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Child Abuse COVID Drugs How sick is this?

Handing over America’s youth to the mRNA mafia…

America is now the only country in the world that allows for experimental mRNA injections for kids under 5 years old, and sadly, rather unsurprisingly, a significant portion of my country is celebrating this insanity.

By Jordan Schachtel

The Dossier

America is now the only country in the world that authorizes COVID shots for infants

It appears that the United States just became the only country in the world to “vaccinate” babies and toddlers with COVID injections.The Dossier is a reader-supported publication. To receive new posts and support my work, consider becoming a subscriber…

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The chief pharmaceutical propagandist in the White House has described these shots as “lifesaving,” encouraging the shots for a population that remains entirely unaffected by COVID-19. Whose lives are being saved exactly, when the shots have zero benefit, don’t prevent infect or transmission, and can only increase risks to a vulnerable population?
Yes, you guessed it: Big Pharma is the beneficiary…

And Biotech and Pfizer are trumpeting this in ads promoting that everyone get a booster (and/or the original shots) no matter what their age is and that seems to come from the CDC — until you listen to the tag line at the end.
See also:

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Biden Pandemic COVID Drugs Reprints from others.

Take that Karen: ‘Natural Immunity Wins Again’: Study Demonstrates Infection-Derived Immunity Likely Superior to COVID Vaccines

Fireman Jason Wendell protesting against NYC vaccine mandates in Manhattan, New York, on Oct. 26, 2021. (Sarah Lu/The Epoch Times)

By Enrico Trigoso for Epoch Times

Natural immunity wins again

A new study published by the New England Journal of Medicine on June 9 found that protection from COVID-19 via natural immunity was superior to that of two doses of Pfizer’s COVID vaccine after the same amount of time elapsed among uninfected people.

“Natural immunity wins again,” Martin Adel Makary, M.D., M.P.H., a public policy researcher at Johns Hopkins University, wrote on Twitter, referring to the new study.

Natural immunity “protection was higher than that conferred after the same time had elapsed since receipt of a second dose of vaccine among previously uninfected persons,” concludes the study.

Pfizer vaccine protection ‘wanes.’

“Infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) provides natural immunity against reinfection,” the study states at the outset, adding that recent studies have shown “waning of the immunity provided by” the Pfizer shot.

The article uses the database of the Israeli Ministry of Health from 2021 at a time when the Delta variant was predominant, among people who were previously infected with the CCP (Chinese Communist Party) virus or who had taken the 2019 vaccine.

For those with immunity from natural infection, the risk of hospitalization and death upon reinfection is exceedingly low

“CDC seroprevalence data shows that 58 percent of the public has already been infected across all age groups (75 percent of pediatric population). For those with immunity from natural infection, the risk of hospitalization and death upon reinfection is exceedingly low,” Dr. Sanjay Verma, a cardiologist who has seen a big increase in heart problems since the vaccines were rolled out, told The Epoch Times.

“Therefore, continued disregard for immunity from natural infection is not only contrary to all the published science, it’s an egregious affront to medical ethics,” he added.

“Throughout the pandemic, public health experts have ignored and even disparaged immunity after natural infection, exclusively emphasizing immunity from COVID vaccines. Many people have been unethically forced into unemployment from vaccine mandates that did not accommodate immunity from natural infection. Repeated studies have shown that immunity after COVID infection is comparable or even better than immunity after COVID vaccination,” Verma said.

Epoch Times Photo
Estimated Covariate-Adjusted Rates of Confirmed Infections per 100,000 Person-Days at Risk. (Screenshot of Fig 3 “Protection and Waning of Natural and Hybrid Immunity to SARS-CoV-2,” From The New England Journal of Medicine)

A chart showing the different levels of protection and waning efficacy against infection shows that those in the 4 to <8 months “1 dose + recovered” group didn’t experience significantly fewer infections than the “recovered, unvaccinated” group in the same time frame.

In addition, the data doesn’t show the 4-8 month result for people who took 3 doses.

Categories
Corruption COVID Drugs Politics

Same junk, different name: Novavax will pursue indefinite boosting, and there’s no trial data on Omicron

Prior to COVID Mania, Novavax and its competitors had never brought a product to market

The rubber stamp.

On Tuesday, the FDA’s advisory committee — a concoction of massively corrupt individuals who entertain a plethora of conflicts of pharmaceutical interests — unanimously voted to clear Novavax’s COVID injection on the path to FDA emergency use authorization.

This “expert” panel, which again and again has presented a green light for mRNA injections for young children, has concluded that Novavax’s product is a worthy COVID vaccine. Why? Because they say so.

Should the Maryland-based company receive FDA clearance, they will become the 4th company in the U.S. — and the first since February 2021 — to enter the COVID vaccine government gravy train.

Don’t expect Novavax to be the cure for a coronavirus that you were looking for. There’s several reasons why you should expect this product to work as poorly as the rest of them.

Novavax was designed for the original COVID strain

The Novavax COVID-19 shot was designed in early 2020 and has not been updated to combat any current variants. This is also true for the Pfizer and Moderna shots, which were designed on an mRNA platform, and never updated.

