Friday, August 25, 2023

The Highly Mutated BA.2.86, the Detecting Lab and Immunity Questions
Yesterday, TrialSite reported that the Centers for Disease Control and Prevention (CDC) picked up on a new SARS-CoV-2 variant, one highly mutated, termed BA.2.86. In the United States, the mutated variant was sequenced in Michigan thanks to the ongoing surveillance occurring at the University of Michigan Clinical Microbiology Laboratory.

The University of Michigan Clinical Microbiology Laboratory in the report is termed the originating lab, while the submitting lab was the Lauring Lab, University of Michigan, Department of Microbiology and Immunology. This lab is led by Adam Lauring, M.D., Ph.D., a Professor of Internal Medicine, Infectious Disease and Microbiology & Immunology.

The Clinical Microbiology Lab is led by Michael Bachman, M.D., Ph.D., and Paul R. Lephart, Ph.D., D(ABMM), both Associate Directors of the prominent Midwestern lab—one staffed by 55 medical technologists and clinical laboratory scientists. The laboratories provide service 365 days a year to meet the medical needs of Michigan Medicine and the clients of the “M-Labs” program.

The Clinical Microbiology Laboratory has close ties with Adult and Pediatric Infectious Diseases, the Infection Control Program, the Department of Pharmacy, and the School of Public Health. Close collaboration is key among the various functional areas, thus providing the ongoing analysis of interactions between organisms and antimicrobial agents that allow for dynamic reporting to clinicians on the floors and foster productive research collaborations that directly result in improving the quality of care provided to patients.

The Clinical Microbiology Laboratories are accredited by the College of American Pathologists (CAP) and active in the CAP Laboratory Accreditation and Proficiency Testing programs

More on the variant

CBS News coverage of the latest variant discovered revealed some useful information. Kathleen Conley, a CDC spokesperson told the network news, “Today we are more prepared than ever to detect and respond to changes in the COVID-19 virus.” Conley empathized that “Scientists are working now to understand more about the newly identified lineage in these four cases and we will share more information as it becomes available.”

Alexander Tin covered the story for CBS News HealthWatch.

Is BA.2.86 a more threatening or dangerous variant of SARS-CoV-2? Will it lead to more severe COVID-19? While the World Health Organization went on the record that the variant includes dozens of genetic changes, for comparison it’s a similar situation in some ways to how Omicron emerged as a materially different stain than, say, delta.

But public health agencies and academic research centers need more data to determine the risk levels associated with BA.2.86. TrialSite reported that this newly detected strain has been detected in Israel and Denmark as well.

The concern, among other things, is that the mutations could aid the pathogen in its ability to evade immunity, both of the natural (previous infection) as well as vaccine-induced type. There is no real threat at this point given the pathogen has only been detected in a few places. Also, it may well be the case that the human body’s current immune responses help fight off the mutant. Or for that matter, the mutant may not be able to compete with existing highly infectious strains.

CBS News obtained a presentation from a Fred Hutch Cancer Center evolutionary biologist, Jesse Bloom, Ph.D., conveying what could be considered potentially disturbing information about the latest variant. “Deep mutational scanning indicates BA.2.86 variant will have equal or greater escape than XBB.1.5 from antibodies elicited by pre-omicron and first-generation Omicron variants.”

Some of the mutations exist in parts of the virus that could help it evade immunity provided by prior vaccination or infection.

But Bloom also suggested the collective immunity may well be ready to take on BA.2.86, “[T]here are also broader mechanisms of immunity elicited by vaccination and infection that provide some protection against severe disease even for very heavily mutated variants.”

What are the implications for the latest vaccine that will likely be approved by FDA, and recommended by CDC for the fall season?

A monovalent mRNA vaccine produced by both Pfizer-BioNTech and Moderna are under clinical study. TrialSite reported on a trial site looking to enroll adolescents in Cincinnati Ohio for the Moderna clinical trial.

The FDA recommended that the vaccine makers tailor this COVID-19 season’s vaccine to XBB.1.5, an Omicron variant. As TrialSite has reported recently, while this strain predominated circulating Omicron variants across America just a few months ago it is now at 10.3% or lower. TrialSite estimates that by October XBB.1.5 will be under 5% of all circulating SARS-CoV-2 variants, if not less.

What does this mean for COVID-19 vaccine effectiveness? And what about the emerging predominant variants? For example, EG.5 at over 17% of SARS-CoV-2 cases according to the CDC now is the pathogen to watch. The good news for vaccination and natural immunity supporters---EG.5 is an XBB descendent so perhaps the vaccine’s effectiveness will be better than expected. Or perhaps Moderna pointed out, according to CBS News, that its shot provides "a significant boost in neutralizing antibodies" for EG.5.

Yet according to the Fred Hutch evolutionary biologist Jesse Bloom, all bets are off if BA.2.86 is able to outcompete and overcome other fast-moving, mutating Omicron variants. That scenario could represent trouble for our collective immunity. BA.2.86 heavily mutated would be a “fairly poor match” for the current vaccines under clinical development which again target XBB.

A reminder tempering the concern. With each progressive mutation under the Omicron umbrella of variants, COVID-19 becomes ever milder all things considered. And there are treatments available. Yes, it still can turn severe and even deadly but the case fatality rate now ranks with influenza, if not even less dangerous for healthy people.

