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[Heliobas Disciple]

NAC & COVID

Examining some of the evidence for NAC use in treating and preventing COVID.

moderndiscontent.substack.com

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NAC & COVID
Examining some of the evidence for NAC use in treating and preventing COVID.
Modern Discontent
Aug 17

So far we’ve gone over some of the pharmacological effects of NAC and pointing to its ability to restore glutathione levels being its main mechanism of action.

Here, we’ll look at some of the clinical data in regards to NAC use against COVID and see what the evidence tells us.

A few important studies

Before we look specifically at COVID, I wanted to cite two studies that have been referenced quite a few times in the literature. These two studies are likely what was used to make a case for the use of NAC, similar to other repurposed drugs such as Ivermectin or Hydroxychloroquine which relied on previous clinical studies.

Attenuation of influenza-like symptomatology and improvement of cell-mediated immunity with long-term N-acetylcysteine treatment (De Flora, et. al.)

One such study that has been referenced multiple times is a study from De Flora, et. al. which looked at long-term NAC supplementation and whether that would attenuate symptoms of the flu during the cold season.

In this study, researchers provided effervescent NAC tablets1 to participants and measured their rate of influenza-like infection over the cold seasons. They also measured participants' cell-mediated immunity to see if NAC would have an effect on immunological responses to infections:

The present multicentric study, referred to as the NACIS study (acronym for N-acetylcysteine in Immune System), was designed in order to evaluate the efficacy of NAC, administered orally throughout the cold season, in preventing the occurrence and reducing the severity of influenza-like episodes in general, and specifically those caused by the influenza A/H1N1 virus. Another goal of this study was to assess the effect of NAC treatment on cell-mediated immunity.​

The researchers found that the NAC group had fewer incidences of influenza-like symptoms and that symptoms were more mild within the NAC group compared to the placebo group:

Of the 99 influenza-like episodes occurring in 62 subjects within the placebo group, 47 (48%) were classified as mild, 46 (47%) as moderate, and 6 (6%) as severe, according to the criteria reported in "Materials and methods". Of the 46 influenza-like episodes occurring in 37 subjects within the NAC group, 33 (72%) were classified as mild, 12 (26%) as moderate, and 1 (2%) as severe. As assessed by χ2 analysis, the frequency of mild forms was higher in the NAC group than in the placebo group, with a difference approaching the significance threshold (p=0.06), whereas the frequency of moderate forms was significantly higher in the placebo group than in the NAC group (p=0.02). The differences were particularly pronounced by mid-season, after 3 months of treatment, when mild, moderate and severe episodes were 9, 22 and 3 in the placebo group and 8, 4 and 0 in the NAC group, respectively (p=0.002), and after 4 months, when mild, moderate and severe episodes were 10, 6 and 0 in the placebo group and 3, 0 and 0 in the NAC group, respectively (p=0.006).​

From De Flora, et. al. Fig. 1 (left) and Fig 2 (right) show rates of influenza-like symptoms and number of symptoms, respectively. In both instances, the NAC treated group (black bars) showed lower rates of symptoms and fewer symptoms in general compared to the placebo group (white bars). Note, however, that these results were contingent upon a high degree of self-reporting, and therefore may suffer from lack of transparency on the participant’s parts.


Interestingly, the researchers measured cell-mediated immunity2 as well using a test similar to an allergy test, such that participants had their skin exposed to 7 different antigens to see if there would be a reaction (i.e. rash or other skin alterations). Given these limitations, the researchers found that long-term use of NAC increased the number of immunological competent (normoergic- their skin reacted to the antigen) participants and attenuated the number of nonresponsive (anergic-their skin did not respond) participants.



The results of this study are interesting, as both the NAC group and the placebo group started with the same cell-mediated response at month 0, suggesting that NAC may have helped improve cell-mediated immunity by the end of the 6 month assessment.

Overall, the results of this study provided some of the first looks into NAC as a possible prophylactic against respiratory infections. You’ve likely seen this study mentioned in reference to the 25% of NAC participants who experienced influenza-like symptoms compared to the 79% in the placebo group3. I've seen it referenced in many online articles as an argument in favor of NAC use for respiratory infections because of these findings.

As a caveat, note that some of the reporting provided to the researchers are heavily subjective and dependent upon the participant’s self-reporting:

Each subject was supplied with a personal diary card, and instructed to fill in any sign and/or symptom suggestive of an influenza-like episode, based on a suitable check list. Influenza-like episodes were assessed based on the presence of two or more of the following signs and/or symptoms: fever (≥38°C), asthenia, lack of appetite, headache, myalgia/arthralgia, coryza/rhynorrhoea, sore throat, catarrh and cough. At monthly intervals, the clinicians evaluated the diary card and performed a complete medical examination. The patients were also asked to contact the clinicians soon after the onset of any sign or symptom, and, whenever necessary, additional clinical examinations were performed.​

As such, there’s a possibility that some patients may not have reported their symptoms which may have altered their symptomatic status (i.e. wrongly categorized them as asymptomatic, seroconverted). This is a general consequence of studies that rely on self-reporting since it’s hard to discern how transparent participants are being in their note-taking or awareness of their own symptoms.

However, given these results there was some founded hopes that NAC may serve as a useful prophylactic for influenza, and that use may be broadened to other respiratory illnesses such as COVID.


N-acetylcysteine improves oxidative stress and inflammatory response in patients with community acquired pneumonia (Zhang, et. al.)

A more recent study from Zhang, et. al.4 looked at the role of NAC in attenuating oxidative damage and the inflammatory response from pneumonia-like illness.

Oxidative damage and inflammation are intrinsically tied, and it’s assumed that these two are likely to lead to pulmonary damage during a case of pneumonia. Therefore, attenuating both should, in theory, lead to improved outcomes with reduced organ damage.

Patients who were diagnosed with pneumonia were randomized to either a group that was provided standard of care5 (control group) or one that was provided standard of care along with 600 mg of NAC twice a day (1200mg/day) for 10 days.

The diagnostic and inclusionary criteria were as follows:

The CAP diagnostic criteria were as follows: an acute pulmonary infiltrate evident on chest radiography and consistent with pneumonia; symptoms of a lower respiratory tract infection: fever, cough, and purulent sputum, with confirmatory findings of a clinical examination; acquisition of the infection outside a hospital, long-term care facility, or nursing home. The patients were included if they had the diagnostic criteria defined above, were diagnosed with bacterial community-acquired pneumonia according to American Thoracic Society/Infectious Diseases Society of America (ATS/IDSA) Guidelines[13,14] and if they were aged ≥18 years.​

Because this study wanted to look at NAC in attenuating oxidative damage and inflammation, the researchers measured biomarkers from participants to see if there would be indications of improvement6:

The primary endpoint indicators were the changes in oxidative stress parameters (MDA, TAOC, SOD) and TNF-a after treatment in the NAC group compared with those in the nonNAC group. The secondary endpoint indicator was whether there was a difference in CT scores after treatment in the NAC group compared with the non-NAC group.​

Relevant biomarkers were measured at the start of the study as well as at the 7 day mark. Improvements to biomarkers between the NAC group and the standard-of-care group showed that patients provided NAC showed greater improvement measures of the oxidative biomarker MDA as well as the inflammatory cytokine TNF-α relative to the non-NAC group. Measures of TAOC also appeared to have improved in the NAC group to a higher degree, however for SOD measures there didn’t appear to be significant improvements compared to the non-NAC group:

After 7 days plasma levels of MDA and TNF-a decreased more (MDA: p 0.004, TNF-a <0.001) in the NAC group than the non-NAC group, and there was a reliable increase of TAOC content in the NAC group (p 0.005). An improvement was seen in plasma SOD activity after treatment, but there was no significant difference in the rise of plasma SOD activity between groups (p 0.368). The results are shown in Table 3 and Fig. 2. No side effects were reported with NAC administration.​

Figure 2. The above graphs map out biomarkers relevant to oxidative and inflammatory responses. Note that the oxidative molecule MDA and the inflammatory cytokine TNF-α should decrease, and here it appears that the NAC group (in blue) showed a higher decline in MDA and TNF-α levels compared to the non NAC (control) group. For TAOC there should be an expectation that

Interestingly, CT scan results, which were used to measure improvements with pneumonia, showed no statistically significant improvements in the NAC group compared to the non-NAC group7, inferring that pulmonary damage and pneumonia may not be alleviated through NAC use.

So although this study did not show greater improvement scores for NAC patients, the results do suggest that NAC may reduce oxidative stress and inflammation caused by pneumonia.

What’s important from this study is that the researchers used a highly accessible form of NAC (tablets) which would be easy to administer at an at-home environment, similar to the one given in the De Flora, et. al. study8.

However, it’s worth noting that this study used a very small sample size, likely driven by issues in recruitment9:

Initially 86 patients were considered for inclusion in the study. Twenty-nine patients were excluded and so 37 cases were in the NAC group and 24 cases in the non-NAC group. Eighteen cases did not complete the study. So, 39 pneumonia patients completed the study. Of these, 21 subjects were included in the NAC group and 18 in the non-NAC group.​

This may have altered results due to not having the eligibility necessary for meeting effect size.

Also, note that the researchers never examined the etiological agent responsible for pneumonia, such that there was no information as to whether the pneumonia was caused by a viral, bacterial, or fungal infection. The researchers do rely on CT scans for diagnosis, as well as if participants met the guidelines for bacterial pneumonia from the American Thoracic Society/Infectious Diseases Society of America (ATS/IDSA):

Another limitation is that the study did not record details of the etiologic agent. Patients in our study were diagnosed with bacterial community-acquired pneumonia according to ATS/IDSA Guidelines. For the pathological features, treatment and disease course of tuberculosis and fungus infection are different from those of bacterial pneumonia, patients considered to have tuberculosis or fungus infection were not included. Primary viral pneumonia was defined in patients presenting during the acute phase of influenza virus illness with acute respiratory disease and unequivocal alveolar opacification involving ≥2 lobes with negative respiratory and blood bacterial cultures. There might be some differences in oxidative stress status between bacterial and viral pneumonia.[26] Primary viral pneumonia cases were not admitted to the study either.​

Since different infections are likely to lead to different levels of oxidative damage and inflammation, we should keep in mind that the results here are likely to be influenced by the type of pathogen i.e. no direct relationship to viral pneumonia in this study.

In short, these two studies- along with a few others not mentioned here- provide much of the basis for examining NAC within the context of COVID. Given these results it’s no wonder why NAC has been looked at, and considering that NAC is widely available (or at least used to be) it makes sense why research continues to look into NAC as a possible prophylactic and therapeutic against COVID.

[continued next post]

 

[Heliobas Disciple]

[continued from post above]

NAC/COVID Clinical Studies

When looking at NAC with respect to COVID, I’ll be blunt and say that the results are conflicting. Heck, the results are conflicting for clinical studies of Ivermectin, Hydroxychloroquine, Fluvoxamine, Remdesivir… you get the idea.

Therefore, it’s sometimes more important to parse out differences in methodology rather than the actual results, as differences in results could alter the conclusions of a clinical trial. Remember that this heterogeneity is found in many clinical studies which makes it hard to directly compare studies.

Here are few things to look out for in clinical studies:

• Dosing: Differences in dosing are going to have an effect, such that higher doses may be more therapeutic while also increasing the likelihood of adverse reactions. Note that studies may not have a standard therapeutic dose and the dose used may be one derived from prior studies rather than ones that have shown a good degree of effectiveness.
• Loading dose: Some studies may also use what’s called a loading dose followed by a maintenance dose. A loading dose essentially provides a high level of the drug/supplement up front followed by lower doses, with the assumption that quickly ramping up the serum levels of a therapeutic within minutes bypasses the gradual increase that may take hours or even days, meaning that therapeutic levels can be reached more quickly. It may also attenuate much of the metabolism that occurs through the first pass effect, with the caveat that toxicity may occur as a consequence. Note that some studies may or may not use a loading dose and that may influence results.
• Timing: What should be made clear at this point is that timing of a therapeutic is important. For the most part, early use of an antiviral therapeutic is better- target the pathogen at very low levels before there needs to be concerns over balancing damage from the pathogen and possible adverse reactions from the therapeutic. However, remember that the therapeutic effects should still match the disease. COVID is considered to be at least a biphasic disease with viral infection being followed by systemic inflammation of multiple organs. This means that the timing of NAC should corroborate with the intentional use of the drug- could early NAC use affect the inflammatory response needed to mount a proper immune response against an antigen, contrasted with late use during a cytokine storm that may attenuate the oxidative damage and hyperinflammatory response? It’s worth examining what the intended use of NAC is within a clinical study to understand if the timing seems appropriate with respect to the MOA.
• Route of administration: A few studies will either rely on oral or intravenous administration of NAC. Remember that oral use suffers from low bioavailability due to the first pass effect with the pro being that oral administration is far easier and can be done at home during the early stages of the infection. Intravenous NAC use may increase serum levels more quickly with the caveat that it may require an in-hospice setting.
• Measures of Improvement: Results are interpreted based on the markers being measured. As such, the results of some studies are contingent upon which measures are looked at. Some may look for biomarkers indicating oxidative stress or inflammation such as the Zhang, et. al. study while others may look at oxygen levels, mortality, and days hospitalized. Keep in mind that the interpretations of results rely on the measures taken.

There are likely to be a few more things worth considering, but we’ll look at a few studies and examine differences in methodology.

A pilot study on intravenous N-Acetylcysteine treatment in patients with mild-to-moderate COVID19-associated acute respiratory distress syndrome (Taher, et. al.)​

The first study we’ll look at is one from Taher, et. al.10 that intended to use NAC to treat COVID during the early stages of ARDS. The intended use of NAC within this study was to see if NAC could dampen the excessive inflammatory response during ARDS:

Considering this evidence, it is speculated that NAC target multiple mechanisms related to COVID-19 excessive inflammation. Thus, it is reasonable to assess NAC as a potential therapy for COVID-19. However, at present, clinical information on using NAC for COVID-19 treatment consists almost exclusively of single case reports [21–23] and one small case series study [24]. Hence, we designed this double-blind, placebo-controlled study to determine whether patients with mild-to-moderate COVID19-associated ARDS would benefit from intravenous NAC administration as adjuvant therapy to standard therapy.​

Patients were randomized to either receive intravenous NAC at a dosage of 40mg/kg/day11 diluted in a 5% dextrose solution for 3 days. The placebo group was given intravenous dextrose solution alone. All participants were also given antioxidant supplements such as Vitamin C (1000 mg bid), Vitamin D (1000 mg bid) and Zinc (50 mg daily).

It’s also worth noting that a majority of participants also received other medical interventions such as Hydroxychloroquine, Dexamethasone, Azithromycin, and other antiviral agents (Table 1).

Primary outcomes looked at 28-day mortality rates and measures of clinical improvement:

As the primary efficacy outcomes, the following were compared between the two groups from baseline up to day 28 post-randomisation: (1) overall 28-day mortality, (2) clinical status on study day 28, using an 8-point ordinal scale of the WHO Master Protocol (V.3.0, 3 March 2020) […]​

Secondary outcomes included measures such as ventilation, ICU/hospital stay, and measures of organ damage and ARDS.

Although the results showed reduced mortality and greater improvement among the NAC group the results did not meet statistical significance:

According to the obtained results, although the overall 28-day mortality rate was lower in the NAC group than to the placebo group [12 of 47 patients (25.5%) in the NAC group vs. 14 of 45 patients (31.1%) in the control group], no statistically significant differences were found between the two groups (p value = 0.64; Table Table2).2). Results regarding the comparison of the distribution of the clinical status at day 28, using the 8-point ordinal scale of the WHO, are shown in Fig. 2. Although the distribution of the clinical status at day 28 in the NAC-treated group shifted towards better outcomes than did placebo-treated group, it did not reach a statistical significance level (p value = 0.83).​

And it appears that secondary outcomes were comparable among the NAC groups and the non-NAC groups (Table 212).

Based on these results the researchers suggest that NAC did not appear to improve clinical outcomes within their study.

There’s a few possible reasons for this, with one clear observation being that the 3-day use of NAC may not have been long enough to see improvement.

There’s also an issue of timing. Median time of symptom onset for these patients was 7 days, but note that this symptom onset period is likely referring to the initial start of the disease and not the start of ARDS symptoms, although the measures used to diagnose ARDS appear to be consistent with other studies13. With no indication with time of ARDS onset and start of therapeutics (aside from diagnosis at time of hospitalization), it's hard to determine if delayed use of therapeutics may influence the response. Granted, it may be assumed that hospitalization may occur immediately after ARDS symptom onset. It's also a bit of an oxymoron to suggest mild-to-moderate ARDS symptoms.

One thing that may be worth considering is the cellular stress occurring during ARDS. Given the prior post on NAC’s mechanisms of action, it appears that it is Glutathione and not NAC that is the main active metabolite responsible for antioxidation.

That would mean that cells must uptake NAC, have it undergo deacetylation to form L-cysteine within the cytosol, and then enter into the necessary enzymatic pathway to form GSH.

Although this may be readily achieved under normal or mild cellular stress, this may not be possible when cells are undergoing severe stress and damage already- the cells may not have the capacity to produce GSH. This may explain why NAC may be considered ineffective during symptoms of ARDS, and if that’s the case it may be worth looking into use of GSH rather than NAC to bypass the necessary enzymatic reactions that may not be possible under high cellular stress.

So severe symptom onset may not be just a consequence of GSH depletion, but also the cells’ inability to initiate GSH repletion as well when under high stress.

Overall, the results of this study may be a consequence of implications and hindsight- when patients may need to start presenting with worse symptoms before they are given treatments they may paradoxically be too deep into their infection. It’d be impossible for researchers to determine who may convert over from typical flu-like symptoms into ARDS, but it may also be argued that use of NAC may not wait until it’s too late.

Although the general evidence for NAC use is conflicting, the researchers do suggest that additional research should be done into looking at NAC:

However, although the current clinical data are conflicting, there is a rationale to study NAC as an adjunct therapy to prevent and treat COVID-19 infection. Research has revealed that despite the potent antioxidant and anti-inflammatory effects of NAC, unlike glucocorticoids with intrinsic immunosuppressive drawbacks, NAC is not immunosuppressive. In fact, NAC not only does not increase the risk of infections but also, through regulatory actions on the immune system, may decrease the risk of infections [33].​

Combined Metabolic Activators Accelerates Recovery in Mild‐to‐Moderate COVID‐19 (Altay, et. al.)

This study is rather exhaustive so we won’t go into too many details. However, unlike the Taher, et. al. study this one looked at patients with mild-moderate COVID symptoms and whether the use of metabolic activators could lead to quicker and better improvement of patients.

Metabolic dysfunction is considered to be driving factor for many different diseases including COVID, so it was assumed by the researchers that a combination of metabolic activators (CMA) should be beneficial in fighting COVID.

