The Biden Administration Monday announced a $5 billion program to accelerate the development of next-generation COVID-19 vaccines and treatments.
[Of course, the elephant in the room is: “Why? We already have effective treatments, ones that don’t kill people.” Oh, wait: they’re cheap, and Big Pharma can’t make more Billion$ from them. Carry on…..]
Like Operation Warp Speed, which developed and distributed vaccines in the early days of the pandemic, Project NextGen will cut across government agencies and involve public-private collaborations, a senior Biden official told USA TODAY.
Current vaccines, developed rapidly in the heat of the emergency, are “really good, but they’re not great,” said Michael Osterholm, an epidemiologist who worked with the administration to develop the new program. “There is a substantial amount of work (to be done) to take these good vaccines and hopefully achieve better vaccines.”
Project NextGen has three primary goals, which Osterholm and colleagues laid out in a “roadmap” issued in February: Develop a nasal vaccine that will hopefully prevent infection as well as severe disease; develop longer-lasting vaccines; and create “broader” vaccines that protect against all variants and several different coronaviruses
[ Why do they need a “new” nasal vax when two already exist? Oh, wait. Same answer.]
It will also include funding to develop more durable monoclonal antibodies resistant to new variants, according to the administration. Antibodies were highly effective treatments earlier in the pandemic but have not been able to keep up with the virus as it evolved and are no longer available.
The Biden administration Monday announced a $5 billion program to accelerate the development of next-generation COVID-19 vaccines and treatments.
Like Operation Warp Speed, which developed and distributed vaccines in the early days of the pandemic, Project NextGen will cut across government agencies and involve public-private collaborations, a senior Biden official told USA TODAY.
Current vaccines, developed rapidly in the heat of the emergency, are “really good, but they’re not great,” said Michael Osterholm, an epidemiologist who worked with the administration to develop the new program. “There is a substantial amount of work (to be done) to take these good vaccines and hopefully achieve better vaccines.”
Project NextGen has three primary goals, which Osterholm and colleagues laid out in a “roadmap” issued in February: Develop a nasal vaccine that will hopefully prevent infection as well as severe disease; develop longer-lasting vaccines; and create “broader” vaccines that protect against all variants and several different coronaviruses
It will also include funding to develop more durable monoclonal antibodies resistant to new variants, according to the administration. Antibodies were highly effective treatments earlier in the pandemic but have not been able to keep up with the virus as it evolved and are no longer available.
The administration said the initial allocation of $5 billion for Project NextGen would be financed through money saved from contracts costing less than originally estimated. The investment was first reported Monday by the Washington Post.
Dr. Gregory Poland, director of the Mayo Clinic’s Vaccine Research Group who was also involved in the earlier roadmap, said he and others have been advising the White House since last summer to launch something like Project NextGen.
The funding is a start, he said, “but much more will be needed to accomplish all three goals,” he said. “The need though is urgent and now – something government generally doesn’t do well, hence the key will be prioritization and implementation.”
The Biden administration Monday announced a $5 billion program to accelerate the development of next-generation COVID-19 vaccines and treatments.
Like Operation Warp Speed, which developed and distributed vaccines in the early days of the pandemic, Project NextGen will cut across government agencies and involve public-private collaborations, a senior Biden official told USA TODAY.
Current vaccines, developed rapidly in the heat of the emergency, are “really good, but they’re not great,” said Michael Osterholm, an epidemiologist who worked with the administration to develop the new program. “There is a substantial amount of work (to be done) to take these good vaccines and hopefully achieve better vaccines.”
Project NextGen has three primary goals, which Osterholm and colleagues laid out in a “roadmap” issued in February: Develop a nasal vaccine that will hopefully prevent infection as well as severe disease; develop longer-lasting vaccines; and create “broader” vaccines that protect against all variants and several different coronaviruses
It will also include funding to develop more durable monoclonal antibodies resistant to new variants, according to the administration. Antibodies were highly effective treatments earlier in the pandemic but have not been able to keep up with the virus as it evolved and are no longer available.
The administration said the initial allocation of $5 billion for Project NextGen will be financed through money saved from contracts costing less than originally estimated. The investment was first reported Monday by the Washington Post.
Dr. Gregory Poland, director of the Mayo Clinic’s Vaccine Research Group who was also involved in the earlier roadmap, said he and others have been advising the White House since last summer to launch something like Project NextGen.
