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Heliobas Disciple

TB Fanatic
(fair use applies)


Thailand study of young adults post jab showed nearly 30% with cardiovascular injuries
It is amazing what you find when the people doing the study are honest.

Steve Kirsch
18 hr ago


Executive summary

A new study on cardiovascular impacts of the COVID vaccines done in Thailand is particularly troubling: 29% of the young adults experience non-trivial changes in their cardiac biomarkers.

It is amazing what you find when scientists doing a study are honest and want to know the truth.

“Why isn’t a study like this being done in the US?” asks UCSF Professor Vinay Prasad.

Heck, we don’t even know the d-dimer of people before vs. after the vax.

This is just more evidence of corruption of the medical community that nobody was calling for any of this data.

These vaccines are a disaster. Every day, the evidence gets worse and worse.

Will this new study stop the vaccines for kids? Of course not!

Look, even if the shots killed every child under 20 who takes it, they’d write off the death to something else and recommend that kids get the shot. The brainwashing is that bad. It’s stunning. Facts do not matter.

Note: This was originally buried in my Fox justification article but it's important enough to call out in a separate article.


The Thailand study

Consider this Thailand study:

https%3A%2F%2Fbucketeer-e05bbc84-baa3-437e-9518-adb32be77984.s3.amazonaws.com%2Fpublic%2Fimages%2F84f00bc6-444d-4b4a-9eff-fc238a30a1d5_606x740.png


18% of kids had an abnormal EKG post-vaccine?!? That has to be extremely troubling. A vaccine is not supposed to do that. Are doctors telling parents the vaccine causes serious heart issues in 18% of kids? At least let them know.

The paper noted that “Cardiovascular effects were found in 29.24% of patients, ranging from tachycardia, palpitation, and myo/pericarditis.” Wow.
Almost 30% of the cases?!?! That’s not “rare.”

Finally a 3.5% rate of myo/pericarditis (including subclinical) among males 13-18 is not rare either. We were lied to by the CDC. Big time.

Interestingly, this is consistent with the number of myocarditis rates at Monte Vista Christian School in Watsonville, CA which was in excess of 1% but they wouldn’t reveal any of the details beyond that publicly; gotta keep the school safe from lawsuits. Major credit there goes to Head of School Nikki Daniels for making sure that nobody found out that the shots they gave at the school were hurting kids. When adverse reactions started showing up, they did the right thing: they kept their mouths shut.
.
 

Heliobas Disciple

TB Fanatic
(fair use applies)


The Thailand myocarditis study, briefly
3.5% of boys show evidence of pericarditis or myocarditis after the 2nd dose of the Pfizer/BioNTech Covid vaccine. (A belated recap.)

Brian Mowrey
9 hr ago

Although Vinay Prasad has already provided a somewhat-punch-pulling recap of the preprint study from Thailand,1 it hadn’t received a lot of attention in the more anti-mainstream edges of the substack ecosystem. This changed a few hours ago with a somewhat-too-sensational Steve Kirsch post.2 My overview is at best a “middle-chair” summary at this point.

Still, it would be odd not to offer a take here, given that this journal keeps the myocarditis issue on the radar generally,3 and this study is groundbreaking in that it shows rates of post-mRNA-injection myocarditis in teens captured by actual screening, eliminating under-reporting and capturing subclinical (non-symptomatic) heart damage. And so here goes.

The Set-Up​

The study:4


Mansanguan, S. et al.

314 teens already first-dosed with the Pfizer/BioNTech Covid vaccine (BNT162b2), and without prior cardiac issues or adverse reactions, were tested for cardiac markers before and then 3 and 7 days after receipt of the 2nd dose (and again if presenting with cardiac symptoms). Emphasis added:

High-sensitivity cardiac troponin-T assay (HS-cTnT) and CK-MB isoenzyme levels were determined for all participants at baseline, and on Day 3, Day 7 and Day 14 (optional) after the second dose vaccination. HS-cTnT was measured using the Elecsys troponin-T hs assay (Roche Diagnostics, Mann- heim, Germany); serum levels > 14 ng/L were considered elevated.

“Elevated” troponin, in the context of suspected myocarditis (i.e., not in the context of a heart attack or sepsis or other obvious trauma), clinches the diagnosis.

Not only does this study screen for myocarditis, to find cases in teens that would otherwise be missed in a clinical setting, it also collects a baseline measurement to observe the change driven by the mRNA injection. This makes it a first.

For context, previous estimates of post-Covid-vaccine-dose-2 myocarditis have been implausibly low. Even the values derived by Hoeg, et al. - which set off a firestorm of MD-twitter criticism by almost doubling the CDC’s official rate5 - are minuscule when converted to percentage form.


Høeg, TB. et al. Fig 1.
“.016%” is not what the Thailand study found.


3.5% Peri/Myocarditis in teen boys​

Minus 13 subjects lost to follow-up, there were 99 girls and 202 boys tested this way overall. No girls presented with cardiac complications or threshold-defined “elevated” troponin-T findings. 3 boys presented with symptoms and an additional 4 were flagged for elevated troponin-T (following a normal baseline).

https%3A%2F%2Fbucketeer-e05bbc84-baa3-437e-9518-adb32be77984.s3.amazonaws.com%2Fpublic%2Fimages%2Ff3bc9068-c361-406f-95f6-c21033686b3b_1612x997.png

Mansanguan, S. et al. Table 3 (click to expand; a recent monitor upgrade has me realizing my images are hard on the eyes when not using retina-style displays, oops)

Using the 14 pg/mL threshold, the combined (clinical and subclinical) rate of myocarditis is 2.5% for all boys observed. This rate is similar in both the 13-15 and 16-18 age groups. Separately, the pericarditis rate is similar in both age groups as well. This consistency is impressive, despite the hazard of extrapolating from only a handful of events.

Expected background rate?​

Of course, studies which do not include controls burden the reader with having to bring their own knowledge of the expected background rate of whatever is being measured; in this case subclinical myocarditis in teen boys in Thailand. Naturally, each subject’s visit 1 (baseline) value serves as a self-control: They are not showing elevated troponin-T before the 2nd dose; and near-or-above-14 results are returned on both post-dose visits for each boy afterward.

Additionally, the lack of any over-threshold results among the 99 girls serves as a control in the context of this specific study’s assay (Roche Elecsys6) and method. By definition, "background rates" for any threshold on a given assay vary with the population being tested - but the results among girls demonstrate that a return of 0 is possible (even after mRNA injection). In a population of healthy7 boys with sub-14 baseline values, it seems safe to treat the expected background rate as 0.

Un-measured 1st dose effects​

Because the study intervenes on subjects who have already received 1 dose, “baseline” values provide a muddy picture of true before-mRNA-injection levels vs. already-fading cTnT release from dose-1-induced cardiac damage. As illustrated by subject 1 in Table 3 above, cTnT tends to linger in serum for over a week, due to slow breakdown (proteolysis).8 Depending on the duration of cell damage induced by mRNA-vaccination, cTnT elevations after the 1st dose may be sustained for longer than after an acute event (due to continual release).

It could thus certainly be the case that the baseline values in Table 3 offer a glimpse of post-dose-1 subclinical myocarditis (implying that immune sensitization is not the primary etiology for myocarditis, which is what I am inclined to believe; instead, damage during dose 1 merely raises the baseline of damage and patient awareness so that additional damage is more likely to advance from a subclinical to a clinical level).

In Table 3, subject 4 may be an example of lingering high troponin-T from the first dose (some sources cite anything above 4 pg/mL as being above-normal, which would throw in subjects 3 and 69). However, accuracy thresholds for high sensitivity assays cut off at these lower levels, as will be discussed below.

Still just the tip of the iceberg?​

Notably, the sub-14 troponin-T values for subjects 4 and 7, on day 3 (visit 2), are still above baseline. It would be irrational for an observer to not consider those results to be associated with and still reflect the release of troponin induced by the 2nd dose.

The numbers on Day 3 may not reach the chosen threshold, but they still reflect damage and destruction of heart cells.

Likewise, all sub-threshold elevations in the remaining 294 teens in this study, were these values presented (they aren’t), could appropriately be interpreted in the context of them having just received the same poison. While “14” serves as a proxy for the accuracy of the test (Roche pegs the “CV” for their assay at 13pg/mL; implying that results below that value are more likely to include noise), it doesn’t define how many killed cells in a teen’s heart it takes to induce the short- or medium-term risk of a cardiac event, or to shave years off their eventual lifespan.

Moreover, a general rise in troponin-T (if it were included in the presented data, which it isn’t) in a large sample would by definition indicate the effect of the 2nd dose beyond the noise of the assay at sub-14 values.

The following example recycles the baseline values from Table 3. This allows for the semi-arbitrary designation of a new “above-normal” threshold (in these teen boys, in this assay) of 8. The rate of induced-high-ness is simply the number of 8-or-highers after minus the number before:


A similar evaluation of the raw data for the Thailand study should make it possible to judge the true rate of subclinical (and clinical) myocarditis - and it may be well over the 2.5% value derived here, for both male and female teens. (Additionally, if any subjects were excluded because of cardiac issues arising after the first dose, or if any were lost to follow-up due to issues after the second, these should also be factored in.)

18% Abnormal ECG?​

Such a process might yield a result exactly in accordance with the findings for electrocardiogram “abnormalities.” If these were further shown to be consistent by sex - for example, if 40 more boys had above-8 cTnT and 40 boys had abnormal electrocardiagrams, compared to 14 girls - it could be neatly demonstrated that the findings for ECG abnormalities were driven by the mRNA injections.

Otherwise, it is difficult to put too much stock into the ECG results. They seem alarming, but may not reflect the effect of the BNT162b2 injection as opposed to background noise or something about the setting of the tests:

After vaccination, ECG revealed that of the 301 patients, 247 (82.06%) had normal sinus rhythm, while an abnormal ECG finding was noted in 54 patients (17.94%)


https%3A%2F%2Fbucketeer-e05bbc84-baa3-437e-9518-adb32be77984.s3.amazonaws.com%2Fpublic%2Fimages%2Fece061e0-6547-422d-b5c0-062ba5d9e91e_967x454.png

Mansanguan, S. et al. Table 4

Even if these cardiac abnormalities are induced by BNT162b2, it could be via some more indirect and innocuous etiology. For example, fever (recorded for 50 patients) leading to disruption of the autonomic nervous system. Again, if this could be shown to match the “true” sex-dependent myocarditis rate in the raw data, it would have more weight as an indicator of cardiac harms over just “nerves.”

For now, the 2.5% rate for boys exceeding the troponin threshold is horrifying enough.



1 Prasad, Vinay. “What does the Thailand Myocarditis Study Teach Us?” (2022, August 13.) Vinay Prasad's Observations and Thoughts.
2 Kirsch, Steve. “Thailand study of young adults post jab showed nearly 30% with cardiovascular injuries.” (2022, August 16.) Steve Kirsch's newsletter.
Kirsch uses a reference in the abstract to “cardiovascular effects” being found in 29.24% of patients to support his headline. As noted in my analysis of the EGC-abnormalities section, most of these “effects” might not reflect injury, though the raw data would help make that clear.
3 See “Reversal.”
4 Mansanguan, S. et al. “Cardiovascular Effects of the BNT162b2 mRNA COVID-19 Vaccine in Adolescents.” preprints.org
5 See “Myo-Card Me a River.”
6 Elecsys® Troponin T high sensitive
7 As in, not being examined in the context of known cardiac issues, and those with such issues being excluded. Pre-existing conditions are listed in table 1.
https%3A%2F%2Fbucketeer-e05bbc84-baa3-437e-9518-adb32be77984.s3.amazonaws.com%2Fpublic%2Fimages%2Fca01cbc1-fad9-46cc-841e-07fe51cb37da_957x507.png

While “Patients who had a history of cardiomyopathy, tuberculous pericarditis or constrictive pericarditis and severe allergic reaction to the COVID-19 vaccine were excluded from the study,” no value is given for how many (if any) met that criteria and were excluded.
8 Daněk, J. et al. “Troponin levels in patients with stable CAD.” Cor et Vasa. Volume 59, Issue 3, June 2017, Pages e229-e234
9 Normal troponin levels: Healthy ranges and what high levels mean
A further reference point is Høeg, TB. et al.’s review, which found sub-14 medians in reported post-vaccine myocarditis (Fig. 3).
 
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Heliobas Disciple

TB Fanatic
View: https://www.youtube.com/watch?v=8ghdyIRg748
Thailand Myocarditis After Vaccine Study | What can we learn? | A Doctor and Professor Reflects
29 min 47 sec

Aug 13, 2022
Vinay Prasad MD MPH

Link to the full essay: https://vinayprasadmdmph.substack.com...



The substack article about this video:

(fair use applies)


What does the Thailand Myocarditis Study Teach Us?
Taking safety signals seriously is imperative; the US CDC & others have failed to do that
Vinay Prasad
18 hr ago

The goal of vaccination programs is to protect people from diseases as safely as possible. Vaccines and diseases are not supposed to have harms that are even in the same ball-park as each other; Vaccines are supposed to be much, much, much safer than the diseases they prevent or diminish. When it comes to an 80 year old who never had COVID19—back in Jan 2021— there is no doubt about it; the benefit of 2 doses of mRNA vaccines is orders of magnitude greater than any known or unknown risk, and should be pursued.

When it comes to young men— both past and present— the story is complicated and nuanced. As early as Feb 2021, we had reports from Israel that young men were experiencing myocarditis— an inflammation of the wall of the heart— after COVID19 vaccine administration. Preliminary figures varied but reports placed it in the 1/3000 to 1/5000 ballpark. Many were hospitalized.

That 1/3-5k ballpark is deeply concerning. Suddenly it was clear that myocarditis was a serious safety concern in this age/sex group that meant, we ought to make a concerted effort to lower harms in this group. Here are some things we could have done (either under the auspices of a randomized trial) or as part of a natural experiment.
  1. Just give 1 dose (it was clear dose 2 had much higher rates of myocarditis) and dose 1 provided the bulk of the protection against hospitalization. We could follow outcomes as part of natural experiments.
  2. Provided exemptions for people who had and recovered from covid or those with + nucleocapsid Ab. It remains unclear how much a 22 year old who had and recovered from COVID benefits from vaccination (with respect to clinical endpoints not Ab titers)
  3. Tested lower doses of the vaccine (Pfizer was 30micrograms/ Moderna 100mcg); we could have administered lower doses, spread the timing of the doses apart (other nations did this, we did it too late) and measured rates of hospitalization; This could have been done as part of a national effort led by CDC (Can you lower myocarditis with a lower dose & preserve most of the efficacy?)
  4. Banned the use of Moderna. It was clear that Moderna was associated with a higher rate of myocarditis, and other nations & Kaiser Portland moved swiftly against it.
  5. Set a higher bar for boosters in young men; as the 3rd dose can cause myocarditis and it is not clear how much this benefits them.
  6. Immediately stopped pushing doses in all adults who have had and recovered from Omicron, pending a new trial in this population.
Instead of taking any of these actions, which we suggested at the time, the public health community downplayed, gaslighted and mislead about the concern. Initially the CDC director said (in what must have been incorrect), “"We have not seen a signal and we've actually looked intentionally for the signal in the over 200 million doses we've given," Some ‘experts’ chose to report rates of myocarditis among all recipients lumping in 20 year old men with 80 year old women.

This is as colossally stupid as combining men and women to report ovarian cancer statistics.

Just as with Vaccine Induced Thrombocytopenia and Thrombosis caused by J&J, which I wrote about at the time, loud physician voices not trained in data-interpretation downplayed the concerns on social media. In the case of VITT, they said it was just like a blood clot in the leg (it isn’t), and in the case of myocarditis they repeated that it was “mostly mild” and had to occur less often than myocarditis post infection. Of course, for a 22 year old man who already had 1 dose of Moderna, it was clear that he had 2 choices going forward (a) breakthrough or (b) breakthrough after the 2nd dose. The latter path certainly has a higher rate of myocarditis than the former.

Many doctors missed the plot: the purpose of talking about myocarditis is not to be critical of vaccines— they are a tremendous good— but to take seriously safety signals so that we can personalize or tailor appropriate vaccine strategies to the right ages to maximize efficacy and minimize harm. That’s Medicine 101.

Enter the new Thailand study. The US FDA has specifically asked Pfizer to prospectively assess the incidence of subclinical myocarditis for young people at time of EUA as part of post market commitments.



In keeping with the FDA’s tradition of being lax, the agency gave Pfizer till 2022 and 2024 to provide these data. That’s pretty shitty for a live problem that affects millions of boys, where the information can be generated in 1 month by a company shoveling billions into its pockets.

What happens next? Does the CDC skip Pfizer and go ahead and run biomarkers on the next 1000 kids who get the vax? pre-and post doses? with and without a control getting vax a month later? How about UK or WHO? Sadly, no one did. We turn to the first, and only prospective evaluation, and it comes from Thailand.

I will get right to the point. The authors ran a bunch of tests on kids (202 boys, 99 girls) aged 13-18 who got the 2nd dose of Pfizer, after getting the first dose without adverse events. The EKG changes in the pre-print are not the story. The story are rates of cardiac biomarkers and how often they are elevated. 3 patients had chest pain and biomarker elevation; 4 patients had no chest pain but elevated cardiac biomarkers. These were all in boys.

7/202 boys had overt or subclinical myocarditis (3.5%) or roughly 2 orders of magnitude more common than prior reports from passive adverse event reporting of myocarditis.



I want to quote a section from cardiologist Dr. Anish Koka, who has written a nice and more detailed post on this paper:
  • I can assure you, and the mostly ER doctor contingent on twitter that brays about “mild myocarditis”, that there are no cardiologists who want to see their child have a cardiac troponin that is 2x normal or 40x normal after administration of some therapeutic. What exactly does one to do with an adolescent with a troponin that is 2x normal that is asymptomatic? Given the theoretical risk of malignant cardiac arrhythmias I would imagine most cardiologists would follow the current guidelines for myocarditis and advise against strenuous cardiac activity for some months. Sudden cardiac death in young athletes is obviously a fearsome complication that is very real and it is likely some proportion of sudden cardiac death is from subclinical myocarditis.
If the study included Moderna, I, like Dr Koka, expect worse results. I don’t know what to expect in men 18-30, but I am worried.

What is the point?

The toothpaste is largely out of the tube for initial vaccine decisions; All we can do is try to move forward making the best medical decisions. The results of this study should be a call to arms. Here are several take-home messages:
  1. The fact the US, CDC, NIAID, FDA, etc etc. have to rely on a Thailand preprint for the first prospective study of cardiac biomarkers is mind-boggling negligence. The US and this CDC have shown that either they are incompetent to take safety signals seriously, or indifferent to safety. They earn Grade F. This study should have been done in the USA, by Pfizer 1 month after EUA was granted. End of story.
  2. We have to rethink the safety/ efficacy of the original series for the few adolescent men who have not had covid and not been vaccinated. Lower doses, longer time between doses, omitting dose 2, must all be tested.
  3. Because #2 comprises so few boys, this mainly has implications going forward for our indefinitely booster plans:
    1. Boosters should not be mandated without robust RCT evidence of benefit to others. (that has never happened)
    2. We must run large RCTs of boosters in this age group and test lower doses— looking for optimal safety/ efficacy before we move forward.
    3. Every time you change the spike protein construct, you might get LESS myocarditis, but you might also get MORE myocarditis. Novavax proves it is not the mRNA but spike that is the issue. Vaccine makers must be tasked to generate clinical data and not mere Ab titer data for approval.
    4. Use of EUA for any further vaccine outside of nursing home patients no longer makes sense, traditional BLA is needed for more doses.
    5. The US CDC should issue an apology for not taking safety signal more seriously, and work to build back trust in vaccines. Already, there is spillover into childhood immunization— a dangerous precedent.
    6. Pre-pandemic, I lamented that doctors who spent a large percentage of their intellectual time debunking cupping or other obviously useless things were not providing much value for science education, and COVID19 vaccine debates vindicate that view. These groups have been absolutely unable to shatter their pre-existing heuristics (vaccine good/ any concern bad) to novel products with fundamental different risk benefit. The real lesson is that careful understanding of EBM remains poorly taught to doctors; instead many think by blind allegiance to political party or relying on simple rules that serve them well in times of peace, but fall apart in times of war.
    7. There has to be a point where we conclude that the benefit of the nTH dose of the vaccine is outweighed by the harm. That is true for all drug products, and that is true here. These findings suggest that may come faster than we think, or may already have passed.
    8. Anyone who had COVID should be exempt from any further vaccine or booster requirement until credible data is generated in these groups— data of net clinical benefit.
Ultimately, I will have more to say on this topic, but awaiting a big project to complete. This study does matter; it is important. It is the first prospective study of biomarkers post vaccine. It came from Thailand. It is concerning. It captures so many failures with drug safety. When we are scared, naturally reason is suppressed. In this case, too many people have been too scared for too long; they took something great— the COVID19 vaccine— and found a way to bungle the policy around it.


There are a few more videos about this Thai study, I will post them now:

View: https://www.youtube.com/watch?v=ekTR0w2M9-U
Thai vaccine heart complications
18 min 26 sec

Aug 16, 2022
Dr. John Campbell

Cardiovascular Effects of the BNT162b2 mRNA COVID-19 Vaccine in Adolescents https://www.preprints.org/manuscript/... Study focuses on cardiovascular effects, particularly myocarditis and pericarditis events, after BNT162b2 mRNA COVID-19 vaccine injection, in Thai adolescents, 13 to 18, both sexes This prospective cohort study, students from two schools aged 13–18 years, who received the second dose of the BNT162b2 vaccine. All healthy and without any abnormal symptoms before receiving the second dose of vaccine. Data collected Demographics Symptoms Vital signs ECG, echocardiography Cardiac enzymes Collected at baseline, Day 3, Day 7, and Day 14 N = 314 Analysis, n = 301 Cardiovascular effects Found in 29.24% of patients, ranging from tachycardia, palpitation, and myopericarditis. Most common cardiovascular effects Tachycardia, 7.64% Shortness of breath, 6.64% Palpitation, 4.32% Chest pain, 4.32% Hypertension, 3.99% Abnormal ECG finding, 54 patients (17.94%) Seven participants (2.33%) (all male) At least one elevated cardiac biomarker or positive lab assessments Myopericarditis Confirmed in one patient after vaccination. Two patients had suspected pericarditis Four patients had suspected subclinical myocarditis Three patients had minimal pericardial effusion Myocarditis and Sudden Cardiac Death in the Young https://www.ahajournals.org/doi/10.11... Myocarditis accounts for up to 20% of sudden cardiac deaths in young adults. During the follow-up period, (14 days) After receiving the second dose of vaccine, two patients were hospitalized, one patient was supervised in the ICU during hospitalization, (mainly for observation of arrhythmia). Conclusion The clinical presentation of myopericarditis after vaccination was usually mild, with all cases fully recovering within 14 days. Hence, adolescents receiving mRNA vaccines should be monitored for side effects. Clinical Trial Registration: NCT05288231 Incidence, risk factors, natural history, and hypothesised mechanisms of myocarditis and pericarditis following covid-19 vaccination: living evidence syntheses and review https://www.bmj.com/content/378/bmj-2... Male adolescents and male young adults are at the highest risk of myocarditis after an mRNA vaccination. https://www.cdc.gov/coronavirus/2019-... Vaccines for COVID-19 COVID-19 vaccines are safe, effective, and free. COVID-19 Vaccines for Children and Teens https://www.cdc.gov/coronavirus/2019-... CDC recommends covid -19 vaccines for everyone 6 months and older and boosters for everyone 5 years and older,
 

Heliobas Disciple

TB Fanatic
(fair use applies)


Thailand study of young adults post jab showed nearly 30% with cardiovascular injuries
It is amazing what you find when the people doing the study are honest.

