The Playground

Quote from THHuxleynew

So as I understand it - you are recommending that people aged 59 should deliberately get themselves a dose of COVID without vaccination?

I in general I recommend better drugs like Bordeaux. But If you have all the medical drugs at home getting an infection by using a swab is recommended for all no risk people. With a swab you get a low dose and not a direct deep lung infection and you can immediately kill the virus after the PCR test by the now recommend iodine solution....

All the Amish people did it.

Here from the vortex friends once more outstanding Ivermectin news from Africa's ivermectin countries.

COVID-19: The Ivermectin African Enigma

The low frequency of cases and deaths from the SARS-CoV-2 COVID-19 virus in some countries of Africa has called our attention about the unusual behavior of…

www.ncbi.nlm.nih.gov

Ohhhh all these happy wormy people...

Quote from THHuxleynew

I am afraid Jed that this is not evidence.

Sure it is. Not conclusive perhaps. It may be caused by confounding effects. But there is a clear correlation between positive ivermectin results and populations known to be infested with worms. In many cases, the worms are not diagnosed. There are reportedly hundreds of millions of cases in India. So I think it is highly likely there are undiagnosed cases in a blind test of ivermectin.

Furthermore, logically, if a correlation is shown in other studies, what could have caused it other than worms? Ivermectin has no other therapeutic value.

The CDC has new recommendations for disposable masks:

Quote from RobertBryant

The experts at the CDC still recommend Remdesivir

one year after Solidarity..

hands in their pockets for Gilead,,

It is extremely unlikely any expert at the CDC is being paid off by Gilead. If found, that employee would go to prison for a long time, and his or her professional career would be over. He could only do menial jobs after getting out of prison. Most professional scientists are not willing to risk their careers for a payoff. Also, these people are middle class. They do not have huge houses. (I know this because some of them live in my neighborhood, which is middle class, and about 3 miles from the CDC.) Uncle Sam knows exactly how much money they are being paid. If they suddenly got more money, the IRS would probably notice.

Gilead officials would also get in trouble, and be sent to prison.

Unless you have some valid reason for thinking these people are being paid off, or you have read a news story alleging that, I suggest you refrain from saying things like this. Not because you will hurt the reputations of the CDC scientists -- that's not going to happen. But because saying things like that makes you look like a fool.

hands in their pockets is charity,,

Russell just states the obvious

Quote from JedRothwell

Sure it is. Not conclusive perhaps. It may be caused by confounding effects. But there is a clear correlation between positive ivermectin results and populations known to be infested with worms. In many cases, the worms are not diagnosed. There are reportedly hundreds of millions of cases in India. So I think it is highly likely there are undiagnosed cases in a blind test of ivermectin.

Furthermore, logically, if a correlation is shown in other studies, what could have caused it other than worms? Ivermectin has no other therapeutic value.

Jed,

I will stick with this one since you will be more capable of changing views than W.

Is there this correlation? Yes, of course

Does this correlation give us even low confidence of causality? No, it does not.

Could there be causality? Yes, of course.

Now, you are saying - well there is a hypothesised causal mechanism for this correlation (ivermectin + worms helps COVID mortality). That is true, but there is no reason for this hypothesis other than the correlation.

You are asking: how else could this correlation happen?

I agree - if there were no other way the correlation could happen then obviously the causal hypothesis looks strong.

There are very many other ways the correlation could happen, therefore the causal hypothesis is not strong.

All you need is some factor or set of factors that correlate with COVID outcomes and ivermectin and worm infestation.

In fact you don't even need that. Suppose random factors influence COVID outcomes. It is pretty easy to cherry-pick data showing whatever correlation you like. You would need to be sure somehow that the specific methodology used that shows this correlation was not retro-fitted.

Just to give some idea: there are known strong causal mechanisms between all of:

U. under-development

P. low average age of population

W. worm infestation

H. lack of modern healthcare (ICU etc)

I. ivermectin supply as COVID therapeutic

C. good COVID recovery rates

They go like this:

U -> P (known demographic trends)

U -> H (known feature of under-development)

H -> I (doctors want to do something, and if there is no other healthcare a very cheap pill that might help will be almost irresistible)

P -> C (the exponential mortality/age relationship)

U -> W (underdevelopment => lack of good water, sanitation, etc => worm infestation)

None of those (obvious) causal relationships involve any direct causal relationship between ivermectin, or worms, and COVID outcomes, they are however enough to explain correlations.

