Quote from Fm1

The clear winner from OWS was its very first acute ambulatory product, monoclonal antibodies.

Just one more sales pitch. The clear winner is the Ziverdoo kit fro 1$/person/cure. No Omicron wave in India!!

Quote from Wyttenbach

Just one more sales pitch. The clear winner is the Ziverdoo kit fro 1$/person/cure. No Omicron wave in India!!

I Usually agree with you but you are wrong on this. Yes I agree ivermectin works but it's not prescribed by doctors in North America or Canada. The only treatments available, that seemed to work were taken away, with the only option for most being the jab. When you deny the public of approve drugs to force the jab, that's a crime. And india as of today is n the mist of another growing wave of infections. A new variant is making the rounds n ndia

Intriguing results of new national poll about COVID and vaccine deaths

Intriguing results of new national poll about COVID and vaccine deaths

Looks like there been massive under-counting of COVID and vaccine deaths. A new poll by Rasmussen has some data that validates what many of us already…

www.trialsitenews.com

Looks like there been massive under-counting of COVID and vaccine deaths.

A new poll by Rasmussen has some data that validates what many of us already believe, namely that the vaccines are dangerous, unsafe and need to be pulled from the market immediately.

The survey of 1,078 American adults was conducted on March 27-29, 2023 by Rasmussen Reports. The margin of sampling error is +/- 3 percentage points with a 95% level of confidence.

A big finding is that nearly as many Americans believe someone close to them died from side effects of the COVID-19 vaccine as died from the disease/infection itself.

This latest Rasmussen Reports national telephone and online survey finds that 11% of American adults say a member of their household died from COVID-19, while 86% answer no. That percentage equates to roughly 25 million adults. Both the 11% and 25 million figures are incredibly high. They also equate to a very high number of households, many millions. Are all these figures consistent with what CDC says is the total number of COVID deaths of just over 1 million? NO! The survey result indicates a massive under-counting of COVID deaths by the government. And that many more millions of Americans died from COVID! How can this be explained? One possible answer is that many deaths occurred at homes rather than hospitals. Another is that ordinary people viewed some deaths in their household were incorrectly attributed to various ordinary health problems (such as cardiac deaths) were actually caused by COVID infection.

Ten percent (10%) say a member of their household has died whose death they think may have been caused by side effects of COVID-19 vaccines, while 85% say there were no such deaths in their household. This figure is shockingly inconsistent with the approved narrative, actually propaganda, of “safe and effective” which has been so actively spread by corporate (“main stream”) media and the US Government and the entire public health and health care establishments. Here too this survey result indicates a massive under-counting of vaccine deaths if some 25 million Americans have this view. Various studies indicate a total of some 500,000 vaccine deaths.

These findings come at a time when overall concern about COVID-19 is clearly on the decline. Forty-eight percent (48)% of Americans are less concerned about COVID-19 than they were a year ago, compared to 20% who say they’re more concerned. Thirty-one percent (31%) say their concern about COVID-19 has not changed much in the past year.

More Democrats (16%) than Republicans (12%) or those not affiliated with either major party (6%) say a member of their household died from COVID-19. More Republicans (15%) than Democrats (13%) or the unaffiliated (5%) say a member of their household has died whose death they think may have been caused by side effects of COVID-19 vaccines.

The section above is key, because the difference between Democrats and Republicans is almost the same concerning either deaths from COVID or COVID vaccines. If there had been statistical significance between these two groups, Rasmussen would have indicated that.

Please keep in mind that it is now widely accepted by those who follow the data that the COVID vaccines available in the United States do not prevent infection, replication, or spread of SARS-CoV-2, and do not prevent either hospitalized disease or death from COVID-19 disease. Given these facts, references to these biologic medical products as “vaccines” is merely propaganda. They clearly do not “vaccinate” in the classic sense. But they make billions of dollars for vaccine makers.

Other details about the poll:

Fifty-five percent (55%) of Republicans, 43% of Democrats and 45% of the unaffiliated are less concerned about COVID-19 than they were a year ago. Thirty-one percent (31%) of Democrats, 17% of Republicans and 13% of the unaffiliated are more concerned about COVID-19 than they were a year ago.

The only significant male-female divide on these questions is that more men (24%) than women (17%) say they’re more concerned about COVID-19 than they were a year ago. This is particularly true for men under 40.

Adults under 40 are significantly more likely than their elders to say they’re more concerned about COVID-19 than they were a year ago. A solid majority of Americans over 40 have become less concerned about COVID-19 in the past year, but just 35% of those under 40 feel the same. Women under 40 are most likely to answer yes when asked whether a household member has died either due to COVID-19 or to side effects of the COVID-19 vaccine.

Fifty percent (50%) of whites, 39% of blacks and 46% of other minorities are less concerned about COVID-19 than they were a year ago. Nineteen percent (19%) of whites, 24% of blacks and 22% of other minorities are more concerned about COVID-19 than they were a year ago. Whites and blacks are less likely than other minorities to say a household member has died either due to COVID-19 or to side effects of the COVID-19 vaccine.

Married adults and those with children at home are more likely than their single or childless peers to say a household member has died either due to COVID-19 or to side effects of the COVID-19 vaccine.

Americans with annual incomes over $100,000 are more likely to say they’re more concerned about COVID-19 than they were a year ago, compared to those with lower incomes. Higher income Americans are also more likely to say a member of their household died from COVID-19.

Remarkably, among those who say a member of their household died from COVID-19, 54% also say a member of their household has died whose death they think may have been caused by side effects of COVID-19 vaccines.