Steve Kirsch
18 hr ago


Executive summary

A new study on cardiovascular impacts of the COVID vaccines done in Thailand is particularly troubling: 29% of the young adults experience non-trivial changes in their cardiac biomarkers.

It is amazing what you find when scientists doing a study are honest and want to know the truth.

“Why isn’t a study like this being done in the US?” asks UCSF Professor Vinay Prasad.

Heck, we don’t even know the d-dimer of people before vs. after the vax.

This is just more evidence of corruption of the medical community that nobody was calling for any of this data.

These vaccines are a disaster. Every day, the evidence gets worse and worse.

Will this new study stop the vaccines for kids? Of course not!

Look, even if the shots killed every child under 20 who takes it, they’d write off the death to something else and recommend that kids get the shot. The brainwashing is that bad. It’s stunning. Facts do not matter.

Note: This was originally buried in my Fox justification article but it's important enough to call out in a separate article.


The Thailand study

Consider this Thailand study:

https%3A%2F%2Fbucketeer-e05bbc84-baa3-437e-9518-adb32be77984.s3.amazonaws.com%2Fpublic%2Fimages%2F84f00bc6-444d-4b4a-9eff-fc238a30a1d5_606x740.png


18% of kids had an abnormal EKG post-vaccine?!? That has to be extremely troubling. A vaccine is not supposed to do that. Are doctors telling parents the vaccine causes serious heart issues in 18% of kids? At least let them know.

The paper noted that “Cardiovascular effects were found in 29.24% of patients, ranging from tachycardia, palpitation, and myo/pericarditis.” Wow.
Almost 30% of the cases?!?! That’s not “rare.”

Finally a 3.5% rate of myo/pericarditis (including subclinical) among males 13-18 is not rare either. We were lied to by the CDC. Big time.

Interestingly, this is consistent with the number of myocarditis rates at Monte Vista Christian School in Watsonville, CA which was in excess of 1% but they wouldn’t reveal any of the details beyond that publicly; gotta keep the school safe from lawsuits. Major credit there goes to Head of School Nikki Daniels for making sure that nobody found out that the shots they gave at the school were hurting kids. When adverse reactions started showing up, they did the right thing: they kept their mouths shut.
.


I decided to quote an article for each video I am posting. This way you don't have to scroll around looking for them. There were 3 posts about the Thai study and there are 3 videos, so it works out well.



View: https://www.youtube.com/watch?v=wrxcOoE1ngo
Thailand Myocarditis - Has enough research been done on covid vaccines in children?
8 min 40 sec

Streamed live on Aug 16, 2022
Vejon Health - Dr. McMillan


Thailand has recently shared a pre-print paper on myocarditis in adolescents using specific cardiac markers.
Cardiovascular Effects of the BNT162b2 mRNA COVID-19 Vaccine in Adolescents
This is basic research that should have been done in children to review the risk of myocarditis.
Is there any excuse that we had to wait this long to see these results?
 

Heliobas Disciple

TB Fanatic
(fair use applies)


The Thailand myocarditis study, briefly
3.5% of boys show evidence of pericarditis or myocarditis after the 2nd dose of the Pfizer/BioNTech Covid vaccine. (A belated recap.)

Brian Mowrey
9 hr ago

Although Vinay Prasad has already provided a somewhat-punch-pulling recap of the preprint study from Thailand,1 it hadn’t received a lot of attention in the more anti-mainstream edges of the substack ecosystem. This changed a few hours ago with a somewhat-too-sensational Steve Kirsch post.2 My overview is at best a “middle-chair” summary at this point.

Still, it would be odd not to offer a take here, given that this journal keeps the myocarditis issue on the radar generally,3 and this study is groundbreaking in that it shows rates of post-mRNA-injection myocarditis in teens captured by actual screening, eliminating under-reporting and capturing subclinical (non-symptomatic) heart damage. And so here goes.

The Set-Up​

The study:4


Mansanguan, S. et al.

314 teens already first-dosed with the Pfizer/BioNTech Covid vaccine (BNT162b2), and without prior cardiac issues or adverse reactions, were tested for cardiac markers before and then 3 and 7 days after receipt of the 2nd dose (and again if presenting with cardiac symptoms). Emphasis added:

High-sensitivity cardiac troponin-T assay (HS-cTnT) and CK-MB isoenzyme levels were determined for all participants at baseline, and on Day 3, Day 7 and Day 14 (optional) after the second dose vaccination. HS-cTnT was measured using the Elecsys troponin-T hs assay (Roche Diagnostics, Mann- heim, Germany); serum levels > 14 ng/L were considered elevated.

“Elevated” troponin, in the context of suspected myocarditis (i.e., not in the context of a heart attack or sepsis or other obvious trauma), clinches the diagnosis.

Not only does this study screen for myocarditis, to find cases in teens that would otherwise be missed in a clinical setting, it also collects a baseline measurement to observe the change driven by the mRNA injection. This makes it a first.

For context, previous estimates of post-Covid-vaccine-dose-2 myocarditis have been implausibly low. Even the values derived by Hoeg, et al. - which set off a firestorm of MD-twitter criticism by almost doubling the CDC’s official rate5 - are minuscule when converted to percentage form.


Høeg, TB. et al. Fig 1.
“.016%” is not what the Thailand study found.


3.5% Peri/Myocarditis in teen boys​

Minus 13 subjects lost to follow-up, there were 99 girls and 202 boys tested this way overall. No girls presented with cardiac complications or threshold-defined “elevated” troponin-T findings. 3 boys presented with symptoms and an additional 4 were flagged for elevated troponin-T (following a normal baseline).

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Mansanguan, S. et al. Table 3 (click to expand; a recent monitor upgrade has me realizing my images are hard on the eyes when not using retina-style displays, oops)

Using the 14 pg/mL threshold, the combined (clinical and subclinical) rate of myocarditis is 2.5% for all boys observed. This rate is similar in both the 13-15 and 16-18 age groups. Separately, the pericarditis rate is similar in both age groups as well. This consistency is impressive, despite the hazard of extrapolating from only a handful of events.

Expected background rate?​

Of course, studies which do not include controls burden the reader with having to bring their own knowledge of the expected background rate of whatever is being measured; in this case subclinical myocarditis in teen boys in Thailand. Naturally, each subject’s visit 1 (baseline) value serves as a self-control: They are not showing elevated troponin-T before the 2nd dose; and near-or-above-14 results are returned on both post-dose visits for each boy afterward.

Additionally, the lack of any over-threshold results among the 99 girls serves as a control in the context of this specific study’s assay (Roche Elecsys6) and method. By definition, "background rates" for any threshold on a given assay vary with the population being tested - but the results among girls demonstrate that a return of 0 is possible (even after mRNA injection). In a population of healthy7 boys with sub-14 baseline values, it seems safe to treat the expected background rate as 0.

Un-measured 1st dose effects​

Because the study intervenes on subjects who have already received 1 dose, “baseline” values provide a muddy picture of true before-mRNA-injection levels vs. already-fading cTnT release from dose-1-induced cardiac damage. As illustrated by subject 1 in Table 3 above, cTnT tends to linger in serum for over a week, due to slow breakdown (proteolysis).8 Depending on the duration of cell damage induced by mRNA-vaccination, cTnT elevations after the 1st dose may be sustained for longer than after an acute event (due to continual release).

It could thus certainly be the case that the baseline values in Table 3 offer a glimpse of post-dose-1 subclinical myocarditis (implying that immune sensitization is not the primary etiology for myocarditis, which is what I am inclined to believe; instead, damage during dose 1 merely raises the baseline of damage and patient awareness so that additional damage is more likely to advance from a subclinical to a clinical level).

In Table 3, subject 4 may be an example of lingering high troponin-T from the first dose (some sources cite anything above 4 pg/mL as being above-normal, which would throw in subjects 3 and 69). However, accuracy thresholds for high sensitivity assays cut off at these lower levels, as will be discussed below.

Still just the tip of the iceberg?​

Notably, the sub-14 troponin-T values for subjects 4 and 7, on day 3 (visit 2), are still above baseline. It would be irrational for an observer to not consider those results to be associated with and still reflect the release of troponin induced by the 2nd dose.

The numbers on Day 3 may not reach the chosen threshold, but they still reflect damage and destruction of heart cells.

Likewise, all sub-threshold elevations in the remaining 294 teens in this study, were these values presented (they aren’t), could appropriately be interpreted in the context of them having just received the same poison. While “14” serves as a proxy for the accuracy of the test (Roche pegs the “CV” for their assay at 13pg/mL; implying that results below that value are more likely to include noise), it doesn’t define how many killed cells in a teen’s heart it takes to induce the short- or medium-term risk of a cardiac event, or to shave years off their eventual lifespan.

Moreover, a general rise in troponin-T (if it were included in the presented data, which it isn’t) in a large sample would by definition indicate the effect of the 2nd dose beyond the noise of the assay at sub-14 values.

The following example recycles the baseline values from Table 3. This allows for the semi-arbitrary designation of a new “above-normal” threshold (in these teen boys, in this assay) of 8. The rate of induced-high-ness is simply the number of 8-or-highers after minus the number before:


A similar evaluation of the raw data for the Thailand study should make it possible to judge the true rate of subclinical (and clinical) myocarditis - and it may be well over the 2.5% value derived here, for both male and female teens. (Additionally, if any subjects were excluded because of cardiac issues arising after the first dose, or if any were lost to follow-up due to issues after the second, these should also be factored in.)

18% Abnormal ECG?​

Such a process might yield a result exactly in accordance with the findings for electrocardiogram “abnormalities.” If these were further shown to be consistent by sex - for example, if 40 more boys had above-8 cTnT and 40 boys had abnormal electrocardiagrams, compared to 14 girls - it could be neatly demonstrated that the findings for ECG abnormalities were driven by the mRNA injections.

Otherwise, it is difficult to put too much stock into the ECG results. They seem alarming, but may not reflect the effect of the BNT162b2 injection as opposed to background noise or something about the setting of the tests:

After vaccination, ECG revealed that of the 301 patients, 247 (82.06%) had normal sinus rhythm, while an abnormal ECG finding was noted in 54 patients (17.94%)


https%3A%2F%2Fbucketeer-e05bbc84-baa3-437e-9518-adb32be77984.s3.amazonaws.com%2Fpublic%2Fimages%2Fece061e0-6547-422d-b5c0-062ba5d9e91e_967x454.png

Mansanguan, S. et al. Table 4

Even if these cardiac abnormalities are induced by BNT162b2, it could be via some more indirect and innocuous etiology. For example, fever (recorded for 50 patients) leading to disruption of the autonomic nervous system. Again, if this could be shown to match the “true” sex-dependent myocarditis rate in the raw data, it would have more weight as an indicator of cardiac harms over just “nerves.”

For now, the 2.5% rate for boys exceeding the troponin threshold is horrifying enough.



1 Prasad, Vinay. “What does the Thailand Myocarditis Study Teach Us?” (2022, August 13.) Vinay Prasad's Observations and Thoughts.
2 Kirsch, Steve. “Thailand study of young adults post jab showed nearly 30% with cardiovascular injuries.” (2022, August 16.) Steve Kirsch's newsletter.
Kirsch uses a reference in the abstract to “cardiovascular effects” being found in 29.24% of patients to support his headline. As noted in my analysis of the EGC-abnormalities section, most of these “effects” might not reflect injury, though the raw data would help make that clear.
3 See “Reversal.”
4 Mansanguan, S. et al. “Cardiovascular Effects of the BNT162b2 mRNA COVID-19 Vaccine in Adolescents.” preprints.org
5 See “Myo-Card Me a River.”
6 Elecsys® Troponin T high sensitive
7 As in, not being examined in the context of known cardiac issues, and those with such issues being excluded. Pre-existing conditions are listed in table 1.
https%3A%2F%2Fbucketeer-e05bbc84-baa3-437e-9518-adb32be77984.s3.amazonaws.com%2Fpublic%2Fimages%2Fca01cbc1-fad9-46cc-841e-07fe51cb37da_957x507.png

While “Patients who had a history of cardiomyopathy, tuberculous pericarditis or constrictive pericarditis and severe allergic reaction to the COVID-19 vaccine were excluded from the study,” no value is given for how many (if any) met that criteria and were excluded.
8 Daněk, J. et al. “Troponin levels in patients with stable CAD.” Cor et Vasa. Volume 59, Issue 3, June 2017, Pages e229-e234
9 Normal troponin levels: Healthy ranges and what high levels mean
A further reference point is Høeg, TB. et al.’s review, which found sub-14 medians in reported post-vaccine myocarditis (Fig. 3).


View: https://www.youtube.com/watch?v=ozcpl9IJlno
Thailand's Study - Vaccine Associated Myopericarditis in Children
47 mim 55 sec

Streamed live on Aug 16, 2022
Drbeen Medical Lectures


Heart Damage by BNT162b2 in Children (Preprint Thai Study)
In this prospective cohort study of school children receiving BNT162b2 vaccine the researchers from Thailand have stunning data. Let's review.

URL list from Monday, Aug. 15 2022

Cardiovascular Effects of the BNT162b2 mRNA COVID-19 Vaccine in Adolescents[v1] | Preprints

Myocarditis Cases Reported After mRNA-Based COVID-19 Vaccination in the US From December 2020 to August 2021 | Vaccination | JAMA | JAMA Network

Related document to the above letter

Myocarditis after BNT162b2 Vaccination in Israeli Adolescents | NEJM

Persistent Cardiac Magnetic Resonance Imaging Findings in a Cohort of Adolescents with Post-Coronavirus Disease 2019 mRNA Vaccine Myopericarditis - The Journal of Pediatrics

CPK-MB test - Wikipedia
 

Heliobas Disciple

TB Fanatic
While I'm here posting videos, there are a few more to post, not related to the Thai study.


View: https://www.youtube.com/watch?v=Kg2PGTSsQaE
COVID+ Again
57 min 57 sec

Streamed live on Aug 16, 2022
Drbeen Medical Lectures

And, also answering your questions about the Thailand study.
Disclaimer:This video is not intended to provide assessment, diagnosis, treatment, or medical advice; it also does not constitute provision of healthcare services. The content provided in this video is for informational and educational purposes only. Please consult with a physician or healthcare professional regarding any medical or mental health related diagnosis or treatment. No information in this video should ever be considered as a substitute for advice from a healthcare professional.
 

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View: https://www.youtube.com/watch?v=Cf9y2eNmbUA
CDC Reorg, SARS-COV-2 Persistence for Years, and More News
51 min 53 sec

Streamed live 3 hours ago
Drbeen Medical Lectures

As I have been away for a few days I thought it will be good to catch-up on the major news. Let's check them together.
Disclaimer:This video is not intended to provide assessment, diagnosis, treatment, or medical advice; it also does not constitute provision of healthcare services. The content provided in this video is for informational and educational purposes only.Please consult with a physician or healthcare professional regarding any medical or mental health related diagnosis or treatment. No information in this video should ever be considered as a substitute for advice from a healthcare professional.

URL list from Wednesday, Aug. 17 2022

U.S. to end purchase of COVID-19 vaccines as industry pivots to commercial market
https://finance.yahoo.com/news/us-to-...

Walensky, Citing Botched Pandemic Response, Calls for C.D.C. Reorganization - The New York Times
https://www.nytimes.com/2022/08/17/us...

Understanding mRNA COVID-19 Vaccines | CDC
https://web.archive.org/web/202207221...

Understanding mRNA COVID-19 Vaccines | CDC
https://www.cdc.gov/coronavirus/2019-...

SARS-CoV-2 infection and persistence throughout the human body and brain | Research Square
https://www.researchsquare.com/articl...

British regulator 1st to OK Moderna's updated COVID booster
https://www.yahoo.com/news/british-re...

$10 million settlement announced for workers forced to take COVID shots – ClarkCountyToday.com
https://www.clarkcountytoday.com/news...

Pfizer CEO Bourla shows mild symptoms after testing positive for COVID
https://www.yahoo.com/news/pfizer-ceo...

Omicron BA.4 and BA.5 Can’t Be Neutralized by Prior Infection
https://www.contagionlive.com/view/om...

Omicron BA.4/BA.5 escape neutralizing immunity elicited by BA.1 infection | Nature Communications
https://www.nature.com/articles/s4146...

California officials warn of misleading COVID rapid test results
https://www.yahoo.com/news/california...

When COVID-19 or flu viruses kill, they often have an accomplice – bacterial infections
https://www.yahoo.com/news/covid-19-f...

Updated COVID boosters could be available in 3 weeks, White House predicts
https://www.yahoo.com/gma/updated-cov...
 

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View: https://www.youtube.com/watch?v=e6xj14QYsoc
Near Infrared Light Reduces Inflammation via TLR4 In Vitro
21 min 59 sec

Aug 17, 2022
MedCram - Medical Lectures Explained CLEARLY

Roger Seheult, MD of MedCram explains how near infrared light reduces inflammation via TLR4. See all Dr. Seheult's videos at: https://www.medcram.com (This video was recorded on August 16, 2022)

Infrared light therapy relieves TLR-4 dependent hyper-inflammation of the type induced by COVID-19 (Communicative & Integrative Biology) | https://www.ncbi.nlm.nih.gov/pmc/arti...
 

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(fair use applies)



New Covid boosters expected soon for everyone over age 12
Berkeley Lovelace Jr. - NBC News
Wed, August 17, 2022, 6:47 PM

White House Covid coordinator Dr. Ashish Jha said on Wednesday that the newly updated Covid boosters will be available to teens and adults "in a few short weeks."

"I believe it’s going to be available and every American over the age of 12 will be eligible for it," Jha told NBC News' Lester Holt.

The new boosters target the omicron subvariants BA.4 and BA.5, as well as the original strain of the virus. BA.5 accounts for nearly 90% of new Covid cases in the U.S., according to the Centers for Disease Control and Prevention.

Full coverage of the Covid-19 pandemic

The Food and Drug Administration will determine how well the updated shots protect against the virus, Jha said, adding that he expects that they should "work much better at preventing infection transmission and serious illness" than the current boosters.
When should you get another booster?

Currently, adults ages 50 and up, as well as the immunocompromised, are eligible for a second booster four months after receiving their first.

With the new shots coming soon, should eligible people get their next shot now, or wait for the updated versions?

At first glance, when to get your next shot may seem straightforward: Waiting sounds like a reasonable option because the redesigned boosters should provide the best level of protection against the dominant circulating forms of the virus.

But it’s become an increasingly complicated question in a country where vaccine uptake has varied considerably and people carry different levels of risk.

Many eligible people in the U.S. are vaccinated, but have not received a booster shot. Some are double-boosted. Confounding matters further is whether a person has been infected or reinfected.

The level of immunity across the country is "strikingly different now than it was just a year ago," Dr. William Schaffner, an infectious diseases specialist at the Vanderbilt University Medical Center, said.

To make matters even more confusing, if people get their next shot early this fall, there is some concern among scientists about whether they’ll still have enough immune protection against the virus during the winter months, when Covid cases are expected to rise again.

Research has shown that antibodies generated from the existing vaccines begin to decline after only a few months.

“There’s not a clear-cut answer,” said Dr. Katherine Poehling, a vaccine expert and pediatrician at Atrium Health Wake Forest Baptist in North Carolina. Timing your next vaccine, she said, is about as tricky as “timing the stock market.”

The best way to time your next Covid shot may be to look at your individual risk factors — such as age and underlying conditions — as well as the level of spread in your community and the time since your last vaccine dose, experts say.

The elderly and those with weakened immune systems are often at the highest risk of severe complications from Covid, but so are other groups, such as those with diabetes, asthma or chronic lung disease.

“I’d say that if somebody were in a community with a high transmission rate and they were very vulnerable, they may want to avail themselves immediately with a booster that is currently available,” said Dr. Ofer Levy, the director of the Precision Vaccines Program at Boston Children’s Hospital.

On the other hand, someone who is young, healthy and lives in a community where Covid transmission is low may be able to make the decision to wait for the updated booster, he said.

The existing vaccines that a young healthy individual already received should still provide “protection against the worst outcomes, which is intensive care unit admission and death,” he said.

To be sure, putting off vaccination until the updated booster becomes available is still a gamble for anyone: Covid cases are still high in the U.S., with more than 98,000 cases per day, on average, according to data from the CDC.

Furthermore, federal health officials still haven’t decided whether they will immediately distribute the updated doses to all U.S. adults or start with those most at risk, such as the elderly,

Whether officials make the vaccine immediately available to everyone who is eligible will depend on how much supply Pfizer-BioNTech and Moderna are able to manufacture and distribute by next month, according to a person familiar with the discussions. If supply is initially limited, the updated doses may first go to those most at risk, such as the elderly or the immunocompromised.

That strategy could mirror the U.K.'s, which is offering updated boosters next month to people over 50 and those whose jobs or health conditions put them at high risk. (The U.K.'s new boosters differ from the ones that will be offered in the U.S., in that they target the original version of omicron, called BA.1, that circulated earlier this year.)

Speaking at a webinar with the U.S. Chamber of Commerce webinar Tuesday, Jha said people, if eligible, should get a booster shot now, and that they should still be able to get the updated booster shot in a few months.

"My general feeling is no reason to wait, go get it, even if we’re only a few weeks away" from the updated booster, he said.

Schaffner, of Vanderbilt University Medical Center, agreed that people shouldn't wait, noting that there's no guarantee that they'll be able to get the updated vaccines.

Levy, of Boston Children’s Hospital, said there's no downside to getting an additional shot now if eligible: "I think folks should take advantage. We have safe and effective vaccines. Get immunized. That's the bottom line."
 

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U.S. to end purchase of COVID-19 vaccines as industry pivots to commercial market
Anjalee Khemlani
Wed, August 17, 2022, 12:18 PM

Vaccine makers have been working on a transition to a commercial market in the U.S. by next year, as White House COVID-19 Response Team coordinator Dr. Ashish Jha said Tuesday the U.S. government will stop buying treatments, tests and vaccines by this fall.

