Tag: coronavirus

Clinical Trial Results Were Clear: Pfizer’s COVID Vaccine Delivered More Risk Than Benefit

U.S. Health Secretary Robert F. Kennedy Jr.’s recent decision to terminate the COVID-19 emergency use authorization (EUA) declarations invites reconsideration of the evidence that launched this extraordinary regulatory chapter.

The U.S. Food and Drug Administration’s (FDA) first EUA for a COVID-19 vaccine rested on its determination that the known and potential benefits of the Pfizer-BioNTech vaccine outweighed its known and potential risks. Yet the pivotal trial report did not bring those benefits and risks together within a common quantitative framework.

Better late than never: more than five years later, I did — and what I found was startling.

At first glance, the famous 95% efficacy against protocol-defined, laboratory-confirmed symptomatic COVID-19 — based on eight versus 162 cases in a trial that randomized 43,548 participants — seems highly promising.

But when this finding is considered alongside the broader set of participant-relevant outcomes (dispersed across the trial publication, its Supplementary Appendix, and the contemporaneous FDA review materials), the overall clinical picture looks markedly different.

Depending on the counting period used, the vaccine group had 2-8 fewer cases of severe COVID-19, whereas the safety data showed numerical excesses of 4-101 participants across clinically consequential adverse-event categories. These categories are not directly comparable, and some may overlap.

Even so, the evidence did not establish that the vaccine’s clinically consequential benefits outweighed its potential harms. Nor did the trial establish that vaccination reduced the overall burden of COVID-19-like symptoms, let alone that it reduced person-to-person transmission.

Crucially, this conclusion does not rest on hindsight: the relevant evidence was already before the FDA when it issued the EUA.

The full basis for this conclusion is presented in my comprehensive reassessment of the evidence, currently available as a preprint. That reassessment is necessarily detailed because the relevant data are complex, scattered across multiple documents and subject to important methodological and interpretive qualifications.

The present column is not intended to replace that analysis, but to distill several of its central findings and implications for a broader readership.

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Sen. Ron Johnson Unloads Devastating Safety Data on Fauci — Says COVID Shot Logged Nearly 7,000 Death Reports Per Year While FDA Ignored Warning Signs and Pushed Remdesivir

Sen. Ron Johnson (R-WI) dropped another bombshell during Wednesday’s explosive Senate hearing with Dr. Anthony Fauci, confronting the former COVID czar with adverse event data that he argued should have triggered urgent scrutiny years ago—but instead was ignored while federal health agencies relentlessly promoted COVID vaccines and Remdesivir.

Johnson’s latest exchange came after he previously confronted Fauci with stacks of studies on ivermectin and questioned why federal officials dismissed evidence supporting alternative treatments before Fauci invoked his Fifth Amendment right against self-incrimination during the hearing.

The Wisconsin senator displayed comparative adverse-event figures during the hearing, arguing they represented safety signals that federal regulators refused to adequately investigate.

“These are averages. Again, it doesn’t prove causation, but there’s correlation. It’s there. It’s there for a safety signal,” Johnson said.

The chart, titled “Drug Adverse Event Comparison” and labeled “FDA and CDC Data: Worldwide,” compared adverse event reports, total reported deaths, and average deaths per year across multiple products.

According to the chart presented by Johnson:

  • Ivermectin (30 years, 1996–2026): 5,127 adverse events, 518 deaths, averaging 17 deaths per year.
  • Hydroxychloroquine (HCQ) (38 years, 1988–2026): 37,270 adverse events, 5,404 deaths, averaging 142 deaths per year.
  • Flu vaccines (36 years, 1990–2026): 243,335 adverse events, 2,770 deaths, averaging 77 deaths per year.
  • Dexamethasone (57 years, 1969–2026): 143,017 adverse events, 25,589 deaths, averaging 448 deaths per year.
  • Tylenol (57 years, 1969–2026): 184,186 adverse events, 42,627 deaths, averaging 747 deaths per year.
  • Remdesivir (69 months): 10,657 adverse events, 2,751 deaths, averaging 546 deaths per year.
  • COVID-19 vaccines (68 months): 1,677,227 adverse events, 39,182 deaths, averaging 6,922 deaths per year.