Even during the Delta variant surge TrialSite always reminded that 90-95% of the COVID-19 cases were mild to moderate, but that persons in high-risk categories (e.g., elderly, persons with comorbidities, immunocompromised) faced considerably higher threat. TrialSite emphasized with national and state public health agencies that face a U.S. population with a staggering reality—about 70% of the adult population is either overweight or obese as reported by Harvard T.H. Chan School of Public Health. During the pandemic, there was little time to risk stratify, and obesity itself was/and is a risk factor. Meaning a good half, of the country’s adults likely fell in the higher risk category. This remains so, although the case fatality rate is under 1%. But generally, the Omicron variants are more infectious, meaning they spread faster, yet overall lead to milder outcomes.


Murdoch Children’s Bombshell: Medicinal Value of COVID-19 Vaccines Now Questionable Among Healthy Children

According to researchers at Australia’s Murdoch Children’s Research Institute, COVID-19 vaccines have demonstrated efficacy against severe incidence of SARS-CoV-2 in children and adolescents, but their value proposition as a mass medical tool becomes questionable considering the unfolding dynamics of today: high pre-existing infection and low risk when infected.

Researchers led by John Hart from the academic medical center for young people Down Under acknowledge that most children now have been infected by SARS-CoV-2, meaning they have built up immunity, and the vaccine’s benefit in healthy children is minimal. They argue any energies and attention placed on COVID-19 vaccination campaigns should be used to advocate for vaccines known to offer higher medical value, such as the measles vaccine. The ramifications of this recent set of findings are substantial.

Published in the BMJ Pediatrics Open, the international review was led by medical researchers from the Australian medical institute. They explored the challenges and considerations of COVID-19 vaccination, especially in low-and middle-income countries with high levels of community transmission and infection-derived immunity.

The team’s review, led by Hart, a medical epidemiologist, suggests that any COVID-19 vaccination scheme moving forward, especially in low-and middle-income countries should be coupled with routine childhood vaccination program that the researchers acknowledge “have greater impact on illness and death, including for measles, pneumonia and diarrheal disease.”

Mild for most

The Australian team found that about two-thirds of all young people that had COVIS-19 and were hospitalized in the first two years of the COVID-19 pandemic did not require medical intervention. Deaths, the investigators reported, “were extremely rare in children.”

Closing in on child herd immunity?

The researchers also point out that the vast majority of children have been infected with SARS-CoV-2. As immunity has increased over time, the disease continues to evolve. Prior research led by Murdoch Children’s found that croup, triggered by the novel coronavirus, declined in 2022 despite the rise of new variants.

Also, data from the Pediatric Active Enhanced Disease Surveillance (PAEDS) network in America found that rates of pediatric multisystem inflammatory syndrome (PIMS-TS), what was a major driver for childhood vaccination, were “Substantially lower during the Omicron COVID-19 variant period.” TrialSite reported on similar findings in the UK.

Net takeaway

While there are still cases where COVID-19 vaccination is recommended, the Australian researchers are clear—they value of these vaccines for children has markedly diminished. In fact, they use the COVID-19 vaccination push as a primary means of promoting more substantive medical vaccination, such as measles. Reading between the lines, and on the face of the piece, the investigators are more concerned about standard vaccination rates, especially in low-and moderate-income countries.

One takeaway called out by this independent media, children achieved herd immunity against SARS-CoV-2 by infection, not vaccination.



Thursday, August 24, 2023

What You Need to Know About New ‘Eris’ COVID Variant

The new COVID-19 virus variant spreading now, “Eris,” is currently the predominant strain in the United States, according to data from the U.S. Centers for Disease Control and Prevention (CDC). Although it’s increasingly reported worldwide, health experts say it poses a low risk to public health, as there is no evidence it causes different or more severe symptoms than previous omicron offspring.

The Essentials

A subvariant of the omicron lineage, Eris, otherwise known as EG.5, was detected as early as February 2023. As of Aug. 23, Eris has been detected in more than 50 countries and is responsible for an estimated 20.6 percent of all cases in the United States.

Meanwhile, FL.1.5.1 is now the second most prevalent strain, accounting for over 13 percent of cases.

On Aug. 9, the World Health Organization (WHO) designated Eris as a variant of interest (pdf), meaning it possesses genetic characteristics that could increase its transmissibility, virulence, and ability to evade vaccines.

The WHO had previously labeled Eris as a variant “under monitoring” after a surge in COVID-19 infections in early July.

The current variant of interest list also includes two other omicron cousins—XBB.1.5 and XBB.1.16.

If Eris is upgraded to a variant of concern, governments would need to increase preventative measures, such as mask mandates in hospitals, testing, or physical distancing.

There have already been growing concerns that Eris could trigger governments to revive some COVID-19 restrictions.

How Dangerous Is It Compared to Other Variants?

Eris is a descendent of omicron variant XBB.1.9.2.

Eris carries an additional amino acid mutation, known as F456L, in the spike protein. This mutation has been shown to escape immunity gained from previous variants and may help the new variant transmit quickly.

The CDC said there is no evidence Eris causes more severe disease than other omicron descendants, and it seems to cause similar symptoms.

Similar to those of earlier COVID-19 virus strains and that of the common cold, symptoms may include the following:

Muscle pain.
Chest pain.
Sore throat.
Runny nose.
Fever and chills.
Nausea or vomiting.
Loss of taste or smell.

New Generation ‘Variant Under Monitoring’

Health authorities have also been tracking a highly mutated strain called BA.2.86, or “Pirola” by some, which has caught scientists by surprise after it was picked up by COVID-19 testing on three continents.

This variant has scientists on alert because its emergence is reminiscent of the early days of the omicron variant in late 2021 when researchers in southern Africa noticed a lineage that quickly spread globally.

