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FDA Rubber-Stamps Remdesivir for Infants Without Evidence of Safety, Efficacy

By Madhava Setty, M.D. | The Defender | April 27, 2022

The U.S. Food and Drug Administration (FDA) on Monday approved the use of the antiviral therapy, remdesivir, to treat COVID-19 in infants four weeks and older.

Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a press release:

“As COVID-19 can cause severe illness in children, some of whom do not currently have a vaccination option, there continues to be a need for safe and effective COVID-19 treatment options for this population.

“Today’s approval of the first COVID-19 therapeutic for this population demonstrates the agency’s commitment to that need.”

According to the press release, the FDA’s decision to approve the therapy, marketed under the name Veklury, is supported by a clinical study conducted on infants 4 weeks and older weighing a minimum of 6.6 pounds.

The study is underway and will not be completed until February 2023. There are no published results.

However, Gilead Sciences, maker of remdesivir and sponsor of the study, provided the following details in a company press release:

  • A total of 53 hospitalized pediatric patients were enrolled in the clinical study.
  • 72% suffered adverse events.
  • 21% suffered serious adverse events determined to be unrelated to the drug.
  • Three children died from either underlying conditions or COVID-19.

Nevertheless, Gilead Science assured that “no new safety signals were apparent for patients treated with Veklury.”

The study was of single-arm, open-label design.

A single-arm study has no control group, making it impossible to compare its effectiveness against standard of care.

Open-label means participants and investigators were aware they were receiving the drug, making it impossible to separate placebo from drug effect.

Studies show little or no benefit

Beyond the absence of any publicly available data on the efficacy and safety of this drug in humans of this age, available studies on older subjects indicate remdesivir offers no more than a meager benefit to those who survive its use.

In fact, this is why the World Health Organization (WHO) in November 2020 recommended against the use of remdesivir to treat COVID-19. The WHO only recently (April 22, 2022) updated its recommendation to support the drug’s use in patients who are at high risk for hospitalization.

Nevertheless, the FDA explains its long-standing support of remdesivir use in adults here, citing six studies that had the greatest impact on the agency’s position.

Here is a summary of the findings of each study from the FDA’s webpage:

  1. ACTT-1 Trial: Time to clinical recovery was shortened from 15 days to 10 through the use of remdesivir. There was no difference in mortality. The drug was no better than placebo when administered to patients who required high-flow oxygen, non-invasive respiratory support, mechanical ventilation or extracorporeal membrane oxygenation at baseline. A benefit was seen only in patients who required low levels of supplemental oxygen.
  2. Discovery Trial: There was no clinical benefit of remdesivir in hospitalized patients who were symptomatic for >7 days and who required supplemental oxygen. There was no difference in mortality between remdesivir and standard of care. Investigators judged three of 429 participants who received remdesivir died from the drug.
  3. WHO Solidarity Trial: Remdesivir did not decrease in-hospital mortality or the need for mechanical ventilation compared to standard of care. Four hundred and forty patients in this study were also enrolled in the Discovery trial above.
  4. Journal of the American Medical Association (moderate disease): After 10 days of treatment with remdesivir, clinical status was not significantly different from standard of care.
  5. New England Journal of Medicine (severe disease): No difference between five and 10 days of remdesivir treatment. No placebo group, thus “the magnitude of benefit cannot be determined.”
  6. PINETREE study: Three consecutive days of IV remdesivir resulted in an 87% relative reduction in the risk of hospitalization or death when compared to placebo.

As demonstrated, the first five studies used to justify the FDA’s approval of remdesivir showed little, if any, benefit to hospitalized patients with moderate or severe disease.

This is in contrast to the sufficiently proven benefit of off-label use of the previously licensed medications hydroxychloroquine and ivermectin.

Only the PINETREE study investigated the benefit of remdesivir for outpatient use. In that study, the drug provided a substantial benefit in preventing hospitalization when given in three separate doses over three days.

However, only eight individuals under the age of 18 were enrolled in the study, and none were younger than 12.

The primary endpoint, a composite of COVID-19-related hospitalization or death from any cause, did not occur in the under-18 group.

In other words, the study — funded by Gilead Sciences — showed the drug offered no benefit in this cohort.

Nevertheless, in reporting on the FDA’s approval of remdesivir for infants and young children, CNN found someone to support the FDA’s decision.

CNN wrote:

“The FDA’s approval of remdesivir for young children is ‘great,’ said Dr. Daniel Griffin, an instructor in clinical medicine and associate research scientist in the Department of Biochemistry and Molecular Biophysics at Columbia University.”

Safety ‘not established’ in pediatric patients

Not only is there scant evidence that remdesivir is an effective treatment for COVID-19, the drug’s safety is debatable.

With regard to its use in infants, even the FDA must acknowledge nobody knows how safe it is.

After all, the manufacturer’s label states:

“The safety and effectiveness of VEKLURY (remdesivir) have not been established in pediatric patients younger than 12 years of age or weighing less than 40 kg.”

With regard to pharmacokinetics (where the drug distributes in the body) the label states:

“The pharmacokinetics of VEKLURY in pediatric patients have not been evaluated.”

An indictment of the drug regulatory process

Let’s reflect on what the director of the FDA’s Center for Drug Evaluation and Research said regarding the approval of remdesivir for treating COVID-19 in infants 4 weeks and older:

“As COVID-19 can cause severe illness in children, some of whom do not currently have a vaccination option, there continues to be a need for safe and effective COVID-19 treatment options for this population. Today’s approval of the first COVID-19 therapeutic for this population demonstrates the agency’s commitment to that need.”

To summarize:

  • Some children do not have a vaccination option.
  • They need a safe and effective treatment.
  • The FDA meets that need by approving a drug with no safety and efficacy record in children.

Safety and efficacy apparently can be conveniently established by fiat, not evidence.

In the end, the FDA’s approval of remdesivir is not an assurance of the drug’s safety and efficacy but an indication the agency is no longer interested in protecting the public from potentially harmful and ineffective therapies — or, in other words, in doing its job.

There will undoubtedly be doctors like Griffin who welcome this approval.

However, I don’t believe every pediatrician will accept the FDA’s guidance so readily.

It’s not easy to place an intravenous line to administer remdesivir in the tiny vein of an irritable baby coming from home with a positive rapid test. And then do it again the next day. And the day after that.

At some point, clinicians’ sensibilities will be challenged enough to compel them to actually examine how the FDA arrived at its conclusions.

Guidelines are meaningless if doctors choose not to abide by them.

Madhava Setty, M.D. is senior science editor for The Defender.

© 2022 Children’s Health Defense, Inc. This work is reproduced and distributed with the permission of Children’s Health Defense, Inc. Want to learn more from Children’s Health Defense? Sign up for free news and updates from Robert F. Kennedy, Jr. and the Children’s Health Defense. Your donation will help to support us in our efforts.