The chart also highlighted that 9,342 reported deaths occurred on days 0, 1, or 2 following COVID-19 vaccination.

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China Brings Back Masking for Vulnerable People as Summer Coronavirus Spike Sweeps South

The Chinese Center for Disease Control and Prevention (CDC) began encouraging vulnerable residents – such as the elderly, pregnant women, and those with chronic diseases – to seek out Wuhan coronavirus vaccine products and use sanitary masks as the rate of coronavirus infections skyrocketed in July.

The Chinese state newspaper Global Times first announced in English the CDC warning of a spike in Wuhan coronavirus cases on July 26, insisting that the virus appears to be spreading much faster in southern China than in the north and that it does not appear to be causing severe infections in most people. Experts suggested that hot temperatures driving people indoors to air conditioning has created similar conditions to winter, when many do not go outside because of the cold and the limited air circulation facilitates infections.

Hong Kong’s South China Morning Post identified the culprit of the latest outbreak as the “Omicron NB.1.8.1 variant,” which is reportedly spreading at a “moderate” level but mostly a threat to the elderly or those with other health complications.

The Chinese CDC warned last week that it was documenting more cases of coronavirus than influenza this month, suggesting accelerating rates of infection. The vast majority of those diagnosed with the disease were reportedly between the ages of 15 to 59, suggesting that children and the elderly did not represent the majority of cases.

“The [Wuhan coronavirus] test positivity rate stood at 16.3 percent, up 4.3 percentage points from the previous week, while the influenza positivity rate was 12.6 percent, down 0.9 percentage points week on week,” the Global Times detailed.

The Global Times added that the Chinese government was now encouraging the elderly and those with health complications to “preventive measures, such as wearing masks in crowded places or on public transportation.” All were encouraged to update their vaccine product dosages, particularly pregnant women.

The state outlet China Daily reported an update on Wednesday from Beijing’s CDC discouraging residents from concern, stating that the rate of transmission in the capital city was “within normal cyclical fluctuations” and not straining medical facilities. Overcrowding in Chinese hospitals is a recurring problem during waves of respiratory infections, particularly those targeting children, as many parents choose to take their children to be hospitalized for intravenous treatment rather than attempting to treat respiratory symptoms at home. During past waves of respiratory infections citizens have documented chaotic scenes in city hospitals as emergency rooms failed to offer proper services to the large crowds of people flooding their waiting rooms and ran out of seats of IV fluid treatment.

“The [Beijing health] center said visits to fever clinics remain low across the city, hospitals have sufficient medicine supplies, and the latest increase in cases has not placed noticeable pressure on the healthcare system,” according to China Daily.

The current transmission data available from China indicates that the situation in southern China is more precarious. The U.S.-based Epoch Times, which conducted much of the early reporting exposing the calamity in Wuhan, China, as the coronavirus first began spreading in 2020, noted in its reporting on Wednesday that the gap between cases in the north and south had “widened significantly” and that one potentially complicating factor could be widespread floods in the region that have killed and displaced large numbers of people. The newspaper, citing biomedical science professor Xiaoxu Sean Lin, cited that flooding could potentially cause situations such as “population displacement, centralized sheltering, poor ventilation, overcrowded medical facilities, and compromised nutrition and rest,” all of which help spread respiratory illness.

Lin described the current reports out of the Chinese communist regime as “only the tip of the iceberg,” as many Chinese do not report symptoms consistent with a coronavirus infection, particularly when caused by a variant that only prompts mild symptoms to occur. The outbreak causing a rise in cases has been identified as “Omicron NB.1.8.1.” The South China Morning Post listed common symptoms as “fever and a sore throat.”