“There’s a little bit of déjà vu all over again,” said Adam Lauring, a virologist and infectious-disease physician at the University of Michigan in Ann Arbor, whose lab identified one individual infected with BA.2.86, in an interview with Nature.

Health authorities first detected BA.2.86 in Denmark on July 24, and it has also been spotted in the UK, United States, and Israel.

None of the cases appears to be linked, including three infections in Denmark found in different parts of the country. This geographical distribution is another feature of BA.2.86 that is garnering scientists’ attention.

This suggests the variant may already be fairly widespread, Jesse Bloom, a viral evolutionary biologist at the Fred Hutchinson Cancer Center in Seattle, told Nature. “It’s got to have been transmitting a fair amount.”

The UK Health Security Agency said a recent case was reported in a person with no recent travel history, “suggesting a degree of community transmission within the UK.”

However, experts do not expect BA.2.86 to have the same impact as omicron due to response practice with earlier COVID-19 waves and vaccine rollouts. “There’s good reason to think it won’t be like the omicron wave, but it’s early days,” Mr. Lauring said in the Nature interview.

Current Vaccines

Pfizer, Moderna, and Novavax have created new versions of their vaccines to target another omicron sublineage—XBB.1.5—similar to Eris, so health authorities hope the vaccines will work on new variants.

However, according to the WHO, the F456L mutation Eris carries has been shown to decrease the neutralization of most XBB.1.5 neutralizing antibodies.

Listed by the WHO as a “variant of concern,” XBB.1.5 previously dominated transmission in the United States for several months straight but was surpassed by XBB.1.16, or Arcturus, in July.

The new CDC director, Dr. Mandy Cohen, anticipates that these vaccines will be available at common locations such as pharmacies and anticipates an annual COVID-19 shot, integrating it into routine health practices.


Another Covid Medication Gets authorization from FDA Despite a Phase 3 “Miss”

When the Covid pandemic started, there was a rush to find a vaccine to combat the disease. Initially, issues arose with the Johnson and Johnson shot and it was discontinued, but the Pfizer mRNA jab was approved. Both shots were authorized by the Food and Drug Administration (FDA) under emergency use authorization (EUA) although the Johnson and Johnson’s (Janssen) authorization was later revoked. The mRNA jabs were later formally approved. But questions still arose over whether or not the Pfizer and later Moderna vaccines were fully vetted before EUA was granted. Now it appears history has repeated itself.

Known as vilobelimab, this experimental product now available on an emergency basis was developed via human-mouse chimeric IgG4 kappa antibody targeting human C5a in plasma.

Gohibic gets EUA

In April, the FDA granted emergency use authorization for the use of the Gohibic injection for the treatment of Covid-19 in hospitalized adults. The medication is to be used within 48 hours of a patient who’s been intubated or is on a heart-lung machine. The press release for the medication says, “There is limited information known about the safety or effectiveness of using GOHIBIC to treat people in the hospital with COVID-19.

Available results from clinical trials in adults indicate that treatment with GOHIBIC may decrease the risk of dying in hospitalized adults with COVID-19 when initiated within 48 hours of receiving IMV or ECMO. The safety and effectiveness of GOHIBIC have not been studied in children hospitalized with COVID-19.”

Authorized despite Phase 3 “miss”

According to the FDA, the Gohibic clinical trial showed that patients treated with the drug had a lower risk of death by day 28 and day 60 of treatment compared to placebo. However, there is a phase 3 clinical trial “twist”. In a randomized trial, Gohibic reduced the risk of death in the sickest patients by 27% compared with placebo during a 28-day period. In that trial, the drug missed “statistical significance” on the trial’s primary endpoint. But in another analysis and two other post hoc analyses the medication’s improvement was significant. The treatment targets inflammation that leads to progression of the Covid virus.

Drug maker talks to FDA

Despite the results of the trial, the maker of Gohibic, InflaRx, talked to the FDA and then applied for the EUA last September. InflaRx was founded in 2007 in Germany and has offices in Ann Arbor, Michigan. In a press release, the Chief Executive Officer (CEO) of InflaRx, Niels Riedemann said that Gohibic will bring hope to Covid patients who despite vaccines and other treatment options, are still developing viral sepsis and are progressing to critical status.

The company has a supply of Gohibic which is readily available, but Riedemann didn’t reveal the price of the medication. However, he did expect to charge a five-digit figure per patient for the drug. Once again, it appears Covid is a continual cash cow for Big Pharma CEOs.


The World’s Longest Natural Experiment on Vaccine Efficacy

Lack of controls in evaluating vaccine efficacy makes all inferences speculative

In early 2021, the COVID-19 vaccine campaign was launched, based on clinical findings of 95% efficacy in late 2020 (Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine).

But this efficacy relied on relative risk measures that are more appropriate for epidemiological population studies that measure exposure and response to risk factors without controlling for confounding factors that could produce the same results from other sources.

Confounding factors are controlled in a vaccine clinical trial through randomization of participants to the vaccine and placebo groups, thereby equally distributing all known and unknown confounding factors. Randomized controlled clinical trials require absolute measures of risk reduction to prove causation of vaccine efficacy, not relative risk reductions that only observe associations of effectiveness. (Relative risk reduction: Misinformative measure in clinical trials and COVID-19 vaccine efficacy).

The absolute risk reduction of the COVID-19 vaccine clinical trials was approximately 1%, which rendered the vaccine clinically insignificant (Outcome Reporting Bias in COVID-19 mRNA Vaccine Clinical Trials). Generally, a significant clinical effect reduces a risk by at least 50% or increases a risk by at least two-fold.