"My hope is that in 2023, you're going to see the commercialization of almost all of these products. Some of that is actually going to begin this fall, in the days and weeks ahead. You're going to see commercialization of some of these things," Jha said at a U.S. Chamber of Commerce Foundation event.

Tests have already been available commercially at pharmacies, grocery stores and online, and treatments — those that remain effective — are pivoting to commercialization for 2023.

Of the four vaccines available in the U.S., only two have regulatory approval to go commercial: Moderna (MRNA) and Pfizer/BioNTech (PFE/BNTX).

Both companies have U.S. government orders for booster doses this fall, and are only planning to transition out after those doses have been delivered — but have not determined details such as price of doses, coverage by insurers, and details of how to transition logistics away from the government partnership.

Moderna, by comparison, said it is already working on commercialization.

"The commercial organization has already engaged with commercial payers and the channel, both channel distributors as well as key pharmacies, in anticipation of this shift. Internationally, we expect public health authorities to remain key purchasers of vaccines but we are also identifying markets where there may be a private commercial market as well," Arpa Garay, chief commercial officer, said during an earnings call this month.

Novavax (NVAX), which only just got emergency use authorization and is filing for booster approval in adults, and Johnson & Johnson (JNJ), do not have approval.

Novavax said it intends to pursue full approval by then end of 2022 and pricing will "be similar to the premium-priced influenza market in the U.S."

J&J faced waning demand in recent months as the Centers for Disease Control and Prevention (CDC) warned against potential blood clot risks, and advised Moderna and Pfizer doses be used to boost protection against emerging variants. J&J did not respond to a request for comment Wednesday.

Insurers are awaiting guidance from the government, as well as the official end of the public health emergency, which is set to expire October 13 — and has a 60-day notice if the Biden administration intends to lift it. All signs point to another extension, which would leave in place coverage and rules for vaccines, treatments, tests, and even provisions for telehealth and other pandemic-related shifts in policy and operations.

But once the emergency declaration is lifted, it opens the floodgates to a myriad complexities. Who will be paying out of pocket costs and copays, including through Medicare, remains unclear. The Centers for Medicare and Medicaid Services (CMS) did not respond to a request for comment Wednesday.

But with Congress unwilling to budge on ongoing funding, the U.S. is facing a potential cliff in vaccine availability. Currently, the U.S. has ordered booster doses for adults in the fall, but not enough for all.

The government has ordered 105 million Pfizer doses for delivery through the end of 2022, with an option to purchase 195 million more, and 66 million doses from Moderna through the end of 2022. The 171 million doses is about two-thirds of the more than 250 million needed to give each adult an additional booster.
 

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Brazil federal police accuse Bolsonaro of COVID-linked scaremongering

by Ricardo Brito; Peter Frontini
Wed, August 17, 2022, 9:07 PM

BRASILIA (Reuters) - Brazil's federal police on Wednesday accused President Jair Bolsonaro of discouraging mask use during the pandemic and falsely suggesting that people who got vaccinated against COVID-19 ran the risk of contracting AIDS.

In a document sent to Brazil's Supreme Court, a police delegate said Bolsonaro's effort to discourage compliance with pandemic-linked health measures amounted to a crime, while his effort to link AIDS with vaccination amounted to a misdemeanor.

The police asked Supreme Court Justice Alexandre de Moraes, who is in charge of the probe, to authorize the police to charge Bolsonaro and others involved in the case.

In a social media livestream last October, the far-right president said, without presenting any evidence, that UK government reports had shown that people fully vaccinated against COVID-19 had developed AIDS.

Bolsonaro, who has declined to take the vaccine, was temporarily suspended from both Facebook and YouTube after the comments.

The police said additional steps were needed to conclude the investigations, including hearing from Bolsonaro.

The solicitor general's office, which typically provides legal representation for the president, did not immediately respond to a request for comment.
 

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CDC director announces shake-up, citing COVID mistakes
By MIKE STOBBE
yesterday

NEW YORK (AP) — The head of the nation’s top public health agency on Wednesday announced a shake-up of the organization, saying it fell short responding to COVID-19 and needs to become more nimble.

The planned changes at the Centers for Disease Control and Prevention — CDC leaders call it a “reset”— come amid criticism of the agency’s response to COVID-19, monkeypox and other public health threats. The changes include internal staffing moves and steps to speed up data releases.

The CDC’s director, Dr. Rochelle Walensky, told the agency’s staff about the changes on Wednesday. It’s a CDC initiative, and was not directed by the White House or other administration officials, she said.

“I feel like it’s my my responsibility to lead this agency to a better place after a really challenging three years,” Walensky told The Associated Press.

The Atlanta-based agency, with a $12 billion budget and more than 11,000 employees, is charged with protecting Americans from disease outbreaks and other public health threats. It’s customary for each CDC director to do some reorganizing, but Walensky’s action comes amid a wider demand for change.

The agency has long been criticized as too ponderous, focusing on collection and analysis of data but not acting quickly against new health threats. Public unhappiness with the agency grew dramatically during the COVID-19 pandemic. Experts said the CDC was slow to recognize how much virus was entering the U.S. from Europe, to recommend people wear masks, to say the virus can spread through the air, and to ramp up systematic testing for new variants.

“We saw during COVID that CDC’s structures, frankly, weren’t designed to take in information, digest it and disseminate it to the public at the speed necessary,” said Jason Schwartz, a health policy researcher at the Yale School of Public Health.

Walensky, who became director in January 2021, has long said the agency has to move faster and communicate better, but stumbles have continued during her tenure. In April, she called for an in-depth review of the agency, which resulted in the announced changes.

“It’s not lost on me that we fell short in many ways” responding to the coronavirus, Walensky said. “We had some pretty public mistakes, and so much of this effort was to hold up the mirror ... to understand where and how we could do better.”

Her reorganization proposal must be approved by the Department of Health and Human Services secretary. CDC officials say they hope to have a full package of changes finalized, approved and underway by early next year.

Some changes still are being formulated, but steps announced Wednesday include:

—Increasing use of preprint scientific reports to get out actionable data, instead of waiting for research to go through peer review and publication by the CDC journal Morbidity and Mortality Weekly Report.

—Restructuring the agency’s communications office and further revamping CDC websites to make the agency’s guidance for the public more clear and easier to find.

—Altering the length of time agency leaders are devoted to outbreak responses to a minimum of six months — an effort to address a turnover problem that at times caused knowledge gaps and affected the agency’s communications.

—Creation of a new executive council to help Walensky set strategy and priorities.

—Appointing Mary Wakefield as senior counselor to implement the changes. Wakefield headed the Health Resources and Services Administration during the Obama administration and also served as the No. 2 administrator at HHS. Wakefield, 68, started Monday.

—Altering the agency’s organization chart to undo some changes made during the Trump administration.

—Establishing an office of intergovernmental affairs to smooth partnerships with other agencies, as well as a higher-level office on health equity.

Walensky also said she intends to “get rid of some of the reporting layers that exist, and I’d like to work to break down some of the silos.” She did not say exactly what that may entail, but emphasized that the overall changes are less about redrawing the organization chart than rethinking how the CDC does business and motivates staff.

“This will not be simply moving boxes” on the organization chart, she said.

Schwartz said flaws in the federal response go beyond the CDC, because the White House and other agencies were heavily involved.

A CDC reorganization is a positive step but “I hope it’s not the end of the story,” Schwartz said. He would like to see “a broader accounting” of how the federal government handles health crises.

___
 

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Walensky, Citing Botched Pandemic Response, Calls for C.D.C. Reorganization
Among other flaws, public guidance during the coronavirus pandemic was “confusing and overwhelming,” the agency said.

By Sharon LaFraniere and Noah Weiland
Aug. 17, 2022

WASHINGTON — Dr. Rochelle P. Walensky, the director of the Centers for Disease Control and Prevention, on Wednesday delivered a sweeping rebuke of her agency’s handling of the coronavirus pandemic, saying it had failed to respond quickly enough and needed to be overhauled.

“To be frank, we are responsible for some pretty dramatic, pretty public mistakes, from testing to data to communications,” she said in a video distributed to the agency’s roughly 11,000 employees.

Dr. Walensky said the C.D.C.’s future depended on whether it could absorb the lessons of the last few years, during which much of the public lost trust in the agency’s ability to handle a pandemic that has killed more than 1 million Americans. “This is our watershed moment. We must pivot,” she said.

Her admission of the agency’s failings came after she received the findings of an examination she ordered in April amid scathing criticism of the C.D.C.’s performance. The report itself was not released; an agency official said it was not yet finished but would be made public soon.

Dr. Walensky laid out her basic conclusion from the review in candid terms: The C.D.C. must refocus itself on public health needs, respond much faster to emergencies and outbreaks of disease, and provide information in a way that ordinary people and state and local health authorities can understand and put to use.

In an interview on Monday, Dr. Walensky stressed that hundreds of Americans were still dying each day from the coronavirus and that while the country has not yet seen deaths from the outbreak of a new disease — monkeypox — it has presented some of the same challenges for the agency.

The C.D.C. has been criticized for years as being too academic and insular. The coronavirus pandemic brought those failings into public view, with even some of the agency’s staunchest defenders criticizing its response as inept.

It remains unclear whether Dr. Walensky, an infectious disease expert whom President Biden picked to lead the agency in December 2020, can bring about the changes many see as necessary.

“Can she do it? I don’t know. Does it absolutely need to be done? Yes. Is it just a reorganization that is required? I don’t think so,” Dr. Jennifer Nuzzo, an epidemiologist and director of the Pandemic Center at Brown University School of Public Health.

Others said it was difficult to judge Dr. Walensky’s moves without more information, including the report she commissioned. The review was led by James Macrae, who has held senior positions at the Department of Health and Human Services, which oversees the C.D.C. He interviewed about 120 people inside and outside the agency.

“Just saying we’re strengthening this and that — the devil is in the details here,” said Dr. Howard Markel, a professor of the history of medicine at the University of Michigan who has advised the C.D.C.

The agency has been under fire since the outset of the coronavirus pandemic two and a half years ago. It bent to political pressure from the Trump White House to alter key public health guidance or withhold it from the public — decisions that cost it a measure of public trust that experts say it still has not recaptured. It also made its own serious errors, including deploying a faulty Covid-19 test that set back the nation’s efforts to curtail spread of the virus.

While it has steadied itself since Dr. Walensky assumed control about 18 months ago, the C.D.C. has continued to fall short.

Its public guidance has often been confusing, even to public health experts. Leaders of its Covid team rotate so frequently that other senior federal health officials have at times been unsure about who is in charge. And important data was sometimes released too late to inform federal decisions, including studies on breakthrough infections that could have influenced a federal recommendation on authorizing a round of booster shots.

Regardless of who led the agency, “an honest and unbiased read of our recent history will yield the same conclusion,” Dr. Walensky told employees. “It is time for C.D.C. to change.”

She outlined in broad terms how she hopes to transform operations by emphasizing public health needs, especially with a quicker response to emergencies like infectious disease outbreaks. One of her top priorities is to deliver clear, concise messages about public health threats, in plain language that can be grasped without sifting through voluminous pages on a website.

“I think for a long time, C.D.C. has undervalued the importance of direct communication to the public with information the public can use,” said Dr. Richard E. Besser, who served as acting director of the agency during the Obama administration.

Dr. David Dowdy, an epidemiologist at Johns Hopkins Bloomberg School of Public Health, said messages to the general public need to be “very clear, very simple, very straightforward,” not framed for scientists. “I do think that culture is changing, but we need it to change faster,” he said.

Other planned changes are more bureaucratic but could have a big impact. A new executive team will be created to set priorities and make decisions about how to spend the agency’s annual $12 billion budget “with a bias toward public health impact,” according to a media briefing document. Two scientific divisions will now report directly to Dr. Walensky’s office, a move that appears aimed at speeding up delivery of data. Mary Wakefield, a former deputy health secretary in the Obama administration, was appointed to lead the reforms.

Dr. Walensky hopes to cut down the review time for urgently needed studies, emphasizing production of “data for action” as opposed to “data for publication,” the briefing document said.

In an interview, Dr. Walensky said that while “some of the data are messy, and some of the data take time, I’ve really tried hard to push data out when we had it.”

The agency aims to alter its promotion system so that it rewards employees’ efforts to make an impact on public health and focuses less on the number of scientific papers published.

“That’s not going to change anything overnight. But in the long run it will have a huge impact,” said Kyle McGowan, who served as chief of staff for the agency during the Trump administration and fiercely criticized the administration’s interference in C.D.C. decision-making after he left the agency.

Dr. Walensky also plans to create a stronger cadre of officials who respond to public health crises by training more staff and requiring that those officials remain in their positions for at least six months. Previously, officials in charge of the pandemic response often left after only a few months — a system that helped mitigate burnout but also sowed confusion.

Dr. Walensky stressed that she would not let the burden of responding to a public health threat fall on just a few people. “This is an agencywide top priority to respond when we are called upon,” she said.

“We’ve had the same people who deploy over and over again,” said Mr. McGowan. “What they need is for more people to deploy longer.”

Many of the C.D.C.’s experts are accustomed to conducting narrowly focused research that undergoes lengthy reviews, and they are uneasy with the kind of urgent action needed to address public health threats.

That type of research is still critical, many experts say. “Having expertise in those rare diseases is very valuable. And it becomes valuable at times you just don’t really know,” said Dr. Mitchell Wolfe, who left the C.D.C. in June after serving as its chief medical officer.

“I think monkeypox is a great example. A year ago people would have asked why you have a monkeypox expert,” he said.

And some of the C.D.C.’s problems are beyond its control: Much of its funding is tied to work on specific diseases and cannot be shifted to address public health threats. The agency also lacks legal authority to compel state and local health departments to deliver public health data.

The pandemic itself is another impediment. The agency’s massive complex outside Atlanta sits mostly empty, while employees, including Dr. Walensky, work remotely.

“The actions that are being taken all strike me as actions that make sense and would make C.D.C. a more effective public health agency,” said Dr. Besser, the former C.D.C. acting director.

But he said it was hard to see how Dr. Walensky could execute wholesale changes when she only sees most of her staff at a distance. “I don’t know how you motivate and inspire culture change when people aren’t together,” he said.
 

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CDC director orders agency overhaul, admitting flawed Covid-19 response
Rochelle Walensky wants to boost transparency by releasing data more quickly and to improve communication with the public.

By Krista Mahr
08/17/2022 12:01 PM EDT

The Centers for Disease Control and Prevention is launching an overhaul of its structure and operations in an attempt to modernize the agency and rehabilitate its reputation following intense criticism of its handling of the coronavirus pandemic and, more recently, the growing monkeypox outbreak.

On Wednesday, CDC Director Rochelle Walensky shared a series of changes with CDC leadership and staff designed to “transform” the organization and its work culture by improving how the agency shares information, develops public health guidance and communicates with the American public.

“For 75 years, CDC and public health have been preparing for COVID-19, and in our big moment, our performance did not reliably meet expectations,” Walensky said in a statement. “As a long-time admirer of this agency and a champion for public health, I want us all to do better.”

The CDC restructuring follows two reviews conducted in recent months, one by Health Resources and Services Administration official Jim Macrae into the CDC’s pandemic response and another by CDC Chief of Staff Sherri Berger into agency operations.

The reviews concluded that the “traditional scientific and communication processes were not adequate to effectively respond to a crisis the size and scope of the COVID-19 pandemic,” according to an agency statement.

Specifically, Macrae’s review, which included 120 interviews with CDC staffers and people outside the agency, recommended a series of improvements, including releasing scientific findings and data more quickly to improve transparency, translating science into practical and easy-to-understand policy, improving communication with the public, working better with other agencies and public health partners, and training and incentivizing the agency’s workforce to respond better to public health emergencies.

There is consensus within the CDC that it “needs to make some changes for how it communicates and how it operates — to be faster, to be nimbler, to use more plain spoken language,” said a CDC official, who was granted anonymity to discuss the changes before they were announced.

“People work incredibly, incredibly hard and care deeply about trying to make sure that the American people have the right information,” the official said. “Maybe the way that a lot of the [Covid-19] response was structured, and some of the incentives that people have here, are just not aligned properly to really put the focus toward getting information to people quickly and how that information can benefit Americans’ health.”

An embattled agency

The CDC has come under intense pressure from Americans of all political stripes since the earliest days of the pandemic.

It has fended off a battery of allegations over the course of the crisis, from putting politics over its vow to “follow the science” to bungling messaging to putting Americans’ lives at risk as pandemic restrictions have eased.

As public health officials came under attack across the country, so has the agency’s authority to implement Covid-19 mitigation measures, with critics on one side accusing the agency of federal overreach and critics on the other accusing the agency of not doing enough.

The CDC’s authority has been challenged in multiple court cases. Last year, the Supreme Court struck down its moratorium on evictions during the pandemic. The government has appealed a Florida federal district court judge’s April decision to strike the CDC’s directive that people wear masks on airplanes, trains and other public conveyances.

This year, the agency has struggled to strike a balance between the competing interests of a virus that continues to find ways to evade vaccines and natural immunity, and a public that is weary of taking the sort of precautions that federal and state governments have mandated.

As the Omicron variant swept the nation, the agency came under fire for shortening its recommended quarantine guidelines. This spring, its shift to assessing community-level risk by weighing hospitalizations and the burden on the health care system over the level of transmission was both confusing and put Americans at unnecessary risk, many public health experts say.

Last week, the CDC’s decision to lift quarantine recommendations for unvaccinated individuals exposed to the virus, including in schools, also drew criticism from doctors and public health experts who say the agency is embracing individual responsibility over public health when it is responsible for the latter.

Several school districts, including those in New York City and Philadelphia, are taking more precautions than the CDC now recommends as students return.

Walensky has repeatedly pointed out that the agency was underfunded before the pandemic started, noting that the public health workforce was seriously depleted and the agency has been hamstrung by structural issues, including limited access to data from states.

In an interview with POLITICO earlier this year, she said the CDC alone would not be able to bring Covid-19 under control, and called for broader investment in public health at the state and local levels.

“I actually really think many people have thought this is CDC’s responsibility, to fix public health [and] the pandemic,” Walensky said. “The CDC alone can’t fix this. Businesses have to help, the government has to help, school systems have to help. This is too big for the CDC alone.”

Nevertheless, Americans’ approval of the agency’s job steering the nation through a pandemic that has killed more than a million Americans has plummeted.

In March 2020, 79 percent of Americans said public health officials, including those at the CDC, were doing a good job responding to the pandemic, according to a survey by Pew Research Center. By May 2022, only 52 percent of Americans thought so, Pew found.

The agency’s more recent handling of the monkeypox outbreak, which many epidemiologists worry is now past the point of containment in the country, has again sparked widespread criticism that the CDC is unable to rise to the demands of a complicated public health crisis as it unfolds in real time.

A new roadmap

Among the structural changes to come out of the reviews are the appointment of former HHS Deputy Secretary Mary Wakefield to lead a team overseeing the overhaul, as well as the creation of a new executive council, built by Wakefield and reporting to Walensky, that will “determine agency priorities, track progress and align budget decisions, with a bias toward public health impact.”

The agency did not offer a specific timeline for when the council would be established, but noted broadly in a statement that “the work ahead will take time and engagement at all levels of the organization.”

The overhaul of the CDC’s approach to communicating with the public has already begun, and will include revamping and streamlining the agency’s web site and creating simplified public health guidance. The agency will also create a new equity office, working across all functions of the organization from hiring to policy to improve the agency’s diversity.

The overhaul seeks to change “the CDC’s culture” by moving away from a “misaligned” approach of incentivizing staff to publish their research in scientific publications and instead encouraging personnel to produce research and data aimed at public health policy and action, the CDC official said.

The agency is also considering measures that will speed up the publication of data and scientific findings, training more staff to be ready to respond in a public health emergency and setting up emergency staffing to ensure there are no personnel gaps during a crisis.

Walensky will also seek more authority for the CDC, through Congress and the Biden administration, to mandate data collection from states, to move money to external partners faster during an emergency and to offer more competitive salaries for recruiting, among other things.
 

Heliobas Disciple

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The CDC Failed, So Spin It Off and Make It More Powerful?
By Jeffrey A. Tucker
August 17, 2022

The failure of the CDC to manage Covid-19 was baked in from the first moments of its response. A government agency was never going to mitigate much less get rid of this sort of pathogen. This is because the virus never cared a whit about prestige degrees, job descriptions, big budgets, high-end connections, media agitprop, or polls. It went on its merry way, hit everyone, and immune systems adapted as they always have done.

The great experiment was an enormous flop.

The costs of the experiment we know: it is the catastrophe that Donald Henderson predicted it would be in 2006.

Thus does it make sense that the present overlords of the agency have admitted at least partially to have made some errors. The question is what were these errors. From the latest news concerning some impending shakeup, I see no evidence of any serious rethinking of the crazed and cockamamie lockdown orders it issued from March 2020 onward. Not even preposterous mandates like plexiglass at retail counters, two years of school closures, “six feet of distance,” mask mandates, and limits on how many people you can have in your home have prompted remorse.

Instead, every indication is that the CDC believes the real problem was that it did not have a high-enough budget and enough power. Plenty of lawmakers are willing to go along – not that anyone is asking them. Therefore, its tremendous pandemic powers need to be tweak and invested mainly in a division known as the Office of the Assistant Secretary for Preparedness and Response, or ASPR.

Says The Washington Post:

The Biden administration is reorganizing the federal health department [HHS] to create an independent division that would lead the nation’s pandemic response, amid frustrations with the Centers for Disease Control and Prevention.

Joy!

The new head of this high-level division (same level as FDA/CDC) is Dawn O’Connell who has a background in literature (Vanderbilt) and law (Tulane), not science or medicine. She is a political appointee who took the reins as Assistant Secretary of Health and Human Services for Preparedness and Response, as confirmed by the Senate in 2021. She is now elated to report that her division will be elevated to become just as important as the CDC and the FDA.

Here is her memo to the staff:

ASPR Team:

As you know firsthand, ASPR is at the forefront of many of HHS’s and the Biden-Harris Administration’s top priorities. Whether your work involves strengthening our core preparedness and response capabilities, tackling new and emerging challenges, or providing essential support services to the team, please know that the work that you do matters and that it is making a big difference.
In recognition of the tremendous value this team brings to the Department and the American people – and due to the increasing size and scope of what we do – I asked Secretary Becerra to consider making us an Operating Division and I am pleased to report that Secretary Becerra has made the critically important decision to elevate our team from a Staff Division to an Operating Division (OpDiv)!
This change allows ASPR to mobilize a coordinated national response more quickly and stably during future disasters and emergencies while equipping us with greater hiring and contracting capabilities. As an OpDiv, we are now in the same category as other large HHS teams with core operational responsibilities such as CDC, NIH, FDA, CMS, and ACF. This change is an important next step for our organization which has continued to grow and evolve since its creation in 2006 – the pace of which has quickened over the past year. This change is also a recognition of the good work you all have been and continue to do on behalf of the American People….
Along with this reclassification, moving forward we will be known as the Administration for Strategic Preparedness and Response (ASPR). The adjustment to our name signals our elevation to an OpDiv, while maintaining the equity and brand recognition we have built with key internal and external stakeholders, particularly over the course of the pandemic.

