Thursday, April 25, 2024

COVID-19 Vaccine Emails: Here’s What the CDC Hid Behind Redactions

The U.S. Centers for Disease Control and Prevention (CDC) hid how a woman who suffered chest pain and other symptoms following COVID-19 vaccination received a shot because of a mandate at work, newly obtained documents show.

The agency also redacted how multiple children were diagnosed with Kawasaki Disease after receiving a COVID-19 vaccine, according to the documents.

The Epoch Times obtained more than 1,400 pages of emails from the CDC concerning its Clinical Immunization Safety Assessment (CISA) project, which analyzes post-vaccination problems reported by health care providers. The tranche included numerous redactions.

While redactions are allowed under the Freedom of Information Act, there were signs that too much information was being hidden.

The Epoch Times appealed some of the redactions.

The CDC agreed to remove some of them, revealing what the agency initially shielded.

In one email, a provider reports a 30-year-old woman who suffered chest pain and leg twitching following COVID-19 vaccination. The original copy of the email stated in part that she “got vaccine due to [redacted].”

In the updated copy, the CDC removed the redaction, showing that the woman received a vaccine because of a mandate at work.

Several other portions of the emails that are now unredacted show the CDC hid how multiple children, including a 2-year-old, were said to have suffered from a serious inflammatory illness called Kawasaki Disease shortly after receiving a shot.

One girl suffered inflammation around the eyes, swollen lips, high fever, and a rash, and “was admitted last week with Kawasaki,” one of the girl’s parents wrote on Dec. 5, 2021, the new documents show. She received a dose of the Pfizer-BioNTech vaccine two weeks prior.

Dr. Matthew Oster is a cardiologist who works for the CDC.

“The biggest question, of course, here, is whether this was truly [redacted] or whether this was [redacted] related to the vaccine,” Dr. Oster wrote after hearing about the case.

The cleaner copy of the email showed that the redactions covered “KD,” or Kawasaki Disease, and “MIS-C,” or multisystem inflammatory syndrome in children.

“We do now have a small number of cases like this one,” Dr. Oster said.

The CDC has portrayed MIS-C as only being caused by COVID-19, but studies have found that there were MIS-C cases before the COVID-19 pandemic and that some people suffered the syndrome after vaccination without evidence of COVID-19. The CDC says on its website that the agency is “investigating reports of multisystem inflammatory syndrome in children (MIS-C) associated with coronavirus disease 2019 (COVID-19), which may present with Kawasaki disease-like features.”

Another email originally hid the age of a male child and what his doctor suspected he suffered after receipt of a second dose of Moderna’s vaccine.

The boy was 2 years old, the newly obtained documents show, when he was admitted with what a pediatric infectious disease doctor suspected was “atypical Kawasaki Disease.” The documents show that the doctor also considered MIS-C as a diagnosis in light of how the boy’s sister tested positive for COVID-19 on the same day the boy started showing symptoms of fever, although multiple COVID-19 tests on the boy returned negative.

The doctor said he had a “low suspicion” for a COVID-19 vaccine reaction but still submitted a report to the Vaccine Adverse Event Reporting System (VAERS), which the CDC helps run.

Kawasaki Disease was detected as a safety signal for the Pfizer and Moderna vaccines among children aged 5 to 11 when the CDC first ran an analysis on VAERS data in 2022, according to files previously obtained by The Epoch Times. The analysis did not include children younger than 5. Kawasaki disease after COVID-19 vaccination has been reported in the literature, although a study on patients with a history of the disease who contracted COVID-19 or were vaccinated uncovered no signs of problems.

An internal CDC message, now fully unredacted, showed that an official described there being “another CISA ‘inquiry’ about a child with atypical Kawasaki Disease.” Another official said the reports were “very rare” while a third said the normal CDC processes were sufficient to monitor for the disease post-vaccination “unless there’s a specific ask or data need.”

Other removed redactions show that:

A person reporting symptoms after COVID-19 vaccination was reporting that the symptoms included Coxsackievirus and that he himself was the patient. The provider wrote, “I ... don’t know whether to fear another vax more or less than the risk of infection.”

A patient who was reported as suffering heart inflammation after a third Pfizer dose, and came back with the inflammation one year later, was 17 and a male.

The CISA expert who said the woman who suffered chest pain could get additional vaccine doses was Dr. Oster. Previously disclosed emails showed the program repeatedly said people with post-vaccination symptoms should receive more doses.

A patient with “intense malaise” and other symptoms about six months after a Pfizer shot had an elevated heart rate, per a portable electrocardiogram, and sinus tachycardia per a cardiology consultation.

Words and phrases that were redacted originally, but not any longer, include “your daughter”, “hospitalist”, “the parents”, “cardiac workup”, “a physician”, “I believe”, “patient was started on a course of Prednisone”, and “does not drink, smoke, or use any drugs.”

Every single email chain for which redactions were protested was returned with at least some redactions cleared.

The original version claimed that the redactions were appropriate under exceptions outlined in the Freedom of Information Act, including an exception that protects “personnel and medical files and similar files” if their disclosure “would constitute a clearly unwarranted invasion of personal privacy.”

A CDC official told The Epoch Times in an email that the agency, after receiving the appeal, conducted a “careful review” and removed some of the redactions. The official did not explain why the CDC wrongly redacted so much information.

The CDC “has provided modified records for the pages listed in your appeal,” an official with the U.S. Department of Health and Human Services, the CDC’s parent agency, told The Epoch Times in an email. Appeals of CDC Freedom of Information Act requests are lodged with the department.

Fits Pattern

Any person can request information through the Freedom of Infection Act (FOIA), and agencies across the government typically redact portions of responsive documents or withhold them entirely. Agencies “often use FOIA exemptions improperly, withholding records simply because they may reveal problems at the agency or just ‘paint the agency in a bad light,’” Melissa Wasser, a lawyer at the Project On Government Oversight, told senators in 2022. People “consistently receive large swaths of arbitrarily redacted information,” she added.

When presented with signs that information was improperly redacted or withheld, people primarily have two options: lodge an appeal or sue.

Both methods have worked to extract information from the CDC during the pandemic.

An Epoch Times appeal in another case, for example, returned a copy that removed significant redactions that were applied to an internal email describing what Pfizer and Moderna told them about studies that were being done regarding heart inflammation and COVID-19 vaccines.