The funding is a start he said, “but much more will be needed to accomplish all three goals,” he said. “The need though is urgent and now – something government generally doesn’t do well, hence the key will be prioritization and implementation.”
Why do we need new coronavirus vaccines?
When the current vaccines were developed, speed was a priority along with safety and effectiveness. They were 95% effective at preventing all disease when first released in late 2020. But their effectiveness against mild disease, in particular, wanes over just a handful of months.
Protection may also not be as good as the virus continues to evolve. The current bivalent booster is aimed at both the original virus and the BA.5 variant.
But SARS-CoV-2, the virus that causes COVID, is the third new coronavirus to pop up in the last two decades, following Middle-Eastern Respiratory Syndrome (MERS) and Severe Acute Respiratory (SARS). If and when a fourth turns up, it would be great to already have a vaccine that could protect against” it,’ said Osterholm, who directs the Center for Infectious Disease Research and Policy at the University of Minnesota.
[ “…when a fourth turns up, it would be great TO ALREADY HAVE a vaccine that could protect against it…” Hmm, Bill Gates & friends have already told us there’s another pandemic coming, is there something they know that we don’t?]
A nasal vaccine is the third item on the wish list. The idea is that by delivering a vaccine directly to the area where the virus enters the body, scientists could set up a barrier of protection to prevent even mild infections and transmission from one person to the next.
[But didn’t they tell us initially that surface contact would spread it? DISINFECT EVERYTHING! And what about people who breathe more through their mouths — like people with allergies such as Hay Fever?]
“I think an initiative like this is much needed and should have been put in place much sooner,” said John Moore, an immunologist at Weill Cornell Medical College in New York.
What happens next?
Reaching these goals will likely be more difficult than it sounds, Moore said.
“Anyone familiar with vaccine development knows that translation into a practical product is a much harder and more expensive process” than simply creating a basic vaccine, he said. “A lot of designs that look good in the early stages fizzle out because they cannot be manufactured efficiently under the conditions required for human trials.”
[And when did they have time for human testing under Warp Speed?]
Dr. Paul Offit, a pediatrician who directs the Vaccine Education Center at Children’s Hospital of Philadelphia, is skeptical that any of these goals are realistic.
Researchers have been trying for more than 40 years to develop vaccines against multiple strains of flu and against HIV, the virus that causes AIDS. Both have proven elusive, he said, because the viruses mutate so much, as does SARS-CoV-2.
Meanwhile, nasal vaccines are still being tested in clinical trials, so it’s not yet clear how effective they’ll be against COVID. A nasal vaccine for the flu doesn’t provide any more protection than a shot, Offit said, and it’s most effective in young children who have never been exposed to the flu virus before. At this point, nearly every American has already been exposed to the virus that causes COVID.
Moore agrees that developing a nasal vaccine should be a high priority, but “it’s seriously naive to believe that it will be easy to make one.”
Offit worries that the emphasis on making COVID vaccines better will undermine public trust in the ones we already have. He said the current vaccines have been “amazing,” but that vaccines can only do so much.
What did Operation Warp Speed do?
Under the Trump administration, Operation Warp Speed spent about $30 billion beginning in March 2020 to develop, manufacture and distribute COVID-19 vaccines.
The federal government essentially placed bets on six different drug companies hoping at least a few of them would prove successful. Each received over $1 billion (although Pfizer/BioNTech developed its vaccine without government support) with a promise of a guaranteed market if they succeeded.
►Moderna and Pfizer/BioNTech both developed, tested, passed regulatory hurdles and produced millions of doses of their mRNA vaccines in under a year. Previously, the fastest vaccine had taken four years to bring to market.
►Johnson and Johnson also developed a vaccine based on a different technology. While effective, the vaccine led to a rare side effect and is no longer widely available in the United States.
►Novavax pursued a third type of vaccine technology and has also won emergency regulatory approval, though it is not widely available.
►The other two efforts, one by Sanofi and another by AstraZeneca, fell behind early and were not advanced beyond preliminary testing.
[It’s obvious I’m skeptical of the claims here. If the previous record for developing a vaccine was FOUR YEARS, how did they manage to develop –AND TEST– them so quickly (less than a third of that time)? Why weren’t these vaccines pulled after the deadly side effects became apparent? It only took a ‘mere’ 50 deaths to yank the swine flu vaccine; how many THOUSANDS have died/been seriously affected by the clot shots?]