Citing Peng Jie, deputy director of the infectious diseases department at Southern Medical University’s Nanfang Hospital, the Morning Post noted that some experts are concerned about an “increasingly unpredictable” trend of coronavirus infections in the summer. While the Chinese CDC typically documents an increase in cases of all major respiratory diseases in the winter, state reports have explicitly noted that they have not documented a similar increase this summer of cases of influenza or respiratory syncytial virus (RSV), which also tend to spread more severely among children and the elderly.

Speaking to the Epoch Times, Taiwanese infectious disease specialist Cheng Yuan-yu posited the air conditioner theory for why coronavirus appears to be spreading at a faster rate.

“High outdoor temperatures drive people flocking to air-conditioned environments, which leads to spending extended periods in enclosed indoor spaces and has increased risk of indoor airborne transmission,” Cheng reportedly said. If this factor is driving infections, Cheng continued, that would mean situations such as “people going to work while sick, the confined environments of commuting, waning immunity, biases in testing and health care-seeking behavior” would result in more cases of people aged 15 to 59 being diagnosed with coronavirus, rather than children or the elderly.

The Wuhan coronavirus was originally identified in the eponymous central Chinese city of Wuhan as a novel pathogen in early 2020, though reports indicated that the first diagnosed case could have surfaced as early as November 2019. As a result of the Chinese Communist Party violently silencing those identifying a new virus, allowing “super-spreader” events to take place to obscure the spread of the disease, then engaging in human rights atrocities to imprison people in the city, the virus went on to infect millions of people around the world, killing over 7 million people.

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Fauci Admits To Working Against Trump’s 2020 Re-Election Bid In Shocking Diary

Anthony Fauci’s newly released diary entries, made public by Sen. Rand Paul, reveal that Fauci privately viewed efforts to fast-track COVID-19 treatments and vaccines before the 2020 election as politically motivated — and show he recorded personally intervening to support FDA officials resisting pressure for emergency authorizations.

The entries were first highlighted by Justin Hart of the Rational Ground Substack.

The entries, spanning five months in 2020, detail Fauci’s concerns about what he repeatedly described as an effort to deliver President Donald Trump an “October surprise” ahead of Election Day. They also identify the administration officials he believed were applying pressure and document a call in which Fauci wrote that he and other top federal health officials assured the FDA’s top vaccine regulator they would support him if he refused to approve a vaccine prematurely.

The diary centers on several key figures. Peter Marks led the FDA’s Center for Biologics Evaluation and Research, the office responsible for reviewing vaccine applications. Then-FDA Commissioner Stephen Hahn oversaw Marks. Fauci also references then-White House Chief of Staff Mark Meadows, Health and Human Services Secretary Alex Azar, NIH Director Francis Collins, Fauci deputy Cliff Lane and Larry Horowitz, whom he identifies as someone working closely with then-House Speaker Nancy Pelosi.

One of the earliest entries, dated June 20, 2020, focuses not on White House political aides but on then-White House coronavirus response coordinator Deborah Birx.

Fauci wrote that he had become increasingly frustrated with Birx, accusing her of wanting to bypass traditional clinical trials in favor of emergency authorizations.

“Deb has ststed [sic] that we should noit [sic] do clinical trials since ‘I want to see every infected person in a nursing home get plasma early on and steroids later. Forget the trial, we need to do this on EUAs. She says the same thing about vaccine trials. Clearly, she is trying to provide Trump with his October surprise. I may need to blow the whistle on her.”

The diary entry suggests Fauci believed months before the election that accelerating vaccine approvals was being driven by politics rather than science, and that he was already considering publicly opposing the effort.

By late July, Fauci recorded similar concerns about Meadows.

In a July 26 entry, Fauci wrote that after watching Meadows on television, he believed the chief of staff was “trying to get an ‘October Surprise’” and warned of an effort to push an early vaccine approval.

The following day, after briefing Trump in the Oval Office on vaccines and therapeutics, Fauci wrote that the president acknowledged a vaccine might not be ready before Election Day, though “he was not happy about it.”

