Vaccinate with BNT162b2?
The UK, Canada and the United States have all approved the Pfizer / Biontech RNA vaccine BNT162b2 for marketing in an emergency. The European Medicines Agency EMA intends to get approval on December 21st or 29th, 2020. Why is the vaccine not receiving regular approval? Because there is not enough data for this and Pfizer doesn’t want any. With such a license, Pfizer would be liable for the numerous vaccine damage to be expected, while in the case of an emergency approval the state (i.e. the taxpayer) would be liable. And that’s what Pfizer expects, in a way, rightly. But one after another.
The data that drug regulators see is essentially the results reported in the NEJM study article by Pfizer and Biontech (regulators see even more details than outsiders). The vaccine is an RNA molecule packaged as lipid nanoparticles that codes for the spike protein of SARS-CoV-2, the causative agent of COVID-19. With this protein, the virus docks onto cells of the respiratory epithelium and can infect them. The vaccination is carried out by injecting two vaccine doses of 30 μg each 21 days apart. Muscle cells absorb the nanoparticles, rewrite the mRNA they contain into protein, cut it up into fragments and present them to the immune system via MHC receptors. The immune system can react and develop antibodies against the foreign viral protein.
In a very short time, 43,448 subjects took part in the study, of whom 21,720 received vaccine and 21,728 placebo. The median age of the study participants was 52 years, 42 percent were older than 55, but the publication does not provide information on how many patients were in the age group over 80, in which over 90 percent of deaths from COVID are observed. However, the median age clearly shows that there couldn’t have been too many really old people.
The main questions of the study were the following:
1. Which acute side effects can be observed?
2. Can protection against a mild variant of COVID-19 be achieved by comparing a vaccine with a placebo?
3. Can protection against a severe variant of COVID-19 be achieved by comparing vaccine against placebo?
The mild variant includes the typical symptoms of a flu-like infection: fever, cough, shortness of breath, cold, muscle pain, loss of taste or smell, hoarseness, diarrhea or vomiting. The severe variant includes respiratory failure, shock, kidney or liver failure, severe neurological dysfunction, or death. In both cases, virus RNA must also be detected in the respiratory tract in addition to the symptoms.
What answers does the study give?
First the study proves perfectly that the vaccine is acutely well tolerated. The injection site reactions and the essentially mild flu symptoms are to be expected, quickly reversible and normal. In the meantime, a few severe allergic reactions up to anaphylactic shock have occurred in use, which was to be expected given the design of the vaccine, since RNA in the extracellular space is toxic and can trigger allergic reactions.
If nanoparticles are not absorbed into the cells and dissolve, the viral RNA gets there naked and can lead to such reactions. The vaccine should therefore no longer be given to allergy sufferers, according to the MHRA. If the vaccine has any benefit, that risk, which is well treatable if the vaccinating doctor correctly diagnoses the condition and acts swiftly, would be acceptable, but acceptable.
Secondly The study shows that influenza-like infection from SARS-CoV-2 is rare, as only 162 out of around 18,000 in the placebo group had such an infection: 0.9 percent of the test subjects. We do not know how many became infected during the study, but this number confirms how rarely SARS-CoV-2 even leads to the development of flu symptoms; 95 percent of those infected have no or mild symptoms. The study proves that the vaccination, averaged over all age groups with an average age of 52 (an age at which hardly anyone dies from SARS-CoV-2), is effective against mild flu symptoms, although the nature of the symptoms is not itemized . The study thus proves that BNT162b2 is effective in vaccinating against coughs, runny noses, hoarseness and mild fever caused by SARS-CoV-2.
Third the study makes no statement about the effectiveness of the vaccine against severe viral pneumonia or death from COVID-19. Because this clinical picture simply did not occur among the 40 thousand study participants, not even among the placebo recipients. This is not surprising, since death from COVID is rare and epidemiologically does not play any role – it is a natural cause of death for very old people; according to this LMU study, there is no excess mortality.
In order to prove that the vaccine protects the elderly from death, one would only have had to include people over the age of 70 in the study and conduct the study in winter in order to have at least a few dead or seriously ill in the study and to obtain data . But then, with a high probability, you would not have seen any effect, since the people who die from COVID suffer from an immune system failure. And those whose immune system is weak does not respond well to a vaccine and cannot recruit the immunity that is formed in the event of illness. It is the same with influenza.
With its study, Pfizer has shown that the vaccine can protect young patients from mild flu if a vaccine is used that is manufactured close to the sequencing of the pathogen’s RNA so that the pathogen does not mutate too much. But what we don’t know is the dangers of the vaccine. Because normally a vaccine is only approved for clinical testing if it has been extensively examined toxicologically in animal experiments, including for long-term damage.
So it was negligent to allow the study presented here. Then, as the toxicologist Stefan Hockertz emphasizes, the vaccinated persons from phase II are observed for two years in order to determine long-term damage. These are mostly insidious autoimmune diseases that are triggered by the vaccine vector (these are the nanoparticles) or the vaccine adjuvants (these are additives in the vaccine that stimulate the immune response). The vaccination against swine flu (pathogen: Influenza A H1N1) resulted in long-term effects such as incurable narcolepsy, a neurological disease in which one suddenly falls asleep during the day, or the equally difficult to treat Guillain-Barré syndrome, a chronic inflammation of the peripheral nervous system, so often that the vaccinations were stopped.
Since the animal experiments on the chronic toxicity of the vaccination were skipped and the long-term effects of the vaccination in humans were not recorded before the approval, the approval authorities cannot approve the vaccine at all; namely, this contradicts all the rules by which they work. Pfizer is not interested in it either, because then you would be liable for the damage.
Therefore, the authorities have emergency approvals. This means that the vaccinees will be used as guinea pigs for the next one to two years, because that’s how long it takes to recognize the chronic consequences of the vaccination. Toxicologist Stefan Hockertz calls this “willful gross bodily harm” through vaccination.
However, vaccination will in all likelihood not help the elderly against death from COVID. And should you as a young person under 70 accept the risk of being disabled for life in the worst case in order to protect yourself against mild flu?
Dr. Jochen Ziegler is a doctor and biochemist. He works as a consultant for private health care providers and lives with his family in Hamburg.