April 27, 2022 Posted by | Mainstream Media, Warmongering, Science and Pseudo-Science, War Crimes | , , , | Leave a comment

Denmark Suspends COVID Vaccine Campaign, EU Set to End Mass Testing

By Michael Nevradakis, Ph.D. | The Defender | April 27, 2022

Denmark on Tuesday became the first country to suspend its national COVID-19 vaccine campaign after health officials said the pandemic is under control there.

Bolette Soborg, director of the Danish Health Authority’s department of infectious diseases, on Tuesday said Denmark is “winding down” the mass vaccination program, and that invitations for vaccinations would no longer be issued after May 15.

“We plan to reopen the vaccination programme in the autumn,” Soborg said, adding: “This will be preceded by a thorough professional assessment of who and when to vaccinate and with which vaccines.”

Public health authorities cited several factors contributing to the decision to end the national vaccination campaign. These include a decline in the number of new reported infections, stabilized hospitalization rates and an overall high level of vaccination.

This decision comes just a few months after Denmark eliminated all COVID-19-related restrictions, becoming the first European Union (EU) member state to do so.

On February 1, the country dropped restrictions ranging from vaccine passports to mask mandates. Public health authorities at the time said COVID-19 was no longer considered a critical threat to public health.

Despite a “surge” in reported infections in Denmark, attributed to the Omicron variant, health authorities said these cases are not placing a heavy burden on the country’s health system.

Denmark’s health authorities are the first to explicitly state that future COVID-19 vaccination drives will be targeted, rather than universal.

EU set to announce ‘post-emergency’ phase of pandemic, Fauci says U.S. out of ‘pandemic phase’

Denmark’s decision comes as several other countries appear to be walking back mass-scale COVID-19 vaccination and related public health initiatives.

In an interview Tuesday on PBS NewsHour, Dr. Anthony Fauci said, “We [the United States] are certainly right now in this country out of the pandemic phase.”

However, when asked whether there will be an end to the COVID-19 pandemic, he said that’s “an unanswerable question.”

In the U.K., the country’s Health Security agency this week announced it is slashing its staff by almost half, and reducing its COVID-19 budget by nearly 90% compared to 2021 levels.

And the European Commission — the executive branch of the EU — is reportedly preparing to announce the EU has entered a new “post-emergency phase” of the COVID-19 pandemic, Reuters reported today, citing a draft document the news agency said it reviewed.

Despite there being no official statements yet from EU officials, according to Reuters, the draft document, prepared by EU Health Commissioner Stella Kyriakides, states:

“This Communication puts forward an approach for the management of the pandemic in the coming months, moving from emergency to a more sustainable model.”

In practical terms, this would mean an end to mass COVID-19 testing, already shut down in several EU countries.

This approach contrasts with China’s “zero-COVID” policies — which have resulted in mass testing and a renewed wave of mass lockdowns.

In a possible reflection of the EU’s new policy direction — and its stark differentiation from China’s COVID policies — Greek health minister Thanos Plevris said recently “we are entering the phase of co-existing with COVID … we don’t believe in the zero-COVID policy, like in China.”

According to Reuters, the EU’s draft document is non-binding on member-states and states that “COVID-19 is here to stay,” with a likely emergence of new variants and “surges,” necessitating that “vigilance and preparedness remain essential.”

The document asks EU governments to be ready to re-enact emergency measures if deemed necessary, though the nature of these “emergency measures” does not appear to be specified.

However, the draft document does address the introduction of more sophisticated means of detecting outbreaks of — and the spread of — COVID-19, highlighting that “[t]argeted diagnostic testing should be put into place.”

Such “targeted” testing would focus on “priority groups,” such as people close to outbreaks, those at risk of developing severe COVID-19 symptoms and medical staff who are in regular contact with vulnerable populations.

The draft document also suggests surveillance and tracking of COVID-19 infections should be adapted and targeted, focusing more on genomic sequencing and less on the mass reporting of “cases.”

This new surveillance system would amount to one that, according to Reuters, is “similar to that used to monitor seasonal flu, in which a limited number of selected healthcare providers collect and share relevant data.”

As reportedly stated by the document, “[t]he objective of surveillance should no longer be based on the identification and reporting of all cases, but rather on obtaining reliable estimates of the intensity of community transmission, of the impact of severe disease and on vaccine effectiveness.”

However, unlike Denmark’s approach, the document states that vaccines remain essential, with a recommendation that EU member states consider enacting strategies to bolster vaccination levels among children age 5 and up prior to the start of the new school year.

Some EU member states, such as Greece, have strongly hinted wide-scale COVID-19 vaccinations and restrictions may resume in September.

Michael Nevradakis, Ph.D., is an independent journalist and researcher based in Athens, Greece.

© 2022 Children’s Health Defense, Inc. This work is reproduced and distributed with the permission of Children’s Health Defense, Inc. Want to learn more from Children’s Health Defense? Sign up for free news and updates from Robert F. Kennedy, Jr. and the Children’s Health Defense. Your donation will help to support us in our efforts.

April 27, 2022 Posted by | Aletho News | , , | Leave a comment

Corruption of Language, Corruption of Thought

With a brief discourse on totalitarian regimes and conspiracy theories

By Aaron Kheriaty, MD | April 27, 2022

In his classic dystopian novel 1984, George Orwell famously wrote, “If you want a picture of the future, imagine a boot stamping on a human face—for ever.” This striking image served as a potent symbol for totalitarianism in the 20th Century. But as Caylan Ford recently observed, with the advent of digital health passports in the emerging biomedical security state, the new symbol of totalitarian repression is “not a boot, but an algorithm in the cloud: emotionless, impervious to appeal, silently shaping the biomass.” The new forms of repression will be no less real for being virtual rather than physical.

These new digital surveillance and control mechanisms will be no less oppressive for being virtual rather than physical. Contact tracing apps, for example, have proliferated with at least 120 different apps in used in 71 different states, and 60 other digital contact-tracing measures have been used across 38 countries. There is currently no evidence that contact tracing apps or other methods of digital surveillance have helped to slow the spread of covid; but as with so many of our pandemic policies, this does not seem to have deterred their use.

Other advanced technologies were deployed in what one writer has called, with a nod to Orwell, “the stomp reflex,” to describe governments’ propensity to abuse emergency powers. Twenty-two countries used surveillance drones to monitor their populations for covid rule-breakers, others deployed facial recognition technologies, twenty-eight countries used internet censorship and thirteen countries resorted to internet shutdowns to manage populations during covid. A total of thirty-two countries have used militaries or military ordnances to enforce rules, which has included casualties. In Angola, for example, police shot and killed several citizens while imposing a lockdown.

April 27, 2022 Posted by | Civil Liberties, Full Spectrum Dominance, Timeless or most popular | , | Leave a comment

New Zealand Used Selective Science and Force to Drive High Vaccination Rates

By J.R. Bruning | Brownstone Institute | April 26, 2022

We expect that knowledge produced and applied in a health emergency will produce information that is protective of health. But it is increasingly apparent that over the last two years New Zealand’s Ardern government has designed policy, regulation, and information to coercively steward citizens to accept a drug under provisional consent.

