US COVID-19 Vaccines Proven to Do More Harm than Good

Written by scivisionpub.com on August 27, 2021. Posted in Current News

For decades, true scientists have warned that pivotal clinical trial designs for vaccines are dangerously flawed and outdated [1]. Vaccines have been promoted and widely utilized under the false claim they have been shown to improve health.

However, this claim is only a philosophical argument and not science based. In a true scientific fashion to show a health benefit one would need to show fewer overall deaths during an extended period in the vaccinated group compared to a control group.

Less stringent indicators of a health benefit would include fewer severe events of all kinds, fewer days hospitalized for any reason, lower heath care expenses of all types, fewer missed days from work for any health reason. No pivotal clinical trial for a vaccine preventing an infectious disease has ever demonstrated an improvement in health using these scientific measurements of health as a primary endpoint.

Instead, vaccine clinical trials have relied on misleading surrogate endpoints of health such as infection rates with a specific infectious agent. Manufactures and government agents have made the scientifically disproved and dangerous philosophical argument that these surrogate endpoints equate to a health benefit.

True medical scientists, outside the vaccine fields, have embraced the use of true health measurements as the proven proper scientific endpoint of clinical trials. Decades ago, a pharmaceutical manufacturer would only need to show that a chemotherapeutic agent shrank a tumor or reduce cancer deaths to obtain FDA approval. Manufacturers would market their products under
the fraudulent philosophical argument that shrinking tumors or reducing cancer deaths equates to improved survival.

However, many of the toxic chemotherapeutic agents would destroy vital organs and actually reduce survival while decreasing cancer deaths at the same time. The FDA and comparable agencies around the world switched to “all cause mortality” as the primary endpoint for pivotal cancer drug trails. The gold standard for marketing approval is to show that those receiving a cancer drug actually live longer than those who do not.

Typically, new “miracle” anticancer drugs only prolong survival about 2 months but this added time may be spent severely ill suffering from adverse events caused by the chemotherapy. Application of true scientific principles often severely deflates the hype promoting pharmaceutical products.

All previous vaccine trials have suffered not only from lacking a proper primary clinical endpoint put also from insufficient perspective follow up of adverse events. The trials have failed to account for the well-established toxicity data and epidemiology data that vaccines are associated with chronic immune mediated disorders that may not develop for years after immunization.

These adverse events, for example type 1 diabetes, are quite common, develop 3 or more years after immunization, and can exceed the reduction in infectious complications induced by the vaccine as was shown with a hemophilus vaccine [1]. Pivotal trials for the recombinant hepatitis B vaccine prospectively recorded adverse events for about 7 days after immunization and newer vaccines typically prospectively follow patients 6 months for adverse events.

Method
Data from all three US COVID-19 vaccines was published in the New England Journal of Medicine [4-6]. Data from these three publications and the accompanying published appendixes provided the bulk of the information analyzed. On rare occasions supplemental data was found on the FDA’s website (https://www.fda.gov/advisory-committees/advisory-committee-calendar) in briefing documents pertaining to FDA advisory panel committees for COVID-19 vaccines from Pfizer-BioNTech, Moderna, and Janssen.

The scientific primary endpoint, “all severe events”, in the treatment group and controls was calculated by adding all severe or life threatening events reported in the clinical trials by the manufacturers. Severe events included both severe cases of COVID-19 and all other severe events in the treatment arm and control arm respectively.

A Chi square analysis using a 2×2 table was used to calculate statistical p values. An online statistical chi square calculator (https://www.socscistatistics.com/tests/chisquare) was used. Statistical calculations ignored small differences in total subject number between efficacy and adverse event populations. The randomized number, shown in Table 1, was used as the study population for statistical calculations.

In general, the population for adverse events was slightly higher than that for efficacy. Given the statistical significant p, values generated (see Table 1), these small differences do not appear to be material. The FDA document entitled Guidance for Industry Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, 2007, provided the following definitions for adverse events.

Grades 3, Severe: Prevents daily activity and requires medical intervention.

Grades 4, Potentially life threatening: ER visit or hospitalization.

Results

Moderna
The Moderna pivotal Phase III trial results and protocol are published in the New England Journal of Medicine (NEJM) [5]. The primary endpoint was COVID-19 illness starting 14 days after the second dose of vaccine however the trial had a secondary endpoint which was patients developing severe COVID-19 symptoms. This later endpoint allowed for a direct comparison to severe adverse events.

The study randomized 30,420 individuals, 15,210 were randomized to receive injections with Moderna’s mRNA-1273 vaccine and 15,210 were randomized to receive injections with placebo. Two shots were administered 28 days apart. “Solicited” adverse events were collected 7 days after immunization and “unsolicited” adverse events were reported up to 28 days after administration of each vaccine or approximately 56 days after the first dose according to protocol.

Because of dropouts, adverse events were recorded on 15,185 vaccinated patients and 15,166 placebo patients (reference 5, appendix table S8). The treatment group had 11 cases of symptomatic COVID-19 infections and 0 cases severe COVID-19 infections (reference 5, appendix table S13). There were 234 cases of severe “unsolicited” adverse events in the treatment group (reference 5, appendix table S8), and an additional 3,751 “solicited” severe or life threatening (Grade 3 or Grade 4) adverse events (reference 5, appendix table S3 and S4).

By contrast, the control group had 185 cases of symptomatic COVID-19 infections and 30 cases of severe COVID-19 infections. However, only one of these case of COVID-19 out of 15,166 controls required admission to an intensive care unit (see reference 5, appendix table S13). There were 202 cases of severe “unsolicited” adverse events in the placebo group and an additional 711 “solicited” severe or life threatening (Grade 3 or Grade 4) adverse events.