The unredacted information showed that Moderna had not tested samples from vaccine recipients for subclinical myocarditis because it was waiting for a “specific cardiac biomarker [to] be identified.” An outside study from Switzerland later found signs of subclinical heart inflammation in about one out of 35 people.

The CDC acknowledged that the information had been wrongly redacted. It reasoned that the information “cannot be considered confidential” because it was shared before and “is readily available to the public,” although some of the details had never been made public previously.

Among other lawsuits, meanwhile, one led to the release by the CDC of answers from its V-safe surveillance survey while a second prompted the disclosure of what participants wrote in free-text fields after the CDC left off adverse events of special interest from the survey. Some of the data had never before been described publicly, while other information from the system had only been outlined in CDC-authored studies and presentations.


U.S Government Continues to Ignore COVID-19 Externalities--Injured Suffer with Abysmal Compensation Record

Vaccine injury activist Wayne Rohde reports that the track record for COVID-19 vaccine injury compensation continues to demonstrate a complete lack of support for the many people adversely impacted by the COVID-19 countermeasures. For example, take the Countermeasures Injury Compensation Program (CICP), the organization mandated to help individuals hurt by such countermeasures. How many claims have they awarded and reimbursed in 2024—just one.

According to Rohde, author of “The Vaccine Court: The Dark Truth of America’s Vaccine Injury Compensation Program,” this abysmal result derives from HRSA’s just released April CICP compensation statistics.

Rohde's, whose son was impacted by a vaccine injury, reports in his blog that “…we should not expect anything positive. Just a pathetic operation. They continue to disappoint.”

In fact, Rohde reports the only compensated petition (accurately described as medical expense reimbursement) marks the 12th comp case overall.

“Just one comp since March 5th. A COVID-19 vaccine causing syncope. A fainting injury. It is still serious. The injured petitioner fainted, fell to the ground, maybe suffering a concussion, highly possible jaw and dental injuries.”

What’s the total for this latest injury? $4,493.00 to cover unreimbursed medical expenses. That makes 12 petitions compensated for a total of $39,203 since 2021.




Wednesday, April 24, 2024

Pfizer ‘Chose Not to’ Tell Regulators About SV40 Sequence In Covid Shots

A senior Health Canada official says pharma giant Pfizer made a conscious decision to not advise regulators that its mRNA COVID-19 vaccine contained a DNA sequence from the Simian Virus 40 (SV40).

This information appears among multiple emails between staff from key drug regulators, including Health Canada (HC), the U.S. Food and Drugs Administration (FDA), and the European Medicines Agency (EMA). The information was obtained through an access-to-information request.

On Aug. 23, 2023, Dr. Dean Smith, a senior scientific evaluator in HC’s Vaccine Quality Division, wrote an email to a colleague at the FDA about SV40.
Health Canada had obtained confirmation two weeks earlier from Pfizer that SV40 DNA sequences were present in its COVID-19 vaccine.
“I understand that there have been internal discussions at CBER [Center for Biologics Evaluation and Research] regarding the presents [sic] of an SV40 enhancer/promoter sequence, noting that its presence is unrelated to the purpose of the Pfizer’s plasmid as a transcription template for their mRNA COVID-19 vaccine,” wrote Dr. Smith.

“Pfizer has communicated to us recently, that they apparently chose not to mention this information to EMA, FDA or HC at the time of their initial or subsequent submissions.”

Dr. Smith added the information had been independently made public in April 2023, via a pre-print study from U.S. scientist Kevin McKernan.

Mr. McKernan, a genomics expert, had found quantities of DNA in the mRNA shots above the regulatory threshold set out by the health agencies. Dr. Smith wrote that the study had resulted in “questions coming to agencies.”

The Epoch Times had contacted HC on the matter on July 17. The first email related to SV40 within Health Canada released in the access-to-information package was sent two days later, on July 19.

In that email, Dr. Tong Wu of HC’s Vaccine Quality Division reached out to his colleague Dr. Michael Wall, a senior biologist evaluator.

“Co [Pham, executive director of HC’s Centre for Vaccines, Clinical Trials and Biostatistics] agreed to have an IAS for the SV40 promoter sequence as we discussed today. We can talk about it tomorrow,” Dr. Wu wrote. “IAS” could be a reference to an Issue Analysis Summary to evaluate a new regulatory affair.

As first reported by The Epoch Times in October, Health Canada was not aware of the SV40 enhancer presence. Since then, the FDA and the EMA have both confirmed they also weren’t aware of its presence.

Health Canada has since maintained that the SV40 enhancer/promoter sequence is a “residual DNA fragment” in Pfizer-BioNTech COVID-19 vaccine. “The fragment is inactive, has no functional role, and was measured to be consistently below the limit required by Health Canada and other international regulators,” the agency has repeatedly said.

‘ZERO Checks’

This view has been challenged by Mr. McKernan and others, including Dr. Philip Buckhaults, professor of cancer genomics and director of the Cancer Genetics Lab at the University of South Carolina.

In response to the information released by Health Canada, Mr. McKernan posted a thread on the X platform. “No prior vaccine in Canada has been approved with such a sequence contaminant,” he said.

“Pfizer assured [HC] the sequence is not material to plasmid manufacturing,” he added. “This is an overt lie. You cannot make plasmids without the promoter for the antibiotic resistance gene. It is active in mammalian cells. If it’s not needed, why is it in there?”

Mr. McKernan also noted how HC has asked Pfizer for its Polymerase Chain Reaction (PRC) protocol, saying this means “they have performed ZERO checks on this DNA contamination themselves and are entirely relying on the word of the manufacturer.”

A response to a Canadian Member of Parliament’s question tabled in the House of Commons by Health Canada appears to be line with this observation. “It is important to assess the results using the authorized validated assays performed by the vaccine manufacturers to ensure that the quality of commercial vaccine lots are comparable to lots shown to be safe and efficacious in clinical studies,” said Health Canada in December.

Concerns related to the presence of unintended DNA in the mRNA shots pertain to their potential to integrate into the human genome and cause issues like cancer. The Florida State Surgeon General Dr. Joseph A. Ladapo has called for a halt of mRNA shots over these risks.

Health Canada said in March in a document tabled in Parliament that “any claims that the presence of the SV40 promoter enhancer sequence is linked to an increased risk of cancer are unfounded.”

Dr. Buckhaults has started a scientific study to ascertain those integration risks. On April 23, he wrote on X that he had confirmed previous findings that the amount of DNA in mRNA shots exceeds the limit set by regulators.

