Friday, September 22, 2023

Another Friday Hiatus

I have had a busy day today so not much time for blogging. Will be back on Sunday.

My health is slowly improving

Note that I have recently done a substantial update to my big article on the nature of conservatism. Some interesting new reading there I hope. Find the article here:

Thursday, September 21, 2023

Breakthrough Infections and the elderly

A breakthrough infection is when a vaccinated person still gets the disease. Study suggests that the elderly are LESS affected by breakthrough infections. The study authors were Chinese but their data was international, not Chinese

Published in the journal of Infectious Disease by Jing et al., “SARS-CoV-2 vaccine breakthrough infection in the older adults: a meta-analysis and systematic review,” as the durability challenges of the COVID-19 vaccines lead to waning vaccine effectiveness, associated breakthrough infections tend to rise.

The study authors, affiliated with the Tianjin University of Traditional Chinese Medicine in the northern coastal metropolis of about 14 million people, come to the bombshell conclusion contrary to popular understanding: elderly persons face far less risk for breakthrough infection than is popularly understood, and that the risk of severe COVID-19, hospitalization and death due to breakthrough infection remains perhaps even lower risk than for breakthrough infection alone.

Do these findings alter the risk-benefit calculus for vaccination? Could these results be because of vaccination or natural Immunity? These are important questions. While TrialSite doesn’t anticipate that this important meta-analysis will be picked up by mainstream press in the West the outcomes, limitations aside, are important for further consideration.

The study, published in BMC infectious Diseases and represented by corresponding author Xiaohui Jing with the Tianjin University of Traditional Chinese Medicine in Tianjin, China raises significant questions. Much of the data generated by U.S. public health sources points to far more COVID-19 risk associated with older individuals. Yet this study out of China points to an opposite conclusion.

The Study

Designed as a systematic review or meta-analysis, from November 2, 2022, the study team reviewed 30 studies published across English language journal platforms from PubMed and Embase to Cochrane Library and Web of Science. Employing the use of a random-effects model the team calculated pooled estimates of the prevalence and occurrences of COVID-19 breakthrough infections in elderly persons.

Mindful of the influence of bias, the study team employed use of funnel plots, Egger’s regression test, as well as sensitivity analyses while following standard guidelines for this class of study-- Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA).

The Results

The study authors report across 30 publications reveals a pool prevalence of COVID-19 breakthrough infection among the elderly at 7.7 per 1,000 individuals (95% CI, 4.0-15.0), with pooled incidence equaling 29.1 per 1000 person-years (95%CI 15.2–55.7).

The China-based researchers take away from their meta-analysis that the prevalence and incidence of SARS-CoV-19 breakthrough infection in older adults was low. But more eye opening was the finding associated with the risk of hospitalization, severe disease and death associated with the elderly and breakthrough infections, which was even lower than the risk of breakthrough infection.

Study Limitations

Jing and colleagues disclosure a handful of limitations including 1) study data restricted to publications in English, 2) the inclusion of studies with a sample size greater than 500 may result in the loss of small eligible studies; 3) Lots of heterogeneity was observed in the included studies; 4) most of the studies included in this study were observed within six months of vaccination; 5) some studies provided little information about the potential influencing factors such as vaccine type, vaccine dose, gender, prior infection, time from vaccination to breakthrough infection, comorbidity, and lifestyle of the included older adults on the prevalence and incidence of COVID-19 breakthrough infection and finally 6) It was also impossible to conduct meta-analyses among some groups due to the less information from studies assessing those factors. Clearly more research is required.


Supreme Court Issues Pause on Banning Biden Administration from Contacting Social Media Platforms

In early September, a federal appeals court in New Orleans ruled that the White House, the Federal Bureau of Investigation (FBI) and social media companies to remove content or posts the Biden administration considers to be misinformation. This included posts about COVID-19.

The court ruled the government had most likely overstepped the First Amendment by urging major social platforms to remove the content the Biden administration thought was misleading.

The decision came down from a three-judge panel for the Fifth Circuit in New Orleans, ruling that the White House and the Surgeon General had “coerced the platforms to make their moderation decisions by way of intimidating messages and threats of adverse consequences” and “significantly encouraged the platforms’ decisions by commandeering their decision-making processes.” The court also found the FBI used coercion in its interactions with the social media companies which took down 50% of the online posts the bureau’s agents deemed “troublesome”.

A theme generally considered to be a pattern during COVID-19: that the Biden administration was directly, or indirectly censoring Americans, attacking any critical voices not concurring with the standard pandemic narrative.

The New Orleans panel upheld a decision by a lower court judge declaring that the government pressured Facebook, Google, X (Twitter) and YouTube into censoring posts related to COVID-19 and allegations of election fraud.

But the Fifth Circuit judges also put a 10-day injunction, or hold, on the lower court’s ruling in order to give the Justice Department, which is defending the Biden administration, a chance to appeal to the Supreme Court. And, last week the highest court in the land responded.

Temporary Hold

Last Thursday, the U.S. Supreme Court temporarily put on hold an order restricting the ability of President Joe Biden's administration to encourage social media companies to remove content it considers misleading, including about the Covid-19 pandemic. The order was issued by Conservative Supreme Court Justice Samuel Alito, and it pauses the lower court ruling until September 22.

In their filing against the lower court ruling, the Justice Department said, “The court cited no precedent for that boundless theory, which would allow any state or local government to challenge any alleged violation of any constituent’s right to speak.” Additionally, the Justice Department said, “The Fifth Circuit’s decision contradicts fundamental First Amendment principles. It is axiomatic that the government is entitled to provide the public with information and to ‘advocate and defend its own policies.’”