That is all guesswork - and possibly wrong. My point is that it is very easy for these confounding factors - which (particularly U) are very large for COVID, to generate correlations. Similarly, it is difficult to have enough data to rule out these confounding factors, or others not thought of: these are just examples. The best tools work well only on linear relationships, and the underlying causal mechanisms are often not linear.

It is - so to speak - a can of worms.

THH

Quote from JedRothwell

It is extremely unlikely any expert at the CDC is being paid off by Gilead. If found, that employee would go to prison for a long time, and his or her professional career would be over. He could only do menial jobs after getting out of prison. Most professional scientists are not willing to risk their careers for a payoff. Also, these people are middle class. They do not have huge houses. (I know this because some of them live in my neighborhood, which is middle class, and about 3 miles from the CDC.) Uncle Sam knows exactly how much money they are being paid. If they suddenly got more money, the IRS would probably notice.

Gilead officials would also get in trouble, and be sent to prison.

Unless you have some valid reason for thinking these people are being paid off, or you have read a news story alleging that, I suggest you refrain from saying things like this. Not because you will hurt the reputations of the CDC scientists -- that's not going to happen. But because saying things like that makes you look like a fool.

I find the whole social media conspiracy theory stuff about big pharma childish and annoying.

On the one had, of course they will push for their own drugs, and present evidence from their own trials etc in the best possible light. They have money to throw at trials. Luckily - high quality trials must be pre-registered with specified endpoints, must have well-defined transparent methodology, must have discussion of possible bias due to lack of blinding, etc. Not meeting those, or changing them, (without good reason) casts doubt on the reputation of those carrying out the trials. So if you stick to highest quality info the ability of big pharma to cherry pick is limited.

Regulators tend to be quite sticky - having recommended a drug it takes quite a bit to unrecommend it, and vice versa. Also, they are only human, a well-presented case from big Pharma will win out over a badly presented case + public PR campaign.

Does financial inducement come into this? Possibly, at the margins. We know how easily GPs have in the past been swayed by free stuff from pharma (the UK at least has strong ways to avoid that by using NICE). Equally, NICE was designed exactly to provide objective estimates of drug utility independent of pharma and it would be strange if a setup designed to do get genuine best practice guidelines independent of pharma pressure was much influenced by big pharma money. I can't comment on the US equivalents, because I don't know. NICE is well thought of as an example of best regulatory practice. And NICE (just about) still recommends remdesivir.

Are regulators always right? Obviously not, at the edge there will be uncertainty.

Is remdesivir helpful? Well:

• It is an antiviral and they tend not to be as good as you might expect.
• There is some highly positive RCT evidence, from a high quality early intervention trial run by the manufacturer (Gotlieb et al 6. from refs below).
• There is some profoundly negative (that is neutral) data from big third party RCTs.
• There is lab evidence that indicates - yes remdesivir does kill COVID at the levels it can safely be administered.
• The initial trial data leading to its recommendation was underwhelming.

Were I in hospital I'd not want it, in spite of current recommendations. I'd take it (if offered under supervision) as early intervention.

https://www.nejm.org/doi/full/10.1056/NEJMe2118579?query=recirc_curatedRelated_article

Compare that with ivermectin:

• There is profoundly negative (that is neutral) evidence from high quality RCTs.
• There is lab evidence indicating it has no effect on COVID at levels that can be safely used therapeutically (e.g. that are used by FLCC etc). In fact no effect even at levels much higher than can safely be administered.
• There is some highly positive RCT evidence of dubious quality but as far as I know none of the high quality 3rd party trials have been positive, and there are big ongoing ones, which is a negative.
• There is a whole mass of trial data, mostly positive, but with all the significant results moving to neutral as you move from lower to higher quality evidence.
• There is a massive fanatical PR campaign and at least one provably fraudulent highly positive and (for a while) influential big RCT, with one other big RCT untransparent and therefore similarly dubious
• Independent researchers in this area get social media death threats if they do not positively endorse ivermectin

It is pretty similar to remdesivir, with the difference that (as an antiviral) the lab evidence is much much more negative.

I'd not want it under any circumstances - don't like being guinea pig unless there is decent chance of the intervention working. It is pretty clear ivermectin does not function as an antiviral. It is a drug with complex interactions, so you cannot rule out it functioning in some other way. In that situation it does not help having proposed molecular pathways - you find those all over the place for everything. You need evidence from trials that it has some positive effect.