Thus must we ask: what the heck is going on here? The Biden administration has no idea. Indeed the Washington Post reports that “some senior Biden administration officials said they were unaware of the plan to reorganize the department, which was approved by HHS Secretary Xavier Becerra and has been held close by his deputies.”

This point is crucial. This is how the administrative state works. It cares nothing for the elected officials who come and go. It moves on its own, fueled by money baked into the budgets and with power hardly anyone dares to challenge. There is never any accountability. There is only one path forward: more power. Elections be damned.

The most important part of the memo here is the idea of mobilizing a “coordinated national response.” It drove these people utterly bonkers that during the pandemic, several states went their own way. South Dakota never shut down. Georgia opened a month after the shutdowns. Florida and Texas were next. Finally all the states with Republican governors opened while most states with Democratic governors remained closed to some degree.

The empirical results are incredibly obvious. The open states performed as well and often better on disease demographics. Meanwhile their economies did not suffer nearly as much. The kids stayed in school. The churches functioned. There were live musical performances. The museums, libraries, and playgrounds opened. People are less traumatized.

The migration of people from blue to red tells the whole story. Masses of people fled the lockdown states for the open states.

A “coordinated national response” would make such federalist solutions impossible. Forget the 9th and 10th Amendments. These agencies and these people care nothing for them, nor actual science which would encourage a plethora of experiments in the management of a pathogen. These bureaucrats in Washington think they have all the answers, and they demand complete compliance.

Meanwhile, the CDC itself is being reorganized. But don’t be fooled by any appearance of contrition. They still have a legal appeal in process that would put a mask back on your face when traveling. The new agency to which some its pandemic responsibilities will be transferred will have a 1,000-person staff to start, people paid the big bucks to sit around coming up with new ways to whip up disease panic and start another crackdown.

A better solution would be to abolish the CDC. States can handle all its responsibilities. It did not even exist until 1947. Its purpose was mosquito control, spraying a now-banned chemical (DDT) everywhere. These days we handle that by going to Home Depot.

The CDC as an agency grew out of the 1944 Public Health Services Act that permitted nationally ordered quarantines for the first time. The legislative history of that thing remains a mystery to me. Regardless, it is nowhere justified in the US Constitution. This act needs to go too. So too all the federal agencies to which it gave rise. This is the only real solution.

Certainly creating a new agency is not the answer. And note that ASPR has its roots in 2006 as an outgrowth of the Bush administration’s obsessive panic over bioterrorism. It was also the first year that anyone imagined that lockdowns could be an appropriate path for any free society. It was the year that “social distancing” was invented by a cabal of computer scientists with zero experience in infectious disease.

These fanatics need to be out of power completely, and the regulations, laws, and agencies that enabled them to ruin the country and its freedoms must be ended. This is what any responsive government in a modern society would do. It would see failure and call it and then do something about it. It certainly would not go in this new direction and reward the disease planners with more power and money!

We must learn real lessons and act on them.
 

Heliobas Disciple

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In an effort to address its missteps during Covid, CDC plans an ‘ambitious’ agency overhaul
By Helen Branswell
Aug. 17, 2022

The Centers for Disease Control and Prevention, an agency that has had its reputation battered by a series of missteps in the Covid-19 pandemic, and a slow response to the monkeypox outbreak, will undergo an “ambitious” overhaul, Director Rochelle Walensky announced Wednesday.

In an email to staff, Walensky said the renewal effort will focus on making the agency more nimble and responsive to needs that arise in health emergencies. The priority will be to gather data that can be used to rapidly dispense public health guidance, rather than craft scientific papers.

Walensky also said the agency needs to acknowledge the flaws of its response to Covid-19. Those mistakes date to the earliest days of the pandemic, when a test designed by CDC scientists to detect the new disease failed to work on the ground — leaving the country blind to how quickly the SARS-CoV-2 virus was transmitting at a critical juncture when aggressive measures could have slowed Covid’s spread.

That error happened on Walensky’s predecessor’s watch. But the agency has continued to struggle since her arrival at the beginning of the Biden administration, notably with confusing messaging about how long people who have been infected need to isolate to try to prevent onward transmission.

“For 75 years, CDC and public health have been preparing for Covid-19, and in our big moment, our performance did not reliably meet expectations,” Walensky said in the email, sent to the agency’s 11,000-person staff.  “My goal is a new, public health action-oriented culture at CDC that emphasizes accountability, collaboration, communication, and timeliness.”

Outside experts expressed enthusiasm — though some of it tempered — for the changes Walensky is proposing.

Jay Varma, who spent 20 years at CDC before becoming director of the Cornell Center for Pandemic Prevention and Response at Weill Cornell Medicine, applauded many of the points Walensky stressed, particularly her promise to reform the culture of the agency and build up the capacity of its staff to respond to emergencies. Over the past two decades or so, Varma told STAT, public health agencies like the CDC have become increasingly bureaucratic.

“If your culture is not aligned entirely with what your mission is, it doesn’t matter how good the strategy is. It doesn’t matter what your org charts are. It is all about the workforce culture,” he said.

But Varma warned effecting change in the agency’s culture will be challenging.

“It’s an agency run by geeks. It’s run by doctors and Ph.D.s,” Varma said. “What are doctors and scientists notoriously bad at? Managing. They’re really good at hypothesis-driven research and analyzing information and making predictions about what might happen. What they’re really bad at is managing people in an effective way.”

Though Walensky’s statement focused on her intention to reform the culture of the CDC, she said there would be structural changes as well. To that end, she announced she has appointed Mary Wakefield, who served as an acting deputy secretary of Health and Human Services near the end of the second term of the Obama administration, to lead a team to help implement the reform. Wakefield’s first day at the agency was Monday.

The changes Walensky plans to make will help the agency focus on what she sees as its top priorities: preparedness and response, equity, global health, laboratory science and data modernization.

The announcement comes on the heels of a review of the agency’s response to Covid that Walensky commissioned in the spring. Jim Macrae, associate administrator for primary health care at the Health Resources and Services Administration — part of HHS — was tasked in early April with doing a swift assessment of the CDC’s performance during the pandemic. To date, Walensky has only received an oral briefing on Macrae’s findings, which have not been publicly disclosed.

Macrae and Wakefield previously worked together at HRSA, where she served as administrator from 2009 to 2015.

Macrae’s evaluation was reportedly based on interviews with 120 CDC staff members and key external figures and is said to reflect a consensus on how the CDC should communicate with the public going forward.

It is said to have focused on the need to share scientific data faster and to translate the science the agency generates into practical policies that are easy to comprehend. It also reportedly calls on CDC to strengthen its capacity to respond to public health emergencies — a key responsibility of the agency.

In response to Macrae’s findings, Walensky is creating a new executive council that will report to her, along with a new equity office.

Varma was also enthusiastic about Walensky’s goal to have the agency share scientific findings more quickly, suggesting the vetting process for publishing CDC science — typically through its online journal Morbidity and Mortality Weekly Review, or MMWR — has long been mired in excessive layers of review that keep the agency from sharing information public health agencies elsewhere need to know.

He pointed to an MMWR report issued Tuesday on a case of polio detected in June in New York state. “Why did it take so long to get that out there? If this is a real public health emergency, shouldn’t at least some of that information have been out earlier?”

The article, he suggested, would have gone through an extensive review process at various levels of the CDC, including by officials concerned that anything published by CDC authors might be interpreted as official government policy. “So that is the type of thing, a cultural thing, that needs to change. Where you say: ‘Getting information out, even if it’s preliminary and imperfect, is a priority,’” Varma said.

Some of the improvements Walensky signaled she would like to make will require new authorities from Congress — a fact she acknowledged in her statement. The agency’s capacity to rapidly craft data-based guidance in disease outbreaks, for example, is wholly reliant on jurisdictions around the country agreeing to share data with the CDC. She suggested she will ask Congress to mandate data sharing with the agency.

Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, called Walensky’s reform objectives “an important first step.”

“You can’t begin to fix something until you begin to understand what the problems are,” he said.

But he noted that some of the data flow problems the CDC complains about are the result of their own limitations, saying the lack of interoperability between information systems is behind some of the issues. Osterholm pointed to the current monkeypox outbreak as an example.

“Right now the states have been prepared to provide the CDC with information on monkeypox cases through the notifiable disease system, but CDC can’t accept it,” he said. “They don’t have the software ability to do that yet.”

That points to another challenge Walensky will face in trying to bring about the changes that need to be made at the CDC. A number of the reforms she has identified will take money. Whether Congress will be open to increasing the budget of an agency seen to have fumbled the Covid and monkeypox responses remains to be seen.
 

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Risk of ‘brain fog’ and other conditions persists up to two years after Covid infection
By Elizabeth Cooney
Aug. 17, 2022

Among the many worrying consequences of Covid-19, neuropsychiatric conditions rank high. A year ago researchers from Oxford University reported that 1 in 3 patients experienced mood disorders, strokes, or dementia six months after Covid infection. Now the same group is back with a longer-term analysis of 1.25 million Covid patient records, including what they believe is the first large-scale look at children and at new variants.

Their news is both bad and good.

Up to two years after Covid-19 infection, the risk of developing conditions such as psychosis, dementia, “brain fog,” and seizures is still higher than after other respiratory infections, the researchers report in their study published Wednesday in the Lancet Psychiatry. But while anxiety and depression are more common soon after a Covid-19 diagnosis, the mood disorders are transient, becoming no more likely after the two months than following similar infections such as flu.

Children were not more likely to be diagnosed with anxiety or depression, right away or up to two years after Covid, and their risk of brain fog subsided over two years. But they were still more likely than children recovering from other respiratory infections to have seizures and psychotic disorders. Overall, the likelihood of all these diagnoses was lower in children than in adults.

On variants, the risk of neuropsychiatric diagnoses rose, from 10% higher for anxiety to 38% for brain fog — after the Delta variant emerged than after the alpha version. Similar risks continued with Omicron, even though that variant has milder effects during the acute phase of infection.

“What these data show in this very large cohort retrospectively analyzed is that the mood disorders and anxiety problems that are really, really prevalent in long Covid tended to resolve in a matter of months, which is great news for patients with long Covid who are not used to suffering in those ways,” Wes Ely, a critical care physician at Vanderbilt University Medical Center and associate director for research for the VA Tennessee Valley Geriatric Research and Education Clinical Center, told STAT. He was not involved in the Oxford studies.

“The other finding of this fascinating investigation is that the cognitive problems, the neurocognitive deficits that make people have brain fog, do not resolve so quickly,” he said. “Clinically, in my own practice and in our long Covid clinic, this is exactly what we’re seeing: that the acquired dementia that these patients get tends to be lasting and very problematic.”

To reach their conclusions, the Oxford team combed through data on 14 neurological and psychiatric diagnoses entered into electronic health records in the TriNetX network, mostly from the U.S., over a two-year period. For a control group, the 1.25 million Covid patients were matched with an equal number of patients with any other respiratory infection and no history of Covid. Compared with the people in the control group:
  • Adults under 65 with a history of Covid infection up to two years previously had a higher risk of cognitive deficit, better known as brain fog (640 vs. 550 cases per 10,000 people), and muscle disease (44 vs. 32 cases per 10,000 people).
  • Adults 65 and over who had Covid over the same time span had more diagnoses of brain fog (1,540 vs. 1,230 per 10,000 people), dementia (450 vs. 330 per 10,000 people), and psychotic disorder (85 vs. 60 per 10,000 people).
  • Children who had Covid were more likely to have seizures (260 vs. 130 cases per 10,000 children) and psychotic disorders (18 vs. 6 per 10,000 children).
Max Taquet, National Institute for Health and Care Research academic clinical fellow in psychiatry at Oxford and a study co-author, stressed that the elevated risk for seizures and psychotic disorders in children was still low. “It’s important to keep in mind the absolute numbers are often very small, much smaller than in adults,” he said on a call with reporters.
Related: ‘There’s no one long Covid’: Experts struggle to make sense of the continuing mystery

Taquet made the same point about adults. “I think it’s very clear that this is not a tsunami of new dementia cases,” he said. “Equally, I think it’s hard to ignore it, given the severity of the consequences of dementia diagnoses. A 1.2% increase in the population in absolute terms and compared to in other previous infections is hard to ignore.”

Paul Harrison, professor of psychiatry at Oxford and a study co-author, said these numbers were still important. “Certainly for some conditions, there appears to be a nontrivial and persisting greater risk of these diagnoses being made,” he said on the call with reporters. “And for some of those diagnoses, it’s highly likely that those people are going to need medical attention.”

While waiting for the mechanisms of long Covid — and any potential treatments — to be understood, “What’s important for me as a physician is that we know that we can have long-term outcomes in very severe persistent and disabling, neuropsychiatric disorders,” some of which can be treated, Teodor Postolache, professor of psychiatry at the University of Maryland School of Medicine, said.

An editorial published with the paper sounds a note of caution on psychiatric diagnoses.

“Dementia has an insidious onset, and the cohort is likely to have had some participants with undiagnosed or subclinical cases at baseline,” Jonathan Rogers and Glyn Lewis of University College London write. “Although concerning, the findings regarding psychosis and dementia need replication in a cohort in which there is more thorough ascertainment of case status.”

Electronic health records have limitations in how well they reveal complicated neuropsychiatric conditions — which might mean they are underreported, another long Covid researcher said. “I can tell you for a fact that it is really difficult to express in medical records, particularly if you’re busy doing a lot of them, all the nuances that sort of go along with the neurocognitive issues,” Steven Deeks, a professor of medicine at University of California, San Francisco, told STAT. “This stuff can be subtle. This is only picking up very blunt stuff. At the end of the day, it provides additional proof that long Covid is real, that some people can have profound symptoms, and that they can persist for a couple of years.”

Rachel Sumner, a senior research fellow at Cardiff Metropolitan University, called the study results “alarming” while Covid continues to spread. “The finding of complex and potentially severe psychiatric and neurological fallout of Covid infection adds yet more weight and concern to the impact of repeated infections that will occur should the virus continue to be allowed to spread to re-infect with little to no control, ” she said in a statement.

The study didn’t explore the causes of the neuropsychiatric illnesses, but Vanderbilt’s Ely said the prevalence it reports lines up with emerging research on different parts of the brain being affected by the SARS-CoV-2 virus, corresponding to mood disorders and to cognitive impairment. And he’s worried about what comes next.

“This paper … fits the narrative both of clinically what I see in practice, but also the actual brain science that we’re coming up against,” he said. As for cognitive impairment, he said,“This is something that is very hard for people to cope with because they can’t go back to work. They have to retire early, and they desperately need answers.”
 

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Watch: Shoppers At Shanghai Ikea Flee Sudden COVID Lockdown
by Tyler Durden
Wednesday, Aug 17, 2022 - 09:50 PM

Though America's Centers for Disease Control and Prevention (CDC) took a turn toward Covid rationality last week, "Zero-Covid" madness is still raging in China.

Just ask the poor people who were at a Shanghai Ikea on Saturday evening. One minute they're innocently eyeing furniture and appliances, the next they're being told they can't leave the store or go home.

An announcement was made over the store's public address system, notifying shoppers the store had been ordered to close and to prevent anyone from leaving, due to contact tracing. Shocked by suddenly being condemned to quarantine, many opted to make a run for it.

Video captured a dystopian scene in which guards attempt to close doors on the escapees, some of whom are screaming in their panic. The guards were overpowered, but it's not clear what happened to the fleeing shoppers next.

Yesterday, an abnormal health code case was presented at an IKEA in Shanghai, & the entire mall was suddenly blocked
Some ppl forced their way out for fear of being sent to concentration camps, but there is actually nowhere to escape under #AmazingChina’s digital surveillance pic.twitter.com/MWpbTOJ3kz
— Donna Wong (@DonnaWongHK) August 14, 2022

Those who were trapped in the store had to first linger there for four hours -- from 8pm til midnight -- before being transported to quarantine hotels, reports Bloomberg. Then they faced quarantine for two days followed by five days of monitoring.

The mass-detention was triggered merely because a close contact of a six-year-old boy who tested positive had visited the store. It's not clear if that individual was in the store at the time. What's more, the 6-year old wasn't even symptomatic.

VIDEO: Chaotic scenes at Ikea store in Shanghai with shoppers trying to escape as authorities tried to quarantine them VIDEO: Ikea store shoppers in Shanghai flee from authorities trying to quarantine them pic.twitter.com/jmKWFrUXEu
— Insider Paper (@TheInsiderPaper) August 15, 2022

While the video of the incident is dramatic, it's hardly the first such episode, as Chinese citizens continue to live in a dark game of contact-tracing roulette. Others have been suddenly detained while working in offices, exercising at gyms or dining in restaurants.

Of China's major cities, Shanghai has been hit hardest. Between March 10 and July 31 of this year alone, the city endured 92 days of full or partial lockdown. This spring, it got to the point where apartment-dwellers were screaming in unison from their balconies:

View: https://www.youtube.com/watch?v=3SRuKZ5P1io
2min 29 sec

Last week, the CDC updated its guidelines, with one of the bureaucracy's epidemiologists saying "we know that Covid-19 is here to stay." Two proclamations were particularly welcome, even if they were terribly overdue:
  • "It's no longer recommended to screen those without symptoms."
  • "Unvaccinated people now have the same guidance as vaccinated people."
In China, however, there's no sign that the Zero-Covid regime will be relaxed anytime soon, despite mounting damage to China's economy, and despite growing Chinese discontent.
 

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Judge Green Lights Lawsuit Challenging San Diego’s COVID Vaccine Mandate for Employees
A lawsuit challenging San Diego’s COVID-19 vaccine mandate for municipal employees will move forward after a federal judge on Tuesday rejected the city’s request to dismiss the complaint.

By Michael Nevradakis, Ph.D.
08/17/22

A lawsuit challenging San Diego’s COVID-19 vaccine mandate for municipal employees will move forward after a federal judge on Tuesday rejected the city’s request to dismiss the complaint.

U.S. District Judge Gonzalo Curiel said the city’s motion to dismiss did not address recent developments in case law and public health guidance pertaining to COVID-19 public health measures, restrictions and requirements.

The San Diego City Council on Nov. 29, 2021, voted 8-1 in favor of approving the mandate. The subsequent ordinance required current and newly hired or appointed city employees, elected officials, board members and volunteers to be “fully” vaccinated for COVID-19.

ReOpen San Diego, a nonprofit citizens group, in February filed the suit alleging the mandate kept “an entire category of individuals from meaningful participation in city government” by barring the unvaccinated from entering city buildings or attending municipal meetings.

The city’s motion to dismiss cited the U.S. Supreme Court’s decision in 1905 in Jacobson v. Massachusetts, a case that pertained to mandatory smallpox vaccinations, which held that local governments have the authority to implement laws and ordinances in response to public health threats.

In rejecting the motion, Judge Curiel held this argument did not directly address the allegations made in ReOpen San Diego’s lawsuit challenging the city’s restrictions.

Responding to the decision, Arie Spangler, an attorney representing ReOpen San Diego, remarked:

“The majority of governments (and employers) are now backing away from COVID vaccination mandates, the data is showing that the currently available vaccinations do not prevent transmission or infection, and the city has been unable to present any credible authority supporting its position that it has a legal right to require elected officials, board and commission members and volunteers to provide proof of vaccination in order to serve the city.”

Spangler was referring to, among other recent developments, the new guidance from the Centers for Disease Control and Prevention (CDC) that eliminates quarantine and distancing recommendations, and distinctions between vaccinated and unvaccinated individuals.

ReOpen San Diego initially threatened to sue in December 2021, in a letter sent to the city demanding city officials revoke the mandate. The group argued the mandate unlawfully restricted the pool of potential candidates for public office.

When the city didn’t respond, the group filed a suit alleging the mandate is unconstitutional and discriminatory, and seeking to cease enforcement of the mandate, declare the mandate unlawful and award legal fees to the plaintiffs.

The lawsuit alleged the city’s ordinance and related policies “operate[d] to exclude an entire category of individuals from meaningful participation in city government … due solely to a personal medical decision whether to be vaccinated for COVID-19 (or an individual’s refusal to disclose their COVID-19 vaccine status).”

The lawsuit also claimed: “The Ordinance and Plan are … blatantly illegal, as they violate the U.S. Constitution and state and local law and offend the foundational principles of democracy.”

Amy Reichert, co-founder of ReOpen San Diego, in February said, “This is the only recourse we have, as the people, to be able to protect our meaningful participation in government.

“I absolutely believe in keeping people safe when it makes sense,” Reichert said. “This doesn’t make sense, and it’s discriminatory on its face.”

ReOpen San Diego organized protests and rallies against COVID-19-related mandates and restrictions, dating back to 2020.

According to the San Diego Union-Tribune, the group has “clashed with county supervisors and other local officials at public meetings and orchestrated hours of public comments denouncing pandemic restrictions.”

San Diego city officials, at the time the lawsuit was filed, described the mandate as a “lawful and necessary step to protect public health,” adding that medical or religious exemptions to the mandate could be requested.

Evidence from multiple jurisdictions, however, suggests such exemptions are rarely approved.

For example, data from the city of Boston, provided in July 2022, showed less than half of municipal employees who sought an exemption to the city’s vaccine mandate received them.

Evidence from military whistleblowers and from lawsuits challenging vaccine mandates for military service members reveal only a small fraction of exemption requests have been approved.

New CDC guidance on COVID may fuel more legal challenges

In a recent interview on CHD.TV’s “Good Morning CHD,” New York-based attorney Jim Mermigis, whose firm has been active in challenging vaccine and mask mandates, said legal actions may increase now that the CDC has loosened its COVID-19 recommendations.

The CDC’s revised guidance may also bolster legal challenges that were already in play.

An Epoch Times report on Tuesday highlighted successful efforts to challenge COVID-19 vaccine mandates in California school districts, including the Los Angeles Unified School District (LAUSD) and the Piedmont Unified School District. These lawsuits were supported, in part, by Children’s Health Defense (CHD).

The same Epoch Times story also mentioned successful efforts to block a proposed California bill, SB 871, that would have required vaccination for children at all school levels between kindergarten and 12th grade, in order to attend school within the state.

Separately, in early July, a Los Angeles Superior Court judge ruled in favor of the father of a 12-year-old boy, who filed a lawsuit challenging the LAUSD’s vaccine mandate.