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Fauci, vast majority of scientists he consulted didn’t believe ‘wet market’ COVID origin: ‘diary’

Neither Anthony Fauci nor the vast majority of scientists consulted by the then-director of the National Institute of Allergy and Infectious Diseases accepted the Chinese “wet market” theory of COVID-19 origin in early 2020, before they changed the official consensus in the “Proximal Origin” paper several weeks later, according to purported Fauci diary entries published by Sen. Rand Paul, R-Ky.

“It now appears using epi data and genomic data that the first infection was in early December and was not connected to the market,” Fauci allegedly wrote in his personal notes Jan. 26, 2020 after the Chinese health minister said the novel coronavirus was spreading asymptomatically.

“Remember, early on the Chinese were saying that there is no human to human transmission and all the original 27 cases were from the market,” Fauci allegedly wrote, referring to the Huanan Seafood Wholesale Market about 12 kilometers from the Wuhan Institute of Virology, the prime suspect for the lab-leak theory. “Now we know the market was not the source, it was the amplifier.”

Fauci’s alleged Feb. 1, 2020 personal notes recount the phone call that eventually produced the Proximal Origin paper, which concluded natural origin was the only credible explanation for COVID’s emergence.

Only two of a dozen scientists on the call were “sure that this could occur naturally and we should not waste our time and divert effort to pursue this,” Fauci said, referring to the possibility that SARS-CoV-2’s unusual ability to easily infect humans was engineered. One of those two worked on gain-of-function research, he said.

According to Fauci, “the rest felt that deliberate insertion [virus engineering] was possible and given the fact that Dr. Zheng-Li Shi at the University of Wuhan has been working for years in GOF in coronaviruses to allow adaptation of the spike protein to bind to the human ACE2 receptor, we could not let this go.”

Paul has not answered Just the News on the nature of Fauci’s purported diary, reproduced in Paul’s 1,141-page document titled “Tony’s Diary Package,” published Saturday afternoon. The entries begin Dec. 30, 2019.

“Dr. Anthony Fauci took meticulous notes about his work,” Paul’s preface reads. “He made note of conversations, decisions, and his thoughts about actions taken by politicians and other officials. This is his own historical record containing almost-daily entries,” many of which “completely undermine the official narrative that Fauci and other public health officials espoused.”

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Fauci Bragged in His Diary About Forcing California and New York to Shut Down Schools After Years of Claiming ‘I Had Nothing to Do With It’

Newly released entries from Dr. Anthony Fauci’s personal diary show that the longtime NIAID director was not only deeply involved in closing down schools across the country but was actively proud of his role in getting California and New York to send millions of children home as he dictated the nation’s disastrous COVID response.

This directly contradicts Fauci’s repeated public claims that he had “nothing to do with” school closures, a lie he peddled for years even as American kids suffered catastrophic learning loss, mental health crises, and social isolation under the policies he helped create.

The bombshell comes from the 1,141-page “Tony’s Diary” package released this week by Senator Rand Paul, Chairman of the Senate Homeland Security Committee, ahead of Fauci’s sworn testimony before the panel on Wednesday.

Fauci has repeatedly insisted publicly that critics were wrong to blame him for the school closures.

“They always come back and say, Fauci was responsible for closing schools. I had nothing to do—I mean, let’s get down to the facts,” he claimed in 2022.

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Federal Court Rules For Woman Fired For Refusing COVID-19 Vaccine

Kaiser Permanente wrongly fired an employee who declined to receive a COVID-19 vaccine because she gave proper notice to the company of her religious objection to COVID-19 vaccination, a federal appeals court has ruled.

Mimi Weiss, who worked for Kaiser Permanente’s The Permanente Medical Group for 20 years before being fired, “plausibly alleged that she provided notice of her religious conflict with the mandate in her initial request for a religious exemption,” Circuit Judge Danielle Forrest wrote on July 24 for a unanimous panel of judges on the U.S. Court of Appeals for the Ninth Circuit.