In this study, researchers deployed a combination of L-serine, L-carnitine, and NAC. Some participants also received standard of care which included Hydroxychloroquine or Favipiravir14:

Treatment started on the day of diagnosis. Both placebo and CMA were provided in powdered form in identical plastic bottles containing a single dose to be dissolved in water and taken orally one dose in the morning after breakfast and one dose in the evening after dinner. Each dose of CMA contained 3.73 g l‐carnitine tartrate, 2.55 g N‐acetylcysteine, 1 g nicotinamide riboside chloride, and 12.35 g serine. All participants also received oral HQ or FP for 5 d. The patients were contacted by telephone daily to assess symptoms and adverse events. All patients came for a follow‐up visit on Day 14. Further information is provided in the Appendix in the Supporting Information.​

This study is interesting since it was one that did not provide weight-dependent doses. It’s also an early study with people being recruited at time of PCR positive testing.

It’s also worth noting a few concerning details, such as randomization leading to a 3:1 ratio between CMA groups and standard of care, so the group sizes are not comparable. Also, note that this study skewed younger (mid-30s) than other studies and most participants did not have comorbidities, which may explain the positive results in this study compared to other studies.

The important results here would be from Section 2.1 and 2.2, but I’ll take from the 2.2 results which looked at the number of days until symptom-free onset until Day 14.

Fortunately the researchers provide an easy to read chart and graph:

Part A outlines the study timeline, with Part B being the more important graph here. CMA participants are shown in blue while Placebo group is shown in orange. The graph maps the number of days until a participant has been considered to be symptom free from COVID, and the results suggest that symptoms alleviated far quicker in the CMA group than the Placebo group with half of the participants becoming symptom-free by day 6 and day 9 respectively. Interestingly, CMA participants appeared to have no more symptoms by day 10.

Although both groups were provided either Hydroxychloroquine or Favipiravir, the researchers conducted a separate analysis controlling for these drugs as possible confounders, and the results suggest that CMA reduced days of symptoms independent of the additional drugs:

We observed that the mean recovery time was again shorter in CMA group than in placebo group (5.76 vs 9.32 d, p < 0.0001) in the patients treated with HQ only (Figure S1A, Supporting Information) and (5.54 vs 8.77 d, p = 0.00034) in the patients treated with FP only (Figure S1B, Supporting Information). We also compared the independent effect of the HQ and FP on COVID‐19 patients and found that these two drugs had a similar efficacy on the recovery of the patients in all (Figure S2A, Supporting Information), placebo (Figure S2B, Supporting Information) and CMA (Figure S2C, Supporting Information) patient groups. Hence, we observed that CMA administration accelerated the recovery of the COVID‐19 patients independent of the standard therapy.​

As an early treatment option these results seem very promising. However, there is an issue of these results being highly subjective. Symptom measures were taken over the phone and only a full medical examination was given at the 14 day mark, suggesting that patients may not have been transparent about their results. Symptoms are also not an indication of infection, so there are some tenuous associations as well:

For the primary purpose, the proportion of patients who fully recovered from COVID‐19, as demonstrated by being symptom free within the 14 d of the initial diagnosis of COVID‐19, was determined. This was amended to include self‐reporting of daily symptoms and clinical status using a binomial scale (present/absent) via daily telephone visits by clinical staff.​

There is also the matter of NAC being given in conjunction with other supplements that may confound the results as well.

But even given these caveats the study does provide some promising results, especially within the context of early use therapy.

Should NAC be used for COVID?​

Although we covered a few studies here there are quite a few that have not been evaluated. In essence, the results are conflicting, likely due to methodology.

The Taher, et. al. study looked at NAC within the context of ARDS, and at that point the use may be considered too late. Compounded with the fact that cells may be under too much stress to produce GSH there may be arguments that GSH may be considered a more rational supplement to use.

The Altay, et. al. study has quite a few caveats but does provide some promising results for early use where NAC may be more beneficial. This is taking into account that control of inflammation itself does not attenuate immune function, which was argued against in the Taher, et. al. Discussion.

But probably the most important feature from all of these studies is that there appears to be overwhelming evidence in support of the safety and tolerability of NAC. Even if the drug in question may have conflicting evidence, the lack of egregious toxicity and adverse reactions should suggest that NAC use not be hindered by concerns over possible toxicity.

Hopefully as more studies come about more evidence can substantiate the use of NAC. For now, remember to do your own research and seek out additional medical advice to see if NAC would be viable for your given circumstances.

And apologies for this rather long-winded post, the next one will hopefully be much shorter and just be a look at L-cysteine, NAC, glutathione, and why one may be used over the other.

 

[Heliobas Disciple]

I Was Right About The Pfizer CEO!

Were media outlets paid to publish false "fact checks" in order to smear journalists investigating the deadly COVID vaccines?

emeralddb3.substack.com

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I Was Right About The Pfizer CEO!
Were media outlets paid to publish false "fact checks" in order to smear journalists investigating the deadly COVID vaccines?
Emerald Robinson
Aug 15


Telling the absolute truth is a dangerous business these days — which explains why so few journalists do it anymore. And, as we should all know by now, lies don’t get you banned on Twitter — only the truth gets you “permanently suspended.”

Exhibit A: My tweet about the CEO of Pfizer not being fully vaccinated and having to cancel a trip to Israel over it.


A veritable firestorm erupted on social media — as various frauds and fakes surfaced from the Washington swamp to “fact-check” my tweet. Twitter added a “context warning” to the original tweet. An emergency life-raft for neo-cons and NeverTrumpers called The Dispatch printed a full page rebuttal — which is a giant red flag that certain people were probably taking money from Big Pharma to push the COVID vaccines.

According to Stephen Hayes, I am “a frequent purveyor of bad information” which is practically the highest compliment one can receive in American journalism — when you consider the source.


A year later, Jordan Schachtel bothered to read the Pfizer CEO’s new biography and found, of course, that my tweet was accurate.

It was the “fact check” that was false.


He pointed interested readers to a key passage in a recent Wall Street Journal review of the Pfizer CEO’s new book as well.


Was Pfizer’s PR department making false statements?


Why did The Dispatch try to smear me?

Did The Dispatch receive any funding from Big Pharma or its affiliates? Or from the federal government’s HHS to push the COVID vaccines?

My attorneys will be asking them such questions very soon.

Emerald Robinson’s The Right Way​

Fox News & Newsmax Took Biden Money To Push Deadly COVID Vaccines To Its Viewers​

Two days ago, Chris Pandolfo at Blaze Media revealed that his media organization had filed FOIA requests regarding the Biden Administration’s covert funding of the deadly new vaccines and the American corporate media. What they discovered will certainly shock you — and…​

5 months ago · 958 likes · 74 comments · Emerald Robinson​

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​

Here is a video of Emerald Robinson on the War Room with Steve Bannon on August 16, 2022 discussing the above susbtack article.

11 min 19 sec

Emerald Robinson Was Right About The Pfizer CEO

Emerald Robinson Was Right About The Pfizer CEO

rumble.com

And here is a follow up video with Naomi Wolf and Steve Bannon that was recorded immediately after the one above where they are discussing what happened to Emerald Robinson.

12 min 12 sec

Bannons & Naomi Wolf Breaks Down The Lies And Conflicts Of Interest Of Pfizer

Thanks for watching. Please subscribe to USA Patriot News!

rumble.com

 

[Heliobas Disciple]

WHO: World coronavirus cases fall 24%; deaths rise in Asia

LONDON (AP) — New coronavirus cases reported globally dropped nearly a quarter in the last week while deaths fell 6% but were still higher in parts of Asia, according to a report Thursday on the pandemic by the World Health Organization.

apnews.com

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WHO: World coronavirus cases fall 24%; deaths rise in Asia
yesterday

LONDON (AP) — New coronavirus cases reported globally dropped nearly a quarter in the last week while deaths fell 6% but were still higher in parts of Asia, according to a report Thursday on the pandemic by the World Health Organization.

The U.N. health agency said there were 5.4 million new COVID-19 cases reported last week, a decline of 24% from the previous week. Infections fell everywhere in the world, including by nearly 40% in Africa and Europe and by a third in the Middle East. COVID deaths rose in the Western Pacific and Southeast Asia by 31% and 12% respectively, but fell or remained stable everywhere else.

At a press briefing Wednesday, WHO Director-General Tedros Adhanom Ghebreyesus said reported coronavirus deaths over the past month have surged 35%, and noted there had been 15,000 deaths in the past week.

“15,000 deaths a week is completely unacceptable, when we have all the tools to prevent infections and save lives,” Tedros said. He said the number of virus sequences shared every week has plummeted 90%, making it extremely difficult for scientists to monitor how COVID-19 might be mutating.

“But none of us is helpless,” Tedros said. “Please get vaccinated if you are not, and if you need a booster, get one.”

On Thursday, WHO’s vaccine advisory group recommended for the first time that people most vulnerable to COVID-19, including older people, those with underlying health conditions and health workers, get a second booster shot. Numerous other health agencies and countries made the same recommendation months ago.

The expert group also said it had evaluated data from the Pfizer-BioNTech and Moderna vaccines for younger people and said children and teenagers were in the lowest priority group for vaccination, since they are far less likely to get severe disease.

Joachim Hombach, who sits on WHO’s vaccine expert group, said it was also uncertain whether the experts would endorse widespread boosters for the general population or new combination vaccines that target the omicron variant.

“We need to see what the data will tell us and we need to see actually (what) will be the advantage of these vaccines that comprise an (omicron) strain,” he said.

Dr. Alejandro Cravioto, the expert group’s chair, said that unless vaccines were proven to stop transmission, their widespread use would be “a waste of the vaccine and a waste of time.”

Earlier this week, British authorities authorized an updated version of Moderna’s COVID-19 vaccine that targets omicron and the U.K. government announced it would be offered to people over 50 beginning next month.

 

[Heliobas Disciple]

Review finds CDC mishandled COVID-19 pandemic response

A scathing internally initiated review of how the Centers for Disease Control and Prevention handled COVID-19 has found that its approach toward the pandemic failed to meet the moment of crisis, and offered a series of changes intended to revamp the agency and make it more nimble. "For 75...

news.yahoo.com

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Review finds CDC mishandled COVID-19 pandemic response
SASHA PEZENIK and CHEYENNE HASLETT - ABC News
Wed, August 17, 2022, 4:01 PM·3 min read

A scathing internally initiated review of how the Centers for Disease Control and Prevention handled COVID-19 has found that its approach toward the pandemic failed to meet the moment of crisis, and offered a series of changes intended to revamp the agency and make it more nimble.

"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," CDC Director Rochelle Walensky said in a statement on Wednesday.

A fact sheet outlining the review, obtained by ABC News and confirmed by the CDC, said that the "need for change came through loud and clear."

Walensky ordered the review in April after the CDC had come under frequent fire for its muddled and inconsistent messaging on COVID mitigation measures.

During interviews with roughly 120 agency staff and key external stakeholders, the review found that it "takes too long for CDC to publish its data and science for decision making," that its guidance is "confusing and overwhelming" and that agency staff turnover during the COVID response "created gaps and other challenges for partners," according to findings obtained by ABC News.

And while Walensky also defended, in part, the overwhelming job of handling the pandemic, the center said the country's public health infrastructure is "frail." The review also revealed the CDC's "operating posture" was "not adequate to effectively respond to a crisis the size and scope" of COVID.

The CDC's goals going forward will focus on improving "accountability, collaboration, communication, and timeliness" within and outside the agency, the report said.

"As a long-time admirer of this agency and a champion for public health, I want us all to do better and it starts with CDC leading the way," Walensky said in a statement.

As part of the suggested solutions, Walensky committed to sharing scientific findings and data faster, rather than at the typical speed for academic publication.

"Produce data for action" rather than "data for publication," said a CDC briefing document summarizing the changes.

The new recommendations also put a large emphasis on improving public health communications to the American people. "The website is not easy to navigate," the document said.

To spearhead the next steps towards the agency's overhaul, Walensky intends to appoint former Obama administration Deputy Health and Human Services Secretary Mary Wakefield to oversee the shift and "help implement the vision."

The review also outlines plans to create a new executive council reporting to Walensky, which will "determine agency priorities, track progress, and align budget decisions, with a bias toward public health impact."

"There were a lot of challenges for CDC and a lot of deficiencies that were identified during this response," said Dr. Richard Besser, CEO of the Robert Wood Johnson Foundation, a former acting director of the CDC and a former ABC News chief medical correspondent. "Hopefully the things that are being addressed here will lead to a better response in the future."

"It is exciting though to see a couple things," Besser, who was interviewed as part of the CDC review, added. "One, the acknowledgement that there are major deficiencies -- and an action plan for moving forward. Because you can study things to death. And the things that are laid out here will lead to a more effective agency."

Walensky did not provide a timeline for the changes, but said she will provide regular updates internally.

"None of these challenges happened overnight," the CDC said in a statement. "The work ahead will take time and engagement at all levels of the organization."

 

[Heliobas Disciple]

Fauci urges Black Americans to get Covid booster shots in preparation for fall surge

Dr. Anthony Fauci has an important message for Black Americans: get a booster shot.

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Fauci urges Black Americans to get Covid booster shots in preparation for fall surge
Greg Nash; Claretta Bellamy
Thu, August 18, 2022, 1:47 PM

Dr. Anthony Fauci has an important message for Black Americans: get a booster shot.

In a recent interview with TheGrio, Fauci, who is director of the National Institute of Allergy and Infectious Diseases, urged the Black community to get a Covid booster shot in preparation of the fall surge, when the Covid infection rates are expected to rise. He said that the Food and Drug Administration will soon authorize an updated booster shot, known as the bivalent BA.5 vaccine, which is a closer match to the circulating Omicron variants of Covid.

“If the African-American population… want to diminish their risk of infection and severe disease, stay heads up for the availability of this updated bivalent BA.5 vaccine,” he said of the booster that could be available as soon as mid-September.

He also noted that Covid infection rates continue to disproportionately affect Black Americans because of two key factors: their occupations and underlying health conditions.

“African Americans as a group, generally, are employed in jobs that put them out into society in contact with individuals where the risk of getting infected is greater than someone who can actually do their job behind a computer screen or in front of a Zoom,” Fauci noted, before adding that underlying conditions, like diabetes, hypertension and chronic lung disease that disproportionately affect Black Americans and other people of color, “make it more likely that if you do get infected, you’ll have a severe outcome.”

Fauci said it’s “very disturbing” that Covid deaths have remained around 400 per day during the summer surge.

“If you look at the infection rate now as late into the summer as mid-August, we’re still seeing well over 100,000 documented cases every day,” Fauci said. “And since so many people get infected and get the home test and never report that they’re infected, the actual number of infections is probably multifold, more than just 100,000 a day.”

He said that because Covid keeps producing new variants and cannot be eradicated or eliminated, the goal is for the population to gain immunity. This includes getting the Covid infection rates down, “so that even though the virus still is around, it doesn’t have a significant impact on our lifestyle, the way Covid has over the last two and a half years.”

 

[Heliobas Disciple]

When should I get a COVID booster? Next-generation antibody tests could help.

Scientists are working on COVID antibody tests to help people know when their own protection is fading and a booster may be needed.

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When should I get a COVID booster? Next-generation antibody tests could help.
Karen Weintraub, USA TODAY
Thu, August 18, 2022, 1:09 PM·6 min read

Since late last year, federal officials have been asking, practically begging people to get booster doses of the COVID-19 vaccine. But more than half of Americans have ignored the request even for a first booster, not really sure whether it's necessary.

Now, a coterie of scientists wants to help people make more informed decisions by letting them know when their own protection is fading.

Antibody tests have been on the market since early in the pandemic, but they do little more than tell people whether they have been already infected with COVID-19. A newer generation test would look specifically at the levels of neutralizing antibodies and either give a precise level or a "low," "medium," "high" reading, providing more actionable information.

As with most things to do with COVID-19, though, it's complicated.

A new at-home test was shown to work in an MIT research lab but hasn't yet been scaled up or made simple enough for general use. Testing companies don't want to invest in the long, complex process of winning federal approval. It remains unclear how much neutralizing antibody someone needs to be protected. And some worry that the information will be misleading, encouraging people to get shots they don't need.

The backstory​

MIT researcher Hojun Li, who led the development of the new test, wanted to know whether his blood cancer patients at Boston Children's Hospital and Dana-Farber Cancer Institute were protected by their COVID-19 vaccinations.
The bone marrow transplants used to treat children with blood cancer deplete the immune system's B cells, which are needed to fight off disease. For these children, knowing whether they are safe to go out in public could literally mean the difference between life and death.

Li hopes his test, taken maybe once a month, could help those kids and everyone else identify when it's time to top off their protection or avoid public settings.

What is an antibody test?​

Neutralizing antibodies are capable of preventing a virus from entering a cell and reproducing in it. Roughly speaking, the more neutralizing antibodies, the more protection against infection.

While the immune system's T cells can protect against severe disease and usually last longer than neutralizing antibodies, a low neutralizing antibody level reveals vulnerability to infection. Because current vaccines do a good job of protecting against severe disease but not an infection, it could be useful to know when your level of neutralizing antibody drops too low to be protective.

Dr. Michael Mina, a former Harvard epidemiologist and now chief science officer at the digital health company eMed, said he has been using existing antibody tests for the past year to track his and his family's antibody levels. A sharp increase after a booster showed the immune system of a family member responded the way it should, but current antibody tests can't tell when it's time for another boost.

Mina described Li's new test as "a really good advance."

How low is too low for antibodies?​

Unfortunately, scientists still don't know how much neutralizing antibody someone needs to be protected against COVID-19.

But determining "correlates of protection," knowing how much antibody is enough, has been elusive in the pandemic.
Li said that's because it has been difficult to track people's neutralizing antibody levels over time, to see how low they have to get to be vulnerable. His test could help figure that out, either going forward or by looking at blood samples collected over time from vaccine manufacturers.

In the meantime, based on current medical research, someone with antibody titers above 1 in 1,000 (a measure of how diluted a blood sample has to be to lose its antibody protection) has little to worry about, he says while someone in the 1 to 100 range is probably at risk for infection and may want to consider getting a booster.

There's a gray area, he said, and people at low risk for severe COVID-19 might be willing to live with 1 in 100 or 1 in 200. If he were over 65, immunocompromised, or had lots of health conditions, Li said he'd probably "want to stay above 1 in 400 or 1 in 500."

Why don't we already know the key levels?​

Existing tests can say whether you have any neutralizing antibodies, but not whether you have enough to be protected.
Determining a "correlate of protection" for each variant would require regular blood tests from hundreds to perhaps 1,000 people, checking their antibody levels and how low they have to fall before an infection.