Missouri AG Plans to Oppose Appeal

A spokesperson for Missouri Attorney General Andrew Baily said he plans to oppose the administration's Supreme Court appeal. "We are rooting out this censorship enterprise and will hold any wrongdoers accountable," Bailey said in a statement. Missouri and Louisiana were the original plaintiff’s in the lawsuit claiming the administration threatened the social media platforms with antitrust enforcement and reforms to tech platforms’ liability shield, known as Section 230 of the Communications Decency Act, if they didn’t comply with the government’s takedown requests.

The Justice Department said there was no coercion beyond the private and public appeals to companies by officials. “Rather than any pattern of coercive threats backed by sanctions, the record reflects a back-and-forth in which the government and platforms often shared goals and worked together, sometimes disagreed, and occasionally became frustrated with one another, as all parties articulated and pursued their own goals and interests during an unprecedented pandemic,” the Department of Justice said in their filing.

TrialSite’s main news website, on the topic of censorship has experienced continuous problems, not directly because the website is independent, but indirectly as groups such as News Guard have attempted to challenge content, all clearly labeled as opinion, on the TrialSite platform.

Also, TrialSite content has been censored on social media platforms such as YouTube. For example, a documentary about Ivermectin, balanced, objective and not taking any sides, was deleted by the subsidiary of Google. Another example when the nation of Slovakia authorized on an emergency basis the use of ivermectin during the COVID-19 pandemic, Facebook deleted the TrialSite post even though the article was based on a formal government ruling. It was as if facts didn’t matter.

Censorship is alive and well in America during the age of COVID-19.




Wednesday, September 20, 2023

Eris (E.G5) –The Current Variant of Interest

The new SARS-CoV-2 subvariant EG.5, also called Eris, is responsible for the increase in COVID-19 infections and is currently causing concern. The Centers for Disease Control and Prevention (CDC) estimates that about 24.5% of the total number of cases in the United States reported from Feb 2023 up until September 2023 are due to EG.5. Researchers are trying to update the COVID-19 vaccines to target the new variants. TrialSite previously reported on the World Health Organization’s (WHO) concerns about this strain.

Eris is a sub-variant of the Omicron variant. The first case of EG.5 was reported on Feb 17, 2023. Similar to other variants, it shows symptoms like fever, nausea, headache, sore throat, etc. It also demonstrates high transmissibility, which is concerning for researchers. Additionally, the variant can evade the immune response generated by antibodies that were developed either by vaccination or previous infection with other variants.

How concerning is this new variant?

EG.5 has one mutation in its spike protein that makes it different from the Omicron variant. This genetic change helps it to escape the immune response, which makes it more contagious. The World Health Organization (WHO) has declared it a “variant of interest” which means there is a need to focus on it because its transmissibility may cause a rapid increase in hospitalization.

Stanley Martin, MD., the Director of Infectious Diseases at Geisinger Medical Centre said that there is no need to worry about this variant unless you are above 65 or immunocompromised. However, you should be aware of this variant and take precautionary measures if you live around immunocompromised or elderly people because there is a risk of passing this variant on to them.

Dr. Brett Osborn, a board-certified neurosurgeon, said that in most cases, it is a self-limiting variant, so there is nothing to be concerned about.

Will the updated vaccine protect against EG.5?

There is currently no specific vaccine against EG.5; however, an updated version of the COVID-19 vaccine is expected to be released in September 2023. The vaccine manufacturing companies Pfizer/BioNTech, Moderna and Novavax are creating COVID-19 booster vaccines that will target XBB.1.5 (a subvariant of Omicron), but they expect that this booster will also provide some level of protection against EG.5 because they are closely related strains. The U.S. Food and Drug Administration (FDA) has recommended these booster vaccines and explained that they will continue to monitor the safety and effectiveness of COVID-19 vaccines. Anyone above the age of two is eligible for this booster vaccine.

Moderna’s clinical trials have confirmed that the booster vaccine will effectively target EG.5 and FL.1.5.1 (another subvariant of Omicron). The antiviral medicine, Paxlovid, also provides protection and works well against EG.5.

Experts' opinions on COVID-19 variants and vaccines
Osborn said that SARS-CoV-2 and its variants are here to stay, and we have to live with them because their mutation rate is high, like the influenza virus. Mostly, RNA viruses (those containing RNA as genetic material) become less harmful with time and pose less threat to lives, but there is also a chance that one of the strains will become virulent, which may lead to an increase in the death rate.

Scott Roberts, MD, an infectious diseases specialist, said that the vaccine takes about three months to provide high efficacy. The people who get vaccinated immediately after the vaccine release in September will have the maximum protection in the upcoming year.

Updated vaccine or booster shot?

The FDA and other health authorities have shifted in language from “booster” to “updated COVID-19 vaccine” because the booster only reinforces the immunity obtained from the previous vaccines, while the updated COVID-19 vaccine is designed to induce a new immune response against the existing variants. The term “updated COVID-19 vaccine” helps to normalize the idea of getting the COVID-19 vaccine on a regular basis, just like annual flu shots.

Bottom line

The current death rate associated with the Eris variant appears low. On the other hand, since many medical experts are warning the public about its high contagiousness, preventive measures such as mask-wearing, handwashing and maintaining appropriate distance remain important.