In what amounts to the world’s longest natural experiment, it took many months for a national public health official to declare to the public what the clinical trial results had already proven back in 2020 due to their low absolute risk reductions: that the COVID-19 vaccines would not prevent SARS-CoV-2 infections (CDC Director Rochelle Walensky tells Wolf Blitzer that COVID Vaccines won't prevent transmission - YouTube 1:20).

And to suggest that the vaccines would at least keep you out of the hospital has never been clinically proven. Just because you are vaccinated and stay out of the hospital doesn't prove the vaccines had anything to do with it. It's just another one of those unproven associations.

By now the truth about the COVID-19 vaccine failure should be evident to anybody who cares to look and listen. However, are the lessons learned? Are we better equipped now to prevent more failed vaccine campaigns based on misleading statistics that benefit pharmaceutical profits? That last phrase provides a clue to the answer, and the world's longest natural experiment on vaccine efficacy is likely to continue on indefinitely.




Wednesday, August 23, 2023

Long COVID damage can linger for 2 years, leading to elevated risk of disability, hospitalization, and death, landmark new study finds

Long COVID—and the increased risk of death, disability, and hospitalization it brings—can persist for two years, according to a landmark study published Monday in Nature Medicine.

It’s the first study to look at a broad range of potential health effects stemming from the virus in the two years after infection. Most previous studies had only examined the initial year after infection, or a more narrow range of health effects in a period slightly longer than a year.

For those who contracted the virus in 2020 and were hospitalized with it, the risk of both death and hospitalization remained “significantly elevated” for two years, according to researchers with the U.S. Department of Veterans Affairs and Washington University.

Among those who contracted the virus the same year and weren’t hospitalized during their initial infection, the risk of death remained statistically significant for six months, researchers found. The risk of hospitalization remained elevated for about a year and a half.

“The findings highlight the substantial cumulative burden of health loss due to [long COVID] and call for attention to the care needs of people with long-term health effects" due to the virus, the study’s authors wrote.

A longer road for those who were hospitalized

Researchers examined the Department of Veterans Affairs medical records of nearly 140,000 individuals who survived COVID during 2020, as well as nearly 6 million who weren’t known to have contracted the virus that year. They followed them for two years to gauge their risk of death from all causes, as well as the incidence of 80 conditions known to be post-acute sequelae of COVID (PASC), frequently referred to as long COVID.

At the two-year mark, the risk of most of those health conditions—69%—was insignificant for those who hadn’t been hospitalized with the virus. But "substantial" risk remained "impacting several major organ systems." The chance of developing blood, lung, gastrointestinal, or musculoskeletal conditions remained elevated, in addition to fatigue and diabetes, suggesting a longer-lasting risk for these ailments, the authors stated.

In a Monday blog entry, Dr. Eric Topol, a professor of molecular medicine at Scripps Research and founder and director of the Scripps Research Translational Institute, wrote that the statistic was the "only reassuring finding for non-hospitalized people in the study."

For those who had been hospitalized with the virus, the risk of most of conditions—65%, affecting all organ systems examined, and including cardiovascular, blood, endocrine, gastrointestinal, kidney, mental health, musculoskeletal, and pulmonary issues—remained significant for the entire two years. The findings are a nod to the "the difficult and protracted road to recovery among those whose disease was sufficiently severe to necessitate hospitalization during the acute phase of infection," researchers wrote.

The study's findings "show that while risks of many (but not all) post-acute sequelae decline and become non-statistically significant over time, the decline is less pronounced among those who were hospitalized in the acute phase of infection," the authors wrote.

The good news for everyone: Researchers found no increased risk of cancer among those who had experienced COVID, hospitalized or not.

While significant, the study had its limitations, as the authors point out. All participants were veterans, and most were older males. Long COVID as a whole may look different—in both duration and symptoms—in a primarily female, or younger, population. As Topol pointed out, the study's prototypic participant, a 61-year-old male, is far different from a female in her thirties—the demographic for which long COVID is thought to be most prevalent.

Further, all participants were infected during the first year of COVID, before variants like Delta and Omicron evolved. While thought to be less common, long COVID from later strains may feature important differences.

What's more, those with a record of COVID infection were compared to those with no record of a COVID infection during the same year. But some of them may have had COVID without knowing, or telling their doctor, skewing rates of death, hospitalization, and disability in the COVID crowd for better or worse.

Long COVID's long-term impacts on the immune system

Another new study, published Aug. 18 in the journal Cell, details the long-term immune system changes that severe COVID can trigger. The findings help elucidate why some with long COVID have symptoms tied to prolonged inflammation, like lung and kidney damage and neurological changes—and may have implications for anyone who has experienced the virus, regardless of severity.

Researchers with Weill Cornell Medicine in New York City and other institutions examined data from the blood of tens of patients—those who had recovered from severe COVID, and those who had recovered from other types of critical illness. In particular, they were able to isolate and analyze a rare type of stem cells found in blood—CD34+ hematopoietic stem and progenitor cells—thanks to a new technique they developed that made bone marrow biopsy unnecessary.

Among their findings: Monocytes—a type of white blood cell produced every few days from stem cells—showed changes in epigenetic programming up to a year after severe COVID infection.

Epigenetic programming refers to the epigenome—comprised of factors like chemicals, stress, diet, drugs, and disease that modify DNA, telling it "what to do, where to do it, and when to do it,” according to the U.S. National Institutes of Health. Those changes, to what could be casually referred to as DNA's "packaging," can be passed down from cell to cell as they divide, and from generation to generation.

