In the first half of 2020 the push to make a coronavirus was moving at breakneck speed. As the clinical phase I trials began in march of 2020 the first of a few dozen healthy volunteers in Seattle, Washington, received a vaccine produced by the american company Moderna in a Phase I Safety Trial sponsored by the U.S. Gov. National Institute of Allergy and Infectious Disease (NIAID) of the National Institute of Health (NIH). Four vaccine candidates were now being prepared for clinical trials.
The Moderna and Pfizer BioNTech vaccines are so-called messenger RNA biologicals – marketed as “vaccines” – that are transported into the body’s cells with the help of nanoparticles that are necessary because mRNA is a large and negatively charged molecule that cannot penetrate into the cells on its own. Inside the cells, they then encode using their mRNA surface proteins that are similar to the surface proteins of the Corona Virus – so-called Spike Protein.
The Oxford-AstraZeneca and Jansenn – Jonson & Johnson biologicals are also based on genetic instructions for building the spike protein. However, unlike Pfizer-BioNTech and the Moderna , which store the instructions in single-stranded RNA, the Oxford-AstraZeneca and Jansenn “vaccines” use double-stranded DNA (read more here).
On 18 March 2020 as Moderna was ready to test its “Vaccine” the journal Nature asked the following “Five key questions as trials begin”
- Do people develop immunity?
- If humans do develop immunity, how long does it last?
- What kind of immune response should vaccine developers look for?
- How do we know if a vaccine is likely to work?
- Will it be safe?
In this publication it was argued that when vaccines are given to a large number of healthy people, the most important issue related to the concept of safety is a phenomenon observed in animal models of corona vaccines called Antibody Dependent Enhancement (ADE).
In studies of an experimental SARS vaccine reported in 2004, vaccinated ferrets (experimental animals) developed harmful inflammation in the liver after being infected with the virus. Their conclusion was that those vaccines induce antibody responses in blood in immunized animals but also induce antibodies that enhance infection by early human SARS-CoV and animal SARS-CoV–like viruses .
Peter Hotez, a vaccine scientist at Baylor College of Medicine in Houston, Texas, said that potential vaccines should be tested in animals first to rule out disease enhancement, before trials move on to humans. He stated that pushing SARS-CoV-2 vaccines to human tests quickly, because of the possibility that these vaccines could enhance disease he states that “I’m not sure this is the vaccine you want to do it for”.
“the NIH will move to larger human studies only once human and animal studies confirm that the vaccine is safe”.
On July 13, 2020, a more comprehensive article was published in Nature in which the authors write:
“Antibody-dependent enhancement (ADE) of disease course is a general concern because the mechanisms underlying antibody protection against viruses have a theoretical potential to amplify the infection or trigger harmful immunopathology after vaccination.”
On September 13, 2020, a third article was published in Nature Microbiology entitled:
After a comprehensive review of the issue, the authors conclude with the following statement –
“ADE has been observed in SARS, MERS and other human respiratory viral infections, indicating a real risk of ADE for SARS-CoV-2 vaccines and antibody-based interventions. However, clinical data have not yet been able to fully establish a role for ADE in human COVID-19 pathology »
The authors go on to state that- “In the future, it will be crucial to evaluate animal and clinical data sets for signs of ADE, and to balance ADE-related safety risk against intervention effects if clinical ADE is observed. Ongoing clinical studies in animals and humans will provide important insights into the mechanisms of ADE in COVID-19. »
So – over time – if the vaccinated are exposed to SARS-Cov2 or possible other corona viruses, what is the probability that their will be an increased risk in vaccinated groups for serious side effects and deaths that can occur after 3 months, 6 months or even one year after receiving the vaccine?
On October 21, 2020, at the same time as the Phase 3 studies ended the recruitment of patients, Peter Doshi, Associate Editor of the British Medical Journal, writes a column entitled
Doshi reviews in detail the parameters related to efficacy measures in the Covid19 vaccine studies where he concludes that as these studies are constructed with only 7 days follow-up after the last dose they will not be able to say anything about real clinical effect related to hospital admissions, deaths or possible reduction of risk of infection.
“Comparing vaccines on the basis of currently available trial (interim) data is made even more difficult by disparate study protocols, including primary endpoints (such as what is considered a COVID-19 case, and when is this assessed), types of placebo, study populations, background risks of COVID-19 during the study, duration of exposure, and different definitions of populations for analyses both within and between studies, as well as definitions of endpoints and statistical methods for efficacy.
Importantly, we are left with the unanswered question as to whether a vaccine with a given efficacy in the study population will have the same efficacy in another population with different levels of background risk of COVID-19.
This is not a trivial question because transmission intensity varies between countries, affected by factors such as public health interventions and virus variants. The only reported indication of vaccine effectiveness is the Israeli mass vaccination campaign using the Pfizer–BioNTech product.