Current evidence suggests that updated COVID-19 booster shots can be an effective tool for prevention, especially for high-risk people such as the elderly or those suffering from severe health conditions. Still, vaccine hesitancy might affect the vaccination rates. This emphasizes the importance of transparent sharing of information with the public about COVID-19 vaccines.


Viral RNA Can Persist for 2 Years After COVID-19: Preprint Study

A new study may explain why some people who get COVID-19 never return to normal and instead experience new medical conditions like cardiovascular disease, clotting dysfunction, activation of latent viruses, diabetes mellitus, or what’s known as “long COVID” after SARS-CoV-2 infection.

In a recent preprint study published on medRxiv, researchers conducted the first positron emission tomography (PET) imaging study of T cell activation in individuals who previously recovered from COVID-19 and found that SARS-CoV-2 infection may result in persistent T cell activation in a variety of body tissues for years following initial symptoms.
Even in clinically mild cases of COVID-19, this phenomenon could explain the systemic changes observed in the immune system and in those with long COVID symptoms.

However, most of the participants were vaccinated and the study didn't investigate the link between the existence of viral RNA and vaccination.

To carry out the study, researchers conducted whole-body PET scans of 24 participants who were previously infected with SARS-CoV-2 and recovered from acute infection at time points ranging from 27 to 910 days following COVID-19 symptom onset.
A PET scan is an imaging test that uses a radioactive drug called a tracer to assess the metabolic or biochemical function of tissues and organs and can reveal both normal and abnormal metabolic activity. The tracer is usually injected into the hand or vein in the arm and collects in areas of the body with higher levels of metabolic or biochemical activity, which can reveal the location of the disease.

Using a novel radiopharmaceutical agent that detects specific molecules associated with a type of white blood cell called T lymphocytes, researchers found uptake of the tracer was significantly higher in post-acute COVID-19 participants compared to pre-pandemic controls in the brain stem, spinal cord, bone marrow, nasopharyngeal and hilar lymphoid tissue, cardiopulmonary tissues, and gut wall. Among males and females, male participants tended to have higher uptake in the pharyngeal tonsils, rectal wall, and hilar lymphoid tissue compared to female participants.

Researchers specifically identified cellular SARS-CoV-2 RNA in the gut tissue of all participants with long COVID symptoms who underwent biopsy—in the absence of reinfection—ranging from 158 to 676 days following initial COVID-19 illness, suggesting that tissue viral persistence could be associated with long-term immunological concerns. Although the uptake of the tracer in some tissues appeared to decline with time, the levels still remained elevated compared to the control group of healthy pre-pandemic volunteers.

"These data significantly extend prior observations of a durable and dysfunctional cellular immune response to SARS-CoV-2 and suggest that SARS-CoV-2 infection could result in a new immunologic steady state in the years following COVID-19," the researchers wrote.

To determine the association between T cell activation and long COVID symptoms, researchers compared post-acute COVID-19 participants with and without long COVID symptoms at the time of PET imaging. Those with long COVID symptoms reported a median of 5.5 symptoms at the time of imaging. Findings showed a “modestly higher uptake” of the agent in the spinal cord, hilar lymph nodes, and colon/rectal wall in those with long COVID symptoms.

In participants with long COVID who reported five or more symptoms at the time of imaging, researchers observed higher levels of inflammatory markers, “including proteins involved in immune responses, chemokine signaling, inflammation responses, and nervous system development.” Compared to both pre-pandemic controls and those participants who had COVID-19 and completely recovered, people with long COVID showed higher T cell activation in the spinal cord and gut wall.

All But 1 Participant Was Vaccinated

Researchers attribute their findings to SARS-CoV-2 infection, although all but one participant had received at least one COVID-19 vaccination prior to PET imaging.

To minimize the impact of vaccination on T cell activation, PET imaging was performed more than 60 days from any vaccine dose, except for the one participant who received a booster vaccine dose six days prior to imaging. Others who had received a COVID-19 vaccine within four weeks of imaging were excluded.

Researchers also grouped participants by receipt of a COVID-19 dose greater than or less than 180 days prior to PET imaging.

The researchers said their study had several other limitations, including small sample size, limited correlative studies, evolving variants, rapid and inconsistent rollout of COVID-19 vaccines, which required them to shift their imaging protocols, using pre-pandemic individuals as controls, and the extreme difficulty of finding people who had never been infected with SARS-CoV-2.

"In summary, our results provide provocative evidence of long-term immune system activation in several specific tissues following SARS-CoV-2 infection, including in those experiencing Long COVID symptoms," the researchers concluded. "We identified that SARS-CoV-2 persistence is one potential driver of this ongoing activated immune state, and we show that SARS-CoV-2 RNA may persist in gut tissue for nearly 2 years after the initial infection."


CDC Director Responds to COVID-19 Mask Mandate Speculation

The director of the U.S. Centers for Disease Control and Prevention (CDC) responded to speculation that COVID-19-related mask mandates or lockdowns could return, coming after the agency recommended new vaccine boosters for nearly all Americans.

CDC Director Mandy Cohen was asked on Sept. 12 whether she feels confident that there won't be widespread lockdowns, school closures, and a reversion to mask mandates.

"Right now, we have all the tools we need to keep this virus at bay if we use the vaccines and we use testing and treatment," Ms. Cohen told WCNC, a Charlotte, North Carolina, TV station.

"What I see is I don’t see any need for mandates or those kinds of things right now. But we have to keep watching this virus, seeing how it changes, and if we need to make other recommendations, we will," the CDC head said.