THH

But Ivermectin in India at least is never used alone. In Ziverdo medication it is always given with Zn and doxycycline which presumably boost its anti-viral action. The addition of HCQ or just natural quinine and quinidine would also from theoretical studies also give a booster, whereas compared to vaccine boosters would seem to be much more effective. But we await the full Anti-Bat double blind data.

Quote from Dr Richard*

But Ivermectin in India at least is never used alone. In Ziverdo medication it is always given with Zn and doxycycline which presumably boost its anti-viral action. The addition of HCQ or just natural quinine and quinidine would also from theoretical studies also give a booster, whereas compared to vaccine boosters would seem to be much more effective. But we await the full Anti-Bat double blind data.

It's a freaking cold virus now, get some hot and sour soup,

Israel Investigational Therapy Improves All Patient’s COVID-19—Looks like a Powerful Potential Therapy from Israel

Israel Investigational Therapy Improves All Patient’s COVID-19—Looks like a Powerful Potential Therapy from Israel

Amorphical is an Israeli biotech venture launched in 2004 developing novel solutions that target a number of diseases. They have progressed

trialsitenews.com

Amorphical is an Israeli biotech venture launched in 2004 developing novel solutions that target a number of diseases. They have progressed investigational products developing treatments based on naturally rare forms of calcium used by nature’s most “sophisticated calcium-producing machine” called the blue crayfish to develop uniquely bioactive manometric compositions named Amorphous Calcium Carbonate (ACC). During a Phase 2 clinical trial, the company reports that all 18 hospitalized patients were given the treatment. All 18 of the study participants received the drug known as Amor-18.

The study participants in the study drug arm did very well while the 19 participants in the placebo arm did far less—six of them had to be transferred to intensive care and two died, reports the Jerusalem Post. Two patients in serious condition were granted access to the study via compassionate care.

The Drug

Amor-18 as reported by multiple Israeli media including the Jerusalem Post uses the biotech company’s ACC as the primary inputs for this orally or inhaled therapeutic that can modulate acidic pH changes on a cell by cell basis. As the drug impacts these pH changes it becomes harder for COVID-19 to enter the cell, let alone replicate. Thus the drug is helping to stop the pathogen from progressing into a more severe infection.

The Study

This phase 1/2 study (NCT04900337) initially targeted 100 participants and included two parts including 1) a training period of a single-arm active treatment open-label of assessing the optimal method of study drug administration not to mention the review of the safety of the combination administration on five (5) patients and 2) once DSMB review of the collected data in the first part of the study leads to an authorization the study commences to the next phase involving a randomized (1:1) placebo-controlled two-arm study involving up to 95 participants.

The whole study period per patient will be 22 days (21 treatment days) or until the patient has recovered and/or is discharged from the hospital, whichever comes first. The study according to the disclosure in Clincialtrials.gov also involved Tel-Aviv Sourasky, Shamir MC, and Ziv Medical Center.

The Results

Yossi Ben, CEO of Amorphical went on the record, “We are excited about the results of the clinical trial, which would bring real hope to COVID-19 patients in Israel and around the world, and are especially encouraging three days with the start of the fifth wave of the Omicron variant.” The CEO went on to declare the drug can inhibit the entire family of SARS-CoV02 variants.

The Trial Site Locations

In Israel, the clinical trial was conducted at Ziv Medical Center in Safed while a new and larger study is conducted now at Zif Medical Center, Shamir, Kaplan, and Mayanei Hayeshua medical centers.

Moreover, the company reports they will be expanding trial site locations to Brazil and soon centers in Europe and the United States.

Dr. Nashat Abu Saleh, co-director of the coronavirus department, Ziv Medical Center reports “Since the patients treated with the drug recovered within a few days and were released toothier home, this was 100% successful.”

Lead Research/Investigator

∙ Dr. Nashat Abu Saleh

∙ Kamal Abu-Jabal, MD, Ziv Medical Center

∙ David Zeltser, Tel-Aviv Sourasky MC

∙ D. Ronit Zaidenstein, Shamir MC

Call to Action: The study is expanding to Europe and America

Trial: Israeli drug prevents 100% of COVID-19 patients from deterioration

All 18 hospitalized individuals administered the treatment developed by Israeli biotech company Amorphical in a phase II trial recovered and were discharged in…

m.jpost.com

University of Minnesota PI Submits EUA Application to FDA for Fluvoxamine

University of Minnesota PI Submits EUA Application to FDA for Fluvoxamine

The University of Minnesota’s David Boulware went on the record that he went through the process of submitting an Emergency Use Authorization (EUA)

trialsitenews.com

The University of Minnesota’s David Boulware went on the record that he went through the process of submitting an Emergency Use Authorization (EUA) application for fluvoxamine to the U.S. Food and Drug Administration (FDA).