More than three years after “15 days to slow the spread” of COVID-19, most voters have less trust in government health experts – and in the news media, too

Quote from Fm1

And india as of today is n the mist of another growing wave of infections. A new variant is making the rounds n ndia

This (claiming fake news) is what happens if you live in a widely criminal ruled "neusprech" state with a truth ministry...

India has and sees nothing!!! https://www.mygov.in/covid-19

Ironically half of today's Covid cases come from the vaccine only state of Kerala.... A state that after July 2021 killed more than 10x people compared to others..

Uttar Pradesh (124) 230 Million people has 10x less cases than Kerala (1193) or has a 50x lower Cov-rate.

Do you have an idea who spreads all this fake news in USA?

coming soon MRNA fortified food and milk

Chinese Load Cow's Milk with mRNA Exosomes--Successfully Immunize Mice

COVID-19 mRNA Vaccine Assault Possible Through Food Supply

Chinese Load Cow's Milk with mRNA Exosomes--Successfully Immunize Mice

COVID-19 mRNA Vaccine Assault Possible Through Food Supply

petermcculloughmd.substack.com

675By Peter A. McCullough, MD, MPH

The nation’s food supply can be manipulated by public health agencies to influence population outcomes. A great is example is fortification of cereal grains with folic acid — the synthetic form of folate — which successfully reduced the incidence of neural tube defects (e.g. spina bifida). Now an oral route of administration is being considered specifically for COVID-19 vaccination using mRNA in cow’s milk.

Zhang and colleagues have demonstrated that a shortened mRNA code of 675 base pairs could be loaded into phospholipid packets called exosomes derived from milk and then using that same milk, be fed to mice. The mice gastrointestinal tract absorbed the exosomes and the mRNA must have made it into the blood stream and lymphatic tissue because antibodies were produced in fed mice against SARS-CoV-2 Spike protein (receptor binding domain).

Norman Fenton vs. The Lancet

Norman Fenton vs. The Lancet

The scientific journal, The Lancet, is facing a major public backlash after Professor, emeritus professor of risk at Queen Mary University of London,…

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The scientific journal, The Lancet, is facing a major public backlash after Professor, emeritus professor of risk at Queen Mary University of London, released a tweet alleging a lack of transparency by the journal in response to criticism of published research in 2021 on the effectiveness of the Pfizer/BioNTech COVID-19 vaccine against COVID-19 in Israel. Professor Fenton then published an article showing the details of the correspondence with The Lancet where they heavily redacted parts of the letters, including authors’ names and potentially derogatory remarks against Fenton’s actions. These events reveal the importance of transparency in scientific research and raise questions about The Lancet's editorial process.

On March 6, 2021, The Lancet published a study on the Israeli population claiming that the Pfizer/BioNTech COVID-19 vaccine was 95% effective. Professor Fenton challenged this result by submitting a response stating that the research was compromised due to the following grounds:

Failure to adjust for a declining infection rate inflated the vaccine’s efficacy.

The study did not consider people who received a single or a second dose as “fully vaccinated” and disregarded all COVID-19 cases reported from this group resulting in an exaggerated result.

There was no information on the vaccine’s adverse reactions, especially deaths. Therefore, no decision can be made on the risks and benefits of the vaccine.

The research integrity was compromised because Sharon Alroy-Preis, the lead author of the study, declared no conflict of interest for not holding stock and stock options in Pfizer yet she was the Head of Public Health Services at the Israeli Ministry of Health (IMOH) when Israel had an agreement with Pfizer to use its vaccine to monitor its effects exclusively. Their collaboration clearly stated that results should be jointly prepared and published by Pfizer and IMoH, and named Alroy-Preis as the IMoH representative who would handle conflicts between the parties.

Considering these major flaws, Professor Fenton, in his letter, requested that the article be retracted.

The Lancet's late response

After 20 months, Professor Fenton received a response from The Lancet’s senior editor, Josefine Gibson, stating that they were not able to pursue an exchange because they did not receive a formal response from Alroy-Preis.

Professor Fenton then took this experience to Twitter which resulted in more than 1M views and hundreds of comments from people expressing their opinion on the controversy.

The Lancet reached out to Professor Fenton to publish his letter but eventually decided against it citing the following reasons:

The reported adverse reactions are “substantial” given the existing evidence on the effectiveness and safety of the Pfizer/BioNTech vaccine.

Alroy-Preis clearly gave her affiliation with the IMOH in the paper and they do not consider it as a conflict of interest or a challenge to the integrity of the data.

In response, Professor Fenton requested from Elsevier, the publisher of The Lancet, access to all internal correspondence that had resulted in the rejection of their letter. Professor Fenton described the extent of redaction as, “clearly not done solely for the legitimate protection of the names of third parties.”

He highlighted in his article what he claimed as alarming unredacted comments such as “helpful background on Fenton” which seemingly questioned his academic appointment or accusing him and his colleagues of “anti-vax posts on Twitter,” and “holding off further email” implying their offer to consider his letter was not genuine.

Professor Fenton also noted in his article that The Lancet had only taken action when their delayed action had received a negative response on Twitter, yet the potentially flawed study promoting the Pfizer/BioNTech vaccine will remain unchallenged.

Professor Fenton informed Elsevier that if he’s not provided with a proper and full response with most of the comments unredacted, he will have to report them to the Information Commissioner’s Office (ICO).

Implications of this controversy

Transparency in scientific journals such as The Lancet is crucial as it ensures the integrity and reliability of the research published. Accurate and unbiased information helps to maintain public trust in scientific research and aids in medical decisions and policies, especially in the midst of a public health crisis.