Her comment comes as the CDC issued a recommendation that people should receive the updated COVID-19 booster shot that targets the XBB1.5 subvariant. The U.S. Food and Drug Administration similarly authorized and approved the new mRNA-based shots, made by Pfizer and Moderna.

Meanwhile, since mid-August, there has been widespread speculation that the CDC and other federal agencies may attempt to recommend or push lockdowns, vaccine mandates, or masking mandates because of a small upswing in COVID-19 cases across the United States. A small number of schools, colleges, hospitals, and private businesses have implemented masking mandates, sparking alarm among some GOP officials and candidates.

CDC Advisory Committee on Immunization Practices Meet on COVID-19 and Vaccines

Several weeks ago, meanwhile, the Transportation Security Administration told The Epoch Times that claims that the agency held discussions that it would be reimplementing mandates or lockdowns are incorrect. Meanwhile, a spokesman for the CDC told the Associated Press around the same time that reports of pending lockdowns are "utterly false."
When asked by The Epoch Times about discussions around a possible federal mask mandate recommendation, a spokesperson said late last month that COVID-19 hospital admission levels "are currently low for 96 percent" of the United States. A separate spokesperson told other outlets that there were no agency discussions about bringing mask mandates back, and no new masking guidelines have been issued on the CDC's website in recent days.




Tuesday, September 19, 2023

Myocarditis and COVID-19 Vaccines: How the CDC Missed a Safety Signal and Hid a Warning

Even after deaths from myocarditis—inflammation of the heart—were reported and myocarditis was designated as a likely side effect of the shots, U.S. officials kept recommending vaccination for virtually the entire populace.

That led to millions of young people receiving a vaccine.

Many of those people suffered.

Aiden Ekanayake, 14, was one of them. He received a dose of the Pfizer-BioNTech vaccine in May 2021, and a second dose in June 2021.

Two days after the second dose, Aiden was woken in the middle of the night with pain that was comparable to when he tore his anterior cruciate ligament. His mother, Emily, rushed him to the hospital, where he spent days receiving care. Even after he was discharged, his exercise was limited for more than four months.

Ms. Ekanayake trusted the U.S. Centers for Disease Control and Prevention (CDC) before the experience. Now, she does not. "I hate them. I think they're evil," Ms. Ekanayake told The Epoch Times.

No Transparency

The CDC, America's public health agency, was warned by Israel on Feb. 28, 2021, about a "large number" of myocarditis cases after Pfizer COVID-19 vaccination, documents obtained by The Epoch Times show.

Internally, the warning was designated as "high" importance and set off a review of U.S. data. The review found 27 reported cases in the United States, according to a U.S. government memorandum dated March 9, 2021. The incidence rate was low, but "missing and incomplete data make it challenging to assess causation," the memo stated. The U.S. Food and Drug Administration (FDA), it said, "has not made a final determination regarding the causality."

Weeks later, neither the CDC nor the FDA had alerted the public to the issue, even after the death of a previously healthy 22-year-old Israeli woman and briefings from Israeli officials and U.S. Department of Defense (DOD) researchers.
Like Israel, the DOD was recording a higher-than-expected number of myocarditis cases. Patients were mostly young, healthy males.

The CDC met with military officials twice behind closed doors in April 2021. Military officials presented data during at least one of the meetings to the CDC. That presentation, which has never been released to the public, "included our preliminary patient data and analysis that suggested to us that myocarditis was indeed a possible side effect to the messenger RNA COVID-19 vaccines (within the US military)," Dr. Jay Montgomery, one of the presenters, told The Epoch Times via email.

The Pfizer and Moderna vaccines use messenger RNA (mRNA).

On April 27, 2021, after the meetings, then-CDC Director Dr. Rochelle Walensky finally spoke about the matter in public, during a White House briefing.

Dr. Walensky said "we have not seen any reports" of myocarditis after vaccination. That's false, according to CDC data—the agency received 141 reports of myocarditis in the Vaccine Adverse Event Reporting System (VAERS) by the end of March 2021. Another 24 cases were recorded in the Vaccine Safety Datalink, a second system run by the CDC.

Additionally, before the briefing, Dr. Walensky was copied on multiple threads discussing myocarditis and a related condition, pericarditis, including a thread about doctors in California seeing the cases, internal emails obtained by The Epoch Times show. She responded to one of the threads, saying the information was "super helpful."

"We have not seen a [safety] signal," Dr. Walensky also told reporters during the briefing, "and we’ve actually looked intentionally for the signal in the over 200 million doses we’ve given."

The CDC and FDA are supposed to monitor data from VAERS, which officials have described as the country's "early warning system" for possible vaccine problems. But they failed to detect a safety signal for myocarditis after COVID-19 vaccination that triggered on Feb. 18, 2021, when using a statistical analysis method called Proportional Reporting Ratio (PRR), according to archived VAERS data from the National Vaccine Information Center, The Epoch Times confirmed.

The CDC initially said it started running PRRs in February 2021, but later acknowledged that was false. The agency now says it did not start PRRs until 2022. The first time the CDC ran complete PRRs, officials detected a signal for myocarditis, according to files obtained by The Epoch Times.

"It's unimaginable that they wouldn't have seen the signal," Brian Hooker, senior director of science and research at Children's Health Defense, who detected an early signal for myocarditis in VAERS using a different method, told The Epoch Times. "They were alerted by the DOD. They were alerted by the Israeli Ministry of Health. And so, if they just didn't know then, they have absolutely no excuse because they were warned."

