EMERGENCY! TRUMP MUST GO TO PRISON! FOR ECONOMIC MALPRACTICE! USA IS NOW ON THE EDGE OF TOTAL COLLAPSE ELON MUSK SLAMS TRUMP FOR TAX CUTS FOR THE RICH ADDDING TO THE BUDGET DEFICIT, NATIONAL DEBT AS TRUMP BRINGS US TO COLLAPSE

IN THE ENIVRONMENT OF TRUMP S TRADE WAR, SABOTAGING THE US ECONOMY, TRUMP S HUGE TAX CUTS FOR THE SUPER RICH  WILL FUEL INFLATION

THE NOTION THE TAX CUTS WILL FUEL ECONOMIC GROWTH AND SO GENERATE MORE TAXES TO PAY OFF THE EXTRA DEBT AND SERVICE THE GROWING BUDGET DEFICIT IS FANTASTICAL

TRUMP S TAX CUTS WILL LIKE FUEL INFLATION AS THEY DID DURING TRUMP S FIRT TERM

FUELLING INFLATION WILL COMPEL THE FED TO RAISE INTEREST RATES

LOWERING INTEREST RATES WILL FUEL INFLATION, WILL NOT BOOST THE ECONOMY

A WEAKER DOLLAR WILL FUEL INFLATION TOO

BOND RATES WILL SOAR AS THE ECONOMY COLLAPSES

MILLIONS OF AMERICANS WILL LOSE THEIR HOMES AS THEY CANNOT AFFORD THEIR MORTGAGES

BANKS WITH MORTGAGE BASED ASSETS IN THEIR PORTFOLIO WILL GO BANKRUPT

RAISING INTEREST RATES IN AN ENVIRONMENT OF RECORD GOV DEBT WILL LEAD TO  A MASSIVE RECESSION, US ECONOMIC COLLAPSE

US CREDIT RATING IS UNDER THREAT RISKING A SEMI AUTOMATIC RISE IN INTEREST RATES

TRUMP IS FUELLING DEFAULT FEARS BY HIS MAR A LAGO ACCORD, PLANNING TO DEFAULT ON BONDS, GIVE ZERO INTEREST

ANY NEW US CURRENCY CANNOT BE CREATED AND BACKED BY BITCOIN (A PONZI SCHEME)  OR GOLD (TOO LITTLE TO BACK AN ECONOMY IN THE 20TH CENTURY

PHYSICAL GOLD COULD NOT SUPPORT THE COMPARATIVELY TINY ECONOMY OF ANCIENT ROME LET ALONE A MODERN ECONOMY LIKE ITALY OR THE USA

ANY GOLD WILL HAVE TO BE DEBASED WITH OTHER METALS, FUELLING INFLATION

WILL ALSO FUEL SOCIAL UNREST AS FOOD STAMPS WILL BE CUT, THE RICH CRASH THE ECONOMY AND  FILL THEIR POCKETS AT THE EXPENSE OF THE REST

THEY MAY SOON FIND THEIR BITCOIN HOLDINGS ARE WORTHLESS AND THEY ARE THE VICTIMS OF PUMP AND DUMP PONZI SCHEME

STARVATION MAY BE LOOMING FOR MAINSTREAM AMERICANS AS THE ECONOMY COLLAPSES

LIKELY TRUMP, GATES, SOROS AND HIS CRONIES ARE PLANNNG TO BUY UP FARM LAND, ASSETS FOR PENNIES AFTER CRASHING THE ECONOMY, CAUSING INFLATION, HYPERINFLATION, DEFLATION

CHINA WILL SOON BUY UP MAR A LAGO AS TRUMP WILL END UP THE BIGGEST VICTIM OF HIS CRAZY ECONOMIC PLANS ALONG WITH GATES, SOROS

CHINA MAY BUY UP THE ESTATE OF PAM BONDI AND ANY ASSETS IN FLORDIA ETC BEFORE SHE GOES TO PRISON ALONG WITH TRUMP, RFK JR, GATES, SOROS