Transparency ensures that the researchers' potential conflicts of interest are disclosed and that their work can be evaluated without bias. In published articles, research transparency standards are vital to attaining its ultimate goal of improving public trust in science.

Interview with Professor Norman Fenton

In an interview with TrialSite, Professor Fenton shared his experience and his thoughts on how the stance of many peer-reviewed publications on COVID-19 vaccine studies impacts research and the research community.

“The narrative that an extremely effective vaccine [with 95% efficacy] was created has been perpetuated because it’s never been allowed to be challenged by anything other than alternative media. Those who only follow peer-reviewed publications will not have been aware that there have been serious challenges posed to the exaggerated numbers published in those studies,” Dr. Fenton told TrialSite.

“There isn't any way for people to highlight systematic flaws in [COVID-19 vaccine] studies and challenge those claims, even via responses to the journal.” Dr. Fenton pointed out that other scientists have experienced similar rejections from journals when they attempted to highlight systematic errors in COVID-19 vaccine studies.

“Despite real-world evidence growing about the harms and effectiveness [of many COVID-19 vaccines], there’s an ever-shrinking forum for people showing that these problems exist. Instead, we’re labeled and vilified.”

In a recent article, Dr. Fenton draws attention to a paper published in March 2023 that examines bias in studies of COVID-19 vaccine effectiveness. The authors’ conclusions about sources of bias in many COVID-19 observational studies reiterate some of the flaws that Dr. Fenton raised about Pfizer’s vaccine trials in his letter to The Lancet.

However, such papers may not receive the widespread attention that high-impact journals do. “Even more dangerous is the prospect that if it doesn’t appear in the mainstream academic journals, it doesn’t actually exist as valid evidence, hence creating a closed-loop feedback system,” says Dr. Fenton in his article.

Dr. Fenton pointed out that the problem may be compounded because vaccine studies in general may not be held up to the same standard of rigor that other interventions receive, since it’s established to classify those who contract a disease within 14-days of receiving a vaccine for the same as unvaccinated.

“In COVID-19 observational studies, there have been additional confounders, like testing bias,” said Dr. Fenton.

Since Elsevier hasn’t responded to his request for a less redacted version of The Lancet’s correspondence, Dr. Fenton told TrialSite that he will be proceeding with reporting them to the ICO.

Bottom line

In summary, this controversy between Professor Fenton and The Lancet could potentially undermine public trust in scientific research. Researchers, editors and publishers must place great importance on accountability and transparency in the publishing of scientific research to allow for the identification of errors and ensure that corrections are made promptly.

FOIA Requests Reflect Future COVID-19 Vaccine Litigation? Will Pfizer & Moderna be Buried in Lawsuits?

FOIA Requests Reflect Future COVID-19 Vaccine Litigation? Will Pfizer & Moderna be Buried in Lawsuits?

What do Freedom of Information Act requests inform about ongoing and upcoming COVID-19 litigation? A recent analysis,  based on data from FOIAengine,…

www.trialsitenews.com

What do Freedom of Information Act requests inform about ongoing and upcoming COVID-19 litigation? A recent analysis, based on data from FOIAengine, which tracks these requests, offers some insights. And while this FOIA site is costly, folks can find a free FOIA generator here. While vaccine firms currently have strong legal protections, their “immunity from Covid vaccine injury lawsuits won’t last forever – it’s set to expire next year, on October 1, 2024.” And Pfizer is a “sitting duck--- according to Docket Alarm analytics that show the company has been involved in an average of 88 new proceedings per day over the last three months.” And of course, Pfizer and Moderna are suing each other in Massachusetts over mRNA patents. According to FOIAengine, many law firms have been “bombarding” FDA and other agencies with requests relating to both leading vaccine companies.

TrialSite scans multiple litigation and supports consumer/patient advocacy, a critical function across American society. Recently courtesy of Law Street Media we took a look a solid overview of the COVID-19 litigation landscape.

Background

In March 2020, the US government invoked the 2005 PREP Act to prevent folks from suing vaccine firms over the coronavirus products. This created a “safe harbor” from lawsuits for Pfizer, Moderna, and Johnson & Johnson in order to incentivize moving “quickly to fight the deadly virus. And it worked. Vaccines came out in record time, hundreds of millions of Americans were protected, and the share prices of Pfizer and Moderna soared to all-time highs.” Other than actions for willful misconduct, this created immunity for at least four years. People injured by a vaccine were not allowed to take a case to court; their only remedy is a claim to the Countermeasures Injury Compensation Program (CICP), “the PREP Act’s litigation alternative for injuries experienced during public health emergencies.” These CICP claims have a very low success rate; about 3%. HHS is in charge of processing them; they are currently evaluating 11,252 adverse reaction claims. They have already reviewed 631 of these claims and only granted 21.

Give us the lot numbers

Over the past 13 months 135 FOIA requests have mentioned Pfizer or Moderna. And “FOIA requests can be an important early warning of bad publicity or litigation to come.” The top requester was the law firm Siri & Glimstad, which has nine offices around the USA. This law office specializes in vaccine litigation. It has made hundreds of FOIA requests to FDA and NIH since the start of the pandemic. Tellingly, 10% of FOIA’s mentioning either of the top vaccine firms over the last 13 months have been from Siri. The firm says that it is not taking any CICP cases due to the minimal success rate. Siri considers COVID-19 litigation going forward to be “an unsettled issue.” Many of their requests to FDA, “are sweeping in scope, consistent with a plaintiff’s law firm that’s vacuuming up documents in preparation for coming legal actions.” As an example, they have asked for lot numbers of each dose of vaccine used in the US, “as well as copies of the Certificates of Analysis for each vaccine lot.”