Strict lockdowns were promised to end when 90% of the population was vaccinated. This was unprecedented: policy endpoints required population-level uptake of novel technology, no matter whether the individual was at risk or not.

In addition, data production was contracted by the department intent on a 90% vaccination rate. For decades governments have promoted ‘evidence-based science’ as the gold standard for public reasoning and risk deliberation. What we saw was internally produced and contracted science that focused on case rates, while (inconvenient) information in the published scientific literature on vaccine risk, waning and breakthrough was ignored.

This produced a tightly controlled scope of knowledge production that then failed to adhere to long-established democratic and public health principles. Responsible risk governance requires that governments must be responsive to data that indicates a technology is not as effective or is possibly more harmful than estimated, – for a democratic government’s primary role is the protection and safety of all citizens. Technology must not be valorized, and uncertainty set aside, in order to achieve policy ends.

Universal Vaccination Assumed from April 2021

New Zealand’s Unite Against Covid-19 ‘elimination’ strategy was confirmed in the first quarter of 2020. Policy, propaganda and legislation predominantly centred around the case, or infection rate, rather than the fatality rate as the measure of risk.

Even though the clinical trials did not demonstrate that the vaccine prevented transmission and infection, the Government promoted ‘the jab’ as a way to protect families in the Unite Against Covid-19 campaign. Persistent reporting of case rates fostered a perpetual state of fear and uncertainty among the population, who perceived infection from the SARS-CoV-2 virus to be something more like Ebola.

The Ardern government’s intention for the entire population to get the mRNA vaccine was declared through the signing of a supply agreement. This intention was then embedded in policy and regulation via the Traffic Light system, designed to nudge the population over 12 into compliance.

It was known by July 2021 that the vaccine waned and was leaky. Breakthrough infections were relatively common and for many. The clinical trials remain incomplete, lacking long-term safety data. The trials did not demonstrate that the vaccine prevented hospitalization and death.

However, in April 2022 in New Zealand, mandatory vaccinations remain compulsory for border workers, and workers in health and disability; corrections; defence; Fire and Emergency New Zealand (FENZ) and Police. These professions must be vaccinated and have received a booster vaccination against COVID-19.

At ‘Traffic Light Orange’ Kiwis ‘must wear a face mask’ in retail businesses, on shared and public transport, in government facilities and when visiting a healthcare service. This is despite the fact that Omicron ripped through New Zealand in February.

In the first week back at school and university after the summer holidays –the obedient mask-wearing young friends of my kids, including my son, from Otago and Canterbury down on the South Island up to the capital Wellington and Auckland – were locked down with Omicron in their first weeks back at university. No evaluation of Omicron and mask efficacy has been provided by the state.

The Risk Modellers

Government policy processes have persistently excluded uncomfortable knowledge that suggested uncertainty or risk. First, the policy accompanying and justifying Covid-19 legislation and Orders, and modelling by the contracted institution Te Pūnaha Matatini (TPM) contained narrow reasoning central to the state’s claims, locking in the narrative that infection was the predicator of risk, modelling wave after wave of infection.

Second, policy supporting the legislation excluded consideration of age-stratified risk and failed to address common principles of infectious disease management embedded in the New Zealand Health Act. Third, reviews of the scientific literature that could publicly identify and communicate risk relating to vaccine-related harm and issues relating to efficacy simply never occurred.

The gaps are considerable. The Government’s Covid-19 Unite campaign failed to communicate age-stratified risk of hospitalization and death as the pandemic evolved. New evidence on infection fatality rates were not reported to the public. In modelling papers, TPM used old infection fatality rate statistics that overestimated death rates.

The potential for the vaccine to wane or for breakthrough infection to occur was ignored in a major policy paper focussed on elimination and by the modellers at TPM. The role of natural infection in producing a broader, and protective structural response, assisting populations to shift to herd immunity status was downplayed. While herd immunity was recognized, testing and data modelling was undertaken to identify naturally derived herd immunity in the population. Later modelling exclusively associated herd immunity with vaccination.

Perhaps the problems addressed here are not surprising, when most modelling was undertaken outside of New Zealand’s public health institutions. Instead, number-crunching was carried out by data analysts, mathematicians affiliated with TPM, with scarce few infectious disease epidemiologists trained in public health ethics participating. And of course, the science and data modelling were directly funded by the government departments and Ministries dedicated to over 90% vaccine compliance.

Global vaccination policies ignored the fact that infection-related risk always centered on the aged and infirm and those with complex multimorbid conditions. Disconcertingly, the clinical trial data had conceded that vaccine efficacy remained uncertain for the most at-risk of harm from Covid-19 – the immunocompromised, autoimmune and people who were frail, and those with inflammatory conditions (see p.115). In addition, as coronaviruses readily mutate, it was highly probable the vaccine would have a short shelf life.

Early Treatments Sidelined

Governments are entrusted with an overarching obligation to protect health – this includes putting populations directly at risk through bad policy. There was always a role for safe, established drugs with a long history of safe use that had undergone complete testing before launching onto the market.

Early treatments could have been integrated as a major tool to prevent hospitalisation and death. Early treatments avoid the dilemma of mutating variants while acting to protect at-risk groups whose immune systems might not be as responsive to a vaccine.

Conventionally doctors are at liberty to repurpose drugs for their patients, such as antivirals with a long history of safe use. However, in July 2021, the government locked in approved drugs for treatment.

From at least October, New Zealand doctors were instructed to ‘not use any other antiviral outside of a clinical trial’ while Medsafe warned against use of the safe antiviral Ivermectin for a respiratory virus. Yet the clinical guidelines were intended as last resort medicine for the hospitalized, rather than designed as protective nor preventative at home therapies.

These directives have fractured the practice of informed consent, which forms the basis of trust in the doctor-patient relationships. Even the New Zealand Medical Council, the organisation that grants licences to practice medicine, declared that there was ‘no place for anti-vaccination messages in professional practice.’ These actions may unwittingly undermine trust in vaccines and the doctor-patient relationship for years to come.

The implications of silencing doctors, some who have had their medical licenses suspended, when observed alongside the above-mentioned data gaps, are extraordinary.

Ethical questions continue to be sidelined. The principle of proportionality, embedded in the 1956 Health Act, has been effectively dropped. Proportionality, which allows for individual risk, is a core consideration in public health. Medicine is a technology, and the space where biology meets technology – including medicine – is never constant, and requires value-based judgement. Risk management of a medical intervention for a pregnant woman, young person or child requires significantly different deliberation to a 75-year-old.

Democratically Unaccountable Legislation

Since January 2020, a tsunami of rights-limiting has been rolled out purposefully and consistently. There was scant citizen consultation with public input limited to a few short days in most cases. The unprecedented barrage of rules and orders released by the Ardern government entrenched requirements for almost everybody to get the mRNA vaccine.

By mid-2021 – before most mandates – the scientific literature was revealing that the vaccine waned; that breakthrough infection occurred and that there was extensive evidence that it produced a wide range of side effects, and even death. This knowledge should have invalidated any workforce vaccine mandate, but instead by October, the state doubled down and locked in mandates and regulations that would legally and socially coerce most of the population over 12 into accepting the shot.