Children's Health Defense, a nonprofit that says its mission is to end childhood health epidemics, first obtained the emails between Israel and the CDC.

Dr. Walensky, who has since departed the CDC, has not responded to a request for comment about her myocarditis claims.

A CDC spokesperson told The Epoch Times via email: "CDC has been continuously monitoring the safety of COVID-19 vaccines since they began to be administered in the United States. At the time of the director’s press conference, CDC did not have sufficient evidence to conclude there was a safety signal for myocarditis following mRNA COVID-19 vaccination."

The CDC has said it did not run PRRs in 2021 because officials were relying on a different analytic method, called Empirical Bayesian data mining. It's unclear when that method, utilized by the FDA, first detected a signal for myocarditis. The FDA has declined to answer questions on the matter. The CDC has told The Epoch Times that its 2022 detection of a signal for myocarditis using PRRs was "consistent with" the data mining results.

Both the CDC and FDA use contractors to process VAERS data.

"Even FDA doesn't really know the mechanics of how its contractor does the data mining," one CDC official said in an email obtained by The Epoch Times. The official and the FDA did not respond to requests for comment on the email.
A safety signal is a sign that an adverse event may be caused by a vaccine. Authorities say signals can only be substantiated with further research.

"Once the safety signal comes up, why not start warning the public about the fact that' hey, you can take it if you want, but understand that there is this risk that we have discovered and we are looking into it," Dr. Anish Koka, an American cardiologist, told The Epoch Times.

One possible motivation for not fully examining the issue was that it could have led to a halt in vaccination. The CDC and FDA essentially imposed a pause on Johnson & Johnson's shot on April 13, 2021, after a small number of blood clotting cases.
"A pause of the Pfizer/Moderna administration (much like the J&J blood clot pause) will have an adverse impact on US/CA vaccination rates," one military official said in a message obtained by The Epoch Times that was flagged for top CDC officials.

Between February 2021 and May 2021, the percentage of the U.S. population that had received a COVID-19 vaccine soared from 14.2 percent to 50.5 percent.

"It was most likely a strategic move in order to make sure that they didn't curtail vaccination rates," Mr. Hooker said.

"Due to the large number of reports that we are receiving at this time, processing is taking longer than usual," one official said. The message was sent to a woman who said she'd filed a VAERS report for her son's myocarditis on April 21 but that the report had still not appeared in the system days later.

Elaine Miller, a CDC official, wrote around the same time that there were "processing delays" for VAERS reports.

One of the contractors used by the CDC estimated before the vaccines were rolled out that no more than 1,000 reports would be filed per day. The number soared above that estimate by the end of 2020, internal documents obtained by The Epoch Times show.

Workers for the contractor, General Dynamics Information Technology, increased the speed at which they processed but were "unable to keep up with the increased surge in reports at current staffing levels," the contractor informed the CDC in one message.

The backlog increased to nearly 94,000 reports even after the contractor hired nearly 300 additional staff members.

Dr. Adam Hirschfeld, 36, of Ohio, submitted a report to VAERS soon after suffering myocarditis following COVID-19 vaccination in January 2021. It took months for the CDC to respond to him. "I could have been dead by then," Dr. Hirschfeld told The Epoch Times.

Health care providers who administer COVID-19 vaccines are required to report serious adverse events, including all cases of myocarditis, to VAERS.

But not all doctors were following the rules, other emails show.

"Providers aren't reporting these cases to VAERS," Dr. John Su, one of the CDC's top vaccine safety officials, wrote to colleagues on May 17, 2021. He also wrote that the "myocarditis thing" was "exploding."

CDC officials, in correspondence with officials in Washington state, said around the same time that nine post-vaccination myocarditis cases had not been reported to VAERS.

The backlog was eventually cleared. VAERS data show that 146 cases of myocarditis or pericarditis were reported by the end of March 2021. An additional 158 cases were reported in April 2021 and 487 more were entered in May 2021.

Just a third of the cases reported to VAERS through April 26, 2021, were fully processed as of May 3, 2021, according to an internal presentation.

In addition to Dr. Walensky's false claim, the CDC has falsely told other health officials and media outlets that it did not receive any reports until May or June 2021, internal emails show.

Another CDC vaccine safety monitoring system, V-safe, did not include myocarditis despite the CDC and FDA identifying the heart inflammation as an adverse event of special interest, or a possible side effect, for the COVID-19 vaccines before they were authorized. The Vaccine Safety Datalink did include myocarditis but did not detect a signal until 2022, possibly because it was using a too-narrow case definition. A fourth system, run by the FDA and partners like CVS, detected a signal in 2023.

Cases Started in January

Doctors started seeing postvaccination myocarditis cases in January 2021, months before the public was informed about them.

The U.S. military researchers, for instance, detailed in a paper that 22 previously healthy service members suffered from myocarditis after vaccination as early as January 2021.
Seventeen cases happened in January 2021 alone in Israel, Israeli researchers reported in another study.

Dr. Dror Mevorach, a co-author of the paper, said he tried warning Pfizer of the possible link between myocarditis and its shot.

"They refused to believe me for a period of four months," Dr. Mevorach told Haaretz. Pfizer did not respond to a request for comment.




Monday, September 18, 2023

FDA Has 'Gone Rogue' in Its Approval of New COVID-19 Boosters: Dr. Robert Malone

The Food and Drug Administration (FDA) has "gone rogue," according to virologist Dr. Robert Malone, who accused the federal agency of sacrificing its own rules and regulations with its decision to recommend the latest batch of COVID-19 boosters, which only have limited clinical trial data attesting to their efficacy and safety.