"With the expense and complexity of current technology, nobody seems excited about trying to run that study," Li said.
An at-home test like Li's would make that process much easier.

How soon can I get a test like this?​

Li runs a small lab at MIT and can't produce tests on a large scale.

He has tested himself only a few times, finding his titers at 1 in 900 a few weeks after getting his initial two Pfizer vaccine doses but just 1 in 20 four months later. He has since had two boosters because he can't afford to bring COVID-19 into his blood cancer ward at Boston Children's.

To make more tests, he's trying to collaborate with a large testing lab. So far, the ones he has talked to have said they're interested – if he can get his test through the Food and Drug Administration's regulatory process. That's not something his team or MIT have the expertise or resources to do, Li said, so he's going to keep trying to find a partner.
Mina said the FDA may not authorize a test without a full clinical trial, which could cost something like $50 million. “This simply isn't realistic," he said.

Instead, the FDA should use correlates of protection to judge a test's effectiveness, he said, criticizing the government for not following people close enough to have figured out the correlates already.

"We have spent the last 2½ years scaring elderly people half to death about this," Mina said. "The more information we can give them about what's going on in their body I think is really valuable."

What are the concerns about these tests?​

Wenda Gao, chief scientific officer of Antagen Pharmaceuticals, a biotech company in Canton, Massachusetts, developed a similar test to Li's, but decided not to market it.

"We don't want to push the general public to boost too often," he said. "That may not be good for immunity. For a healthy person, sometimes we need to be very cautious."

Getting repeated shots with the original vaccine might make it harder to mount an immune response to a newer variant, he said.

The average person also may not need more than three shots, he said, because T-cells are already providing protection against severe disease. (So far, fourth shots have been approved for those over 50 and people with immunocompromising conditions or medications.)

And it may be a waste for some immune-suppressed people to get additional shots, Gao said, because they are not getting any benefit from them at all.

Instead, his company is focused now on developing vaccines that can provide broader protection.

 

[Heliobas Disciple]

Arcturus' COVID-19 Booster Shows Durability Against Omicron Variants

Arcturus Therapeutics Holdings Inc (NASDAQ: ARCT) announced updated data from its ongoing ARCT-154 booster clinical trial. The new results demonstrate a broad neutralizing antibody response against omicron variants of concern, including BA.5, lasting up to at least six months after administering...

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Arcturus' COVID-19 Booster Shows Durability Against Omicron Variants
Vandana Singh
Thu, August 18, 2022, 12:00 PM

• Arcturus Therapeutics Holdings Inc (NASDAQ: ARCT) announced updated data from its ongoing ARCT-154 booster clinical trial.
• The new results demonstrate a broad neutralizing antibody response against omicron variants of concern, including BA.5, lasting up to at least six months after administering a low-dose (5 mcg) ARCT-154 booster.
• “Our next generation low-dose self-amplifying (STARR™) mRNA technology continues to differentiate itself from conventional mRNA vaccine technology,” said Joseph Payne, President & CEO.
• “Further validation of the breadth and duration for the immune responses to ARCT-154 are planned in upcoming pivotal clinical trial activities,” he added.
• Related: Arcturus Reports Three-Month Durability Results From ARCT-154 COVID-19 Booster Trial.
• After one month and three months, neutralizing antibody responses to Omicron BA.5 were 33- and 20-fold elevated over pre-boost responses, respectively.
• After six months, neutralizing antibody responses to omicron BA.1, BA.2, and BA.5 ranged from 22-52 fold, 25-55 fold and 9-24 fold elevated over pre-boost responses, respectively.
• These data show sustained neutralizing responses to antigenically distinct variants of concern, including omicron BA.5, for at least six months after vaccination.
• Price Action: ARCT shares are down 6.79% at $19.05 on the last check Thursday.

 

[Heliobas Disciple]

UK to Roll out Moderna’s Omicron COVID-19 Booster Vaccine From September

The UK will start the rollout of Moderna’s new vaccine against the Omicron COVID-19 variant in the first full week of September.

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UK to Roll out Moderna’s Omicron COVID-19 Booster Vaccine From September
By Alexander Zhang
August 18, 2022

UK health authorities have said they will start the rollout of Moderna’s new vaccine against the Omicron COVID-19 variant in the first week of September.

NHS England said care home residents and people who are housebound will be among the first to be vaccinated as the rollout begins from Sept. 5. A wider rollout is due to start on Sept. 12.

NHS Chief Executive Amanda Pritchard said: “The NHS was the first health care system in the world to deliver a COVID-19 vaccine outside of clinical trials, and will now be the first to deliver the new, variant-busting vaccine when the rollout begins at the start of September.”

The NHS will also be rolling out the flu vaccine and encouraging eligible people to take up the offer from the first of the month where possible.

Pritchard urged anyone who is invited to take up both an autumn booster and flu jab, “to do so as quickly as possible—it will give you maximum protection this winter.”
Heart Inflammation Risks

The UK was the first country in the world to approve Moderna’s bivalent vaccine, which targets both the original strain of the virus and the Omicron variant.

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) announced on Aug. 15 that the vaccine had been found to meet the regulator’s standards of safety, quality, and effectiveness.

The MHRA said that the vaccine’s side effects are the same as those seen in the original Moderna booster dose and were “typically mild and self-resolving.”

“No serious safety concerns were identified,” the regulator said.

But there have been well-documented cases of side effects associated with previous COVID-19 vaccines produced by Moderna.

A French peer-reviewed study concluded in June that for both the Pfizer and Moderna vaccines, the risk of myocarditis, a type of heart inflammation, skyrockets a week after vaccination.

The risk of myocarditis after receiving the Moderna vaccine was 30 times greater than unvaccinated control groups, and the largest association for myocarditis following the Moderna jab was 44 times higher risk for persons aged 18 to 24 years.

The U.S. vaccine maker admitted in June that more than 1,000 cases of myocarditis had been detected in recipients of Moderna’s COVID-19 vaccine who are under 40 years old.

The company did not report cases of pericarditis, another heart inflammation condition that has been linked with the vaccines produced by both it and Pfizer.

Both myocarditis and pericarditis can have serious repercussions, with doctors often ordering patients to stop all physical activity for a period of time.

Zachary Stieber and PA Media contributed to this report.

 

[Heliobas Disciple]

New and Recurrent Cancers After mRNA Vaccines, Studies Suggest Immune Changes

Since receiving Moderna COVID-19 vaccines, Bonnie Eisenberg experienced relapse of her breast cancer 8 years after being in ...

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New and Recurrent Cancers After mRNA Vaccines, Studies Suggest Immune Changes
BY Marina Zhang
August 18, 2022

Since receiving Moderna COVID-19 vaccines, Bonnie Eisenberg experienced relapse of her breast cancer 8 years after being in remission.

The 73-year-old was diagnosed with stage 2 breast cancer in 2012. After successful treatment, she had been in remission since 2014.

Ever since then, her doctor has measured tumor marker levels in her body to monitor for relapse.

Tumor markers are usually proteins that indicate possible tumor or cancer growth. High levels of tumor markers may indicate cancer but it is not definitive.

There are many markers that can be tested, but the one that her doctor particularly focused on was the carcinoembryonic antigen (CEA), a tumor marker common to cancers of the breast, colon and rectum, prostate, ovary, lung, thyroid, and liver.

Since 2014, Eisenberg dutifully took monthly CEA tests along with others. The tests continuously returned with numbers in the normal range, which her doctor said was from 0 to 4.0 ng/mL.

Eisenberg’s average CEA results had been at 0.4 ng/mL, indicating her cancer was under control.

“Everything’s been going fine,” Eisenberg told The Epoch Times, “I was one of his best patients. He never worried about me.”

However, that changed after she got vaccinated. She received her first Moderna shot in January 2021 and experienced various common adverse effects including fever, shakes, “you name it, I had it,” she said.

That month, her CEA test rose to 3.7 ng/mL.

However, since it was still within the normal range, both Eisenberg and her doctor were not concerned.

After all, tumor cells are not limited to cancer patients. It is a known fact that everyone can have cancerous cells; what matters is whether the immune system can keep the cancer in check.

Eisenberg took her second shot in February 2021 and again suffered the same adverse effects.

Her CEA numbers jumped to 5.2 ng/mL that month.

This took her out of the normal range. Yet because Eisenberg has been such a stable patient, and because her result was so close to the normal range, both she and her doctor dismissed the results.

“Maybe I should have been a little more on the doctor. Since I was so good. We weren’t really that concerned about it.”

Boosters became available in October 2021. Eisenberg was not happy to take it given her previous adverse reactions, but she and her husband took it anyway. She experienced the same terrible adverse reactions.

In October 2021 and December 2021, she had CEA tests taken.

On Dec. 13, 2021 at 8 o’clock in morning, she received a call from her doctor. He was very concerned.

“When you’re getting a phone call that early in the morning, something’s wrong. He says to me: ‘Bonnie, we have to scan you.’ What’s the matter? [I asked]. My mark was up to 17.6 [ng/mL]—I was in trouble.”

Eisenberg was immediately sent for a CAT scan, as well as MRI and PET scans.

On the PET scans, it showed that her previously dormant breast cancer has “metastasized,” meaning that it has spread to locations outside the breast.

“When he hit me with this, even now … it’s just a very hard thing to accept. It’s just something that should have never taken place.”

“[The cancer] went to all my bones … it didn’t go to any of my body organs, but it was over every bone you could think of. On the PET scan I lit up like a Christmas tree.”

A metastasizing breast cancer would automatically put her in stage 4, the worst stage for cancers.

Eisenberg is convinced that the vaccine is responsible for her cancer recurrence. The increase in CEA levels correlated well with her vaccine timeline, and she is adamant that she will not get any more vaccinations, fearing that she will really die from it.

In the same month (December 2021), Eisenberg started targeted therapy. The main medication she takes for her cancer costs about $14,000 a month “but I just have a little copayment coverage for it.”

She also has a hormone blocker as well as a monthly injection of denosumab ($3,000 each) to prevent bone fractures. Luckily, her insurance covers the cost of denosumab.

Eisenberg has responded very well to her drugs, and her cancer is back in remission now.

Since she started treatment again, her CEA numbers dropped from 4.7 in January 2022 to below 1 ng/mL in June 2022. Her numbers are just like how she was before vaccination.

The bright spots representing cancer cells are also gone on her new PET scans.

Nonetheless, things have not returned to normal; the drug side effects Eisenberg complains of are likely to accompany her for the rest of her life.

“I have to be on [medication] for the rest of my life. I can’t stop it … he [the doctor] can lower the milligrams and stuff like that … but you always have to be watched. What I have is not going away.”

Her breast cancer medication reduces white blood cell counts, significantly weakening her immune system and puts her at risk of infections. This new worry hangs on Eisenberg’s mind, and in crowded places, she feels compelled to put on a face mask.

The drug also causes her hair to thin, and as a “hair girl,” Eisenberg is bothered by the reality that she can no longer straighten her hair.

The denosumab injections can also cause loss of bone mass leading to eventual breakdown. Eisenberg is glad to have greater intervals introduced between each injection and possible reduced dosages for her medications.

Given her stage 4 relapse, Eisenberg is considered fortunate to be back in remission.

Eisenberg shared her experience with other women also in remission who have not been recommended to do monthly tests, or women who responded very poorly to potent breast cancer treatments.

She hopes that her story will be able to help others so that the same does not happen to them.

“Whatever erupted inside me from the shot, something happened because they don’t even know what it does to the immune system … [the doctors, people at Moderna] don’t even know; there’s no answers. Nobody has any answers. I don’t care who you talk to. You’re not gonna get an answer. They don’t know.”

“There’s possibly other girls like me now. They don’t even know what’s happening inside them because if they’re not tested properly, they’re not going to know.”

In the history of the Vaccine Adverse Event Reporting System (VAERS), a total of 93 breast cancer cases have been reported as an adverse effect of a vaccine, of which 77 of the cases are reported after COVID-19 vaccines.

What Current Research Shows Us

The current research suggests the COVID shots altered the innate immune system, which is likely to alter the adaptive immune system.

Within the body, we have the innate immune cells that are quick-acting, inflammatory, and target all foreign molecules the same way.

Some of these innate immune cells will eventually activate adaptive immune cells, called the T and B cells. These cells begin to work a few days after infection and require activation from innate immune cells to function properly. These T and B cells target infections and cancers through specific and varied pathways. They create an immune memory afterwards so that the immune system will be able to act faster the next time.

Innate Immune System Alterations: Interferons

Interferons (IFN) are antiviral proteins. There are three major types: type I, II, and III, categorized based on the receptors each IFN binds to.

One of the most important IFN is type 1 IFN; it acts globally, targeting many tissues and organs to protect from infections, autoimmune diseases, as well as cancers.

Studies show that they are particularly important in the early response to infection and cancer.

“Impaired type I IFN signaling is linked to many disease risks, most notably cancer, as type 1 IFN signaling suppresses proliferation of both viruses and cancer cells by arresting the cell cycle,” the authors, led by Dr. Stephanie Seneff from the Massachusetts Institute of Technology wrote.

IFN-alpha and IFN-beta are type 1 IFNs; these molecules alert other cells of a virus or cancer, and also stop infected and cancerous cells from proliferating, causing diseased cells to die.

However, research on spike protein and mRNA vaccines suggests that IFN-alpha action may be impaired when exposed to spike protein.

A study that exposed human cells to spike protein DNA to induce the cell to produce spike protein found that the cell shipped out the spike protein with two forms of microRNAs (miRNAs) that inhibited molecules that activated IFN-alpha/beta.

miRNA are short strands of RNA molecules that bind to the DNA in cells and can therefore regulate cell activity. These two miRNA inhibited an essential protein that activates the IFN-alpha/beta pathway. This implies that vaccinated individuals will have a reduced IFN-alpha/beta response and poorer immune clearance.

Seneff said that the reduced symptoms in the vaccinated are likely because of this reduced pathway, since the initial symptoms of COVID-19 are caused by actions of the interferon action. This is why many vaccinated individuals are getting infected with rebound symptoms.

“[The vaccinated] don’t get the symptoms … don’t feel as sick, but actually, you’re spreading the disease like crazy because you’re not fighting it off.”

This also means that the virus will stick around in vaccinated individuals for longer, and if the disease is not cleared after a long period of time, it can cause severe disease down the line.

This hypothesis also concordant with hospitalization and mortality rates in New South Wales, an Australian state where over 95 percent of the population has been fully vaccinated, with many people receiving one or two boosters.

Hospitalitization rates and mortality rates are significantly higher in the boosted and fully vaccinated cohort, with lower rates in the unvaccinated and patients that have only received one dose.

Reduced T-Cell Response

T-cells and B-cells are adaptive immune cells, meaning that they engage in specific and targeted attacks rather than attacking all foreign invaders the same way, which is what innate immune cells do.

Both cell types are very powerful, but both need to be activated first through innate immune system pathways to develop strong, specified attacks.

Killer T-cells engage in close combat with diseased and cancerous cells by punching holes into them whereas B plasma cells work long-range, releasing antibodies into fluids in the body to surround and neutralize toxins, bacteria, and viruses. B-cells also play a role in cancer, though their function and importance are not well understood.

T-cells have been extensively studied for the important role they play in cancer by killing cancer cells directly. The activity of T-cells have often been used to predict disease outcomes in cancer patients.

However, recent studies have shown that innate immune function has been altered in those injected with the COVID shots. A preprint study found receptors that activate T-cell action, including TLR7/8 (toll like receptors 7 and 8), are reduced in vaccinated individuals.

Further, a Chinese study of people who have been vaccinated with the spike protein-inducing COVID-19 shots found that gene activity for what proteins and pathways are turned on and off have changed across most immune cells.

This raises questions about our traditional understanding of the innate immune cell to T-cell activation pathway and whether vaccinated individuals will have an immune system that responds similarly to how it was before vaccination.

The study found T-cell activity was reduced as well as an increased inflammatory response in the immediate weeks following vaccination, which, in the long-term, puts people at risk for cancer.

“These data suggested that after vaccination, at least by day 28, other than generation of neutralizing antibodies, people’s immune systems, including those of lymphocytes (T-cells, B-cells, natural killer cells) and monocytes (innate immune cells), were perhaps in a more vulnerable state,” the authors wrote.

These findings overlap with pathologist Dr. Ryan Cole’s observations at his medical laboratory, Cole Diagnostics.

Cole told Jan Jekielek on American Thought Leaders that after vaccinations started rolling out in the older population, he noticed the reappearance of Molluscum contagiosum, a parapoxvirus that most people get in childhood and is kept in check by the immune system from the teenage years onward.

Though the uptick is unusual, as Cole saw more cases he grew concerned that the vaccines may be driving a form of “immune dysregulation,” meaning a possible breakdown to established immune controls. Since these viruses are normally kept in check by T-cells, which also keep cancers in check, a loss of immune memory against viruses could be a sign of loss of control in cancers.

“About a month or two later, all of a sudden there are certain types of cancers that I commonly see in the laboratory, after 500,000 patients … I started seeing endometrial cancers go up and there’s certain type … Melanomas, I started seeing thicker and earlier as well.”

Since then he has shared his findings in other lectures and found that other doctors and nurses around the world have made similar observations of increased rates of cancer cases.

An analysis by The Expose on VAERS data also indicated an uptick of cancer after COVID-19 vaccines by 143,233 percent.

In addition to cancers relapsing, there are also cases of sudden cancer development in previously cancer-free people after vaccination.

Cheryl Rolf shared her late husband John Rolf’s experience with a sudden onset of esophageal cancer within a month or two after vaccination.

“He was vaccinated with the first vaccine March 1st of 2021, and then the second vaccine on March 29th,” Cheryl Rolf, his wife told The Epoch Times during a phone call.

A few days after his second vaccination, John, who had always been healthy, started to cough, and soon he would sporadically choke on his food, and “that gradually increased in frequency over time.”

In August, John’s doctor sent him for a scan, showing suspicious growth at the base of the esophagus, and by late August, John was diagnosed with stage 3 esophageal cancer.

“The oncologist said he marked [John] curative,” Rolf said. “He planned for him [John] to fully recover from this.”

Esophageal cancer is a rarer form of cancer that predominantly affects men aged 45 to 70. Smoking, long-term heavy consumption of alcohol, bile reflux, nerve problems in the esophagus, and obesity are all risks of esophageal cancer.

Considering John’s age of 68 years at the time, he was at risk. However, he had no medical or family history of cancer. He also did not have stomach reflux, nor did he smoke, and only drank alcohol occasionally. He was not obese.

In early September, John started his chemo and radiotherapy and it was a particularly tortuous experience for him.

John’s trouble with swallowing soon worsened, coupled with nausea and an altered sense of taste from chemo, he soon “seemed to have given up trying to eat or drink.”

