Chapter 2–Covid for Ethics Presentation On Vaccines For Children

2 The Pfizer COVID-19 vaccine lacks efficacy

2.1 What does the evidence show? Pfizer persistently touts the 95% efficacy of its vaccine, based on the clinical trials that formed the basis of the emergency approvals granted by the FDA [29] and the European Union [30]. In a more recent study on ado- lescents [31], the claimed efficacy has been raised to no less than 100%. However, these claims cannot be taken at face value.
7

2.1.1 Absolute vs. relative efficacy. In Pfizer/BioNTech’s first reported clinical trial, 43,548 participants underwent randomization, of whom 43,448 received injections. The experimental vaccine (BNT162b2) was administered to 21,720 persons, and 21,728 re- ceived placebo. Across both groups, a total of 170 COVID-19 “cases” was recorded, of which 162 occurred in the placebo group, whereas 8 cases were observed in the BNT162b2 group. Based on these figures—8/162 ≈ 5%—Pfizer proceeded to claim 95% effi- cacy. Clearly, however, this efficacy is only a relative value—in absolute terms, less than 1% of the placebo group developed COVID-19, and therefore less than 1% of the vaccine group was protected from it.

The situation is similar with the subsequent, smaller test carried out on 12-15 years old adolescents [31].

Here, the vaccine group comprised 1131 individuals, whereas the placebo group included 1129 persons. In the latter group, 16 individuals were subse- quently diagnosed with COVID-19, whereas no such cases occurred in the vaccine group. True to form, Pfizer/BioNTech converted this absolute efficacy of 1.4% to a relative one of 100%; only the latter value is highlighted in the abstract of the published study.

2.1.2 Negative impact of BNT162b2 on overall morbidity in adolescents. In the cited vaccine study on adolescents, a “case” of COVID-19 was determined as follows:

The definition of confirmed COVID-19 included the presence of ≥ 1 symptom (i.e., fever, new or increased cough, new or increased shortness of breath, chills, new or increased muscle pain, new loss of taste or smell, sore throat, diarrhea, vomiting) and being SARS-CoV-2 NAAT-positive [= PCR-positive] dur- ing, or within 4 days before or after, the symptomatic period (either at the central laboratory or at a local testing facility and using an acceptable test).

Thus, a single symptom from a laundry list of non-characteristic symptoms, plus a positive finding from an unreliable laboratory test (cf. Section 1.2.6), was deemed suffi- cient to establish the diagnosis. While the study goes on to list several clinical criteria of severe disease, it gives no indication that any test persons actually suffered any of those. It can therefore be assumed that very few non-severe, and no clinically severe cases of COVID-19 occurred in the entire test population.

In stark contrast to these numbers pertaining to the disease from which the vaccina- tion is supposed to protect, side effects from the vaccination were exceedingly common. Apart from injection site pain occurring in a high percentage of the vaccine group (79% to 86%), fatigue (60% to 66%) and headache (55% to 65%) abounded. Severe fatigue and headache were reported by several percent of the test persons. Severe headache, in par- ticular, may be associated with underlying thrombotic events (see Section 3.1.3.2). It is therefore clear that, if we consider both COVID-19 and vaccine adverse effects, overall morbidity was far greater in the vaccinated than in the placebo group.

2.1.3 Unlikely claims and contradictions in Pfizer’s evidence on efficacy. We saw above that the reported efficacy of Pfizer’s vaccine is very modest when expressed in absolute terms. Even this low efficacy, however, cannot be accepted at face value. This is apparent from the assessment reports prepared by the FDA [29] and the EMA [30].

2.1.3.1 Sudden onset of immunity on day 12 after the first injection. A key illustra- tion that occurs in both reports compares the cumulative incidence of COVID-19 among the vaccinated and the placebo group. This graph, which is shown as Figure 9 in the EMA report, is here reproduced in Figure 1B. Up to day 12 after the first injection, the cumu- lative incidences in the two groups track each other closely. After day 12, however, only
8

A
B
Figure 1 Reproduction of Figure 7 (A; neutralizing antibody titres on various days after the first injection) and of Figure 9 (B; cumulative incidence of COVID-19 among vaccinated and placebo groups) from the EMA assessment report [30]. Note the logarithmic y axis in B. See text for discussion.

the placebo group continues to accumulate further new cases at a steady pace, whereas the slope of the graph drops to almost zero in the vaccine group.

This remarkable observation suggests that immunity sets in very suddenly and uni- formly on day 12 exactly among the vaccinated. Since the second injection occurred 19 or more days after the first one, this would imply that one injection is enough to estab- lish full immunity. This conclusion, however, is not stated, and in fact Pfizer does not report any data at all on test persons who received one injection only.

A sudden onset of full immunity on day 12 after the first exposure to the antigen is not at all a biologically plausible outcome. Typically, immunity develops more slowly and gradually; and such a pattern is in fact reported for this very same vaccine (BNT162b2) in Figure 7 of the EMA report, reproduced here as Figure 1A. The figure shows the increase of neutralizing antibodies to SARS-CoV-2 as a function of time after the first injection of the vaccine.
9

Table 1 Subjects without evidence of infection in vaccine and placebo groups at various time points in the clinical trial. Data excerpted from Table 4 in [30]. See text for discussion.