Dr. Malone made the remarks in an interview with EpochTV's "Crossroads" program on Sept. 11, the day that the FDA cleared new COVID-19 vaccines in a bid to counter the waning effectiveness of the currently available shots.

"It's difficult to conclude anything other than the FDA is no longer feeling bound by their own rules and regulations," Dr. Malone said. "The term is—they've gone rogue."

Dr. Malone objected to the lack of clinical trial data on humans demonstrating effectiveness and safety of the updated vaccines, arguing that should preclude their approval by the FDA.

He said that, essentially, the FDA allowing the new vaccines to be used under an emergency use authorization on the premise that “neutralizing antibodies as detected in mice and their cross-reactivity are a correlative protection—That's a lie. There are no established correlates of protection for SARS-CoV-2."

FDA officials didn't respond by press time to a request by The Epoch Times for comment.

However, in a statement announcing its approval, the FDA said that the decision was supported by its evaluation of "manufacturing data" from vaccine producers and "non-clinical immune response data on the updated formulations including the XBB.1.5 component."

The benefit-risk profile of previously approved mRNA COVID-19 vaccines is "well understood," the FDA said, adding that the similar manufacturing process for the updated vaccines "suggests that the vaccines are a good match for protecting against the currently circulating COVID-19 variants."

Advisers to the Centers for Disease Control and Prevention (CDC) followed with their own recommendation on Sept. 12, urging nearly all Americans to get the new vaccines, which will be available to children as young as 6 months old this month.

The new vaccines target XBB.1.5, a sub-type of the Omicron variant of the SARS-CoV-2 virus, which causes the disease COVID-19. However, the XBB.1.5. subvariant has already largely been displaced by newer strains of the quickly evolving virus, including EG.5, according to the CDC.

"There's essentially no data," Florida Surgeon General Dr. Joseph Ladapo said at a recent news conference, where he suggested that people might be better off passing on the new round of shots.

"Not only that, but there are a lot of red flags," Dr. Ladapo added, while pointing to studies finding that the effectiveness of the vaccines turns negative over time.

“There's been no clinical trial done in human beings showing that it benefits people, there's been no clinical trial showing that it is a safe product for people."

He also noted that studies have linked previous versions of the COVID-19 vaccine to cardiac problems such as heart inflammation.

"It's truly irresponsible for FDA, CDC, and others to be championing something ... when we don't know the implications of it," Dr. Ladapo said.

While acknowledging the current vaccines' waning effectiveness, CDC Director Mandy Cohen penned an op-ed in The New York Times on Sept. 13, in which she called the updated COVID-19 vaccines "one of the most effective tools in combating the virus."

"Covid-19 vaccines are the best way to give the body the ability to keep the virus from causing significant harm. Extensive studies and real-world experience have shown that they are safe and they work," she wrote. "And most Americans take them."

Dr. Cohen said the vaccines were put through extensive clinical trials before they were introduced in 2021 and "since then, their safety has been intensely monitored."

She didn't address criticism, such as that the updated vaccines haven't been subjected to clinical trials.

In its green-light statement, the FDA said it's "confident in the safety and effectiveness of these updated vaccines and the agency's benefit-risk assessment demonstrates that the benefits of these vaccines for individuals 6 months of age and older outweigh their risks."

That FDA endorsement, however, stands in contrast to remarks made by Dr. Paul Offit, an FDA adviser, who suggested to the UK's Daily Mail that younger, healthy people who have already been vaccinated don't need one of the new doses.

"We are best served by targeting these booster doses to those who are most at risk of severe disease," such as people older than 75, Dr. Offit said. "Boosting otherwise healthy young people is a low-risk, low-reward strategy."

In his remarks at the news conference, Dr. Ladapo asked people to make decisions based on their “resonance of truth” rather than depending on “very educated people telling you what you should think.”

“When they try to convince you to be comfortable and agree with things that don't feel comfortable and don't feel like things you should agree with, that's a sign ... And I encourage you and certainly beg and hope that you do listen to it, because it will serve you right,” he said.

A January–July 2023 study that analyzed data from 33 California state prisons found that individuals who received new COVID-19 booster shots were more likely to contract COVID-19 compared to those who didn't receive the jabs.
The infection rate among the group that received the bivalent booster shots came in at 3.2 percent—higher than the 2.7 percent among the unvaccinated.

Late last month, the CDC conceded that the new BA.2.86 strain can cause infection even among people who have previously been vaccinated against COVID-19.

“The large number of mutations in this variant raises concerns of greater escape from existing immunity from vaccines and previous infections compared with other recent variants,” the agency said in its assessment.


Dr. Marty Makary Weighs in on the New COVID Vaccines Biden Is Pushing

Dr. Marty Makary — a rare voice of reason and sanity throughout the COVID-19 pandemic — is out with a review of the "real data" behind the new vaccines being pushed by the Biden administration and Democrat leaders around the country.

Makary, along with Dr. Tracy Høeg, open their analysis of the new vaccines Biden & Co. are pushing for Americans as young as six months old with an alarming scenario that's anything but hypothetical.

What if I told you one in 50 people who took a new medication had a 'medically attended adverse event' and the manufacturer refused to disclose what exactly the complication was — would you take it?

And what if the theoretical benefit was only transient, lasting about three months, after which your susceptibility goes back to baseline?