“[John] was supposed to be taking more food and fluids in—he was getting some in—but he was also spitting up an awful lot of yellow phlegm … he couldn’t just drink things like you and I do. He gets to take a sip and try to get it down.”

Dehydration and weight loss meant that he also needed hydration once every three days.

John finished his treatment regimen in mid-October 2021 and doctors planned for him to make a physical recovery from the therapy, gain his strength back, and then remove his tumor through surgery.

However, on Oct. 25, three days after he received his last hydrofusion, John passed away in his sleep.

“I got up and he said ‘I want to sleep some more’ and he didn’t get up. I went and looked [later] and he had passed away.”

Rolf called 911 and moved John onto his back and gave compressions until the paramedics came, but John was gone.

“It was a horrific experience.”

Fourteen cases of esophageal cancers have been reported to VAERS in total for all vaccines, of which one included metastatic cancer (stage 4). Eleven esophageal cancer cases were reported as an adverse event of COVID-19 vaccine, including the single stage 4 cancer case.

Multiple Myeloma After mRNA Vaccination

Stanley Pruszynski also shared his wife’s sudden development of multiple myeloma after two doses of the COVID-19 Moderna vaccine.

Multiple myeloma is a “cancer in the blood … there’s no cure for it because you can’t cure blood cancer,” Pruszynski said.

It affects immune cells, making patients particularly at risk of dying from infections.

The majority of multiple myeloma patients in remission relapses in a few years, and most will later succumb to complications of the disease, particularly infections.

Pruszynski’s wife, Bonnie, then 69 years old, has been very healthy throughout her life. She was adopted into her family, therefore it is unknown if her family has a medical history of cancers, but she had no medical history of previous cancers.

Pruszynski said that Bonnie was very fit. The two would go on walks of five miles a day, and usually it would be him who would want to take a break.

However, two weeks after her second Moderna dose in February, Bonnie developed flu symptoms with constant coughing and night sweats and would get little sleep.

These symptoms persisted and medication did little to improve her condition. She began to feel weak and would ask for breaks on walks before Pruszynski did. She was often scared, she would fall and need to hold onto the walls when navigating their apartment.

In April, Bonnie fell and was taken to the emergency room.

On admission, her hemoglobin level was so low that she was given a blood transfusion.

“They [doctors] tried running some blood tests; the blood wasn’t separating properly to do the testing … well, it turns out that it was because of her hemoglobin levels,” Pruszynski said.

In June, Bonnie was diagnosed with multiple myeloma and started chemotherapy. She started stem cell therapy in December 2021 and spent Christmas in the hospital.

Stem cell therapy is a dangerous yet ambitious therapy to reset the immune system.

First, stem cells will be harvested from the body and stored. The other white blood cells in the body will then be wiped out, often using chemo and radiotherapy. Once the immune system is obliterated, the stem cells will be transferred back into the body to restart the immune system anew.

Bonnie’s fatigue improved and her cancer went into remission, but she still feels weak. The two now walk a quarter of a mile a day, compared to the five miles they used to.

Bonnie now works remotely with reduced hours. Pruszynski estimates that her salary is likely halved.

Pruszynski said that Bonnie has had high blood protein levels for many years. This condition can be a precursor to diseases and often comes with symptoms, though Bonnie was not affected.

Pruszynski therefore suspects that the vaccine, particularly the spike protein it generates, which is known to be toxic, may have triggered something in Bonnie’s immune system leading to blood cancer.

“They give her an estimate of maybe five to 10 years, maybe less. They don’t really know. They don’t have a clue but eventually it will kill her.”

There are a total of 89 multiple myeloma cases reported to VAERS, including plasma multiple myeloma, recurrent myeloma, and recurrent plasma multiple myeloma for all vaccines, and 65 of the cases were reported for COVID-19 vaccines.

 

[Heliobas Disciple]

Updated COVID-19 Booster Shots for Over-12s Expected Within Few Weeks: White House Official

The newly-updated COVID-19 booster shots targeting the latest Omicron variants of COVID-19 will be available to Americans over ...

www.theepochtimes.com

(fair use applies)


Updated COVID-19 Booster Shots for Over-12s Expected Within Few Weeks: White House Official
By Katabella Roberts
August 18, 2022

The newly-updated COVID-19 booster shots targeting the latest Omicron variants of COVID-19 will be available to Americans over the age of 12 in the coming weeks, White House COVID-19 Response Coordinator Dr. Ashish Jha said on Wednesday.

“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, adding that the booster jab will be available to teens and adults “in a few short weeks.”

The availability of the newly-updated shots will depend on whether they are cleared for authorization as expected by the Food and Drug Administration and Centers for Disease Control and Prevention, Jha said earlier this week.

If authorized, the booster jabs could be available by the start of September at the earliest.

“We’re going to know more about this in the upcoming weeks and these vaccines will become available by early- to mid-September,” Jha said at an event hosted by the U.S. Chamber of Commerce Foundation, ABC News reported.

“But the big picture, bottom line, is these are substantial upgrades in our vaccines,” Jha added. “And those vaccines are coming very, very soon.”

U.S. drug regulators recommended in June that vaccine makers reformulate their shots to include components of BA.5 and BA.4, another Omicron subvariant.

Newly-Updated Boosters Will ‘Work Much Better’

The newly-formulated booster shots target both BA.4 and BA.5, as well as the original strain of the virus. Presently, BA.4 and BA.5 appear to be the most vaccine-evasive strains of the virus and also largely bypass immunity from a previous infection.

As of Aug. 18, BA.5 cases account for 88.8 percent of all COVID-19 cases in the United States, followed by BA.4 (5.3 percent) and a newer version of BA.4 known as BA4.6 (5.1 percent), according to the Centers for Disease Control and Prevention.

As cases continue to rise, the Biden administration has signed a $1.74 billion federal contract with Moderna to supply 66 million initial doses of the company’s “bivalent” booster shot. It has also signed a $3.2 billion agreement with Pfizer for another 105 million shots.

Both contracts with Pfizer and Moderna include options that enable the government to purchase millions more doses down the line, should they need to, and should they secure the money to do so.

Jha said on Tuesday that he expects the shots to “work much better at preventing infection transmission and serious illness” than the current boosters.

“What’s really limited us is a lack of resources, but we are pulling from other high-priority items. So my hope is that we’re gonna be able to have this for every single adult in America. We will know more about that in the upcoming weeks I think,” Jha added.

The new booster shots come as demand for them has dropped, with roughly 108 million people in the United States receiving their first booster shot, according to CDC data.

 

[Heliobas Disciple]

Trial suggests metformin effective at reducing odds of serious outcomes for COVID-19 patients seeking early treatment

In work published in the New England Journal of Medicine, researchers—led by the University of Minnesota Medical School and School of Public Health—have found that metformin, a commonly prescribed diabetes medication lowers the odds of emergency department visits, hospitalizations, or death due...

medicalxpress.com

(fair use applies)


Trial suggests metformin effective at reducing odds of serious outcomes for COVID-19 patients seeking early treatment
by Kat Dodge, University of Minnesota Medical School
August 18, 2022

In work published in the New England Journal of Medicine, researchers—led by the University of Minnesota Medical School and School of Public Health—have found that metformin, a commonly prescribed diabetes medication lowers the odds of emergency department visits, hospitalizations, or death due to COVID-19 by over 40 percent—and over 50 percent if prescribed early in onset of symptoms. The study also found no positive effect from treatment with either ivermectin or low-dose fluvoxamine.

"We are pleased to contribute to the body of knowledge around COVID-19 therapies in general, with treatments that are widely available," said Carolyn Bramante, MD, principal investigator of the study and an assistant professor of internal medicine and pediatrics at the U of M Medical School. "Our trial suggests that metformin may reduce the likelihood of needing to go to the emergency room or be hospitalized for COVID-19."

Bramante noted that this was a secondary outcome of the trial; the primary outcome included whether someone had low oxygen on a home oxygen monitor, and none of the medications in the trial prevented the primary outcome.

The COVID-OUT trial was the nation's first to study whether metformin, a medication for type 2 diabetes; low-dose fluvoxamine, an antidepressant; and ivermectin, an antiparasitic, or their combinations could serve as possible treatments to prevent ER visits or hospitalization, as well as Long-COVID.

The study design was simple—patients were randomly assigned to receive one of the three drugs individually, placebo, or a combination of metformin and fluvoxamine or metformin and ivermectin. Although the study was placebo-controlled with exact-matching placebo pills, Dr. Bramante says 83% of volunteers received medications supported by existing data because of the six-arm design. Each participant received 2 types of pills to keep their treatment assignment masked, for 3 to 14 days of treatment. Each volunteer tracked their symptoms, and after 14 days, they completed a survey.

View: https://www.youtube.com/watch?v=8nvM2cR1dpw
Dr. Carolyn Bramante from the University of Minnesota answers questions about COVID OUT. Credit: University of Minnesota Medical School
12 min 24 sec

The 1,323 participants in the trial were limited to adults with a body mass index greater than or equal to 25 kg/m2, which qualifies as overweight—for instance, someone who was at least five feet and six inches tall and weighed more than 155 pounds. To qualify for the study, volunteers enrolled within three days after receiving a positive COVID-19 test. It was among the first randomized clinical trials for COVID-19 to include pregnant women.

The study included those who were vaccinated and those who were not. This is the first published trial where the majority of participants were vaccinated.

"Although we know COVID-19 vaccines are highly effective, we know that some new strains of the virus may evade immunity and vaccines may not be available worldwide. So we felt we should study safe, available and inexpensive outpatient treatment options as soon as possible," said Bramante. "Understanding whether outpatient treatments could ensure more people survive the illness if they contract it and have fewer long-term symptoms is an important piece of the pandemic response."

The clinical trial launched in January 2021 after U of M Medical School researchers identified, through computer modeling and observational studies, that outpatient metformin use appeared to decrease the likelihood of mortality from, or being hospitalized for COVID-19. Their research, in partnership with UnitedHealth Group, was published in the Journal of Medical Virology and in The Lancet Healthy Longevity. Test-tube studies also found that metformin inhibited the COVID-19 virus in lab settings. These findings, along with additional prospective studies supporting the use of higher-dose fluvoxamine and ivermectin, provided the evidence to include all three medications as well as combination arms.

"Observational studies and in vitro experiments cannot be conclusive but do contribute to bodies of evidence," said Bramante, who is also an internist and pediatrician with M Health Fairview. "To complete this study, we enrolled volunteers nationwide through six institutions in the U.S., including in Minneapolis."

 

[Heliobas Disciple]

Researchers discover 'weak spot' across major COVID-19 variants

Researchers at the University of British Columbia have discovered a key vulnerability across all major variants of the SARS-CoV-2 virus, including the recently emerged BA.1 and BA.2 Omicron subvariants.

medicalxpress.com

(fair use applies)


Researchers discover 'weak spot' across major COVID-19 variants
by University of British Columbia
August 18, 2022

Researchers at the University of British Columbia have discovered a key vulnerability across all major variants of the SARS-CoV-2 virus, including the recently emerged BA.1 and BA.2 Omicron subvariants.

The weakness can be targeted by neutralizing antibodies, potentially paving the way for treatments that would be universally effective across variants.

The findings, published today in Nature Communications, use cryo-electron microscopy (cryo-EM) to reveal the atomic-level structure of the vulnerable spot on the virus' spike protein, known as an epitope. The paper further describes an antibody fragment called VH Ab6 that is able to attach to this site and neutralize each major variant.

"This is a highly adaptable virus that has evolved to evade most existing antibody treatments, as well as much of the immunity conferred by vaccines and natural infection," says Dr. Sriram Subramaniam, a professor at UBC's faculty of medicine and the study's senior author. "This study reveals a weak spot that is largely unchanged across variants and can be neutralized by an antibody fragment. It sets the stage for the design of pan-variant treatments that could potentially help a lot of vulnerable people."

Identifying COVID-19 master keys

Antibodies are naturally produced by our bodies to fight infection, but can also be made in a laboratory and administered to patients as a treatment. While several antibody treatments have been developed for COVID-19, their effectiveness has waned in the face of highly-mutated variants like Omicron.

"Antibodies attach to a virus in a very specific manner, like a key going into a lock. But when the virus mutates, the key no longer fits," says Dr. Subramaniam. "We've been looking for master keys—antibodies that continue to neutralize the virus even after extensive mutations."

The "master key" identified in this new paper is the antibody fragment VH Ab6, which was shown to be effective against the Alpha, Beta, Gamma, Delta, Kappa, Epsilon and Omicron variants. The fragment neutralizes SARS-CoV-2 by attaching to the epitope on the spike protein and blocking the virus from entering human cells.

The discovery is the latest from a longstanding and productive collaboration between Dr. Subramaniam's team at UBC and colleagues at the University of Pittsburgh, led by Drs. Mitko Dimitrov and Wei Li. The team in Pittsburgh has been screening large antibody libraries and testing their effectiveness against COVID-19, while the UBC team has been using cryo-EM to study the molecular structure and characteristics of the spike protein.

Focusing in on COVID-19's weak points

The UBC team is world-renowned for its expertise in using cryo-EM to visualize protein-protein and protein-antibody interactions at an atomic resolution. In another paper published earlier this year in Science, they were the first to report the structure of the contact zone between the Omicron spike protein and the human cell receptor ACE2, providing a molecular explanation for Omicron's enhanced viral fitness.

By mapping the molecular structure of each spike protein, the team has been searching for areas of vulnerability that could inform new treatments.

"The epitope we describe in this paper is mostly removed from the hot spots for mutations, which is why it's capabilities are preserved across variants," says Dr. Subramaniam. "Now that we've described the structure of this site in detail, it unlocks a whole new realm of treatment possibilities."

Dr. Subramaniam says this key vulnerability can now be exploited by drug makers, and because the site is relatively mutation-free, the resulting treatments could be effective against existing—and even future—variants.

"We now have a very clear picture of this vulnerable spot on the virus. We know every interaction the spike protein makes with the antibody at this site. We can work backwards from this, using intelligent design, to develop a slew of antibody treatments," says Dr. Subramaniam. "Having broadly effective, variant-resistant treatments would be a game changer in the ongoing fight against COVID-19."

 

[Heliobas Disciple]

Ivermectin, luvox fail as COVID-19 treatments

Two drugs touted as potential COVID-19 treatments, ivermectin and fluvoxamine, don't do a thing to improve patients' oxygen levels and keep them out of the hospital or the morgue, a new clinical trial has shown.

medicalxpress.com

(fair use applies)


Ivermectin, luvox fail as COVID-19 treatments
by Dennis Thompson
August 18, 2022

Two drugs touted as potential COVID-19 treatments, ivermectin and fluvoxamine, don't do a thing to improve patients' oxygen levels and keep them out of the hospital or the morgue, a new clinical trial has shown.

Neither of the two repurposed drugs proved effective against COVID among overweight or obese patients who received them within seven days of symptom onset, according to results published Aug. 18 in the New England Journal of Medicine.

A third drug, metformin, did not meet the primary objective of improving oxygen levels, but it did slightly lower the odds that a patient would develop severe COVID, said lead researcher Dr. Carolyn Bramante, an assistant professor of internal medicine and pediatrics at the University of Minnesota Medical School.

"Metformin did lower the odds of emergency department visits, hospitalization or death by more than 40%, more than 50% if prescribed early," Bramante said. "However, this is a secondary outcome, so it cannot be considered definitive."

Ivermectin, fluvoxamine (Luvox) and metformin are all approved by the U.S. Food and Drug Administration for other purposes, and early in the pandemic all were floated as possible treatments for COVID.

Ivermectin, a dewormer, was promoted in particular by some as an alternative treatment for COVID. Fluvoxamine is an antidepressant, and metformin is a diabetes medication.

The failure of the three drugs to meet the clinical trial's primary objective is "not surprising, because antiviral therapy is something that is usually highly specific and targeted," said Dr. Amesh Adalja, a senior scholar with the Johns Hopkins Center for Health Security in Baltimore. Specific drugs usually have to be newly developed to treat specific viruses.

In this clinical trial, more than 1,300 COVID patients were randomly selected to be treated with one of the three drugs individually, a placebo pill, or a combination of metformin and fluvoxamine or metformin and ivermectin.

Participants had to be overweight or obese, which is one of the known risk factors for severe COVID. A little more than half had been vaccinated.

None of the three drugs helped patients' blood oxygen levels remain normal. But metformin did help lower the risk of severe COVID and death.

Metformin has been around for a hundred years, and in the 1940s was used as an antiviral medication, Bramante said. More recent lab studies have indicated that metformin can act against SARS-CoV-2, the COVID virus, when the two meet in a test tube.

"Probably the medication that was least talked about for early treatment of COVID-19 was metformin, but in a way metformin actually has the most sort of stepwise methodological data that led us to believe that it would be effective against SARS-CoV-2," Bramante said.

Infectious disease expert Dr. William Schaffner said this clinical trial should close the door on the idea that ivermectin or fluvoxamine can help treat COVID.

"Early on, on the basis of semi-anecdotal information, there were thoughts that these drugs might work," said Schaffner, medical director of the Bethesda, Md.-based National Foundation for Infectious Diseases.

"It's clear that as more rigorous, larger and better-structured studies came along, that was denied," he said. "And this last study really supports the notion that these drugs ought not to be used, because they've been now shown to be ineffective in repeated studies."

It might be worth continuing to study metformin's effectiveness against COVID "very carefully," Schaffner said.

But, he added, there's less need to search for such repurposed drugs now, given that the Omicron strain of COVID causes less severe illness.

In addition, there are now COVID treatments available that have been proven to work, Adalja noted.

"At this stage of the pandemic, the fact that drugs like Paxlovid and monoclonal antibodies are available should preclude the use of any repurposed drugs that have not shown benefit," Adalja said.

 

[Heliobas Disciple]

Severe COVID-19 increases risk of life-threatening blood clots

Individuals hospitalized with COVID-19 are more likely to develop venous thromboembolism—a potentially life-threatening condition—than those hospitalized with influenza, according to a new study from the Perelman School of Medicine. The study, published in the Journal of the American Medical...

medicalxpress.com

(fair use applies)


Severe COVID-19 increases risk of life-threatening blood clots
by Alex Gardner, University of Pennsylvania
August 18, 2022

Individuals hospitalized with COVID-19 are more likely to develop venous thromboembolism—a potentially life-threatening condition—than those hospitalized with influenza, according to a new study from the Perelman School of Medicine. The study, published in the Journal of the American Medical Association, evaluates the absolute risk of hospitalized deep venous thrombosis or pulmonary embolism events within 90 days after admission.

"Our research found this association both before and during vaccine availability, showing that the risk was not stemming from vaccination," says Vincent Lo Re III, an associate professor of infectious diseases and epidemiology and the study's first author. "And that's particularly important because individuals say they do not want to receive a COVID-19 vaccination because of clotting risks. COVID-19 itself is the true risk of these dangerous clots, not the vaccines."

