All vaccines must pass clinical trials lasting between five and ten years. These periods are not a whim, but a necessity to evaluate possible adverse effects in the medium and long term. In the case of unprecedented vaccines (such as those of covid), the time frame can be even longer and the probability of successfully passing all phases of the trial does not exceed 2%. Surprisingly, however, within a few months, several covid vaccines appeared to be successful, which is unheard of, since an effective and safe vaccine against any type of coronavirus had never been approved before. To give you an idea, instead of ten years the average duration of the first trial that led to Pfizer’s license was 46 days and the subsequent average follow-up was just three months. As you will understand, technology can speed up production, but the waiting time to properly assess efficacy and safety cannot be shortened. Even so, in those three months, the adverse effects of the covid vaccines in a healthy population carefully pre-selected for the trials were mild but still shocking: after the second dose, an unusually high percentage suffered symptoms equal to or worse than they would have if they had passed the disease, with fevers from 38 to 40 degrees Celsius, chills, muscle pain and headache. This was not normal.
After these trials of a few weeks’ duration and under enormous political pressure, the vaccines were approved for emergency use, at which point their adverse effects were declared taboo and silenced by the politics-media-pharma gang. This omertà did not bode well, since censorship is always an attempt to hide the truth: if vaccines were so safe, why fear? One year later, and despite the worrying data and the growing concern among the medical community, the watchword continues to be, first, to deny the existence of the side effect, then to deny the cause-effect relationship and, finally, to emphasize that they are “very rare” cases.
Needless to say, any serious adverse side effect of a vaccine will be statistically rare and vaccines that have been withdrawn from the market over time for safety reasons are no exception, because the level of tolerance to serious side effects in a vaccine must necessarily be very low. Why?
First, do no harm
In medicine, both therapeutic treatments (which cure diseases) and prophylactic treatments (which prevent diseases) must be determined by the circumstances of each patient, for whom the potential benefits of treatment must outweigh its potential risks, since, as the Hippocratic oath states, the fundamental maxim for the physician is primum non nocere, i.e. “first, do no harm”.
This principle must be applied with particular rigor when it comes to vaccines that involve injecting a drug into perfectly healthy individual to protect him only in the event of contracting a disease, and contracting it severely. Thus, the vaccinated person is obliged to take the risks inherent to the vaccine today with a 100% probability in exchange for potential future benefits. Therefore, no matter how low the probability of serious effects may be, it can never be accepted that a vaccine becomes a Russian roulette. Thus, in 1976, the USA stopped a flu vaccination program after 1 death per million vaccinated and 10 cases per million of Guillain-Barré syndrome.
Since its approval for emergency use, the clinical trial of covid vaccines lost its scientific character and the evidence on its safety came to depend, with its inherent limitations, on follow-ups of the official databases of different governments. In the USA, this database is the VAERS (Vaccine Adverse Event Reporting System), jointly managed by the CDC and the FDA, which has been collecting adverse effects since 1990 as an “early warning system to detect possible safety problems”.
Well, its results on the potential danger of covid vaccines are extremely disturbing: almost 12,000 deaths have been reported after vaccination (58 cases per million of those fully vaccinated), 12,500 cases of life-threatening situations (60 cases per million) and 13,000 people have ended up with a permanent disability (63 cases per million). The sum of the three concepts brings us close to one case per 5,000 vaccinated, an unprecedented ratio. But the most telling indication that something fishy is going on is that the number of deaths reported after vaccination in 2021 is far higher than the sum of deaths after vaccination for all vaccines over the previous 30 years, a like-for-like comparison of the same database with a relatively comparable number of doses given. Look closely at this chart, because a picture is worth a thousand words:
These alarming results are so at odds with the official narrative that for the first time VAERS has been the subject of an ad hoc debunking attempt under the criticism that it shows effects “after” vaccinating and not necessarily “because of” vaccinating. This distinction between correlation and causation is theoretically correct but misleading, since taken to the extreme it would disqualify the indicative validity of pharmacovigilance (why have VAERS, then?). Naturally there will be cases where there is no causal relationship, but it is well documented that historically VAERS has underestimated the incidence of adverse effects by an order of magnitude. In fact, on its own website VAERS explains that, although “not designed to determine whether a vaccine caused a health problem, this database is especially useful for detecting unusual patterns of reported adverse effects.” If this isn’t unusual, please define “unusual”. Finally, 33% of the deaths “after” being vaccinated by covid occurred less than seven days after the shot, and 51% died less than a month later. This chronological relationship is another obvious indication of causality.