“Adequate justice” sought

Managing partner Aaron Siri says that both FOIA requests and related follow-up lawsuits were “extremely useful” for his clientele, which includes the Informed Consent Action Network. ICAN has filed several dozen FOIA lawsuits in federal courts, and another client has two FOIA cases against FDA in Dallas federal court. (When a FOIA request is not honored, parties can file a suit to enforce the release of documents.) These plaintiffs are trying to determine what federal agencies know about safety issues early in the pandemic; as Mr. Siri puts it, “for purposes of transparency.” The lawyer also said that the data produced so far shows a “troubling numbers of people reporting that they had to seek medical care after their Covid-19 vaccine.” Siri continues that after PREP expires, “it remains unclear how the government will handle what is likely an unprecedented amount of claims of vaccine injury in such a small time period….

There are very organized and cohesive groups of people who have been injured by these vaccines, and it appears that they will not stop until there is some form of adequate justice and compensation available to them.”

Twice-Daily Oral Zinc in the Treatment of Patients With Coronavirus Disease 2019: A Randomized Double-Blind Controlled Trial

Twice-Daily Oral Zinc in the Treatment of Patients With Coronavirus Disease 2019: A Randomized Double-Blind Controlled Trial - PubMed

Our results showed that, in COVID-19 patients, oral zinc can decrease 30-day death, ICU admission rate and can shorten symptom duration. Clinical Trials…

pubmed.ncbi.nlm.nih.gov

Abstract

Background: Zinc supplementation has been considered a potential therapy for coronavirus disease 2019 (COVID-19). We aimed to examine zinc efficacy in adult patients with COVID-19 infection.

Methods: We conducted a prospective, randomized, double-blind, placebo-controlled multicenter trial. Patients who were tested positive for COVID-19 without end-organ failure were randomized to oral zinc (n = 231) or matching placebo (n = 239) for 15 days. The primary combined outcome was death due to COVID-19 or intensive care unit (ICU) admission ≤30 days after randomization. Secondary outcomes included length of hospital stay for inpatients and duration of COVID-19 symptoms with COVID-19-related hospitalization for outpatients.

Results: 190 patients (40.4%) were ambulatory and 280 patients (59.6%) were hospitalized. Mortality at 30 days was 6.5% in the zinc group and 9.2% in the placebo group (OR: .68; 95% CI .34-1.35); ICU admission rates were, respectively, 5.2% and 11.3% (OR: .43; 95% CI .21-.87). Combined outcome was lower in the zinc group versus the placebo group (OR: .58; 95% CI .33-.99). Consistent results were observed in prespecified subgroups of patients aged <65 years, those with comorbidity, and those who needed oxygen therapy at baseline. Length of hospital stay was shorter in the zinc group versus the placebo group (difference: 3.5 days; 95% CI 2.76-4.23) in the inpatient group; duration of COVID-19 symptoms decreased with zinc treatment versus placebo in outpatients (difference: 1.9 days; 95% CI .62-2.6). No severe adverse events were observed during the study.

Conclusions: Our results showed that, in COVID-19 patients, oral zinc can decrease 30-day death, ICU admission rate and can shorten symptom duration. Clinical Trials Registration. ClinicalTrials.gov, NCT05212480.

Quote from Fm1

The Lancet could potentially undermine public trust in scientific research

This is no longer possible. Only big pharma servants read the crappy Lancet journal...

Swiss National Health Authority Backs off of COVID-19 Vaccination: Recommendation Not, even for Vulnerable Populations

Swiss National Health Authority Backs off of COVID-19 Vaccination: Recommendation Not, even for Vulnerable Populations

Recently several groups and individual Substack critical of the COVID-19 vaccines declared that Switzerland has banned COVID-19 vaccines. Is this true? Not…

www.trialsitenews.com

Recently several groups and individual Substack critical of the COVID-19 vaccines declared that Switzerland has banned COVID-19 vaccines. Is this true? Not quite in those terms. But the Switzerland’s Federal Health Agency (Bundesgesundheitsamt, BMG) made material changes to the national vaccination schedule that certainly hasn’t received mainstream press attention in North America. The agency has backed away from recommending COVID-19 vaccination this spring and summer. Of course, it’s off-season for respiratory viruses, which could be part of the explanation. However, what else does the national Swiss health authority now promulgate on the topic of COVID-19 vaccination?

As mentioned above the BMG withdraws any COVID-19 recommendation for the spring and summer of 2023. However, the agency remains open for COVID-19 vaccine assessment for at-risk individuals, meaning the elderly, persons with comorbidities, those with immunosuppressed conditions.

The agency notes that a majority of the population has been vaccinated, an implicit message that the COVID-19 vaccine products do contribute to some protection against the Omicron-based variants. However, BMG also conveys that many have been infected already acknowledging that natural immunity can potentially be superior to vaccination itself while they acknowledge the overall Omicron pathogen becomes far less acute. On that note, TrialSite recently reported on one study in China covering the BA.5 Omicron subvariant—over 90% of the study participants infected with SARS-CoV-2 omicron were asymptomatic!

Of course, come the colder seasons later in 2023 and BMG reminds the agency will re-evaluate the recommendations.

Is BMG recommending COVID-19 vaccine for “particularly vulnerable people?”

In what could be a surprise move from a North American perspective the Swiss national health authority is backing off on any recommendation for COVID-19 vaccine. Clearly the agency has some concerns they are not overtly sharing with the masses.

BMG recommends that if individuals seek a COVID-19 vaccine they can consult with their physicians as “Vaccination can be useful in individual cases because it improves protection against serious illness for several months.”