TRUMP, LUTNIK AND BESSENT NEEDS TO GO TO PRISON FOR ECONOMIC MALPRACTICE

CANNOT BE ALLOWED TO GET AWAY WITH THEIR DELIBERAT ECOLLAPSE OF THE US ECONOMY TO ENHANCE THEIR FORTUNES AND GET TOTAL CONTROL OF THE IMPOVERISHED AMERICANS

FROM MEDIA

Elon Musk has hit out at President Donald Trump's signature tax and spending bill, describing it as a "disgusting abomination", in a widening rift between the two.

The tech billionaire posted on X that the bill would add to the US budget deficit and saddle Americans with "crushing" debt.

The budget, which includes huge tax breaks and more defence spending, was passed by the House of Representatives last month and is now being considered by senators.

"Shame on those who voted for it," said Musk, hinting that he may try to unseat the politicians responsible at next year's midterm elections.

In a series of posts on X on Tuesday, Musk said that the "outrageous, pork-filled" spending bill will "massively increase the already gigantic budget deficit to $2.5 trillion (!!!) and burden America [sic] citizens with crushingly unsustainable debt".

In American politics "pork" refers to spending on projects in lawmakers' constituencies.

Musk has previously vowed to fund campaign challenges against any Republican that votes against Trump's agenda. But on Tuesday he fired a warning to those who backed the bill.

"In November next year, we fire all politicians who betrayed the American people," he wrote.

CHINA PREPARES TO CRUSH THE US ECONOMY, BRING PRODUCTION LINES TO A HALT AFTER TRUMP AND HIS WEF CRONIES MISCALCULATE IN THEIR TRADE CHAOS

 TRUMP HAS CAUSED ECONOMIC RUIN TO AMERICA

HIS ILL JUDGED TRADE WAR AGAINST CHINA HAS EXPOSED THAT AMERICA NEEDS CHINESE IMPORTS FAR MORE THAN CHINA NEEDS US EXPORTS

THIS FACT HAS BEEN CENSORED USING CRIMINAL MEANS ALSO BY TRUMP, KUSHNER E 17 449

THE RESULT WILL BE RECESSION

Trump said Xi Jinping was “extremely hard to make a deal with” as China is preparing to destroy much of what is left of America s manufacturing base by withholding key products as part of a trade war initiated by Trump.

Trump said the Chinese leader was “very tough” in a post on his Truth Social account  sent at around 2am Washington time.

This , as the threat of factory production lines grinding to a halt  in the USA  highlighting " the immense power of China in this crucial market, and the power of its hand in negotiations," as The Telegraph reports.

He may have been kept awake by the prospect of prison due to economic malpractice  after he and his cronies, 9 11 insider Howard Lutnik and ex Soros staffer Scott Bessent were radically wrong to assume the Chinese economy need a deal with the USA or America s export market.

"Trump has a tough pill to swallow: it is his arch-rival who looks to have the better negotiating hand," and as his MAGA supporters may decide they want to see Trump and his family and cronies in prison for economic crimes.

China’s near-total dominance of the world’s supply of rare-earth metals – which are used in the manufacture of everything from cars and computer chips to F-35 fighter jets and nuclear-powered submarines – means Xi can squeeze the US where it hurts.

“Critical minerals are one of the most important bargaining chips for China in its negotiations with Washington. China will really hold on to this, as a significant point of leverage,” says Matilda Buchan, a senior analyst at Asia House, a London think tank.

What incentive does China have to deliver products to a government which declares openly China its biggest enemy, makes thinly veiled threats to destroy China, attac China, overthrow the CCP just for gowing their own economy.

China has a central bank which can print free money to make virtually limitless investments in business while Trump refuses to renationalie the Fed.