Venous thromboembolism, which is comprised of both deep vein thrombosis and pulmonary embolism, begins when a blood clot forms in a vein deep within the body, often the leg or pelvic region. The condition is dangerous because the clot can block blood circulation. During arterial thromboembolism, a clot causes a sudden interruption of blood flow to an organ or body part which in turn can lead to tissue damage, heart attack, or stroke.

Although COVID-19 is primarily considered a respiratory illness, some evidence suggests the virus may also induce excessive blood clotting, or hypercoagulability, in the body, but early studies on the topic were smaller and inconclusive.

This Penn study was the largest yet to tackle the issue, comprising of over 90,000 total patients. Among people hospitalized with influenza, the 90-day absolute risk of developing venous thromboembolism was 5.3%. For those hospitalized with COVID-19, the 90-day risk was 9.5% before vaccine availability and 10.9% after COVID-19 vaccines became available. The 90-day risk of arterial thromboembolism was 14.4 percent in patients hospitalized with influenza compared with 15.8 percent in those with COVID-19 before vaccine availability and 16.3 percent during vaccine availability.

Lo Re and colleagues said one potential explanation for the increased risk may be the coronavirus's ability to infect endothelial cells, which can incite inflammation and abnormalities in the coagulation process. However, the research team says more research is needed to confirm the association and investigate potential causes and possible mechanisms behind the blood conditions.

With collaboration from colleagues in Canada and Europe, the Penn researchers plan on examining COVID-19-related thrombotic cases outside the hospital setting and via an international meta-analysis.

 

[Heliobas Disciple]

COVID-19 test-to-stay programs work, says a new study

Test-to-stay programs in pre-K-8 schools minimize new COVID-19 infections and can help reduce the need for prolonged quarantines for exposed individuals, reports a new Northwestern Medicine study.

medicalxpress.com

(fair use applies)


COVID-19 test-to-stay programs work, says a new study
by Kristin Samuelson, Northwestern University
August 18, 2022

Test-to-stay programs in pre-K-8 schools minimize new COVID-19 infections and can help reduce the need for prolonged quarantines for exposed individuals, reports a new Northwestern Medicine study.

The study's findings are congruent with results from test-to-stay (TTS) programs in New Jersey, Utah and Massachusetts. This is the first study to estimate days of learning saved by test-to-stay programming in an elementary and middle school setting.

TTS, as defined by the Centers for Disease Control and Prevention, is the use of contact tracing and high-frequency, low-barrier testing that allows school-associated close contacts who are not fully vaccinated to continue in-person learning during their quarantine period.

The study was a retrospective analysis of the incidence rate of COVID-19 in the Campbell Union School District (CUSD) in San Jose, California. The study authors compared students in CUSD who participated in a test-to-stay program starting in September 2021 (6,186 students) with students from a similar (in size and demographics) school district in Lincoln, Nebraska that did not offer a TTS program option. It found those who participated in TTS had fewer COVID-19 infections and saved an estimated 8,088 days of in-person instruction that would have been missed if they had needed to quarantine after an exposure.

The study was published August 13 in the journal Public Health. It was conducted before the CDC on Aug. 11 loosened their isolation guidelines to no longer recommend unvaccinated people quarantine at home after an exposure, thus opening the door to more schools adopting test-to-stay programs.

"Test-to-stay is a great model that I wish more schools would implement because we have shown it is a way to keep kids in classrooms while still working to minimize the unnecessary spread of the virus," said lead author Dr. Regina Royan, emergency medicine research fellow and clinical instructor of emergency medicine at Northwestern University Feinberg School of Medicine.

In total, 3,794 COVID-19 tests were reviewed. There were 90 positive tests among those who participated in the TTS program and 1,052 among those who did not. Of the close contacts who participated in TTS, 2,648 remained negative for COVID-19, and two tested positive. The incidence of COVID-19 among individuals who participated in TTS was 0.21% compared to 2.49% among individuals who did not participate in TTS. Those who participated in TTS were 90.4% less likely to test positive in a given week compared to those who did not participate in TTS, the study found.

'Detrimental persistent absenteeism due to COVID-19'

The study points out that students in the U.S. experienced full or partial school closure for 71 weeks with the greatest number of closures occurring in 2020. This led to the upheaval of traditional in-person education, interruption in learning, inequitable technology access, social isolation and limited access to quality nutrition and safe environments. These school closures disproportionately affect minority and low-income families, further widening the disparity of education and health in the U.S., the study authors wrote.

"Persistent absenteeism due to COVID-19 is detrimental to child development, impacting social and emotional well-being, access to nutrition and learning," the study authors wrote. "Quickly identifying students, staff and close contacts who test positive for COVID-19 can mitigate infection spread amongst school systems, thus maximizing in-person education for students."

 

[MinnesotaSmith]

Biden admin quietly ends COVID-19 testing targeting unvaccinated fed workers

Go about your business

hotair.com

Biden admin quietly ends COVID-19 testing targeting unvaccinated fed workers​

JAZZ SHAW Aug 18, 2022

AP

"There’s yet another sign of a partial return to normality inside the federal government and the Biden administration running up the white flag in terms of the vaccination wars. Starting next week, there will be no more “special” COVID testing protocols for federal employees based on their vaccination status. Offices that require testing (particularly in healthcare facilities) will have all employees tested and will no longer inquire as to the worker’s vaccination status. Offices without mandatory testing requirements will cease mandating testing for unvaccinated workers. While this should come as a welcome change and be seen as an end to discriminatory practices, some of these employees must have one question on their minds. Why couldn’t they have done this from the beginning? (Government Executive)

The Biden administration is instructing agencies to cease all COVID-19 testing aimed specifically at unvaccinated employees, marking a new approach in the fight against the coronavirus and the push to get all federal workers inoculated.
Agencies will no longer conduct “serial screening testing” based on vaccination status as they shift away from differential treatment based on whether employees are up to date on their shots. They will also stop asking employees, contractors and visitors if they are vaccinated before entering federal buildings as they will no longer differentiate safety protocols based on vaccination status. The administration distributed the guidance in an email from the Chief Human Capital Officers Council, which was obtained by Government Executive and first published by Federal News Network. The changes will go into effect by Aug. 22.
Some facilities in settings that require it will continue testing all employees. Agencies will not, however, initiate any new testing programs that are not already underway. Similarly, some agencies at certain sites can continue requesting vaccination information, but the council told agencies to stop using the governmentwide vaccination certification form.

This new policy is as close as the federal government has come to admitting that the pandemic is over and COVID is here to stay. There is also no mention in the announcement of the government continuing its attempts to fire everyone who refused to comply with the vaccine mandates.


Isolation policies were also changed as part of this announcement. Up until now, anyone shown to have potentially been exposed to the virus through contact tracing followed rules based on their vaccination status. The unvaccinated were required to stay out of the office while the vaccinated were not forced to isolate themselves unless they began to show symptoms. Now, everyone will be allowed to remain in the office as long as they remain asymptomatic.

As far as masking goes in federal offices, the same rules will also apply to everyone. In areas rated as having high transmission rates, masks will be required indoors for all regardless of vaccination status. Local masking rules will also be recognized. But aside from that, masks are optional.

So what happened to the vaccine mandate? Weren’t the unvaccinated all supposed to be fired by now? Well, that policy remains on hold while challenges to it make their way through the appeals process. It’s estimated that more than 100,000 federal workers remain on the payroll while not being vaccinated. One legal analyst speculated that the more the country accepts that the vaccine will be with us permanently, the less likely the courts will be to side with the mandates.

So what happens to all of the workers who were either fired or resigned from their jobs in anticipation of being fired because they refused to comply? What compensation will be available to them for the disruption of their careers? Are we all supposed to just forget about them, return to our normal lives, and pretend all of this never happened? As I’ve said from the beginning, I predict that history will not look back kindly on the federal government’s handling of the pandemic in many ways. And one of the worst was the creation of a second, lower class of citizens composed of those who wouldn’t roll up their sleeves. But I suppose we should count ourselves lucky that the government didn’t take us all the way to internment camps."

 

[Heliobas Disciple]

sweden birthrate update: june data

assessing hypotheses on causality

boriquagato.substack.com

(fair use applies)


sweden birthrate update: june data
assessing hypotheses on causality
el gato malo
13 hr ago

about 5 weeks ago, i posted THIS update to the swedish natality data and tried to lay out some testable hypotheses on cause. the june data is now out, so i wanted to update the series and see how it was mapping against hypotheses. recall that in july, we were assessing two leading theories with regard to the sudden and sharp drop in swedish birth rate:



there is plausible support for both.

the peak vaccine impulse in sweden was april to july of 2021.

the alignment with covid vaccine rollout is quite precise for commencement and based on the biological studies (info HERE and HERE) the expectation that this result (if it is occurring) would remain pronounced for at least 6 months appears sound and there is good reason to suspect that some effects may persist for longer.

on the other hand 2021 showed high birth rates relative to 2020 and so perhaps 2022 is just a difficult comparison and the summer of 2021 was a time that people were out traveling and not seeking to conceive.

the key to science and scientific theory is making testable predictions to assess hypotheses. to that end, i laid this out in july:



so, let’s see how we’re doing:

the june births per million population number was 907, down from 913 in may. this is not unexpected as births are highly seasonal and june has been below may in each of the last 3 years as well. but as can be seen from this graph, births remain quite low in june.



this june was easily the lowest of the last 4 years



and on a percentage vs year ago basis was a slight improvement over may (-7.5% vs -7.9%) but remains at extremely low levels by historical standard.



births are remarkable consistent by month. the first 6 months of 2019, 20, 21 were 51.3%, 51.6%, and 51.3% of full year births respectively. using the average of these (51.4%) to estimate full year 2022 gets us this. (estimate in red)



and seen as % change we get this:



so what does this mean? it is vaccines or blackout babies and travel plans?

unfortunately, i think this outcome is still somewhat equivocal.

it’s very clear that something highly unusual is going on and continues to go on. these birth rates are exceedingly low and remain so.

it’s tempting to say that the june outcome really bolsters the idea of vaccine driven effect because june 2022 births were conceived in september of 2021 once the great summer 2021 walkabout wound down. this is not unreasonable and may well be the best base prior. but it’s also not without some possible conflicting data

one could argue that june % drop looks large because june 2021 was a very high birth rate for a june month. it was up 2.8% vs 2020 (though 2020 was a low june, down 2% from prior year so perhaps it was june 2021 that was the odd comp.) so the baseline for comparison here is still a bit muddy and we’re really only working with one month of post “walkabout summer” conception opportunity.

adding to this, june of 2020 showed the smallest drop vs may in any of the past 4 years. this could be consistent with a “we’re all home again” birth rate recovery.



but even this is not easy data to read as it might well be that the smaller drops are a function of overall levels being so low.

this is making it difficult to draw any conclusion that seems definitive. you can still sort of argue either side convincingly.

matters should become more clear in the next 2-3 months. the comps will become cleaner as the 2021 divergence from averages becomes less pronounced, we get more distance from summer travel, and also get further way from the tail end of the vaccination impulse.

there are a lot of cross currents and potentially competing effects here and our two hypotheses are not mutually exclusive and may instead be mutually reinforcing.

it’s just going to take time. you cannot rush 9 month gestational data.



but here’s what to look for:

if we see a sharp rise in relative birth rates over the next couple months with % variance vs prior year getting back above the -2% range, i think we can start to conclude with some confidence that covid vaccines, if they had any effect on birth rates, were transitory in their impact.​

​

on the other hand, if birth rates remain deeply depressed in the -4-8% range, i think we’re seeing support for the idea that there is some other cause than blackout baby boom and world opening bust in play. given the hard, independent science here (linked above), i think that would put vaccine induced infertility at the top of the suspects list as we have sound a priori reason to suspect effect and tight temporal linkage on commencement.​

the tricky one will be trying to pin down/separate societal behavior changes from transitory vaccine effects (presuming such a case pertains). the timing overlap there is significant and that makes it heard to tease out of this sort of society scale data. i suspect we’d really need to see data on variance in birthrate between the vaxxed and unvaxxed for that one.

that seems like it would be the gold standard study:

if we could compare the birth rates among the vaxxed vs the unvaxxed in 2022 compared to their birth rates in past years (controlling for age, race, and other meaningful demographics) we could really pin this down. unfortunately, i suspect that will be difficult in sweden as they make a real point of not collecting or reporting data by race etc and i expect some cross confounds with high birth rate immigrants that might also be low vaxx.

but there are lots of countries that would have all this data.

it’s disappointing that no one is doing this simple work to see what the risk is.

this may just be my cynicism talking, but i suspect that many agencies have meaningful insight into the shape of this data and if there were an obvious non-signal from vaccines on fertility they’d be contracting studies and shouting it from the rooftops.

i fear we may be in another of these “don’t look for what you don’t want to find” situations and, on balance, given the hard science on ovary concentration, sperm suppression, menstrual disruption, etc from the mRNA jabs, i would honestly be pretty surprised if they did not have at least transitory effect on fertility.

it feels like a sound hypothesis, but i don’t think we have society scale proof yet. that’s going to take another couple months to emerge. but the fact that we’re even having this discussion at this point is terrifying and points to egregious lapses in testing and assessment by the very agencies that so actively pushed these products on pregnant women without having done anything like enough work on the topic.

this sort of ready, fire, aim! revisionism and neglect has served us poorly and the fact that is has been left to the internet to mop up after the misapprehension and misbehavior of “experts” speaks poorly of the utility of the regulatasuarus.

perhaps it’s time we put him out to pasture.

 

[Heliobas Disciple]

A guide to US colleges and universities for those planning to survive their education

This resource notes which schools mandate "vaccines" and boosters, and which ones don't

markcrispinmiller.substack.com

(fair use applies)


A guide to US colleges and universities for those planning to survive their education
This resource notes which schools mandate "vaccines" and boosters, and which ones don't
Mark Crispin Miller
7 hr ago

Check columns E and F:

US Colleges Mandate Info - NoCollegeMandates.com - Google Drive

 

[Heliobas Disciple]

New Data Confirms Injections Cause Previously Rare Creutzfeld Jacobs Disease – Misinformed & Biased Alex Berenson Claimed "Fringe Scientists" Do Not Have Proof: Here Is The Proof

by Sid Belzberg Last fall my colleagues Adam Gaertner and others hosted this website for a few months: https://prions.rip During those few months in the fall we received about 15,000 hits. We requested at the time that anyone who after the injection experienced serious neurological problems or...

2ndsmartestguyintheworld.substack.com

(fair use applies)


New Data Confirms Injections Cause Previously Rare Creutzfeld Jacobs Disease – Misinformed & Biased Alex Berenson Claimed "Fringe Scientists" Do Not Have Proof: Here Is The Proof
2nd Smartest Guy in the World
17 hr ago

by Sid Belzberg

Last fall my colleagues Adam Gaertner and others hosted this website for a few months:

Prions - Preparing for the Potential Prion Apocalypse

Preparing for the Potential Prion Apocalypse

prions.rip

During those few months in the fall we received about 15,000 hits.

We requested at the time that anyone who after the injection experienced serious neurological problems or their loved ones to submit a report to the site.

We received 60 reports, including 6 cases of diagnosed Creutzfeld Jacobs Diseases (CJD). Normally this disease affects 1 in a 1,000,000 people. To get 6 cases you would need 6,000,000 hits to the site assuming everyone reports. The chances of getting 1 case in 15000 hits is 1 in 66. To see 6 cases in 1 group of 15000 is 1/66^6 or 1 in 82,000,000,000, or 20 times more likely to win a powerball lottery!

We recently put the site back up, and again ask if anyone that has experienced serious neurological events post-vax to please submit a report here: Prions - Preparing for the Potential Prion Apocalypse

* * *

"Fringe scientists" that supported our hypothesis last year included the late Dr. Luc Montagnier, Nobel laureate.

Here is my comment on Alex Berenson’s substack.

---

To reiterate, CJD is an exceptionally rare disease that is now a known and established severe adverse reaction (SAE) from the DEATHVAX™. Injecting this slow kill bioweapon can cause ailments that are about as likely to develop in the real word as getting struck by lighting twice.

The proof is now irrefutable.

 

[Heliobas Disciple]

PSYOP-22 Update: Covid and China

From this substack’s anonymous tipster: As predicted a month or two ago, the Ba2.75 covid variant known as Centaurus is starting to spread. It is now appearing on the global Nextstrain report as it is up to 2% of worldwide cases. See frequencies colored by Clade on chart. (Omicron 22D)

2ndsmartestguyintheworld.substack.com

(fair use applies)


PSYOP-22 Update: Covid and China
2nd Smartest Guy in the World
14 hr ago

From this substack’s anonymous tipster:

As predicted a month or two ago, the Ba2.75 covid variant known as Centaurus is starting to spread.

It is now appearing on the global Nextstrain report as it is up to 2% of worldwide cases. See frequencies colored by Clade on chart. (Omicron 22D)

Nextstrain / ncov / gisaid / global / 6m

The Centaurus variant is 10 times more contagious than the recent Ba5 variant (wave just ending) and you can see how fast that grew in just two months from a similar starting point.

Of major concern is that Centaurus may be moving from India to China (via Tibet).

Tibet had ONLY 1 case of covid from 2020 until last month. They have now reported over 500 cases two days running and now over 700 on Wed.

Centaurus is suspected. China is trying to seal the border crossing, but airports are still open there. Tibet is a major Chinese tourist spot.

China enforces lockdowns as Covid cases spiral in Xinjiang, Tibet | CanIndia News

China’s prior lockdown policies have resulted in their population having almost ZERO natural immunity due to exposure. So the virus will likely be like our first exposure to the Delta strain which caused the most deaths and hospitalizations.

If Centaurus gets loose in China, it will be unstoppable for them, but, I’m sure they’ll try.

Watch for major lockdowns and supply disruptions ahead. Perhaps worldwide major financial market implications as well.

---

As this substack has warned many a time, the crash to end all crashes in PSYOP-MARKET-CRASH will coincide with PSYOP-22.

Stock “markets” will become highly unstable after Labor Day.

PSYOP-SUPPLY-CHAIN-BREAKDOWN and PSYOP-HYPERINFLATION will serve to exacerbate the accelerating Great Reset.

 

[Heliobas Disciple]

Dr. Geert Vanden Bossche and Dr. Paul Elias Alexander discuss the COVID vaccines, the monkeypox vaccine, innate immunity in children and why COVID vaccines must not be given to children.