And what if we told you the Food and Drug Administration cleared it without any human-outcomes data and European regulators are not universally recommending it as the Centers for Disease Control and Prevention is?

Writing in The New York Post, Makary and Høeg say that's all scientists know about the new vaccines from Pfizer and Moderna that are being more than recommended by the Biden administration.

"The push is so hard that former White House COVID coordinator Dr. Ashish Jha and CDC head Mandy Cohen are making unsupported claims the new vaccine reduces hospitalizations. long COVID and the likelihood you will spread COVID," the doctors' analysis explains. "None of those claims has a shred of scientific support," and "if the manufacturers said that, they could be fined for making false marketing claims beyond an FDA-approved indication."

Yet, the Biden administration is plunging ahead with another push to drive up the use of these new vaccines, a push that blows past what The Science™ says or The Experts™ have concluded.

"The questions surrounding Moderna’s new COVID vaccine approved this week are still looming," Makary and Høeg say of the reality being ignored by the White House. "Pfizer’s version, approved this week as well, also has zero efficacy data and has not been tested on humans at all," they note. "We only have data about antibody production from 10 mice."

Does the Biden administration view the American people as any better than lab rats? It seems not based on this situation.

What's more, the doctors note that neither the FDA nor Moderna have disclosed "what happened to the patient who took the new vaccine and had a complication that required medical attention."

Were there contributing factors to the complication? How serious was it? Are there any long term effects from the complication?

None of these answers have or are likely to come from the Biden administration in their push to get the new vaccine administered far and wide. Why even have regulators if they are apparently unwilling to scrutinize the things they approve?

Despite the White House's refusal to give Americans the full, honest picture, Makary and Høeg are among those reminding America's leaders that "[t]he public has a right to know." Indeed.




Sunday, September 17, 2023

How we can prevent COVID mandates from coming back

A recent uptick in COVID-19 cases, accompanied by the predictable hysterical media coverage, has spurred nationwide chatter about a possible return to pandemic restrictions, from school closures to mask mandates. This is not baseless supposition, as schools, universities, and hospital systems across the nation have recently reinstituted masking and quarantine requirements. Sen. Ed Markey, D-Mass., recently reinstated a mask mandate in his Capitol Hill offices, while MSNBC pundit Mehdi Hassan has been working overtime to convince his audience that school closures did not actually harm children—a formidable task given the evidence refuting his claims.

People living in hub cities and other blue jurisdictions have reason to worry that their political leaders might turn back the clock on pandemic restrictions ahead of the 2024 election cycle. Despite scads of legal challenges from individuals and groups negatively impacted by lockdowns and vaccine requirements, the law still offers little protection. Mandates levied by state and local governments tended to survive lawsuits due to the Constitution’s allocation of police power to the states, so courts have given governors and state legislatures the green light to continue inflicting pandemic theater on their constituents. 

Whether or not the Biden administration will attempt to implement mandates at the federal level—as some have speculated despite the presidential proclamation ending the COVID-19 emergency this past May—is another matter. In contrast to state and local COVID-19 restrictions, most federal mandates imposed by presidential decree have not withstood legal challenges. Thus, for Americans who are more concerned about COVID-19 tyranny than the virus itself, there is reason to be hopeful that even if restrictions return, they won’t be as totalizing and intrusive as the last round.

First and foremost, President Biden’s vaccine mandates, which he instituted through executive orders in the fall of 2021, were by and large a failure (apart from the mandate for health care workers at facilities that receive federal funds). The president attempted to use federal statutes obviously meant to serve entirely different purposes to compel vaccine-hesitant Americans to get the shot. Altogether, the mandates applied to around 100 million Americans.

One of the most extensive involved the administration’s instrumentalization of the Occupational Safety and Health Act (OSHA) to force private companies that employed 100 or more people to require vaccination or frequent testing as a condition of continued employment. Preliminarily enjoining the mandate, the Supreme Court recognized that the president lacked this authority, since Congress had only authorized OSHA to regulate workplace safety, not impose “broad public health measures” that were “untethered, in any causal sense, from the workplace.”

The White House’s misuse of the Procurement Act to force all employees of federal contractors to receive a COVID-19 inoculation met a similar fate. The act’s stated purpose is to provide for the “economical and efficient” procurement of government contracts. Several United States Courts of Appeals rightly held that Congress, in enacting this statute, clearly did not intend to provide for the federal executive to impose vaccination on one-fifth of the nation’s workforce. Thus, Biden had exceeded his delegated powers. Likewise, a 10-judge majority of the 5th Circuit Court of Appeals upheld a district court’s ruling preliminarily enjoining the federal employees’ vaccine mandate. While as a technical matter the decision addressed jurisdiction, in determining that the plaintiffs could bring their case in federal court, the ruling set the groundwork for a successful challenge on the merits of the claims, and was widely seen as a victory for the plaintiffs.

We need politicians with practical plans to avoid a replay of restrictions—especially given that most COVID-19 mandates proved not only useless, but harmful.

Vaccine mandates were not the only pandemic restriction imposed through federal executive decree to be preliminarily enjoined. When, in July 2020, Congress failed to renew an emergency act halting evictions from properties that participated in federal assistance programs or were subject to federally backed loans, the Centers for Disease Control and Prevention (CDC), an agency within the Department of Health and Human Services (HHS), extended the moratorium and broadened it to include all residential properties nationwide. In an unprecedented move, the CDC even provided for criminal penalties for noncompliant landlords. The CDC’s dubious statutory justification for this sweeping order was its authority to “make and enforce such regulations as in [the surgeon general’s] judgment are necessary to prevent the introduction, transmission, or spread of communicable diseases[.]” According to the agency, the eviction moratorium was necessary because economic hardship during the pandemic meant many tenants could no longer afford to pay rent, and forcing them out of their homes would disseminate COVID-19.