Weiss was working fully remotely, or off-site, in August 2021 as a senior managerial consultant when Kaiser Permanente imposed a COVID-19 vaccine mandate. Weiss, a Christian Jew, within weeks filed for a religious exemption, and Kaiser Permanente initially approved the request.

In September 2021, though, Kaiser Permanente said employees had submitted religious accommodation requests with identical language. Expressing concern that some of the requests were not legitimate, the company asked employees to file fresh requests using their own words. Officials then asked Weiss new questions, including, “What else besides the COVID-19 vaccine do you refuse to put in your body as a result of your religious belief?”

Weiss said she would not provide private information. Kaiser Permanente placed her on unpaid leave. Then it fired her for not complying with the mandate, prompting a lawsuit by Weiss.

A federal judge in 2024 ruled against her, concluding that Weiss had not provided Kaiser Permanente with sufficient notice of the conflict between receiving a vaccine and her beliefs.

The Ninth Circuit ruling overturns that decision, pointing to a previous opinion in which the appeals court said that to provide notice, an employee must only give “enough information about [her] religious needs to permit the employer to understand the existence of a conflict,” and that requiring any more details “would permit an employer to delve into the religious practices of an employee in order to determine whether religion mandates the employee’s adherence.”

Applying that framework to the current case means that Weiss did give adequate notice, the panel said, because she identified herself as a Christian Jew, listed specific doctrines that she said barred her from receiving a COVID-19 vaccine, and outlined her belief that she should not “introduce foreign substances” into her “body temple” that would “change how [her] Creator designed it.”

In a split 2-1 decision, the panel also said that Weiss has shown sufficient evidence to bring forth allegations that Kaiser Permanente violated her right to privacy.

Kaiser Permanente did not return a request for comment by publication time.

“I never imagined my faith would end up costing me my job,” Weiss said in a statement.

“I wasn’t asking Kaiser for special treatment, just the freedom to live according to my conscience. After 20 years of service, I didn’t think that was too much to ask.

“I’m grateful the court recognized that religious employees should not have to give up their beliefs or their privacy to keep their jobs.”

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RFK Jr. Says HHS Found Fauci Diaries Across 11 Different Servers

Health officials located the diaries of Dr. Anthony Fauci across nearly a dozen different servers, Health Secretary Robert F. Kennedy Jr. said on July 27.

“It took us about eight months to dig these out of 11 separate servers, where they had been sequestered and secreted,” Kennedy said during an appearance on Fox News.

After obtaining the private entries of Fauci, who was the head of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health (NIH) from 1984 to 2022, officials with the Department of Health and Human Services (HHS) handed over the documents to Sens. Rand Paul (R-Ky.) and Ron Johnson (R-Wis.). The senators have been investigating the origins of COVID-19 and the response to the COVID-19 pandemic.

Paul, the chairman of the Senate Committee on Homeland Security and Governmental Affairs, subsequently released diary entries from December 2019 through December 2022, combined into one document.

“I think the starkest impression that you get from reading these diaries is this massive dichotomy between what he was saying privately and what he was simultaneously saying publicly,” Kennedy, whose HHS oversees NIH, said on Fox.

Fauci’s institute had provided funding to a Wuhan laboratory to run experiments on coronaviruses, at least one of which added a feature to a virus. A 2018 research proposal outlined work that would insert a feature called a furin cleavage site into a coronavirus, which may have been done at the Wuhan lab.

In a diary entry, Fauci recounted how, during a Feb. 1, 2020, call, 9 of the 11 scientists felt that deliberate insertion of the furin cleavage site into the COVID-19 virus was possible, noting past work done at the Wuhan lab.

Fauci, though, repeatedly promoted the theory in public that the virus, known as SARS-CoV-2, came from nature.

“There was a study recently that we can make available to you, where a group of highly qualified evolutionary virologists looked at the sequences there and the sequences in bats as they evolve,” Fauci told a White House briefing in April 2020. “And the mutations that it took to get to the point where it is now is totally consistent with a jump of a species from an animal to a human.”