“Yes, there was more than 10 ng/dose. I am sure of it now,” he wrote while posting his methodology. This is the same threshold applied by Health Canada.

Even if the amount of DNA was below, there are still concerns the threshold was set for regular vaccines and not the new technology using lipid nano particles (LNP).

Dr. Buckhaults wrote that the “10 ng limit is not appropriate for LNP encapsulated DNA,” adding that “as far as I know there have been no safety studies for this situation. It was not possible because of the abbreviated timeline during the emergency you saw authorization.”

Seeking ‘Remedy’

In his August 23 email to the FDA employee, Dr. Smith said HC Canada did not view the SV40 issues as an “urgent risk topic.” However, the official responsible for evaluating the safety of vaccines expressed concerns about how news of the SV40 could impact the upcoming fall 2023 vaccination campaign.
“It would be unfortunate if the information circulating had a negatively [sic] impact on public acceptance of the vaccine this year or in the future,” he said.

Despite being of this view, Dr. Smith said regulating agencies should work to encourage Pfizer to “remedy the situation” before the campaign.

In the email, Dr. Smith said HC believed the upcoming rollout of the fall COVID-19 vaccine campaign meant the agencies should be “on the same page.”

Mr. Smith’s email was written a day after Pfizer provided a response to a Quality Clarifax submitted by HC around the SV40 promoter. If deficiencies are identified in Clinical Trial Applications, HC may request additional information, which is known as a Clarifax.

On August 29, HC senior biologist Dr. Wall wrote an email to senior evaluator Dr. Tong Wu, where he said he and Mr. Smith agreed they should not inform Pfizer of their interaction with the EMA and U.S. FDA on the SV40 promoter, “especially they [sic] do not seem to care much at this moment.”

“However, we can not say nothing! Please see the following text that Julie and I worked out,” Mr. Wall added, before providing a draft comment to Pfizer’s response that was blacked out.

The same day, Dr. Wall also sent an email to Dr. Wu with a draft of the Clarifax questions to be sent to Pfizer, which included the statement, “Health Canada would continue to work with international regulatory partners to achieve harmonisation regarding removal of these sequence elements from the plasmid for future strain changes.”

Pfizer did not respond to a request for comment from The Epoch Times

Commenting on DNA contamination, Health Canada reiterated its previous position on the matter.

“Based on its evaluation of the data and scientific information for the vaccine, Health Canada has concluded that the risk/benefit profile continues to support the use of the Pfizer-BioNTech vaccine,” said spokesperson Anna Maddison.

Dr. David Speicher, a Canadian virologist who replicated the findings from Mr. McKernan and Dr. Buckhaults with Canadian mRNA vials, told The Epoch Times he’s preoccupied about what’s been revealed in the internal Health Canada emails. He notes that while Health Canada has dismissed the DNA fragments as biologically inactive with no functional role, they judged worthy to hold discussions with other regulators.

“We know from testing several vials that the level of SV40 enhancer-promoter in the XBB.1.5 booster is at similar levels as the others Pfizer COVID modRNA vaccines, making it just as problematic,” he says. “Pfizer has not cleaned up the vaccine, yet the regulators are sadly more concerned about vaccine uptake in the population rather than the health risks from these vaccines.”




Tuesday, April 23, 2024

COVID-19 Vaccine Protection Among Children Plummets Within Months: CDC Study

Children who received an original COVID-19 vaccine have little protection against hospitalization just months after vaccination, according to a new study from the U.S. Centers for Disease Control and Prevention (CDC).

Children initially have 52 percent protection against hospitalization but that estimated effectiveness plummeted to 19 percent after four months, according to the paper.

Protection against so-called critical illness also dropped sharply, from 57 percent to 25 percent, researchers found.

The researchers include CDC employees and the paper was published in the CDC’s weekly digest on April 18.
The study covered children who received two or more doses of the original Pfizer-BioNTech or Moderna COVID-19 vaccines from Dec. 19, 2021, through Oct. 29, 2023.

The study involved children aged 5 to 18 who were hospitalized with acute COVID-19 and tested positive for the illness and compared them to a control group of children hospitalized with COVID-19-like symptoms but who tested negative for COVID-19.

Researchers drew data from the Overcoming COVID-19 Network, which includes health care sites in most of the United States, and ended up with 1,551 case patients and 1,797 in the control group.

The study found that “receipt of ≥2 original monovalent COVID-19 vaccine doses was associated with fewer COVID-19–related hospitalizations in children and adolescents aged 5–18 years; however, protection from original vaccines was not sustained over time,” Laura Zambrano, a CDC epidemiologist, and her co-authors wrote.

It also recorded a similar drop in protection against critical illness, defined as being placed on mechanical ventilation, vasoactive infusions, extracorporeal membrane oxygenation, or dying.

The researchers asserted that the results highlighted the current CDC guidance that all people aged 6 months and older receive one of the newest COVID-19 vaccines, which were introduced in the fall of 2023 with clinical data from just 50 humans and no efficacy estimates. The CDC only publishes papers in its weekly digest, the Morbidity and Mortality Weekly Report, after they’re shaped to “comport with CDC policy.” The papers are not peer-reviewed.

Ms. Zambrano did not respond when asked for data suggesting that the currently available shots provide longer-lasting protection than the original vaccines.

The CDC’s website says, in promoting vaccination, that COVID-19 vaccines are “effective at protecting people from getting seriously ill, being hospitalized, and dying” but the hyperlink that ostensibly supports the statement goes to a page that is not live.

U.S. authorities have been moving COVID-19 vaccines to a once-a-year model, similar to influenza vaccines. The model features updating the formulation of the vaccines on an annual basis, in an acknowledgment that any protection the vaccines give quickly wanes. The formulation is typically updated in the fall.

Just 14 percent of children, and 23 percent of adults, have received one of the newest vaccines as of April 6, according to CDC estimates. The available vaccines are messenger RNA (mRNA) shots from Pfizer and Moderna and an alternative from Novavax.

Dr. Jane Orient, executive director of the Association of American Physicians and Surgeons, noted that, according to the new paper, the maximum effectiveness estimates against hospitalization were 61 percent, regardless of how the data were sliced, that more deaths were recorded among the case patients, and the median hospitalization duration was four days for both groups.