It’s probable that the mountain of legislation produced over the last two years never fulfilled democratic norms of accountability and transparency. For science in a pandemic to be harnessed to serve the public interest, the institutions that set those terms of reference must be guided by principles that protect health.

The failure of government agencies to draw on peer-reviewed scientific literature while prioritizing internal modelling is clear from tracking the literature stored online with the relevant agencies. Most compellingly, it is documented in the policy supplied in support of the unprecedented quantity of law-making.

It appears that from late 2019, institutional interests anticipated that there would be hesitancy around vaccine safety. Yet there was no public forum. Instead, groups who sought to question the safety of the novel mRNA vaccine remained outside ‘accredited’ media, possibly due to the chilling effect of unprecedented Covid-19 funding and advertising boosts which effectively captured mainstream media.

That the New Zealand state mandated not-at-risk people accept a novel technology, creating rules (as nudge policies) that limited economic and social life for the non-vaccinated when there was early evidence the vaccine was leaky and potentially harmful, will take years to unpick. As mandates continue, injured groups continue to face barriers to justice following vaccine injury and death.

Ultimately, practices such as this raise nagging doubts concerning the state’s capacity to honor broader obligations to protect health and the public interest in future emergency situations. New Zealand’s response to the Covid-19 pandemic serves as a case study – a precedent, for future health emergencies.

A deeper dive on this discussion can be found in the paper, Covid-19 Emergency Powers and on Rumble. The paper is offered to assist academic and legal experts, citizens and communities to consider use of policy and science by the Ardern Government from 2020-2022. I question the potential for the New Zealand state to navigate future pandemics, and future techno-controversies, in the public interest.

J.R. Bruning is a consultant sociologist (B.Bus.Agribusiness; MA Sociology) based in New Zealand. Her work explores governance cultures, policy and the production of scientific and technical knowledge. Her Master’s thesis explored the ways science policy creates barriers to funding, stymying scientists’ efforts to explore upstream drivers of harm. Bruning is a trustee of Physicians & Scientists for Global Responsibility (PSGR.org.nz). Papers and writing can be found at TalkingRisk.NZ and at JRBruning.Substack.com and at Talking Risk on Rumble.

April 26, 2022 Posted by | Civil Liberties, Full Spectrum Dominance, Science and Pseudo-Science, War Crimes | , , , | Leave a comment

They just won’t let go of masks

By Guy Hatchard | TCW Defending Freedom | April 26, 2022

The writer is in New Zealand

AS the pandemic fades, should we meekly accept new restrictions or seek new freedoms?

An article in the New Zealand autumn 2022 AA Directions magazine advises that ‘masks are going to be part of our day-to-day lives for the foreseeable future’, and teaches us how to recognise whether someone is smiling behind their mask.

Yesterday in Stuff, science columnist Dr Siouxsie Wiles finally gets around to admitting that ‘you can’t rely on mRNA vaccines’. Her answer? Be stricter about mask wearing.

Dr Wiles, a British microbiologist who received the 2021 New Zealander of the Year Award for pandemic science communication, cites a new study which she says supports continuing use of masks at gatherings. Click on the link (most people don’t) and you arrive at a study that involves theoretical modelling rather than verified effects.

Mask studies (of which there are many) have not demonstrated large reductions in Covid transmission. They tend to be very technical in nature and focus on the comparative viral loads found in nasal and mask swabs. These measurements can be connected to Covid transmission only via theoretical modelling.

Back in the real world, the near universal combination of vaccination and mask wearing to date in New Zealand has not stopped Omicron transmission.

A study published in ClinMed entitled ‘Adverse Effects of Prolonged Mask Use among Healthcare Professionals during Covid-19’surveyed 343 healthcare professionals in New York City hospitals obliged to wear masks throughout most of their working day. They reported: headaches (71 per cent), skin breakdown (50 per cent), and impaired cognition (24 per cent). Yes, you did read that right, one quarter of medical professionals wearing masks suffer decreased intellectual capacity.

Even costly N95 masks do not stop the passage of air around them essentially negating their purpose and prompting the observation that it is like trying to stop mosquitos with chicken wire. Surgical masks or their equivalent are mainly required in hospitals and dirty environments such as sawmills or building sites to protect the wearer from inhaling human tissue or large particulates.

So will Dr Wiles advise us next week to wear a full deep-sea diving suit? In the crazy world of the new subnormal apparently nothing absurd can be ruled out.

Hiding the truth from the public has become a medical imperative

There is a certain hysteria surrounding the realisation that mRNA vaccines don’t actually work and may be harmful. When my kids were growing up we used to read an amusing book to them, Lies My Mother Told Me. How many lies have we been told? Too many.

For example, the Pfizer mRNA vaccine is:

·         95 per cent effective

·         Completely safe

·         Mostly stays in the upper arm muscle, as most traditional vaccines do

This last is interesting because Pfizer knew before they released the mRNA vaccine that it didn’t stay in the upper arm. They had completed an animal study which suggested that most of the mRNA vaccine spread throughout the body instead of staying at the injection site. The lipid nanoparticles (LNP), which encase the mRNA and help to breach cell walls are highly mobile and ensure that the mRNA spreads rapidly to all the organ systems in the body. If you want the full story see this article by clinical immunologist Dr Byram Bridle.

If we had known this, we would have realised early on that adverse reactions such as liver and kidney damage, strokes, cardiac events, neurological conditions and sudden-onset cancers were not unrelated to vaccination, as many victims were assured at the time by the NZ Ministry of Health, GPs and hospital staff.

Medical professionals assessing the causal connections between mRNA vaccination and subsequent adverse events were relying upon their prior knowledge about traditional vaccines. They thought they knew that vaccine ingredients mostly stayed at the injection site and eventually appeared in lymph nodes as they were cleaned up by the immune system. Pfizer neglected to tell them this was not the case. In fact Pfizer didn’t seem to inform anybody: the damning data was hidden in an obscure study buried in the requirements of the various national regulatory processes supposedly scrutinising safety. Anyone sounding the alarm seemed to be cancelled by the media and relegated to the ranks of conspiracy theorists.

Now that we have some hard NZ data showing that the protective effect of mRNA vaccination is a myth, there appears to be a rush on the part of seasoned and highly decorated Covid science communicators like Dr Siouxsie Wiles, member of the NZ Order of Merit, to throw us a lifeline. We may not actually choose to be saved. We might instead get on with our own lives and make the best of what opportunities we can discover for ourselves. At least we will be rowing our own boat, not sinking in the good ship misinformation.

April 26, 2022 Posted by | Deception, Science and Pseudo-Science | , , | Leave a comment

The Nation’s Top Scientists Lied

By Dr. Scott Atlas | Brownstone Institute | April 13, 2022

This adapted excerpt is from Dr. Scott W. Atlas’ bestselling book, A Plague Upon Our House, published by Bombardier. 

