Lower safety standards and the truth about COVID-19 vaccine ‘efficacy’ (FAQ Part 2)

Explain how vaccines are held to lower safety standards than drugs. How did this happen?

New drugs, including vaccines (vaccines are also drugs) are normally required to undergo several standard preclinical and clinical studies before being allowed for public use. Preclinical studies are done “in vitro” (ouside the living animal, e.g. in a petri dish) or “in vivo” (in a whole, living animal, e.g. a rat). Clinical studies are those done on actual human subjects. USFDA regulations for preclinical toxicology studies of vaccines require the components (e.g., antigens and adjuvants) to be tested for any adverse effects. These studies should follow good laboratory practice (GLP) guidelines as described in the Code of Federal Regulation. In general, there are five types of toxicology study: 1.Single and/or repeat dose,  2.Reproductive and developmental, 3.Mutagenicity, 4. Carcinogenicity, and 5.Safety pharmacology.(1) However, unlike drugs, vaccines have been allowed to be marketed by regulatory authorities even when most of the vaccine safety studies (e.g., reproductive and developmental, mutagenicity and carcinogenicity), have not been done. Safety pharmacology studies are also inadequate for most vaccines and there are no long-term safety studies done on vaccines. The vaccine studies themselves have often deviated from accepted scientific methods of enquiry, especially regarding use of placebos. Instead of using true placebos (ex. saline solutions or sugar water) or substances that have no significant biological effects,  the researchers usually use another vaccine  or  the vaccine carrier fluid as the control “placebo,” which obscures the results of the study. Additionally, there are hardly any independent study done on vaccines and most of the studies on vaccine safety that get published are designed and funded by the pharmaceutical industry.(2)

The lowered safety standards for vaccines (and for that matter, drugs, although to a lesser extent) came about mainly because of the intense lobbying of Big Pharma on government policy makers and regulators and because government officials routinely take up high paying jobs at pharmaceutical companies and company officials get appointed to positions of power in government, going through the so-called “revolving door.”(3,4)

Can you explain more about why the COVID-19 vaccine “efficacy rates” are misleading?

The “efficacy rate” used to promote the vaccines is highly misleading because it does not reflect the true percentage of the population that is protected by the vaccine. It is based on the technical parameter called “relative risk” used commonly in clinical trials to compare the ratio of incidence rates of a health outcome in two groups of people, those exposed to a factor of interest and those not exposed. It is usually expressed as the incidence rate in the experimental group, divided by the incidence rate in the control group. For example, in the Moderna study examining the effect of the mRNA vaccine  on the incidence of Covid-19, it was reported that only 11 out of 14,134 (or 0.077 %) subjects who received the vaccine (experimental group) developed Covid-19 while 185 out of 14,073 (or 1.131%) subjects who did not receive the vaccine (control group) developed Covid-19. (8) The “absolute risk” for the vaccinated group is 0.077% and the “absolute risk” for the unvaccinated group is 1.131%. The “absolute risk” is the parameter indicative of real life situation efficacy rate, in contrast to the misleading relative “efficacy rate” derived from the “relative risk” used by researchers in comparing experimental and control groups. The “relative risk” of getting Covid-19 for those who were vaccinated “relative” to the unvaccinated is calculated to be 5.9%  (0.077/1.131 x 100). This is now misleadingly translated to a relative “efficacy rate” of 94.1% which is in turn wrongly interpreted to mean that the vaccine protects 94.1% of the people from getting Covid-19. The fact that about 98.9% of the 14,073 subjects who were not vaccinated did not get Covid-19 anyway is lost in communicating the “efficacy rate.” In reality, the Moderna sponsored study on mRNA vaccine actually shows that only about 1% of the population is protected from getting Covid-19 and that is the true “efficacy rate” of Moderna’s vaccine based on the results of their own study.

Is there scientific basis for the theory that mass vaccinations have caused the rise of more infectious variants of COVID-19?