COVID, mRNA vaccines, and monkeypox vaccines, innate immunity and why children should not get the non-neutralizing antigen-specific (high-specificity) COVID vaccines that drives infection in vaccinee

palexander.substack.com

(fair use applies)


Dr. Geert Vanden Bossche and Dr. Paul Elias Alexander discuss the COVID vaccines, the monkeypox vaccine, innate immunity in children and why COVID vaccines must not be given to children.
COVID, mRNA vaccines, and monkeypox vaccines, innate immunity and why children should not get the non-neutralizing antigen-specific (high-specificity) COVID vaccines that drives infection in vaccinee
Dr. Paul Alexander
9 hr ago


SOURCE:

COVID and monkeypox vaccines, innate immunity and why children shouldn't get COVID vaccines

Dr. Geert Vanden Bossche and Dr. Paul Elias Alexander discuss the COVID vaccines, the monkeypox vaccine, innate immunity in children and why COVID vaccines must not be given to children. August 17, 20

rumble.com

36 min 09 sec
~~~~~~~~~~~~

my comment:

download link:

https://sp.rmbl.ws/s8/2/F/B/F/p/FBFpf.caa.mp4?u=3&b=0

 

[Heliobas Disciple]

Newly-Obtained Moderna Documents Show mRNA COVID Vaccines Cause 'Skeletal Malformation' - Here's What Happened To The Offspring Of Lab Rats Who Were Jabbed | The Gateway Pundit | by Alicia Powe

Rats that were injected with Moderna’s experimental mRNA editing COVID vaccines developed rib malformations, according to documents newly obtained internal documents from the pharmaceutical giant via a Freedom of Information Act request by Judicial Watch.

www.thegatewaypundit.com

(fair use applies)


Newly-Obtained Moderna Documents Show mRNA COVID Vaccines Cause ‘Skeletal Malformation’ – Here’s What Happened To The Offspring Of Lab Rats Who Were Jabbed
By Alicia Powe
Published August 18, 2022 at 6:18pm

Rats that were injected with Moderna’s experimental mRNA editing COVID vaccines developed rib malformations, according to documents newly obtained internal documents from the pharmaceutical giant via a Freedom of Information Act request by Judicial Watch.

The government watchdog obtained 700 pages document package from the pharmaceutical company including excerpts of Moderna’s formal Biological Licensing Application application, a form drug manufacturers are required to submit to the Food and Drug Administration for approval.

“The documents have not yet been made public, but were analyzed by former pharma executive Alexandra Latypova and reviewed by The Epoch Times,” The Epoch Times reports.

The documents also contain test results of reproductive toxicology tests conducted on rodents. The test results confirm Moderna’s gene-editing shots cause skeletal disfigurement in the offspring of rats that were injected with doses of mRNA-1273 or Spikevax mRNA.

Six of 149 baby rats had wavy ribs and 5 of those also had rib nodules, according to Moderna’s internal documents.

“mRNA-1273-related variations in skeletal examination included statistically significant increases in the number of F1 rats with 1 or more wavy ribs and 1 or more rib nodules. Wavy ribs appeared in 6 fetuses and 4 litters with a fetal prevalence of 4.03% and a litter prevalence of 18.2%. Rib nodules appeared in 5 of those 6 fetuses,” the document states.

“F1” refers to a rat’s offspring in the document, “litter” is a reference to a group birth of rats, and “wavy ribs” refers to ribs that are deformed.

“Maternal toxicity in the form of clinical observations was observed for 5 days following the last dose (Gestation Day 13), correlating with the most sensitive period for rib development in rats (Gestation Days 14 to 17)” the documents state.

More from the Epoch Times:

According to Latypova’s analysis, only female rats were studied (male rats were not treated with the Moderna vaccine).​

​

The females got a human dose of 100mcg Spikevax mRNA, 28 and 14 days prior to mating and gestation days 1 and 13.​

​

“1/2 rats euthanized before delivery to examine fetuses, the rest followed to 21 days after delivery,” Latypova stated, “No numbers are provided for the study size.”​

…​

​

“Reproductive toxicology is the study of adverse effects of medicinal products on reproduction. The FDA requires reproductive toxicity testing for any NME to be used in women of childbearing potential,” according to Latypova, who has worked in more than 60 pharmaceutical companies, mainly focusing on creating and reviewing clinical trials, many of which were submitted to the FDA.​

The FDA has assured the public COVID-vaccine are “safe and effective” and have no adverse effects on postnatal developments.

“No vaccine-related fetal malformations or variations and no adverse effect on postnatal development were observed in the study,” the FDA states on its January 30 label for Moderna’s Spikevax vaccine.

The Center For Disease Control are adamant that pregnant women get a COVID-19 injection.

Yet, doctors have warned still births are unprecedentedly rampant among fully vaccinated mothers.

Per court order, the FDA release Pfizer trial data each month. According to a Pfizer adverse events report published on July 1, a staggering 44 percent of all women who participated in Pfizer’s COVID vaccine trial ended up losing their unborn babies. Pfizer maintains the abnormal number of still births has no correlation to it’s COVID vaccination trial.

Meanwhile, National Institute of Health only began evaluating the effects of COVID vaccines on the immune responses of pregnant women in June.

Investigators evaluating the NIH study, MOMI-Vax, enrolled approximately “750 pregnant individuals and 250 postpartum individuals within two months of delivery who have received or will receive any COVID-19 vaccine authorized or licensed by the U.S. Food and Drug Administration. Their infants also will be enrolled in the study,” the NIH states in a June 23 press release. “Participants and their infants will be followed through the first year after delivery.”

 

[Heliobas Disciple]

Lab Rat Offspring Got Rib Malformations After COVID Vaccination: Moderna Trial Documents

Moderna documents regarding their COVID vaccine trial on animals, obtained via a Freedom of Information Act request by ...

www.theepochtimes.com

(fair use applies)


Lab Rat Offspring Got Rib Malformations After COVID Vaccination: Moderna Trial Documents
By Enrico Trigoso
August 16, 2022 Updated: August 17, 2022

Moderna documents regarding their COVID vaccine trial on animals, obtained via a Freedom of Information Act request by Judicial Watch, showed that some of the offspring of rats that were injected with Moderna’s mRNA shot developed rib malformations.

The 700 pages contain a portion of the formal Biologics Licensing Application (BLA) package that a manufacturer is required to submit to the FDA for approval.

The documents have not yet been made public, but were analyzed by former pharma executive Alexandra Latypova and reviewed by The Epoch Times.

Included in the documents are test results that show that Moderna mRNA shots caused statistically significant skeletal malformations in the offspring of the rats that took the mRNA-1273 (Spikevax mRNA) doses.

“mRNA-1273-related variations in skeletal examination included statistically significant increases in the number of F1 rats with 1 or more wavy ribs and 1 or more rib nodules. Wavy ribs appeared in 6 fetuses and 4 litters with a fetal prevalence of 4.03% and a litter prevalence of 18.2%. Rib nodules appeared in 5 of those 6 fetuses,” according to Moderna’s internal documents.

F1 refers to the rat offspring and litter indicates a group-birth of rats.

“Maternal toxicity in the form of clinical observations was observed for 5 days following the last dose (Gestation Day 13), correlating with the most sensitive period for rib development in rats (Gestation Days 14 to 17)” the documents state.

“Wavy ribs” refers to ribs not properly shaped.

In other words, 6 out of about 149 baby rats had wavy ribs and 5 of those also had rib nodules.

According to Latypova’s analysis, only female rats were studied (male rats were not treated with the Moderna vaccine).

The females got a human dose of 100mcg Spikevax mRNA, 28 and 14 days prior to mating and gestation days 1 and 13.

“1/2 rats euthanized before delivery to examine fetuses, the rest followed to 21 days after delivery,” Latypova stated, “No numbers are provided for the study size.”

In addition, there is no study report, but only Moderna’s own interpretation of the outcomes.

The results were part of reproductive toxicology tests done by Moderna, which is the only reproductive toxicology test for the product, according to Latypova.

It is not known how the dose translates from humans to rats.

“Neither Moderna nor Pfizer provided any dose calculations or justification information for dose selection in animal studies,” Latypova told The Epoch Times.

“Doses of drugs, or especially biologics do not necessarily have linear relationships with toxicity or efficacy. It is likely a much more complex relationship and unfortunately not known at all.”

“Reproductive toxicology is the study of adverse effects of medicinal products on reproduction. The FDA requires reproductive toxicity testing for any NME to be used in women of childbearing potential,” added Latypova, who has worked in more than 60 pharmaceutical companies, mainly focusing on creating and reviewing clinical trials, many of which were submitted to the FDA.

Despite the abovementioned lab results, the FDA issued a statement on Jan. 30 saying that there were no adverse effects on postnatal developments.

“No vaccine-related fetal malformations or variations and no adverse effect on postnatal development were observed in the study,” the FDA stated on the label for Moderna’s Spikevax vaccine.

“In a developmental toxicity study, 0.2 mL of a vaccine formulation containing nucleoside-modified mRNA (100 mcg) and other ingredients that are included in a 0.5-mL single human dose of SPIKEVAX was administered IM to female rats on four occasions: 28 and 14 days prior to mating, and on gestation days 1 and 13,” reads the FDA publication.
Pfizer Vaccine Also Caused Abnormal Ribs in Rats

In August of 2021, Elsevier published a peer-reviewed study (pdf) titled “Lack of effects on female fertility and prenatal and postnatal offspring development in rats with BNT162b2, a mRNA-based COVID-19 vaccine.”

BNT162b2 is the Pfizer jab.

All the authors of the publication were employed by Pfizer, BioNTech, or Charles River, a Pfizer contractor.

This publication suggests that there was a “lack of effects” in postnatal offspring development, but the study shows that there was a 295 percent increase (8.3 percent compared to 2.1 percent in the control group) in abnormal ribs in vaccinated rat offspring. A huge increase in what is described as the “supernumerary lumbar.”

‘This Was an Extremely Dangerous Warning’

“Skeletal abnormalities in the bony rib cages are absolutely important and were statistically increased in the rat offspring of the experimental group compared with the placebo group,” James Thorp, an MD board-certified in obstetrics and gynecology, as well as maternal-fetal medicine, told The Epoch Times after reviewing Latypova’s analysis of Moderna’s BLA package.

“In clinical obstetrics and maternal-fetal medicine we see similar findings in skeletal abnormalities prior to birth that are extremely serious and often lethal. This was an extremely dangerous warning signal in reproductive toxicology studies and was never brought to the light of day to protect our global citizens. The CDC, Pfizer, Moderna, and the flagship medical journals of the medical industrial complex lied to the American public and should be held accountable,” Thorp said.

Thorp recently analyzed and verified the most recent Vaccine Adverse Event Reporting System (VAERS) data related to COVID-19 vaccines and compared them to the influenza vaccines, finding numerous abnormalities.

The CDC website recommends the COVID vaccines during pregnancy in order to “prevent severe illness and death in pregnant women.”

The American College of Obstetricians and Gynecologists also “strongly recommends that pregnant individuals be vaccinated against COVID-19,” adding that pregnant women’s complete vaccination should be a “priority.”

Moderna, Pfizer, the CDC, and the FDA did not respond to requests for comment.

 

[Heliobas Disciple]

The FDA KNEW: 44% of pregnant women miscarried following covid vaccination but shots were given emergency authorization anyway

In making the decision to grant emergency use authorization (EUA) to Wuhan coronavirus (Covid-19) "vaccines," the U.S. Food and Drug Administration (FDA) knew full well at the time that nearly half of all pregnant women would end up miscarrying as a result of the injections. The latest

www.naturalnews.com

(fair use applies)


The FDA KNEW: 44% of pregnant women miscarried following covid vaccination but shots were given emergency authorization anyway
by: Ethan Huff
Thursday, August 18, 2022

This article may contain statements that reflect the opinion of the author

In making the decision to grant emergency use authorization (EUA) to Wuhan coronavirus (Covid-19) “vaccines,” the U.S. Food and Drug Administration (FDA) knew full well at the time that nearly half of all pregnant women would end up miscarrying as a result of the injections.

The latest Pfizer document drop shows that 44 percent of all pregnant women who participated in Pfizer’s mRNA (messenger RNA) jab trials ended up losing their unborn babies. To the FDA, this still constitutes a “safe and effective” drug. (Related: A Wisconsin doctor who worshipped covid injections suffered a miscarriage after getting hers.)

After these women lost their children, Pfizer tried to claim that the deaths had nothing to do with its shots. The FDA apparently took Pfizer’s word for it and proceeded to authorize, and later approve, the injections as a remedy for the Fauci Flu.

The thousands upon thousands of pages of documents that Pfizer and the FDA tried to conceal for 75 years demonstrate a shocking pattern of intentional deceit by the two entities. Both Pfizer and the FDA have been working overtime to try to withhold the truth from the public – but that truth is now coming out.

Big Pharma and the FDA are LIARS

Unfortunately for the millions of women who already took the jabs, the damage is already done. Many have already learned the hard way that Operation Warp Speed is really just Operation Death Speed, including for unborn babies.

The women who participated in the Pfizer trial all took between one and four injections of Pfizer’s mRNA concoction. Forty-two received the drug immediately while eight received a placebo initially followed by the real drug later.

By March 31, 2021, all of the pregnant women in the trial – 50 in total – had taken at least one dose of Pfizer’s BNT162b2 experimental injection. The following explains how Pfizer knowingly hid the disastrous results.

“Pfizer notes the miscarriages as serious adverse events (SAEs) with ‘moderate’ (2) or ‘severe’ (3) toxicity ratings. However, all the miscarriages were reported as being unrelated to the trial vaccine – i.e., having ‘Other’ causes – and marked as ‘Recovered / resolved’ adverse effects. To reiterate, not only does Pfizer deny any vaccine-related causality and assert the losses of life had other causes, but it also categorizes losing a baby as a ‘resolved adverse effect’ – like a headache that went away.”

In other words, the loss of a pregnancy is just collateral damage – a “side effect” that quickly got “resolved” once the babies died. This is how Pfizer operates, by the way: just hide the truth, recategorize it, or flat-out lie about it – and the FDA does the exact same thing.

By April 1, the FDA was fully aware of the fact that a “significant percentage” of pregnant women who get jabbed for the Fauci Flu suffer “abortion spontaneous.” Even so, the agency proceeded to do nothing, allowing many more pregnant women to take the shots.

The FDA “failed in its duty to study the data and investigate what basis Pfizer had for marking the fetal deaths as unrelated to the vaccine and having ‘Other’ causes,” reports explain.

The FDA also failed to at least tell the public that there is a serious risk involved for unborn babies who are exposed to covid shots via their mothers. Without that information, notes the Daily Clout, “women were not able to give informed consent for receiving Pfizer’s mRNA COVID vaccine.”

To say that the FDA failed implies that it simply made a mistake, which is not the case. The corrupt federal agency lied on behalf of Pfizer by withholding the truth from the public, which is a crime against humanity as well as a dereliction of duty.

More stories like this one can be found at ChemicalViolence.com.

Sources for this article include:

UndercoverDC.com

NaturalNews.com

 

[Weft and Warp]

I have to respond to that study on Ivermectin, Fluvoxamine, and Metformin on post #64974. The link/source didn't give the dosages used in the study so I did a search to locate it --- Here's the abstract: https://www.nejm.org/doi/full/10.1056/NEJMoa2201662 .

The abstract didn't mention what the dosages were either, but if you click on the pdf version you can read the full study. This is what I found about the dosages:

The groups received the trial drugs according to the following doses: immediate-release metformin administered with an increase in dose over 6 days to 1500 mg per day for 14 days, ivermectin at a dose of 390 to 470 μg per kilogram per day for 3 days, and fluvoxamine at a dose of 50 mg twice daily for 14 days.


Metformin is prescribed for 14 days, ending with a dose of 1500 mg/day.
Fluvoxamine is prescribed as a 50 mg dose, two times a day for 14 days.

Ivermectin is prescribed at a dose between 390-470 ug/kg per day for 3 days.


Now something I noticed again, (just like in other studies in the past) was that they weren't treating the patients early enough for ivermectin to be the most effective. See here:

nonhospitalized adults who had been enrolled within 3 days after a confirmed diagnosis of infection and less than 7 days after the onset of symptoms.

So, there could have been participants in this trial that had been sick for 5 or 6 days before getting any of those medicines at all! That is way too late to start IV. (I'm not sure about the metformin or the fluvoxamine either)

I don't know if this was on purpose (which was the case in some of the studies we've read about over the last 2 or so years)---- or if it was just their ignorance of how ivermectin works best against this virus,----or if it was just that they couldn't start this study any earlier due to needing to wait for positive test results before going forward with their research.

Another thing I noticed was that they were only giving between 390-470 ug/kg per day. ( FLCCC recommends between 400-600 ug/kg/day. So the dosage was good, but on the lower side of what is recommended by FLCCC.

Also, WHY did they give it to them for only 3 days??? The other medicines were given for 14 days.

I don't know if they were trying to get bad results or what. But in my opinion, at least for the IV portion of this study, this study is very faulty!

post #64974

 

[Crusty Echo 7]

I don’t like the MSM including Fox in any fashion but it is good to more like this popping up.

Biden still pushing federal worker vaccine mandate despite eased CDC guidelines​

Appeals court set for Sept. 13 hearing on Biden administration's federal worker vaccine mandate​

By Tyler Olson , Bill Mears | Fox News

CDC director admits botched COVID response

Fox News medical contributor Dr. Marc Siegel responds to the CDC COVID response and growing cases of monkeypox
NEWYou can now listen to Fox News articles!
President Biden's administration is still pursuing litigation to implement a federal worker vaccine mandate despite recently changed Centers for Disease Control Prevention (CDC) guidelines for both vaccinated and unvaccinated people.

The case, called Feds for Medical Freedom v. Biden, is set for a hearing before the entire Fifth Circuit Court of Appeals on Sept. 13. It stems from a case filed in Texas last December that resulted in a federal trial court issuing a nationwide injunction against the federal government enforcing its vaccine mandate for civilian employees.

A panel at the appeals court then ruled for the Biden administration, overturning the trial court. But the Feds for Medical Freedom workers group asked the entire 17-judge appeals court to weigh in. The court agreed, putting its previous ruling on hold and preventing the mandate from being enforced until a final ruling is issued. Now the Biden administration is set to go to court to try to enforce that mandate next month.

But the CDC recently changed its coronavirus guidelines, making recommendations on quarantine and prevention effectively equal between vaccinated and unvaccinated people.

President Biden's administration is still pursuing litigation to enforce a federal worker vaccine mandate, despite recently loosened COVID-19 guidelines from the CDC. (Chip Somodevilla/Getty Images)

"CDC’s COVID-19 prevention recommendations no longer differentiate based on a person’s vaccination status because breakthrough infections occur, though they are generally mild, and persons who have had COVID-19 but are not vaccinated have some degree of protection against severe illness from their previous infection," the latest updated guidelines say.
The guidelines also say that "quarantine of exposed persons is no longer recommended, regardless of vaccination status." This recommendation, according to the CDC, is meant to help "limit the social and economic impacts" of the virus mitigation measures.

Manhattan Institute senior fellow for constitutional studies Ilya Shaprio told Fox News Digital that those changes in the CDC guidelines will complicate the Biden administration's efforts to enforce the federal employee vaccine mandate.