Novavax is not a “traditional” vaccine

Perhaps the most prevalent marketing behind Novavax advances the claim that the product is a more traditional vaccine, akin to an inactivated vaccine that is associated with a Flu shot.

This idea is presented to the public with the hopes that “vaccine hesitant” individuals will take Novavax shots instead of the ostensible more edgy mRNA shots.

But in reality, the Novavax shot does not contain the traditional inactivated virus. It is usually defined as a subunit protein shot.

It’s not mRNA, but it’s also not traditional or “normal” in the sense that most understand.

Novavax has never brought a product to market

Similar to their competitors in Moderna and BioNTech, Novavax has never brought a product to market. That didn’t stop the government from investing $1.6 billion in taxpayer funds in the company.

In its 33 year history, Novavax has attempted to bring a handful of products to market, including Ebola and Flu vaccines, but the company never succeeded prior to COVID Mania. They have zero track record of success, safety, and/or efficacious products.

The Novavax shot, like mRNA COVID injections, has a demonstrated increased risk for heart inflammation

Myocarditis was observed in several of the trial participants within 2 weeks of injection.

Stat News reports: “Five of the cases of myocarditis and pericarditis in the Novavax trial were reported within two weeks of vaccination. One case may have been caused by Covid, not the vaccine, but there were no clear alternative explanations for the other cases. Four cases of heart inflammation occurred in young men.”

Myocarditis is not just a Novavax side effect. It remains a major issue among the experimental mRNA injections sold by Pfizer and Moderna.

Much to the delight of depraved Pfizer and Moderna executives, if the myocarditis narrative can stick to Novavax, it could sink their potential market share. After the FDA advisory committee published their concerns, the stock market reacted negatively to Novavax, despite the green light for an FDA emergency use authorization.

More boosters

Novavax and the FDA panel has already acknowledged that two doses of the Novavax shot will not be enough to “protect” people from a coronavirus. Therefore, repeated boosting is already being discussed as a probable path forward for this latest pharmaceutical.

There is no trial data on Omicron variant

The shot was developed over two years ago, and it has not been tested for Omicron. The FDA said in a statement:

“Relevant data to assess effectiveness of NVX-CoV2373 (Novavax shot) against the Omicron variant and sublineages, including observational data from use in other countries where the vaccine has been deployed, are currently unavailable.

And yet, the stellar advisory committee approved it anyway.

As Forbes reports, even Novavax has acknowledged that the shot may not work as well for the mutation that is actually present today in 2022. The report says:

“Novavax said its vaccine showed ‘cross-reactive immune response’ against omicron and other coronavirus variants, though it noted that the neutralizing response for the omicron variant was four times lower than for the original coronavirus.

Not a cure.

The Novavax shot has been approved in several countries already and their inhabitants have not become immune from COVID-19 or cured of a disease.

Although there are dozens of different COVID “vaccines” available throughout the world, none have demonstrated a discernible difference in outcomes. In reality, this is just another questionable pharmaceutical product that joins the endless and continuing list of questionable pharmaceutical products on the market.

 

Categories
Biden Pandemic COVID Drugs Science

Take THAT Karens: Latest CDC Data Shows Covid-19 Infections Higher in Boosted Americans Compared to Unboosted

By Jim Hoft  Published June 6, 2022 at 4:00pm

The latest data from the Centers for Disease Control and Prevention (CDC) revealed that breakthrough Covid-19 infections in April was worse in boosted Americans compared to the vaccinated but not boosted.

According to the data analyzed by far-left CBS, the week of April 23 showed that boosted Americans are catching COVID-19 at nearly double the rate of those who have not been boosted. But claimed the unvaccinated remain the highest group.

The unvaccinated rate is a bit misleading as CDC includes those with 1 dose and even 2 doses under 14 days. In the UK, they separate those with zero doses from those who received the vaccination. They categorized it as follows: Unvaccinated, within 21 days of first dose, 21 days or more after first dose, within 21 days of second dose, and 21 days or more after second dose.

The reality is the jabs, initial or boosters, do not prevent infection or transmission of the virus. During Omicron and Delta waves, it was the vaccinated population who were severely infected.

This April, an analysis of CDC data by The Epoch Times reveals that the most vaccinated areas of the United States are experiencing the highest numbers of covid cases – and it’s not just by a little bit. The infection rate is significantly higher than in the areas where vaccine compliance is lowest.

In other words – the data indicates that, at best, the vaccines don’t work; and at worst, they are contributing to the spread of the virus.

According to The Epoch Times analysis, the Covid infection rate in US counties that have a vaccination rate of 62-95% is 23% higher than the Counties that have a vaccination rate of just 11-40%.

The data showed that the least vaccinated counties tended to be on the smaller side, with an average population of around 20,000 – much less than the 330,000 average among the most vaccinated counties.

The Gateway Pundit previously reported that a recent data from over 5,000 Walgreens stores, the unvaccinated have the lowest incidence of COVID.

