike protein, it is important to understand how this protein is distributed in the body. Toxicity could be limited if the vaccine, and hence the synthesis of the spike protein, were confined to the injection site in muscle tissue but outside the bloodstream. However, if the vaccine gets into the bloodstream, an expression of the spike protein in the blood vessels and toxicity due to the activation of blood clotting is to be expected.

The liver plays a central role in lipid and lipoprotein metabolism in general, while the adrenal glands and ovaries take up lipoproteins to make cholesterol, which they then convert into their respective steroid hormones. Such a role of lipoproteins in the transport and cellular uptake of lipid nanoparticles is indeed recognized [37]. It is therefore to be expected that other organs with a high lipoprotein uptake rate will be affected in a similar manner. These include in particular the placenta, which, like the ovaries, produces large amounts of steroid hormones (progesterone), and the mammary glands, which absorb cholesterol contained in lipoproteins and release it into breast milk.

• A high expression of spike protein in the ovaries carries the risk of considerable damage to this organ with possible consequences for female fertility. The uptake of the vaccine by the mammary cells opens up two potential avenues of toxicity to the breastfed child: first, the expression of the spike protein and its secretion into breast milk, and second, complete transfer of the vaccine into the milk.

In this context, we would like to point out that both the VAERS database and the EU register for adverse drug reactions (EudraVigilance) report on deaths in breastfed newborns after vaccinations of the mothers

• Contaminating DNA injected with the vaccine can insert itself into the host cell's genome and cause potentially harmful mutations. Bacterial DNA also non-specifically promotes inflammation.

• Within just five months of starting vaccinations, EudraVigilance recorded 12.886 deaths related to the COVID-19 vaccines, of which nearly half (6.306) were from the Pfizer vaccine. During the same period, VAERS recorded a total of 4 deaths, 406% of which were associated with the mRNA vaccines, with Pfizer accounting for 91% and Moderna for 44%.

The litany of diagnoses in both databases that indicate a pathological activation of blood clotting is almost endless - Heart attacks, strokes, thromboses in the brain and other organs, pulmonary embolism; but also thrombocytopenia and bleeding resulting from excessive consumption of platelets and coagulation factors in disseminated intravascular coagulation. These disease mechanisms caused many of the deaths summarized above; in other cases they have caused severe acute illnesses which in many cases are left with severe disabilities.

• Serious reactions also include seizures, other neurological symptoms, particularly those related to motor control, and severe systemic inflammation with damage to multiple organs. Here, too, long-term or even permanent residual damage is very likely in many of these patients.

Pfizer and EMA's reckless attitude towards the use of novel and previously untested chemicals as components of drugs or vaccines without extensive studies of toxicity, including genotoxicity, is completely unscientific and unacceptable. Overall, it is clear that the risk of ADE is recognized in theory, but not taken into account in practice. Given the numerous references to ADE in experimental SARS vaccines, this is completely irresponsible.

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