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:

Fatigue.
Muscle pain.
Chest pain.
Headache.
Sore throat.
Runny nose.
Congestion.
Cough.
Fever and chills.
Nausea or vomiting.
Diarrhea.
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.

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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.

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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.

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Also see my other blogs. Main ones below:

http://edwatch.blogspot.com (EDUCATION WATCH)

http://antigreen.blogspot.com (GREENIE WATCH)

http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)

http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)

http://snorphty.blogspot.com (TONGUE-TIED)

https://immigwatch.blogspot.com (IMMIGRATION WATCH)

https://awesternheart.blogspot.com (THE PSYCHOLOGIST)

http://jonjayray.com/blogall.html More blogs

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