The unvaccinated show an 18% COVID rate. This is lower than those with 3 doses of the vaccine who have a 19.2 COVID rate.
Those with three doses, with their last dose taken over five months ago, have the highest COVID rate at 31.3%.

Categories
Back Door Power Grab Biden Pandemic Corruption COVID Drugs Science

That OTHER Global COVID Summit

17,000 physicians and medical scientists make a plea to restore scientific integrity and end the national emergency

While global bureaucrats were meeting on May 12, 2022 at a summit hosted by President Biden to discuss how to “turn vaccines into vaccinations,” and how to increase demand for unwanted injections, another COVID summit was taking place.

The alternate summit focused on some big questions: Why have patients been denied life-saving medical treatments? Why are we not researching the damage being caused by the injections? Why are medical professionals still being censored by media companies, Big Tech and their own institutions?

The group known as the Global COVID Summit represents 17,000 physicians and medical scientists from all over the world who have signed on to a declaration based on the following ten foundational principles:

1.    We declare and the data confirm that the COVID-19 experimental genetic therapy injections must end.

2.    We declare doctors should not be blocked from providing life-saving medical treatment.

3.    We declare the state of national emergency, which facilitates corruption and extends the pandemic, should be immediately terminated.

4.    We declare medical privacy should never again be violated, and all travel and social restrictions must cease.

5.    We declare masks are not and have never been effective protection against an airborne respiratory virus in the community setting.

6.    We declare funding and research must be established for vaccination damage, death and suffering.

7.    We declare no opportunity should be denied, including education, career, military service or medical treatment, over unwillingness to take an injection.

8.    We declare that first amendment violations and medical censorship by government, technology and media companies should cease, and the Bill of Rights be upheld.

9.    We declare that Pfizer, Moderna, BioNTech, Janssen, Astra Zeneca, and their enablers, withheld and willfully omitted safety and effectiveness information from patients and physicians, and should be immediately indicted for fraud.

10.  We declare government and medical agencies must be held accountable.

Read more and watch the entire summit here or watch an in-depth interview with some of the Global COVID Summit doctors here.


With dozens of previously healthy young athletes literally dropping dead after getting jabbed, and hundreds of people seriously ill after getting jabbed, the Biden regime has now approved it for children — statistically the LEAST likely to contract Covid-19 — as young as FIVE years old.

WHY?

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Biden Pandemic Corruption COVID Crime Drugs Economy Education Elections Faked news How funny is this? How sick is this? Leftist Virtue(!) Opinion Politics Progressive Racism Reprints from others. Stupid things people say or do. The Courts

Ding Dong the wicked witch is gone.

Friday the 13th was Jen Psaki’s last day as the Bagdad Ali of the White House. I want to thank Joel B. Pollak for this list.

Yes some — particularly in the establishment media — have called her the “best ever,” perhaps because the job of explaining Joe Biden’s failures is simply so difficult. Here are some of the most memorable moments of her tenure, for better or for worse:

17. COVID and masks. Despite sanctimonious lectures about pandemic precautions, Psaki somehow managed to contract COVID twice. She also struggled to explain the White House’s double standards on wearing masks on federal property.

16. “Circle back.” Psaki drew mockery from conservatives over her repeated promises from the podium to “circle back” with reporters when she did not know the answer to questions — or perhaps when she knew, but preferred not to answer.

15. Hoaxes. Psaki repeated some — not all — of the famliar liberal hoaxes about Trump, most notably the “bleach” hoax, insisting — despite glaring evidence to the contrary — that he had told Americans to inject bleach to cure COVID (he did not).

14. Defaming Kyle Rittenhouse. In the midst of the Rittenhouse trial, Psaki criticized “vigilantes with assault weapons.” After Rittenhouse was acquitted, she refused to walk back Biden’s false claim that Rittenhouse was a “white supremacist.”

13. War on “misinformation.” Psaki vowed her briefings would fight “misinformation,” and defended — to her last week — the Biden administration’s “disinformation” office. But she herself spread disinformation about Russia, and Hunter Biden.

12. Space Force snub. Psaki appeared to snub the sixth branch of the U.S. armed forces when she mocked a reporter’s query about whether Biden intended to continue Donald Trump’s addition to the military. She later clarified that she supported it.

11. Major dog cover-up. When Biden’s dog, Major, was accused of biting a Secret Service agent, Psaki downplayed the incident. Later, documents suggested that Psaki misled the public about the real threat the dog posed to agency staff.

10. Border denial. Psaki made it clear she did not want reporters to ask about the crisis at the southern border, chastising reporters for “maddening” questions about it. She claimed Biden’s policy was more “moral” and “humane” than Trump’s.

9. Refusing to condemn protests at Supreme Court justices’ homes. It took Psaki days to condemn violence after a draft opinion reversing Roe was leaked, and she actually encouraged the arguably illegal protests outside the homes of justices.

8. Dismissing the idea of free COVID tests. Psaki initially scoffed at the idea of sending free COVID tests to every American as too costly to undertake. A few days later, mid-omicron wave, the administration belatedly began doing so.