There were 3 deaths in the placebo group and 2 in the vaccinated group (reference 5, appendix table S8).

Pfizer-BioNTech
The Pfizer-BioNTech (Pfizer) pivotal Phase III trial results are published in the New England Journal of Medicine [6]. The Pfizer trial was classified as a Phase 1/2/3 trial. Two shots were administered 21 days apart. The primary endpoint was confirmed COVID-19 infections 7 days after the second dose. A post hoc analysis of severe COVID-19 infections was included in the appendix published by the NEJM. The study randomized 43,548 individuals of which 100 did not receive injections, 21,720 received injections with the vaccine and 21,728 received injections with placebo.

“Solicited” adverse events were collected 7 days after immunization and “unsolicited” severe adverse events were reported up to 14 weeks after administration of the second dose. However, median safety follow up for “unsolicited” events was only approximately 2 months after the second dose at the time of publication in the NEJM. In the treatment arm there was 1 case of severe Covid-19 (reference 6, appendix table S5), 240 “unsolicited” severe adverse events and 21 “unsolicited” life threatening adverse events (reference 6, appendix table S3).

In the placebo arm, there were 9 cases of severe COVID-19, 139 “unsolicited” severe adverse events and 24 “unsolicited” life threatening adverse events. Pfizer used a safety subset of approximately 8,183 (both vaccinated and unvaccinated) to record “solicited” adverse events at 7 days. These data that are not shown in Table 1 in part because the data was depicted graphically in the NEJM manuscript.

Janssen
The Janssen pivotal Phase III trial design and trial results are published in the New England Journal of Medicine [4]. The primary endpoint was prevention of molecularly confirmed, moderate to severe–critical COVID-19 14 days post vaccination however a secondary endpoint was prevention of molecularly confirmed, severe–critical COVID-19 14 days post vaccination. This later endpoint allowed for a direct comparison to severe adverse events.

The study randomized 19,630 to receive a single injection with Janssen’s adenovirus COVID-19 vaccine and randomized 19,691 to receive a single injection with placebo. “Solicited” adverse events were collected 7 days after immunization and “unsolicited” adverse events were reported up to 28 days after administration of the single dose of vaccine. The treatment group had 21 cases of severe or critical COVID-19 infections while the placebo control group had 78 (reference 4, appendix table S9).

Further analysis shows that only 2 of 19,514 immunized patients needed medical intervention for COVID-19 infections starting 14 days after immunization, while only 8 of 19,544 controls needed medical intervention for COVID-19 infections starting 14 days after placebo injection where the COVID-19 infection was confirmed by a central lab (reference 4, appendix table S10).

There were 83 “unsolicited” and approximately 492 “solicited” serious adverse events in the vaccinated group compared to 96 “unsolicited” and approximately 157 “solicited” serious adverse events in the control group (reference 4, appendix table S7). There were 3 deaths in the treatment group and 16 in the control group (reference 4, appendix table S7).

Discussion

Scientific analysis of the data from pivotal clinical trials for US COVID-19 vaccines indicates the vaccines fail to show any health benefit and in fact, all the vaccines cause a decline in health in the immunized groups. Health is the sum of all medical events or lack there of. COVID-19 vaccines are promoted as improving health while in fact there is no evidence that these vaccines actual improve health in the individual or population as a whole.

The current analysis used the proper scientific endpoint of “all cause severe morbidity”, a true measure of health. By contrast, manufactures and government officials promote the vaccines using a surrogate measure of health, severe infections with COVID-19, and the disproved philosophical argument that this surrogate endpoint equates to health. This substitution of philosophy for science is extremely dangerous and is certainly leading to a catastrophic public health event.

Review of data from the three COVID-19 vaccines marketed in the US shows complete lack of a health benefit and even an increase in severe events among vaccine recipients. The proper scientific clinical trial endpoint, “all cause severe morbidity” was created by combing all severe and or life threatening events, both infectious and non-infectious, occurring in the vaccinated and placebo control groups respectively.

The data (Table 1) shows there are clearly more severe events in the vaccinated groups. The results are highly statistically significant. The use of a true scientific measure of health as an endpoint for a vaccine trial gives a contrasting result compared to the use of a non-scientific surrogate endpoint of heath, severe infections with COVID-19.

There is an old saying, fool me once shame on you, fool me twice shame on me. This saying can be applied to the COVID-19 mass immunization program. The US anthrax attack of 2001, which originated at US army is Fort Detrick, has demonstrated that there are people in the US government who desire to attack US citizens with bioweapons [10].

According to the chief FBI agent leading the investigation of the US anthrax attack, conspirators were likely not apprehended in part because the investigation was prematurely ended and prior to stopping the investigation, people at the top of the FBI deliberately tried to sabotage the investigation [11]. In the US anthrax attack of 2001, people high in the US government publicly anticipated the anthrax attack as early as 1999 [10].

Similarly with the COVID-19 attack, people high in government anticipated the COVID-19 attack [12,13] several years before the attack took place [10]. There is even data that an effort was made in 2018 to protect certain populations against COVID-19 by immunizing them with MMR vaccine [14].In such a hostile government environment, the citizens need to individually evaluate the science of immunization with COVID-19 vaccines and not rely on philosophical arguments propagated by government officials.

In this case there is no scientific evidence that the COVID-19 vaccines improve the health of the individual, much less of the population as a whole. Mass immunization with COVID-19 vaccines is certainly leading to a catastrophic public health event.

The bottom line

These Covid vaccines have been promoted and widely utilized under the false claim they have been shown to improve health, but the claim is only a philosophical argument and not science based, and in a mounting numnber of cases, these vaccines can be shown to be detrimental to your health.

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