Editor of the British Medical Journal, Peter Doshi’s latest paper shows COVID-19 vaccines associated with increased risk of serious adverse events.

Editor of the British Medical Journal, Peter Doshi’s latest paper shows COVID-19 vaccines associated with increased risk of serious adverse events.

Doctor Crashes FDA Meeting and Shares the Whistleblower Story They Ignored - Tennessee Star

Peter Doshi, editor of the British Medical Journal (BMJ) is once again bravely sticking his neck out with his latest co-authored paper.

He and six other authors from the US, Spain and Australia decided to investigate serious adverse events of special interest following mRNA vaccination in randomized trials.

They used a World Health Organisation (WHO) endorsed priority list of adverse events of special interest (AESIs) to identify serious adverse events that occurred during phase III clinical trials on which emergency use authorisation (EUA) was based. The list comprised of adverse events based on the specific vaccine platform, adverse events associated with prior vaccines in general, theoretical associations based on animal models and COVID-19 specific immunopathogenesis.

The study looked at the Pfizer and Moderna trial data which was expected to follow participants for two years. However, after EUA, participants were unblinded and those in the placebo arm offered the vaccine. This meant post authorisation data was less reliable so, to preserve randomisation, the authors used interim datasets from approximately 4 months after the trials commenced.

A serious adverse event (SAE) was defined as an adverse event that results in any of the following conditions: death; life-threatening at the time of the event; inpatient hospitalisation or prolongation of existing hospitalisation; persistent or significant disability/incapacity; a congenital anomaly/birth defect; medically important event, based on medical judgement.

SAE tables were located for both the Pfizer and Moderna trials submitted for EUA in the US. For the Moderna trial, these SAEs were from dose 1 but for Pfizer they were from dose 1 to 1 month after dose 2.

The authors found that, in the Pfizer trial, there was a 36% higher risk of SAEs, unrelated to COVID-19 in vaccinated participants in comparison with the placebo group. The Moderna trial had a 5% higher risk of SAEs. Combined there was a 15% higher risk of SAEs in the vaccine recipient group.

52 AESIs were reported in the Pfizer vaccine group versus 33 in the placebo group. This meant there was a 57% increased risk of serious AESIs and an absolute risk increase of 10.1 serious AESI per 10,000 vaccinated participants.

In the Moderna trial, there were 87 serious AESIs in the vaccine group versus 64 in the placebo group, representing a 36% increased risk. In this trial, there was an absolute risk increase of 15.1 serious AESIs per 10,000 vaccinees.

Combined, there was a 43% increased risk of serious AESIs and an absolute risk increase of 12.5 serious AESIs per 10,000 vaccinated participants.

In both trials, the largest increase in absolute risk was in coagulation disorders. There were more cardiovascular AESIs in the vaccine group in the Pfizer trial but it was balanced in the Moderna trial.

Taking into consideration the harm-benefits, they compared AESIs with vaccine risk reduction for COVID-19 hospitalisation. With the Moderna vaccine, the risk of AESIs was 15.1 per 10,000 participants compared with a Covid hospitalisation risk reduction of 6.4 per 10,000. The Pfizer trial had a AESI risk of 10.1 per 10,000 compared with a hospitalisation risk reduction of 2.3 per 10,000 participants. Therefore, with both vaccines, the risk of AESIs surpassed the risk reduction for COVID-19 hospitalisation.

The paper looks at the FDA reviews of SAEs which concluded that, for Pfizer, were “balanced between treatment groups”. For Moderna, the FDA said that SAEs were “without meaningful imbalances between study arms”. This current study, however, found an increased risk of SAEs so they tried to understand how there could be two very different conclusions. They concluded that the main reason for the discrepancy may be because the FDA used a different, larger analysis population. This was because the FDA included all individuals who had received at least one dose, irrespective of the duration of post-injection follow up time. The authors, in this paper, used a study population with medial follow up >2 months after dose 2, of which 98.1% had received both doses. Therefore, the FDA’S analysis included thousands of additional participants with very little follow-up, of which the large majority had only received 1 dose.