Similar efforts in many parts of the U.S. have resulted in the near-elimination of school vaccine mandates at the state level. According to an Aug. 8 report by Vox, “No state in the country is planning to require student vaccinations, a marked turnaround from where things seemed to be headed last winter.”

Only Washington, D.C., has announced a mandatory COVID-19 vaccination policy for the 2022-2023 school year, for students 12 and over. CHD, in a letter sent by Robert F. Kennedy, Jr., the organization’s chairman and chief legal counsel, threatened to sue if the mandate isn’t lifted.

Conversely, Louisiana Gov. John Bel Edwards announced in May that COVID-19 vaccines will be removed from the state’s list of required immunizations for students.

And earlier this week, the New York City Department of Education announced it would be reinstating, pending internal review, 82 teachers who were suspended on suspicions of submitting fake COVID-19 vaccination cards.

Beyond education, a state appeals court on Aug. 15 ruled that a California church that was issued $200,000 in fines for defying the state’s COVID-19 restrictions, will not have to pay those fines.

The court cited a 2020 decision by the U.S. Supreme Court finding California’s restrictions against indoor religious gatherings were unconstitutional.

In July, a first-of-its-kind settlement in Illinois awarded $10.3 million to more than 500 current and former healthcare workers in the state who were denied religious exemptions to the state’s vaccine mandate, and allowed them to reapply for their jobs at their previous seniority level.

The previous month, the 5th U.S. Circuit Court of Appeals blocked the Biden administration’s vaccine mandate for federal employees until at least September, when the case will be heard before the court’s full 17-judge panel.

In May, New York City paused its vaccine mandate for New York Police Department employees, pending the filing of depositions in a class action lawsuit challenging the mandate.

And, two judges hearing lawsuits challenging vaccine mandates in New York City recused themselves from their respective cases in June after financial disclosures revealed they held investments in Pfizer and other vaccine manufacturers. A third judge refused to step down, citing “outdated information” about her holdings.
 

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White House COVID Czar Admits 6-foot Social Distancing Rule ‘Not the Right Way’
By Jack Phillips
August 17, 2022

White House COVID-19 czar Ashish Jha on Tuesday admitted that the six-foot social distancing rule that was implemented in early 2020 isn’t actually effective.

Over the past several years, “a lot of time” was spent “talking about six feet of distance, 15 minutes of being together. We realize that’s actually not the right way to think about this,” he said during a White House briefing on COVID-19.

“That’s not the most accurate way to think about this,” Jha said, adding that it is about “the quality of air you’re breathing around you.”

In a crowded indoor area with poor ventilation, people can “get infected” with COVID-19 “in minutes,” Jha said, adding that being outdoors you can be “outside for long periods of time” and not get infected.

Jha made those comments in regards to the U.S. Centers for Disease Control and Prevention (CDC) having relaxed guidelines around COVID-19. That included dropping the six-foot social distancing rule.

The agency last week rescinded a number of rules and made key updates to its recommendations, now stating that unvaccinated and vaccinated individuals should essentially be treated the same, while explicitly saying that those with a prior infection have protection against severe illness.

Starting in early 2020, federal health agencies issued a recommendation that people keep at least six feet of distance away from one another. Health departments, businesses, corporations, and schools across the United States then adopted the rule, leading to restrictions such as capacity limits and lockdowns.

‘Nobody Knows’

A former administration for the Food and Drug Administration, Scott Gottlieb, revealed in late 2021 that the six-foot rule was made up.

“Nobody knows where it came from,” Gottlieb, a Pfizer board member, told CBS News. “Most people assume that the six feet of distance, the recommendation for keeping six feet apart, comes out of some old studies related to flu, where droplets don’t travel more than six feet.”

The CDC, he said, initially recommended a 10-foot rule, and the six-foot rule was a compromise between the federal health agency and Trump administration officials.

“So the compromise was around six feet. Now imagine if that detail had leaked out. Everyone would have said, ‘This is the White House politically interfering with the CDC’s judgment.’ The CDC said 10 feet, it should be 10 feet, but 10 feet was no more right than six feet and ultimately became three feet,” Gottlieb remarked.

The CDC also said in its update that it’s no longer recommending unvaccinated people to quarantine after exposure. Unvaccinated people who have been in close contact with an infected person aren’t advised to go through a five-day quarantine period if they haven’t tested positive or shown symptoms, according to the revised guidelines.

Regardless of vaccination status, according to the CDC, “you should isolate from others when you have COVID-19” or are “sick and suspect that you have COVID-19 but do not yet have test results.” Previously, the CDC said fully vaccinated people who were exposed could skip the quarantine period.
 

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Novavax Seeks FDA Authorization for Emergency Use of COVID-19 Vaccine Booster
By Katabella Roberts
August 17, 2022

Novavax is seeking emergency authorization of its COVID-19 booster shot in adults aged 18 and older from U.S. regulators, the company announced on Monday.

In a press release, the biotechnology company based in Maryland said it has submitted an application to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) for its protein-based booster shot.

If authorized, the Novavax vaccine would be the first protein-based COVID-19 booster for adults.

“It’s important for people to have a choice as they evaluate how to stay protected against COVID-19, and boosters are an invaluable tool to build upon immunity obtained from previous vaccinations,” said Novavax President and CEO Stanley Erck in a statement.

“Based on the data presented to the FDA’s VRBPAC [Vaccines and Related Biological Products Advisory Committee] and the CDC ACIP [Advisory Committee on Immunization Practices], we believe our vaccine offers a broad, long-lasting immune response against a range of variants.”

The vaccine is different from the mRNA and viral-vector COVID-19 vaccines, and the protein-based technology used within it has been utilized for decades to combat diseases like shingles and hepatitis.

The Novavax vaccine delivers proteins along with immunity-stimulating adjuvants—a substance that enhances the body’s immune response to a vaccine—directly to a person’s cells, rather than via mRNA, to spur an immune response.

“The Novavax COVID-19 Vaccine, Adjuvanted contains purified protein antigen and can neither replicate nor can it cause COVID-19,” the company states.

Phase 3 Trials

Novavax’s application for EUA is supported by data from its phase 3 trial of over 25,000 adults in the United States and Mexico, during which researchers found that the vaccine was 90.4 percent effective against COVID-19, and its UK-sponsored COV-BOOST Phase 2 trial.

“As part of an open-label booster phase of the [phase 3] PREVENT-19 trial, a single booster dose of the Novavax COVID-19 Vaccine, Adjuvanted was administered to healthy adult participants at least six months after their primary two-dose vaccination series of the Novavax COVID-19 Vaccine, Adjuvanted,” the company said.

“The third dose produced robust antibody responses comparable to or exceeding levels associated with the efficacy data in the primary series Phase 3 clinical trials. In the COV-BOOST trial, the Novavax COVID-19 Vaccine, Adjuvanted induced a significant antibody response when used as a heterologous third booster dose.”

Following the booster shot, “local and systemic reactions had a median duration of approximately two days,” according to Novavax, while “medically attended adverse events, potentially immune-mediated medical conditions, and severe adverse events occurred infrequently following the booster dose.”

The booster shot would be available to individuals who received two doses of the Novavax vaccines, as well as to those who got another vaccine.

The FDA granted EUA for the initial two-shot Novavax vaccine for adults 18 and over in July and the Biden administration promptly announced a deal with the company to purchase 3.2 million doses of the vaccine.

Novavax had hoped that individuals who had declined to take Pfizer and Moderna mRNA vaccines over the risk of heart inflammation would opt to take theirs instead, Reuters reported.

However, the European Medicines Agency (EMA) earlier this month recommended adding a warning for two types of heart inflammation: myocarditis and pericarditis, to Novavax’s shot—marketed under the name Nuvaxovid—owing to a small number of cases reported in those who received the vaccine.

The EMA’s Pharmacovigilance Risk Assessment Committee also requested the “marketing authorization holder of Nuvaxovid provides additional data on the risk of side effects occurring.”

Novavax on Aug. 8 halved its full-year revenue forecast saying it does not anticipate significant sales of its COVID-19 shot this year in the United States amid dwindling demand.
 

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Moderna to Commence Construction of World’s First mRNA Factory on Australian College Campus
By Jessie Zhang
August 16, 2022

The U.S. pharmaceutical giant Moderna has finalised arrangements with the Australian and Victorian governments to build the world’s first mRNA production facility located on a university campus.

The construction at Melbourne’s Monash University is expected to commence at the end of 2022, with production anticipated to begin by the end of 2024.

The company said that the facility is expected to produce up to 100 million mRNA respiratory vaccine doses annually, targeting respiratory viruses, including COVID-19, seasonal influenza, respiratory syncytial virus, “and other potential respiratory viruses, pending licensure.”

“We look forward to being a part of the Monash Clayton precinct and contributing to the R&D ecosystem in Melbourne and across Australia,” Moderna General Manager Michael Azrak said in a statement on Aug. 15.

The prime minister of Australia and the premier of Victoria said that the plan for the ten-year partnership to create a “homegrown” mRNA ecosystem has been completed.

It is designed to reduce Australia’s dependence on imported mRNA vaccines, vulnerability to supply disruptions, and delays, according to the Australian ministers.

Premier of Victoria Daniel Andrews said that this agreement means that Australia will be home to Moderna’s only mRNA manufacturing centre in the Southern Hemisphere.

“We’re not wasting a second in making sure we have access to the vaccines we need to keep Victorians safe,” Andrews said.
Vaccine Development Rushed

However, a professor of medicine at Australia’s Flinders University has said that, in his opinion, the mRNA development was rushed, and that this may have contributed to issues with adverse reactions.

“I think there was early leadership by Oxford University [AstraZeneca] with the adenovirus viral vector being put into human trials very quickly, you saw that similarly with Moderna and its mRNA approach,” Nikolai Petrovsky told The Epoch Times previously.

“This created a ‘follow the leader’-type mentality with (manufacturers) Sputnik and Johnson and Johnson copying the Oxford approach and Pfizer following Moderna with the mRNA approach.”

Last year, the Victorian government made a significant $50 million (US$35 million) investment to establish “mRNA Victoria,” an initiative responsible for leading the mRNA vaccine industry for future generations.

As part of this initiative, they granted Monash University $5.4 million to create the mRNA production facility on its campus.
 

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EXCLUSIVE: It pays to be rich! America's wealthiest, including Tom Brady, Khloe Kardashian, Reese Witherspoon, Kanye and Nancy Pelosi's husband took millions in PPP loans – and nearly all have been forgiven
  • Celebrities including Kanye West, Jay-Z and Khloe Kardashian received millions in government PPP (Payment Protection Program) loans, set up for desperate businesses hit by the Covid pandemic
  • DailyMail.com can now reveal the exact amounts that these millionaires took out via the government program
  • Kanye West's Yeezy LLC borrowed $2,363,585, with $1,772,689 being spent on payroll for 106 staff
  • Khloe Kardashian's denim brand Good American LLC had a loan of $1,245,405 approved on April 14, 2020, mostly for the payroll of 57 workers. The full amount, plus interest, was forgiven
  • In most cases, the loans have been 'forgiven' so the full amount, including interest, will not have to be repaid, despite the owners' wealth
By Chris White For Dailymail.com
Published: 09:29 EDT, 17 August 2022 | Updated: 11:40 EDT, 17 August 2022

The companies of mega-rich celebrities, including billionaires Kanye West and Jay-Z, received millions in government PPP loans – and in virtually every case the A-listers have been let off the hook for paying back the full amount.

For the first time, DailyMail.com can reveal the exact amounts that these wealthy companies got through the Payment Protection Program, which was set up for desperate businesses hit by the Covid pandemic.

In all but two of the cases we examined, the company was 'forgiven' despite the star owners being multi-millionaires. The status of the others is unknown.

The loan program cost US taxpayers $953billion, with the University of Texas estimating that 15 percent of PPP claims – around $76billion – were fraudulent.

It was claimed that after the first round of PPP loans, up to 90 percent of ethnic minority business owners were unsuccessful at getting the loan and were at the 'end of a line', according to an Associated Press survey, which showed a disproportionate amount of white people in rich areas being approved for a loan.

Yet celebs and their businesses had no problems.

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DailyMail.com can now reveal the exact amounts that these millionaires – and some billionaires – took out via the government program

Kanye West's Yeezy LLC, based in La Palma, California, borrowed $2,363,585, with $1,772,689 being spent on payroll for 106 staff.

ProPublica, which has published the amount and status of every federal loan, states that Yeezy's loan status is 'not disclosed.'

Yeezy's Adidas sneaker line's profits increased during the pandemic from $1.3 billion in 2020 to $1.7 billion in 2021, a rise of 31 percent.

Kanye West himself has a net worth of about $2billion.

A subsidiary, Yeezy Schloss LLC, borrowed $15,625 for one employee and was forgiven all but $147.

A loan will be forgiven, including the one percent interest, through a complicated calculation based on the amount, how many employees were maintained during the coronavirus crisis and on what hours/wages were compared to pre-covid.

Kanye's one-time sister-in-law Khloe Kardashian's denim brand Good American LLC had a loan of $1,245,405 approved on April 14, 2020, mostly for the payroll of 57 workers.

The full amount, plus interest, was forgiven.

Khloe's net worth is reportedly $60million.

The company is said to be worth $12.7 million and made $1million in sales on its first day of business in 2016.

Jay-Z is associated to two firms approved for a loan two years ago.

Malibu Entertainment is linked to his streaming platform Tidal and took $2,106,398 to secure 95 jobs and was let off of repaying the full amount.

His champagne brand Armand De Brignac Holdings – where he holds a 50 percent stake – borrowed $293,119 for payroll, which was fully disbursed. It is not stated if the loan was paid back.

Sean Combs's cable network, Revolt Media and TV LLC, took $1,929,252 for 134 jobs, which was forgiven.

The two rappers are among the highest paid celebrities in the world, with Jay-Z worth $1.3billion, while Combs, aka Puff Daddy or Diddy, is just behind with a net worth of $900million.

NFL legend Tom Brady is set to become the game's first ever billionaire when he eventually retires with part of his income coming from the wellbeing site TB12, based on the Tom Brady diet, which he co-founded with body coach Alex Guerrero.

The company, TB12 Inc, was given $960,855 to help secure 80 jobs. The full amount, plus interest of nearly $12,000, is fully forgiven.

Jeff Koons is America's richest artist, but his firm Jeff Koons LLC still applied for $1,091,200 to keep 53 jobs, which was fully forgiven.

Reese Witherspoon's clothing company, Draper James LLC, was given $975,472 in the first PPP round for payroll and rent, and had the loan wiped out.

Some rock bands succeeded in their firms being bailed out by government, as the music scene was forced to shutdown.

Pearl Jam Touring Inc had its $629,335 loan forgiven after saving 28 jobs.

Green Day Inc and Green Day Touring Inc succeeded with three loans between them, worth $452,302 for 39 jobs, with it all nearly being forgiven, less $66,000.

The movie industry was also badly hit by lockdowns. Legendary director's firm Francis Ford Coppola Presents LLC was approved for a loan of $7,147,038, which covered the wages of 469 workers and didn't have to be repaid.

Political figures also cashed in on the government program.

Jared Kushner's family were granted three PPP loans for their various businesses.

The Kushner family's newspaper publisher Observer Holdings, LLC was approved in the first round of loans on April 27, 2020. The company got a $800,407 loan used toward payroll, utilities, rent and saved 41 jobs.

The loan, including interest, was forgiven in full.

The Kushner family hotel business Princeton Forrestal, LLC was approved for a $1,569,977 loan also in April 2020. The funds went to payroll, saving 196 jobs. The loan, including interest, was cleared.

Esplanade Livingston, LLC, which owns the land housing Kushner's family's Westminster Hotel in New Jersey, was granted a $630,735 loan, which went to paying 56 employees. The entire loan was forgiven.

House Speaker Nancy Pelosi's husband Paul Pelosi has a 8.1percent share in EDI Associates, a restaurant business which took out two PPP loans.

EDI Associates, based in San Rafael, was granted a $711,708 loan. The loan went to the salaries of 52 employees.

EDI Associates, this time based in Sonoma, California, applied for a loan in February 2021, and was granted $996,392.

In both cases, the loans, including interest, were forgiven.

Earlier this month, President Joe Biden signed a bill that will give the Justice Department more time to investigate and prosecute those who fraudulently collected PPP loans.

In March, Biden vowed, 'We're going after the criminals who stole billions in relief money meant for small businesses and millions of Americans.'
 

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No link between COVID-19 vaccination in pregnancy and higher risk of preterm birth or stillbirth

by British Medical Journal
August 17, 2022

Vaccination against COVID-19 during pregnancy is not associated with a higher risk of preterm birth, small for gestational age at birth, or stillbirth, concludes a large study from Canada published by The BMJ today.

These findings can help inform evidence based decision making about the risks and benefits of COVID-19 vaccination during pregnancy, say the researchers.

COVID-19 infection during pregnancy has been associated with higher risks of complications, including admission to hospital and death for pregnant individuals, as well as preterm birth and stillbirth.

COVID-19 vaccination during pregnancy has been shown to be effective against COVID-19 in pregnant individuals as well as their newborns, but evidence about pregnancy outcomes after COVID-19 vaccination during pregnancy from large studies is limited.

To address this, researchers set out to assess the risk of preterm birth, small for gestational age at birth, and stillbirth after COVID-19 vaccination during pregnancy.

They used a population-based birth registry to identify all liveborn and stillborn infants with a gestational age of at least 20 weeks or birth weight of at least 500g in Ontario, Canada between 1 May and 31 December 2021.

This information was then linked to the database that captures all COVID-19 immunizations in the province.

A wide range of potentially influential factors were taken into account. These included mother's age at delivery, pre-pregnancy body mass index, reported smoking or substance use during pregnancy, pre-existing health conditions, number of previous live births and stillbirths, area of residence and income.

Of 85,162 births, 43,099 occurred in individuals who received one dose or more of a COVID-19 vaccine during pregnancy—42, 979 (99.7%) received an mRNA vaccine, mainly Pfizer-BioNTech or Moderna.

The researchers found that vaccination during pregnancy was not associated with any increased risk of overall preterm birth (6.5% among vaccinated v 6.9% among unvaccinated), spontaneous preterm birth (3.7% v 4.4%), or very preterm birth (0.59% v 0.89%)

No increase was found in risk of small for gestational age at birth (9.1% v 9.2%) or stillbirth (0.25% v 0.44%).

Findings were similar irrespective of what stage (trimester) of pregnancy vaccination was given, number of doses received during pregnancy, or which mRNA vaccine product.

This is an observational study, so can't establish cause and the researchers point to some limitations, such as being unable to assess COVID-19 vaccination before pregnancy or around the time of conception and being limited to assessment of mRNA vaccine products.

However, results remained unchanged in additional sensitivity analyses designed to assess the impact of different methodological approaches, suggesting that they are likely to be robust.

As such, the researchers say that "our findings—along with extant evidence that vaccination during pregnancy is effective against COVID-19 for pregnant individuals and their newborns, and that COVID-19 during pregnancy is associated with increased risks of adverse maternal, fetal, and neonatal outcomes—can inform evidence based decision making about COVID-19 vaccination during pregnancy."

"Future studies to assess similar outcomes after immunization with non-mRNA COVID-19 vaccine types during pregnancy should be a research priority," they add.
 

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Intranasal vaccination produces potent systemic immunity against HIV and SARS-CoV-2 in animal models
by Delthia Ricks , Medical Xpress
August 17, 2022

intranasal-vaccination.jpg

Long-lived antigen-specific IgG and IgA plasma cells are established in mice following intranasal immunization with amph-protein, without induction of anti-PEG antibodies. BALB/c mice (n = 3 animals per group) were immunized i.n. with 5 µg amph-eOD mixed with 25 µg cdGMP adjuvant and boosted 6 weeks later with the same formulation. Female reproductive tract (FRT) and bone marrow (BM) eOD-specific IgG and IgA antibody-secreting cells (ASCs) were assessed by ELISPOT at 20 weeks post immunization. (A) Representative well images and (B) quantified number of antibody-secreting plasma cells per 500,000 cells are shown. All data are presented as mean ± s.e.m. (C) Serum samples from mice immunized as in Fig. 4A and F with saponin (collected at week 11) or cdGMP adjuvants (collected at week 12) were analyzed by ELISA for anti-PEG IgG, comparing to a reference anti-PEG IgG standard. Credit: Science Translational Medicine (2022). DOI: 10.1126/scitranslmed.abn1413

Even though most viruses cause infection directly through mucosal cells, the vast majority of vaccines are administered intramuscularly in a cellular mismatch that doesn't always produce optimum immunity.

SARS-CoV-2 infects through the nasal mucosa, HIV via the genital and anal mucosa. But those two aren't alone, a host of other viruses, including those that cause influenza, measles and polio—along with many, many others—infect humans through mucosal tissue.

Now, a large multi-institution team of scientists is working on an intranasal method of immunization to determine if it's possible to produce effective protection against HIV and SARS-CoV-2 via vaccination directly into mucosal cells. Scientists accomplished these feats by developing a method to deliver vaccine proteins across a sometimes unyielding mucosal border. To date, the research has been conducted in in animal models—mice and nonhuman primates—but results so far suggest a promising method to test in human clinical trials.

"To combat the HIV epidemic and emerging threats such as SARS-CoV-2, immunization strategies are needed that elicit protection at mucosal portals of pathogen entry," wrote Brittany Hartwell of the Massachusetts Institute of Technology and colleagues from multiple collaborating U.S. institutions. Their investigation is published in Science Translational Medicine.

"Immunization directly through airway surfaces is effective in driving mucosal immunity, but poor vaccine uptake across the mucus and epithelial lining is a limitation. The major blood protein albumin is constitutively transcytosed bidirectionally across the airway epithelium."

Albumin has often been inhospitable to vaccine payloads making their way into mucosal cells. As a result of that stumbling block, uptake of vaccine via mucosal routes has been limited. By developing a completely new strategy to get the payload effectively into mucosal cells, the group of scientific collaborators is on the verge of ushering in a new-to-science innovation that ensures the delivery of immunizing proteins.

In their journal report, Hartwell and colleagues present what they call an amph-protein strategy, which allows immune-stimulating proteins to "hitchhike" across mucosal surfaces. Their amph-proteins consist of viral proteins conjugated to an amphiphilic tail that binds albumin, a blood protein, and thus enables crossing the mucosa by interacting with the neonatal Fc receptor. The neonatal Fc receptor, or FcRn, is also known as the Brambell receptor. It protects the antibody, IgG, or immunoglobulin-G and albumin from catabolism and also ushers IgG across epithelial cells.

The team turned to animal models to determine whether this experimental intranasal method could effectively deliver immunizing proteins through mucosal surfaces and produce potent vaccine immunity against two notorious viruses: HIV and SARS-CoV-2. The study demonstrated that intranasal vaccination produced systemic immunity.