“I do not see how a clinician whose concern is treating patients and whose job does not depend on pushing mRNA vaccines would find this a basis for recommending shots—quite the contrary,” Dr. Orient, who was not involved in the research, told The Epoch Times in an email. “It reeks of conflict of interest.”

Stated limitations of the paper include not assessing post-infection immunity and a lack of sequencing data.

The conflict of interest section runs 688 words and includes some of the authors reporting funding from Pfizer and Moderna or ownership of Pfizer stock.


UC Riverside Breakthrough: Novel Live-Attenuated RNA Virus Vaccine Eliminates Chasing Strains?

According to a recent University of California, Riverside (UCR) media release, scientists at the Inland Empire-based Southern California research center recently demonstrated a novel RNA-based vaccine strategy that is effective against any strain of a virus and can be used safely even by babies or the immunocompromised.

This would be a monumental breakthrough, one that would eliminate the current “chasing of strains” involved with the flu and now COVID-19 shots. Specifically, the team led by Rong Haia Ph.D. and Shou- Wei Ding, Ph.D. characterized a unique live-attenuated RNA virus vaccine, where attenuation resulted from the elimination of the viral RNAi suppressor and enhanced the production of virus- targeting small- interfering RNAs.

The UCR team demonstrates that single-dose immunization with the vaccine just 2 days in advance induced full protection in neonatal and adult mutant mice lacking adaptive immunity. Also, the immunized mutant mice remained protected against lethal challenge for at least 90 days postvaccination.

Human enterovirus- A71, influenza A, and dengue viruses all encode a similar RNAi suppressor, suggesting potential for developing a distinct type of virus vaccine to confer rapid and effective protection in infants and other immune- compromised individuals.

TrialSite this week purchased the study, reviewing below in conjunction with the UCR News media entry.

The Problem

Researchers on an annual basis make attempts to predict the four influenza strains that are most likely to be prevalent during the upcoming flu season. And every year, people line up to get their updated vaccine, hoping the researchers formulated the shot correctly.

Ditto for COVID vaccines: these vaccine products are reformulated to target sub-variants of the most prevalent strains circulating in the U.S.

What’s the Breakthrough?

Based on a recent breakthrough published earlier in the week in Proceedings of the National Academy of Sciences (PNAS), the new strategy would eliminate the need to create all these different shots, because it targets a part of the viral genome that is common to all strains of a virus.

“What I want to emphasize about this vaccine strategy is that it is broad,” said UCR virologist and paper author Rong Hai. “It is broadly applicable to any number of viruses, broadly effective against any variant of a virus, and safe for a broad spectrum of people. This could be the universal vaccine that we have been looking for.”

The Novel Vaccine

With traditional vaccines contain either a dead or modified, live version of a particular virus, with these products the body’s immune system recognizes a protein in the virus and mounts an immune response. Eliciting T-cells to attack the virus, thereby inhibiting the spread of the pathogen. It also produces “memory” B-cells that train your immune system to protect you from future attacks.

Interestingly enough, this novel vaccine discovered at UCR uses not mRNA, but actually also a live, modified version of a virus. The difference, however, from others; this novel candidate does not rely on the vaccinated body having this traditional immune response or immune active proteins — which is the reason it can be used by babies whose immune systems are underdeveloped, or people suffering from a disease that overtaxes their immune system. Rather, the experimental vaccine relies on small, silencing RNA molecules.

According to Shouwei Ding, distinguished professor of microbiology at UCR, and lead paper author “A host—person, a mouse, anyone infected— will produce small interfering RNAs as an immune response to viral infection. These RNAi then knock down the virus.”

Jules Bernstein reported on this finding for UCR News, educating that viruses typically generate RNAi response blockers in the form of proteins. According to Ding, “If we make a mutant virus that cannot produce the protein to suppress our RNAi, we can weaken the virus. It can replicate to some level, but then loses the battle to the host RNAi response.” Elaborating on this concept, Ding shared with the UCR reporter, “A virus weakened in this way can be used as a vaccine for boosting our RNAi immune system.”

Validating in Early-Stage Study

When the researchers tested this strategy with a mouse virus called Nodamura, they did it with mutant mice lacking T and B cells. With one vaccine injection, they found the mice were protected from a lethal dose of the unmodified virus for at least 90 days. Note that some studies show nine mouse days are roughly equivalent to one human year.

There are few vaccines suitable for use in babies younger than six months old. However, even newborn mice produce small RNAi molecules, which is why the vaccine protected them as well. UC Riverside has now been issued a US patent on this RNAi vaccine technology.

In 2013, the same research team published a paper showing that flu infections also induce us to produce RNAi molecules. “That’s why our next step is to use this same concept to generate a flu vaccine, so infants can be protected. If we are successful, they’ll no longer have to depend on their mothers’ antibodies,” Ding said.

Their flu vaccine will also likely be delivered in the form of a spray, as many people have an aversion to needles. “Respiratory infections move through the nose, so a spray might be an easier delivery system,” Hai said.

Additionally, the researchers say there is little chance of a virus mutating to avoid this vaccination strategy. “Viruses may mutate in regions not targeted by traditional vaccines. However, we are targeting their whole genome with thousands of small RNAs. They cannot escape this,” Hai said.

Ultimately, the researchers believe they can ‘cut and paste’ this strategy to make a one-and-done vaccine for any number of viruses.

“There are several well-known human pathogens; dengue, SARS, COVID. They all have similar viral functions,” Ding said. “This should be applicable to these viruses in an easy transfer of knowledge.”




Monday, April 22, 2024

Fighting an invisible illness: the curse of Long Covid

Note that she fell ill AFTER being vaccinated


The first time I got Covid it landed me in hospital on Christmas Day. It was 2022 and my husband dropped me off outside Emergency, our two worried kids watching from the car. I didn’t want to leave them but I had no choice: I’d been ­experiencing wave after wave of horrible nausea, and I had never felt my heart beat so fast. I felt on the verge of collapse. Being Covid positive, I was told by hospital staff to wait on a bench outside and that’s where I sat, miserably, until a nurse came to see me.

“So you have Covid,” she said. “Well, what did you come here for? Do you think I have a magic pill that’s going to make you feel better?” The rational, fact-finding journalist part of my brain knew what she said was correct – there wasn’t a quick fix, and being Christmas the ­hospital was operating with skeleton staff who were overworked and exhausted at this point in the pandemic. But I had never felt so sick in my life, and I simply did not know what else to do. Surely there was someone who could help me?

