CRISIS IN DEMOCRACY AS RFK JR AND TRUMP BREAK EVERY ELECTION PLEDGE TO FOLLOW STANDARD SCIENCE IN APPROVING JABS
NEW MODERNA COVID MRNA JAB APPROVED DESPITE A FLAWED DESIGN, MAJOR SIDE EFFECTS
DR JOHN CAMPBELL CALLS THE DECISION HUBRIS, SPECULATES ON FINANCIAL INTERESTS
ANY ATTEMPT TO GIVE THE AMERICANS MORE OF THESE SHOTS COULD TRIGGER A MASS ARMED UPRISING JOINED BY THE US MILITARY WHO PLEDGE AN OATH TO PROTECT AMERICANS FROM DOMESTIC TYRANTS ALSO GIVING PEOPLE BIOWEAPONS
THE APPROVAL SHOWS RFK JR, TRUMP, GATES AND PHARMA ARE LIVING IN A WORLD OF FANTASY AND DELUSIONS
RFK JR, TRUMP NOW IDENTIFIED AS CONTROLLED OPPOSITION IN THE POCKET OF CRIMINALS, NEED TO FACE TRIAL LIKE GATES, SOROS, BOURLA AND BESSENT
Must watch video by Dr John Campbell on the unbelievable decision bt RFK Jr and the FDA to approve yett another dangerous jab on the basis of flawed design breaking election promises.
https://www.youtube.com/watch?v=BgWun8AkUWs&t=180s
The reasons why Dr John Campbell and other are right to be shocked , disappointed and horified that Moderna s new mRNA covid jab got approval from the FDA are varied and complicated. But they have a lot to do with the fact that Moderna s mRNA covid jab is known to have killed large numbers of people and caused mass sickness.
And this new mRNA covid jab, which produces spike protein, has a flawed trial design and sparse data which points to significant adverse events as well.
This, despite the pledge that RFK Jr made to voters that the FDA would follow science and data to ensure the vaccines Americans are given safe and effective drugs and jabs.
Even under the best conditions, clinical trials with a placebo arm or randomized controlled trial (RCT) don't always deliver satisfying results. But in trials where there is no placebo, where one group is given a vaccine and is compared only with another group with an almost similar vaccine to see the comparative advantage (active controlled trial) then the result cannot give an answer to the key question. Does it work? Is it safe?
Moreover, the study does not clairfy what exactly the new Moderna mRNA vaccine is comparatively more effective at fighting than the old jab.
To sum up. The design is flawed! The science is bad.RFK Jr and Trump have broken their promise to make science the golden standard and guide of public health policiy.
The FDA under RFK Jr has approved a jab on the basis of a flawed study design which from the outset has little chance of providing a clear answer to the key question of whether it works.
But the sparse results presented by Moderna and the FDA do suggest the new jab is anything but safe.
Ok Even while it is not clear if it works, it is clear it harms.
The limited data published by Moderna is associated with significant serious adverse events. including to the heart.
There is no long term data
The bottom line is the same scientific fraud is being perpetrated by the FDA under RFKJr and Trump as under the Biden administration during covid.
Dr John Campbell says the decision to approve this new jab shows hubris and may be due to financial interests.
Other MAGA influencers like Megyn Kelly and Tucker Carlson are speculating the Trump admin may be controlled by the Epstein blackmail ring, a key to understanding the operations of govenrment.
From media
https://bmcmedresmethodol.biomedcentral.com/articles/10.1186/s12874-023-01970-0
Active-control trials, where an experimental treatment is compared with an established treatment, are performed when the inclusion of a placebo control group is deemed to be unethical. For time-to-event outcomes, the primary estimand is usually the rate ratio, or the closely-related hazard ratio, comparing the experimental group with the control group. In this article we describe major problems in the interpretation of this estimand, using examples from COVID-19 vaccine and HIV pre-exposure prophylaxis trials. In particular, when the control treatment is highly effective, the rate ratio may indicate that the experimental treatment is clearly statistically inferior even when it is worthwhile from a public health perspective. We argue that it is crucially important to consider averted events as well as observed events in the interpretation of active-control trials. An alternative metric that incorporates this information, the averted events ratio, is proposed and exemplified. Its interpretation is simple and conceptually appealing, namely the proportion of events that would be averted by using the experimental treatment rather than the control treatment. The averted events ratio cannot be directly estimated from the active-control trial, and requires an additional assumption about either: (a) the incidence that would have been observed in a hypothetical placebo arm (the counterfactual incidence) or (b) the efficacy of the control treatment (relative to no treatment) that pertained in the active-control trial. Although estimation of these parameters is not straightforward, this must be attempted in order to draw rational inferences. To date, this method has been applied only within HIV prevention research, but has wider applicability to treatment trials and other disease areas.
https://bmcmedresmethodol.biomedcentral.com/articles/10.1186/s12874-023-01970-0
What is an active controlled trial?