Going into the experiments scientists knew that intranasal vaccines can elicit stronger and more protective antibody responses than injected intramuscular vaccines. But they were also well aware that some experimental mucosal vaccines have been limited by poor vaccine uptake across mucosal linings.

What they wanted to find out is whether it was possible to tweak how the vaccine is delivered and, in turn, demonstrate how the mucosal vaccination route leads to a substantially more powerful antibody response. If they could do that—and their research ultimately proved that they could—then they would be on the cusp of a vaccine that could provide protection against HIV and SARS-CoV-2—and any potential variant. Their first step was developing a vaccine platform that could be tested in mice and nonhuman primates.

When formulated with the HIV protein Env gp120, or the receptor binding domain of SARS-CoV-2, the amph-proteins evoked strong antiviral antibody responses in serum and nasal mucosa in immunized mice and nonhuman primates.

"Intranasal immunization with amph-conjugated HIV Env gp120 or SARS-CoV-2 receptor binding domain proteins elicited 100- to 1000-fold higher antigen-specific IgG and IgA titers in the serum, upper and lower respiratory mucosa, and distal genitourinary mucosae of mice compared to unmodified protein," Hartwell wrote, referring to the antibodies immunoglobulin-G and immunoglobulin-A.

"Amph receptor binding domain immunization induced high titers of SARS-CoV-2–neutralizing antibodies in serum, nasal washes, and bronchoalveolar lavage. Furthermore, intranasal amph-protein immunization in rhesus macaques elicited 10-fold higher antigen-specific IgG and IgA responses in the serum and nasal mucosa compared to unmodified protein, supporting the translational potential of this approach," Hartwell asserted in the paper.

The results suggest that using amph-protein vaccines to deliver antigen across mucosal epithelia is a promising strategy to promote mucosal immunity against HIV, SARS-CoV-2, and eventually other infectious diseases as additional vaccines using this strategy are developed. "Amph-proteins persisted in the nasal mucosa of mice and nonhuman primates and exhibited increased uptake into the tissue … leading to enhanced germinal center responses in nasal-associated lymphoid tissue," Hartwell concluded.

Francis Szoka, a professor in the department of Bioengineering and Therapeutic Sciences at the University of California, San Francisco, praised the vaccine research by Hartwell and colleagues for its innovative approach. "These results could bode well for the possibility of a vaccine to prevent HIV infection and have the potential to contribute to the goal of a variant-agnostic SARS-CoV-2 vaccine," Szoka reported in a related Focus article (published in Science Translational Medicine) that explores the study's clinical implications.
 

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Increased risk of some neurological and psychiatric disorders remains two years after COVID-19 infection
by University of Oxford
August 17, 2022

A new study published in The Lancet Psychiatry from the University of Oxford and the National Institute for Health and Care Research (NIHR) Oxford Health Biomedical Research Centre investigated neurological and psychiatric diagnoses in over 1.25 million people following diagnosed COVID-19 infection, using data from the US-based TriNetX electronic health record network.

The study reports on 14 neurological and psychiatric diagnoses over a 2-year period and compares their frequency with a matched group of people recovering from other respiratory infections. It also reports data in children and older adults separately, and compares data across three waves of the pandemic. To our knowledge, these are the first robust data addressing these important questions.

Confirming previous studies, many of the disorders are more common after COVID-19. Notably, the increased risk of anxiety and depression subsides within two months of COVID-19 and, over the whole 2-year period, are no more likely to occur than after other respiratory infections. In contrast, diagnoses of many neurological disorders (such as dementia and seizures), as well as psychotic disorders and 'brain fog,' continue to be made more often after COVID-19 throughout the two years.

Results in children (under 18) showed similarities and differences to adults. The likelihood of most diagnoses after COVID-19 was lower than in adults, and they were not at greater risk of anxiety or depression than children who had other respiratory infections. However, like adults, children recovering from COVID-19 were more likely to be diagnosed with some conditions, including seizures and psychotic disorders.

More neurological and psychiatric disorders were seen during the delta variant wave than with the prior alpha variant. The omicron wave is associated with similar neurological and psychiatric risks as delta.

The study has several limitations. It is not known how severe, or how long-lasting, the disorders are. Nor is it clear when they began, since problems may be present for some time before a diagnosis is made. Unrecorded cases of COVID-19 and unrecorded vaccinations introduce some uncertainty into the results.

Professor Paul Harrison, Department of Psychiatry, University of Oxford, and Theme Lead, NIHR Oxford Health Biomedical Research Centre, who headed the study, says that "it is good news that the excess of depression and anxiety diagnoses after COVID-19 is short-lived, and that it is not observed in children. However, it is worrying that some other disorders, such as dementia and seizures, continue to be more likely diagnosed after COVID-19, even two years later. It also appears that omicron, although less severe in the acute illness, is followed by comparable rates of these diagnoses."

Dr. Max Taquet, NIHR Academic Clinical Fellow, University of Oxford, who led the analyses, says that "the findings shed new light on the longer-term mental and brain health consequences for people following COVID-19 infection. The results have implications for patients and health services and highlight the need for more research to understand why this happens after COVID-19, and what can be done to prevent these disorders from occurring, or treat them when they do."
 

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Study: Most people infected with omicron didn't know it
by Cedars-Sinai Medical Center
August 17, 2022

The majority of people who were likely infected with the omicron variant of SARS-CoV-2, the virus that causes COVID-19, didn't know they had the virus, according to a new study from Cedars-Sinai investigators. The findings are published in JAMA Network Open.

"More than one in every two people who were infected with omicron didn't know they had it," said Susan Cheng, MD, MPH, director of the Institute for Research on Healthy Aging in the Department of Cardiology at the Smidt Heart Institute at Cedars-Sinai and corresponding author of the study. "Awareness will be key for allowing us to move beyond this pandemic."

Prior studies have estimated that at least 25% and possibly as many as 80% of people infected with SARS-CoV-2 may not experience symptoms. Compared to other SARS-CoV-2 variants, the omicron variant is associated with generally less severe symptoms that may include fatigue, cough, headache, sore throat or a runny nose.

"Our study findings add to evidence that undiagnosed infections can increase transmission of the virus," said Sandy Y. Joung, MHDS, an investigator at Cedars-Sinai and first author of the study. "A low level of infection awareness has likely contributed to the fast spread of omicron."

As part of research into the effects of COVID-19 and the impact of vaccines, the investigators began collecting blood samples from healthcare workers more than two years ago. In the fall of 2021, just before the start of the omicron variant surge, the investigators were able to expand enrollment to include patients, thanks to study infrastructure and biospecimen processing support provided by Sapient Bioanalytics.

Of the healthcare workers and patients who have participated in the research, investigators identified 2,479 people who had contributed blood samples just prior to or after the start of the omicron surge. The investigators identified 210 people who likely were infected with the omicron variant based on newly positive levels of antibodies to SARS-CoV-2 in their blood.

Next, the investigators invited study participants to provide health status updates through surveys and interviews. Only 44% of study participants with newly positive SARS-CoV-2 antibodies had awareness of being infected with the virus. The majority (56%) were unaware of any recent COVID-19 infection. Of the study participants who were unaware, only 10% reported having any recent symptoms that they attributed to a common cold or other type of infection.

More studies involving larger numbers of people from diverse ethnicities and communities are needed to learn what specific factors are associated with a lack of infection awareness, according to the investigators.

"We hope people will read these findings and think, 'I was just at a gathering where someone tested positive,' or, 'I just started to feel a little under the weather. Maybe I should get a quick test.' The better we understand our own risks, the better we will be at protecting the health of the public as well as ourselves," said Cheng, the Erika J. Glazer Chair in Women's Cardiovascular Health and Population Science at Cedars-Sinai.

Cheng and colleagues are also studying patterns and predictors of reinfections and their potential to offer long-lasting immunity to SARS-CoV-2. In addition to raising awareness, this information could help people manage their individual risk.
 

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Study investigates how antiviral treatment promotes emergence of new SARS-CoV-2 variants
by Franziska Ahnert-Michel, Leibniz-Institut für Virologie (LIV)
August 17, 2022

antiviral-treatment-pr.jpg

Graphical abstract. Credit: Cell Reports Medicine (2022). DOI: 10.1016/j.xcrm.2022.100735

Do patients with prolonged infections contribute to the emergence of new SARS-CoV-2 variants? A research team from the Leibniz Institute of Virology (LIV) and the University Medical Center Hamburg-Eppendorf (UKE) has investigated this question in more detail and has now been able to show that it is not the prolonged infection per se that leads to the emergence of new variants. Rather, it requires an evolutionary bottleneck such as can be created by antiviral treatment. The results have now appeared in the journal Cell Reports Medicine as a pre-proof version.

Prolonged SARS-CoV-2 infections occur primarily in immunocompromised patients and have been repeatedly discussed as important contributors in viral evolution: Reduced immune restriction could lead to a broad increase in viral diversity within the host, favoring the emergence of new variants, especially if antiviral treatments—such as with Remdesivir or convalescent plasma—exert selection pressure for the acquisition of escape mutations.

Analysis of genomic diversity in prolonged infections

In the published study, a research team led by Prof. Adam Grundhoff (LIV) and Prof. Nicole Fischer (UKE) has now investigated whether patients with prolonged infections generally exhibit increased viral evolution, which could allow for the more rapid emergence of SARS-CoV-2 variants, or whether certain treatment regimens promote the emergence of new mutations.

For this purpose, the genomic diversity within the host was investigated by whole genome sequencing in longitudinal samples from 14 patients with prolonged viral persistence (30–146 days) during severe COVID-19 disease; including immunocompromised and immunocompetent patients with or without antiviral treatment to assess the occurrence of mutations with and without selection pressure.

"Overall, the virus was remarkably stable in the vast majority of individuals studied. However, in one patient treated with Remdesivir, we observed that a high number of mutations occurred immediately after the start of treatment—including at least one mutation that was highly likely to confer increased resistance to Remdesivir," explains Prof. Adam Grundhoff, head of the LIV Virus Genomics Research Group.

Antiviral treatment promotes evolutionary bottleneck

Patients with prolonged SARS-CoV-2 infection and antiviral Remdesivir treatment showed a significant increase in viral intra-host diversity with newly emerging mutations. In contrast, in patients receiving anti-inflammatory treatment alone, the emergence of new variants was observed only sporadically.

"Our work shows that it is not the long duration of the infection per se that leads to the emergence of new variants. Rather, this requires an evolutionary bottleneck, such as can be created by antiviral treatment. This finding is particularly important in view of the recent discussions on the use of Remdesivir for the treatment of non-hospitalized high-risk patients, but also for the introduction of potentially new antiviral therapeutics," says Prof. Nicole Fischer from UKE.
 

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Reduced myocardial blood flow is new clue in how COVID-19 is impacting the heart
by Houston Methodist
August 17, 2022

Patients with prior COVID may be twice as likely to have unhealthy endothelial cells that line the inside of the heart and blood vessels, according to newly published research from Houston Methodist. This finding offers a new clue in understanding COVID-19's impact on cardiovascular health.

In a new study published today in JACC: Cardiovascular Imaging, Houston Methodist researchers examined the coronary microvasculature health of 393 patients with prior COVID-19 infection who had lingering symptoms. This is the first published study linking reduced blood flow in the body and COVID-19.

Using a widely available imaging tool, called positron emission tomography (PET), researchers found a 20% decrease in the ability of coronary arteries to dilate, a condition known as microvascular dysfunction. They also found that patients with prior COVID-19 infection were more likely to have reduced myocardial flow reserve—and changes in the resting and stress blood flow—which is a marker for poor prognosis and is associated with a higher risk of adverse cardiovascular events.

"We were surprised with the consistency of reduced blood flow in post COVID patients within the study," said corresponding author Mouaz Al-Mallah, M.D., director of cardiovascular PET at Houston Methodist DeBakey Heart and Vascular Center, and president elect of the American Society of Nuclear Cardiology. "The findings bring new questions, but also help guide us toward further studying blood flow in COVID-19 patients with persistent symptoms."

Dysfunction and inflammation of endothelial cells is a well-known sign of acute COVID-19 infection, but little is known about the long-term effects on the heart and vascular system. Earlier in the pandemic, research indicated that COVID-19 could commonly cause myocarditis but that now appears to be a rare effect of this viral infection.

A recent study from the Netherlands found that 1 in 8 people had lingering symptoms post-COVID. As clinicians continue to see patients with symptoms like shortness of breath, palpitations and fatigue after their recovery, the cause of long COVID is mostly unknown.

Further studies are needed to document the magnitude of microvascular dysfunction and to identify strategies for appropriate early diagnosis and management. For instance, reduced myocardial flow reserve can be used to determine a patient's risk when presenting with symptoms of coronary artery disease over and above the established risk factors, which can become quite relevant in dealing with long COVID.

Next steps will require clinical studies to discover what is likely to happen in the future to patients whose microvascular health has been affected by COVID-19, particularly those patients who continue to have lingering symptoms, or long COVID.
 

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Attitudes toward mandatory COVID-19 vaccination in Germany
by Deutsches Aerzteblatt International
August 18, 2022

It has become obvious that sufficiently high immunity to COVID-19 cannot be achieved in Germany through voluntary vaccination alone. On this background, Thomas Rieger and Carsten Schröder from the German Institute for Economic Research, Berlin, together with Christoph Schmidt-Petri from the Karlsruhe Institute of Technology, investigated the acceptance of a policy of general mandatory vaccination against COVID-19. The scientists also investigated the questions of which population groups are supportive of such a measure, which ones are opposed, and what their reasons are, respectively.

The authors used for their analysis representative data from the Socio-Economic Panel (SOEP). The SOEP consists of a random sample from the population resident in Germany, whose members participate in annual surveys. Because of the far-reaching consequences of the COVID-19 pandemic, the SOEP 2021 was enhanced by including a new COVID-19 survey module. In the time period from January through December 2021, 17,132 participants were interviewed regarding their attitudes regarding a policy of general mandatory vaccination against COVID-19. Furthermore, data were collected on participants' sociodemographic characteristics, health, political attitudes, and trust in the legal and political systems. The authors used univariate, bivariate, and multivariate statistical analyses to evaluate these data.

They found that a slight majority of survey participants were supportive of mandatory general vaccination against COVID-19. The primary reason given was the attitude that otherwise, not enough people would undergo vaccination. The most important reason given by those opposed to mandatory vaccination was the desire for individual freedom of choice. The group of supporters were older, fewer of them had received tertiary education, they were less healthy, tended to have no children, had centrist political orientations, and had more trust in politics. These differences were, however, not terribly pronounced compared with the group of opponents of mandatory vaccination. The biggest difference actually consisted in the fact that notably more supporters were vaccinated against COVID-19 than opponents (90% versus 60%).

In the authors' view, future analyses should investigate the question of how attitudes towards mandatory COVID-19 vaccination change over time and can be influenced. In this context, in addition to whether or not mandatory vaccination is introduced in Germany, it is likely to play a role how this would be implemented in detail.
 

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Novel bivalent C-19 vaccines: What does common immunological sense predict in regard to their impact on the C-19 pandemic?
Geert Vanden Bossche
, DVM, PhD
Opinion Article
Aug. 16, 2022, 11:00 a.m.

Bivalent mRNA booster candidates[1] have been developed as a next step in the development of C-19 vaccines to combat the virus; these new vaccines target the induction of a broader immune response than the original vaccines and have to some extent already been approved by regulatory authorities (e.g., FDA, MHRA).

One wonders though why studies conducted to test these new vaccines have only enrolled baseline seronegative participants whereas the new vaccines will predominantly be administered to people who have already been vaccinated with first generation C-19 vaccines. This is quite striking as usage of these updated C-19 vaccines to fight dominantly circulating Omicron variants in previously C-19-vaccinated populations is highly contra-indicated as it violates all basic principles of vaccinology. The latter dictate that infection-enhancing antibodies (IEABs), which are directed at a conserved antigenic site comprised within spike protein (S), will be rapidly re-stimulated by the Omicron-adapted S-based vaccine. While re-stimulation of these antibodies (Abs) will not require cognate T help (Th), priming of immune responses against variable and previously unrecognized antigenic motifs (so-called ‘epitopes’) of S is cognate T help-dependent and will therefore require uptake, processing, and presentation of the corresponding antigenic peptides (i.e., derived from those epitopes) by antigen-presenting cells (APCs).

As previously reported, C-19 disease in C-19 vaccinees is most likely mitigated by inhibition of trans infection of viral particles that are tethered to the surface of tissue-resident dendritic cells (which subsequently migrate to distant organs) and by strengthening activation of cytotoxic CD8+ T cells/ lymphocytes (CTLs) directed at a universal epitope comprised within S protein. Both mechanisms are facilitated by IEABs that typically enhance receptor-mediated viral entry when anti-S Abs lose their neutralizing capacity due to growing resistance of SARS-CoV-2 (SC-2) variants. Sustained, Th-independent activation of CTLs will allow these lymphocytes to also recognize and kill APCs that cross-present (on MHC class I molecules) the universal, S-associated CTL epitope following uptake and processing of vaccinal antigen (Ag) by professional APCs (i.e., dendritic cells). This will prevent these APCs from priming Th-dependent Ab responses towards new (i.e., Omicron-specific) immunogenic B cell epitopes comprised within vaccinal Omicron-derived spike protein. More specifically, immune responses in healthy vaccinees not only sideline the innate immune response but also prevent APCs from inducing new adaptive immune responses either by blocking Ag uptake (i.e., due to adsorption of SC-2 particles to their surface) or preventing Ag presentation by killing professional APCs after they’ve internalized the vaccine-derived S antigen (comprising the conserved CTL epitope) as previously illustrated (see figure attached below).

Consequently, the immunological effect of vaccination in thoroughly C-19 vaccinated subjects is much different from that of a natural (breakthrough) infection. In the case of a breakthrough infection, the aforementioned defense mechanisms largely fail to result in APCs preventing trans infection or activating cytotoxic CD8+ T cells, and thus fail to protect the host against C-19 disease.

This implies that the immune system of a C-19 vaccinated person cannot rely on conventional Ag-presentation to enable immune recognition of new, S-associated epitopes unless the virus breaks through the host’s (temporary) immune defense facilitated by short-lived IEABs. However, increased frequency of re-infection (i.e., as a result of enhanced susceptibility of vaccinees to infection) leads to a reduced likelihood that the virus will break through the fragile, Th-independent immune defense of vaccinees. This in turn will lower the chances for the vaccinees to generate natural immunity against any new variant, or for that matter any new S-derived vaccinal antigen (i.e., regardless of the antigenic characteristics of the Omicron (sub)variant it originates from).

Conclusion:​


Updated C-19 vaccines comprising new mRNA- or protein-derived S-associated sequences of one or more Omicron (sub)variants will only further deteriorate the already dire consequences of C-19 mass vaccination—abundant cell surface-expressed and/ or free circulating S protein will cause a unilateral and potentially protracted recall of IEABs without priming neutralizing Abs against new Omicron-specific antigenic sequences in the vast majority of healthy vaccinees. Whereas the purpose of these novel vaccines is to enhance protection against continuously evolving variants, they will have exactly the opposite effect, in that they will enhance the evolutionary dynamics of the virus. Continued mass vaccination with novel Omicron-adapted vaccines will only increase population-level immune pressure on viral virulence by the IEABs (which currently have a virulence-inhibiting effect at the level of the lower respiratory tract). Large scale vaccination with these updated vaccines will merely expedite natural selection and expansion of SC-2 variants that will exhibit a high level of virulence and infectiousness in vaccinees, while sparing the unvaccinated from this impact.

[1] Based on both the original Wuhan variant and either Omicron subvariant BA.1 or Omicron subvariant BA.4/5 lineage

public


Figure from "Epidemiologic ramifications and global health consequences of the C-19 mass vaccination experiment"

Acute, self-limiting viral infections that don’t lead to systemic/severe disease (and possibly death) are terminated by M(ajor) H(istocompatibility) C(omplex)-unrestricted, cytotoxic CD8+ T cells that have no memory and the activation of which is triggered by a universal, pathogen-nonspecific Tc epitope comprised within the spike (S) protein. Unless an infected person progresses to developing severe disease, this is what allows a fairly rapid recovery from disease after primary productive infection (and certainly before fully functional virus-neutralizing Abs peak) [according to 2a-2b-2c-2d pathway]. However, rather than stimulating de novo generation of new neutralizing Abs towards variants that escaped the neutralizing activity of vaccine-induced Abs, exposure of vaccinees to these immune escape variants will rapidly recall their non-neutralizing, infection-enhancing Abs (those are directed against an antigenic site that is conserved within the N-STD of all SC-2 variants).

In vaccinees with poor experience in fighting productive infection (and hence, poor training of their innate immune defense according to pathway 1a-1b-1c) prior to C-19 vaccination, infection-enhancing Abs[2] that are responsible for preventing severe disease by binding to DC-tethered virus (according to 3a-3b-3c-3d pathway) can synergize with strongly activated cytotoxic CD8+ Tc-mediated killing (3c’) to even prevent C-19 disease all together and hence, render vaccinees asymptomatic despite their high susceptibility to re-infection (B + C à D). As prevention of disease is not due to prevention of productive infection but to accelerated abrogation of infection, these vaccinees will continue to shed and transmit SC-2 upon re-infection. Whereas innate immune effector cells are MHC-unrestricted and polyspecific (i.e., NK cells) and, therefore, don’t drive immune escape, the infection-enhancing-Abs are Ag-specific (i.e., S-specific) and – if sustained at high enough titers for a long enough time by a large part of the population – will promote natural selection of immune escape variants that can resist the virulence-inhibiting capacity of these Abs. This is because vaccinees cannot prevent productive viral infection; consequently, the immune pressure they exert on viral virulence is suboptimal in that it cannot prevent the expansion in prevalence of immune escape SC-2 variants that have the capacity to overcome this immune pressure. Resistance of viral variants to the virulence-inhibiting activity of infection-enhancing Abs will inevitably cause Ab-dependent enhancement of severe disease (ADESD).


[2] As previously explained, the non-neutralizing, infection-enhancing Abs are currently hampering trans infection at the level of distant organs such as the lower respiratory tract; this is what’s currently exerting population-level immune pressure on viral virulence.

Bivalent mRNA booster candidates[1] have been developed as a next step in the development of C-19 vaccines to combat the virus; these new vaccines target the induction of a broader immune response than the original vaccines and have to some extent already been approved by regulatory authorities (e.g., FDA, MHRA).