What I didn’t realise in that moment was that, 16 months later, I would still be struggling with this same feeling of utter desperation, hopelessness and fear. Because since the acute phase of the infection ended, I have been ­struggling with the mysterious and debilitating condition known as Long Covid.

I am not alone: it is estimated that one in 10 people who contract Covid develop Long Covid, which is defined in Australia as being symptomatic three months after the original infection. According to research publishedlast year, as many as 65 million people have Long Covid worldwide, with numbers ­increasing with each new wave of the viral ­infection. In Australia, there is no national registry keeping tabs on the number of cases but a recent federal parliamentary inquiry into Long Covid heard there could be anywhere between 200,000 and two million sufferers.

What is clear from data collected globally since the pandemic began is that Long Covid affects more women than men, especially women in their thirties and forties. (Being a 45-year-old woman, I am a fairly typical case.) As a patient, and as a journalist, I wanted to understand why Long Covid remains largely a mystery, even though scientists and physicians have had more than four years to get to grips with it. The first key question, for me: why are women getting Long Covid more than men?

“I wish I could tell you but we just don’t know yet,” says Professor Steven Faux, who ­co-founded one of the first Long Covid clinics in Australia, at St Vincent’s Hospital in Sydney. “There are a handful of reasons [being explored]. One is psychosocial, that we put women in harm’s way when it comes to caring for people because most nurses are women. “

There is another issue, he says. “A group of researchers in the US said, ‘We think it is happening in that period because they’re perimenopausal and no one is looking at that. Is that possible?’”

But, Faux says, the most fascinating theory is US immunologist Professor Akiko Iwasaki’s research around the hormonal response – that the female’s immune system is more aggressive than the male’s, and turns on faster and stronger to protect any potential unborn child. But it then exhausts itself and it can’t keep fighting against the virus and stop it from developing reservoirs in different organs.

Faux sees more women than men at St Vincent’s Long Covid clinic (55 per cent female patients compared with 45 per cent male). The most common age group is 31-45 years, followed by 46-60 years. This echoes the experience of other clinics in Australia and overseas and was also noted as a concern by the parliamentary committee inquiry into Long Covid. “There’s just a lot more women,” Faux says.

The reason I am talking to Faux in his tiny ­office at St Vincent’s between clinic appointments on a Thursday afternoon is not only ­because is he one of the leading Long Covid experts in Australia and I selfishly want to pick his brain, but because he is the first person in this country to have written a comprehensive guide to the illness. To be published in May, Long Covid: Expert Advice, from Diagnosis to Treatment and Recovery is aimed at patients, people just like me, who have been struggling to get better. It also advocates for us. And it does so in a particularly empathetic way.

“If you are living with Long Covid, we know that in your own ways you try to keep going, try to be the person you were, while battling the fear that you will never be the same,” Faux writes early on, setting the tone. “This book is an attempt to say to all of you: we see you.”

Those few sentences in the book encapsulate my experiences in a way that no other doctor has been able to. It’s comforting to simply read Faux’s acknowledgment of the awful symptoms – the erratic heartbeat, the exhaustion, the brain fog, the doctors’ ­appointments, the specialists’ appointments, juggling work, juggling children and the heavy weight of waking up every morning and not feeling any better.

“One of the things about Long Covid is that it’s a largely invisible illness,” Faux writes. “When you have it, you don’t necessarily look any different. It is not like you’ve lost a limb or have a cast on your harm. Fatigue or cognitive impairment is often subjective; it’s hard to show people you are fatigued because the only way to do that is to complain about the symptom.”

Faux is the Director of Pain Medicine at St Vincent’s, and previously spent 22 years as the director of rehabilitation. He has spent almost 30 years helping people ­recover from injury and illness. He and his ­colleagues recognised early on in the ­pandemic that there was a need to plan beyond the acute infection stage. And after working on the front line in the Covid wards for months, he saw first-hand what was coming. “What I knew of previous pandemics, and the effects of viral illnesses such as HIV and polio, was that the pandemic was about to ­deliver thousands of people who would be ­damaged by this infection and who would ­require rehabilitation,” he writes.

His unit soon started getting referrals for Covid patients who still had symptoms after three months. They called themselves “long haulers” on social media and were reporting breathlessness, coughing and exhaustion.

“We initially thought it was because the virus was destroying their lungs and they needed pulmonary rehab – but then a lot of the people we were ­seeing couldn’t go back to work because they couldn’t concentrate,” Faux tells me.

“I had colleagues emailing me saying, ‘Are you using brain injury rehab for these people?’ and it was then I ­realised that if we didn’t do something proactively, we were going to end up with an army of people who were disabled for some time.”

More than 200 different symptoms are now ascribed to Long Covid. According to a 2021 review quoted by Faux in his book, the most common is fatigue (45.1 per cent), followed by breathlessness, then insomnia, difficulty waking, anxiety, depression, brain fog, muscle pain, palpitations, headaches and a loss of taste and smell. But it can be hard to pin down. “People with Long Covid often say they don’t feel themselves, or are unable to get on with things as they used to, but many can’t really articulate what they feel,” he writes. “At the St Vincent’s clinic I’ve seen people lose their jobs as a result of Long Covid. I’ve seen it place stress on relationships and cause untold anxiety.”

Faux estimates there could be as many as one million Australians living with Long Covid, given that around one in ten people who get Covid develop Long Covid and more than 11 million Australians are thought to have contracted Covid since the pandemic began. “This figure would place Long Covid high on the list of the most significant medical conditions ­affecting the Australian population,” he points out. “Compare this with type 2 diabetes at 1.3 million, asthma at 2.7 million, heart disease or stroke at 1.2 million and cancer at 1 million.”

I managed to avoid Covid for the first two years of the pandemic, and I was beginning to think I was one of the lucky ones until I finally tested positive. This, of course, was well after the peak of the pandemic, after lockdowns, and after almost every Australian had been vaccinated. By then, we had certainly heard of Long Covid. The Weekend Australian Magazine had reported on the condition back in 2020 – a growing army of Covid “long-haulers”, many of whom had only a mild case of Covid-19, ­describing “a medley of lasting symptoms”.

When I fell ill, three days after my son tested positive in December 2022, I wasn’t too worried. I was fully vaccinated. The symptoms were ­initially mild: I had a temperature for a few days, a slight cough and felt generally unwell. But the symptoms dramatically escalated one evening when I was cooking dinner for my ­family. A wave of nausea and dizziness hit, my heart started beating fast and erratically and I thought I was going to faint. I immediately stopped what I was doing and lay down on the couch, waiting for it to pass. It didn’t.