No evidence of infection before dose 1
No evidence of infection prior to 14 days after dose 2

Difference (= infection between day 0 and day 14 after dose 2)
93.1% 85.6%
7.5%
93.0% 85.0%
8.0%

Vaccine Placebo

The induction of neutralizing antibodies is the declared purpose of the Pfizer vaccine. Generally speaking, antibodies are protein molecules produced by our immune system when it encounters antigens—macromolecules that do not occur within our own bodies. These antigens are often part of infectious microbes, including viruses. An antibody binds to a specific feature on the surface of its antigen; this feature is called the epitope of the antibody in question.

In the context of virus infections, antibodies can be neutralizing or non-neutralizing. A neutralizing antibody recognizes an epitope that is essential for the function of the virus, for example because this epitope must make contact to a receptor molecule on the surface of the host cell which the virus must enter in order to replicate. A non- neutralizing antibody simply happens to recognize a surface feature (epitope) that plays no essential role in the infectiousness of the virus.

Considering the foregoing, we should expect that the blood level of neutralizing an- tibodies should reflect the degree of clinical immunity to the virus. This is, however, not at all what we see in Figure 1A.

On day 21 after the first injection, that is, a full 9 days after the purported sudden onset of full clinical immunity, the amount of neutralizing antibodies in the blood has barely risen above the background level. The maximal level of neutralizing antibodies is observed only on day 28 after the first injection, at which time most test persons would already have had their second injection. The time course of cellular (T-cell) immunity was not reported, but in the absence of proof positive to the opposite it can be assumed to resemble that of the antibody response.

It is very difficult to reconcile the two contrasting observations of sudden onset of full clinical immunity on day 12, but neutralizing antibodies appearing only weeks later. Yet, neither the EMA reviewers nor those of the FDA appear to have been interested in the problem.

2.1.3.2 The Pfizer documentation contradicts itself on COVID-19 incidence after vac- cination. Table1liststhepercentagesofsubjectsinthevaccinegroupandtheplacebo group who showed no evidence of SARS-CoV-2 infection on day 0 (before the first dose) and on day 14 after the second dose, respectively. From the differences between the two time points, we can work out that 7.5% of the subjects in the vaccine group and 8% in the control group converted from negative to positive—that is, became infected—between the two time points.

According to [29], the second dose was administered approximately 21 days after the first, although all subjects who received it between days 19 and 42 after the first injection were included in the evaluation. If we take day 35 after the first injection as the approximate time point of the comparison, we see from Figure 1B that the cumulative incidence between day 0 and day 35 is more than twice higher in the placebo group than in the vaccine group; but from Table 1, we see that it is almost the same. Moreover, with both groups the numbers are substantially higher in the table than in the figure.
10

Table 2 Incidence of COVID-19 among subjects not previously infected but vaccinated, or pre- viously infected but not vaccinated. Data excerpted from Tables 6 and 7 in [29]. See text for discussion.
Vaccine
Placebo
Cases Incidence (%)
Total Cases 19965 9
18198 8
1767 1
Incidence (%)
0.044
Total
All subjects Initially negative
Previously infected
20172 169 18325 162

These two sets of data cannot possibly be reconciled; one must be false. Since, as discussed, the sudden onset of immunity implied by Figure 1B lacks any biological plau- sibility, it is most likely that it is this data set which was fabricated.

2.1.3.3 Pfizer’sdataimplythatthevaccineprotectsfromCOVIDmoreeffectivelythan does prior infection with the virus. We can also scrutinize Pfizer’s reported data in order to compare the immunity conferred by the vaccine to that induced by prior natural infection with the virus. The relevant data are summarized in Table 2.

The reported 8 cases of COVID-19 among vaccinated persons who had initially tested negative for the virus amount to an incidence of 0.044%. Pfizer also reports 7 cases among persons who had initially tested positive but were not vaccinated. Since this group is considerably smaller, those 7 cases translate into an almost ninefold higher incidence (0.38%).
I

t is common knowledge that vaccines will at best approach, but not surpass the im- munity conferred by the corresponding natural infection. Very robust immunity after prior natural infection with SARS-CoV-2 has recently been reported [10]; in that study, not a single case of COVID-19 was observed among 1359 individuals who had remained unvaccinated. Robust immunity after infection is also confirmed by comprehensive lab- oratory investigations [11]. Therefore, the above analysis corroborates yet again that the trial results reported by Pfizer cannot be trusted. That neither the FDA nor the EMA picked up on any of these inconsistencies does not instil confidence in the thoroughness and integrity of their review processes.

2.2 Whatevidenceislackingtomakethecase? Wehadalreadymentionedthespecious and contrived character of the endpoint used in Pfizer’s clinical trials—namely, the count- ing of a COVID-19 “case” based on nothing more than a positive PCR result, together with one or more items from a list of mostly uncharacteristic clinical symptoms. We must therefore ask if the vaccine provides any benefits that are more substantial than the claimed—but, as discussed above, most likely fabricated—reduction in the count of such trivial “cases.”