Uncoordinated phase 3 trials do not satisfy public health requirements; platform trials designed to address public health relevant questions with a common protocol will allow decisions to be made, informed by common criteria and uniform assessment. These considerations on efficacy and effectiveness are based on studies measuring prevention of mild to moderate COVID-19 infection; they were not designed to conclude on prevention of hospitalisation, severe disease, or death, or on prevention of infection and transmission potential. Assessing the suitability of vaccines must consider all indicators, and involve safety, deployability, availability, and costs.”
Were the MRNA (Moderna, Pfizer-BioNTech) and Virus Vector (AstraZeneca and Janssen – Johnson and Johnson) Vaccines shown to be Effective?
The approval of the Pfizer-Biontech vaccine builds on an American / German study with approx. 44,000 participants. About 22,000 received the vaccine, the rest received the placebo vaccine. Two doses were given at 3 week intervals. Two doses were given at 3 week intervals.
The approval of the Moderna Vaccine is based on a study with approx. 30,000 participants, half of whom received the vaccine, while the rest received a placebo vaccine. Two doses were given at 28-day intervals. The Pfizer-Biontech study claims that the vaccine was 95% effective in preventing covid-19 disease one week after the last dose, while the Moderna vaccine is claimed to be 94.1% effective in protecting against covid-19 disease from 14 days after the second dose.
In the publication on the safety and efficacy of the Pfizer-BionTech mRNA Covid-19 vaccine published in the New England Journal of Medicine on December 10, 2020, the authors conclude that the vaccine has a 95% efficacy .
The efficacy analysis is associated only with the first 170 showing a SARS-CoV-2 RT-PCR positive test associated with mild symptoms.
“In all ongoing phase III studies where details are provided, laboratory-confirmed cases, even with only mild symptoms, will meet the definition of the primary endpoint.”
Pfizer and Moderna’s studies, for example, have defined a positive laboratory test with an unspecified cough as a basis enough to count as a Covid-19 case. ” For the age group over 65, far too few people are included in this age group to be able to say anything about the end point”.
Doshi emphasizes his previous concerns with the choice of the primary endpoints that are in no way related to important clinical endpoints such as hospitalizations, death or injury or risk of infection.
As he writes…
“All attention has focused on the dramatic efficacy results: Pfizer reported 170 PCR-confirmed covid-19 cases, divided 8 to 162 between vaccine and placebo groups. However, these numbers are overshadowed by a group of patients “suspected covid-19” – those with symptomatic covid-19 who were not confirmed by PCR. According to the US Food and Drug Administration (FDA) report on Pfizer’s vaccine, there were “a total of 3410 cases of suspected but unconfirmed covid-19 in the total study population, 1594 occurred in the vaccine group compared to 1816 in the placebo group.”
Here, there is no statistically or clinically significant difference between vaccinated and non-vaccinated.
But regardless of the effect measure when the follow-up period associated with the analysis of endpoints is only weeks and not months or years – in reality these studies remain a solid biological experiment overshadowed by a possibly real, but still unknown risk of so-called antibody-dependent amplification for those vaccinated as described in animal experiments.
On December 11, 2020 -so then – with a complete lack of safety and clincally relevant and meaningful efficacy data – the US Food and Drug Administration (FDA) issued the first emergency use authorization (EUA) for a vaccine to prevent COVID-19 caused by SARS-CoV-2 in people aged 16 years and older. The authorization use permitted the Pfizer-BioNTech vaccine to be distributed in the United States.
On 21 December 2020, the European Medicines Agency (EMA) granted a conditional marketing authorization for the Pfizer-BionTech Comirnaty .
On 6 January the European Medicines Agency (EMA) granted a conditional marketing authorization for the Moderna vaccine .
On 29 January 2021, the EMA recommended granting a conditional marketing authorization for the COVID-19 vaccine to AstraZeneca in persons aged 18 and over. The company at time of authorization had completed four studies. All four studies were used to look at safety. Two of the studies were used to calculate the effect.
As the studies had a follow-up to end point evaluation of only weeks – not months or years – at time of the launch of the mass vaccination programs there were no long term saftey data and were therefore highly experimental in nature. It was known from animal experiments that corona vaccines could induce so called Antbody Dependant Enhancement – and as has been highlighted, is a phenomena that has been observed in laboratory animals that were observed with severe organ damage after having been exposed too live corona viruses (read more here).
As the mass vaccination program got under way it soon became clear that these “vaccines” were giving more frequent severe adverse reactions and deaths than had been reported from the phase III clincal trials or from the mass vaccination campaigns in 1976 and 2009 H1N1 swineflu outbreaks.
CUMULATIVE ANALYSIS OF POST-AUTHORIZATION ADVERSE EVENT:
REPORTS OF PF-07302048 (BNT162B2) RECEIVED THROUGH 28-FEB-2021
Pfizer’s safety database contains cases of AEs reported spontaneously to Pfizer, cases
reported by the health authorities, cases published in the medical literature, cases from
Pfizer-sponsored marketing programs, non-interventional studies, and cases of serious AEsmreported from clinical studies regardless of causality assessment.