CDC Director Robert Redfield’s congressional testimony on September 23, 2020, immediately caught my attention. I watched in disbelief as Redfield told Congress that “more than 90 percent of the population”—more than three hundred million people in the US—remains susceptible to the illness.

The statement was based on incomplete and outdated data, as well as an apparent lack of understanding of the literature, and it struck me as one of the most erroneous and fear-inducing proclamations of any public health official to that moment. Approximately two hundred thousand Americans had already died from COVID; the last thing the public needed was an exaggeration of the future risks, implying to some that ten times that number could still die.

First of all, the numbers didn’t add up. At that point, confirmed cases in the US already totaled approximately seven million, and the CDC itself had estimated that approximately ten times the number of confirmed cases, a very conservative estimate, were likely to have had the infection. A Stanford seropositivity study back in April had shown that confirmed cases underestimated the total infections by a factor of approximately forty times. It made no sense that only 9 percent, or thirty million Americans, had been infected.

Second, the 9 percent calculation was blatantly wrong. That number came from antibody testing by the states. I looked at the CDC website myself, and sure enough, the data was based on antiquated testing from several states.

Some antibody totals were pulled from several months earlier, before many of those states had experienced a significant number of cases. It therefore grossly underestimated the number of cases that had already occurred. The data was simply not valid, but you needed to pay attention to the details.

More importantly, Redfield’s basic claim was fundamentally flawed. The conclusion that serum antibody testing revealed the entire population of those protected from COVID was counter to an entire body of published literature and contrary to fundamental knowledge of immunology, including other coronavirus infections.

It was well known that antibody tests showed one cross-section in time—they were transient—even though immune protection can last. From studies on SARS-2 and most other viruses, antibody levels change over a span of months. They typically appear in the first couple of weeks, peak in a few months, and then decrease over a span of several months.

The literature on COVID had already shown these patterns. A month before this press conference, a Nature Reviews Immunology study on COVID-19 explicitly stated, “The absence of specific antibodies in the serum does not necessarily mean an absence of immune memory,” and explained, “memory B-cells and T-cells may be maintained even if there are not measurable levels of serum antibodies.”

Japan’s study demonstrated this dramatically. In their study, antibody levels increased from 5.8 percent to 46.8 percent over the course of the summer. The most dramatic increase occurred in late June and early July, paralleling the rise in daily confirmed cases within Tokyo, which peaked on August 4.

Out of the 350 individuals who completed both offered tests, 21.4 percent of those who tested negative became positive, and 12.2 percent of initially positive participants became negative for antibodies. A striking 81.1 percent of IgM-antibody-positive cases at first testing became negative in only one month. They stated that “[antibody tests] may significantly underestimate previous COVID-19 infections.” It had also been widely reported in several major scientific journals that antibody responses are not necessarily detectable in all COVID patients, especially those with less severe forms.

But the flaws in Redfield’s estimate extended deeper. Even those familiar with first-year college biology know that other components of the immune system, memory B-cell and T-cells, provide protection from virus infections. Some T-cells kill the virus, and they also help antibodies form. T-cells develop and provide protection that lasts far longer, even after antibodies disappear—sometimes for years in other SARS viruses.

T-cells for this virus had already been documented, even in people unexposed to SARS-2, meaning that in these cases, cross-protection was present from T-cells originating in response to other coronaviruses. T-cells had also been found in individuals with completely asymptomatic SARS-2 infections.

NIH Director Francis Collins had highlighted that very data in his Director’s Blog a few weeks earlier, writing, “In fact, immune cells known as memory T cells also play an important role in the ability of our immune systems to protect us against many viral infections, including—it now appears—COVID-19.”

Scientists from some of the top research institutions in the world, like Sweden’s Karolinska Institute, San Diego’s La Jolla Institute, Duke University, Berlin, and others had published this evidence. Karolinska demonstrated T-cell immunity in both asymptomatic and mild cases of COVID—even if antibody-negative.

Singapore researchers had noted robust T-cell responses to this virus, SARS2, from seventeen-year-old SARS1 samples. Since T-cells are obviously not discovered by antibody tests, those individuals were not included in Redfield’s count. Yet he apparently had not considered this essential, indeed fundamental, point as he testified to Congress and made headlines.

After watching this debacle on TV, I knew full well what was coming later that day. The media would latch on to this and create even more public panic. I also knew that the responsibility for clarifying this grossly erroneous statement would be mine. There was no question it would come up at the president’s press conference, and even if it did not, it still needed to be explained.

I rushed over to Derek Lyons’s office to update him and to make sure we would alert the president beforehand. A few others in the West Wing were there, so I summarized to them what had been said to Congress.

The mood ranged from amazement to dejection to frustration. An advisor to the president on legal matters warned me, with a smile on his face, “Scott, don’t just bluntly say, ‘Redfield is wrong!’ Say something softer, like ‘He misstated things.’”

I nodded, knowing that I needed to restrain my words, even though this was the same man who had tried to destroy me in the national press a few days earlier. But this wasn’t personal at all. Clarifying the facts about the pandemic and countering the unending barrage of misinformation and pseudoscience about it, in this case coming from within the administration itself, was one of my most important roles in this national crisis.

During the pre-brief in the Oval Office a few hours later, I outlined the issue to the president. It was decided, as expected, that I would answer the question when it came up. And so it did.

A reporter from ABC News directly asked me if Redfield’s statement that more than 90 percent of Americans remained susceptible to the disease was true. I took the friendly advice I had received earlier in the day.

“I think that Dr. Redfield misstated something there,” I said, and then did my best to calmly explain the problems with outdated information and the contribution of cross-reactive T-cells and T-cell protection that would not have been included in his data. I correctly stated what was widely known and factual—that the protection from the virus “is not solely determined by the percent of people who have antibodies.” During my answer, as I fended off interruptions, I tried to explain in understandable language as best I could.

I also made a serious effort to be somewhat delicate, because I felt extremely uncomfortable about having to correct the director of the CDC on the national stage.

Unfortunately, my disgust with the confrontational mood in that press room prevented me from being more diplomatic when that reporter asked, “Who are we to believe?” My reflexive answer was “You’re supposed to believe in the science, and I am telling you the science.” Then I referred him to several expert scientists by name. However, I had the strong sense that he was not really interested in the facts at all. Rather, it was another attempt to amplify discord.

After exiting the press room, I walked alongside the president. He briefly stopped to check the news coverage on the set of TV monitors outside the briefing room, as he typically chose to do. After some banter between the president and the staff standing in the area, we began walking back toward the Oval Office.

President Trump turned to me on his right, smiling wryly but with a genuinely puzzled look on his face. “Is Redfield political or just stupid?” he asked, subtly shaking his head. I looked right back at the president and hesitated. The answer was obvious to both of us.

Needless to say, the media immediately played up the disagreement between me and Redfield. It fed into their narrative of conflict between me and the other Task Force doctors, one that Redfield personally caused with his offensive and unwarranted remark that everything I said was “false.”