Trump seems trying to destroy the American econony to impose a tyranny by the oligarchs.

https://www.telegraph.co.uk/business/2025/06/04/trump-tariffs-china-xi-trade-deal-deadline-ftse-100-markets/

From The Telegraph

Trump cornered

The threat of factory production lines grinding to a halt highlights the immense power of China in this crucial market, and the power of its hand in negotiations.

China’s mines churn out about 61pc of the world’s rare earths, according to the International Energy Agency (IEA). Chinese refiners and manufacturers also hoover up most of the rare earths from elsewhere, processing 92pc of the world’s supply.

It is refining that is key, as this is the process that turns the material into a usable product.

The country has a particular stranglehold on the manufacture of magnet alloys containing rare earths, which have near-ubiquitous application in computing, vehicular and electrical systems.

“Particularly as you move further down the supply chain, from mined products towards downstream highly engineered products, China’s market share only grows,” Merriman says. “Its grip only gets tighter.”

https://www.telegraph.co.uk/business/2025/06/04/trump-cornered-china-weaponises-rare-earths-dominance/

Trump has a tough pill to swallow: it is his arch-rival who looks to have the better negotiating hand.

China’s near-total dominance of the world’s supply of rare-earth metals – which are used in the manufacture of everything from cars and computer chips to F-35 fighter jets and nuclear-powered submarines – means Xi can squeeze the US where it hurts.

“Critical minerals are one of the most important bargaining chips for China in its negotiations with Washington. China will really hold on to this, as a significant point of leverage,” says Matilda Buchan, a senior analyst at Asia House, a London think tank.

...

willingness to weaponise the rare-earths supply chain is so potent a threat to the US economy and military that it has already pushed the White House into de-escalating its planned trade war with China.

After Trump’s April 2 “liberation day” announcement raised tariffs on US imports from China to an eventual peak of 145pc, Beijing’s retaliation included a ban on exports to the US of magnet alloys containing key rare-earth materials.

The impact was quickly felt. On May 9, some of the biggest carmakers in the US – including General Motors, Toyota, Volkswagen and Hyundai – wrote to the White House warning that unless China’s export ban was lifted, they would soon have to start cutting back production.

...

Beijing did not just slap a ban on exports, it built a new bureaucratic structure to underpin future rare-earths trade.

China-based companies wanting to export metal alloys containing more than a trace of seven key rare earths – samarium, gadolinium, terbium, dysprosium, lutetium, yttrium and scandium – now need to apply for a licence from the commerce ministry.

FBI, COMEY, MUELLER HID THE ORIGINS OF THE RUSSIAGATE INVESTIGATION FROM SCRUTINY USING A SECRET PROHIBITED ACCESS CODING

THREE GUESSES WHAT NAME MAY HAVE BEEN HIDDEN BY THE PROBITED ACCESS CODE TO HIDE THE TRUE ORIGIN OF RUSSIAGATE AND THE FACT COMEY, THE FBI KNEW SOROS, GATES AND BIDEN WERE PLANNING A BIOWEAPONS ATTACK ON THE AMERICANS USING CENSORSHIP IN 2016,2017?

From media

This contrasts with FBI documents categorized in Sentinel as “Restricted Access.” While that restriction prevents FBI agents from viewing the contents of “Restricted Access” files, Sentinel will nonetheless show there are hits for the search terms. Other investigators will thus know that potentially relevant evidence exists. Not so with the “Prohibited Access” code, which will leave other FBI wrongly believing there are no responsive documents.

That senior officials overseeing the investigation into the origins and handling of Crossfire Hurricane did not know of the “Prohibited Access” coding, and that Mueller’s special counsel office used that functionality to render invisible materials connected to the investigation into President Trump, is scandalous. Now in question is the entirety of Special Counsel John Durham’s investigation into the Russia-collusion hoaxers, as well as Inspector General Michael Horowitz’s investigation into FISA abuse related to Carter Page.