Yes. There is compelling scientific, historical and empirical evidence that mass vaccinations are causing the rise of more infectious variants of Covid-19. Mass vaccination exerting selection pressure that give rise to more infectious and potentially more pathogenic variants is a well-recognised scientific phenonmenon, in much the same way as the overuse of antibiotics gives rise to the development of antibiotic resistance. This phenomenon has occurred several times in the past as a result of mass vaccinations with the influenza vaccine, pneumococcal conjugate vaccine, polio vaccine and hepatitis B vaccine, among others.(9,10,11,12) The mechanism of selection pressure and immune escape, particularly with the Covid-19 virus, has been explained quite clearly by Dr. Geert Vanden Bossche, a well-known vaccinologist who also issued a warning on the potentially disastrous consequences of mass vaccination at this time.(13) There is now empirical data that show that mass vaccinations with Covid-19 vaccines have likely resulted in the emergence of more infectious variants. For example, in Israel, it was reported that about 90 percent of new COVID-19 infections were caused by the virus’s Delta variant, while about half of the adults infected in the recent outbreak were fully vaccinated. This was announced by Ran Balicer, who leads an expert advisory panel for the Israeli government. Some 55 percent of Israel’s 9.3 million population have received both doses of the Pfizer vaccine, officials said.(14) In the United Kingdom there has been a rapid increase in the detection of variants. There are 4 current variants of concern and 9 variants under investigation. The Delta variant accounted for approximately 95% of sequenced and 92% genotyped cases from 7 to 21 June 2021, about the same  time that 60% of the population has received 2 doses of the Covid-vaccine. (7)

Why is it that health authorities always say that incidence of adverse events after vaccination cannot automatically be related to vaccines? How do you establish the causal link?

If the adverse events reported are not serious (slight fever, mild to moderate pain, weakness etc.) they actually readily admit that these are related to the vaccines. However, when there are reports of serious adverse events, especially death, after vaccination, what the health authorities actually always say automatically is that these are not related to the vaccines. I think they say this because: 1) they are following orders to say so, 2) they have been conditioned to follow a standard reply of denying serious adverse effects; 3) because of their blind adherence to their mistaken belief that vaccines cannot possibly cause any serious adverse effect, or 4) because they have vested interests in promoting the vaccines. Upon being confronted with repeated and consistent occurrences of adverse events after vaccination, they modify their stance and say that “some” reports of adverse events might “possibly” be true but occur only rarely and  these reports are being investigated by a team of “experts.” Invariably, however, these “experts” conclude that the reported adverse events are “coincidental” and are not related to the vaccination.

It is true that an adverse event following vaccination cannot be automatically related to the vaccine but it cannot be automatically be dismissed either because at the very least, this is a warning signal. The more warning signals (reports of adverse event), the more likely these signals are actually related to the vaccine. A causal link can be established by looking at certain criteria that point to a cause and effect relationship. Probably the most important criterion is the time relationship, i.e., the adverse event occurred after the vaccination. However, the usual practice of observation of possible adverse event following vaccination is very short (usually only minutes, hours or a few days after vaccination). This is highly inadequate because adverse effects of vaccines can occur even months or years after vaccination (e.g., cancer and autoimmune adverse effects). Almost always, the vaccinated person is not properly informed about the plausibility of adverse events long after the vaccination procedure and when an adverse event presenting as a defined or undefined illness does occur long after the vaccination, the vaccinated person (or even the health professional consulted by the person) would no longer suspect that the vaccination might be related to the observed illness.

The other major criterion is called “biological plausibility,” meaning the adverse event can be explained by, or in coherence with, existing biological and scientific knowledge and is therefore believable. If present, evidence of detailed and specific biological mechanisms that would explain the adverse event would strengthen causality but is not necessary. Logical inference from existing scientific evidence is enough to establish  “biological plausibility.” One other important criterion is consistency of the association between the occurrence of the adverse event and vaccination. For example, the biologically plausible adverse event or similar adverse events are occurring in similar time relationship in other areas or have occurred in the past, recent or even years past. Consistency of association can also be inferred from similarities in circumstances surrounding the occurrence of the adverse events, for example, similar genetic and environmental factors contributing to the occurrence of the adverse events. Another important criterion which is often ignored by authorities is the presence of credible testimonial evidence. If the person reporting the adverse event after vaccination is the injured person himself/herself and claims that the injury was caused by the vaccine, the testimony should be taken seriously because there is hardly any person who would falsely claim an adverse event after vaccination. On the other hand, when that person consults the doctor, the doctor almost always immediately dismisses the complaint as unrelated to the vaccine because of the strong belief by the doctor that vaccines are safe and therefore cannot possibly cause the adverse event.  This is one of the major reasons why most adverse events are not reported. It has been estimated that in the US, as low as 1% of adverse events after vaccinations are ever reported officially.(15).