One wonders though why studies conducted to test these new vaccines have only enrolled baseline seronegative participants whereas the new vaccines will predominantly be administered to people who have already been vaccinated with first generation C-19 vaccines. This is quite striking as usage of these updated C-19 vaccines to fight dominantly circulating Omicron variants in previously C-19-vaccinated populations is highly contra-indicated as it violates all basic principles of vaccinology. The latter dictate that infection-enhancing antibodies (IEABs), which are directed at a conserved antigenic site comprised within spike protein (S), will be rapidly re-stimulated by the Omicron-adapted S-based vaccine. While re-stimulation of these antibodies (Abs) will not require cognate T help (Th), priming of immune responses against variable and previously unrecognized antigenic motifs (so-called ‘epitopes’) of S is cognate T help-dependent and will therefore require uptake, processing, and presentation of the corresponding antigenic peptides (i.e., derived from those epitopes) by antigen-presenting cells (APCs).
 

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The Thailand myocarditis study, briefly
3.5% of boys show evidence of pericarditis or myocarditis after the 2nd dose of the Pfizer/BioNTech Covid vaccine. (A belated recap.)

Brian Mowrey
9 hr ago

Although Vinay Prasad has already provided a somewhat-punch-pulling recap of the preprint study from Thailand,1 it hadn’t received a lot of attention in the more anti-mainstream edges of the substack ecosystem. This changed a few hours ago with a somewhat-too-sensational Steve Kirsch post.2 My overview is at best a “middle-chair” summary at this point.

Still, it would be odd not to offer a take here, given that this journal keeps the myocarditis issue on the radar generally,3 and this study is groundbreaking in that it shows rates of post-mRNA-injection myocarditis in teens captured by actual screening, eliminating under-reporting and capturing subclinical (non-symptomatic) heart damage. And so here goes.

The Set-Up​

The study:4


Mansanguan, S. et al.

314 teens already first-dosed with the Pfizer/BioNTech Covid vaccine (BNT162b2), and without prior cardiac issues or adverse reactions, were tested for cardiac markers before and then 3 and 7 days after receipt of the 2nd dose (and again if presenting with cardiac symptoms). Emphasis added:

High-sensitivity cardiac troponin-T assay (HS-cTnT) and CK-MB isoenzyme levels were determined for all participants at baseline, and on Day 3, Day 7 and Day 14 (optional) after the second dose vaccination. HS-cTnT was measured using the Elecsys troponin-T hs assay (Roche Diagnostics, Mann- heim, Germany); serum levels > 14 ng/L were considered elevated.

“Elevated” troponin, in the context of suspected myocarditis (i.e., not in the context of a heart attack or sepsis or other obvious trauma), clinches the diagnosis.

Not only does this study screen for myocarditis, to find cases in teens that would otherwise be missed in a clinical setting, it also collects a baseline measurement to observe the change driven by the mRNA injection. This makes it a first.

For context, previous estimates of post-Covid-vaccine-dose-2 myocarditis have been implausibly low. Even the values derived by Hoeg, et al. - which set off a firestorm of MD-twitter criticism by almost doubling the CDC’s official rate5 - are minuscule when converted to percentage form.


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Updates to "Thailand"
With apologies for email bandwidth impact. And: back-in-office notice!

Brian Mowrey
7 hr ago

EC-Does It​

Yesterday’s post has been updated to include a less dismissive treatment of theECG abnormalities section of Mansanguan, et al. This change was made as a response to excellent counter-arguments offered by Stephanie Brail in her own post on the study.

Wholistic
Thai Study on mRNA Cardiovascular Damage in Teens: A Round Up
If you haven’t heard, a damning study has come out of Thailand titled Cardiovascular Effects of the BNT162b2 mRNA COVID-19 Vaccine in Adolescents. It’s a pre-print, meaning it’s not officially peer reviewed yet, though supposedly it will be published in a peer-reviewed journal soon, so be mindful of that when sharing it with your smarmy “is it peer revi…
Read more
9 hours ago · 12 likes · 7 comments · Stephanie Brail

In particular, Brail highlights the clarification sourced from Tracy Beth Høeg on baseline rates of ECG abnormalities before injection, which are less than 1%. This renders the post-injection rate much more impressive, in my eyes. Of course, I would still like the raw data, so I can “kick the wheels” of the authors’ findings for myself - but for now I am less on the fence.

Another writer’s work on the Thailand study deserves highlighting. While I am very picky about recommending other newsletters, here is an instance of “getting the record straight” that is at the moment being unfairly looked-over. The author “Alvin” at Seeking Health & Truth offered a review a week ago that correctly noticed and highlighted the disparity in rates between boys and girls:

Seeking Health & Truth
18% of Adolescents have Abnormal ECGs After Pfizer COVID-19 Vaccination, a 3500 Times Increase in Myopericarditis Risk (Boys).
I haven’t written much on the safety of the COVID-19 mRNA experimental vaccines since it gets a good deal of coverage from team reality. But I just read a pre-print study out of Thailand focusing on cardiovascular adverse events in adolescents aged 13-18 years old…
Read more
5 days ago · 2 likes · Alvin

What the authors don’t comment on is that all 7 participants were male. So, if we use the number of male participants (202) as the denominator, we get (7/202) x 100 = 3.5%.​

This is good study-reviewing. Notice what isn’t already highlighted, highlight it. Employ imagination.

Today, Alvin provided feedback to another prominent substack on the same discrepancy, resulting in a modification to the post in question without any credit. This is bad form on the part of the other poster (who has no excuse for failing to highlight the discrepancy in the first place). While I was not aware of Alvin’s post before publishing my own, I feel credit is due for his getting this right before anyone else.
http://null

 

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Horowitz: German insurance claims hint at millions of unreported vaccine injuries
Daniel Horowitz
August 15, 2022

What if 1 in 23 individuals jabbed with the COVID bioproduct experienced an adverse reaction strong enough to trigger an insurance claim? Now consider the fact that 5.31 billion people in the world received at least one jab, with hundreds of millions receiving three or four jabs, and you will realize we are in uncharted waters in human history.

According to data from Techniker Krankenkasse, the largest German medical insurance company, there were a total of 437,593 insurance claims billed under the four diagnostic codes for vaccine injury in 2021. To put those numbers in perspective, the total numbers billed for a vaccine injury code in the two preceding years was 13,777 and 15,044, respectively. As the Daily Skeptic notes, given that TK insures 11 million people, that means 1 in 23, or 4.3%, had a medical treatment billed for vaccine injury. And that assumes all 11 million were vaccinated. The background vaccination rate in Germany is 78%, although most of the unvaccinated are children, so the rate of injury per vaccinated person is likely even higher (5.1%).

Putting aside confounding factors, but just to provide a rough estimate to open your mind to the scope of this problem, a 4.3% clinical level injury rate, if extrapolated for the 223 million vaccinated in the United Sates, would equal approximately 9.6 million injured Americans. While that number sounds unconscionable, remember that this data harmonizes almost perfectly with the Israeli health ministry survey that found a 4.5% rate of neurological side effects just from those who received booster shots (not total doses, which is likely more).

However, this data, and the extrapolation for the U.S. population, is even more credible when you look at the VAERS data. The total number of reported hospitalizations, urgent care visits, or doctor’s visits reported to VAERS (just for the U.S.) for the COVID shots as of Aug. 5 is 337,579.


image.png


An underreporting factor of roughly 28 would get you 9.6 million clinical-level injuries. Leading VAERS expert Dr. Jessica Rose estimated, using independent rates of anaphylaxis events from a Mass General study, an underreporting factor as high as 41 for serious adverse events in VAERS.

Obviously, vaccine injury billing codes, VAERS data for doctor visits, and the Israeli health ministry survey are not the exact same data point, but they all seem to coalesce around a rate of several percentage points of injury beyond the typical mild symptoms one would expect to experience from the shot. Moreover, we can actually independently verify the German billing data more precisely by using the same diagnostic codes for vaccine injury in the U.S. military. The four codes tabulated in the German TK billing data for 2021 are the following:
  • T.88.0: Infection following immunisation
  • T.88.1: Other complications after immunisation
  • U.12.9: Adverse effects after Covid-19 immunisation
  • Y.59.9: Complications due to vaccines or biological substances
I asked a source in the military with access to the Defense Medical Epidemiology Database (DMED) system to pull equivalent data on vaccine injury. While some of these codes did not come up, here is the data for T50.B95, “Adverse Effect of Other Viral Vaccine.”

image.png


The rate of increase is 11.6-fold, not as dramatic as the 30-fold increase in Germany, but this is just one code. Also, it’s likely that the military population would have a higher baseline background rate of reported adverse effects annually than a civilian population because they receive many more vaccines every year per capita.

When using ICD codes to extrapolate the scope of vaccine injury, keep in mind that these numbers likely substantially understate the total adverse events. Most doctors worship the vaccine with religious fervor, and there is a virulent stigma against implicating the vaccine for a particular malady or injury. So the fact that medical billing codes are hinting at this degree of cataclysmic injury is astounding. Moreover, there are no billing codes for death, which is clearly being underreported.

That the shots are still even being made available, much less coerced upon the public in many circumstances, represents the greatest violation of the Nuremberg Code of all time. It’s not even the fact that they are experimenting on all of humanity. The data is in and the shots have affirmatively been proven dangerous. They are no longer even experimental.

In a shocking letter, the incoming president of the Australian Medical Professionals Society, Christopher Neil, made it clear that Australian doctors must not be gagged in speaking out and offering informed consent. “Indeed, now 17 months later and after numerous forms of pressure to take up the COVID-19 injectables in various age categories, a tremendous amount of data is available to more fully and accurately inform clinicians about these products,” wrote Dr. Neil to the Australian Colleges and Associations of Medicine, Health, and Science, and members of Parliament. “This literature includes over one thousand peer reviewed studies reporting of the harms being seen around the world, up to December 2021.”

Neil observes the obvious – that the degree of adverse event reporting is sky-high. “To be clear, the TGA has received more Adverse Event reports in 2021 through June 2022 for the COVID-19 vaccines, than they have been seen for all other vaccines in the preceding 50-year period.”

If you just take the data from VAERS and the EudraVigilance system of the European Medicines Agency, there were a total of 76,253 dead and 6,033,218 injured, as of mid-July. That in itself is mind-blowing, but if you adjust for an underreporting factor of 41, that would total nearly 1.9 million deaths and 247 million injuries! Amazingly, yet sickeningly, 247 million injuries would equal 4.6% of all the people jabbed on this third rock from the sun – nearly exactly the extrapolated rate of injury from the German medical billing data!

Some are asking whether Steve Deace and I were overly dramatic in calling this the Fourth Reich and demanding a Nuremberg trial. But as the days pass and the sheer horror of this becomes apparent, the public will want to know why there was no demand to abide by the Nuremberg Code from day one.
.
 

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"sweeping reorganization" at CDC to "restore public trust"
that phrase may not mean what they hope you think it does

el gato malo
11 hr ago




here’s the face you make when you read this headline:

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but then you read the text of the story and realize that it’s just the same people who have been such interminable fonts of incomprehension, disinformation, and outright fraud grabbing even more power and remaking an agency that is already a weapons grade dysfunction junction into one even more able to wreak mischief and menace upon the populace.

CDC director Dr. Rochelle Walensky met with senior leadership at the agency this morning to lay out her plans for overhauling how the agency works. She plans to remake the culture to help the agency move faster when it responds to a public health crisis. She also wants to make it easier for other parts of the government to work with the CDC, and wants to simplify and streamline the website to get rid of overlapping and contradictory public health guidance.

and expressions change.

sigh.

The changes will be aimed at improving the culture and restoring public trust after the agency's acknowledged missteps in its response to the Covid-19 pandemic.

i mean, come on. pull my other paw, it plays jingle bells.

there is no way that even someone like rochelle walensky could be so out of touch as to presume that the reason that the people have lost faith in CDC is that they “need to be more streamlined to act faster and be better integrated into other parts of government.”

that whopper is not going to pass muster even for the most raddled of “team cognitive dissonance.” they are not even trying to be honest anymore. at the same time they have adjusted their “guidance” to look an awful lot like the great barrington declaration they just spent 2 years disparaging and yet they are claiming that the problem is that they did not have the power and structure to do more aggressive stuff more quickly.

this is just straight up soviet.

this is not an attempt at reform, it’s an attempt at greater institutional capture and encroachment by the same people who brought you “the staggering misstatements and imperial overreach that got us here.”

it’s farce. this is pretext for greater centralization of unaccountable power masquerading as “reform to regain trust.”
make no mistake: there is nothing trustworthy about this.

• The Division Laboratory Sciences and the Office of Science will now report directly to the CDC director, a move aimed at improving accountability of the delivery of timely information

so, the director now gets to tell the labs and the office of science what to do. directly. yeah, hard to see how THAT could be abused.

A new office of intergovernmental affairs—a hub where states health departments and other federal agencies with interact with CDC

and the agency will then directly foist whatever they concoct onto the states.

• A new equity office, which will increase diversity both in CDC's workforce and add that lens to its public health activities

and, of course, shifting hiring from “competence” to “diversity” always works out well, right? what federal agency has not seen performance gains from that policy?

• The CDC is going to create a new online mechanism for the pre-publication delivery of science

• The agency is going to streamline and simplify its guidance documents and website


so, after 3 years of publishing inaccurate claim after inaccurate claim and studies that crossed well over the line into outright fraud, the solution is to find ways to publish even less well vetted “pre-publication” science and to “simplify” the website to justify providing even less data and to pull down all the evidence of things you got wrong without any pesky questions being asked?

because all that sounds like to me is a way to make sensational claims and prescriptions without having to provide any supporting data.

are we seriously calling that the road to regaining trust?

call me mr cynical paws, but when i read this

The reforms follow a period of review and introspection at the CDC. In April, Walensky announced Jim Macrae, associate administrator for primary health care at the Health Resources and Services Administration, would lead a one-month review of the agency's Covid-19 response efforts. At the same time, she charged three of her deputies to scrutinize operations and recommend strategic changes. Walensky has been meeting with groups of staff in person as employees return to their office after months of remote work.

all i see is “after thorough review, fox commission to reshape henhouse security to be more responsive to vulpine needs.”

all i see is “after thorough review, fox commission to reshape henhouse security to be more responsive to vulpine needs.”

and, of course, CNN is utterly thrilled to carry dirty water here and misframe the facts on the ground. but it’s not going to work.

the revisionism in this history is going to fool exactly no one:

The course correction comes after significant stumbles at the agency in response to the Covid-19 pandemic. The US had little capacity to test for infection during the early months of the pandemic, largely because the agency released a flawed test to public health laboratories. That kept the nation blind, for months, to the extent of the virus's spread.
The agency has also been criticized throughout the pandemic for issuing public health guidance that some saw as confusing and ineffective.
Many also felt it wasn't moving fast enough to respond.

sorry, but:


this is what they think people are upset about and what lost public health agencies the public trust?

it wasn’t the fraudulent mask studies they published and the reams of made up guidance and guidelines that fell apart faster than knock off ikea furniture from uzbekistan?

it wasn’t pushing lookdowns that were known not to work and explicitly contra-indicated by 100 years of evidence based pandemic study?

it wasn’t claiming that the vaccines would provide herd immunity and become “a dead end for the virus” only to near instantly recant when the jabs failed to work as advertised?

or their total failure to even to the basic rudiments of their job and monitor the VAERS system for danger signals despite the biggest spike of reported vaccine adverse events in human history?

and then quietly erasing vaccine safety claims from their website? (just “streamline and simplify” i guess?)
and manipulating efficacy data and playing “hide the ball” with all cause death and cancer reporting? (see safety claims link above)

this is a classic false framing. you straw man a question no one asked and then answer it as though it resolves an objection in order to sidestep the real points of criticism and blame the victims for being unsatisfied.

but it’s pure farce.

this is like watching the “bukhara gazette” publish a piece in 1221 that claims that the major objection to the mongol conquest was the way they failed to clean up the horse apples the steppe ponies left on the lawn.

after having been so savagely wrong that it initiated, aided, abetted, and justified probably the worst peace time disaster per unit time in US history, they not only want more power:

Walensky also plans to ask Congress to grant the agency new powers, including mandating that jurisdictions share their data.

they are trying to claim that the whole problem was “communication” and “coordination.”

but i think we’re about at the end of the “we’re not fools and liars, you just did not understand what we meant!” gag reel.

this “re-org” is just puppet show pantomime to make happy noises like they “did something” while ratcheting the choke chain of top down dictatorial power tighter, concentrating it in fewer hands, and extending its reach.

if you have any friends who grew up behind the iron curtain or in other such repressive regimes, ask them about this. they’ll give you an earful. (mine certainly have)

if i had a nickel for every time i’ve heard “this is what i fled (insert communist utopia) to get away from,” i’d outbid elon for twitter.

this is real, no joke soviet style government theater.

and it’s hilarious to watch them think that it can work in the age of social media. this didn’t even work in russia where they had total control of media.

everyone learns to read between the lines.

they learn that what you say is always the opposite of what you’re doing.

i mean, jeez guys, at least mix it up a little.

it’s these sorts of shenanigans being streisand effected into the stratosphere that are driving ideas like “dissolve the CDC” into the mainstream as the overton window shifts, we the people are getting ready to defenestrate rochelle and co through it.

and the more they dissemble and play make believe and try to claim that the problem was just that we did not understand how right they were, the more clear this becomes.

this is a path of self-immolation. it’s is an entire technocratic edifice imploding. and every new speed wobble is greater than the last.

their credibility is in tatters and every new “remedy” makes it worse. it’s surprisingly hard to lie your way out of being thought a liar.

they think they are setting up the power structures for the next outrage but the alternative outcome is that they are digging the hole in which they will be buried.

which way that ball bounces is up to us.

choose well.
 

Heliobas Disciple

TB Fanatic
(fair use applies)


CDC Director Proposes Changes
Among the changes is lowering the standards of the level of evidence used to make regulatory decisions. Sigh. Please tell your Senators about #PLANB. THAT is a #Reset.

James Lyons-Weiler
9 hr ago

CDC director Rochelle Walensky announces shake-up of the organization, citing COVID mistakes UPDATED ON: AUGUST 17, 2022 / 7:01 PM / CBS/A

AP in Italics; My Comments in Bold

NEW YORK (AP) — The head of the nation's top public health agency on Wednesday announced a shake-up of the organization, saying it fell short responding to COVID-19 and needs to become more nimble.

Top public health agency? Says who? Evidently FDA no longer has much to say about what CDC recommends?

The planned changes at the Centers for Disease Control and Prevention — CDC leaders call it a “reset”— come amid criticism of the agency's response to COVID-19, monkeypox and other public health threats. The changes include internal staffing moves and steps to speed up data releases.


Staffing moves should be interesting. Boot Destefano, Boyle, and every other person involved in data cookery.

The CDC's director, Dr. Rochelle Walensky, told the agency's staff about the changes on Wednesday. It's a CDC initiative, and was not directed by the White House or other administration officials, she said.

“Even the White House wants to distance itself from CDC.”

“I feel like it's my my responsibility to lead this agency to a better place after a really challenging three years,” Walensky told The Associated Press. (Typo not mine)

It is traditional after a dismal failure for leadership to take responsibility by resigning.

The Atlanta-based agency, with a $12 billion budget and more than 11,000 employees, is charged with protecting Americans from disease outbreaks and other public health threats. It’s customary for each CDC director to do some reorganizing, but Walensky’s action comes amid a wider demand for change.

Have you read about #PlanB?

The agency has long been criticized as too ponderous, focusing on collection and analysis of data but not acting quickly against new health threats.

Because actually thinking before you act is… thinking.

Public unhappiness with the agency grew dramatically during the COVID-19 pandemic.

Nominated for the understatement of the decade.

Experts said the CDC was slow to recognize how much virus was entering the U.S. from Europe, to recommend people wear masks, to say the virus can spread through the air, and to ramp up systematic testing for new variants.

THAT IS NOT WHAT OUR COMPLAINTS HAVE BEEN. YES, I’M YELLING BECAUSE SHE KNOWS THIS. SHE’S BEEN SERVED.

“We saw during COVID that CDC’s structures, frankly, weren’t designed to take in information, digest it and disseminate it to the public at the speed necessary,” said Jason Schwartz, a health policy researcher at the Yale School of Public Health.

“Turn-key model FULL ON!”

Walensky, who became director in January 2021, has long said the agency has to move faster and communicate better, but stumbles have continued during her tenure. In April, she called for an in-depth review of the agency, which resulted in the announced changes.

The CDC has been investigating the CDC… got it…”

"It’s not lost on me that we fell short in many ways” responding to the coronavirus, Walensky said. "We had some pretty public mistakes, and so much of this effort was to hold up the mirror ... to understand where and how we could do better."

At what? Hiding the mistakes? “Public mistakes” are the issue? No. The issue is that you think that public mistakes are the issue.

Her reorganization proposal must be approved by the Department of Health and Human Services secretary. CDC officials say they hope to have a full package of changes finalized, approved and underway by early next year.

I hereby offer to write her resignation letter supporting dismantling the CDC as woefully compromised by conflicts of interest, gross incompetence, fraud, and a monument to fascism.

Some changes still are being formulated, but steps announced Wednesday include:

I hope she gets this message.

—Increasing use of preprint scientific reports to get out actionable data, instead of waiting for research to go through peer review and publication by the CDC journal Morbidity and Mortality Weekly Report.
“AKA Lowering the standards of the level of evidence used to make regulatory decisions; preprints are not peer-reviewed. Neither are CDC studies in MMWR.”

—Restructuring the agency's communications office and further revamping CDC websites to make the agency's guidance for the public more clear and easier to find.

We’ve been hearing this for decades. “If only our messaging was clearer”. No. Try “Make our messaging more independent of Pharma’s agendas, reduce the role of considerations of profitability, and try to make sure that what we see actually reflects empirical reality.

—Altering the length of time agency leaders are devoted to outbreak responses to a minimum of six months — an effort to address a turnover problem that at times caused knowledge gaps and affected the agency’s communications.

“In keeping with the “Less Thinking” model of CDC 2023, we will allow less time for intractable problems because the public just isn’t buying it anymore. Just follow orders, and you’ll be fine.”

—Creation of a new executive council to help Walensky set strategy and priorities.
Sign me up. #PlanB.

—Appointing Mary Wakefield as senior counselor to implement the changes. Wakefield headed the Health Resources and Services Administration during the Obama administration and also served as the No. 2 administrator at HHS. Wakefield, 68, started Monday.

“Meet the new boss … same as the old boss” (The WHO, “Won’t Be Fooled Again”)

—Altering the agency's organization chart to undo some changes made during the Trump administration.

ZZZZZZZZZZZZZZZZZZzzzz
z… I’m sorry were you saying something?

—Establishing an office of intergovernmental affairs to smooth partnerships with other agencies, as well as a higher-level office on health equity.

“There already IS an INTERAGENCY COORDINATING COMMITTEE to make sure the entire HHS gets the lies about autism straight… you mean like that?”

Walensky also said she intends to “get rid of some of the reporting layers that exist, and I'd like to work to break down some of the silos."