Whether Special Counsel Durham and Inspector General Horowitz obtained access to all relevant evidence related to the Crossfire Hurricane conspiracy to interfere in both President Trump’s 2020 election and his first administration now remains in doubt — and will until FBI Director Kash Patel reveals the extent to which the get-Trump faction buried evidence of their malfeasance.

https://thefederalist.com/2025/06/02/senior-doj-officials-didnt-know-database-allowed-fbi-to-bury-existence-of-russiagate-documents/

Jamie Dimon talks a lot of sense about the enemy within but time is running out for him to act to remove Trump and the Gates, Soros oligarchy before they destroy the USA

JAMIE DIMON SAYS HE IS MORE WORRIED ABOUT THE ENEMY WITHIN THAN ABOUT CHINA

BUT IF HE WANTS TO SAVE THE USA HE MUST LEVERAGE ALL HIS POWER TO REMOVE THE ENEMY WITHIN 

CAN REMOVE TRUMP, BIDEN, SOROS, GATES LEGALLY AND REBOOT THE USA USING THE GREEK PROSECUTOR PROBES

ALTERNATIVE FOR THE US SUPER WEALTHY IS BECOMING SUPER POOR AS MERELY MOVING THEIR INVESTMENTS INTO OTHER COUNTRIES MAY NOT KEEP THEIR MONEY TOGETHER

From media

MONDAY, JUN 02, 2025 - 01:05 AM

JPMorgan Chase CEO Jamie Dimon argued at the inaugural Reagan National Economic Forum in California that the U.S. should should stockpile guns, ammunition and drones rather than Bitcoin.

“We should stockpiling guns, bullets, tanks, planes, drones, you know, rare earths. We know we need to do it. It’s not a mystery,” Dimon said, referencing President Donald Trump's executive order in March that established a Bitcoin reserve.

Dimon is by now well known for his dislike/disapproval of cryptocurrencies (even though his own bank now allows clients to trade them); which should come as no surprise since the concept of sovereignty and democratizing finance is the nemesis of the established 'trust us with your cash' regime of banking rent-seekers.

“We should be stockpiling bullets,” he continued.

“Like, you know, the military guys tell you that, you know, if there’s a war in the South China Sea, we have missiles for seven days.

Okay, come on. I mean, we can’t say that with a straight face and think that’s okay.

So we know what to do. We just got to now go about doing it. Get the people together, roll up our sleeves, you know, have the debates.”

The sweeping discussion covered everything from the domestic US economy to how the world's "tectonic plates are shifting" in geopolitics in the form of wars, proxy terrorists and the potential proliferation of nuclear weapons. 

Dimon underscored during his address that he does not view China as America's top adversary, and instead pointed his attention to the "enemy within" that could lead to the U.S. losing its status as the world's leader. 

"I'm not as worried about China," Dimon said. 

"China is a potential adversary. They're doing a lot of things well, they have a lot of problems. But what I really worry about is us. Can we get our own act together, our own values, our own capability, our own management?"

Dimon warned that a crack in the bond market is “going to happen” after the US government and Fed “massively overdid” spending and quantitative easing.

“I just don’t know if it’s going to be a crisis in six months or six years, and I’m hoping that we change both the trajectory of the debt and the ability of market makers to make markets,” the JPM CEO said Friday at the Reagan National Economic Forum. 

“Unfortunately, it may be that we need that to wake us up.”

With Swap Spreads starting to blow out again, Dimon maybe right sooner than expected.

“I tell this to my regulators,” Dimon said Friday. 

“I’m telling you it’s going to happen, and you’re going to panic. I’m not going to panic, we’ll be fine. We’ll probably make more money and then some of my friends will tell me that we like crises because it’s good for JPMorgan Chase - not really.” 

But Dimon was not done yet. He took a shot at Democrats and their insane green and border policies...

“Immigration… what the hell were we doing?

The bottom 20% of our population’s wages haven’t gone up in 20 years.

The Biden admin was wasting so much money on “green” stuff that we know won’t work...meanwhile our schools don’t work.”

"Do you think people in rural cities, do you think people in inner cities thought they were getting anything? Do you think that those people think the American government is fair and competent and that this was in their best interest?" he asked rhetorically.