During my first hospital visit on Christmas Day, they checked my heart and found nothing wrong, then hooked me up to a bag of IV fluids. I overheard the doctor ask a nurse whether I was eligible for antiviral drugs. “No, she’s too young,” came the reply. I was discharged a few hours later as there was nothing more they could do. I was back in hospital on New Year’s Eve with the same frightening symptoms. This time I underwent exhaustive tests and spent a night in the Covid ward before being discharged. Two weeks later, I finally tested negative to Covid – though my symptoms remained.

“They will lift,” a close friend reassuringly messaged me. But even as time went by, there was no easing of the symptoms. The godawful nausea meant I had no appetite and lost five kilos, and I couldn’t do anything physical without feeling dizzy. My husband had to take care of me and keep the kids occupied during a month of school holidays. Worst of all, my heart was behaving very strangely. All of a ­sudden I would feel it beating as if it would leap out of my chest, then I would get this horrible jittery feeling like when you’ve had too much coffee. Sometimes this would last for days.

I attempted to go back to my job as a journalist for The Australian’s WISH magazine in the middle of January 2023. I was working from my parents’ house – they were helping look after my children. One day I’d been working for about two hours when another wave of nausea and dizziness hit. I remember crying in despair in front of my husband and kids, frightened that this illness would rob me of my career.

Then came the dreaded “brain fog” reported by many Long Covid sufferers: I kept forgetting words and confusing things. The words and memories were there, I just couldn’t access them. It took away my confidence to write – a key part of my job – as well as my ability to function day-to-day as a mother and wife with school-age children.

Many studies have found that Long Covid affects the brain, and it’s a key part of the rehabilitation program at the St Vincent’s clinic – even though Faux admits the medical profession is at a loss to explain what causes the fog. “It’s unclear whether the effects on the brain are due to the persistence of the virus or to the immune system’s response, but brain ­imaging studies have shown that the parts of the brain involved include the orbitofrontal areas (above the eyes) close to where the olfactory (smelling) nerves enter the brain, and near some of the areas of the memory centres (the hippocampus and limbic systems),” he writes. “There is also evidence of thinning of the brain’s grey matter in those with Long Covid who have brain fog.”

The other debilitating symptom Faux sees that has also changed my life is post-exercise malaise. It means you can’t tolerate any type of exercise, and your body tells you afterwards – not during – with a swift return of symptoms. We’re not talking about the ­serious exertion of running or ­lifting weights in the gym; it can be triggered by the expending of ­energy in almost any way. Carrying too many groceries one evening meant I woke up the next day to find my nausea had returned powerfully, and I found getting out of bed incredibly difficult. The day before, I’d felt fine.

As I grew to understand, people living with Long Covid don’t have a linear recovery. You can have a good day, or even have a good week – and then you can overdo it physically, without realising, and be back to square one. For me, this was when the fear crept in and I found ­myself panicking that I might never recover.

“Living with uncertainty is one of the big ­issues for Long Covid,” explains Faux. “We ­always advise people with Long Covid a bit like we approach cancer rehabilitation – if you’re having a good day, enjoy it and don’t expect it to be the same tomorrow. And if you are having a shit day, then ride it out and maybe tomorrow will be completely different.”

While I was undergoing a series of tests last year to find out why my heart was beating erratically, a doctor helpfully told me that Long Covid is a post-viral syndrome much like Myalgic Encephalomyelitis/Chronic Fatigue Syndrome, and the sheer volume of cases mean the symptoms cannot be dismissed as psychosomatic. “One of the things that people were initially saying with Long Covid is that these people are histrionic, they are putting it on,” Faux says. “But it became clear to me when we opened the clinic and talked to the first patients that they were not.

“The patients we see can’t work and they want to work. They need money and they have to put bread on the table. They don’t have a ­history of chronic pain or diagnosable illnesses. These are people with very little to gain by being sick.”

There is a six- to nine-month waiting list to get into the St Vincent’s Long Covid clinic. Faux and Associate Professor Anthony Byrne, a respiratory physician, set up the team that includes nurses, physiotherapists, a sleep specialist, a neurological rehabilitation expert and a psychologist. Each patient who is referred by their GP gets an assessment and a tailored rehabilitation program. It’s a slow process, but it does work. “If patients are identified early and they get a psychologist and a physio, or a physio and ­occupational therapist, whatever they need, and they start treatment early, the evidence from overseas is that they recover faster,” ­explains Faux. “And the evidence from our ­clinic is that there is a substantial return to work at six months following the commencement of rehabilitation.”

Last April, a federal parliamentary committee made nine recommendations following its inquiry into Long Covid. Among them was that the government should partner with state health departments to develop and fund more multidisciplinary Long Covid clinics. Yet when Health Minister Mark Butler released the federal government’s response to the inquiry, this was not one of the recommendations it supported. In the same month, the government committed $50 million of funding for research into Long Covid and established a national database on the disease. In fact, despite the demand for Long Covid clinics and the committee’s recommendations, governments appears to be withdrawing their support for them. In an RMIT study published last October co-lead author Dr Shiqi Luo stated: “We have insufficient Long Covid clinics to meet the demand”. An ABC investigation last December found five of the country’s 23 clinics have either been scaled back or closed.

Unlike me, Julie Lamrock contracted Covid early in the pandemic, in 2019, when a passenger she collected in her shuttle bus from the Overseas Passenger Terminal disembarked from the Ruby Princess cruise ship.When The Weekend Australian Magazine reported on Covid “long-haulers” in 2020, Julie was still ­experiencing pain, fatigue and brain fog. Her symptoms have never abated. Today, she ­describes her now four-year battle with Long Covid as a “living nightmare”. “Only last year did I start to go out again,” she says. “but the pain is always there. The fatigue is always there. I actually go to sleep in pain and I wake up in pain … and I’m living this every day.”

She says her treatment includes visits to a pain specialist and a pain psychiatrist, but after Nepean Hospital ceased its Covid-19 follow-up service she was no longer being treated as any part of a cohesive Long Covid treatment plan. “There’s nothing happening. Why haven’t I been told to go and see a [particular specialist] doctor? Why isn’t there a system where every doctor can turn around and say, ‘Well, here’s a number you can call and yes, here’s a referral to this clinic, get this done, get that done’?”