What cohorts face materially greater risk against COVID-19 according to BMG?

The agency includes:

Persons aged 65 and up

People aged 16 and over with chronic illness

People aged 16 and over with trisomy 21

Pregnant women

What if the COVID-19 wave surges?

Then, the Swiss national authority will reconsider their current recommendations.

What’s the recommended timing of jabs?

Six months after the last vaccination or from half a year from the last known infection involving SARS-CoV-2.

What vaccines do BMG prefer?

Either the bivalent mRNA vaccine (acknowledging the monovalent vaccine effectiveness has markedly waned; or Novavax protein vaccine.

mRNA vaccine recommendations

The agency announces the importance of mRNA vaccination for pregnant and breastfeeding women.

What about the cost of vaccination in Switzerland?

Individuals must cover their own cost for COVID-19 vaccines now that the government is not recommending at the time.

However, this policy changes with at risk persons. The compulsory health insurance covers the jabs for vulnerable populations.

What about the chatter online that the Swiss authorities have pulled all mRNA COVID-19 vaccines?

Not really the case. Clearly the agency recalculates the risk-benefit analysis, liabilities and the like but remains quite open to reconsidering if COVID-19 surges again. However, the fact that North America media doesn’t cover this story is telling about the confluence of material interests converging on big media.

References

Fatal Massive Multiorgan Inflammation in a Teenager after COVID-19 Booster

Insights from Autopsy Study Help Explain Thousands of Unexpected Deaths from "Unknown Causes"

Fatal Massive Multiorgan Inflammation in a Teenager after COVID-19 Booster

Insights from Autopsy Study Help Explain Thousands of Unexpected Deaths from "Unknown Causes"

petermcculloughmd.substack.com

By Peter A. McCullough, MD, MPH

One of the most vexing questions in the epidemiology of COVID-19 vaccine death is: why are some people fine and others develop fulminant fatal syndromes? This leads to the next logical question: who is the next to die after COVID-19 vaccination? This is a question that parents of a 14-year old Japanese girl wished they would have asked before she rolled up her sleeve for her third BNT1262b2 mRNA COVID-19 vaccine/Pfizer (Comirnaty®) which was not medically necessary nor clinically indicated. In other countries it would not be offered and even the WHO says healthy children don’t need to risk COVID-19 vaccination.

The case was published by Nushida et al who explains the teenager was healthy and may have had POTS from the first two shots. For each of the first two shots she felt sick and missed school—that was a tip off the parents should have noted. After the third shot her sister noticed she was having trouble breathing and the next day she died. The investigators did a detailed analysis to rule out SARS-CoV-2 infection.

2.5% of Epileptics Experience Induced Seizures after 1st dose of Pfizer mRNA COVID-19 Vaccine

2.5% of Epileptics Experience Induced Seizures after 1st dose of Pfizer mRNA COVID-19 Vaccine

Recently published in the journal Epilepsy &amp; Behavior, Western Australia-based researchers affiliated with both the Western Australian Adult Epilepsy…

www.trialsitenews.com

Recently published in the journal Epilepsy & Behavior, Western Australia-based researchers affiliated with both the Western Australian Adult Epilepsy Service as well as the Fiona Stanley Hospital’s Neurology Department report based on a study that while generally COVID-19 vaccines are safe and well tolerated in persons with epilepsy (PWE) , vaccine-induced seizures can and do occur. In this study the Australia-based team assesses the occurrence of COVID-19 vaccine-related seizure exacerbations in epileptic patients. Overall they find that the risks associated with COVID-19 vaccines are less than SARS-CoV-2 infection, however the study finding raises complicated questions as the COVID-19 vaccines are not sterilizing vaccines, meaning the don’t necessary stop transmission.

Epilepsy in Western Australia

A massive chunk of Australia’s land area, the State of Western Australia takes 33% of the entire nation (over a million square miles) with just 2.8 million people with the majority residing in the Perth area (2.2 million).

Out of this population about 20,000 if not more persons are affected by epilepsy.

The Study

The study team recruited adult epileptic patients who received COVID-19 a tertiary epilepsy clinic between June 2021 and April 2022. This real-world study tracked a range of patient data, from demographics to epilepsy history, vaccination details and reported adverse events. The targeted endpoint for this study included an assessment of “seizure exacerbation was defined as occurring within one week post COVID-19 vaccination.

Reporting that 530 epileptic study participants received the COVID-19 vaccine, 75% received the Pfizer mRNA jab (Comirnaty or BNT162b2) as the first dose. A majority of the patients (72%) also were on taking ≥ 2 antiseizure medications (ASM) and had focal epilepsy (73 % ).

Furthermore about 33% of the participants were 12 months seizure free at their first vaccination.

The Findings

As reported by the authors represented by corresponding author Dr. Nicholas D Lawn, MBChB, FRACP, 13 patients (2.5 %) reported a seizure exacerbation following their first vaccination, three of whom required admission.

Lawn and team report no participants were seizure-free at baseline. Even more troubling, six of the PWE reporting seizure exacerbation experienced further exacerbation of seizures with the administration of the second vaccine dose.

Study Metrics

PWE with Exacerbation of Seizures after 1st mRNA Dose

%

13 out of 530

2.5%

PWE with Exacerbation of Seizures after 1st mRNA Dose; Further exacerbation after 2nd dose

6 out of the 13

46%

PWE with Exacerbation of Seizures only after second dose

4 out of 530

.75%

While the study authors downplay these results:

“Seizure exacerbations are infrequently associated with COVID-19 vaccination, mainly in patients with ongoing seizures. The likelihood of COVID-19 infection complications in PWE (epileptic patients) outweighs the risk of vaccination-related seizure exacerbations”

Meaning that according to the Western Australian physician-scientists the risks associated with epileptic seizures are higher with SARS-CoV-2 infection as compared to vaccination.