Later, Dr. Fauci appeared on TV and criticized my straightforward attempt to clarify important information as “extraordinarily inappropriate.” I wondered if he was more concerned with protecting his bureaucrat colleague’s reputation and undermining mine than ensuring that correct information was being told to the American public.

Martin Kulldorff, the world-renowned Harvard epidemiologist, posted his reaction on Twitter: “Scott Atlas stated the simple fact that immunity is higher than those with antibodies, whereupon Dr. Fauci criticizes him without contradicting what was actually said. Stating a simple scientific fact is not ‘extraordinarily inappropriate.’ What is going on?”

Scott W. Atlas, M.D., is the Robert Wesson Senior Fellow in health care policy at the Hoover Institution of Stanford University and a fellow at Hillsdale College’s Academy for Science and Freedom.

April 26, 2022 Posted by | Book Review, Deception, Science and Pseudo-Science | , | Leave a comment

Christian Drosten, Karl Lauterbach try to block Health Ministry committee set to evaluate lockdowns and other containment measures

Health minister Karl Lauterbach caught maskless on a train
eugyppius | April 25, 2022

In March 2021, the German Bundestag ordered the Ministry of Health to set up an expert committee to evaluate the effectiveness of containment measures in Germany, from lockdowns to masks. They required this committee to complete their evaluation by 30 June 2022, and to publish a report before the end of September.

The committee finally convened on 22 April via video conference, delayed apparently because communicating with Karl Lauterbach’s ministry has been a huge problem. In the hours after that meeting, the committee chair notified its members that he had finally heard from Lauterbach. The health minister had raised the idea of extending the evaluation deadline to 31 December, and suggested that the committee mandate might end up being redefined.

As Welt explains, Christian Drosten had previously voiced staunch opposition to the project of investigating the efficacy of containment measures:

… [A]n internal virtual meeting in March, Charité virologist Christian Drosten argued against individually evaluating the containment measures. In a nine-minute speech, he said there was too little data, it was too early for such a study, and one could end up “in hot water,” according to WELT information. In view of this intervention from Drosten, who has been one of the most important advisers to political decision-makers since the start of the pandemic, the committee turned to the Ministry of Health for further instructions.

Nothing came of that meeting; the committee had a mandate from the Bundestag, the legal force of which does not rest upon Drosten’s feelings.

When Welt asked the health ministry to comment on the latest delays, a Lauterbach spokesman said the experts don’t have sufficient data, and that the ministry is in discussions with the Bundestag about how to handle this. He even denied that there would be any delay in the committee’s work, which is plainly a lie, because Welt has documents and off-the-record statements from committee members to the opposite effect. One such member even complained to their reporter that “It shows great disrespect to try to withdraw our mandate to evaluate containment measures after so many hours of work.”

We are asked to believe that containment measures have been super successful in the past, and that they remain an important tool for future waves. Lauterbach himself has promised the return of containment in the Fall, because he did not get his vaccine mandate. At the same time, nobody must be permitted to evaluate the efficacy of these allegedly crucial measures. We can’t be allowed to know which ones work and which ones don’t. That would be dangerous somehow, even for an expert committee. In fact it would be so dangerous, that Christian Drosten, the public face of mass containment in Germany, felt compelled to deliver a secret lecture warning against any such evaluative process.

What’s really galling about all this, isn’t that they’re lying, but that they’re terrible at it.

April 25, 2022 Posted by | Civil Liberties, Deception, Science and Pseudo-Science | , | Leave a comment

Why We Sued to Overturn the Federal Travel Mask Mandate — And Why We Won

By Leslie Manookian | The Defender | April 22, 2022

In America, the ends don’t justify the means. There are legal guardrails in place to protect our basic liberties and rights — even during a pandemic.

That was the message in the decision handed down Monday by a federal judge in our lawsuit to overturn the federal travel mask mandate.

Since early 2021, anyone traveling on a plane, bus or train, or anyone who used a shared ride service — or even walked into an airport or train station — was compelled to wear a face covering, often for hours at a time.

President Biden, on his first full day in office, signed an executive order on mandatory masking.

The Centers for Disease Control and Prevention (CDC), citing a public health emergency, promulgated the order just eight days later.

The CDC circumvented a required notice and comment period and issued no scientific justifications for the specifics of the order.

Americans were supposed to take the government’s word for it, put on our masks and ask no questions.

But when flight attendants announced — repeatedly on each flight — that compliance is required “by federal law,” did you ever wonder: what federal law?

I did. And it led us at the Health Freedom Defense Fund to file suit against the mandate in federal court.

With assistance from our lawyers at the Davillier Law Group, we learned there is no “federal law” compelling masks for travel.

The CDC does not have the statutory authority to issue a sweeping mandate requiring masking. Nor does the agency have the authority to penalize Americans for non-compliance.

The Biden administration claimed its mask mandate was rooted in authority granted under the Public Health Service Act.

However, a careful reading of that law shows Congress never intended to grant such sweeping powers. In fact, the law is limited and specific, as the court pointed out in its decision.

One of the bigger red flags for the court was the CDC’s claim it could bypass a period of public notice and comment.

The CDC cited the pandemic “emergency” as justification for bypassing notice and comment.

Yet, as we all recall, by early 2021, the pandemic had been wreaking its havoc for nearly a year, yet the agency had proposed no such travel mask mandate.

It is hard to justify requiring emergency powers and circumventing all citizen comments when the CDC was marking time on masks for more than a year.

Indeed, if a mask mandate was key to the pandemic battle, Congress could have enacted such a bill, with debate, transparency and accountability. It did not.

In fact, public comment is at the core of credible and transparent regulatory policy because it allows for flaws and pitfalls to be cited and hopefully corrected.

Despite telling us all for years to “follow the science,” the CDC cited no scientific research to justify the mandate, nor did it offer justification for choosing the age of 2 for its exemption — clearly indicating the agency arbitrarily chose that age.

An abundance of research in major medical and scientific publications, including in the Journal of the American Medical Association, details the negative effects of prolonged mask-wearing, including among medical professionals and the military.

The CDC also ignored the serious, and medically verified, concerns voiced by Americans about how mask-wearing creates severe anxiety, as the two individual plaintiffs in our case detailed.

Clearly the federal government simply brushed away bona fide questions about mask efficacy and risk, and chose not to cite rationale of its own.

The government’s rationale is what we parents say often when our children question our demands: “Because I said so.”

That approach usually doesn’t work well with kids — and it sure falls short in setting policy for hundreds of millions of Americans.

As our lawsuit pointed out, never has a president entered an executive order mandating that every American citizen be required to don a type of garment or device, whether when traveling or otherwise, for any reason whatsoever.

And the U.S. Constitution certainly doesn’t grant the president power to enact nationwide edicts just because Congress failed to pass legislation he deems needed.

So now that you can choose to fly or ride mask-free, remember: Even in response to a pandemic, your government cannot do what it wants, when it wants and to whom it wants.

We are governed by laws, not the preferences of elites, and the Constitution is not suspended in an emergency.