Researchers also found that stem cells of those who had experienced severe COVID were more likely to allow activation of inflammation-associated genes. Such cells were also more likely to create a type of blood cell that serves as a "first responder" to infection.

Stem cells "can pass their epigenetic ‘memories’ on to their progeny immune cells, changing those cells’ inflammatory programs," Dr. Steven Josefowicz, an associate professor of pathology and laboratory medicine at Weill Cornell Medicine, told Fortune. "So, when they see another pathogen, they respond in a different way than they would if they came from ... cells that hadn’t seen inflammation to the same extent.”

Such changes to the immune system may persist longer than a year, Josefowicz said, adding that the study only lasted a year. And they may also occur—at least to some extent—in those who had more mild cases of COVID, though further study will be needed to tell.

Who's most at risk for long COVID?

Factors like age, gender, BMI, and pre-existing conditions may put individuals at higher risk for long COVID, according to a study published in March in the Journal of the American Medical Association Internal Medicine.

The U.K.-based study found that certain groups of people are at a significantly higher risk of developing the post-viral condition, thought to affect millions around the world. They include:

Over 40
People with obesity
Those who were immunosuppressed before COVID
People who were hospitalized with COVID
People who had the following conditions before COVID:

anxiety or depression
asthma or COPD

Researchers examined the results of 41 published studies, with a combined total of more than 860,000 patients. They found that the aforementioned conditions were strongly associated with a higher risk of long COVID symptoms persisting three or more months after infection.

The results bolster the case that female gender and older age serve as risk factors for developing long COVID. A potential common thread among several risk categories: pre-existing inflammation, which may extend the acute phase of COVID “even after recovery.” In the case of females, hormones might play a role in inflammatory status, while obesity shares a proinflammatory profile with long COVID, the authors write.

That’s not-so-great news for a giant swath of the population. There is good news, however: At least two doses of COVID vaccination seemed to lower the risk of developing long COVID, researchers found. Other studies have come to similar conclusions, they noted. They include a report from the U.K. Office of National Statistics, which found that those with two doses of COVID vaccine had a 42% lower risk of developing the potentially disabling condition.

What is long COVID?

With more than 200 symptoms identified—from lingering cough and fatigue to ear numbness and a sensation of “brain on fire”—long COVID is undoubtedly not one but multiple conditions, experts say.

True long COVID, some contend, is best defined as a chronic-fatigue-syndrome-like condition that develops after a COVID infection, similar to other post-viral syndromes that can occur after an infection with herpes, Lyme disease, and Ebola, among others.

Other post-COVID complications like organ damage should not be defined as long COVID and better fit into the larger umbrella category of PASC, some experts say. Also known as post-acute sequelae of COVID-19, the term is used to encompass a wide variety of COVID consequences, from chronic-fatigue-like symptoms and subsequent heart disease to lasting lung damage and odd new symptoms like urinary incontinence, itching, and skin lesions.

As of Jan. 16, 15% of U.S. adults reported having long COVID symptoms at some point in the pandemic, and 6% reported lingering symptoms, according to a Jan. 26 report by the Kaiser Family Foundation, citing data from the U.S. Centers for Disease Control and Prevention.

The percent of Americans who’ve experienced COVID and still report long COVID symptoms dropped from 19% in June to 11% in January, according to the report.




Tuesday, August 22, 2023

Health Break

No blogging from me today. Should be ok for tomorrow

Monday, August 21, 2023

Most Intensive Ivermectin Use Had 74 Percent Reduction in Excess Deaths

According to a new peer-reviewed ecological study, a natural experiment occurred when the government of Peru authorized ivermectin for use during the COVID-19 pandemic resulting in evidence of the drug’s effectiveness and ability to reduce excess deaths.

The paper’s results, published August 8 in Cureus, found a 74 percent reduction in excess deaths in 10 states with the most intensive ivermectin use over a 30-day period following peak deaths during the pandemic. When analyzing data across 25 states in Peru, researchers found these reductions in excess deaths correlated closely to ivermectin use during four months in 2020.

When ivermectin was available without restriction, there was a fourteenfold reduction in nationwide excess deaths. Once access to ivermectin was restricted by the government, a thirteenfold increase in excess deaths was observed in the two months following the limitation of its use. The findings align with summary data from the World Health Organization for the same time period in Peru.

Ivermectin is a widely-known and inexpensive treatment against parasitic diseases. Scientists believe the drug can also bind to the spike protein of the SARS-CoV-2 virus, limiting its morbidity and infectivity.

Peru Promoted Then Restricted Access to Ivermectin

Before Peru implemented COVID-19 vaccine mandates, the country relied on mitigation strategies such as lockdowns and therapeutics to control the SARS-CoV-2 virus that causes COVID-19, as did many other nations.

The Peruvian Ministry of Health, on May 8, 2020, approved ivermectin widely for use prompting 25 states in Peru to implement inpatient and outpatient treatments with ivermectin to different extents and in different time frames. Additionally, through the Mega-Operación Tayta (MOT)—a national program led by the Ministry of Defense—Peru’s government began distributing ivermectin on a wide scale.

Through a partnership with 11 other government agencies, MOT aimed to reach every targeted region with rapid response teams to detect COVID-19 cases, administer ivermectin, and provide food to encourage people to isolate for 15 days. Shortly thereafter, MOT began distributing the therapeutic to everyone identified as high-risk, regardless of whether they tested positive or were symptomatic for COVID-19.