"Their schools don't work, they're not getting the skills they need… so we've gotta acknowledge these."

Referring to what he calls "blue tape," Dimon went on to blast the left for their regulatory obsession and desire to make life difficult.

"Democrats, they love it, they want more of it, and they want to make it so confusing. You can't even meet the rules, so you get punished and fined afterward." 

Dimon referred to the U.S. government as a "Leviathan" that is too weak to carry out policies, while simultaneously imposing "things on the American public that they're getting sick of." 

Dimon's solution is that the U.S. needs to celebrate its long-held values.

"Celebrate our virtues: freedom of speech, freedom of religion, freedom of enterprise, equal opportunity, family, God, country," he said.

"You know, and you can acknowledge the flaws that we have, which are extraordinary — what we did the Black population for years. Don't denigrate the great things of this country, because those are two different things."

"We don't talk that much to each other — deal with our policies — this is the enemy within," he continued.

"We've got to fix our permitting our regulations our immigration our taxation, which I, I think they're on their way. We have to fix our inner city schools, our health care system." 

https://www.zerohedge.com/political/big-bank-boss-urges-america-stockpile-bullets-not-bitcoin

TRUMP ALMOST CERTAINLY BACKED ZELENSKY S ATTACK ON RUSSIA TO DEFLECT FROM HIS DESTRUCTION OF THE US ECONOMY, COVID JAB HARMS

According to a Ukraine official, Trump and his team were informed about the decision by Ukrainian forces to destroy dozens of Russian warplanes, including nuclear capable strategic bombers, with a drone attack on air bases deep within Russian territory on Sunday.

When Ukrainian forces decided to destroy 40 aircraft and struck five airfields around Russia, they must have had the backing of Trump.

The operation saw drones hit A-50, Tu-95 and Tu-22M aircraft, escalating nuclear tensions.

Knowing that his base want peace, Trump appears to be have decided to lie to them and claim he had no knowledge of the massive attack deep inside Russian territory just before another round of peace negotiations.

Trump, Kushner, Besssent, Miller, RFK Jr and the other "Epstein?" cronies may be hoping that dragging the USA into war with Russia will help them escape the backlash from their voter base for breaking so many election promises, for  failing to obtain peace, failing to stop the Gaza genocide, failing release the Epstein files, failing to hold Gates and phama accountable for the massive covid jab deaths, failing to protect free speech, failing to improve the economy.

But Trump and his cronies will be disappointed. 

His MAGA voters will not cheer for WW3 with Russia, will not accept martial law, false flags and conscription.

Tthey will not be deflected from the fact Trump is a corrupted fake who has obtained office under false pretenses and is basically following the agenda of the same oligarchy as Biden.

Now that Trump and his cronies have overplayed their hand in the trade war with China and delivered a blow to the US economy, the Senate and Joe Rogan have discussed the 100s of thousands, if not millions of Americans, who died from covid jabs which gave no benefit, they may feel like cornered beasts.

The fact RFK Jr greenlighted another Moderna covid jab using flawed science shows how delusional the clique are.

The backlash was so instant, so huge and so fact based, Moderna had to disable its comments section on X.

Commentators were asking why no one was in prison for the covid jabs and whether Trump and RFK Jr could continue in office when they were breaking their pledges.

https://www.zerohedge.com/geopolitical/will-russias-retaliation-ukraines-strategic-drone-strikes-decisively-end-conflict

Michael Tracey

@mtracey

·

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So we're supposed to believe that no one in the sprawling US intelligence apparatus, which plays a granular, intricate role in the Ukrainian war effort, ever received any "notification" of this massive and unprecedented drone attack on Russian nuclear-capable warplanes

https://www.zerohedge.com/military/ukrainian-drone-swarm-attacks-hit-russian-long-range-bombers

Ukrainian official: We notified the Trump administration in advance of the attack on Russian airports: RTRS

...