The authors discuss the results which show an excess risk of serious AESIs greater than the reduction in COVID-19 hospitalisation. They say that these results are compatible with another analysis (Benn et al) which found no evidence of a reduction in overall mortality. They say that both papers point to the need for formal harm-benefit analyses especially in individuals at low risk of COVID-19 hospitalisation or death.

It is suggested that because the majority of SAEs are relatively common events (e.g. stroke), signal detection is complicated because clinical suspicion of adverse vaccine reactions will be lower than less common SAEs such as myocarditis. Therefore, there is likely to be over and under reporting. Public health messages assuring safety may lower clinical suspicions whereas messages about potential harms may stimulate reports.

Because this study only looked at SAEs occurring past 1 month after dose 2 there may have been undercounting of serious AESIs.

The authors conclude that a systematic review and meta-analysis using individual participant data should be undertaken to address questions of harm-benefit in various demographic subgroups. Full transparency of the COVID-19 vaccine clinical trial data is needed to properly evaluate these questions. Unfortunately, well over a year after widespread use of COVID-19 vaccines, participant level data remain inaccessible.

Source: nakedemperor.substack.com/p/editor-of-the-british-medical-journal-6d1?utm_source=email

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Science magazine admits covid “vaccines” are useless and harmful

Science magazine admits covid “vaccines” are useless and harmful

Image: Science magazine admits covid “vaccines” are useless and harmful

British researchers say that Wuhan coronavirus (Covid-19) “vaccines” do not provide any real protection against the latest “variant” of the disease, which the establishment is calling “Omicron” (Moronic).

A new paper published in the magazine Science reveals that both antibody and T-cell protection are nowhere to be found post-injection. Meanwhile, the shots leave behind mystery substances inside a person’s body, often leading to chronic illness or early death.

Another thing the paper found is that the “fully vaccinated” are suffering so-called “breakthrough” infections with Moronic, as their T-cell response is now artificially tuned towards earlier variants of the disease such as Delta.

“… when vaccinated but previously uninfected people suffer breakthrough Omicron infections, their T-cell response is biased toward earlier versions of Sars-Cov-2 – not to the Omicron variant that has actually infected them,” writes Alex Berenson on his Substack.

“In other words, the mRNA shots appear to permanently wrongfoot the immune systems of people who receive and bias them toward producing T-cells to attack variants that no longer exist – even though they never were infected with those variants at all.”

Covid jabs destroy natural, non-specific immunity

Natural immunity that has not been damaged by pharmaceutical shots bears a component called non-specific immunity that targets invading pathogens non-specifically. In the case of covid, this means fighting against the virus generally rather than specifically in terms of variants.

After a person gets injected, however, that non-specific immunity becomes altered, and suddenly the body is no longer able to fight off infections as they morph and mutate.

“While antibodies are the first line of defense against infection and try to clear the virus from the bloodstream, T-cells are the crucial second line,” Berenson adds. “They attack and destroy infected cells and also work with other parts of the immune system to produce more and better targeted antibodies later.”

“Vaccine advocates have claimed endlessly that mRNA-generated T-cells help keep people from becoming severely ill with Covid even after frontline antibody protection against infection disappears … This study suggests that supposed protection may be a myth, and the low death rates from Omicron are simply a result of Omicron’s general lack of virulence in vaccinated and unvaccinated people alike.”

The British study further found that another big part of the body’s ability to fight off infections, antibodies, also become damaged by the shots. Post-injection, the immune system is left with the ability to produce only one type of coronavirus antibody, when the reality is that many different antibodies are needed.

Those other antibodies would be produced naturally by the body without the shot. But once synthetic mRNA (messenger RNA) chemicals are dispensed, the immune system is left permanently damaged with no way to fight off illnesses that are constantly changing.

The study acknowledged this fact, however it was buried in highly technical language, suggesting that it was simply too politically incorrect to state plainly. The study also failed to compare the immune responses of the vaccinated to the unvaccinated, which is problematic, to say the least.