While the Professor of Medicine, Division of Infectious Diseases and International Medicine at the University of Minnesota recently discussed the promise of the Pfizer antiviral called PAXLOVID, he notes that the medicine isn’t available today and that the FDA has only authorized it for use by those classified as high-risk unvaccinated people or persons with weak immune systems. But there are so many other needs during this pandemic.

He notes the third option in a University of Minnesota press release—fluvoxamine declaring that the SSRI “based on two randomized trials” offers a 30% reduction in hospitalization or lengthy emergency department visits. The academic medical center principal investigator declared, “On December 21, I submitted an application to the FDA requesting Emergency Use Authorization (EUA) to recognize its clinical benefit.” Boulware declared he hopes that his action will lead to a response by the regulatory body in the form of guidance, which could spur physicians to embrace the low-cost, available repurposed drug.

Hi-tech entrepreneur Steve Kirsch founded the COVID-19 Early Treatment Fund (CETF) during the early part of the pandemic to fund early treatment studies. Thanks to Kirsch’s early funding, studies at Washington University School of Medicine in St. Louis, and then the TOGETHER trial led by Edward Mills, this repurposed drug now should be authorized for use against COVID-19. Dr. Michael Goodkin, a member of the TrialSite advisory committee has issued a statement to the Infectious Disease Society of America (IDSA): why haven’t they accepted fluvoxamine?

Some front-line physicians and medical specialists believe that up to 85% of the lives lost during the pandemic in America alone could have been saved with early treatment options.

The University of Minnesota continues a nationwide early at-home treatment trial testing fluvoxamine and other existing medicine.

COVID drug treatments

University of Minnesota Medical School expert David Boulware speaks about the relevance and impact of drug treatment for COVID-19

twin-cities.umn.edu

Home | COVID-OUT: Outpatient Treatment for SARS-CoV-2 Infection, a Factorial Randomized Trial

Existing vaccines are incapable of protecting against Omicron, say scientists

Existing vaccines are incapable of protecting against Omicron, say scientists

The existing Covid-19 vaccines are unable to protect people against the Omicron variant even with a…

www.donga.com

The existing Covid-19 vaccines are unable to protect people against the Omicron variant even with a booster dose, a new study suggests.

According to foreign media reports, the neutralizing capability of antibodies induced by two-dose vaccination with the Pfizer, Moderna, AstraZeneca and Janssen vaccines are significantly inferior against the Omicron variant, according to the study published on Thursday in the journal Nature. Antibodies created in people who recovered from natural Covid-19 infection showed even weaker neutralizing capability. That is, both people who recovered from natural Covid-19 infection and those who are fully vaccinated are still exposed to the risk of Omicron infection

Based on the results, the U.S. scientists predict that the vaccines will not provide sufficient protection even with a booster dose. “It is desirable to take the booster jab because this will strengthen immunity to a certain extent, but it would be inefficient to protect against Omicron infection,” said David Ho, a professor of microbiology and immunology at Columbia University medical school who led the study. “Monoclonal antibody treatment,” which is isolated to bind only with viral antigens was virtually ineffective in treating the omicron variant as well.

The U.S. research team said they have discovered additional mutations dodging antibodies in spike proteins of the Omicron variant. “Omicron avoids neutralizing antibody in the most effective way among the existing Covid-19 variants,” the team said.

Jong-Yeob JO [email protected]

Talking point

Why "any U.S. company would allow such interference" by entering into a shared patent agreement with the DoE or DoD?

Google has!

Why?

...asking for a high five and some compliments.

When I posted an article about Google Inc pursuing cold fusion energy I predicted correctly.

That Google would...

"...develop the technology, through the commercial LENR reactor design phase"

PATENTING

"...in the security of a DoD lab."

The DoE and DoD are co-joined at the hip in matters of national security in regards to energetics -gbgoble

Quote

source

Recent Google Inc LENR Energy Technology Patents

Published on February 12, 2019 https://www.linkedin.com/pulse…regory-goble/?published=t

Skill-Set and History of the Inventors of the Google LENR Patents

‘Google’ is pursuing an alternate LENR energy technology pathway. The work is being done by a group out of Munday Labs at the University of Maryland. Last year Munday Labs received a lucrative DoD contract for two years of continued research. It makes sense that Google Inc. might develop the technology, through the commercial LENR reactor design phase, in partnership with a private industrial laboratory group in the semi conductor or nano technology industries

or in the security of a DoD lab.