On the other hand, an active control trial is one in which an investigational drug is compared with an established treatment that has a known degree of effectiveness, with the aim of either demonstrating that the test treatment is as good as or is superior to the active treatment.[3]
The use of control group in clinical trials has been universally acclaimed by researchers to effectively help discriminate between the actual effects of an intervention and those arising from other factors. However, the choice of the control that provided both scientific and ethical acceptability among researchers has been a source of intense debate. We conducted a literature search on the use of placebo and active controls in clinical trials and X-ray the arguments for and against both choices in randomized control trials and concluded by highlighting the scenarios where the use of placebo is justified.
Keywords: Active control, placebo control, randomized controlled trials, research ethics, Essai actif, groupe placebo, essaies contrôlés randomisé, éthiques de recherche
INTRODUCTION
Randomized controlled trial (RCT) is regarded as the “gold standard” in the evidence-based evaluation of new treatments and interventions and is different from other study designs because they are performed under very rigorous conditions.
A high-quality RCT uses randomization, placebo, and double-blind design to minimize bias by isolating the effect of an intervention from other potential causes and ensuring that confounders are evenly distributed between the treatment group and comparator group. These give the assurance of the highest certainty that the observed treatment effects could be attributed to the intervention, rather than to external factors.[1]
The choice between placebo and active controls in clinical trials affects the quality of the result as well as the ethical and scientific acceptability by both the public and regulatory bodies. It has, therefore, continued to generate discuss among researchers.
In this essay, we reviewed the arguments for and against placebo-controlled trials (PCTs) and concluded by highlighting the scenarios where the use of placebo is ethically justified.
https://pubmed.ncbi.nlm.nih.gov/37074202/
Clinical Trial Hum Vaccin Immunother
. 2023 Dec 31;19(1):2190690. doi: 10.1080/21645515.2023.2190690. Epub 2023 Apr 19.
Interim analysis of a phase 1 randomized clinical trial on the safety and immunogenicity of the mRNA-1283 SARS-CoV-2 vaccine in adults
Patrick Yassini 1 2, Mark Hutchens 3, Yamuna D Paila 4, Lorraine Schoch 4, Anne Aunins 4, Uma Siangphoe 4, Robert Paris 4
Affiliations expand
PMID: 37074202 PMCID: PMC10128428 DOI: 10.1080/21645515.2023.2190690
Abstract
This interim analysis of an ongoing phase 1 randomized clinical trial evaluated the safety, reactogenicity, and immunogenicity of mRNA-1283, a next-generation SARS-CoV-2 messenger RNA (mRNA)-based vaccine encoding two segments of the spike protein (i.e. receptor binding and N-terminal domains). Healthy adults aged 18-55 years (n = 104) were randomized (1:1:1:1:1) to receive two doses of mRNA-1283 (10, 30, or 100 µg) or mRNA-1273 (100 µg) administered 28 days apart, or a single dose of mRNA-1283 (100 µg). Safety was assessed and immunogenicity was measured by serum neutralizing antibody (nAb) or binding antibody (bAb) responses. At the interim analysis, no safety concerns were identified and no serious adverse events, adverse events of special interest, or deaths were reported. Solicited systemic adverse reactions were more frequent with higher dose levels of mRNA-1283 than with mRNA-1273. At day 57, all dose levels of the 2-dose mRNA-1283 regimen (including the lowest dose level [10 µg]) induced robust nAb and bAb responses that were comparable to those of mRNA-1273 (100 µg). mRNA-1283 was generally safe in adults, with all dose levels of the 2-dose regimen (10, 30, and 100 µg) eliciting similar immunogenicity as the 2-dose mRNA-1273 regimen (100 µg).Clinical Trials Registration: Clinicaltrials.gov, NCT04813796.
....
Figure 2. Solicited (a) local and (b) systemic adverse reactions within 7 days of each dose. Percentages are based on participants in the solicited safety population, consisting of all randomly assigned participants receiving ≥1 dose and contributing any solicited adverse reaction data. Number of participants in the dose 1 solicited safety population: mRNA-1283 10
https://pubmed.ncbi.nlm.nih.gov/37074202/#&gid=article-figures&pid=figure-2-uid-1
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding: the potential longer refrigerator shelf life and storage advantages of mRNA-1283 compared to Spikevax; and the ability of mRNA-1283 to maintain effectiveness compared to Spikevax. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna's control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others, those risks and uncertainties described under the heading "Risk Factors" in Moderna's Annual Report on Form 10-K for the fiscal year ended December 31, 2023, filed with the U.S. Securities and Exchange Commission (SEC), and in subsequent filings made by Moderna with the SEC, which are available on the SEC's website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna's current expectations and speak only as of the date of this press release.
https://investors.modernatx.com/news/news-details/2024/Moderna-Achieves-Positive-Interim-Results-from-Phase-3-Trial-of-Next-Generation-COVID-19-Vaccine/default.aspx
https://clinicaltrials.gov/study/NCT05815498?id=NCT05815498&rank=1
Study of mRNA-1283 Injection Compared With mRNA-1273 Injection in Participants ≥12 Years of Age to Prevent COVID-19 (NextCOVE)
ClinicalTrials.gov ID NCT05815498
Sponsor ModernaTX, Inc.