Leslie Manookian is president and founder of Health Freedom Defense Fund, a nonprofit which seeks to rectify health injustice through education, advocacy and legal challenges to unjust mandates, laws and policies that undermine our health freedoms and human rights.

© 2022 Children’s Health Defense, Inc. This work is reproduced and distributed with the permission of Children’s Health Defense, Inc. Want to learn more from Children’s Health Defense? Sign up for free news and updates from Robert F. Kennedy, Jr. and the Children’s Health Defense. Your donation will help to support us in our efforts.

April 23, 2022 Posted by | Civil Liberties, Science and Pseudo-Science | , , , | Leave a comment

How to lie with statistics – Vaccine efficacy edition

The Naked Emperor’s Newsletter | April 23, 2022

Just a quick post to show another method of how to increase vaccine efficacy. This time looking at data from Switzerland and Liechtenstein (S&L).

By mid December 2021, S&L were at the peak of their third wave. It was ok though because 67% of the country had been fully vaccinated, 17% with a booster. 32% of selfish people had still not been vaccinated however.

As the vaccines stop people from going to hospital this would show up in the stats.

Yes, as predicted, there was a slight increase in hospitalisations for fully vaccinated citizens (Moderna – red line, Pfizer – light blue line) but a massive spike in hospitalisations for those pesky unvaccinated (dark blue line).

Job done, vaccine efficacy proven.

But hold on a second, there is another category. “Vaccine unknown, fully vaccinated”. Let’s add this to the graph.

They don’t really want you to see this line so have made it a faint grey colour. However much they would like to pretend it wasn’t there, it is. And it shows a lot of fully vaccinated people going to hospital, and continuing to go to hospital, until March 2022, well after the peak for unvaccinated individuals.

Lot’s of fully vaccinated people going into hospital who have forgotten which vaccines they had. Did they forget or were they too ill? Is this an admin issue or are these people who had a combination of vaccines and so couldn’t be put in one category?

Either way, this grey lined category shifts a lot of people out of the Pfizer and Moderna vaccinated categories. It makes vaccine efficacy look much better than it actually is by saying only this many Pfizer or Moderna vaccinees were hospitalised.

Another great example of how to lie with statistics.

April 23, 2022 Posted by | Deception, Science and Pseudo-Science, Timeless or most popular | , | Leave a comment

TSA mask mandate

By Vinay Prasad | April 20, 2022

Just imagine we had a competent CDC who ran a cluster Random Controlled Trial of cloth masking mandate in airplanes and measured spread. It could even be factorial design and test different ventilation filters. Imagine the trial was negative– a judge would not need to strike down the mandate. It would have fallen by scientific consensus.

Imagine now it were positive. We could have a discussion about the effect size, if it varies by case rate at the flight origin city or traveller origin cities. We could discuss when the tradeoff might be worth it, and when it might be not worth it.

Imagine the trial was large. It could be powered for interaction by age. Do cloth masks protect babies or is it a false reassurance? Does it protect immunocompromised? Or again, false reassurance?

Imagine the trial had arms for different rules. An ok to snack arm or a no snacking arm. Does it work with a rule modification?

We ran zero such trials. The CDC ran no studies. No one knows the answer to these questions, despite their bluster. The truth is it seems highly implausible that wearing a mask on one ear lobe, while eating pretzels for an hour works.

The CDC failed it’s social contract. It implemented a policy and never generated evidence. This turned a scientific question into a political one. Naturally battle lines were drawn.

Finally a judge comes in and throws out the mandate. Many people are upset with the judge. But the judge didn’t fail you. The CDC failed you. It never ran a trial. It never generated knowledge. It kept us in the dark. It should be no surprise that it lost it’s power and legitimacy. It proved it does not deserve the power it was was entrusted by the people. It failed to use science to reduce uncertainty. We should be ashamed of the organization. I certainly am.

April 22, 2022 Posted by | Civil Liberties, Science and Pseudo-Science | , , | Leave a comment

‘Explosive’ Legal Agreement With U.S. Lets Wuhan Lab Destroy Data

By Emily Kopp | U.S. Right to Know | April 20, 2022

The Wuhan Institute of Virology has the right to ask a partnering lab in the U.S. to destroy all records of their work, according to a legal document obtained by U.S. Right to Know.

A memorandum of understanding between the Wuhan lab and the Galveston National Laboratory at the University of Texas Medical Branch states that each lab can ask the other to return or “destroy” any so-called “secret files” — any communications, documents, data or equipment resulting from their collaboration — and ask that they wipe any copies.

“The party is entitled to ask the other to destroy and/or return the secret files, materials and equipment without any backups,” it states.

This right is retained even after the agreement’s five year term ends in October 2022. All documents are eligible for destruction under the agreement’s broad language.

“All cooperation … shall be treated as confidential information by the parties,” the agreement states.

The directors of the maximum biocontainment labs in Wuhan and Texas announced a formal cooperative agreement in Science in 2018. The labs are two of just a handful of facilities in the world that do similar cutting edge work on novel coronaviruses. The lab in Texas, with funding from the National Institutes of Health, was doing biosafety training with the lab in Wuhan, which operates under the Chinese Academy of Sciences. The labs also intended to do joint research projects and share resources, according to the agreement.

The revelation that the Wuhan lab retained the right to call for the destruction of data on U.S. servers funded by U.S. taxpayers comes amid a debate about what sort of investigation is necessary to exculpate the city’s coronavirus research from suspicions it sparked the COVID-19 pandemic. It also raises questions about assurances from Wuhan Institute of Virology senior scientist Zhengli Shi that she would never delete sensitive data.

The clause also raises a number of legal red flags for the Texas lab, experts say.

“The clause is quite frankly explosive,” said Reuben Guttman, a partner at Guttman, Buschner & Brooks PLLC who specializes in ensuring the integrity of government programs. “Anytime I see a public entity, I would be very concerned about destroying records.”

Guttman said that even private entities are expected to have internal records retention and destruction policies, but that as a public institution the Texas lab faces an even higher standard under laws meant to safeguard federal and state taxpayer dollars. These laws include the federal False Claims Act and the Texas Public Information Act. The Galveston National Laboratory is part of the University of Texas System and receives federal funding.

“You can’t just willy nilly say, ‘well, you know, the Chinese can tell us when to destroy a document.’ It doesn’t work like that,” he said. “There has to be a whole protocol.”

The clause could also risk obstructing Congressional investigations into the COVID-19 pandemic.

The Texas lab was “built by the National Institutes of Health to help combat global health threats,” said Christopher Smith, a spokesman for UTMB, in a statement. “As a government-funded entity, UTMB is required to comply with applicable public information law obligations, including the preservation of all documentation of its research and findings.”

“UTMB believes it is an operational — and moral — imperative that all scientists working in biocontainment anywhere in the world have first-hand knowledge of the proven best practices in biosafety and laboratory operations,” Smith continued. “All research at UTMB is subjected to a rigorous and transparent pre-experiment approval protocol, including involvement and oversight by scientific experts who helped design federal guidelines.”