Quote from THHuxleynew

Now, you are saying - well there is a hypothesised causal mechanism for this correlation (ivermectin + worms helps COVID mortality). That is true, but there is no reason for this hypothesis other than the correlation.

There are other reasons for this hypothesis. It is well known that a large number of people in India suffer from parasites. I have seen estimates that over 100 million people do, or more than 1 in 10. In a random sample of patients, including poor people, you are bound to have some patients with undiagnosed cases. It is well known that parasites increase the severity of disease and the likelihood of death. Furthermore, the populations in the other countries with a positive correlation shown in the Bitterman graph, Bangladesh, Malaysia and Columbia, also have parasites. Countries without many parasites have a negative correlation, or zero correlation. So, I agree with Bitterman that this is a likely cause. It is not certain by any means, but there is more than mere positive and negative correlation. There is also a simple and rather easily tested hypothesis that makes sense in medical terms. It is very unlikely ivermectin has any antiviral effect at these doses, but it is certain that it has an anti-parasitic effect.

Small study suggests Omicron antibodies could provide immunity against Delta too

South African data, not yet peer-reviewed, comes from 13 cases; researchers can't definitively say neutralization of Omicron not due to vaccination or previous infection

Small study suggests Omicron antibodies could provide immunity against Delta too | The Times of Israel

A small South African study released Tuesday shows that Omicron infection may enhance immunity against the Delta variant of the coronavirus.

The research, which has not yet been peer-reviewed, initially examined 15 people, some vaccinated and others not, who were infected with Omicron.

The scientists then took samples to see if those people would be able to neutralize Omicron and Delta 14 days later. Two cases were excluded from the study at this stage due to a lack of ability to neutralize Omicron at either the start or end of the research.

Scientists found in the remaining 13 cases a 14-fold increase in ability to neutralize Omicron, as well as a 4.4-fold increase in ability to neutralize the Delta variant of the virus.

The study noted that some of the participants were vaccinated and many were also likely to have been previously infected with an earlier strain of the virus, meaning that the neutralization of Delta could not be definitively attributed to the Omicron infection.

“Participants in this study have likely been previously infected, and more than half were vaccinated. Therefore, it is unclear if what we observe is effective cross-neutralization of Delta virus by Omicron elicited antibodies, or activation of antibody immunity from previous infection and/or vaccination,” the study said.

Seven of the individuals in the study were vaccinated — three with two doses of Pfizer, three with one dose of Johnson & Johnson, and one with two doses of Johnson & Johnson.

Eleven of the original 15 participants were hospitalized for COVID-19, but none required supplementary oxygen treatment.

The study was led by Alex Sigal, a researcher at Africa Health Research Institute who was born in the then-Soviet Union and grew up in Israel, where he studied at the Weizmann Institute of Science in Rehovot.

“The increase neutralizing immunity against Omicron was expected — that is the virus these individuals were infected with,” Sigal tweeted. “However, we also saw that the same people — especially those who were vaccinated — developed enhanced immunity to the Delta variant.”

The research, which has not yet been peer-reviewed, initially examined 15 people, some vaccinated and others not, who were infected with Omicron.

The scientists then took samples to see if those people would be able to neutralize Omicron and Delta 14 days later. Two cases were excluded from the study at this stage due to a lack of ability to neutralize Omicron at either the start or end of the research.

Scientists found in the remaining 13 cases a 14-fold increase in ability to neutralize Omicron, as well as a 4.4-fold increase in ability to neutralize the Delta variant of the virus.

The study noted that some of the participants were vaccinated and many were also likely to have been previously infected with an earlier strain of the virus, meaning that the neutralization of Delta could not be definitively attributed to the Omicron infection.

“Participants in this study have likely been previously infected, and more than half were vaccinated. Therefore, it is unclear if what we observe is effective cross-neutralization of Delta virus by Omicron elicited antibodies, or activation of antibody immunity from previous infection and/or vaccination,” the study said.

Small study suggests Omicron antibodies could provide immunity against Delta too

Scientists at the Africa Health Research Institute in Durban, South Africa, work on the Omicron variant of the COVID-19 virus, Dec. 15, 2021 (AP Photo/Jerome Delay)

Seven of the individuals in the study were vaccinated — three with two doses of Pfizer, three with one dose of Johnson & Johnson, and one with two doses of Johnson & Johnson.