I was referred to a Long Covid clinic by my cardiologist last April. I received a call in June asking me what I needed help with; I told them. I didn’t hear anything back until October last year when I received another call saying the clinic was moving online and Long Covid case management was going back to GPs. I have since learned that what was once my Long Covid clinic is now an eight-week online education program and a support group.

When, in writing this article, I asked Health Minister Mark Butler about the future of Long Covid clinics, he did not directly respond, noting only the need for “multidisciplinary team-based healthcare for people with chronic and complex conditions like Long Covid.” The Department of Health and Aged Care released a plan in February this year addressing Long Covid, now referred to in government circles as PASC (Post-Acute Sequelae of COVID-19). There is no mention of Long Covid clinics. “States and territories decide the mix of the ­services and functions delivered in their jurisdiction … some have used funding to establish clinics for the management of people with PASC,” the plan states. “People with PASC will be able to benefit from the Government’s … commitment” to “expand general practices”.

Faux thinks this approach is flawed, and Long Covid patient care should be done in multidisciplinary rehab clinics because it’s not easy to treat. “The GPs are doing their best, but there’s not enough GPs and it’s very complicated because you’ve got to rule out everything else first,” he says.

People are not going to stop getting Covid and, in turn, Long Covid. “In January of this year, 100,000 positive cases were registered in the country. 100,000 people got Covid. That means about 10,000 people got Long Covid,” Faux tells me. “And every month there’ll be another 10,000. There’s lower vigilance with respect to Covid vaccinations and so we expect that people will get it a little bit more. There’s been no decrease in demand at the clinic.”

Faux quotes research in his book that shows 91 per cent of Long Covid sufferers have improvement in symptoms within 12 months; I was also told this by my cardiologist, who urged me just to hang on, as it was most likely I would get better within a year. And I did. I remember cycling with my family to a pool in February this year and feeling totally fine – fit, even. I had also gone back to reformer pilates. “Finally, I’m properly myself again,” I said to my husband.

But three days later, I tested positive for Covid. This time I was prepared.

After multiple conversations with my kind GP, I found out that even with Long Covid I wasn’t eligible for the antiviral drug Paxlovid as I was too young and was not severely immunocompromised. But I could get a course of antivirals privately for $1200.

It was an extraordinary amount of money, but I was willing to pay it in order to avoid a repeat of what I’d been through before. I dispatched my husband to get the antivirals that night; within two days I’d tested negative to Covid and my symptoms were ­almost gone. I was due to finish the five-day ­antiviral course on a Sunday, and I was already planning to go back to work on the Monday. But as soon as I finished the antivirals, my Long Covid symptoms came back: the crippling ­nausea, the irregular heartbeat, the exhaustion. I started to panic. How could I be back here again?

Five weeks later, I’m sitting in Faux’s ­office. “The statistics say you will get better,” he ­kindly reassures me. I tell him how I’m still struggling with nausea, fatigue and post-exercise malaise. I’ve stopped all exercise and I am back mostly working from home. “It’s going to be slow, and that will be very frustrating – but you have to try and look after ­yourself in that time,” he says. The empathy and understanding he shows me during our hour-long interview is also apparent in every single chapter in his book. Faux not only truly sees me and all people living with Long Covid, he has compiled a comprehensive management plan to help. “Your road to recovery may be a long one, unfortunately, but you are not alone and you are already one step ­closer to your destination,” he writes.

As for the future, Faux is full of hope. He says there is a lot of research being done around the world on the condition, from examination of its causes to trials of drugs to treat it. “It is already better now than it was a year ago, and we’re optimistic that this trajectory will continue,” he notes. “The more we know, the better the outcomes for people with Long Covid will be.”




Sunday, April 21, 2024

Japanese Real-World Observational Study: mRNA Vaccines how Low efectiveness

From February 1 to March 17, 2022, Epidemiological, public health and health economic researchers representing Hiroshima University in Japan along with Japan’s Ministry of Health, Labor and Welfare, Health Insurance Bureau, Medical Economics Division conducted a test-negative case-control study using a dataset of 117,335 individuals, collected through the COVID-19 J-SPEED form in the PCR center at Hiroshima Prefecture, Japan.

The study team, represented by corresponding author Yui Yumiya, Ph.D., MPH, Assistant Professor in the Graduate School of Biomedical and Health Sciences (Medical), estimated a propensity score matching for vaccine status based on participants’ demographic characteristics. Thereafter, the team calculated the odds ratio from logistic regression to determine any association between COVID-19 vaccination status and test positivity rate adjusting for symptoms, exposure to close contact, as well as previous history.

The Hiroshima University-led team of researchers established vaccine effectiveness as a formula (1 –aORs) ×100%). The team concluded that the data generated points to the protective effect of the COVID-19 vaccines against the Omicron strain. However, that’s interpreted in such a way because more unvaccinated are infected than vaccinated. If measured against the World Health Organization standard for vaccine approval, the mRNA vaccines as assessed in this study would fail the WHO 50% vaccine effectiveness test, as even boosted vaccine effectiveness equaled 26.4%.

The results of this AMED-funded observational study were published in PLOS, Global Public Health.

The authors of this study emphasize some strengths, such as the comprehensive data collection conducted across all PCR centers in collaboration with the Hiroshima prefectural office. Considered an “extensive and unique epidemiological survey,” it represents a material contribution, “with no comparable large-scale study conducted in other prefectures of Japan.”

Of course, many limitations with such a study exist (and are mentioned below), but the authors promote their use of detailed information representing occupation and various risk factors (likelihood of close contact and pre-existing conditions) that they articulate enhancing the study’s robustness. Such factors, adjusted within the model, account for potential confounding influence.

PCR Positivity Rates by Vaccination Status: the X axis represents the study period; y axis represents the test positivity rate. The figure displays PCR positive rates for three distinct groups: non-vaccinated, vaccinated with two doses and vaccinated with three doses (booster).


Reporting PCR test positivity rates were 7.9%, 4.5%, and 2.8% for the non-vaccinated (non-vaccinated, vaccinated with a single dose, and vaccinated with two doses less than 14 days ago), vaccinated with two doses (vaccinated over 14 days ago), and three doses, respectively.