The Yellow Card in the UK corroborates these data. In addition to the sudden death of healthy people, regardless of age, a few days or weeks after vaccination, there are the statistically rare but unacceptable serious ischemic and cardiovascular effects caused by vaccination: stroke, thrombosis and thrombocytopenia, pulmonary embolism, myocarditis, pericarditis, atrial fibrillation, angina pectoris, palpitations, tachycardia and arrhythmias. Myocarditis or inflammation of the heart in people under 40, as confirmed by several studies (Nature, British Medical Journal…), implies that damage has been caused gratuitously, given the mildness of covid for that age range. This unnecessary harm has been particularly immoral in the case of the vaccination of teenagers, for whom the mRNA vaccine would have multiplied the risk of myocarditis up to 133 times more than normal, according to a recent study published in the JAMA (Journal of the American Medical Association). Remember that these myocarditis are potentially severe conditions and “of uncertain prognosis in the medium term,” according to the British JCVI. As the Yellow Card specifies, there have also been bizarre menstrual disorders, eye disorders, dermatological, immune and neurological adverse effects, such as cerebral venous sinus thrombosis, Bell’s facial palsy and, more unusually, acute transverse myelitis.
These data are so disturbing that it is inescapable to study whether vaccines have any relation with the unexplained excess of non-covid mortality detected in the second half of 2021 in Western countries, a phenomenon that has experts baffled. One of them stated in the Financial Times that the data pointed to “cardiovascular diseases”. Given that the main novelty in 2021 is the covid vaccination program, that the main adverse effect of vaccines seems to be cardiovascular, and that there are studies on the correlation between vaccination and subsequent short-term mortality, is it not logical to investigate a possible relationship? Likewise, sudden cardiopathies in young professional athletes (soccer players, etc.) are compatible with vaccine adverse effects and should be investigated. Naturally, the media continue to defend the slogan: first they denied that there was an increase in cases and now they deny the relationship with vaccines and even link it to covid with the same rigor with which they could link it to climate change, and I wonder: if that were so, why were there no cases in 2020?
A public health scandal
Despite the evidence of the lack of efficacy of these vaccines and the very clear indications of their lack of safety, politicians, journalists and Big Pharma remain stubborn. Like Groucho Marx, they shamelessly tell us: “Who are you going to believe, me or your own eyes?” They told us that vaccines were “95%” effective in preventing contagion and we only have to look around us: everyone vaccinated and everyone infected. Then we were told that in reality they prevented neither contagion nor transmission (so what’s the point of a covid passport?) but they did prevent severity and death and, according to the Spanish and British official data, roughly three out of four deaths from covid since autumn were fully vaccinated individuals. Finally, we were told that they were extremely safe, and you can see the disaster looming in the horizon to which the data suggest. Fiasco after fiasco, the alliance of Big Pharma, unscrupulous politicians and ignorant and obedient journalists tries to hold up a crumbling house of cards. The latest tactic is to incite frequent “booster” doses (to “boost” the official narrative, of course) despite the Israeli evidence of their uselessness and the European Medicines Agency’s warning about their debilitating effects on the immune system.
After recalling the questionable ethical record of Big Pharma, a very recent editorial in the British Medical Journal, one of the three most prestigious medical journals in the world, sums up the growing outrage at data suppression: “Pharmaceutical companies are reaping huge profits without adequate independent scrutiny of their scientific claims. The purpose of regulators is not to dance to the tune of wealthy global corporations and further enrich them; it is to protect the health of their populations. We need complete transparency of data from all studies, we need it in the public’s interest, and we need it now”.