"I imagine the government is taking a hard look at its litigation posture and any other remaining vaccine mandate cases," he said. "I think the court in this case and in others will have a jaundiced eye towards government representations that a mandate is as required now as it was six or 12 months ago."
Shapiro added: "It goes to the standard of arbitrary and capricious under administrative procedure… If there's really no reason to require this if the CDC itself… is saying that there's no benefit if there's no difference between vaccinated and unvaccinated, then why is he doing this?"

Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky gives her opening statement during the Senate Health, Education, Labor and Pensions hearing on "Next Steps: The Road Ahead for the COVID-19 Response" on Capitol Hill in Washington, U.S., November 4, 2021. (REUTERS/Elizabeth Frantz)
Feds for Medical Freedom president Marcus Thornton added that: "With the CDC drawing little distinction between vaccinated and unvaccinated populations, it is clear that ‘The Science’ does not support forced vaccinations. The administration should therefore rescind its unscientific and unconstitutional executive order mandating COVID vaccinations for all federal employees and contractors.

"Furthermore, it should apologize to the men and women who have been subjected to harassment and abuse, withdraw any and all COVID vaccination requirements, reverse any disciplinary actions taken in regards to vaccination status, and commit itself to upholding individual liberty and medical autonomy," Thornton added.

The Justice Department declined to comment when asked if the change in CDC guidelines will affect its litigation. It also did not answer a question asking if there's reason to continue pursuing the mandate now that there's parity between vaccinated and unvaccinated people in the government's guidelines.

The White House did not respond to a request for comment asking the same questions.
In a brief arguing to the Fifth Circuit last month that the vaccine mandate should be allowed to move forward, one of the chief reasons the government gives for the mandate is preserving workers' efficiency.

CDC DIRECTOR ORDERS REORGANIZATION, SAYING COVID-19 RESPONSE ‘DID NOT RELIABLY MEET EXPECTATIONS’

Just as President Reagan concluded that federal employees’ off-duty use of illegal drugs could negatively affect their workplaces, Executive Order 14043 reflects a determination that contracting and spreading a contagious virus undermines workplace efficiency.
— Justice Department brief in Feds for Medical Freedom v. Biden

That issue may be addressed by the new parity for unvaccinated people in the CDC guidelines, aimed at limiting "economic impacts" of virus mitigation measures.

The Biden administration also presents several other arguments in its brief, both on why it has the authority to implement the mandate and on the need to do it now.

It argued that employees may seek exemptions from the mandate – although such exemptions are very rarely handed out. And the government said vaccination status is not a class, but rather a behavior. This is similar, the government said, to how illegal drug users are not a protected class.

CDC NO LONGER RECOMMENDS STUDENTS QUARANTINE FOR COVID-19 EXPOSURE

"Just as President Reagan concluded that federal employees’ off-duty use of illegal drugs could negatively affect their workplaces, Executive Order 14043 reflects a determination that contracting and spreading a contagious virus undermines workplace efficiency," the government brief says. "The district court’s rationale would call into question requirements like drug testing of federal employees."

The Biden administration is still trying to enforce its vaccine requirement for federal employees. (REUTERS/Emily Elconin)

Feds for Medical Freedom and its allies, meanwhile, argue that Biden simply does not have the authority to force the entire civilian federal workforce to take a COVID-19 vaccine. And they say being vaccinated against COVID-19 is fundamentally different from other behaviors, and constitutes a status.

"The core question before the court is simple: do any of the statutes cited as the basis of Executive Order 14,043 grant the President—or any of his subordinates—authority to compel federal employees to take a vaccine? The answer is no," the America First Legal Foundation said in an amicus brief.

"Executive orders issued by Republican and Democratic presidents exemplify the actual scope of section 7301," America First Legal added. "In 1969, President Nixon allowed many federal employees to participate in labor organizations… In 1997, President Clinton prohibited smoking in the federal workplace… Both executive orders regulated the federal employees’ ongoing workplace conduct. Neither had anything to do with off-the-job conduct, much less with off-the-job medical choices."

America First Legal added: "In contrast, President Biden has commanded federal employees to have ‘fully vaccinated’ status. And as a status-based regulation, the President’s order neither requires, allows, nor proscribes any type of ongoing behavior. Nor does it cover the behavior of all employees. President Biden’s executive order does not regulate the conduct of federal employees who were ‘fully vaccinated’ prior to September 9 at all."

 

[Heliobas Disciple]

I have to respond to that study on Ivermectin, Fluvoxamine, and Metformin on post #64974. The link/source didn't give the dosages used in the study so I did a search to locate it --- Here's the abstract: https://www.nejm.org/doi/full/10.1056/NEJMoa2201662 .

The abstract didn't mention what the dosages were either, but if you click on the pdf version you can read the full study. This is what I found about the dosages:

The groups received the trial drugs according to the following doses: immediate-release metformin administered with an increase in dose over 6 days to 1500 mg per day for 14 days, ivermectin at a dose of 390 to 470 μg per kilogram per day for 3 days, and fluvoxamine at a dose of 50 mg twice daily for 14 days.


Metformin is prescribed for 14 days, ending with a dose of 1500 mg/day.
Fluvoxamine is prescribed as a 50 mg dose, two times a day for 14 days.

Ivermectin is prescribed at a dose between 390-470 ug/kg per day for 3 days.


Now something I noticed again, (just like in other studies in the past) was that they weren't treating the patients early enough for ivermectin to be the most effective. See here:

nonhospitalized adults who had been enrolled within 3 days after a confirmed diagnosis of infection and less than 7 days after the onset of symptoms.

So, there could have been participants in this trial that had been sick for 5 or 6 days before getting any of those medicines at all! That is way too late to start IV. (I'm not sure about the metformin or the fluvoxamine either)

I don't know if this was on purpose (which was the case in some of the studies we've read about over the last 2 or so years)---- or if it was just their ignorance of how ivermectin works best against this virus,----or if it was just that they couldn't start this study any earlier due to needing to wait for positive test results before going forward with their research.

Another thing I noticed was that they were only giving between 390-470 ug/kg per day. ( FLCCC recommends between 400-600 ug/kg/day. So the dosage was good, but on the lower side of what is recommended by FLCCC.

Also, WHY did they give it to them for only 3 days??? The other medicines were given for 14 days.

I don't know if they were trying to get bad results or what. But in my opinion, at least for the IV portion of this study, this study is very faulty!

I agree. Thank you for doing a deeper dive into the study. My goal here is to document/archive the MSM type reports of all things COVID related. It will make a very informative historical record that should we choose to look back on it. I also keep in mind that you can't have an EUA (emergency use authorization) to give the rapidly-brought-to-the-market (without long term testing) vaccine if there is no emergency and if they have drugs that work, there is no emergency... .


HD

 

[Heliobas Disciple]

Judge throws out Maine lawsuit against COVID vaccine mandate

PORTLAND, Maine (AP) — A federal judge has dismissed a complaint from a group of health care workers who said they were unfairly discriminated against by Maine's COVID-19 vaccine requirement. The plaintiffs sued Democratic Gov.

apnews.com

(fair use applies)


Judge throws out Maine lawsuit against COVID vaccine mandate
By PATRICK WHITTLE
today

PORTLAND, Maine (AP) — A federal judge has dismissed a complaint from a group of health care workers who said they were unfairly discriminated against by Maine’s COVID-19 vaccine requirement.

The plaintiffs sued Democratic Gov. Janet Mills and other Maine officials along with a group of health care organizations in the state. The workers argued that the vaccine mandate violated their right to free exercise of religion because it did not provide an exemption for religious beliefs.

Jon Levy, the chief judge of the U.S. District Court for the District of Maine, wrote Thursday that the vaccine mandate was “rationally based” and that “no further analysis is required.”

“Reducing the number of unvaccinated healthcare workers at designated healthcare facilities in Maine is rationally related to the government’s interests in limiting the spread of COVID-19, safeguarding Maine’s healthcare capacity, and protecting the lives and health of Maine people,” Levy wrote.

The workers had remained anonymous since filing the suit until July, when a federal appeals court in Boston said they must reveal their identities. The workers also argued it was their religious right to decline the vaccine over the belief that fetal stem cells from abortions are used to develop them.

Liberty Counsel, a law firm representing the health care workers, said in a statement on Friday that it would appeal the dismissal. The firm said in a statement that Levy’s dismissal was “critically flawed” and “contrary to recent Supreme Court precedent involving COVID restrictions on places of worship and many other Supreme Court decisions.”

The vaccine mandate went into effect in October. The plaintiffs hoped to take their case to the U.S. Supreme Court, but the court declined to hear arguments in the suit earlier this year. The high court did not explain its decision at the time.

The lawsuit named some of the largest health care networks in the state as defendants. One of those networks, Northern Light Health, said in a statement on Friday that it had been validated by the court’s ruling.

“Our health care organization continues to strive always to act in the best interests of our patients and our staff in these challenging times, and we’re gratified that the court completely validated our conduct in this matter,” the statement said.

 

[Heliobas Disciple]

Tucson nightclub wins $1.6M in COVID-19 lockout lawsuit

TUCSON, Ariz. (AP) — The operators of a Tucson nightclub have won a $1.6 million settlement against the landlord who locked them out of their business during the pandemic. The Arizona Daily Star reported Thursday that a jury in Pima County Superior Court sided with Congress Street Clubs, the...

apnews.com

(fair use applies)


Tucson nightclub wins $1.6M in COVID-19 lockout lawsuit
yesterday

TUCSON, Ariz. (AP) — The operators of a Tucson nightclub have won a $1.6 million settlement against the landlord who locked them out of their business during the pandemic.

The Arizona Daily Star reported Thursday that a jury in Pima County Superior Court sided with Congress Street Clubs, the owners of Zen Rock nightclub.

On Aug. 5, they awarded the owners over $1 million to cover the value of the terms left on the lease and over $500,000 for the cost of renovations and equipment.

An attorney for the landlord declined to comment to the newspaper on the decision or a possible appeal.

In the lawsuit, the owners say they closed in March 2020 per Gov. Doug Ducey’s executive order forcing bars and restaurants to shut down. They could not reopen for several months because of social distance restrictions, staff with COVID-19 and then another shutdown in June 2020.

Adam Peterson, an attorney for Congress Street Clubs, said they were not obligated to pay rent during that time under a “force majeure” clause in their lease. That clause relieves tenants hampered by acts out of their control such as governmental restrictions.

The landlord had argued the clause was too vague. By July 2020, the landlord locked the club owners out and seized $150,000 worth of equipment.

 

[Heliobas Disciple]

"Long COVID" response ramps up, with plans to test new treatments

The research is one of several efforts by the Biden administration to address long-term symptoms that linger for some patients.

news.yahoo.com

(fair use applies)


"Long COVID" response ramps up, with plans to test new treatments
Alexander Tin - CBS News
Fri, August 19, 2022, 9:25 AM

It's been one of the biggest mysteries of the COVID-19 pandemic: Why do some people experience at-times debilitating symptoms that linger for months after the initial infection came and went? And what can be done to help those suffering from "long COVID"?

The National Institutes of Health is now hoping to launch its first big clinical trials of potential treatments for patients experiencing long-term symptoms from COVID-19 as early as October, according to a top federal official overseeing the plans.

It's part of the Biden administration's response to the millions suffering from long COVID, with initiatives expected to ramp up over the coming months.

"We're hoping October, November, we could start something big. We might start something small sooner, just to do a pilot first. It depends how the tests work," says Dr. Walter Koroshetz, director of the National Institute for Neurological Disorders and Stroke.

Koroshetz is part of the team that has helmed the NIH's RECOVER initiative to study the wide constellation of lingering symptoms grouped as "long COVID" or "post-COVID" conditions.

Those symptoms can include fatigue, shortness of breath, cough, "brain fog," insomnia, diarrhea, or loss of smell.

Apart from the hoped-for trials of treatments for long COVID, RECOVER has already enrolled close to 7,000 volunteers — and conducted 50 autopsies — to build out an understanding of the lingering effects of the disease, Koroshetz told CBS News.

Harder to recruit have been people early on after they test positive, to study how they later recover over time.

"They're not going into hospitals, which is oftentimes where we have the best ability to enroll, and also, because of home testing, they're not going to doctors," said Koroshetz.

Similar to the agency's "master protocol" studies, which evaluated treatments reducing the risk of hospitalization and death from COVID-19, Koroshetz says the agency has been working for months to spin up sweeping trials for drugs that might be able to address some of the underlying causes for long-term symptoms.

One promising thread in that research is medications that might work for people whose symptoms doctors now suspect are likely caused by the virus persisting in the body, stubbornly infecting patients for months after they first tested positive.

Studying those drugs will first require first tests that can quantify whether the treatments are actually working to clear out simmering SARS-CoV-2 infections. Lingering virus cannot explain every long COVID symptom. Scientists believe the causes range widely, with some patients suffering extended symptoms due to organ damage from the initial infection, or from an overcharged immune response that persists after the virus seems to have cleared.

"If you just throw something at a group of people with post-COVID, you'd have to be really lucky to see anything because of the heterogeneity of this, and because you don't know if you don't know what you're targeting, you have no way of deciding on a dose or duration," said Koroshetz.

NIH is also working on a number of other protocols and grants to develop new treatments across the wide spectrum of long COVID symptoms, Koroshetz added. These include therapy for concentration problems and drugs that might manage cardiac issues.

In the meantime, federal researchers say they hope to soon step up research into helping patients manage and treat their long-term symptoms.

The U.S. Department of Veterans Affairs plans to scale up an effort to coordinate their approach to how their doctors are caring for long COVID patients across their system.

Their new Long COVID Clinic Practice Based Research Network plans to start gathering uniform data on their long COVID patients, which the department hopes could help answer key questions around diagnosis and treatment. They also plan to fund several studies of their own, now being proposed this month from doctors across the V.A.'s hospitals, a spokesperson told CBS News.

The V.A. also recently published a guide for doctors caring for patients with long-term symptoms, which it estimates could number between 24,000 and 42,000 veterans.

"At the time of this writing, it is estimated that 4-7% of those diagnosed with COVID-19, or 2% of the U.S. population, will develop Long COVID," the guide's authors wrote.

However, the authors acknowledged that estimates of the prevalence of long COVID symptoms continues to vary widely depending on how they are measured around the world.

In the United Kingdom, surveys suggest that around 2.8% of the population — or some 1.8 million people — are currently experiencing symptoms that have lasted more than a month since their infection.

In the U.S., 7.5% of adults surveyed say they have symptoms that have lasted at least three months after they first contracted the virus, according to U.S. Census Bureau data published by the Centers for Disease Control and Prevention in June.

More estimates are expected by next summer from the CDC's ongoing National Health Interview Survey, which is expected to wrap up collecting its data at the end of this year.

Data from the CDC-backed INSPIRE cohort study suggests that the most commonly reported symptoms a year after surviving an infection are head-related complaints like headache, loss of taste or smell, or runny nose.

Figuring out how much of that is a result of the virus is tricky. While 29.9% of people who tested positive for COVID reported those symptoms one year later, so did 29.9% of people in the study who tested negative.

The Biden administration has pledged to embark on more research to unlock answers around long COVID, including better surveillance of its prevalence and how to treat it. Officials have called on Congress to fund their "ambitious goals," including a new permanent office to coordinate different agency efforts.

Congress has already set aside some money aimed at tackling long COVID, including $1.15 billion first appropriated in December 2020 that led to the creation of the RECOVER initiative.

Senator Tim Kaine, who has long been a proponent of funding long COVID efforts, said he was optimistic Capitol Hill might be able to devote more money to the issue – despite other long-stalled COVID-19 requests from the White House.

"In terms of the bipartisan nature of this, in the long COVID space, I feel like I've got really good support on both sides of the aisle, in both houses," the Virginia Democrat told CBS News earlier this month.

Kaine — who has spoken out about suffering from long COVID symptoms himself — was among three Democrats to introduce a bill to fund more long COVID efforts back in March. Kaine also cited the spending bills for next year, released last month by Senate Democrats, which include proposals to fund more research at the CDC and the Agency for Healthcare Research and Quality.

Of course, the spending bills remain far from the president's desk.

"Democrats know the path to a successful appropriations process, but today they chose to move in a different direction," Republican Senator Richard Shelby said in a statement late last month, decrying the proposals as "filled with poison pills" and "wasteful, off-budget spending."

Nevertheless, Kaine said he continues to hear from others who are still suffering from long COVID symptoms like himself. That kinship, he believes, could fuel further support for funding research and treatments.

"I'm not finding it hard to convince my colleagues that this is a priority," said Kaine.

 

[Heliobas Disciple]

Keep in mind Fauci gave himself a second Paxlovid course, FDA not-withstanding. ....allowed for me, not thee....

FDA asks Pfizer to test second Paxlovid course in patients with COVID rebound

The drugmaker must produce the initial results of a randomized controlled trial of a second course of the antiviral by Sep. 30 next year, the FDA told Pfizer in a letter dated Aug. 5. The directive follows reports of recurrent viral infection or symptoms, or both, after the first course...

news.yahoo.com

(fair use applies)


FDA asks Pfizer to test second Paxlovid course in patients with COVID rebound
by Leroy Leo
Fri, August 19, 2022, 3:55 PM

(Reuters) -The U.S. Food and Drug Administration (FDA) has asked Pfizer Inc to test the effects of an additional course of its antiviral Paxlovid among people who experience a rebound in COVID-19 after treatment, the regulator said on Friday.

The drugmaker must produce the initial results of a randomized controlled trial of a second course of the antiviral by Sep. 30 next year, the FDA told Pfizer in a letter dated Aug. 5.

The directive follows reports of recurrent viral infection or symptoms, or both, after the first course, including in President Joe Biden and National Institute of Allergy and Infectious Diseases Director Dr. Anthony Fauci.

The incidents, which Pfizer says are rare, prompted the FDA to start talks with the company about the trial in May.

The regulator said a protocol for the study is expected to be finalized this month.

Pfizer is "working with the FDA to finalize a protocol to study patients who may be in need of retreatment" and will provide details when available, a company spokesperson said.

 