7. “Don’t Say Gay’ demagoguery. It was Psaki who started the false — yet effective — claim that Florida had passed a law that literally prohibited people from saying “gay.” The law actually restricts sexual instruction of any kind to K-3 children.

6. Doocy. Among many examples of the Biden administration failing to respect the press, one of the worst was Psaki saying that Fox News made Peter Doocy — one of the few critical voices in the press corps — sound like a “stupid son of a bitch.”

5. Defending inflation. Psaki test-drove several excuses for inflation, first claiming that it was transitory (“inflation is going to come down next year”), then trying to put a positive spin on it as the by-product of an otherwise wonderful economy.

4. Admitting Biden skipped D-Day. Among other clean-up jobs, Psaki had to explain Biden’s unfortunate failure to commemorate the anniversary of D-Day in 2021. She told reporters that the historic occasion was still “close to his heart.”

3. Vacationing while Afghanistan fell. Psaki and many other members of the administration had to be called back from summer vacation when Afghanistan began to fall to the Taliban, a failure that has since defined perceptions of the president.

2. Hunter Biden dodges. Psaki repeatedly (and successfully) dodged questions about Hunter Biden, his laptop, and his connection to his dad’s finances, claiming they were a private matter or the under the purview of the Department of Justice.

1. Baby formula. Psaki’s advice, when asked what parents should do if worried about their babies amid a national shortage of baby formula, was to “call their doctor.” Neither she nor the White House had any solace to offer American families.

One example when Psaki called it right: she did, finally, admit that communism is a “failed ideology,” as Cubans protested in the streets against their oppressive regime. But that, sadly, is all the Biden administration was willing to do to help them.

Categories
Biden Pandemic Child Abuse Drugs Science

TAKE THAT, KARENS! Heart Inflammation More Prevalent Among Vaccinated Than Unvaccinated: Study

via AP
By Zachary Stieber for EPOCH TIMES April 22, 2022

Heart inflammation requiring hospital care was more common among people who received COVID-19 vaccines than those who did not, according to a new study of tens of millions of Europeans.

Rates of myocarditis or pericarditis, two types of heart inflammation, are above the levels in an unvaccinated cohort, pegged at 38 per 100,000 after receipt of a second dose of a vaccine built on messenger RNA (mRNA) technology in males aged 16 to 24—the group studies have shown are most at risk of the post-vaccination condition—researchers with health agencies in Finland, Denmark, Sweden, and Norway found.

“These extra cases among men aged 16–24 correspond to a 5 times increased risk after Comirnaty and 15 times increased risk after Spikevax compared to unvaccinated,” Dr. Rickard Ljung, a professor and physician at the Swedish Medical Products Agency and one of the principal investigators of the study, told The Epoch Times in an email.

Comirnaty is the brand name for Pfizer’s vaccine while Spikevax is the brand name for Moderna’s jab.

Rates were also higher among the age group for those who received any dose of the Pfizer or Moderna vaccines, both of which utilize mRNA technology. And rates were elevated among vaccinated males of all ages after the first or second dose, except for the first dose of Moderna’s shot for those 40 or older, and females 12- to 15-years-old.

Researchers pulled data from national health registers, analyzing 23.1 million people aged 12 or older. The analysis was of data from Dec. 27, 2020, to incidence of myocarditis or pericarditis, or the end of the study time period, which was Oct. 5, 2021.

“The risks of myocarditis and pericarditis were highest within the first 7 days of being vaccinated, were increased for all combinations of mRNA vaccines, and were more pronounced after the second dose,” researchers wrote in the study, which was published by the Journal of the American Medical Association following peer review.

Moderna and Pfizer did not respond to requests for comment.

Some previous studies have indicated that the risk of heart inflammation is higher from the companies’ vaccines, or certain doses of the vaccines, than from COVID-19 itself.

Others have concluded the opposite, including a recent non-peer-reviewed study from the U.S. Centers for Disease Control and Prevention, though that is one of the papers that has estimated a higher rate of post-vaccination heart inflammation.

Authorities in the United States and many European countries continue recommending vaccination for virtually every eligible person, regardless of age, health condition, or prior infection.

The Nordic countries, however, halted use of Moderna’s vaccine in 2021 for youth and young adults due to concerns over post-vaccination heart inflammation.

Ljung said he could not answer whether the results mean some people should consider only a single dose, or no doses, of a COVID-19 vaccine because the Swedish Medical Products Agency doesn’t give those types of recommendations.

In a press release promoting the study, researchers said that occurrence of the heart inflammation is “very rare” and claimed that “the benefits of these vaccines to reduce the risk of severe COVID-19 and death outweigh the risks of side effects.”

Dr. Peter McCullough, the chief medical adviser for the Truth for Health Foundation and a cardiologist who is seeing patients with post-vaccination heart inflammation, disagreed.

The benefits of the vaccines in no way outweigh the risks.