“Unfortunately but unsurprisingly, the scientists did not look at the immune responses of anyone who was not vaccinated – with or without previous infection,” Berenson explains. “Thus the paper offers no direct comparison of the way Omicron may affect antibody and B- and T-cell responses in vaccinated and unvaccinated people.”

“Why didn’t the researchers include unvaccinated people? Maybe because nearly all British adults are vaccinated and most boosted, so the authors wanted to concentrate on the risks Omicron poses to vaccinated people … Or maybe because they worried about what they’d find if they directly compared the two groups.”

Source: www.naturalnews.com/2022-06-23-science-magazine-admits-covid-vaccines-useless-harmful.html

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The Massacre of the Innocents

The FDA and CDC launch a reckless nationwide medical experiment on children

I. The government is coming for your kids

Last week was shrouded in darkness. We saw the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) and the CDC’s Advisory Committee on Immunization Practices (ACIP) assemble the pieces of their Final Solution.

The meetings were surreal as so-called “experts” displayed no critical thinking skills and instead wallowed in clichés supplied to them by the pharmaceutical industry.

Over the course of five meetings in five days we witnessed crimes against humanity, the end of the bourgeoisie, and the likely end of America.

Let’s talk about what actually happened at the meetings, the short and long-term implications of the decisions that were made, and where we go from here.

II. The meetings themselves

The clinical trials of Moderna and Pfizer mRNA shots in kids all had the same flaws — enabled and encouraged by the permissive FDA. Moderna and Pfizer each:

1. Failed to demonstrate actual health benefits (so they relied on junk science “immunobridging” even though there are no valid correlates of protection);
2. Wiped out the control group, so there is no long term safety data; and
3. Caused catastrophic adverse events.

Contrary to their statutory obligations, the FDA/VRBPAC and CDC/ACIP do not act as regulators. Instead they see themselves as partners with Pharma. Indeed FDA and CDC officials often slip and say “we” when referring to the applicant — it’s all one big happy crime family.

At the meetings, the FDA and CDC went to great lengths to exaggerate the risks of Covid in children. As you know, there is no Covid-19 emergency in kids But Emergency Use Authorization requires a public health emergency so the FDA and CDC manufacture one.

Many presentations at the meetings last week cited the same British pre-print study that claims that Covid-19 was the 4th or 5th leading cause of death in children in the U.S. This is false.

Kelley Krohnert from Covid Georgia dismantles the pre-print.

The British academics who wrote the paper make two obvious errors. First they count deaths “with Covid” (tested after they got to the hospital for some other reason or underlying condition) as “from Covid.” If you remove the “with Covid” from the tally, the numbers shrink by about 35%.

The second major error in the pre-print is that the authors “compare the cumulative number of Covid deaths over 26 months to deaths from other causes over a one year period.” Whoops. So the FDA and CDC made their case by double-counting Covid-19 deaths in children.

Once these errors are corrected, Covid-19 drops down to the 8th or 9th leading cause of death. But as Ms. Krohnert explains:

Even given the corrected rankings above, there are also issues with the entire concept of showing the impact of Covid deaths in children using rankings. Rankings overstate the impact of Covid, because the top few causes of death far outweigh the causes further down the list. For example, in ages 1-4, accidents account for almost 25 times as many deaths as Covid-19 on an annualized basis. Furthermore, for each of the 4 age groups covered by the CDC slide, the very broad “accidents” is the leading cause of death. If we break that down further, causes of death like drownings, vehicle crashes, drug overdoses, would be individual causes of death greater than Covid in various age groups.

For those who want to argue, “if-it-even-prevents-one-death(TM)”: Covid-19 is NOT a vaccine-preventable-disease given that these shots do not stop infection, transmission, hospitalization, nor death. And given adverse events, Covid-19 shots will cause a net increase in deaths not a decrease.

If one really cares about the health of children, mandate fences around swimming pools, not experimental gene-modifying injections for the entire childhood population.

Ms. Krohnert contacted the authors of the paper to alert them to these errors and now they are revising the paper (a new draft is due next week). Of course, the FDA and CDC never admit that they were wrong because they don’t actually care about data.