2.2.1 Prevention of severe disease and mortality. Page 48 of the FDA report sums up this question as follows: “A larger number of individuals at high risk of COVID-19 and higher attack rates would be needed to confirm efficacy of the vaccine against mortality.”
We note that this quote not only answers the posed question in the negative, but it also disposes of the entire pretext for granting emergency use authorization for this experimental vaccine. If in a study that involves 40,000 individuals the number of fatal outcomes is too small to permit the detection of any benefit of the vaccine, then surely no “emergency” exists that would justify the very grave risks, and meanwhile manifest no harm, associated with the extraordinarily rushed introduction of this and other COVID- 19 vaccines.

No fatalities at all occurred in the cited study on adolescents [31]; and we already noted that this study does not report any cases of severe disease either. Therefore, in this specific age group, too, neither a meaningful benefit nor an emergency are in evidence.

2.2.2 Effectiveness for those at high-risk of severe COVID-19. Here, the FDA report has this to say: “Although the proportion of participants at high risk of severe COVID- 19 is adequate for the overall evaluation of safety in the available follow-up period, the subset of certain groups such as immunocompromised individuals (e.g., those with HIV/AIDS) is too small to evaluate efficacy outcomes.”

The report shirks the question of risk reduction among those with more common predisposing conditions, such as for example chronic heart or lung disease. Naturally, the clinical study on adolescents [31] is completely barren in this regard. Overall, no evidence has been adduced by Pfizer’s clinical studies to prove clinical benefit in those at high risk of severe COVID-19.

2.2.3 Effectiveness against long-term effects of COVID-19 disease. The FDA report’s verdict is as follows: “Additional evaluations will be needed to assess the effect of the vaccine in preventing long-term effects of COVID-19, including data from clinical trials and from the vaccine’s use post authorization.” In other words, the clinical trials pro- vided no such evidence.

2.2.4 Reduction of transmission. On this topic, the FDA report offers only that “addi- tional evaluations including data from clinical trials and from vaccine use post-autho- rization will be needed to assess the effect of the vaccine in preventing virus shedding and transmission, in particular in individuals with asymptomatic infection.”
In plain language, there is no evidence that transmission is reduced, and in fact the trials were simply not even designed to prove or disprove such an effect.

2.2.5 Duration of protection. The FDA report correctly states (on page 46) that “as the interim and final analyses have a limited length of follow-up, it is not possible to assess sustained efficacy over a period longer than 2 months.” Even if we choose to believe that any efficacy at all has been demonstrated pertaining to the two-month study period, such a short duration of protection does not justify the risks associated with vaccination.

2.2.6 Inadequate efforts to determine the optimal dose. Figure 1A shows that the level of neutralizing antibodies is virtually the same with vaccine (mRNA) doses of 20μg and 30μg, respectively. This raises the question why the higher dose was employed throughout—and not only with adults, on whom these data were obtained, but also with children, whose lower body weights should suggest a dose reduction. Furthermore, the data in Figure 1B suggest that full immunity is induced already by the first dose; appli- cation of the second dose does not change the pace at which new cases accrue in the vaccine group, and therefore apparently has no effect on immunity. This would imply that a one-dose regimen should have been evaluated, which would reduce the overall likelihood of adverse events.

2.2.7 Summary. The clinical trials carried out by Pfizer contain no proof of any benefit conferred by the vaccine with respect to any clinically relevant endpoints. This applies to all tested age groups, and in particular also to adolescents.

One thought on “Chapter 2–Covid for Ethics Presentation On Vaccines For Children

  1. Here 95 % efficacy is suggested to be just 1%,
    However reduction in infections is 20 times less, on relative basis. For any product with an adverse outcome, a 20 times reduction is very high is it not?
    On doses of 25 or 30, it says why not go with the lower dose, given different body mass etc? Yet Moderna used 100 mg which may be way too high, and likely why not used for below age 18. Some studies now suggest Moderna can be effective at 25 mg
    Perhaps adjustment will be made with feedback of severe side effects. Many drugs this can take 10 to 20 years to see outcomes different from the trials, and many negative impacts. Maybe these will be fast tracked for fine tuning, and even where to avoid the vaccine. No doubt data is tilted some as to marketing. Trust but verify means don’t trust blindly, but try to stay informed of risks/benefits.
    For sure this little virus has created havoc and not the delta variant has 1000 times the viral load. WOW. Perhaps N99% masts should be the standard for indoors, especially in health facilities. Even outdoors this bugger likely will be some risk.

    But with Toronto and NY city smog bound with forest fire smoke from thousands of miles away, from apparent climate change, soon we will all need gas masks. These big fires create their own weather, generating dry lightning that starts more fires. Me thinks we are crossing more tipping points, losing trees by fire at a faster rate while adding more CO2. Bill Gates thinks the problem can be solved, I have serious doubt we can change fast enough. Of course many don’t see a problem, and I see Joe Manchin of Wast Virginia has many assets in the coal industry and DIGS COAL. NY worst air quality in the world from forest fires and Edison Electric big on coal. What a example for China or India, Germany? Time to fire up the Kyle.

    Winston Adams, Nfld

    Like

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s