Biden Signs Bill Ending Coronavirus National Emergency.
President Joe Biden on Monday signed a Republican-led bill to terminate the coronavirus national emergency that former President Donald Trump first enacted in March 2020.
Biden’s White House was planning to wind down the national emergency next month on May 11. However, House Republicans put forth bills to end the national emergency before May.
This should have been done in January of 2021. But Biden, Tony the Fauch, CDC, NIH, and the FDA KEPT THIS GOING.
“Under the guise of COVID, President Biden and the Democrats were able to abuse emergency powers and go on a spending spree in order to prevent the American people from returning to normal,” Murphy said in a statement. “After bipartisan votes in both chambers voted to end this declaration, President Bided finally was forced to end this declaration. Medicine needs to be rooted in hard, objective science, not politics.”
“First, @HouseGOP overturned Washington, D.C.’s pro-criminal, anti-police agenda. Now, President Biden signed into law our resolution ENDING the COVID-19 emergency,” Rep. Randy Feenstra (R-IA) tweeted. “Under @SpeakerMcCarthy, House Republicans are delivering real results for American families.”
The GOP-led bill, introduced by Arizona Rep. Paul Gosar (R) passed the House in February by a 229-197 vote. Despite nearly 200 House Democrats voting against the bill, it received bipartisan support in the Senate, which approved it in a 68-23 vote.
With our expectations having dwindled for the ability of the COVID-19 vaccines to end the pandemic, and with growing unease surrounding their longterm side effects, those of us who got the shots are left with the consolation prize of having done the right thing.
But rolling up our sleeves wasn’t a matter of right versus wrong, even though our leaders wanted to make it seem that way.
The prospect of saving lives made it easy to frame vaccine mandates as a moral imperative, but to some that promise was a carrot on a stick they were unwilling to follow. And there was nothing wrong with that.
From the beginning, the pandemic response had us running in lockstep towards unprecedented safety extremes that we were discouraged from questioning, even as those measures began to look increasingly unnecessary. In the back of our minds we had hoped that a vaccine would end the outbreak along with the authoritarian streak that seemed to have been stalking us.
But when the vaccine arrived, it only traded us up from one level of tyranny to the next.
Instead of being leery of the power we were handing our leaders, we let them convince us that snap, unquestioning acceptance of it was a moral urgency.
The science we so dutifully had been following happened to have bent and wended in just such a way to make it necessary that a single QR code scan would stand between every citizen and their access to society, healthcare, education, and employment — perhaps in perpetuity.
The new normal, which we thought couldn’t demand any more from us — between lockdowns, masking, and distancing — now wanted a sacrifice of our bodily autonomy and to install a non-theoretical, centralized mechanism for shutting off disobedient citizens from society.
No amount of moralizing about saving lives was going to convince a conscientious minority that such mounting edicts were a fair trade for our safety. And as we careened toward a future that looked indistinguishable from an authoritarian one, it was precisely their counterbalancing voices that we desperately needed.
So as the majority of us complied, doing our duty to stop the germ, we should have felt solace that others were doing theirs also, doggedly pushing back against a control system we had just given a blank check and all of our trust.
But instead of being leery of the power we were handing our leaders, we let them convince us that snap, unquestioning acceptance of it was a moral urgency.
What we got looked like wartime propaganda, once used to galvanize a nation against an external enemy, now used to turn us against our neighbours and to radicalize support for objectionable government policy.
We were given an hyperbolic choice between total compliance or mass death and were bombarded with daily examples of the good citizen — masked, jabbed, and willing to prove it — compared with the bad — selfish, ignorant, distrusting of authority and clinging to stupid ideas like freedom.
An entire caricature emerged of the “anti-vaxxer,” putting a stink around the mere thought of resistance. Doubt stayed silent and proud displays of compliance became a way to spite the disobedient.
What we got looked like wartime propaganda, once used to galvanize a nation against an external enemy, now used to turn us against our neighbours and to radicalize support for objectionable government policy.
And so we now either hold onto the mobilizing notion that getting vaccinated was “doing the right thing” — in spite of the alternative response being just as principled — or we realize that we lived to experience, first-hand, the kind of mind control that reshapes societies into dystopias overnight.