The recently disclosed Pfizer Document from 28-FEB-2021 of postmarketing experience – Pfizer shows that after only two months of the introduction of the Mass Vaccination Campaigns using the highly experimental gene based biologicals all of 39 096 adverse events had been reported to Pfizer of which 1223 (3.1%) inlcuded fatal adverse outcomes.
General Overview: Selected Characteristics of All Cases Received During
the Reporting Interval
The most disturbing from the dataset presented where the number of cardiovascular adverse events that included 3.3% of the total reported AEs.
AESIs Evaluation for BNT162b2
By the end of March 2021 more adverse events had been reported to the US CDC VAERS reporting system than what had been reported for all vaccines over the last 15 years.
In depth analysis of VAERS Data as of April 2021
It also became apparent that the most common severe adverse reactions were due to what is now coined as Vaccine-induced immune thrombotic thrombocytopenia (VITT) (read more here).
As the the intensity of the vaccination efforts have increased – we are seeing a significant increase in the reporting of vaccine adverse events from the US-CDC-VAERS all the other country specific VAE reporting systems.
There are 91x the number of deaths and 276x the number of coagulopathy events reported after COVID-19 vaccination than after flu vaccination.US-CDC VAERS
In a recent (retracted) article in Vaccines risks and benefits of Covid-19 vaccines were assessed by calculating the number needed to vaccinate (NNTV) to prevent one deathfrom a large Israeli field study, the Adverse Drug Reactions (ADR) database of the European Medicines Agency and of the Dutch National Register (lareb.nl). The number of cases reporting severe side effects and the number of cases with fatal side effects were collected. The NNTV was estimated to be between 200–700 to prevent one case of COVID-19 for the mRNA vaccine marketed by Pfizer, while the NNTV to prevent one death is 16,000 95% CI 9000 – 50,000. The number of cases experiencing adverse reactions has been reported to be 700 per 100,000 vaccinations with 16 serious side effects per 100,000 vaccinations, and the number of fatal side effects is at 4.11/100,000 vaccinations. The conclusion of this study is tyat there is lack of clear benefit that should cause governments to rethink their vaccination policy.
Pfizer is now reporting that there are now about 411 deaths per million doses. This means that about 150,000 people have died (from the Pfizer injections).
As more and more younger people are receiving the Covid-19 Vaccines there is now a substantial increase in the frequency of adverse events reporting to all reporting systems worldwide. This includes reports of fatal cardiovascular events and frequent reporting of epicarditis and myocarditis in children and young people as shown in a recent pre-print publication.
This retrospective epidemiological assessment reviewed reports filed to the US-CDC Vaccine Adverse Event Reporting System (VAERS) between January 1, 2021, and June 18, 2021, among adolescents ages 12-17 who received mRNA vaccination against COVID-19. The authorsfound that Post-vaccination CAE rate was highest in young boys aged 12-15 following dose two. For boys 12-17 without medical comorbidities, the likelihood of post vaccination dose two of 162.2 and 94.0/million respectively. This incidence exceeds their expected 120-day COVID-19 hospitalization rate at both moderate (August 21, 2021 rates) and high COVID-19 hospitalization incidence.
As the risk of hospitalization in healthy children and young people is negligent and close to zero – any serious adverse event in these age groups is of grave and serious concern and were hospitalization after severe adverse reaction from the vaccines is now more frequent than from Covid-19 in the age groups under 40.
Data from the European Mortality Surveillance System (euromomo.eu) showed that excess mortality had increased in all age groups that had received the vaccine with the most disturbing in the yungest age group of 15 – 44. In this age group there was a 2.3 x increase in excess mortality from the previous year (2021). Read more here.
The mortality data for England and Wales from the Office of National Statistics (ONS) from 1 May 2021 until 17 September 2021 shows a significant excess, particularly in the 15-19 year age group. Depending on the baseline chosen, the excess for 15-19 year olds is between 16% and 47% above expected levels (. COVID-19 deaths were too small in number to account for the excess. Read more here.
As the mass vaccination campaign is coming into its 12th month and the vaccine producers are seeking full approval from the regulatory authorities -the clinical observations and epidemiological studies now being reported on vaccine adverse events must be of great concern. There remains major issues related to the reporting of the efficacy and safety of the vaccines from the phase III clinical trials as these now so-called open-label studies have major issues in relation to the reliability of the data being presented.
Sen. Ron Johnson held a panel discussion on November 2, 2021 with doctors and medical researchers who have treated COVID-19 vaccine injuries and are researching the safety and efficacy of COVID-19 vaccines, patients who have experienced adverse events due to the COVID-19 vaccine, and vaccine mandates.