The government of Peru independently tracked daily COVID-19 deaths and all-cause deaths through numerous Peruvian national health databases, allowing researchers to calculate excess deaths. Additionally, they extensively tracked data for deaths and other public health parameters allowing analysis of the potential efficacy of interventions such as ivermectin during the pandemic.

When President Francisco Sagasti took office on Nov. 17, 2020, the government stopped distributing ivermectin and made it available only by prescription. This made the drug significantly more difficult for people to obtain and allowed researchers to see nationwide changes in daily excess all-cause deaths before and after restrictions went into place.

Impact of Ivermectin on Excess Deaths

Excess all-cause deaths were calculated from the total deaths recorded for January through February 2020. During this period, monthly all-cause deaths fluctuated with a mean value of 5.2 percent and a standard deviation of 3.8 percent. By May 2020, total deaths fluctuated by more than double the baseline value calculated in January through February.

An analysis of excess all-cause deaths was performed state-by-state for those aged 60 years and older to establish the date of peak excess deaths during the pandemic’s first wave. Decreases in excess deaths from the peak date of death to 30 and 45 days afterward were tracked. The 25 states were then grouped by the extent of ivermectin distribution: maximal distribution—occurring through operation MOT, medium, and minimal.

Results showed that the 10 MOT states had a sharp decrease in excess deaths after reaching peak values—with a 74 percent drop at 30 days and an 86 percent drop at 45 days after the date of peak deaths. For 14 states that locally administered ivermectin, excess deaths dropped by 53 percent at 30 days and 70 percent at 45 days.

In Lima, where ivermectin treatments were delayed until August—four months after its initial pandemic surge in April—excess deaths only dropped by 25 percent at 30 days and 25 percent at 45 days after peak deaths on May 30.

According to the study, mean reductions in excess deaths 30 days after peak deaths were 74 percent, 53 percent, and 25 percent, respectively, for the maximal, medium, and minimal states that distributed ivermectin. Forty-five days after peak deaths, mean reductions were 86 percent, 70 percent, and 25 percent.

The researchers noted that ivermectin distribution may have yielded such positive numbers due to the drug’s ability to both prevent and treat COVID-19 when distributed to an at-risk population on a greater scale.

Similar Results Observed in Uttar Pradesh, India

Researchers noted similar results with ivermectin distribution in Uttar Pradesh, India, where government teams moved across 97,941 villages as part of a COVID-19 management program to distribute home medication kits that contained ivermectin, doxycycline, zinc, vitamins C and D3, and acetaminophen tablets.

After the mass distribution of ivermectin, the seven-day moving average of COVID-19 deaths in Uttar Pradesh decreased by 97 percent. The cumulative total of COVID-19 deaths per million in population from July 7, 2021, through April 1, 2023, was 4.3 in Uttar Pradesh, compared with 70.4 in all of India and 1,596.3 in the United States, according to the study.

Although Peru had more comprehensive data, the Uttar Pradesh data suggests using ivermectin may prevent and potentially treat COVID-19.

“These encouraging results from IVM [ivermectin] treatments in Peru and similar positive indications from Uttar Pradesh, India, which have populations of 33 million and 229 million, respectively, offer promising models for further mass deployments of IVM, as needs may arise, for both the treatment and prevention of COVID-19,” researchers concluded.

The authors considered factors that could influence their findings, such as the effects of a social isolation mandate imposed in May 2020, the varying genetic makeup of the SARS-CoV-2 virus, differences in seropositivity rates, and population densities across the 25 states. Still, researchers stated the extent and reliability of data showed other factors did not significantly influence study outcomes.


Post-Vaccination Parsonage-Turner Syndrome: A Case Series

Cripes! I have something very like Parsonage-Turner Syndrome right at this moment: All sorts of painful symptoms in my right shoulder. And I have been Covid vaxxed. But the vax was years back and there is no associated muscle weakness so I suspect the resemblance is coincidental. I seem to be healing up anyway

Case reports on COVID-19 vaccination-related neurological events are appearing more frequently in the literature. TrialSite follows these case studies on adverse effects on the central and peripheral nervous system attributed to COVID-19 vaccines. The study summarized here describes six cases related to a rare neurological condition called “Parsonage-Turner syndrome (PTS)” that presented after COVID-19 vaccine shots.

Also called “brachial neuritis”, PTS is a neurological condition characterized by severe pain in the shoulder and upper arm followed by muscle weakness. It mainly affects motor nerves which are responsible for movement. These symptoms may last for months and are usually unilateral.

The condition is commonly seen in men as compared to women and although people of any age can develop the condition, the average age of onset is 41 years.

The study

The current case series published in Case Reports in Neurology in 2022 is entitled “Parsonage-Turner Syndrome Following COVID-19 Vaccination: Clinical and Electromyographic Findings in 6 Patients.”


The reasons behind PTS are unclear, but reported causes include viral infections, surgery, vaccination, and trauma. One theory suggests that viral antigens in vaccines may trigger this syndrome. The condition is associated with various vaccines such as hepatitis B, diphtheria, pertussis, tetanus vaccine, smallpox, and swine flu.

The authors of the case report mentioned that during the first six months of 2021, a rise in PTS diagnoses was observed. A possible reason could be COVID-19 vaccination, so they investigated it further. They suggested that a mechanism behind PTS may be an immunization-induced inflammatory reaction against brachial plexus nerve fibers. Although rare, other case studies investigating the relationship between COVID-19 vaccines and PTS have been reported.


A retrospective analysis was performed with six patients who had acute onset of pain and weakness in their upper extremities post vaccination. These patients were referred for electrodiagnostic (EDX) investigation for their reported symptoms. EDX investigations include electromyography (EMG) and nerve conduction studies and aim to identify the cause of pain. It evaluates muscle and muscle nerve health.