Eleven of the original 15 participants were hospitalized for COVID-19, but none required supplementary oxygen treatment.

The study was led by Alex Sigal, a researcher at Africa Health Research Institute who was born in the then-Soviet Union and grew up in Israel, where he studied at the Weizmann Institute of Science in Rehovot.

“The increase neutralizing immunity against Omicron was expected — that is the virus these individuals were infected with,” Sigal tweeted. “However, we also saw that the same people — especially those who were vaccinated — developed enhanced immunity to the Delta variant.”

Small study suggests Omicron antibodies could provide immunity against Delta too

South Africa–based virologist Alex Sigal poses in his office at the Africa Health Research Institute in Durban, South Africa, Dec. 15, 2021 (AP Photo/Jerome Delay)

Sigal said that if Omicron causes less severe disease, as researchers are cautiously saying, then the newer variant could help to displace Delta as the dominant strain if those infected with Omicron are then less likely to catch the earlier variant.

“If that’s true, then the disruption COVID-19 has caused in our lives may become less,” he said.

Sigal’s research from South Africa, where Omicron was first identified, has been at the forefront of preliminary understanding about the highly contagious variant.

Eran Segal, a computational biologist from the Weizmann Institute and one of the top advisers to Israel’s coronavirus cabinet, said it was “important” research.

“The expected large number of people infected with Omicron in Israel and around the world may therefore significantly increase the level of immunity of the entire population and help eradicate Delta and at least some of the other variants,” Segal tweeted.

The research came after two studies from Britain published last week showed COVID infections with Omicron are less likely to result in hospitalization compared to the Delta variant, the latest research confirming a trend first identified in South Africa.

The preliminary studies — one paper from Scotland and the other from England — were cautiously welcomed by experts, who nonetheless stressed that any advantage in milder outcomes could still be negated by the new strain’s heightened infectiousness, which may still lead to a greater number of severe cases overall.

Neither of the studies has been peer reviewed, but they add to growing evidence about disease outcomes with Omicron.

It remains unclear whether the decreased rate of severe cases seen with Omicron is because of characteristics of the variant, or whether it appears milder because it is coming up against populations with greater immunity from prior infection and from vaccination.

AFP contributed to this report.

Quote from Fm1

The University of Minnesota’s David Boulware went on the record that he went through the process of submitting an Emergency Use Authorization (EUA) application for fluvoxamine to the U.S. Food and Drug Administration (FDA).

The effect of fluvoxamine is quite small compared to other drugs like Ivermectin++ Nitazoxanide++ budenoside etc... But at least it cost almost nothing...The iodine treatment of FLCCC is a real game changer as nobody can block this!

Switzerland numbers still go up with Omicron anywhere between 60..90%. But hospital rate is more or less flat. Here in Zürich is going down despite double cases.

covid_19/COVID19_Fallzahlen_Kanton_ZH_total.csv at master · openZH/covid_19

COVID19 case numbers of Cantons of Switzerland and Principality of Liechtenstein (FL). The data is updated at best once a day (times of collection and update…

github.com

Our positive rate is 21% https://www.covid19.admin.ch/de/overview

Compared with UK positive rate this indicates we have about 80'000 cases a day now. Found 13'000.

Are Governments Ready to Embrace Flexible, Risk-based Approaches to Vaccination in Response to COVID-19?

Are Governments Ready to Embrace Flexible, Risk-based Approaches to Vaccination in Response to COVID-19?

Marty Makary, MD, MPH, remains one of the most prominent critically thinking public health experts during this pandemic. A staunch supporter of COVID-19

trialsitenews.com

Mary Makary, MD, MPH, remains one of the most prominent critically thinking public health experts during this pandemic. A staunch supporter of COVID-19 vaccination, Dr. Makary, a prominent surgeon and editor-in-chief of MedPage Today, also raised the importance of balanced, more unbiased scientific reasoning, often making declarations that haven’t been popular with the dominant government and industry-driven pandemic narrative. For example, Makary has argued that a proper risk-benefit analysis should accompany any mass COVID-19-focused pediatric vaccination drive. Now the surgeon and researcher affiliated with Johns Hopkins University shares with the world concerns about indiscriminate booster campaigns—raising the specter of possible harm associated with such a one-size-fits-all approach embraced by the current U.S. executive branch and its scientific advisors.