Information provided by ModernaTX, Inc. (Responsible Party)
Last Update Posted 2025-05-07
Study Overview
Brief Summary
The purpose of this study (Part 1 and Part 2) is to evaluate the relative vaccine efficacy (rVE), safety, reactogenicity, and immunogenicity of mRNA-1283.222 versus mRNA-1273.222 (Part 1) and mRNA-1283.815 versus mRNA-1273.815 (Part 2).
Official Title
A Randomized, Observer-Blind, Active-Controlled Phase 3 Study to Investigate the Safety, Immunogenicity, and Relative Vaccine Efficacy of mRNA-1283 Compared With mRNA-1273 in Participants Aged ≥12 Years for the Prevention of COVID-19
Design Details
Primary Purpose : Prevention
Allocation : Randomized
Interventional Model : Parallel Assignment
Masking : Quadruple (ParticipantCare ProviderInvestigatorOutcomes Assessor)
Arms and Interventions
Participant Group/Arm Intervention/Treatment
Experimental: Part 1: mRNA-1283.222
Participants will receive single intramuscular (IM) injection of mRNA-1283.222 on Day 1.
Biological: mRNA-1283.222
Sterile liquid for injection
Experimental: Part 1: mRNA-1273.222
Participants will receive single IM injection of mRNA-1273.222 on Day 1.
Biological: mRNA-1273.222
Sterile liquid for injection
Experimental: Part 2: mRNA-1283.815
Participants will receive single IM injection of mRNA-1283.815 on Day 1.
Biological: mRNA-1283.815
Sterile liquid for injection
Experimental: Part 2: mRNA-1273.815
Participants will receive single IM injection of mRNA-1273.815 on Day 1.
Biological: mRNA-1273.815
Sterile liquid for injection
What is the study measuring?
Primary Outcome Measures
Outcome Measure Measure Description Time Frame
Part 1: Geometric Mean Ratio (GMR) of Omicron BA.4/5 mRNA-1283.222 Over the Omicron BA.4/5 mRNA-1273.222 Day 29
Part 1: Seroresponse Rate (SRR) Difference of Omicron BA.4/5 Between mRNA-1283.222 and mRNA-1273.222 Seroresponse at the participant level is defined as an antibody value change from baseline below the lower limit of quantification (LLOQ) to ≥4 × LLOQ, or at least a 4-fold rise if baseline is ≥LLOQ and <4 × LLOQ, or at least a 2-fold rise if baseline is ≥4 × LLOQ. Day 29
Part 1: GMR of the Ancestral Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) D614G mRNA-1283.222 Over the Ancestral SARS-CoV-2 D614G mRNA-1273.222 Day 29
Part 1: SRR Difference of Ancestral SARS-CoV-2 D641G Between mRNA-1283.222 and mRNA-1273.222 Seroresponse at the participant level is defined as an antibody value change from baseline below the LLOQ to ≥4 × LLOQ, or at least a 4-fold rise if baseline is ≥LLOQ and <4 × LLOQ, or at least a 2-fold rise if baseline is ≥4 × LLOQ. Day 29
Parts 1 and 2: rVE of mRNA-1283 and mRNA-1273 (Variant Formulations) to Prevent the First Event of COVID-19 The rVE is defined as the percent of reduction in the hazards of the first occurrence of COVID-19 (mRNA-1283 vs. mRNA-1273) starting 14 days after the booster dose. From 14 days after injection to Day 365
Part 1: Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs) Up to Day 7 (7-day follow-up after vaccination)
Part 2: Number of Participants with Solicited Local and Systemic Reactogenicity ARs in Adolescents and Previously Unvaccinated Participants Up to Day 7 (7-day follow-up after vaccination)
Parts 1 and 2: Number of Participants with Unsolicited Adverse Events (AEs) Up to Day 28 (28-day follow-up after vaccination)
Parts 1 and 2: Number of Participants with Any Serious AEs (SAEs), Medically Attended AEs (MAAEs), AEs Leading to Withdrawal From Study, and AEs of Special Interest (AESIs) Day 1 to end of study (EOS) (Day 365)
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