Along with EDX evaluation, patients’ clinical symptoms, physical exams, MRI findings, COVID-19 vaccination history, and treatments were discussed. Other potential underlying reasons for PTS were excluded.


Four patients had received the Pfizer-BioNTech vaccine while two patients had received Moderna. Symptoms had arisen around 17 days after the injection in either the same arm with the injection site (five patients) or the other arm (one patient). Two patients had received the first dose and four had received the second dose before the symptom onset. EDX evaluation revealed abnormalities and further confirmed the diagnosis of PTS with localization of the disorder to the brachial plexus.

To treat the condition, patients received prednisone/prednisolone, gabapentin, and physical therapy. All of the patients showed improvement in their arm pain in follow-up evaluations. While three did not show improvement in weakness, the other three’s symptoms of muscle weakness improved.




Sunday, August 20, 2023

When corrupted science becomes a threat to population health

‘The medical-political complex tends towards suppression of science to aggrandise and enrich those in power. And, as the powerful become more successful, richer, and further intoxicated with power, the inconvenient truths of science are suppressed. When good science is suppressed, people die.’ BMJ executive editor Kamran Abbasi

Below is a section from the Australian Medical Professionals Society’s (AMPS) submission to the Department of Infrastructure, Transport, Regional Development, Communications and the Arts Communications Legislation Amendment (Combating Misinformation and Disinformation) Bill 2023. The full submission can be viewed here. We encourage you to make a submission here by August 20.

AMPS believes granting ACMA, a government-appointed entity, the authority to label information contradicting official messaging as misinformation or disinformation establishes an alarming and precarious precedent. This becomes especially concerning considering the growing awareness of the effect of corporate conflicts of interest, leading to biased reporting within academia, biased media content, skewed therapeutic guidelines, and profit-driven public policies. History is replete with instances showcasing the consequences of authorities making decisions without being held accountable or having to be transparent about their actions. We must be cautious when policies, based on concealed health advice for instance, are determined by those in power without the requirement for empirical validation, effectively bestowing them the power to define what qualifies as true information.

The extensive sway exerted by pharmaceutical companies’ financial interests across medical academia and public policy presents a notable jeopardy to the credibility of healthcare and societal welfare. The involvement of pharmaceutical companies in financing research, regulation, education, and policy endeavours introduces an intrinsic susceptibility to bias, potentially undermining the impartiality of scientific investigation and policy development. This dynamic could result in an undue prioritisation of profit-centred incentives, overshadowing the imperative of prioritising patient well-being and the broader public health.

Professor Ioannidis describes what he calls a ‘misinformation mess’ where he claims much-published research is not reliable. Having to negotiate such a mess in deciding exactly what is misinformation offers no benefit to patients or decision-makers. It is a risk to public health.

The government must consider that many prominent journal editors have drawn attention to the pervasive influence of financial conflicts of interest on the reliability of research findings.

‘Financial conflicts can compromise the integrity of research,’ warns Dr. Fiona Godlee, editor-in-chief of The BMJ, stressing the potential bias that can result from industry funding.

Dr. Jerome Kassirer, former editor-in-chief of the New England Journal of Medicine, notes in his book, How medicine’s complicity with big business can endanger your health, the ‘shocking extent of these financial enticements and explains how they encourage bias, promote dangerously misleading medical information, raise the cost of medical care, and breed distrust’, highlighting the distortion such conflicts can introduce into the scientific record.

Dr. Virginia Barbour, founding editor of PLOS Medicine, adds, disclosure alone is insufficient to address conflicts, emphasising the need for greater transparency and safeguards against undue influence.

Dr Maria Angell, long-time editor in chief of the NEJM resigned more than 20 years ago after 20 years as editor because of what she described as the rising influence of the Pharmaceutical industry. She said in her book, The truth about drug companies: How they deceive us and what to do about it, ‘Now primarily a marketing machine to sell drugs of dubious benefit, big pharma uses it wealth and power to co-opt every institution that might stand in its way, including the US congress, the FDA, academic medical centres and the medical profession itself.’

These editorial voices collectively emphasise the imperative of robust disclosure mechanisms and stringent evaluation of financial conflicts to maintain the integrity and credibility of research in the face of commercial interests.

AMPS would argue that the demonisation of Ivermectin during the pandemic is a prime example of how financial conflicts of interests that claimed extensive evidence demonstrating the effectiveness of Ivermectin in the treatment and prevention of Covid resulted in harm.

Our submission to the TGA’s rescheduling of Ivermectin showed how statistically significant the evidence base is to support the clinical improvements in time to clinical recovery, time to viral clearance, and reduction in hospitalisation and death from this cheap, safe, fully approved, WHO essential medicine. This medication was banned by the TGA claiming safety and efficacy concerns when their own 2013 Australian Public Assessment Reports (AusPAR) demonstrated safety and instead recommended for example the use of provisionally approved very expensive Remdesivir. Remdesivir in the WHO Solidarity Trial reported in the NEJM was found to have ‘little or no effect on hospitalised patients with Covid, as indicated by overall mortality, initiation of ventilation, and duration of hospital stay’. In fact, in 2020 the WHO recommended against the use of Remdesivir in Covid patients. A study in the Lancet from September 2021 found, ‘No clinical benefit was observed from the use of Remdesivir in patients who were admitted to hospital for Covid, were symptomatic for more than 7 days, and required oxygen support.’ The banning of Ivermectin in favour of antivirals such as Remdesivir appears to make little evidentiary or clinical sense.