Another important criterion in the assessment of causality is the presence of possible alternative causes. Quite commonly, this happens when the patient injured by the vaccine has co-morbidities. In this situation, it is often very difficult to ascertain a clear causal relationship of the adverse event to the vaccination. For example, among the reported cases of cardio-vascular adverse events (stroke, heart attack, etc.) following vaccination with Covid-19 in the elderly who have arteriosclerotic heart disease, hypertension and/or diabetes, it is quite difficult oftentimes to determine whether the adverse event is directly due to the vaccine or not. Most often, even without further investigation, biased health authorities will immediately conclude that the adverse event is caused by the co-morbidity condition and not by the vaccine. It is quite plausible, however, that the vaccine 1) directly caused the cardiovascular event through some specific mechanism (e.g. spike protein inflammatory effect), 2) triggered a cascade of biological events (stress effects, disturbance of homeostatic mechanisms, epigenetic effects, etc.) that caused the cardio-vascular event, 3) perturbation of the very complex immune system, or 4) some other indirect mechanism (non-specific effects). Certain unique characteristics of the adverse events not usually observed in the co-morbidities (e.g. unique thrombo-embolic-bleeding disorder), unusual frequency, consistency of occurrence and clustering of cases may pinpoint the vaccine as the most likely cause.(16) 

The confirmation or denial of the causal link between an adverse event and vaccination is determined usually by health authorities and “experts” using the WHO guidelines (17), which is obviously biased in favor of dismissing a causal relationship. It gives undue importance to reactions that have previously been shown in scientific studies to be caused by the vaccine or classified as a vaccine-related reactions. Absence or paucity of such evidence in the scientific literature is used as a basis for dismissing causal relationship. Reactions observed for the first time during post-marketing surveillance are not considered as ‘consistent with causal association with vaccine.’ Practically all new serious adverse reactions are labelled as coincidental events. It employs an evaluation process that excludes prematurely the role of the vaccine when “other causes” that might possibly explain the adverse event are identified. Subsequently, even if there was strong testimonial evidence, biological plausibility, temporal compatibility and consistency for a causal association between the vaccine and the adverse event, official “review committees” are inevitably led to a conclusion that the vaccine could not have caused that adverse event.

How about the immunocompromised who do not have a robust enough immune system to fight off COVID-19? For them, wouldn’t the benefits of a COVID-19 vaccine outweigh the risks?

No, the purported benefits of a Covid-19 vaccine do not outweigh the risks in the immunocompromised. There is no evidence, scientific or empirical, to support the recommendation that the immunocompromised should be vaccinated. Even mainstream medicine admits that “current data on COVID19 vaccine efficacy and safety in the ICH (immunocompromised host) is sparse.” In fact, there is practically no data to support the recommendation that the immunocompromised should be vaccinated against Covid-19 since immunocompromised people were not included in the original clinical trials for the COVID-19 vaccines. Historically, vaccination is commonly regarded as much less effective, hazardous and often contraindicated for individuals who are immunocompromised, especially those under immunosuppressive drugs ( ex. transplant patients, cancer, etc), the elderly with co-morbidities, or any other condition that weakens the immune system significantly (even those with an active infection like ordinary cough and colds virus). The usual rational management of immunocompromised individuals is not vaccination but prevention from being exposed to potentially infected persons (e.g. isolation, if necessary), ensuring that their immunocompromised status is adequately treated and managed, and supportive management (appropriate nutrition, supplements, psychological support, etc) to strengthen whatever resilience is left of their innate and natural adaptive immunity is adequately in place. However, increasingly over the years, as more and more vaccines are peddled by Big Pharma, mainstream medicine included many immunocompromised patient categories in their recommendations for vaccination on the dubious assumption that the potential benefits still outweigh the potential risks even though evidence is lacking  to show efficacy and safety. They now even insist that the immunocompromised (especially the elderly) be vaccinated against Covid-19 despite admitting that there is lack of evidence to show safety and efficacy of vaccines for the immunocompromised.