If we didn’t come close to permanent social restructuring, we went through all of the motions for it. And the backbone of that change was the effort to foist an exclusionary moral ultimatum onto a policy we should have seen in a spectrum of greys. What’s left to be done is to understand that goodwill can be hijacked and to recognize from the example of COVID exactly what it looks like when it happens again.
Dr. Malone’s comments are in italicsand enclosed in <brackets>
Switzerland stops the COVID vaccines, Spike protein kills brain cells, Twitter at war with Substack.
<Note: Switzerland, a non-aligned nation (not NATO, EU, or BRICS) is generally considered the global hub of the pharmaceutical industry. The Government of Switzerland coming out with this position is a clear recognition that objective scientific analysis of the risk/benefit ratio of COVID-19 “vaccines” does not justify “vaccination” in any cohort. Note that the Swiss position is that physicians can prescribe, but will need to carry the risk of liability in the case of adverse events – the exact opposite position of the US HHS position. This clearly demonstrates that this issue has become politicized in the USA, and that the objectivity of HHS decision-making has been compromised. This decision is based in part on the widespread natural immunity which has developed in Switzerland, something which was long denied by the US Government, US corporate media, and US information technology (social media) companies and their NGO surrogates.>
Machine translated from the original German
By Vanessa Renner Report24 April 07, 2023
Bang: Switzerland withdraws all Covid vaccination recommendations
Switzerland stops the Covid vaccinations: all vaccination recommendations have been withdrawn, doctors can only administer the controversial vaccines in individual cases under certain conditions – but then bear the risk of liability for vaccination damage. When will countries like Germany and Austria follow this example?
The Federal Office of Public Health (BAG) and the Federal Commission for Vaccination Issues (EKIF) stated in their vaccination recommendation (as of April 3rd, 2023) (to be found on this website):
In principle, the FOPH and EKIF will not formulate a recommendation for vaccination against Covid-19 in spring/summer 2023 due to the expected low virus circulation and the high level of immunity in the population.
Vaccination is only possible in individual cases – namely:
Vaccination is possible for people who are particularly at risk (BGP) ≥ 16 years of age if the attending physician considers it to be medically indicated in the respective epidemiological situation in the individual case, a temporarily increased protection against serious illness is to be expected and the last vaccination dose at least 6 months ago.
However, no vaccination recommendation for risk patients is explicitly given here.
In the following, it will be discussed that the effectiveness of vaccinations against current variants is reduced and short-lived – especially for people who are at risk. The adaptation of the mRNA vaccine could not keep up with the development of the variants. The recommendations of the BAG could change if there is a new wave of outbreaks, but even then, according to the document, vaccinations are no longer recommended for people under the age of 65.
No positive risk-benefit ratio
The remarks on “Adverse Vaccination Symptoms” (UIE) are also piquant:
According to the current state of knowledge, the risk of severe UIE with a recommended vaccination is much lower than the risk of a complication from Covid-19, against which the vaccination protects. The benefit of the vaccination administered according to the recommendation therefore outweighs the possible risks.
In the case of the valid non-recommendation, this essentially means that there is no longer a positive benefit-risk ratio for any Covid vaccination.
Liability: the federal government is out, doctors have a duty
The new recommendations also have consequences for liability. This is what the BAG document on the Covid vaccination strategy (as of November 29th, 2022) says:
Compensation by the federal government to injured persons for vaccination damage can only be considered for vaccinations if they were officially recommended or ordered (see Art. 64 EpG).
However, the federal government only stepped in if the damage was not covered by the vaccine manufacturer, the person vaccinating or an insurance company. The person vaccinating – i.e. generally the doctor – can be held liable if he has breached his duty of care. In this context, it is pointed out that the same rules regarding patient information apply to the Covid vaccination as to all other vaccinations.
The fact is, however, that very few doctors are likely to have informed their patients correctly about all the risks and side effects and the limited effectiveness of the Covid vaccinations. The off-label use of vaccines (not unusual for Covid vaccinations, for example, the bivalent mRNA vaccines in Switzerland are not approved as first vaccinations, not as a booster for people under the age of 18, and not as a fifth vaccination) must be discussed become. For doctors, the justification of vaccinations is becoming more difficult due to the changed recommendations, according to a BAG document on liability issues:
If the doctor treating you bases his/her choice or prescription on the vaccination recommendations of the BAG, he/she can prove that he/she has observed the recognized rules of medical and pharmaceutical sciences and has therefore complied with the duty of care under the law on medicinal products.