In other words, without sufficient data, the entire population has been pushed to take the risk of getting vaccinated (or vaccinating their children!) with opaque, largely experimental, ineffective and unsafe vaccines to prevent a disease that is mild for the vast majority. And despite the fact that the risk of developing severe covid was 1,000 times lower for a young person than for an older one, it was decided that vaccination should be universal and not limited to the population at risk. How else can this be explained if not for spurious economic and political interests? We are probably facing the biggest public health scandal ever.
Fernando del Pino Calvo-Sotelo
 Developing new health technologies for… | Gates Open Research
 Evidence does not justify mandatory vaccines – everyone should have the right to informed choice | The BMJ
 Safety and immunogenicity of the ChAdOx1 nCoV-19 vaccine against SARS-CoV-2: a preliminary report of a phase 1/2, single-blind, randomised controlled trial – The Lancet and Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine | NEJM
 Deaths following vaccination: What does the evidence show? – PMC (nih.gov)
 The Vaccine Adverse Event Reporting System (VAERS) Request (cdc.gov)
 Improving Detection of and Response to Adverse Events – Vaccine Safety Forum – NCBI Bookshelf (nih.gov)
 VAERS Ibid.
 Risk of thrombocytopenia and thromboembolism after covid-19 vaccination and SARS-CoV-2 positive testing: self-controlled case series study | The BMJ
 Ischaemic stroke as a presenting feature of ChAdOx1 nCoV-19 vaccine-induced immune thrombotic thrombocytopenia | Journal of Neurology, Neurosurgery & Psychiatry (bmj.com)
 Myocarditis Occurring After Immunization With mRNA-Based COVID-19 Vaccines | Cardiology | JAMA Cardiology | JAMA Network
 Epidemiology of Acute Myocarditis/Pericarditis in Hong Kong Adolescents Following Comirnaty Vaccination | Clinical Infectious Diseases | Oxford Academic (oup.com)
 Risks of myocarditis, pericarditis, and cardiac arrhythmias associated with COVID-19 vaccination or SARS-CoV-2 infection | Nature Medicine
 SARS-CoV-2 vaccination and myocarditis or myopericarditis: population based cohort study | The BMJ
 Myocarditis Cases Reported After mRNA-Based COVID-19 Vaccination in the US From December 2020 to August 2021 | Cardiology | JAMA | JAMA Network
 JCVI statement on COVID-19 vaccination of children aged 12 to 15 years: 3 September 2021 – GOV.UK (www.gov.uk)
 Coronavirus vaccine – weekly summary of Yellow Card reporting – GOV.UK (www.gov.uk)
 Menstrual changes after covid-19 vaccination | The BMJ
 Ocular inflammatory events following COVID-19 vaccination: a multinational case series | Journal of Ophthalmic Inflammation and Infection | Full Text (springeropen.com)
 Spectrum of neurological complications following COVID-19 vaccination – PubMed (nih.gov)
 AstraZeneca’s COVID-19 vaccine: EMA finds possible link to very rare cases of unusual blood clots with low blood platelets | European Medicines Agency (europa.eu)
 Reported orofacial adverse effects of COVID‐19 vaccines: The knowns and the unknowns (nih.gov)
 Acute Transverse Myelitis Following COVID-19 Vaccination (nih.gov)
 UK enters wave of excess deaths not fully explained by Covid | Financial Times (ft.com)
 (PDF) COVID vaccination and age-stratified all-cause mortality risk (researchgate.net)
 Everyone vaccinated and everyone infected – Fernando del Pino Calvo-Sotelo (fpcs.es)
 Actualizacion_537_COVID-19.pdf (sanidad.gob.es) and previous ones
 Covid-19 vaccines and treatments: we must have raw data, now | The BMJ