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The registration and observational studies demonstrate that SARS-CoV-2 vaccines reduce the number of positively tested cases. It is true that the vaccine-induced protection against this specific pathogen does not convincingly prevent infection and transmission (as other vaccines do), and it clearly also appears to wear off quite quickly. However, the traces of this particular virus are found significantly less frequently in the nasopharyngeal swabs of vaccinated persons than in unvaccinated persons. The genetically induced production of viral proteins by human cells leads to a specific and detectable immune response. Undoubtedly, this is a scientifically interesting confirmation of the fact that mRNA and DNA vector technologies work biologically.
However, biologically functioning technology does not mean clinical relevance. Since the symptoms caused by the SARS-CoV-2 virus are largely non-specific, i.e. can also be caused by many other pathogens (if in any doubt, please study the WHO description of Covid-19 symptoms). Are the decisive questions for the clinic, for the patient, for human beings not the following ones?
· Does vaccination against SARS-CoV-2 lead to overall fewer colds, coughs, hoarseness, shortness of breath, fever, chills, aching limbs and headaches, loss of smell and taste, nausea and diarrhoea?
· Does vaccination against SARS-CoV-2 lead to overall less severe forms of respiratory infections, to overall less pneumonias?
· Does vaccination against SARS-CoV-2 lead to overall fewer hospital admissions?
· Does vaccination against SARS-CoV-2 lead to overall fewer deaths?
The pharmaceutical industry could undoubtedly have answered (and could still answer) all these questions with well-designed and not even exceptionally complex clinical trials; of course, the regulatory authorities should have asked these questions.
All currently available data merely report the reduction of ‘Covid-19 cases’ – flu symptoms with a positive test (the only endpoint which succeeded in reaching statistical significance in any of the controlled trials), severe forms with a positive test, hospitalisations with a positive test, mortality with a positive test.
However, nothing at all is gained clinically if infection with this one specific respiratory virus is (somewhat) prevented, but in susceptible people is replaced by infection with e.g. adenoviruses, rhinoviruses, influenza viruses, parainfluenza viruses or other coronaviruses. All these viruses and their multiple subtypes cause similar symptoms, virtually all of them can also cause pneumonias and severe forms. (For an interesting read, see for example this description of the radiologic and CT features of ‘pre-SARS-CoV-2’- atypical pneumonias.) The sheer number of respiratory virus strains and their interchangeability had so far prevented the development of a vaccine (except for influenza, with moderate success). If SARS-CoV-2 is truly more, and more dangerous than another flu virus strain, then surely the clinical trials should convincingly demonstrate prevention of serious disease (and death) – not of common cold symptoms.
However, this is so far all that has really been shown: For example, in the BioNTech/Pfizer registration trial, the loudly acclaimed ‘95 per cent efficacy’ consisted of a reduction in common cold symptoms with a positive test from 162 ‘cases’ in the placebo to 8 ‘cases’ in the vaccinated group. (The trials with the other manufacturers’ vaccines had similar designs and endpoints.)
But altogether 3,410 ‘Covid-19 suspected cases’, i.e. common cold symptoms without a positive test, were reported from the trial. The same clinical symptoms, in twenty times as many people, simply and completely dropped from the analysis because their PCR test had been negative.
One has to search for these data in the FDA application for the product; apparently none of the peer reviewers of the New England Journal of Medicine asked for them, let alone drew any conclusions from them. If they had analysed them, if they had furthermore taken into account the fact that virtually all those flu symptoms which had been defined as clinical endpoints occur also very frequently as side effects of vaccine administration, they would in all likelihood have had to conclude that altogether people were sicker in the vaccinated than in the placebo group.
Given the lack of clinical specificity of the infection caused by SARS-CoV-2, all the respiratory symptoms, all the severe forms, all the hospitalisations and all the deaths – with or without a positive test – should have been disclosed and examined in every one of the vaccine clinical and observational studies. Not only that: they – or at least one of them (preferably overall mortality) – should have been defined as clinical endpoint(s).
The fact that almost everyone now seems to believe that vaccination ‘protects from severe forms’ is solely the result of pharmaceutical marketing and government propaganda. This is precisely what has not been shown in any controlled study, not even for the test-positive severe forms (of which there have always been too few to demonstrate statistical significance), let alone for pneumonias, hospitalisations and deaths overall.
In the six-month analysis of the Pfizer/BioNTech registration study, there were more deaths in the vaccinated than in the placebo group: 20 (including 5 people who had been vaccinated after the study was unblinded) versus 14. Of course, no statistically significant conclusions can be drawn from these data. But they certainly do not point to a mortality advantage of the vaccine.
The true clinical benefit of the Covid-19 vaccines is therefore probably zero – even before any side effects are taken into account. Because these side effects undoubtedly occur, because some of them are undoubtedly serious and potentially deadly, it must be assumed that a true clinical trial with hard endpoints (mortality or possibly also mortality combined with e.g. hospitalisation – overall, not just with a positive test!) would produce a negative result for the vaccination. Perhaps this is the reason why such a trial has not been, and is not being carried out.