At these meetings it is standard practice for FDA and CDC to lie about the benefits of these shots. Indeed the FDA went to great lengths to downplay the risk of vaccine-induced myocarditis in the briefing documents for Moderna and Pfizer. In preparing these documents the FDA relies on fixers — Matt Oster, Tom Shimabukuro, and John Su at CDC and Nicola Klein at Kaiser Permanente — to manipulate the data to fit the Pharma narrative.

However, one of the unusual things about the VRBPAC meeting on Tuesday is that Ruth Link-Gelles from CDC just straight up admitted that these shots have negative efficacy.

Then Tom Shimabukuro (citing his own slides and those from John Su and Nicola Klein) just straight up admitted that these shots cause myocarditis:

So I’m watching at home thinking… ‘no observed health benefits (that’s why they had to switch to immunobriding) and they are admitting that the shots have negative efficacy and cause myocarditis, therefore the risks outweigh the benefits. So how are they going to try to get out of this?’

And their argument is (supplied by Jacqueline Miller, Senior VP at Moderna) that the risk of myocarditis from Covid is greater than the risk of myocarditis from these shots. One of the obvious problems with that argument is that THESE SHOTS DO NOT PREVENT COVID. So the FDA is accepting a known risk from these shots in return for an imagined benefit that does not exist in the real world.

The VRBPAC and ACIP do not care about the facts at all. As George Lakoff famously observed, “facts bounce off of frames” and the frame that guides these public health zombies is, “vaccines are infallible.”

Adverse events. Others have done a better job of flagging adverse events in these clinical trials. Quant genius Jessica Rose wrote an excellent article about the harms in the Pfizer clinical trial and the Moderna clinical trial.

Look at pages 169 to 171 of the FDA briefing document for Moderna that showed 18 serious adverse events in the vaccine group as compared with only 1 in the placebo group in kids 6 through 23 months of age.

Furthermore, no one at the FDA/VRBPAC nor CDC/ACIP can explain why VAERS reports skyrocketed following the introduction of Covid-19 shots at the end of 2020 and why reports of vaccine injury in kids skyrocketed following the authorization of the Pfizer mRNA shot in kids last fall. Indeed FDA honcho Peter Marks had a meltdown at the end of the VRBPAC meeting on Wednesday because VAERS was trending on Twitter (apparently the public was not impressed with the VRBPAC’s self-serving nonsense).

Further observations:

At these meetings there is no critical thinking, no hard questions, and no debate.

There’s no science at all at these meetings, just a theatrical performance of science-y sounding things.

Quite literally, these so-called experts apologized to Moderna for asking them questions.

No one asks about adverse events.

There’s no discussion of antibody dependent enhancement, prion disease, or any of the other nightmare possibilities that seem to be emerging.

No VRBPAC member ever uses the phrase “negative efficacy” — even though the Pfizer application in kids showed negative efficacy between dose 1 and dose 2 and negative efficacy against the Omicron variant.

Antibodies are accepted as a valid measure even though everyone knows that there are no correlates of protection.

No one questioned the fact that FDA and CDC spent a year minimizing the risks of myocarditis and still could not get the safety signal to go away entirely.

No one questioned the fact that the international scientific consensus is that mRNA shots cause myocarditis in young people and that the U.S. is the only country in the world to push these shots on little kids.

The VRBPAC and ACIP members live in an alternative universe where sacrificing children is always acceptable to serve “The Greater Good(TM).”

VRBPAC and ACIP meetings are a horror movie come to life.

While these shots showed no benefit and catastrophic harms… the VRBPAC members wanted MORE, MORE, MORE!

Paul Offit led the charge on Tuesday by arguing that Moderna’s toxic shot should be a THREE dose series instead of the two doses that Moderna was applying for. Because VRBPAC members are selected for ideological conformity and groupthink, several other members piled on and echoed Offit’s call for MORE Moderna doses in kids.

On Wednesday, Offit again led the charge by arguing that Pfizer was “underdosed” (his word) at 3 mcg of mRNA in little kids and that they should have put MORE mRNA in there to produce a larger antibody response — adverse events in children be damned.