While the government, backed by industry and all-too-willing academician advisors (undoubtedly hopeful of more public grants and other financial benefits) continue to promote the full acceleration of mass booster programs, little to no mainstream discussion appeals to the negative side of the health-related ledger: what are the side effects of these vaccines? What about long-term risks? Of course, little is known about long-term health impacts because these products are so new. They have only been in use in the population for about a year. Often, it can take a handful of years before the true health risks associated with medicinal products materialize. But perhaps a glimmer of awareness shines through with growing chatter about vaccination risks alongside all-encompassing benefits.

Recently Makary shared a message from Vinay Prasad, MD, MPH, who introduces a new paper in Nature uncovering differing adverse event risk factors by vaccine product.

Led by corresponding author Julia Hippisley-Cox from the University of Oxford, the study shares how the risks for conditions such as myocarditis and pericarditis are very real, despite the initial clinical trial results.

The self-controlled case series study targeting vaccinated people 16 years of age and up in England analyzed cardiovascular adverse event incidence by vaccine product, including AstraZeneca/Oxford (ChAdOx1), Pfizer-BioNTech (BNT162b2), and Moderna (mRNA-1273).

The study authors discovered that the risks for myocarditis increase under the following conditions:

∙ After the first dose of AstraZeneca and Pfizer

∙ Subsequent to the second dose of Moderna over the 1–28-day post jab period

∙ Following a SARS-CoV-2 positive test

More specifically, according to this real-world data, myocarditis risks increases by the following:

Vaccine Extra myocarditis event per/1 million Stats

AstraZeneca 2 95% confidence interval (CI) 0, 3

Pfizer-BioNTech 1 95% CI 0, 2

Moderna 6 95% CI 2, 8

The authors reported these outcomes for 28 days following a first dose and an extra ten (95% CI 7, 11) myocarditis events per 1 million vaccinated in the 28 days after a second dose of mRNA-1273. In comparison, they find an extra 40 (95% CI 38, 41) such cardiovascular events per million 28 days after preliminary test indicating risks associated with COVID-19 itself. Indicating that overall vaccination could be less risky—but that precludes important subgroup analysis.

The UK-led study extends a growing study literature investigating COVID-19 vaccine-associated adverse events. In this case, significantly so, based on an analysis of 38 million adults in England receiving both the mRNA-based vaccines as well as the AstraZeneca product (adenovirus-mediated vaccine).

The study team discovered heightened myocarditis risk in subgroups (e.g., males under 40) as well as temporal association indicating risks after both the first and second jabs within a seven-day period post-vaccination.

The authors declared, “The excess risk was observed in men and women but was only consistently observed following both mRNA vaccines in those younger than 40 years.” The authors qualify that fewer people under 40 received the mRNA-based vaccines however other national health authorities have already acted, unbeknownst to most of the North American public.

Vaccine Limitations

Dozens of national health authorities have established parameters for vaccination during this unprecedented mass vaccination program. TrialSite provides some examples below that rarely make it into mainstream media in places like the United States, Canada, and even England.

Moderna

Due to heightened risks associated with mRNA-1273 for myocarditis and other events, numerous counties have placed either temporary or permanent restrictions on the use of this novel COVID-19 vaccine product.

TrialSite has reported how all the Scandinavian nations (Denmark, Sweden, Norway, Finland, and even Iceland) have imposed limitations on access to this vaccine. In summary, health authorities in these nations have declared that the risks of cardiovascular-related events are too high for younger people, especially young males. TrialSite notes Moderna’s share price has been on a downward trend as reported by Yahoo Finance. Could traders have known something many others don’t?

AstraZeneca

Numerous nations placed holds, some permanent, some temporary, on this vaccine as TrialSite has reported ongoing. Even Wikipedia is updated on the “Suspensions” associated with this vaccine that had so much promise (more economical, easier to distribute, etc.).

This is not to say that this vaccine hasn’t helped in the war against COVID-19 but the health-related costs associated with the novel product are real. Numerous nations in Europe, not to mention South Africa, Canada, Indonesia, and Australia placed suspensions at one point or another due to safety concerns such as blood clotting and low blood platelets. Still authorized by Europe and other authorities, many nations however transition from a one-size-fits-all approach to a more tailored, risk-based approach to vaccination. Remember, the USA completely stopped the AstraZeneca vaccine program.