What’s the evidence the authors use to come to this conclusion?

The authors point to several studies including three from Germany, Kuwait and China reporting seizure exacerbation in 1.8 to 16% of patients.

See the table

Study Title

Summary

R. von Wrede, J. Pukropski, S. Moskau-Hartmann, R. Surges, T. Baumgartner

COVID-19 vaccination in patients with epilepsy: First experiences in a German tertiary epilepsy center

Our data suggest that vaccination against COVID-19 appears to be well tolerated in PWE, supporting the recommendation of vaccination to PWE.

F. Massoud, S.F. Ahmad, A.M. Hassan,

K.J. Alexander, J. Al-Hashel, M. Arabi Safety and tolerability of the novel 2019 coronavirus disease (COVID-19) vaccines among people with epilepsy (PWE): A cross-sectional study

his study shows that the two vaccines under consideration (BNT162b2 and ChAdOx1nCoV-19)

have a good safety profile and a low risk of epilepsy worsening among a cohort of PwE in Kuwait.

L.u. Lu, Q.i. Zhang, J. Xiao, Y. Zhang,

W. Peng, X. Han, et al.

COVID-19 vaccine take-up rate and safety in adults with epilepsy: Data from a multicenter study in China

The vaccine uptake rate in people with epilepsy was lower than in their same?age controls. The postvaccination effect was no higher than in controls. We found no evidence suggesting worsening seizures after vaccination. Measurement and education focused on increasing the vaccination rate in epilepsy are warranted.

The authors report “Specific groups of PWE may differ in their vulnerability, for example, a study of 120 patients with Dravet Syndrome found 13 % of patients had a self-reported vaccine-associated seizure exacerbation.” See the link.

So, are epileptic patients (PWE) more likely to develop severe complications from COVID-19—including the requirement for mechanical ventilation, ICU admission and death? Yes, the study authors point to literature supporting this claim:

Study Title

Summary

J. Yoo, J. Kim, J. Jeon, J. Kim, T. Song

Risk of COVID-19 Infection and of Severe Complications Among People With Epilepsy: A Nationwide Cohort Study

The presence of epilepsy was not associated with increased susceptibility to COVID-19 infection or mortality related to the infection. However, there was an increased risk of severe complications with COVID-19 in patients with epilepsy; therefore, careful management and monitoring may be necessary

P. Cabezudo-García, N.L. Ciano-Petersen, N. Mena-Vázquez, G. Pons-Pons, M.V. Castro-Sánchez, P.J. Serrano-Castro

Incidence and case fatality rate of COVID-19 in patients with active epilepsy

COVID-19 cumulative incidence was higher in patients with active epilepsy. Epilepsy was associated with fatality during hospitalization. Hypertension was associated with fatality in patients with epilepsy

Interestingly the authors point out that “COVID-19 may not worsen seizures in PWE directly, seizures can be triggered by fevers or other systemic factors, as with other infections.” See the link.

The authors further argue that COVID-19 “may be associated with hypoxia, stroke, systemic inflammatory response syndrome, and encephalitis, all capable of precipitating acute symptomatic seizures in already vulnerable patients ” See the link.

What are study limitations?

The authors report the following limitations that could influence study results:

Most patients in this study had relatively refractory epilepsy, typical of a tertiary hospital epilepsy clinic and they note that actual risk of vaccine-associated seizure exacerbations in the general population of PWE could be lower than the current patient cohort.

A comparison to assess spontaneous fluctuations in seizure frequently wasn’t possible with this study

The study team could only compare seizure exacerbation post-vaccination with each patient’s historical baseline seizure frequencies prior to their vaccination.

Majority of the patients received Pfizer-BioNTech Comirnaty thus limiting generalizability of the findings to other COVID-19 vaccines

Recall bias is a risk associated with this study

About Western Australian Adult Epilepsy Service

Part of the Department of Health for the Government of Western Australia, the Western Australian Epilepsy Service operates out of the Sir Charles Gairdner Hospital. Originally housed at the Royal Perth Hospital, the service was moved to centralize clinical expertise and resources, as part of the State Centre for Neurosciences based at the Queen Elizabeth II Medical Center.

Lead Research/Investigator

Nicholas D Lawn, MBChB, FRACP, Western Australian Adult Epilepsy Service; Fiona Stanley Hospital, Neurology Department

Other authors can be viewed at the source

Call to Action: Follow the link to journal Epilepsy & Behavior.

References

COVID-19 vaccination-related exacerbation of seizures in persons with epilepsy

Although vaccines are generally safe in persons with epilepsy (PWE), seizures can be associated with vaccination, including COVID-19. This study asses…

www.sciencedirect.com

RNA gene therapy (vaxxine) and pregnancy:: https://maryannedemasi.substac…tever-happened-to-pfizers

Pfizer’s official product labelling information for pregnant women refers only to animal studies, stating “No vaccine-related adverse effects on female fertility, fetal development, or postnatal development were reported”.

Unlike Pfizer, Moderna kept its pregnant rodents alive to test the embryos. Documents accessed by Judicial Watch, showed a “statistically significant” number of rats were born with skeletal variations after being injected with Moderna’s mRNA vaccine.