From a practical and moral standpoint, the policy was a fiasco. Noncorporate, middle-class landlords could not afford mortgages and repairs without tenants’ rent. In many instances, tenants did not default out of necessity, but rather because they could get away with it. For example, a Washington Post article featured a Hawaii waitress who lost her job due to business closures and could not stay afloat using rent from small condos she owned since her tenants simply didn’t pay.

The Supreme Court, in Alabama Association of Realtors v. HHS, rightly found that the CDC had exceeded the authority delegated to it by Congress and struck down the moratorium. The court explained in conclusion that: “[O]ur system does not permit agencies to act unlawfully even in pursuit of desirable ends …. It is up to Congress, not the CDC, to decide whether the public interest merits further action here.”

Similar principles came into play when the CDC was taken to court over its public transportation mask mandate. A district court judge in Florida held that the agency lacked power to compel travelers throughout the nation to wear masks on public transit. (The 11th Circuit Court of Appeals dismissed the case, dodging the merits because the government represented that the administration would not attempt to reimpose the mandate.)

Very recently, the Fifth Circuit held that the Food and Drug Administration (FDA) had unlawfully interfered with doctors’ ability to prescribe ivermectin to patients to treat COVID-19 symptoms. Three doctors had challenged FDA tweets ordering Americans to stop taking the medication, which is a commonly used anti-parasitic drug that has been met with controversy in the COVID-19 context. (Some hypothesize that vaccine companies and their allies orchestrated hostility to the drug because its efficacy threatened their profit margins.)They alleged that the FDA’s stance had caused them to suffer adverse professional consequences, including loss of admitting privileges at hospitals and positions at medical schools, as well as referrals to medical boards. The Fifth Circuit agreed, declaring that “[n]othing in the [enabling] Act’s plain text authorizes FDA to issue medical advice or recommendations … while FDA cites plenty of statutory authority allowing it to issue information, it never identifies even colorable authority allowing it to make medical recommendations (at least without notice and comment.”

All of the decisions discussed above are based on a common principle: Generally speaking, the president of the United States and his executive agencies do not have the constitutional authority to impose public health mandates through executive decree. Congressional acts are a different story, though. As the Supreme Court insinuated in Alabama Association, the same public health measures instituted properly, through the legislative process, would probably pass constitutional muster.

Thus, Americans who oppose public health tyranny would be wise to elect national representatives who not only share their concerns, but have practical plans to pass legislation that would protect Americans against future restrictions—especially given that most COVID-19 mandates proved not only useless, but harmful.

Unlike the successful challenges to federal mandates, however, efforts to block COVID restrictions at the state and local levels have been less successful. That is because state and local governments have broad authority (known as “police power” embodied in the Constitution’s 10th Amendment) to pass laws and regulations to address a perceived public health crisis. 

A prime culprit for the current state of affairs is a case from 1905 known as Jacobson v. Massachusetts. Henning Jacobson, a pastor in Cambridge, had defied a law requiring residents of his township to receive a smallpox vaccine during an outbreak of the disease. The Supreme Court rejected Jacobson’s due process challenge. The law was a proper exercise of Massachusetts’ 10th Amendment police power, the court explained, and did not violate Jacobson’s constitutional rights. [T]he police power of a state must be held to embrace, at least, such reasonable regulations established directly by legislative enactment as will protect the public health and safety.”

Courts have since relied on Jacobson to justify upholding most state and local public health mandates, from vaccine requirements imposed by state employers to mask mandates to school and business closures—not only those enacted by legislatures. Attempts to distinguish or revisit Jacobson on various salient grounds, such as the relative lethality of smallpox compared to COVID-19, evolving societal recognition of rights to bodily autonomy, or the fact that the law in question had been passed through the legislative process as opposed to executive decree, usually fail. Instead of engaging in reasoned analysis, courts reflexively apply Jacobson and wash their hands of further analysis.

There are some exceptions to this general rule, most notably in the First Amendment context (the First Amendment provides for Americans’ rights to speak and practice religion without government infringement). Having earlier denied a church’s challenge to California Gov. Newsom’s executive order restricting public gatherings, in November 2020 the Supreme Court struck down an executive order issued by former New York Gov. Andrew Cuomo severely limiting church attendance. The order violated the First Amendment’s Free Exercise Clause, the court held. In a now oft-quoted line, Justice Gorsuch opined in concurrence that “Government is not free to disregard the First Amendment in times of crisis.” 

In another hopeful decision, a district court judge in California preliminarily enjoined a state law prohibiting doctors from dispensing advice or treatment to patients that departs from the “contemporary scientific consensus” on COVID-19. The 9th Circuit Court of Appeals, which heard argument on the constitutionality of the law this past July, appears poised to hold that it presents due process and First Amendment problems.

The common theme underpinning these challenges to state level COVID-19 restrictions, however, is that they implicate enumerated First Amendment rights to free speech and free exercise—in other words, rights that the Constitution explicitly protects. If Americans want to safeguard other liberties, such as the rights to bodily autonomy, to decline medical treatment, and to run a business or to attend school, they should turn to the legislative process. The courts cannot be relied upon to protect our rights to leave our homes, run our businesses, send our children to school, and breathe unhindered.