At this point, the bloodlust of these committees is unquenchable.

In the end, there was no need to even hold the meetings because the decisions were already made before they started.

On Tuesday, VRBPAC voted 21 to 1 to authorize the Moderna EUA application to inject mRNA into kids 6 to 17 years old. (There was 1 abstention — from the new guy, Bruce Gellin.)

On Wednesday, VRBPAC voted 21 to 0 to authorize the EUA applications to inject Moderna into kids 6 months to 5 years old and Pfizer into little kids 6 months to 4 years old.

On Saturday the CDC let it slip that Covid-19 shots in kids will be 10-dose vials. 10-dose vials are terrible because administration errors go up and because it’s impossible to guarantee consistency across doses (unless perfectly shaken before each dose, the ingredients may not be evenly distributed across the 10 doses). The federal government has paid billions of dollars to these companies up front for these shots. The fact that they did not require single dose vials shows that they do not know what they are doing and they have absolutely no concern for your health.

At the end of the meeting Saturday ACIP voted 12 to 0 to authorize the applications to inject Moderna and Pfizer into little kids.

Rochelle Walensky signed off on the Final Solution on Saturday night.

The federal government’s massacre of the innocents began Monday June 20, 2022.

III. The short and long-term implications of these decisions

The VRBPAC and ACIP believe that they achieved some sort of great victory. They got nostalgic at the end of the meeting as they looked back over the Final Solution that they had constructed over the last year. One can imagine Reinhard Heydrich and the other participants in the Wannsee Conference in 1942 felt the same way.

The reality is quite different. The FDA and CDC have guaranteed their own collapse.

Here’s how the next few years are likely to play out:

About one-third to half of the Democratic Party (including the overwhelming majority of the public health establishment) are afflicted with hypochondria, Stockholm Syndrome, and/or Munchausen Syndrome by Proxy. They are going to take their kids to be injected right away at any nearby CVS, Walgreens, or out of the back of a windowless van down by the river. They don’t care — “needles into arms (and legs)” is the only thing that Democrats believe in now. They’re junkies who get high from deadly virtue signaling.

Those poor kids are going to develop a wide range of adverse events — myocarditis, heart attacks, strokes, autoimmune disorders, cancer, endocrine disorders, infertility, and sudden “unexplained” death, to name a few. The over-boosted adults will suffer a similar fate. The bourgeoisie will lose their health, their dignity, and then all of their wealth to the Pharma cartel.

Over time, about half of injured families will come over to our side and become single issue medical freedom voters. That will give us the numbers we need to take power and prosecute the evil doers. All of the demographic advantages that Democrats thought would carry them to permanent majorities will evaporate.

Republicans, who understand vaccine injury better than Democrats at this point, will win the November midterm elections, the 2024 Presidential election, and the majority of local, state, and federal elections for the foreseeable future. Republicans will control all of the appropriations committees and oversight committees that have purview over HHS, FDA, CDC, and NIH. Fauci, Walensky, Califf, and Marks will all quickly retire to avoid being called to testify.

The meritocratic bourgeoisie system that has guided the U.S. for two centuries has already collapsed. It turns out that meritocracy was always a lie. Many of the most esteemed bourgeois institutions in the country were represented at the meetings last week — Stanford, Harvard, NEJM, and the Rockefeller Foundation — and they have no credibility now. When the fate of our nation was on the line they revealed themselves to be fascist clowns whose ideology renders them less smart than the average homeschooled fifth grader. The trust that was the lifeblood of our system is no more.

By failing to listen to the majority of the country that is deeply skeptical of these shots, the FDA and CDC deepened the polarization and made reconciliation nearly impossible.

These decisions will make no difference on the pandemic. If anything these authorizations of more shots for kids mean that the pandemic will continue for years — because the shots do not work and they fuel the evolution of variants that evade vaccines.

One might think that these decisions will lead to civil war or partition of the country into separate independent red and blue countries. At this point there is no need for red states like Texas and Florida to split off to form their own countries because Republicans are about to control EVERYTHING — Congress, the Presidency, and the Courts.