Sounds like less accountability. Hard to do when you already have none.

She did not say exactly what that may entail, but emphasized that the overall changes are less about redrawing the organization chart than rethinking how the CDC does business and motivates staff.

Pizza & Beer and lapdances for CDC Staff? They were good enough for the public for COVID-19 vaccines!

“This will not be simply moving boxes" on the organization chart, she said.

“We’ll also be bringing in some new plants, and moving the furniture around. MAYBE some new carpet.”

Schwartz said flaws in the federal response go beyond the CDC, because the White House and other agencies were heavily involved.

Schwartz also announced he will be seeking employment elsewhere soon. (Satire)

A CDC reorganization is a positive step but “I hope it's not the end of the story,” Schwartz said. He would like to see "a broader accounting” of how the federal government handles health crises.

See #PlanB. The “Government” should NOT handle health crises because they refuse to see the crises they help create.

Plan B Public Health Infrastructure and Operations Oversight Reform for America

https://ijvtpr.com/index.php/IJVTPR/article/view/19

https://www.researchgate.net/figure...B-Public-Health-Infrastructure_fig1_348238837

If you live in the US and are on Twitter, please push this to your Senators and Congressional Representatives on Twitter and elsewhere. This “do-nothing” patch-up job amounts to empty words. Read #PlanB. Make it your mission.

It’s time had come BEFORE COVID-19.
 

Heliobas Disciple

TB Fanatic
(fair use applies)


COVID Policy is a Story of Ego, Incompetence and Unending Commitment to Failure
Ian Miller
10 hr ago

The CDC and Dr. Fauci have done incalculable damage to society with their incessant promotion of ineffective restrictions on normal life.

There, unfortunately, are no comforting explanations for their absurd disregard for reality.

The combination of incompetence, ego, and hubris has been unrelenting in its consistency and refusal to acknowledge mistakes.

But what might be even more concerning is that many of these supposed “experts” happily defend their nonsensical positions by claiming that they represent the truth and others are misleading the public.

No matter how many times that’s proven wrong, it seems impossible for them to move forward and allow the country to permanently get past the pandemic.

School districts, colleges and businesses continue to enforce rules and mandates based on the recommendations of the same people endlessly repeating that the pandemic is not over.

What should be over is anyone paying attention to them ever again.

Unmasked is a reader-supported publication. Paid subscriptions help the work continue, while any and all readership is extremely appreciated

Fauci’s Ego

It’s abundantly clear, two-plus years into the pandemic, that part of the reason why disproven COVID “interventions” have continued for so long is the egos of the supposed experts involved.

Perhaps no one symbolizes the massive, runaway, unchecked self obsession of credentialism better than Dr. Anthony Fauci.

Fauci has repeatedly referred to himself as representing science, and pointedly argued with any criticism of his methods and activism.

But Fauci recently took it a step further, claiming during a discussion that people go to medical school because of what he symbolizes.

According to Fauci, “in an era of the normalization of untruths and lies,” he represents “consistency, integrity” and most laughably, “truth.”

August 10th 2022
40 Retweets123 Likes

It’s hard to believe the hubris and lack of integrity required to make these claims after Fauci’s disastrous tenure running the nation’s COVID response.

Fauci’s Track Record

Fauci has blatantly lied and manipulated the public on multiple occasions; from claiming that he initially said masks didn’t work to protect supply for healthcare workers, to his inaccurate denials of involvement in funding potential gain of function research, his attempts to label those who questioned the origins of the virus as conspiracy theorists, to admitting that he moved the goalposts on vaccination rates to reach herd immunity so more people would get vaccinated.

He criticized governors like Ron DeSantis for following science and reopening their economies, while praising disgraced politicians like Andrew Cuomo because of their ideological alignment.

Not to mention his abhorrent promotion of school closures, ineffective lockdowns and absurd “untruths” about disproven pseudoscience like “double masking.”

And of course, his delusional, profoundly incompetent pronouncements that the vaccines were 100 percent effective.

Given how poorly the medical profession has conducted itself over the past several years, it wouldn’t be a complete shock if many entering medical school do view Fauci as a hero for his actions during the pandemic.

But for anyone paying attention to his actual track record of prolific inaccuracies and relentless political advocacy, it’s abundantly clear that Fauci helped create an unmitigated disaster.

Lockdowns have destroyed economies, leading to runaway inflation while accomplishing nothing in terms of reducing disease burden. School closures have been a historic setback for the nation’s children. Masks, on top of being completely useless, have contributed to learning loss, been an environmental catastrophe and increased societal divisions.

Everything Fauci has recommended has undeniably failed. His tenure will go down in history as one of the country’s biggest unforced errors; a disaster of unimaginable proportions.

But when, like Fauci, you have the world’s biggest ego and the protection of the press, you apparently can feel comfortable making these unfounded, inaccurate, offensive claims about your own self importance.


CDC Finally Updates Guidance to Align With Reality​


Finally, after well over a year of scientific evidence and data confirmed that vaccinated people were just as likely to get and spread COVID as unvaccinated people, the CDC has accepted reality.

The nation’s leading public health agency has now ended different treatments for vaccinated and unvaccinated individuals.

While this is a welcome change, it comes too late for millions of people who were fired from jobs, discharged by the military, or denied entry to schools or events due to vaccination status.

But the important question is, where is the outcry to hire back those who lost their jobs because the “experts” were so hopelessly wrong about the benefits of the COVID vaccines?

Remember too, that the Biden administration, with the full support of the CDC and people like Dr. Anthony Fauci, attempted to force every private business with more than 100 employees to mandate vaccines as a condition of employment.

Thankfully judges struck down that unconstitutional, anti-science attempt, but not before many businesses followed their advice regardless.

Global policies were enacted based on the lie that vaccinated people were far less likely to test positive for COVID and spread it to others. Discriminatory mandates still continue today, and are enforced by governments and corporate executives too cowardly to speak up.

Nearly all of these decisions were made by terrified administrators, politicians and corporate executives because they believed blatant inaccuracies from the CDC.

Will they now condemn their past remarks and apologize, the way they so often do when political activists demand it for some perceived slight?

Of course not. With the protection of a willing media, the CDC will never receive blame for its hopelessly inept guidance, and none of the decision makers involved in creating mandates will ever have to answer for the damage they’ve caused.

But lest you be concerned that the CDC might have put politics entirely behind it, don’t worry, it still recommend useless masking to prevent the spread of COVID.


More School Masking​

Among all the ridiculous COVID policies that have persisted into 2022, school masking might be the most indefensible.
On top of the mountains of evidence that have accumulated over the past several years confirming that masks are useless, data to support masking kids is even worse.

There have been studies conducted in multiple countries concluding that masks do not work in schools, and endless data comparisons showing school districts without mandates had similar or better COVID case rates to those with mandates:

But that doesn’t seem to matter to school administrators.

Just a few weeks ago, a number of districts across the country announced new masking policies.

Despite the conclusive data against forcibly masking kids, that hasn’t stopped yet another school district from imposing harmful, ineffective mandates.

But this one has a new, even more confusing twist.

The Philadelphia school district has mandated masks for the first 10 days of the school year, although for some bewildering reason, pre-k students will be forced to mask the entire year:


“For the first 10 days of the new school year – from August 29 through September 9 – all students and staff will be required to wear masks while in school, regardless of the COVID-19 Community Level,” the announcement reads.

“Students and staff at PreK Head Start programs are still required to wear masks at all times, regardless of the Community Level.”

That’s correct, on top of the ludicrous 10 day mandate, 3 to 4-year olds will be forced to mask at all times, based on nothing.

It gets even dumber.

Any time the area is in the CDC’s entirely arbitrary “high transmission” level, mask mandates will be imposed automatically:

“The letter states that when the Centers for Disease Control and Prevention COVID-19 community transmission level is high, students and staff will be required to wear masks in schools. When the level is medium, masking is ‘strongly recommended.'”

On top of these horrifying policies, students that have been exposed to COVID can remain in school, but only if they’re masked for 10 days.

Forcing kids to wear useless facial decorations for 10 days to assuage the fears of terrified adults is a perfect example of the absurdity of COVID policies in 2022.

Decisions like this in many areas across the country indicate that these administrators intend to keep children masked indefinitely.

If two and a half years of masking being completely ineffective isn’t enough for them to stop, when will it ever end? Their incessant political virtue signaling is going to needlessly harm children, all to avoid admitting they were wrong.

On top of the local officials, the CDC and other “public health experts” share significant blame for this offensive policy.

They could have acknowledged their mistakes and moved on from the pandemic long before this, but instead chose to double down and continue their nonsensical recommendations. So instead of parents and children being able to look forward to a maskless school year, they’ll be forced to endure this pointless ritual to protect the egos of incompetent bureaucrats.

What these districts are doing to children will have tremendous, long lasting harms, with quite literally zero benefit to show for it.

In settings where educators are supposed to protect and educate children, they’re purposefully hurting them instead.



The endless cycle of dangerous misinformation has contributed to seemingly permanent masking and vaccine mandates.

Three key factions continue to work together in conjunction to prolong the pandemic.

“Experts” like Dr. Fauci, whose massive ego led to a bewildering claim to stand for “truth,” have helped contribute legitimacy to school administrators incapable of moving past their politically motivated restrictions.

The CDC, whose guidance that was much too late to fix the damage caused by their incompetence and who still haven’t ended the unscientific ban on unvaccinated travelers.

And school administrators who appeal to authority to justify their inability to move past politically motivated restrictions.

This combination, as long as it’s allowed to continue, will wreak further destruction on society.

As always, pointing out the hypocrisy and inaccuracies in their own statements is the only way to further undermine trust and end their influence.
 

Heliobas Disciple

TB Fanatic
(fair use applies)

What to Know Before Deciding to Take The Novavax Injection
The idea of accepting an injection of spike protein hoping it is safe or effective is absurd. Yet, many are again forced to make a decision threatening their health and ability to support their family

Pierre Kory, MD, MPA
10 hr ago

A subscriber asked me to write a post about my thoughts on Novavax because she “really trusts my judgement.” Flattered, I felt like I should share what they are. So here goes.

Before any medical intervention, but especially in the case of a novel or barely tested one, a long standing practice of medical ethics is that informed consent must be obtained. The emphasis should be on the informed part and not the consent part. Note that informed consent has been one of the foundations of medical ethics, essentially an inviolable standard, or at least it used to be before this “emergency” came along where now you have pharmacists injecting children with barely a mention of the risks, “because they might be too scared to take the shot.”

Informed consent discussions are simple in structure but often complex and time-consuming to conduct. It relies on providing the patient with as detailed and comprehensive a knowledge of the risks, benefits, and alternatives to the intervention.

So, should we go through an informed consent discussion with the novel Novavax injection? Actually, I would not. Why? Because I don’t hold informed consent discussions for interventions I do not recommend or would not want my patient to consider. I instead tell them not to consider and give them my reasons for that recommendation. Thus, I only conduct informed consent discussion for interventions that I feel would bring about greater benefits than risks (generally much greater), and I would only do so for patients with active illness in order to get them better. A vaccine is a much different proposition as they are given to patients without disease.

Why would I not even consider Novavax as a reasonable option? Simple:

  • There has never been a successful or safe coronavirus vaccine. The last 18 months have shown that COVID vaccines lead to increased chances of getting ill, equal or increased chances of transmitting, and higher likelihood of entering hospital and dying. And that is leaving unmentioned the lethality and toxicity of the mRNA platform ones. See my “Vaccine Exemption Letter” post for the data to support these statements. The coronavirus is a rapidly mutating virus, thus vaccines will always be non-neutralizing because by the time they are manufactured and ready for injection, the virus has mutated into forms poorly responsive to older, narrower antibodies.
  • Novavax is still formulated with a two and a half year-old protein for this rapidly mutagenic coronavirus, so it would be like giving a two and a half year old flu shot for this years flu (worse actually). Yet our health system, including every single academic medical center in the country is still mandating and eager to adopt use of an outdated viral protein. I would love to say this is beyond belief, but this is the world we live in now.
  • We now have the omicron variant circulating, which is generally well tolerated by most, particularly those who are healthy or young (and even the old), and especially those with natural immunity.
  • The country now has abundant natural immunity, which even the CDC now admits offers equal protection (actually, natural immunity offers better protection but let’s give the CDC some credit for telling at least a partial truth). So why are we still vaccinating and/or mandating in those who have recovered from COVID?
  • Vaccinating against respiratory viruses works very poorly as the antibodies do not reach high concentrations in the nasal and respiratory mucosa which is where the virus enters. The flu vaccine is almost completely ineffective, even when you get this years flu shot. Not known by most.
  • Vaccinating against respiratory viruses with non-neutralizing vaccines actually weakens and warps the immune system such that you are more likely to get other respiratory viruses or illnesses as well (this has been well reported after flu vaccinations given that those vaccinated against the flu are more susceptible to other respiratory viral infections).
  • Proposing a novel and barely tested product coming out of the pharmaceutical industry to a patient is a wicked proposition in modern times. Note the pharmaceutical industry is a documented criminal industry which has repeatedly put out unsafe and ineffective products (even deadly, i.e opioids, Avandia, Vioxx, Bextra, the list goes on), followed by burying the adverse event data while pushing their wares through control of professional societies, federal/state legislation, and captured agencies. They have paid over $12 billion in criminal fines and over $16 billion in civil fines, just in the last 20 years across the 20 largest settlements. Their history of these actions stretches even longer.
  • The history of criminality around the COVID vaccines dwarfs any actions the industry has done in the past. The Pfizer documents that the PFDA (the P is not a typo) tried to hide for 75 years reveal insane amounts of manipulations to try to show they work and are safe. They didn’t and weren’t. Further the testimony from the Ventavia/Pfizer whistleblower Brook Jackson reveals that the studies were so poorly done with such little follow-up of patients that they are simply not credible. Remember, Pharma. Does. Not. Care. About. Your. Health. Just your wallet (actually the government’s wallet, which I suppose is also your wallet).
So, conceptually, I think the idea of getting any coronavirus vaccine at this point is preposterous. However, let’s try to do a more traditional informed consent using the structure of risks/benefits/alternatives. The following is what I think other providers (or pharmacists egads) should be telling people prior to offering them Novavax, or more accurately, in order to get them to avoid it.

Yes, Novavax is a “non-mRNA" vaccine and is designed more along the line of a traditional vaccine in that an amount of viral protein is injected into the arm, it is then recognized as a “foreign” protein by our immune system which then makes antibodies against it. These antibodies are then thought (“hoped” remember) to help clear the virus rapidly and efficiently after exposure such that we avoid illness. Sounds good on paper. Not. Just ask Geert Vanden Bossche, one of the worlds top immunologists and vaccine experts.

RISKS

Novavax delivers the spike protein. As a self-described clinical expert in spike-protein induced disease, the spike protein is a pathogen. A pathogen is a substance or organism that is capable of inducing illness. Note that I call myself an expert because there are very few of us out here studying it’s pathogenicity, however I would argue Professor Paul Marik has taken the lead across the globe in amassing all the basic science and clinical research underlying the knowledge of the mechanisms and treatments of spike-protein induced diseases. That scholarly document is in evolution, and has over 300 scientific references at this point, with rapid evolutions and additions each week. Note that it appears to be the world’s sole “comprehensive” scholarly work on spike protein pathogenicity and empirically proposed treatments.

Another great sadness about the US COVID response is that almost the entire health system and all of academia have yet to recognize the spike as a pathogen or formulate any approach to treating Long-Haul or Post-Vaccine Injury. Until they do, they will continue to fail to recognize the causes or mechanisms of these syndromes as well as to offer effective treatments. And, it goes without saying, they will not be able to discuss this in thier ill-informed consent discussions. Their deplorable failure at treating these disabling diseases is astounding and will continue for the foreseeable future. Remember, the system docs won’t treat because they are all members of the Church of RCT Fundamentalism (a.k.a “evidence based medicine.”) You know, where they will sit there paralyzed until some massive randomized controlled trial is published in a high-impact medical journal and then is recommended by a federal agency or national medical society. You know what that system produces by now if you read my Substack. Not only will it leave patients untreated for months to years, but while the docs sit around waiting, Pharma, via the agencies and media, will suppress or attack any generic medicines or supplements that front-line doctors and patients have found effective. They will do this with ferocity and depravity until such a time they can “save the day” with the massive promotion of a novel, pricey Big Pharma pill which they will get our government to pay for at a price they set. Think about what happened to ivermectin and hydroxychloroquine until Pharma saved the day with the pathetic and poisonous Paxlovid using our government coffers. Rinse repeat here.

The two major and complex diseases unleashed by the spike are what we call “long haul” and “post-vaccine injury” syndromes. I probably should differentiate post-vaccine into two subtypes, with one being an acute, sudden death syndrome caused by massive heart attacks, myocarditis (which can cause lethal arrhythmias or pump failure), and/or massive strokes. Excess mortality amongst the vaccinated in 2021 skyrocketed and is showing up in Life Insurance industry data in both the U.S and other countries. However I don’t see those events in my practice because they are sudden deaths occurring in asymptomatic patients (who are often swimming or running or doing something else fun until they suddenly drop dead). My practice instead sees patients who suffer with the more chronic subtype consisting of myriad, disabling symptoms across multiple organ systems. Now, whether there is enough spike in Novavax to produce similar deadly events or chronic syndromes in the future, who knows. More on that below.

SHORT TERM RISK DATA

Not looking good here folks. Let’s take a look at the actual published trial of Novavax, and their chart detailing the “side effects." Then let’s compare it to Pfizers mRNA “vaccine” trial published in December 2020. Look carefully. I will interpret these charts below.



Here is how I interpret the data:

  1. The “local” and “systemic” adverse events are absurdly high in both. I remember thinking back in December 2020 when I was reading the Pfizer trial, I said to myself, “Wow, that does NOT look friendly!” Not just the wickedly high frequency of really sore arms with redness and swelling, but the very high rates of “systemic symptoms” of fatigue, headache, chills, vomiting, muscle pain. Very high rates of those. Ouch.
  2. Next, look at the “dose response,” meaning look at the incidence of adverse events after the 2nd shot compared to the 1st shot. If it is higher after the 2nd, it indicates a “dose-response relationship,” which, when we are talking about a therapeutic, is a pillar of evidence to support the efficacy of the drug. For instance, ivermectin in COVID has a strong dose response relationship, meaning the higher the dose, the more effective it is (that is why all the high impact trials tried as much as they could to limit the dose of ivermectin, in particular during history’s most fraudulent trial called the TOGETHER trial).
Conversely, a dose-response in terms of side effects is a pillar of the measure of toxicity. The more you give, the sicker you get. Not cool. Now take a look at Pfizers published chart above, keeping in mind, these are only the short term systemic side effects.

  1. Pfizer: fatigue goes from 47% after the 1st to 59% after the 2nd in young folks and 34% up to 51% in older folks. Chills: 14% to 35% in young, 6% to 23% in old. Same pattern and increases with muscle pains and also joint pains and use of anti-pyretic medications.
  2. Now, take a look at Novavax. Note how they don’t give you the numeral percentages and instead make you crane your neck and use a ruler to estimate the actual incidences and increases. But just looking at the height of the bars from shot 1 to shot 2 and the increases in the yellow at the tops of the bars (yellow = “Grade 3” reactions - i.e. more severe), you see again what looks like a scary shot to me with some of the local and systemic events reported even higher than with Pfizer’s mRNA shot! So, is Novavax safer?
LONG TERM SIDE EFFECTS. Unknown. Remember the famous, “I guess we will just have to give it to see how safe it is” by one of the nations top vaccine experts. I swear, again, and I say this often, you just cannot make this stuff up. So, an informed consent discussion should relate that long term side effects are unknown. Remember as well, we are not in a supposed “emergency” anymore, despite the fact our government keeps renewing its emergency powers. If the person conducting this discussion tries to argue that in terms of long term effects, it is safe and effective because the mRNA vaccines were safe and effective, that is so categorically ridiculous it does not even bare addressing. Again, read my “Vaccine Exemption Letter” post for the data on toxicity and lethality of those vaccines. Do not proceed. My caution would be that spike protein is a pathogen with sequences that we know generate antibodies that then are capable of attacking many tissues (what are called autoantibodies which cause a category of diseases called “auto-immune” diseases). Also, spike protein, when broken down by the body is known to generate amyloid like fragments which are highly thrombogenic (i.e. cause clotting). Spike protein also stimulates immune cells called monocytes and macrophages which disturb numerous organ functions. Spike protein is also toxic to mitochondria which are the energy producing parts of each cell. In summary, don’t sign up for any more spike protein than is already circulating in the world.

Also, Novavax, like the mRNA vaccines uses “nanoparticles” in a “saponin-based adjuvant” solution which is novel and proprietary, patented only in 2020. Well, thats reassuring no? Their published paper states that the adjuvant and the vaccine was found to be “safe and immunogenic” in Phase 1 and 2 trials. Then I found this in the supplementary appendix from one of the earlier trials, ”the mechanism of Matrix-M1 (the adjuvant) is not well defined, but it has been associated with a potent induction of leukocyte activation and migration into the draining lymph nodes in their previous study.” Not reassuring.

EFFICACY

Unknown, but likely ineffective as it has not been tested against Omicron, or any of its sub-variants or whatever future variant will be circulating when it rolls out. Plus, as we know now, all the predicted efficacy reported from COVID-19 vaccine trials were never observed in the real-world, again likely due to trial shenanigans and data manipulations and removal and/or miscategorization of those who fell ill during the trial or simply due to the fact the virus is rapidly mutating. Even if it were effective, we know from the past two years, it would be short lived. I again have to mention natural immunity. It already protects against severe disease and reasonably well from re-infection, and there is no credible data to suggest adding an even older spike protein vaccine using a newly patented adjuvant will better protect you or make you healthier.

ALTERNATIVES TO VACCINATION

For readers of my Substack, you all know that you can always just skip the vaccine and instead just rely on early treatment which has been shown to be near perfectly effective in achieving rapid recovery and avoidance of hospitalization and death, especially when given in synergistic combinations like the FLCCC’s or the AAPS’s protocols. In fact, as you know, no vaccine would ever get an EUA or approval if effective treatments were available. Further, there are now over three dozen effective treatments supported by controlled trials, with many of them repurposed and/or over the counter. I suppose you could also just rely on Paxlovid given its demonstration of such incredible efficacy in treating President Biden and Dr. Fauci.

Hope this helps.
 

BUBBAHOTEPT

Veteran Member
In March, Biden vowed, 'We're going after the criminals who stole billions in relief money meant for small businesses and millions of Americans.'
What a LIAR! :smashblue:
But when, like Fauci, you have the world’s biggest ego and the protection of the press, you apparently can feel comfortable making these unfounded, inaccurate, offensive claims about your own self importance.
THE PROTECTION OF THE PRESS. That is about 50% of all our problems….:kaid:
 
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