“In cardiology we spend our entire career trying to save every bit of heart muscle. We put in stents, we do heart catheterization, we do stress tests, we do CT angiograms. The whole game of cardiology is to pervert preserve heart muscle,” McCullough told The Epoch Times. “Under no circumstances would we accept a vaccine that causes even one person to stay sustain heart damage. Not one. And this idea that ‘oh, we’re going to ask a large number of people to sustain heart damage for some other theoretical benefit for a viral infection,’ which for most is less than a common cold, is untenable. The benefits of the vaccines in no way outweigh the risks.”

Categories
Child Abuse Corruption Drugs Human Traficking Politics

26 Governors Create Border Strike Force ‘In the Absence of Federal Leadership’

Charlotte Cuthbertson for EPOCH TIMES April 20, 2022
Twenty-six governors, all Republican, announced the creation of a Border Strike Force to “disrupt and dismantle transnational criminal organizations” on April 19.

The group of governors signed a memorandum of understanding, pledging to work together to “serve as a force multiplier to target cartels and criminal networks financially and operationally.”

“Together, governors will improve public safety, protect victims from horrific crimes, reduce the amount of drugs in our communities, and alleviate the humanitarian crisis at the Southern Border,” the agreement states.

The group includes two border states—Arizona and Texas—as well as 24 others: Alabama, Alaska, Arkansas, Florida, Georgia, Idaho, Indiana, Iowa, Maryland, Mississippi, Missouri, Montana, Nebraska, New Hampshire, North Dakota, Ohio, Oklahoma, South Carolina, South Dakota, Tennessee, Utah, Virginia, West Virginia, and Wyoming.

“In the absence of federal leadership, states are partnering together to create the American Governors’ Border Strike Force to disrupt and dismantle transnational criminal organizations by increasing collaboration, improving intelligence, investing in analysis, combating human smuggling, and stopping drug flow in our states,” the agreement states.

Epoch Times Photo
A group of illegal aliens is apprehended by law enforcement on a ranch in Kinney County, Texas, on Jan. 15, 2022. (Courtesy of Kinney County Sheriff’s Office)

The governors will coordinate to share intelligence, disrupt smuggling corridors, and assist border states. They plan to focus efforts on targeting cartel finances and border-related crime.

The participating states also plan to review state laws regarding human trafficking, drug trafficking, and transnational criminal organizations “to ensure that such crimes are prosecuted to the fullest extent of the law.”

For example, Arizona doesn’t currently have a state law against human smuggling, while Texas just strengthened its anti-smuggling laws last September.

Epoch Times Photo
A Border Patrol agent walks from the wreckage of Wanda Sitowski’s car after a 16-year-old smuggler ran a red light at 105 miles per hour and caused a fatal crash in Cochise County, Ariz., on Oct. 30, 2021. (Zach Bennett/Sierra Vista News Network)

States can request help from other participating states and state-specific certifications and licenses will be honored among the states. Each state is responsible for its own costs.

The Border Strike Force was announced days after Customs and Border Protection released its March statistics, which show the highest number of Border Patrol apprehensions—209,906—along the southern border since early 2000.

Epoch Times Photo
Border Patrol agents apprehend a group of Cubans who just crossed the Rio Grande from Mexico into Eagle Pass, Texas, on April 19, 2022. (Charlotte Cuthbertson/The Epoch Times)

Mississippi Gov. Tate Reeves wrote on Twitter that “we’re all border states now & we’re going to protect ourselves.”

“Despite what the Biden Admin would have you believe, criminals, drugs & human trafficking don’t just stay on the border. They make their way to every state,” Reeves wrote on April 19.

Idaho Gov. Brad Little accused President Joe Biden of refusing to address the border crisis.

“America’s governors are stepping up. Our multi-state partnership is designed to disrupt and dismantle the transnational criminal organizations taking advantage of the open border with Mexico,” Little wrote on Twitter on April 19.

Arizona Gov. Doug Ducey said his state has had a similar state-level in operation since 2015.

“What we’re doing in Arizona works,” Ducey said in an April 19 statement. “If our entire southern border isn’t secure, our nation isn’t secure.”

Categories
Corruption COVID Drugs How sick is this?

FOIA Request Unearths that Pfizer Planned to Hire 1,800 Employees to Deal with Reporting on Adverse Effects from COVID Vaccine

Pfizer hired 600 employees with a plan to hire a total of 1,800 employees when side effects from its COVID vaccine started showing up.  The employees were hired to address the flood in adverse effects reporting. 

Posted by Jim Holt for The Gateway Pundit April 10, 2022 at 4:00pm

Zerohedge shared a report Authored by Zachary Stieber via The Epoch Times

Pfizer hired 600 employees in the months after its COVID-19 vaccine was authorized in the United States due to the “large increase” of reports of side effects linked to the vaccine, according to a document prepared by the company.

Pfizer has “taken a multiple actions to help alleviate the large increase of adverse event reports,” according to the document. “This includes significant technology enhancements, and process and workflow solutions, as well as increasing the number of data entry and case processing colleagues.”

At the time when the document—from the first quarter of 2021—was sent to the U.S. Food and Drug Administration (FDA), Pfizer had onboarded about 600 extra full-time workers to deal with the jump.