[Heliobas Disciple]

Key GOP senator presses feds for source of vaccine at military bases after whistleblower allegations

Nine military officers sent a whistleblower report to Congress regarding a questionably sourced and labeled COVID vaccine appearing at Coast Guard medical clinics.

justthenews.com

(fair use applies)


Key GOP senator presses feds for source of vaccine at military bases after whistleblower allegations
Nine military officers sent a whistleblower report to Congress regarding a questionably sourced and labeled COVID vaccine appearing at Coast Guard medical clinics.
By Natalia Mittelstadt
August 19, 2022 - 11:51pm

Sen. Ron Johnson (R-Wisc.) is pressing the Pentagon, Food and Drug Administration, and the Centers for Disease Control and Prevention for answers after multiple whistleblowers raised concerns about the provenance of a Comirnaty-labeled COVID-19 vaccine shipped to military bases.

On Monday, nine military officers from across all the branches sent a whistleblower report to Congress regarding a COVID vaccine appearing at Coast Guard medical clinics.

Although labeled as Pfizer's fully-FDA approved Comirnaty vaccine, the vaccine does not appear to have been manufactured in Belgium as is legally required per its FDA approval letter, according to the whistleblowers, and may actually be the Pfizer-BioNTech COVID-19 Vaccine that's under emergency use authorization.

The military can only legally force service members to receive vaccines that are fully approved by the FDA, not those under FDA emergency use authorization. However, service members who have been denied religious exemptions from the military's vaccine mandate are being forced out of the military, despite only emergency use authorization vaccines being made available.

Thus far, federal judges in various court cases have granted preliminary injunctions against the vaccine mandates in the Navy, Air Force, and Marine Corps for service members seeking religious exemptions.

According to one of the whistleblowers, a Coast Guard officer who was denied his request for a religious exemption, the service gave him five days to comply with the vaccine mandate after Comirnaty was delivered to his base's medical clinic.

On Thursday, Johnson wrote a letter to the DOD, FDA, and CDC regarding the whistleblower complaints, asking about:

• the manufacturing location of the vaccine lot delivered to military medical clinics;
• why the Comirnaty-labeled vaccine, which is supposed to have full FDA approval, is listed on a CDC database as a vaccine under emergency use authorization;
• why the vaccine is labeled as Comirnaty if it was created under emergency use authorization;
• identifying all vaccine lot numbers with Comirnaty-labeled vaccines that have been sent to U.S. military bases and are in the CDC database.

 

[Heliobas Disciple]

Federal Government To Stop Paying For COVID Shots, Tests, & Treatments | ZeroHedge

ZeroHedge - On a long enough timeline, the survival rate for everyone drops to zero

www.zerohedge.com

(fair use applies)


Federal Government To Stop Paying For COVID Shots, Tests, & Treatments
by Tyler Durden
Friday, Aug 19, 2022 - 08:40 PM

The Biden administration is starting to transition the federal government away from paying for Covid-19 vaccines, tests and treatments, with the shift likely to materialize this fall.

"One of the things we've spent a lot of time thinking about in the last many months...is getting us out of that acute emergency phase where the US government is buying the vaccines, buying the treatments, buying the diagnostic tests," White House Covid-19 Response Coordinator Ashish Jha said at a US Chamber of Commerce Foundation event on Tuesday.

"My hope is that in 2023, you're going to see the commercialization of almost all of these products," Jha added. "Some of that is actually going to begin this fall, in the days and weeks ahead." Earlier this year, a White House request for another $10 billion in pandemic response funding stalled in Congress.

On Thursday, The Wall Street Journal reported that, on Aug. 30, the Department of Health and Human Services (HHS) will host a meeting of pharmaceutical companies, state health departments and pharmacies to start sorting out how to make the transition, which also include regulatory adjustments.

Referring to the broader transition, Pharmaceutical Research and Manufacturers of America SVP Anne McDonald Pritchett told the Journal “there are issues of reimbursement, equitable access to vaccines and treatment, and distribution that need to be resolved.”

"Resolving the issue of equitable access" loosely translates to figuring out how to still give many tests, vaccines and treatments away to the uninsured and others -- so drug companies will still be reaping some benefit from governmental redistribution of wealth where Covid-19 is concerned.

The federal government has already stopped buying monoclonal antibody treatments, such as Eli Lilly's bebtelovimab. The list price is $2,100 a dose, and Lilly is working with HHS to transition to direct sales to health care providers. At the same time, “Lilly is coordinating with the US government to identify solutions so that uninsured, lower-income individuals can access bebtelovimab,” an Eli Lilly spokeswoman told Bloomberg.

Pfizer and Moderna racked up $79 billion in Covid vaccine sales in 2021 alone, the Journal reports, with sales juiced by public health officials' false claims of efficacy, coupled with coercive vaccination requirements imposed by governments, schools and employers.

Whoopsie...#Biden #vaccine #covid #trust#Bidenlying pic.twitter.com/WKAkLfUv82​

— Dubb'ed Dan (@DubbedDan) August 11, 2022​

Moving forward, Covid-associated prices will be subject to negotiations among drug-makers, pharmacy benefit managers and insurance companies. Kaiser Family Foundation executive vice president Larry Levitt told the Journal the net effect will likely be higher prices and higher insurance premiums.

No idea why WSJ thinks that now the pharma companies are going to make more money. They already profited insanely off of C-19, and a lot of people didn't even want the shots for free.https://t.co/fcwsyehXMh​

— Cecilia Glennon (@CeciliaGlennon) August 18, 2022​

However, after The Wall Street Journal reported on Thursday that planning for the transition is getting underway in earnest, shares of vaccine makers slumped: Moderna was down 5% and Pfizer down nearly 2%. "Moderna will be at a disadvantage as the Covid-19 vaccines enter the commercial market, as it goes up against Pfizer, which has a substantially larger commercial infrastructure," said Josh Nathan-Kazis of Barron's.

While the inept government middleman was in the mix, Pfizer and Moderna were happy to churn out far more vaccines than the market demanded. Between December 2020 and mid-May of this year, US federal agencies, pharmacies and states threw out a whopping 82.1 million Covid-19 vaccine doses.

Meanwhile, in mid-October, the Biden administration is expected to extend the declared Covid-19 public health emergency into January 2023, ensuring midterm voters are still benefitting from expanded Medicaid coverage and higher payments to hospitals.

What a racket.

 

[Heliobas Disciple]

Zerohedge

ZeroHedge - On a long enough timeline, the survival rate for everyone drops to zero

www.zerohedge.com

(fair use applies)


China's Endless COVID Hysteria Is A Dark Experiment In Social Conditioning
by Tyler Durden
Friday, Aug 19, 2022 - 06:40 PM

There are many people that will say that Americans “rolled over” in the face of covid restrictions and vaccine pressures despite extensive evidence that neither of these things had any effect on stopping or stalling the pandemic. But the notion of American pacifism is simply not true. If it were then the US would be looking a lot more like China right now.

Growing opposition to meaningless covid lockdowns and the vaccine passports was a mainstay in the US that made government enforcement impossible. Joe Biden's attempt to introduce federal vax passport rules for businesses failed miserably, red states defied the lockdowns within a few months of the start of the pandemic and the states that kept restrictions in place had HIGHER rates of infection while their economies sank. When it became clear to the establishment that millions of Americans were not going to comply, they had to back off.

Even blue states and cities have been forced to acknowledge that the farce is over; Los Angeles County tried to reintroduce mask mandates recently and the measure collapsed in failure as many municipalities said they planned to ignore any new ordnance. Covid's median Infection Fatality Rate of 0.23% was not enough of a threat to convince the public to abandon their constitutional rights.

Without the millions of courageous people that refused to comply our country might look very different today. The CCP has faced little public opposition over their draconian covid rules, and when they do, they don't worry much because the population is completely disarmed. This has resulted in a veritable nightmare world for the citizenry. In fact, it almost seems like an experiment to find out how much psychological torture and oppression human beings are willing to endure.

Mandate cheerleaders boasted endlessly about how China effectively stopped the spread and was ready to reopen while the western world floundered because we refused to submit and accept medical tyranny “for the greater good.” Now these same people are silent as China goes though an array of outbreaks and lockdowns that cycle perpetually. In the meantime, most of the west has reopened and some places (like dozens of conservative states) have been open well over two years. Remember when leftists and foreign governments said we would be dying off in the streets and ruing our decision to follow the science rather than the hysteria? Yeah, the great cleansing of conservatives they were hoping for never happened.

Open authoritarian systems require dramatic participation by the people being controlled. They have to want to be locked down, otherwise the system cannot continue and it will eventually be toppled. One has to wonder, do the Chinese people even remember anymore why they are locking down? Or, have they just accepted the mandates as the new normal?

Currently, mass covid testing is a regular practice in most major population centers in China. Almost every large indoor business or government building requires proof of a negative covid test. This incessant testing is part of China's “zero covid” policy, and has led to testing booths in almost every neighborhood.

China has been perfecting the use of QR codes and tracking apps to keep the public cataloged; without these apps and codes a Chinese citizen would find it impossible to get a job or participate in the economy. They would die from starvation first; the minuscule chance of dying from covid would be the furthest thing from their mind.

Though PCR testing often reads asymptomatic cases as exactly the same as full blown infections, the CCP does not recognize the difference and treats every case as if each person is Patient Zero in a zombie apocalypse. For example, a six-year-old boy with asymptomatic covid tested positive and was found through tracking apps to have visited an IKEA store in Shanghai a couple of days earlier. So, rather than admitting that the testing and tracking is a failed system that does nothing to prevent covid spread, CCP authorities instead tried to lockdown the IKEA building with hundreds of people inside for a week. Here was the result:

View: https://www.youtube.com/watch?v=Ehwk2SZndhA
1 min 31 sec

Testing madness has even spread to the animals. The government is now requiring testing for 5 million fisherman as well as testing of the FISH being delivered by commercial fishing vessels to Chinese ports.

View: https://www.youtube.com/watch?v=AA99NgoKDKc
1 min 52 sec

The image of a fish being swabbed for covid is rather hilarious, but it's important to note that the CCP probably isn't stupid enough to believe that covid is transmitted through seafood. More likely what this is about is initiating a firestorm of public conditioning to convince the population that covid is around every corner and under every bed forever. The goal here is to engage in a constant fear campaign to make the people more compliant. It is an assessment to see what the government can get away with. And, in China at least, they can get away with quite a lot.

The Orwellian horror that China represents has essentially killed their tourist industry. Millions of potential foreign visitors now fear that they could be trapped within China's borders if they time their visit to coincide with another surprise mass lockdown. China's economy suffers extensively from their lockdown culture, but the CCP does not care. The experiment is more important than anything else.

This will never end. Once a government obtains this kind of all pervasive power they will stop at nothing to keep it. While the US has many problems to deal with and many elitists in positions of authority to unseat, at least we have a chance. Some places, like China, are so poisoned by complacency that they can't escape the boot; it has already landed on them.

 

[Heliobas Disciple]

Geert Vanden Bossche & Marc Wathelet: why have early treament protocols been neglected and even forbidden as a stronghold against infection. This interview focuses mainly on prophylaxis and how early treament protocols have been neglected and even forbidden as a stronghold against infection, desease and complications.

PART 3/6 Geert Vanden Bossche & Marc Wathelet (July 23rd '22)

Here is the 3rd of 6 video fragments recorded that day. This interview focuses mainly on prophylaxis and how early treament protocols have been neglected and even forbidden as a stronghold against infection, desease and complications. On 23 July…

www.bitchute.com

PART 3/6 Geert Vanden Bossche & Marc Wathelet (July 23rd '22)
51 min 32 sec

 

[Heliobas Disciple]

Geert Vanden Bossche
Health Congress Dublin : Declaration of the Protection of Children
August 19, 2022

Health Congress Dublin : Declaration of the Protection of Children

rumble.com

11 min 11 sec

 

[Heliobas Disciple]

Dr. Geert Vanden Bossche: Warning Against Monkeypox Vaccinations
The New American
August 19, 2022

In America, the strategy to tackle the monkeypox outbreak is focused on vaccinations of people considered at-risk.
Yet monkeypox vaccinations will drive adaptive evolution of the virus in the countries heavily vaccinated against Covid, such as the United States, warned Dr. Geert Vanden Bossche. That means that the virus will become more transmissible to cohorts other than homosexual and bisexual men. Because of the mechanism of their action, these shots would prevent the establishment of herd immunity. Moreover, Dr. Vanden Bossche called on people not to vaccinate against the seasonal flu and Covid.

The current monkeypox outbreak is a result of the Covid vaccinations that are connected to Covid reinfections and the related reactivation of cytotoxic t-cells, reminded the scientist. That issue was discussed in detail in his previous interview with The New American.

Dr. Geert Vanden Bossche: Warning Against Monkeypox Vaccinations

In America, the strategy to tackle the monkeypox outbreak is focused on vaccinations of people considered at-risk. Yet monkeypox vaccinations will drive adaptive evolution of the virus in the countrie

rumble.com

28 min 4 sec

 

[Heliobas Disciple]

View: https://www.youtube.com/watch?v=VZ1ppIXCOsU
New covid vaccine for UK
20 min 23 sec
Aug 19, 2022
Dr. John Campbell

Bivalent new vaccine, Moderna press release https://investors.modernatx.com/news/... Omicron-containing bivalent COVID booster candidate, mRNA-1273.214 (original mRNA-1273 vaccine), Superior neutralizing antibody response in baseline seronegative participants. increased neutralizing geometric mean titers (GMT) against Omicron approximately 8-fold above baseline levels. mRNA-1273.214 50 μg booster dose, well-tolerated in the 437 study participants The safety and reactogenicity profile of the mRNA-1273.214 50 μg booster dose was similar to that of mRNA-1273 50 μg BA.1 SARS-CoV-2 variants of concern and variants under investigation in England Technical briefing 44 https://assets.publishing.service.gov... BA.2 3.4% BA.4 17.2% BA.5 78.7% Other 0.7% US variants https://covid.cdc.gov/covid-data-trac... BA.5 88.8% BA.4 5.3% BA.4.6 5.1% BA.2.12.1 0.8% BA.2 0% BA.1s 0% Delta 0% Epidemiology of Myocarditis and Pericarditis Following mRNA Vaccination by Vaccine Product, Schedule, and Interdose Interval Among Adolescents and Adults in Ontario, Canada https://jamanetwork.com/journals/jama... Population-based cohort study of 297 individuals in Ontario, Canada, with myocarditis or pericarditis following COVID-19 vaccination, found higher rates of myocarditis or pericarditis associated with receipt of mRNA-1273 compared with BNT162b2 as a second dose, particularly among male individuals aged 18 to 24 years. The results suggest that there may be product-specific differences in rates of myocarditis or pericarditis after receiving mRNA vaccines First bivalent COVID-19 booster vaccine approved by UK medicines regulator https://www.gov.uk/government/news/fi... Moderna bivalent approved for adult booster doses by MHRA Spikevax bivalent Original/Omicron 25 micrograms targets the original virus strain 25 micrograms targets Omicron Omicron (BA.1) and the original 2020 strain (was also found to generate a good immune response against BA.4 and BA.5) Safety monitoring side effects observed were the same as those seen for the original Moderna booster dose, and were typically mild and self-resolving, and no serious safety concerns were identified. Global covid deaths https://www.worldometers.info/coronav... 6,466,947 Evidence cited by HMRA https://www.thelancet.com/journals/la... Based on official reported COVID-19 deaths, we estimated that vaccinations prevented 14·4 million deaths from COVID-19 in 185 countries, between Dec 8, 2020, and Dec 8, 2021. 19·8 million when we used excess deaths as an estimate Joint Committee on Vaccination and Immunisation (JCVI) updated statement on the COVID-19 vaccination programme for autumn 2022 For autumn 2022 https://www.gov.uk/government/publica... JCVI advises the following groups should be offered a COVID-19 booster vaccine: residents in a care home for older adults and staff working in care homes for older adults frontline health and social care workers all adults aged 50 years and over persons aged 5 to 49 years in a clinical risk group persons aged 5 to 49 years who are household contacts of people with immunosuppression persons aged 16 to 49 years who are carers Time to collect PROSPECTIVE data Cardiovascular Effects of the BNT162b2 mRNA COVID-19 Vaccine in Adolescents https://www.preprints.org/manuscript/... Thai adolescents, 13 to 18, both sexes Cardiovascular effects Found in 29.24% of patients, 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

 

[Heliobas Disciple]

View: https://www.youtube.com/watch?v=OaqrEJ_HVGQ
Long COVID: SARS-COV-2 Persists in Almost All Tissues of The Body (NIH Preprint Study)
49 min 28 sec
Streamed live 7 hours ago
Drbeen Medical Lectures

In this study from NIH, the authors demonstrate the presence of replication competent virus genome in a vast array of human organs and cells even after asymptomatic infection. Let's review.

URL list from Friday, Aug. 19 2022

Covid-19 Can Stay in Body for Months, Study Finds - Bloomberg
https://www.bloomberg.com/news/articl...

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

v1_covered.pdf
https://assets.researchsquare.com/fil...

Defective Measles Virus in Human Subacute Sclerosing Panencephalitis Brain - ScienceDirect
https://www.sciencedirect.com/science...

Defective measles virus in human subacute sclerosing panencephalitis brain - PubMed
https://pubmed.ncbi.nlm.nih.gov/8030228/


ETA: this is the abstract from the study discussed in the video:

SARS-CoV-2 infection and persistence throughout the human body and brain

COVID-19 is known to cause multi-organ dysfunction1-3 in acute infection, with prolonged symptoms experienced by some patients, termed Post-Acute Sequelae of SARS-CoV-2 (PASC)4-5. However, the burden of infection outside the respiratory tract and time to viral clearance is n...

www.researchsquare.com

SARS-CoV-2 infection and persistence throughout the human body and brain

SARS-CoV-2 infection and persistence throughout the human body and brain

COVID-19 is known to cause multi-organ dysfunction1-3 in acute infection, with prolonged symptoms experienced by some patients, termed Post-Acute Sequelae of SARS-CoV-2 (PASC)4-5. However, the burden of infection outside the respiratory tract and time to viral clearance is n...

doi.org

This work is licensed under a CC BY 4.0 License

COVID-19 is known to cause multi-organ dysfunction1-3 in acute infection, with prolonged symptoms experienced by some patients, termed Post-Acute Sequelae of SARS-CoV-2 (PASC)4-5. However, the burden of infection outside the respiratory tract and time to viral clearance is not well characterized, particularly in the brain3,6-14. We performed complete autopsies on 44 patients with COVID-19 to map and quantify SARS-CoV-2 distribution, replication, and cell-type specificity across the human body, including brain, from acute infection through over seven months following symptom onset. We show that SARS-CoV-2 is widely distributed, even among patients who died with asymptomatic to mild COVID-19, and that virus replication is present in multiple extrapulmonary tissues early in infection. Further, we detected SARS-CoV-2 RNA in multiple anatomic sites, including regions throughout the brain, for up to 230 days following symptom onset. Despite extensive distribution of SARS-CoV-2 in the body, we observed a paucity of inflammation or direct viral cytopathology outside of the lungs. Our data prove that SARS-CoV-2 causes systemic infection and can persist in the body for months.