IV. Where do we go from here?

We’re all traumatized right now but we need to keep our head in the game. We need to become the leaders who will take over as things begin to fall apart.

The Advisory Committee on Immunization Practices is still going to vote on Thursday June 23, on Moderna’s EUA application to inject mRNA into kids 6 to 17. You can still register a formal comment — look for the blue comment button in the upper left hand corner or upload your own file.

Then, eight days from now the FDA is going to vote on the “Future Framework”. It’s a proposal to exempt Covid-19 vaccine manufacturers from clinical trials for reformulated shots. It’s literally the worst idea in the history of public health.

Long term we need to shift our strategy from lobbying others to taking power ourselves. Right now it seems the Republican Party is the best vehicle for accomplishing this goal. But honestly at this point, how many national Republican leaders (10? 20?) actually understand the enormity of the catastrophe that has been inflicted upon us over these past two years?

We need to make the point every chance that we get that the November midterm election is not about inflation, guns, abortion, drag shows, nor Ukraine. The 2022 midterm election is about stopping the Pharma genocide. Vote for politicians who publicly speak out against all of the following ongoing atrocities:

• Tony Fauci funded the creation of a gain-of-function virus that got loose and killed 6 million+ people.

• The medical establishment blocks access to safe and effective treatments in order to create the market for vaccines.

• Hospitals used and continue to use the wrong protocols because all of their financial incentives are not aligned with health.

• Poorly tested genetic experiments were injected into BILLIONS of people worldwide causing an increase in all-cause mortality and a wide range of horrific adverse events that are going to wreck human health and the economy for DECADES.

• Social media companies censor life saving information to protect the cartel while enriching themselves; the entire mainstream media is complicit in covering up the genocide.

• Schools and universities are incapable of conducting even basic risk benefit assessments and instead sacrifice the students in their care to the predatory pharmaceutical industry.

• The FDA and CDC sold the American people to the pharmaceutical industry.

THAT’S what needs to be addressed, unraveled, and prosecuted. Everything else is secondary.

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Children’s Heath Defense Letter to FDA

Children’s Heath Defense Letter to FDA

CHD-Letter-to-FDA-VRBPAC-2022-06-10

Source: https://childrenshealthdefense.org/wp-content/uploads/CHD-Letter-to-FDA-VRBPAC-2022-06-10.pdf

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This COVID shot will be available – NEVER!


‘These drugs will not be manufactured’

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BOMBSHELL: Dr. Clare Craig Exposes How Pfizer Twisted Their Clinical Trial Data for Young Children

BOMBSHELL: Dr. Clare Craig Exposes How Pfizer Twisted Their Clinical Trial Data for Young Children

Must watch!

Source: https://rumble.com/v18s66i-bombshell-dr.-clare-craig-exposes-how-pfizer-twisted-their-clinical-trial-d.html

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Clots in COVID-Cadavers and Crystalline Mysteries in Vials Likely Explain Vaccine Death and Injury

Clots in COVID-Cadavers and Crystalline Mysteries in Vials Likely Explain Vaccine Death and Injury

Vaccine injury, death and SADS explained by fibrous clots in blood vessels recently found in COVID-jabbed cadavers, and electron microscopy of vaccine vials.

Source: https://bnt-cdn.b-cdn.net/upload/videos/2022/06/BO9pH1C2w46gbDwHUTeI_16_1493e10f0bd6434da5247432a7028d4b_video_480p_converted.mp4

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CALLER DROPS MASSIVE TRUTH BOMB ON FDA

CALLER DROPS MASSIVE TRUTH BOMB ON FDA

Sam Dodson, an intellectual engineer, called out the FDA for doing “nothing” with the “massive safety signals,” colluding with pharmaceutical companies to suppress trial data for 75 years, ignoring fraudulent data, ignoring adverse events like myocarditis and prion diseases and ignoring issues with infertility.

Source: https://www.bitchute.com/video/2LdQhgpFtujC/

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