Presenting both unadjusted and adjusted analyses, vaccine effectiveness of two doses against infection were 38.5% (95% confidence interval [CI]: 32.8%–43.8%) and 34.7% (95%CI: 28.4%–40.4%), respectively, compared to the non-vaccinated group. Vaccine effectiveness of three doses was 33.8% (95%CI: 25.0%–41.5%) and 26.4% (95%CI: 16.4%–35.2%), respectively, compared to those vaccinated with two doses.

While the authors cite these results in the positive (vaccine affords protection), not only should the actual vaccination effectiveness rate be questioned, but also noted that three dose rates is lower than the VE for two jabs. The authors emphasize the protective influence of the vaccine countermeasures.


All observational studies fall short in terms of evidentiary strength as compared to randomized controlled trials. Consequently, the team’s findings should be interpreted with caution and consideration of such inherent limitations, which include:

No specified estimation of VE for individual vaccine types, booster types (heterologous or homologous), time-sensitive effectiveness (effectiveness at different intervals post-vaccination), or the interval between vaccine doses.
The generalizability of our results may be affected due to the nature of this study population. For example, PCR test recipients who visited a PCR center may have a higher level of health consciousness compared to those who didn’t visit a PCR center.


Another finding of low vaccine effectiveness

How durable was the original monovalent mRNA vaccine when measured against prevention of COVID-19 Omicron-associated hospitalization involving children and adolescents? The Overcoming COVID-19 investigator network recently reported on this data between 2020 and 2023.

The results are challenging, evidencing rapidly waning vaccine effectiveness (VE) based on the known confluence of factors from mutating viral pathogens to the possibility of immunological imprinting (antigenic sin), and frankly, vaccines not engineered for breadth or durability results.

How severe is the waning VE? It is significant. For example, when measuring against hospitalization, VE should be substantially high, as the threshold is different for this class of product than preventing transmission. When the hospitalization incidence occurs a mere four months or more after the hospitalization event the VE rate equals 19% and ranges from as low as 2% to up to 32%. This is a remarkably weak rate evidencing serious concern about the longer-term viability of the COVID-19 countermeasures. The targeted threshold of effectiveness needs to be significantly higher for our children and adolescents.


Authoring this study paper was the Overcoming COVID-19 investigators, part of a study seeking to characterize the development of COVID-19 complications in children and young adults as a consequence of exposure to COVID-19 including the Multisystem Inflammatory Syndrome in Children (MSI-C).

MIS-C emerged as a significant concern during the SARS-CoV-2 delta surge but waned during Omicron.

A real-time surveillance and observational study, the investigation included prospective enrollment of study participants with collection of blood and respiratory samples. What were the risk factors and outcomes of COVID-19 critical illness in the pediatric population? What defined complications in this young vulnerable court and linked to SARS-CoV-2? What about predictive markers of these complications? Finally, what characterized the development and maintenance of adaptive immunity? The Overcoming COVID-19 investigators sought to answer these, and other questions.

How durable is pediatric vacation with use of mRNA COVID-19 vaccine countermeasures? This was a central question driving this investigation. Overall, parents have increasingly opted to keep their children away from the COVID-19 countermeasures.

The authors, represented by corresponding author Laura Zambrano, Ph.D., M.D., senior epidemiologist at the Centers for Disease Control and Prevention (CDC), report that during December 19, 2021–October 29, 2023, the Overcoming COVID-19 Network evaluated vaccine effectiveness (VE) of ≥2 original monovalent COVID-19 mRNA vaccine doses against COVID-19–related hospitalization and critical illness among U.S. children and adolescents aged 5–18 years, using a case-control design.

The authors report, “Too few children and adolescents received bivalent or updated monovalent vaccines to separately evaluate their effectiveness” which most certainly is a telling data point as to the reality of demand for COVID-19 vaccines among parents and their children and adolescents.

For this particular study, the authors led by Zambrano point out that a majority of individuals tested positive for SARS-CoV-2 fell in the unvaccinated category, “despite the high frequency of reported underlying conditions associated with severe COVID-19.”


So, what was the vaccine effectiveness of the original monovalent vaccine against COVID-19–related hospitalizations?

According to the findings here, VE equaled 52% (95% CI = 33%–66%) when the most recent dose was administered <120 days before hospitalization, and 19% (95% CI = 2%–32%) if the interval was 120–364 days. TrialSite suggests the rate of 19% VE in preventing hospitalization 4 months and on represents an incredibly weak record.

Another measure, or slice of the data, was a vaccine administered any time within the previous year, which looks at least somewhat better than the pathetic 19% figure, especially for this category of the original monovalent vaccine against COVID-19–related hospitalization was 31% (95% CI = 18%–43%).

When looking at the definition of hospitalization with more granularity, diffident VE rates emerge. For example, looking at the category “COVID-19-related illness” defined as receipt of noninvasive or invasive mechanical ventilation, vasoactive infusions, extracorporeal membrane oxygenation, and illness resulting in death and VE rates equaled the following:

VE Scenario

VE was similar after excluding children and adolescents with documented immunocompromising conditions.

The CDC authors emphasize that the receiver of ≥2 monovalent mRNA COVID-19 vaccines are associated with fewer COVID-19 hospitalizations during the Omicron period in children and adolescents aged 5–18 years. But this
“protection from original vaccines was not sustained over time, necessitating increased coverage with updated vaccines.”

A majority of hospitalized kids were unvaccinated, and few had received updated vaccine doses despite a high prevalence of underlying comorbidities associated with more severe disease.

The social determinants of health continue to be a factor in vaccination trends, with vaccination rate decline associated with social vulnerability.

The authors acknowledge carefully the overall dismal VE rates, stating:

“VE of original monovalent doses against COVID-19–related pediatric hospitalizations were lower than previous VE estimates reported by the Overcoming COVID-19 Network before Omicron emergence.”

The CDC does not include any risk-benefit analysis within its recommendations, e.g., avoids discussion of myocarditis/pericarditis risk to young adolescent males and avoids the topic of natural immunity when recommending that “all children and adolescents receive updated COVID-19 vaccines to protect against severe COVID-19.”


Not surprisingly, many limitations suggest any interpretation done so with caution. Dr. Zambrano and team identify four major limitations including:

SARS-CoV-2 infection-induced immunity was not assessed

Limited viral sequencing data prevented consideration of subvariant-attributed immune evasion

Limited coverage with bivalent vaccines and currently recommended updated monovalent vaccines precluded the estimation of VE of these formulations

Previously healthy children and adolescents accounted for <20% of case-patients, limiting generalizability