That paper, “The Proximal Origin of SARS-CoV-2,” said that “SARS-CoV-2 is not a laboratory construct or a purposefully manipulated virus” and that no lab-based scenario was plausible.

Fauci was involved with crafting the paper, emails released by Paul show, and the paper’s authors doubted their conclusions both before and after the study’s publication, according to messages made public by Paul and others.

The following month, in May 2020, Fauci told National Geographic that there was no scientific evidence that COVID-19 was made in any lab in China.

Fauci also said in his diary that he had convinced the mayor of New York City to close schools.

“I had a similar call with Ann O’Leary, the [chief of staff] of Gov. Gavin Newsom of California,” Fauci wrote. “Ann said that based on my TV appearances today and yesterday, the Governor has decided to close the schools in California as well as the bars and restaurants.”

Fauci said in a 2022 interview that he had “nothing to do” with schools being closed.

Fauci declined to testify to Paul’s committee on a voluntary basis, prompting the senator in June to subpoena Fauci. The doctor is scheduled to testify before the committee on Wednesday.

Fauci, who has not responded to requests for comment, is covered against many possible charges by a preemptive pardon provided by former President Joe Biden.

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RFK Jr. Reveals the COVID Vaccine Secret That Fauci Hid From Americans

For years, Dr. Anthony Fauci assured Americans that the COVID-19 vaccines were safe and effective. What he never mentioned, according to Health and Human Services Secretary Robert F. Kennedy Jr., is that he may have suffered one of those “rare” adverse events himself, and he hid it from the country while publicly insisting such injuries weren’t happening.

Kennedy appeared on Fox News’s The Ingraham Angle to discuss the newly released diary entries that Sen. Rand Paul (R-Ky.) made public, entries that document Fauci’s day-to-day life during the pandemic, on top of his disturbing obsession with himself and the power he wielded during the pandemic. When Laura Ingraham asked whether there would be any accountability for the trillions of dollars lost, the ruined education of America’s children, and the shattered reputation of the public health establishment, Kennedy didn’t hesitate.

“Yeah, and millions of people injured,” Kennedy said. “So he lied about masks, he lied about social distancing, he lied about the transmission, he lied about natural immunity, he lied about the capacity, as you just said, of the vaccine to prevent infection.”

Then came the bombshell.

“He got vaccinated at a very, very public press conference in January of 2021,” Kennedy said, noting that five months later, the diary reveals, Fauci “had a pulmonary infarction, which is one of the adverse events that NIH, CDC and FDA said are expected from the vaccine.”

“He never told anybody,” Kennedy said. “He got treated for it privately by the best doctors in America at the same time, he was telling everybody that was not an adverse event.”

Think about that for a second. The man who badgered every American into taking the shot, insisting it was perfectly safe, appears to have experienced one of the exact injuries his own agencies flagged, then quietly got elite private care while assuring the public that such reactions weren’t real. Ordinary Americans who reported similar problems got dismissed and mocked. Fauci got the best doctors in America.

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Czech data shows that those who got the Moderna vaccine died more

For the first time, I show the directly standardized survival curves for each 5 year age group in the Czech Republic using the publicly released record-level data.

This data consistently shows the people who got the Moderna vaccine were much more likely to die than those of the same age who got the Pfizer shot. The relative risk (RR) was >1.5 for those under age 60 which is a huge difference.

The comorbidity distribution for both groups of a given age range was very similar (SMD=.05)

This isn’t because Pfizer is more protective of a COVID death because the differences were not specific to COVID periods (and were too large to be explained by effectiveness differences).

There are two remaining explanations:

  1. The Moderna vaccine was more deadly
  2. There was a systematic distribution of vaccines in Czech Republic that no matter what age you were, if you were more likely to die, you were given the Moderna shots.

Explanation is 2 is much less likely because there was no systematic bias in vaccine distribution by brand, and even if there were, the fact that the DCCI distributions were similar and that the younger you were, the more pronounced the effect, would be unusual since 45 year old people are not concentrated in elderly homes and hospital beds.

So the most likely explanation is Moderna was more deadly.

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