The host: SARS-CoV-2 viruses infect human cells using a “key”, called a “Spike protein”, which allows them to enter cells and use their biological systems in order to replicate (replication of which they are not capable independently), causing the disease (COVID-19).
The “bouncer”: the BioNTech-Pfizer vaccine, currently used in Italy, is based on messenger RNA (mRNA) technology. The mRNA carries instructions so that harmless fragments of the viral protein Spike can be translated (synthesized). When the vaccine is given, fragments of the Spike protein are translated, which the immune system (human) recognizes as foreign, as viral (not self). Through fine and complex mechanisms, the immune system deploys our defenses by producing specialized cells, especially antibodies and T cells, to counteract, that is, to block Spike and therefore deactivate the mechanism of entry into the cells.
Anti-Covid vaccine: trial data
The data from the clinical trial, reported in the study by Polack et al, showed that the efficacy of the vaccine is 95%. How was this percentage obtained? More than 36,000 subjects were enrolled and divided into two homogeneous groups (by age, gender and ethnicity): the first group (treatment arm) was administered the vaccine (two doses of vaccine 21 days apart from each other). other), the second group (control arm) was given placebo (two doses of placebo 21 days apart). It was observed that in the first arm, the cases of COVID-19 were 8, in the second arm the cases were 162. The difference is also important to the eye, without the precise statistical significance calculations that, those of competence, performed it is reported. The most common side effects were injection site pain, fatigue, headache, body aches, and fever.
The injected mRNA does not modify the DNA: the DNA is found in the cell nucleus and cannot “physically” interact with the mRNA which performs its function as a discreet and fast MESSENGER, as an “ambassador who does not bear pain” after being absorbed , at the cytoplasmic level, and then degrade in a few days. Among other things, the mRNA injected with the vaccine has the information (sequence of nucleotides, 4 repeating letters) to produce ONLY the protein Spike, it can’t do anything else … it’s like telling a child to produce the word “HOME” using the letters C, M, O and E. Could never make it!
Vaccine effectiveness with a mutating virus
That the virus undergoes mutations is the truth, it changes to survive, to make its ability to infect human cells more efficient. It is necessary to understand in what area of its sequence it changes before announcing, with great fanfare, the uselessness of vaccination based on viral mutations, amplifying anxieties and doubts. If a book consists of 100 pages but the information you are looking for is contained in the first 50 pages, is the fact that page 75 contains errors or is torn off, is it significant for the purpose of finding the desired information? In other words: if the vaccine is drawn on the mRNA sequence useful for translating fragments of the Spike protein, that a mutation, even if it is pathogenetic, occurs in correspondence with other regions of the viral sequence, how likely is it that the vaccine efficiency? Even assuming that a mutation involving Spike occurs, therefore in the first 50 pages of the book, it is very likely that the portions, the fragments useful not to alter the understanding of the text, therefore to preserve the effectiveness of the vaccine, would still be present.
Fear prevails and is understandable up to a certain point, that is, until it is amplified by statements without even the shadow of a scientific basis or theories put forward by those who take fireflies for lanterns, which should not even be placed in antithesis with the statements, based on the evidence, of those who studied the vaccine, validated and approved it. It is said that the vaccine has been little tested and therefore may represent a danger to the community.
The stages of the anti-Covid vaccine trial
We immediately clarify that all the MANDATORY phases of the experimentation aimed at marketing authorization have also been implemented for the anti-COVID-19 vaccine, as well as monitored by the regulatory agencies, the “Food and Drug Administration” (FDA) US and the European Medicines Agency (EMA). The times were shorter than the trials on other drugs for various reasons, for example: 1) the research did not start from scratch, thanks to the data already available for other Coronavirus respiratory diseases (SARS and MERS); 2) mRNA technology is quite simple and does not require some rather long laboratory steps; 3) the funds have been maximized thanks to the financing of various companies, as well as the human resources deployed in the field; 4) many volunteers promptly joined the trial; 5) the regulatory agencies evaluated immediately after phase 3 the dossier containing all the necessary assessments (chemical-pharmaceutical, biological, pharmaco-toxicological and clinical), in order to ensure the safety and efficacy requirements. The study protocol and, above all the results obtained, are in the public domain. However, the high number of subjects enrolled for the clinical trial (more than 36,000) contrasts with the shorter time frames.
Covid vaccine: benefit / risk analysis
The benefit of the immediate availability of the vaccine was considered to outweigh the risk associated with the unavailability of long-term data. The latter, but this is obvious: we will continue to monitor, in fact companies must provide additional data even from new or ongoing studies to confirm that the benefit outweighs the risks. Ditto for the data on pregnancy and breastfeeding: they are “missing” because finding a number of subjects that can reach statistical significance useful for drawing robust conclusions is not easy for obvious reasons. Furthermore, for each drug, monitoring is continuous, in fact there is phase 4 (pharmacovigilance).
As for the “danger” to which one feels exposed, it is good to be clear that any substance introduced into the body has an effect, even unpredictable, whether it is vaccines or drugs taken for headaches or to treat pathological conditions, but even food, which is made up of molecules that interact with our biological systems. The fact remains that the side effects described for the COVID-19 vaccine have been reported above and that the hypothetical “danger” should be considered by putting the benefit obtained, immunity, or the possibility of avoid contagion and disease for themselves, but also contribute to the now famous herd immunity. Let’s imagine that we are all under a shower of bullets and we are all wearing protection (bulletproof clothing): the shots would fail, they would not succeed. If, on the other hand, someone wears the protections and someone does not, the chances of someone being hit are certainly higher; let’s go ahead with the imagination: the injured person could die, but not only … what if his wounds could infect others who were “saved” from the rain of bullets? The results, the consequences of the rain of bullets would be there!
If we think about it, the risk / benefit ratio is applied every day by every living being that breathes on planet earth (and perhaps also on other planets): driving can be a risk, but the benefit you get (quickly covering distances) is indisputable and favors the pro-machine choice every day, taking for granted the confidence in the engineer who designed the machine, even in the absence of a minimum of skills in mechanical engineering. The same scheme could be applied to taking the plane, but also simply to crossing the street.
The characteristics of the anti-Covid vaccine
The AIFA document reporting the characteristics of the “Vaccine COVID-19 mRNA BNT162b2 (Comirnaty)” clearly specifies that the vaccine is made up of mRNA, fat particles to carry the mRNA itself, salts, cholesterol, sugar and water. Yet there are supporters of the thesis “they only inject water, they make fun of us” and supporters of the composition from “Saponificatrice di Correggio”. There is no virus in the vaccine, as in many other vaccines, based on the technology of the attenuated (weakened) pathogen in order to trigger the immune response.
The hope is that everyone can choose whether or not to contribute to herd immunity on the basis of scientific data and not of hypotheses inspired by the pure science fiction of Doctor Facebook or Doctor Google, having in mind and heart the memory of what science, and vaccinations in particular, have allowed, in history, to eradicate many disabling, serious and / or fatal diseases