“More are joining each month with an expected total of more than 1,800 additional resources by the end of June 2021,” Pfizer said.

Pfizer tried to hide the information

In addition, Zerohedge reported:

The analysis of adverse event reports was previously disclosed to the health transparency group, but certain portions were redacted (pdf), including the number of workers Pfizer onboarded to deal with the jump in adverse event reports.

“We asked that the redactions on page 6 of this report be lifted and the FDA agreed without providing an explanation,” Aaron Siri, a lawyer representing the plaintiffs, told The Epoch Times in an email.

After the document was produced, the FDA determined that the three redactions on that page “could be lifted,” an FDA spokesperson told The Epoch Times via email.

The redactions had been made under (b) (4) of the Freedom of Information Act, which lets agencies “withhold trade secrets and commercial or financial information obtained from a person which is privileged or confidential.”

The unredacted version of the document also now shows that approximately 126 million doses of Pfizer were shipped around the world since the company received the first clearance, from U.S. regulators, on Dec. 1, 2020. The shipments took place through Feb. 28, 2021.

It was unclear how many of those doses had been administered as of that date.

As TGP reported previously, after the courts ordered Pfizer to release data on its COVID vaccine, documents showed over 1,200 vaccine deaths in the first 90 days after taking the vaccine.

TGP has reported many additional reports of deaths or injuries caused by the Pfizer vaccine.  The information to date does not look good for the Pfizer vaccine.

Categories
Child Abuse COVID Drugs Science

Protect your kids: Persistent Cardiac MRI Findings in a Cohort of Adolescents with post COVID-19 mRNA vaccine myopericarditis —Actual science

By:Jenna Schauer, MD  Sujatha Buddhe, MD, MS  Avanti Gulhane, MD, DNB, FSCMR Sathish Mallenahalli Chikkabyrappa, MD Yuk Law, MD Michael A. Portman, MD et al for The Journal of Pediatrics

Published:March 25, 2022 DOI:https://doi.org/10.1016/j.jpeds.2022.03.032
Abbreviations:

Late gadolinium enhancement (LGE), Coronavirus disease of 2019 (COVID-19), Nonsteroidal anti-inflammatory drugs (NSAIDs), Intravenous immunoglobulin (IVIG), Left ventricle (LV), Left ventricular ejection fraction (LVEF), Global Longitudinal Strain (GLS)

Myopericarditis, , has emerged as an important adverse event following COVID-19 mRNA vaccination, particularly in adolescents

Patients typically exhibit chest pain and an elevated serum troponin level in the days following the COVID-19 mRNA vaccine. They usually are hemodynamically stable, and symptoms and cardiac biomarkers normalize within a few days cardiac magnetic resonance studies, when performed early, frequently demonstrate abnormalities such as edema and late gadolinium enhancement (LGE), meeting Lake Louise Criteria for diagnosing myocarditis noninvasively ,

In classical myocarditis LGE can be predictive of a poor outcome

Little is known about the prognostic value or expected evolution of these CMR abnormalities associated with post-COVID-19 mRNA vaccine myopericarditis. In this case series we report the evolution of CMR imaging compared with initial, acute phase, CMR in our cohort of patients with myopericarditis post COVID-19 mRNA vaccine.

Methods

This case review includes patients younger than 18 years of age presenting to Seattle Children’s Hospital with chest pain and elevated serum troponin level from April 1, 2021 to January 7, 2022 within one week of receiving the second dose of the Pfizer COVID-19 mRNA vaccine. Institutional Review Board approval was obtained. All patients were evaluated by a pediatric cardiologist, underwent ECG and echocardiogram, and were admitted for observation with telemetry, serial troponin measurements, and repeat cardiac testing as needed. All patients underwent CMR within 1 week of initial presentation and had repeat CMR imaging at 3-8 months follow up. CMR was performed on a 1.5 T Siemens scanner. CMR analysis was performed using CVI42 (version 5.11.4, Circle Cardiovascular Imaging Inc., Alberta Canada). Patients were excluded if they did not undergo CMR or did not have a follow up CMR. Initial and follow up CMR data for each patient were reviewed and compared using paired Student t-test. Statistical significance was defined as a p < 0.05. Statistical analysis was performed using SPSS 27 (SPSS Inc., Chicago, IL).