Allies not informed of Ukraine’s audacious drone attack

Ukraine did not inform its allies of plans to strike dozens of nuclear bombers deep inside Russia, it has emerged. 

The German government was not informed ahead of time of a Ukrainian drone attack striking targets deep within Russia, a government spokesperson said in Berlin this morning.

“The German government was not informed about this, but that is not necessary because the Ukrainians have the right to defend themselves against a war that violates international law,” the spokesperson said.

It is also understood the attack went ahead without Donald Trump knowing. 

https://www.telegraph.co.uk/world-news/2025/06/02/ukraine-russia-war-latest-retaliatory-strikes-peace-talks/

Sir Keir Starmer’s proposed increase to defence spending will require “chunky” tax rises, the boss of the Institute for Fiscal Studies has said. 

Paul Johnson, the director of the think tank, said tax rises were likely to be the “only choice that is available” to the Prime Minister. 

His comments came after Sir Keir unveiled the Government’s long-awaited Strategic Defence Review in a speech in Glasgow.

The Prime Minister has committed to increasing defence spending to 2.5 per cent of GDP by 2027 and has set out an “ambition” to hit 3 per cent by 2034. 

However, it remains unclear exactly how the Government will pay for its plans to upgrade the nation’s armed forces. 

Mr Johnson said it looked like Sir Keir and Rachel Reeves, the Chancellor, would have to turn to tax rises. 

He told Times Radio: “It looks like the Government wants to reinstate the winter fuel payment. It’s thinking about the two-child limit for benefits. 

“We’ve got a spending review next week. And if we’re really going to spend another £10-15 billion a year on defence, whilst inevitably we’re going to spend more and more on health and pensions and so on, you really do have to ask that question, what are the choices that you’re going to make? 

https://www.telegraph.co.uk/politics/2025/06/02/strategic-defence-review-latest-keir-starmer-john-healey/

DR JOHN CAMPBELL SLAMS FDA, RFK JR FOR ALLOWING THE FDA TO GIVE MODERNA S NEW COVID JAB APPROVAL DESPITE A FLAWED TRIAL DESIGN, EVIDENCE OF SIGNIFICANT HARMS!

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)

MODERNA FORCED TO CLOSE COMMENTS ON X AFTER BEING INUNDATED WITH CRITICISM FOR GETTING THE FDA TO APPROVE ANOTHER DANGEROUS MRNA COVID JAB

 Last month, the FDA announced that Covid vaccines would not be offered this fall to healthy children and adults. At the same time, the Trump administration stated that any new Covid vaccines must undergo clinical trials using an inert placebo—such as saline—rather than being tested against existing approved vaccines.

From media

Moderna's X post was met with heavy backlash, as many users voiced outrage over the FDA's approval, under Health Secretary RFK Jr., of yet another round of Covid vaccines.

Moderna's social media team disabled comments on the post. Bottom line: people are furious:

X user KAS14599753: "When your products are so safe and effective, you turn off the comments."

X user Dr Aseem Malhotra: "Complete and total madness. This company ( like Pfizer ) should be under investigation."

X user Gadsden2020: "Gee, I wonder why they don't let everyone comment on this? Could it be that they know people aren't buying their bullshit anymore? We know it's only about the $$$."

X user DocAhmadMalik: "Thank you, Donald Trump, Bobby, Jay, and Aseem, for proving that you are in on the game or totally hopeless."

Despite the backlash on X, Wall Street analysts welcomed Moderna's new Covid vaccine, viewing it as a potential catalyst to lift the battered stock off its 52-week lows (list courtsey of Bloomberg):

...

All you need to know: Moderna disabled comments on its X post—clearly unable to handle the wave of criticism over its new product.

As for Trump's MAHA agenda, X sentiment isn't thrilled—many are voicing frustration with RFK Jr.'s FDA and its latest vaccine approval. Why not approve alternative treatments?

https://www.zerohedge.com/markets/moderna-disables-comments-x-post-announcing-new-covid-shot-amid-backlash