Only the Texas attorney general can make a determination about what otherwise releasable public records should be exempted from disclosure, according to Kelley Shannon, executive director of the Freedom of Information Foundation of Texas. It’s also unlawful to destroy records requested under the Texas Public Information Act.

Liza Vertinsky, an expert in global health law and intellectual property at Emory University, said that the all-encompassing definition of what is considered “secret” in the memorandum of understanding, or MOU, is problematic.

“The way I read the MOU, although it is poorly drafted, ‘secret’ refers to the ‘cooperation and exchanges, documents, data, details and materials’ that are part of this MOU,”  she said. “It is as broad as the MOU, covering what the MOU is intended to cover.”

Edward Hammond, an independent biosafety proponent and a longtime advocate for more transparency at the Galveston lab, also flagged the broad language.

“In agreements like this that I’ve seen before, you have confidentiality provisions in relation to intellectual property… I can’t recall seeing an instance of these more general confidentiality provisions,” he said in an email. “Doesn’t this run against the purportedly pure academic interests of UTMB?”

In 2009, the Galveston lab unsuccessfully lobbied the Texas legislature for an exemption to the Texas Public Information Act to be written in order to prevent records being released to Hammond.

WIV calls data deletion accusations ‘appalling’

The agreement could also undermine claims that the WIV would never delete records. A WIV virus database that went dark in 2019 remains a source of intrigue for reporters, scientists, and U.S. intelligence agencies interested in the pandemic’s origins.

Wuhan Institute of Virology senior scientist Zhengli Shi told MIT Technology Review that allegations by Western biosecurity experts that her lab may have scrubbed records relevant to COVID-19 are “baseless and appalling.”

“Even if we gave them all the records, they would still say we have hidden something or we have destroyed the evidence,” Shi told the outlet, which cast any such suspicions as rooted in anti-Chinese prejudice.

The agreement also seems to address suspicions that the partnership could aid a bioweapons program either in the U.S. or in China, stating the labs will “exchange the virus resources strictly for the scientific research purposes.”

A number of clunky or unusual provisions in the agreement suggests it may have been drafted at least in part by Chinese partners and translated into English.

For example, it states nothing in the agreement should be construed as establishing a relationship between “master and servant,” unusual language in modern American legal documents.

Other documents obtained by U.S. Right to Know demonstrate that despite the formal collaboration, Galveston National Laboratory faced delays in obtaining a sample of SARS-CoV-2, the virus that causes COVID-19, from its partner lab at the pandemic’s epicenter. The Texas lab ended up obtaining its first sample from the U.S. Centers for Disease Control and Prevention.

U.S. Right to Know obtained the WIV-UTMB memorandum of understanding through the Texas Public Information Act as part of an investigation into risky viral research funded through taxpayer dollars.

April 21, 2022 Posted by | Deception | | Leave a comment

CDC Weighs ‘Upgrades’ to COVID Vaccines as Booster Strategy Fails

By James Lyons-Weiler | PopularRationalism | April 21, 2022

According to CNN, CDC’s Advisory Committee on Immunization Practices (ACIP) continue to “mull over” what’s next for Covid-19 boosters, and indeed are even considering what the “upgrades” Covid-19 vaccines. There are indications that they know that “entirely different vaccine formulations could be needed”.

Currently, additional booster doses are recommended only for certain people with weakened immune systems and adults 50 and older.

CDC quoted Dr. Sara Oliver, one of CDC’s epidemic intelligence service officers with the Division of Viral Diseases, who provided a robust soundbite:

“Policy around future doses require continued evaluation of Covid-19 epidemiology and vaccine effectiveness, including the impact of both time and variants, and the ability of doses to improve this protection.”

The specifics CNN cited Oliver as seeing CDC needing to take into account include recent case counts, hospitalization rates, and vaccine effectiveness in the US, and also – shocking – including whether it’s waning over time. They also cited that she thought CDC should weigh “the impacts of circulating coronavirus variants”.

We know vaccine effectiveness is unacceptably low – and given Dr. Fantini’s results may actually be negative, indicating disease enhancement.

Oliver stated that the evolution of the virus will be an important consideration for considering “platforms” for future COVID-19 vaccinations.

It’s not hard to read between the lines here. Readers of PopularRationalism already know that the mRNA vaccines have proven to be worse than a dismal failure. This is CDC putting the word out that a second round of vaccine development is expected, and is about the closest we’ll ever see to CDC admitting the vaccination program has flopped.

And it’s surprising to see ACIP being focused on future “effectiveness”. Clearly, if newly formulated vaccines are proposed, they will be a square one in terms of the regulatory stage of development, and we should be seeing data on efficacy, which is a measure of a vaccine’s ability to reduce transmission in a prospective randomized clinical trial, not effectiveness, which is measured using real-world data.

As the real-world data on COVID-19 vaccine effectiveness came in, it was quite bad, so the net was lowered from “preventing transmission” and “reducing new infections” to “producing an antibody response”.

So far, according to USASpending.Gov, the US has now spent over 3.63 trillion dollars in its response to COVID-19. According to the US Center for Economic Studies, the US suffered record-smashing loss of -9.5% of its GDP in 2020, and over 30% shrinkage in economic growth.

Nevertheless, both Pfizer and Moderna are taking a stab at vaccines meant to be available against Omicron, but it is doubted whether the variant will be around long enough to even be targeted by the new vaccines. Pfizer is hoping for a vaccine that will remain effective for more than a year, while Moderna’s non-peer-reviewed preprint containing data from their internal study of the efficacy of their bivalent vaccine was cited by CDC with the careful caveat that the preprint had “not been peer-reviewed or published in a professional journal.”

In the heyday of the pandemic, Pfizer and Moderna could get away with sending FDA assurances that they would share data mentioned in press releases once the FDA gave EUA or full-out approval. Now that the fog of the pandemic has lifted, it seems that the standard practice of labeling press releases, such as Moderna’s recent one on their bivalent vaccine as “Forward Looking Statements” is in place, so I suspect Moderna, Pfizer and the SEC got my memos.

Due to evidence of lack of efficacy and need, FDA, Pfizer and Moderna have delayed further consideration of COVID-19 vaccines for young children until June, according to Politico (SeekingAlpha, Politico).

Unfortunately, the companies are still communicating “success” as equivalent with “antibody response” when we all know (or at least my immunology students know that they really should be measuring and reporting memory B-cell responses and the degree of match between the antibodies produced by B-cells upon reinfection and whatever variant or variants have taken over after Omicron is a distant memory.

CDC also shared that Kaiser Permanente – which profits from vaccine sales – was in the driver’s seat of the CDC’s ACIP committee, with Dr. Matthew Daley, ACIP Vaccine Working Group Chairperson and senior investigator at the Kaiser Permanente Institute for Health Research issuing “marching orders” to the rest of ACIP to be “be more proactive than reactive” on the future of Covid-19 vaccinations.

This article is just a reminder to those who need it that #ParentsAreWatching, and that #ScientistsAreWatching, too.

April 21, 2022 Posted by | Science and Pseudo-Science | , , , | Leave a comment

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