Results

A total of 35 patients with the diagnosis of myopericarditis associated with Pfizer COVID-19 mRNA vaccine are followed at our institution. Twelve patients were excluded as they never had CMR due to delayed presentation after initial symptoms resolved or admission to other centers. Six patients were excluded as they did not have a follow up CMR, either because they followed up out of state or a study is still pending. One patient was excluded as initial CMR was performed 3 weeks after presentation. Sixteen patients who had both acute phase and follow-up CMR available for review comprised the final cohort. This group had a median age of 15 years (range, 12-17), were mostly male (n=15, 94%), white and non-Hispanic (n= 14, 88%). One patient was Asian and one patient was American Indian. Median time to presentation from the second dose of the Pfizer COVID-19 mRNA vaccine was 3 days (range 2-4 days). All patients had chest pain. The most common other presenting symptoms were fever (n=6, 37.5%) and shortness of breath (n=6, 37.5%). All patients had elevated serum troponin levels (median 9.15 ng/mL, range 0.65-18.5, normal < 0.05 ng/mL). Twelve patients had c- reactive protein (CRP) measured with median value 3.45 mg/dL, range 0-6.5 mg/dL, normal < 0.08 mg/dL.
Ten (62.5%) patients had an abnormal electrocardiogram (ECG), with the most common finding being diffuse ST segment elevation. All patients had an echocardiogram on admission; 14/16 patients had normal left ventricular (LV) systolic function; two patients demonstrated mildly reduced LV systolic function with no dilation. Left ventricular ejection fraction (LVEF) for these two patients was 45% and 53% (normal > 55%). Median left LVEF was 59% (range 45-69%). No patients had pericardial effusion.

The initial CMRs were performed within 1 week of presentation (median 2, range 0-7 days). All were abnormal; all showed evidence of edema by T2 imaging and 15/16 had LGE in a patchy subepicardial to transmural pattern with predilection for the inferior LV free wall. Distribution of LGE can be seen in Figure 1. LV regional wall motion abnormalities were noted in 2 patients. CMR median LVEF% was 54%, range 46-63%. CMR LVEF was mildly decreased in 7 patients. CMR global longitudinal strain (GLS%) measurements were abnormal in 12 patients (median -16.1%, range -13.2% to -18.1%, normal <-18%).

Figure thumbnail gr1

Figure 1Distribution of Late Gadolinium Enhancement (LGE) in American Heart Association Myocardial Segments Figure shows segment with number of patients and percent of cohort.

All patients were treated with nonsteroidal anti-inflammatory drugs (NSAIDs): 75% (n=12) received scheduled dosing (mostly, 10 mg/kg ibuprofen every 8 hours) with the remaining 4 receiving NSAIDs as needed for pain. The median time from vaccination to NSAID initiation was 2.5 days (range 0-4 days) and from symptom onset to NSAID initiation was 1 day (range 0-4 days). The two patients who presented with echocardiographic LV dysfunction were treated with intravenous immunoglobulin (IVIG) plus a corticosteroid per our institutional pathway for treatment of myocarditis

One additional patient received IVIG without corticosteroids. Median hospital length of stay was 2 days (range 1-4 days) with no ICU admission and no significant morbidity or mortality. All patients had resolution of chest pain and down-trending serum troponin level prior to discharge.

All patients underwent follow up CMR at 3-8 months after their initial study (median 3.7 months, range 2.8-8.1 months). The results are compared in Table I. Follow up CMR LVEF (57.7 ±2.8%) was significantly improved from initial (54.5 ± 5.5%, p < 0.05), and none of the patients had regional wall motion abnormalities. LVEF by echocardiogram was normal for all patients at the time of follow up. Eleven patients (68.8%) had persistent LGE, although there was a significant decrease in the quantifiable LGE% (8.16± 5.74%) from the initial study (13.77± 8.53%, p <0.05). Cardiac edema resolved in all but one patient. GLS% remained abnormal in most patients (75%, mean -16.4 ± 2.1%) at follow up without significant change from the initial study (-16.0 ± 1.7, p = 0.6). Examples of initial and follow up CMR images are shown in Figure 2. The patient who received IVIG alone and one patient who received IVIG plus corticosteroid had resolution of LGE, and the other had persistence of LGE.

Table 1Covid Vaccine-Associated Myopericarditis Findings in 16 patients
Initial (Mean±SD)Follow up (Mean±SD)P value
Echocardiographic LVEF %59.4±6.062.6±2.8<0.05
Electrocardiogram

Abnormal

Normal

10 (62.5%)

6 (37.5%)

Peak Serum Troponin (ng/mL)9.0± 5.2
CMR LVEF %54.5 ± 5.557.7 ±2.7<0.05
CMR LGE % (n=15*)13.5± 8.37.7 ± 5.7<0.001
CMR global longitudinal strain % (n=15*)-16.0 ± 1.7-16.4 ± 2.10.5
*Initial source images were not available for reanalysis for one patient.
LVEF% = LV ejection fraction
LGE %= percentage of late gadolinium enhancem
ent
CMR = Cardiac MRI
Figure thumbnail gr2
Figure 2CMR images from 3 days after admission of a 16-year-old male who presented to emergency room with chest pain and elevated troponin 3 days after receiving Pfizer COVID-19 mRNA vaccine. Initial CMR. 1a and 1b. subepicardial to midmyocardial LGE in inferior and inferolateral LV wall from base to apex (arrows). 1c shows T2 hyper-intensity in similar segments, consistent with edema. 1d, 1e and 1f. Follow up CMR 4.4 months later. LGE still persistent but decreased from 26% to 19.84% (arrows), LVEF remained stable at 58%. There is improved T2 hyperintensity.
Eight patients (5 of whom had persistent LGE) underwent 24-hour cardiac rhythm monitoring, all of which studies were normal. Six patients, all with persistent LGE, underwent exercise tests, all of which were normal. Four patients complained of intermittent chest pain at follow up with no identifiable abnormality on evaluation; no therapy or intervention was required. No patient received heart failure medication.