While the immunocompromised are more susceptible to SARS-CoV2 infection and may have greater probability of developing more severe manifestations of Covid-19 disease compared to the non-immunocompromised, the immunocompromised individuals are also much more susceptible to the serious adverse effects of the Covid-19 vaccines. There is really no scientific justification for recommending Covid-19 vaccination in the immunocompromised. The risks from the vaccines are greater since the mechanisms of vaccine toxicity are much more varied and the adverse effects are more likely to be more serious and life-threatening. The adverse effects of vaccines are also less likely to be overcome since the clinical characteristics and management of many types of vaccine adverse effects are largely unknown and less understood compared to the clinical characteristics and management of the Covid-19 disease.

Furthermore, there are many other options in managing Covid-19 disease apart from vaccination. For example, there is ample evidence that those afflicted with Covid-19, including  the immunocompromised, can be treated effectively with ivermectin and some other drugs and modalities to prevent death or serious complications. On the other hand, treatment is largely unknown and untried for the many potential adverse effects of vaccines that are serious or that results in death.

ALSO READ:

Herd Immunity and Vaccines (FAQ Part 1)

Why social movements should oppose mandatory vaccination (FAQ Part 3)

REFERENCES:

1. Preclinical Toxicology of Vaccines. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7161388/

2. Vaccines- Are the Safety Studies Credible?

3. Big Pharma-revolving door keeps spinning. https://thehill.com/blogs/congress-blog/politics/452654-for-big-pharma-the-revolving-door-keeps-spinning

4. Revolving door_Big Pharma_FDA’s haematology-oncology reviewers. https://www.bmj.com/content/354/bmj.i5055.full

5. 13,867 DEAD and 1,354,336 Injuries in European Database of Adverse Drug Reactions for COVID-19 Shots

6. VAERS Data Show Number of Injuries, Deaths Continues to Climb

7. SARS-CoV-2 variants of concern and variants under investigation in England

8. Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine. https://www.nejm.org/doi/full/10.1056/nejmoa2035389

9. Fast-spreading mutation helps common flu subtype escape immune response. https://www.sciencedaily.com/releases/2020/07/200710131520.htm

10. Vaccine Escape Recombinants Emerge after Pneumococcal Vaccination. https://journals.plos.org/plospathogens/article?id=10.1371/journal.ppat.0030168

11. Vaccine-resistant polio strain discovered. https://www.sciencedaily.com/releases/2014/11/141104111408.htm

12. Detection of circulating hepatitis B virus immune escape-Central African Republic. https://www.ijidonline.com/article/S1201-9712(19)30433-3/fulltext

13. Why the ongoing mass vaccination experiment drives a rapid evolutionary response of SARS-CoV-2

14. Vaccinated People Half of New Covid-19 Delta Cases in Israel. https://www.wsj.com/articles/vaccinated-people-account-for-half-of-new-covid-19-delta-cases-in-israeli-outbreak-11624624326

15. Electronic Support for Public Health–Vaccine Adverse Event Reporting System-VAERS.

16. Causality assessment of adverse events following immunization. https://f1000research.com/articles/9-170/v2

17. The New WHO Causality Assessment Algorithm Needs Revision to Restore Public Trust. https://www.bmj.com/content/365/bmj.l2268/rr-0

Romeo F. Quijano MD is a retired professor of the Dept. of Pharmacology & Toxicology, College of Medicine, University of the Philippines Manila. He is a lifelong health and environmental activist.

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