Dr Mike Magee, former physician spokesman for Pfizer, published in 2019 his book Code Blue: Inside America’s Medical Industrial Complex. He powerfully describes the corruption of the US healthcare system.

‘Cosy relationships and generous gratuities have demonstrated a remarkable ability to corrupt even those we would instinctively put on the side of the angels, including members of the biomedical research community, deans of medical schools, directors of continuing medical education programs, officers at the NIH and FDA, and even seemingly altruistic patient advocacy organisations like the American Cancer Society.’

AMPS has also written quite extensively about our concerns regarding the conflict between the government safety and efficacy claims for the Covid vaccinations and the lack of comprehensive safety and efficacy data surrounding these novel immunisations. While the accelerated development and emergency approvals were perhaps motivated by the global health crisis, some experts caution that the available data are not yet as extensive as in standard vaccine development processes.

AMPS has written about our concerns with these vaccines especially for children. According to our Therapeutic Goods Administration (TGA) AusPAR long-term safety data remains a critical gap in our understanding, emphasising the importance of continued post-vaccination pharmacovigilance. Dr. Peter Doshi, an associate editor at The BMJ, underscores the need for transparent and thorough reporting of clinical trial results to ensure the public’s confidence in these vaccines.

Financial conflicts of interest can erode trust in medical research, undermine the credibility of academic institutions, restrict access to transparent data, and ultimately result in the promotion of treatments or policies that prioritise corporate gain over the impartial pursuit of knowledge and the advancement of public welfare. Stricter safeguards and transparency measures are essential to mitigate these dangers and ensure that medical academia and public policy remain steadfastly committed to unbiased and evidence-based decision-making when seeking to define what constitutes mis-or-disinformation.

We should heed Abbasi’s warning before science itself becomes a threat to overall population health, or maybe we are too late.

‘Science is being suppressed for political and financial gain. Covid has unleashed state corruption on a grand scale, and it is harmful to public health. Politicians and industry are responsible for this opportunistic embezzlement. So too are scientists and health experts. The pandemic has revealed how the medical-political complex can be manipulated in an emergency — a time when it is even more important to safeguard science…’


For the COVID-19 Vaccine Injured: Time for Action

A recent letter to the editor of the Peninsula Daily News, a local press serving the Olympic Peninsula in Washington State shares some possible good news for persons struggling with injuries associated with the COVID-19 vaccines. Could real change be around the corner with the proposed bipartisan Vaccine Injury Compensation Act?

A local resident, Kathy Zelenka seeks to influence the area’s politicians to ensure they support the legislation. Why? Because “politicians need to hear that their constituents care.”

The Port Angeles, Washington State resident summarizes the challenge well: “To live in a world where people harmed by a medication are treated with mercy instead of censorship, people must make their voices heard.”

Reaching into the dark past of Germany during WW2, Zelenka cites a quote from Dietrich Bonhoeffer, a Lutheran pastor, theologian and anti-Nazi dissident who is known to have said, “Not to speak is to speak. Not to act is to act.”

Ms. Zelenka educates her local politicians Derek Kilmer and Patty Murray on the new Office of Long COVID Research and Practice launched by the Biden administration and recently reported on by TrialSite. Importantly, she urges local residents to press the politicians to add vaccine injury studies to that new office, or conversely, set up an equivalent office.

She suggests the politicians read “Insult to the Injured: The Case for Modernizing Vaccine Injury Compensation” a recent piece published in Health Affairs co-authored by an advisor to vaccine makers and the director of Vaccine Injury Litigation at George Washington University Law School.

The opinion writer rightly points out that “we need each other.”

React19 is supporting this vaccine injury compensation reform. The largest COVID-19 vaccine injured group in the United States, if not the world, shared some thoughts on the proposed bipartisan legislation.

The organization, which collaborates with TrialSite, is identified as a science-based non-profit offering financial, physical and emotional support for those suffering from long-term COVID-19 vaccine adverse events globally.

Serving React19 as Legal Affairs Director, Christopher A. Dreisbach told TrialSite via email that “in an ideal world the COVID-19 vaccine-injured would be able to hold the pharmaceutical industry directly accountable through personal injury actions. Nonetheless, this bill represents the next best thing.”

As TrialSite has reported, the current COVID-19 vaccine injured population must navigate the completely broken Countermeasures Injury Compensation Program (CICP). The proposed legislation among other things would move the COVID-19 vaccine injured to the at least somewhat functional Vaccine Injury Compensation Program.

According to React19’s counsel:

“By transitioning the COVID-19 vaccines to the VICP, this bill represents the comprehensive reform the vaccine-injured desperately deserve. We commend Representative Doggett and Representative Smucker for their bipartisan effort - an unfortunately rare occurrence in today’s highly polarized political environment.”

React19 has a message for politicians that might try to water down, dilute the proposed legislation:

“Incremental CICP reforms, proposed by other lawmakers, will not make a meaningful difference to the COVID-19 vaccine-injured. That program is simply too broken to fix. This bill is a welcome departure from such a short-cited approach.”

Given that over 230 million people are now considered fully vaccinated, TrialSite estimates that anywhere from half-a-million to just over 2 million people are in dire need of care, suffering with life changing injuries caused by the COVID-19 vaccines.

Many of these people are barely getting by, and the medical establishment hasn’t embraced vaccine injures as key opinion leaders in the National Institutes of Health, Food and Drug Administration and Centers for Disease Control and Prevention have yet to step forward and open up the dialogue publicly.

It’s time they do so.