Judicial Watch: FDA Records Show Significant Number of mRNA Test Rats Born with Skeletal Deformations - Judicial Watch

(Washington, DC) – Judicial Watch announced today that it received 699 pages of records from the Department of Health and Human Services (HHS) regarding data…

www.judicialwatch.org

A balanced overview:: https://swprs.org/covid-vaccines-facts-fears-fraud/

Covid Vaccines: Facts, Fears, Fraud

Once more India.. The vaccine killer state Kerala (1801) still has about 40x more Omicron cases than the Ziverdo state Uttar Pradesh(318)..

Kerala has 7x less population...

japan spikecine 14 yr old victim

14-Year-Old Japanese Girl Dies From Multiple Organ Inflammation, Myopericarditis 45 Hours After COVID Booster - Vision Times

A 14-year-old Japanese girl died 45 hours after taking Pfizer's COVID-19 booster vaccine with multiple organ inflammation and myopericarditis.

www.visiontimes.com

fda director" take the jab to save your life"

Healthcare in America, does it exist at all?

Maternal Mortality Rates in the United States, 2021

https://www.cdc.gov/nchs/data/…20.1%20in%202019%20(Table).

This report presents maternal mortality rates for 2021 based on data from the National Vital Statistics System. A maternal death is defined by the World Health Organization as “the death of a woman while pregnant or within 42 days of termination of pregnancy, irrespective of the duration and the site of the pregnancy, from any cause related to or aggravated by the pregnancy or its management, but not from accidental or incidental causes” (1). Maternal mortality rates, which are the number of maternal deaths per 100,000 live births, are shown in this report by age group and race and Hispanic origin.

This report updates a previous one that showed maternal mortality rates for 2018–2020 (2). In 2021, 1,205 women died of maternal causes in the United States compared with 861 in 2020 and 754 in 2019 (2). The maternal mortality rate for 2021 was 32.9 deaths per 100,000 live births, compared with a rate of 23.8 in 2020 and 20.1 in 2019 (Table).

In 2021, the maternal mortality rate for non-Hispanic Black (subsequently, Black) women was 69.9 deaths per 100,000 live births, 2.6 times the rate for non-Hispanic White (subsequently, White) women (26.6) (Figure 1 and Table). Rates for Black women were significantly higher than rates for White and Hispanic women. The increases from 2020 to 2021 for all race and Hispanic-origin groups were significant.

Shining a spotlight on the maternal health crisis in the United States

The number of women who die giving birth in America each year has nearly doubled in the last two decades.

THE UNITED STATES IS THE ONLY HIGH-RESOURCE COUNTRY WITH A CONSISTENTLY RISING MATERNAL MORTALITY RATE.

Danish Bombshell: Three Levels of Pfizer mRNA Vax Batches with Various Association to SAEs, Including Deaths

Danish Bombshell: Three Levels of Pfizer mRNA Vax Batches with Various Association to SAEs, Including Deaths

A trio of Danish researchers led by high powered physician-investigator Peter Riis Hansen, Department of Cardiology, Copenhagen University Hospital-Herleve and…

www.trialsitenews.com

A trio of Danish researchers led by high powered physician-investigator Peter Riis Hansen, Department of Cardiology, Copenhagen University Hospital-Herleve and Gentofe recently had a research letter published in peer reviewed journal European Journal of Clinical Investigation. Titled “Batch-dependent safety of the BNT162b2 mRNA COVID-19 vaccine,” the investigators found three groupings of Pfizer-BioNTech COVID-19 vaccination batches with low, medium and high rates of adverse events. According to TrialSite contributor Dr. David Wiseman, “Is this modRNA degradation or DNA contamination.” The findings may correspond to Sasha Latypova contributions to TrialSite concerning various levels of vaccine safety associated with batches.

Background

By November 2022, 701 million doses of the Pfizer-BioNTech vaccine are linked to 971,021 suspected adverse events (SAEs) in the European Union. The authors point out that “vaccine vials with individual doses are supplied in batches with stringent quality control to ensure batch and dose uniformity.” They noted that at the individual vaccine batch level, clinical data was never reported and that a scenario “highly unlikely” would be “batch-dependent variation in clinical efficacy and safety of authorized vaccines.” Yet the prospect of investigation into “batch dependent variation” was worthy of investigation, according to the authors. Hence the study, an investigation into SAEs between the different Pfizer-BioNTech batches administered across Denmark and its 5.8 million people from December 2020, to January 11, 2022. This inquiry was possible because all SAE cases are linked with corresponding vaccine batch labels reported to and classified by the Danish Medical Agency according to seriousness of SAE as well as numbers of Pfizer-BioNTech doses in individual vaccine batches registered by the Danish Serum Institute. This data is publicly available if requested.

The study

By linking individual SAES to the batch label(s) of Pfizer-BioNTech dose(s) administered by subject, the authors could report on SAEs at the batch level in Denmark.

They divided total number of SAEs associated by batch by the number of doses in the batch to obtain the rate of SAEs per 1000 doses. They could not apply conventional regression statistics due to the significant heterogenous aspect to the observed relationship between number of SAEs and Pfizer-BioNTech vaccine doses. Rather, the authors employed use of non-hierarchical cluster analysis and general linear model (GLM) test for differences in SAE rates between batches, with reporting conforming to the EQUATOR guidelines.

So, what did they find?

52 different BNT162b2 batches was associated with 7,835,280 doses administered to 3,748,215 persons (2340-814,320 doses per batch), and 43,496 SAEs were registered in 13,365 persons which came to 3.19 ± 0.03 (mean ± SEM) SAEs per person. “In each person, individual SAEs were associated with vaccine doses from 1.531 ± 0.004 batches resulting in a total of 66,587 SAEs distributed between the 52 batches.”