DISCUSSION

We previously reported 15 patients with clinically suspected SARS-CoV-2 mRNA vaccine induced myopericarditis. All patients had an abnormal CMR, with edema and or LGE in addition to clinical symptoms and troponin elevation, and some had abnormal ECG or echocardiogram

We have since established a clinical protocol for serial CMR performance in these patients consistent with the 2021 American Heart Association (AHA) statement that stressed the risk of sudden cardiac death, particularly with exercise, while active inflammation is present.

our patients were restricted from exercise on discharge. Repeat CMR was performed within 3-6 months to guide next clinical decision-making steps; timing was modified in some individuals based on scanner accessibility and safety precautions during the COVID-19 pandemic. Although symptoms were transient and most patients appeared to respond to treatment (soley with NSAIDS), we demonstrated persistence of abnormal findings on CMR at follow up in most patients, albeit with improvement in extent of LGE.
CMR has increasingly been identified as an important diagnostic tool for myocarditis given its ability to identify subclinical injury and fibrosis by markers of LGE and edema. CMR also has been utilized in longitudinal follow up of patients with myocarditis to help therapeutic management, although exact screening protocols remain controversial
The presence of LGE is an indicator of cardiac injury and fibrosis and has been strongly associated with worse prognosis in patients with classical acute myocarditis. In a meta-analysis including 8 studies, Yang et al found that presence of LGE is a predictor of all cause death, cardiovascular death, cardiac transplant, rehospitalization, recurrent acute myocarditis and requirement for mechanical circulatory support]Similarly, Georgiopoulos et al found presence and extent of LGE to be a significant predictor of adverse cardiac outcomes in an 11 study meta-analysis
The persistence of LGE over time and its prognostic value is less well established. Malek et al found that in a cohort of 18 patients with myocarditis, nearly 70% had persistent CMR changes at a median follow-up time of 7 months Dubey et al found similar findings in their cohort of 12 pediatric patients, with persistence of LGE in all patients despite resolution of edema.
Prognostic meaning of LGE in vaccine associated myopericarditis requires further study.
Strain analysis by CMR also has been shown to have prognostic utility in myocarditis even in the setting of normal LV functionStrain testing can be performed without use of contrast material and can be particularly useful in situations where contrast administration is challenging or contraindicated. Notably, in our cohort, though there was significant reduction in LGE at follow up, abnormal strain persisted for the majority of patients at follow up.
This study has certain limitations. Patients who did not seek medical attention during acute illness or did not present with significant symptoms and require hospitalization were not captured, and their disease course may be different. Incomplete CMR data on other patients precludes extrapolation of our CMR findings to all who experienced mRNA vaccine-related myopericarditis. In addition, follow-up CMR timeframes varied from patient to patient making it difficult to predict the timing of CMR changes over time. the total number of patients reported is small, limiting ability to draw conclusions about the effect of treatment modalities or to generalize regarding outcomes of vaccine-associated myopericarditis.
In a cohort of adolescents with COVID-19 mRNA vaccine-related myopericarditis, a large portion have persistent LGE abnormalities, raising concerns for potential longer-term effects. Despite these persistent abnormalities, all patients had rapid clinical improvement and normalization of echocardiographic measures of systolic function. For patients with short acute illness, no dysfunction demonstrated by echocardiogram at presentation and resolution of symptoms at follow up, return to sports was guided by normalization of CMR alone. In patients with persistent CMR abnormalities we performed exercise stress testing prior to sports clearance per myocarditis recommendations We plan to repeat CMR at 1 year post-vaccine for our cohort to assess for resolution or continued CMR changes.
The CDC notes that even though the absolute risk for myopericarditis following mRNA COVID-19 vaccine is small, the relative risk is higher for particular groups, including males 12-39 years of age.

Some studies have suggested that increasing the interval between the first and second dose may reduce the incidence of myopericarditis in this population

These data led to an extension in CDC recommended dosing interval between dose 1 and dose 2 to 8 weeks. Further follow up assessment and larger multicenter studies are needed to determine the ultimate clinical significance of persistent CMR abnormalities in patients with post COVID-19 vaccine myopericarditis

Uncited reference

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Footnotes

No funding was received for this research

The authors declare no conflicts of interest.

Abstract

We describe the evolution of Cardiac MRI (CMR) findings in 16 patients, 12-17 years of age, with myopericarditis after the second dose of the Pfizer mRNA COVID-19 vaccine. Although all patients showed rapid clinical improvement, many had persistent CMR findings at 3-8 month follow up.

Figures

  • Figure thumbnail gr1
    Figure 1Distribution of Late Gadolinium Enhancement (LGE) in American Heart Association Myocardial Segments

    . Figure shows segment with number of patients and percent of cohort.

          • Figure thumbnail gr2
            Figure 2CMR images from 3 days after admission