More Data from Oxford-led Follow-on Study

Back to the mRNA-based vaccines and the most recent Oxford-led study in the preprint (this means it shouldn’t be used for making definitive claims). Males under 40 years of age face a higher risk with the vaccines from Pfizer-BioNTech and Modena than actual COVID-19 infection, thus raising concern that a rigid, one-size-fits-all approach to COVID-19 vaccination should be supplanted with a more tailored, precise approach. After all, that follows the trend in the science of medicine anyway.

Dr. Prasad discussed the limitations of the former peer-reviewed (Nature) study as the exact number of vaccines were known while the actual number of SARS-CoV-2 infections wasn’t certain at all. But with known limitations, he referred to the Oxford-led authors’ updated point of view uploaded to medRxiv for further clarification.

In this update, the authors found a heightened risk of myocarditis following one to 28 days after the third booster dose of Pfizer’s BNT162b2 (IRR 2.02, 95%CI 1.40, 2.91). Not surprisingly, the risks were highest in males aged 40 and under with all vaccines with the various observations in the updated study:

Myocarditis AE events per million est. 1-28 days post first dose

Vaccine Additional event per/1 million Stats

Pfizer-BioNTech 3 95%CI 1, 5

Moderna 12 95% CI 1,17

What about additional adverse events post the second dose?

Vaccine Additional event per/1 million Stats

AstraZeneca 14 95%CI 8, 17

Pfizer-BioNTech 12 95%CI 1, 7

Moderna 101 95%CI 95, 104

Pfizer boost vs. COVID-19 infection

Vaccine Additional event per/1 million Stats

Pfizer 13 95%CI 7, 15

COVID-19 Infection 7 95%CI 2, 11

The authors report that while the risk of myocarditis is very real for those sick with SARS-CoV-2, the risk-benefit analysis contributes to a reasonable position against vaccination of people 40 and under. But why aren’t governing health authorities discussing this science? Dr. Prasad asks publicly why health authorities aren’t and associated political representatives are re-adjusting the “risk radar?”

Medicine is nuanced as Prasad declares and in his point of view “Profit, greed, and power…not so much!!” TrialSite suggests some truth in this argument—the evidence of some forms of regulatory capture is present during this pandemic. TrialSite has accumulated a vast trove of study results, news stories, and various analyses pointing in this direction. Moreover, the level and type of information suppression indicate some forms of collusion between government, industry, and the largest media corporations.

Industry received considerable incentive to develop products and should be held accountable when public finances are involved. Yet they also take on enormous risks—the drug development process is complex, time-consuming, and financially risky. TrialSite suggests for those that seek reform to better understand deeper, more systemic forces are at play during the pandemic including intense investor demand for high returns.

The pharmaceutical industry shouldn’t be unilaterally vilified but also must be held accountable as should public health authorities and government embrace the comprehensive, unfolding science—not just a subset of data or evidence to back a convenient narrative.

TrialSite continually educates that the pharma companies operate in a system that economically and financially punishes executives and their talent for failing to shrewdly exploit financially any rich, fertile profit conditions such as COVID-19.

On the other hand, a balance can be achieved if regulatory and executive branch agencies behave and act independently with the public interest as a goal. Hence the risks and dangers of regulatory capture. But what happens when government and industry get too cozy? Known by some as “Crony Capitalism,” this involves a move away from free-market ideals mitigated by independent and objective regulators to an intertwined dynamic, vulnerable to bias and even corrupted practices.

The pandemic exposed system vulnerability in pandemic response, including a tendency or impulse for some Western governments and health authorities to lean toward authoritarian-centric responses while not only ensuring windfall profits for the winners at the expense of at least some public health considerations. An example would be the ongoing imposition of PREP Act liability shields despite widespread mandates. What happened to consumer rights activism?

Some could argue the growing polarization in places like America only worsened the situation, conflating politics with the economy and public health. However, no orthodoxy, regardless of paradigm or hypothesis, will hasten the demise of the pathogen other than an objective, science- and evidence-driven approach factoring in real-world unfolding and ongoing intelligence. Suppression of data that contradicts or raises questions about the dominant narrative only worsens social and political divides leading to new forms of crises that governments seek to manage, most of the time unsuccessfully

Quote from Fm1

Males under 40 years of age face a higher risk with the vaccines from Pfizer-BioNTech and Modena than actual COVID-19 infection,

10 per 100,000 risk from Moderna vs 1/100,000 from Cov-2 for males < 40

https://www.medrxiv.org/content/10.1101/2021.12.23.21268276v1.full.pdf

Note the risk from Omicron of myocarditis is unknown

but it is likely to be much less than the risk to Pfizer's profits..