The authors had to further analyze 61,847 batch-identifiable SAEs because batch labels were not fully registered or even missing for a total of 7.11% of all Danish SAEs. Out of this analysis 14,509 (23.5%0 were classified as severe SAEs with 579 (0.9%) involving SAE-related deaths.

Vaccine-related SAEs per 1000 doses varies between batches which was an unexpected find for the Danish authors. They reported “2.32 (0.09–3.59) (median [interquartile range]) SAEs per 1000 doses, and significant heterogeneity (p < .0001) was observed in the relationship between numbers of SAEs per 1000 doses and numbers of doses in the individual batches.”

As Wiseman recently noted, the authors found three groupings of Pfizer-BioNTech COVID-19 vaccination batches with low, medium and high rates of adverse events. The authors noted:

“Compared to the rates of all SAEs, serious SAEs and SAE-related deaths per 1.000 doses were much less frequent and numbers of these SAEs per 1000 doses displayed considerably greater variability between batches, with lesser separation between the three trendlines.”

They further identified:

“The observed variation in SAE rates and seriousness between BTN162b2 vaccine batches in this nationwide study was contrary to the expected homogenous rate and distribution of SAEs between batches.”

Limitations

The authors identified limitations with this research letter, which include the following:

Potential for reporting bias given the Danish adverse event reporting system is a passive system, much like Vaccine Adverse Event Reporting System (VAERS) in the USA—potential for both under and over reporting although in USA the CDC and experts in past have suggested underreporting more common.

Incomplete data associated with inputs

Data quality variability

A whole series of questions associated with SAEs not analyzed (specific types, demographics of SAEs, relationship of SAEs with consecutive vaccine doses, temporal trends, etc.

The authors point out that any such signals associated with these reporting systems must be considered hypotheses and not actual causality scenarios.

Riis Hansen and colleagues point out that the “Danish Serum Institute has not issued recalls of BNT162b2 vaccine batches.”

Conclusion

The authors point out that their analysis “suggests the existence of a batch-dependent safety signal for the BNT162b2 vaccine” however further investigation is recommended to further explore both A) the preliminary observation and B) consequences

https://onlinelibrary.wiley.com/doi/10.1111/eci.13998

Civil Society Group in Canada Intensifies Its Investigation Into COVID-19: Was Pandemic Convenient Excuse for Government Overreach?

Civil Society Group in Canada Intensifies Its Investigation Into COVID-19: Was Pandemic Convenient Excuse for Government Overreach?

Canada&rsquo;s Nationwide Citizens Inquiry (NCI) continues a private, civic society investigation into the COVID-19 response organize and led by that…

www.trialsitenews.com

Canada’s Nationwide Citizens Inquiry (NCI) continues a private, civic society investigation into the COVID-19 response organize and led by that country’s national government. Afterall, this is the country that initially had no real strategy for COVID-19 vaccination, depending on a deal with China’s CanSino Biologics, which ultimately failed miserably. Canada, traditionally a solid long-time partner of the United States surprisingly did not participate in Operation Warp Speed initiated by former President Donald Trump. This week the group will continue to conduct hearings this time in Winnipeg this Thursday, April 13, 2023. A group of prominent expert witnesses will offer their point of view, analysis and testimony. The country’s majority political class used the pandemic has a means to tighten their grip on power. For example, during the well-publicized trucker protests, persons who contributed financially to those grassroots, political protests in some cases had their bank accounts frozen. Prime Minister Justin Trudeau enacted the Canadian Emergencies Act, arguing it wasn’t overreach given the mounting crisis across the country. On the other hand, an alternative point of view suggests Trudeau’s actions caused a breakdown in government, and Civil Liberties groups have claimed the use of the Emergencies Act was an abuse of government power.

NCI is a Canada-wide citizen-led and citizen-funded initiative to investigate governments’ COVID-19 policies in a fair and impartial manner that is completely independent from government. Through questioning led by lawyers, individual Canadians and experts will present evidence under oath to Independent Commissioners. The first six days of hearings were held in Truro, NS and Toronto, ON.

These expert witnesses include:

Natalie Bjorklund Gordon – Geneticist and Epidemiologist

Stephen Theriault – Medical microbiologist

Jessica Rose – Expert on the VAERS data

Staff Sgt Rick Abott – Edmonton Police Officer

Jay Bhattacharya – Professor of Medicine at Stanford, co-author The Great Barrington Declaration

Jeffrey Tucker – Founder of the Brownstone Institute

Deanne McLeod – Medical Researcher

Charley Hooper – Researcher on Early Covid Treatment

The Winnipeg hearings, from 9:00 am to 5:00 pm Central, will be broadcast live on the NCI website and on the NCI Rumble Channel. Follow the NCI on social media: https://twitter.com/Inquiry_Canada and https://www.facebook.com/NationalCitizensInquiry

The Winnipeg venue is Holiday Inn Winnipeg – Airport West, 2520 Portage Ave., Winnipeg, MB R3J 3T6 Ph. (204) 885-4478

The conference organizations report that due to limited space in the room, the public is asked to arrange for access through Eventbrite.

Members of the media are asked to provide identification to NCI volunteers on site to obtain access. Prior notification of attendance to [email protected] will assist in assuring seating.

NCI spokesperson, Michelle Leduc Catlin, will be at the hearings and is a contact for assistance.

Other hearings are planned in other locations across this vast country to the north of the U.S.

Hearings will follow in:

Saskatoon, Saskatchewan, from April 20 to 22

Red Deer, Alberta, from April 26 to 28 Further hearings are scheduled for Vancouver, Quebec, and Ottawa.