The “Weltwoche” reports that from now on the doctors have to be liable for the vaccination – which should probably decrease their willingness to vaccinate significantly.
<And then there is this article from the same Swiss source, Report 24. Those paying attention may recall that I was perhaps the first to raise the alarm that the SARS-CoV-2 Spike protein is a toxin and that it interacts with the brain, a statement for which I was repeatedly attacked for spreading false information by a wide variety of media including various “fact-checker” organizations which (falsely) asserted that the SARS-CoV-2 Spike protein used in the vaccines had been modified to make it non-toxic. Are those organizations now liable for the damage incurred when patients accepted the COVID-19 genetic vaccines which caused their bodies to make high levels of Spike protein due to their suppression of scientific information required for true informed consent?>
I guess Nancy Reagan was right after all. Drugs kill brain cells. Only different drugs than she was thinking of. Specifically, the drugs that the FDA and CDC call safe and effective “vaccines” which deliver SARS-CoV-2 Spike protein into your body. This is your brain on C-19 vaccines.
The spike protein can be detected on patients’ immune cells for more than a year after infection
By Heinz Steiner
08 April 2023
A recently published German study indicates that the spike proteins from Covid-19 and the Covid vaccines cause brain cell death. Repeated vaccinations seem to be counterproductive in this respect. This can result in permanent brain damage.
Our results showed accumulation of spike protein in the cranial medulla, meninges and brain parenchyma. Injection of the spike protein alone resulted in cell death in the brain, indicating a direct effect on brain tissue. We observed the presence of spike protein in the skulls of deceased individuals long after their COVID-19 infection, suggesting that spike protein persistence may contribute to long-term neurological symptoms.
Of all the SARS-CoV-2 virus proteins, only the spike protein was detected in the brain parenchyma. “This suggests that the spike protein might have a long lifespan in the body. This notion is supported by the observation that spike protein can be detected on patients’ immune cells for more than a year after infection – a recently published preprint suggests that spike protein can be detected in plasma samples up to 12 months after the diagnosis persists.” And further: “Injection of Spike protein induced a wide range of proteomic changes in the cranial cord, meninges, and brain, including proteins associated with coronavirus disease, the complement and coagulation cascades, neutrophilic degranulation, the formation of NETs and the PI3K-AKT signaling pathway, demonstrating the immunogenicity of the SARS-CoV-2 spike protein in the absence of other viral components.”
The researchers further report: “Our molecular analysis suggests an activation of the immune response in the craniocerebral axis, possibly through the recruitment and increase in activity of neutrophils, similar to what has been reported for the respiratory tract.” Furthermore, the viral proteins would act as an inflammatory stimulus, triggering a “significant immune response in the brain”. The study also states: “Proteins associated with neurodegeneration and damage to the blood-brain barrier were the most dysregulated molecules in the brain. The viral spike protein leads to the activation of RHOA, which triggers the disruption of the blood-brain barrier”.
That is why there are mini infarcts in the brain parenchyma and an increased number of microbleeds in Covid patients (vaccinated people, who are also contaminated with large amounts of spike proteins, were obviously not examined by the scientists). This work proves that the spike protein of the SARS-CoV2 and Covid-19 mRNA vaccine enters the skull marrow, meninges, and brain parenchyma. The spike protein also breaks through the blood-brain barrier. Spike protein alone causes cell death in the brain, activates complement and coagulation pathways leading to blood clots, mini-infarcts[heart attacks], and cerebral hemorrhage, and causes inflammation and local changes associated with neurodegeneration (dementia, Alzheimer’s, Parkinson’s).
We should be aware that the repeated administration of such spike proteins via the experimental gene syringes can be compared to multiple corona infections in terms of contamination of the human body with these spike proteins. But the more often such spike proteins are administered, the greater the potential health problems – in this case also in the human brain. We are talking about irreparable damage here, because the brain cells no longer regenerate.
Twitter at war with Substack: So much for the commitment to free speech.
Twitter restricts posts featuring Substack after it rolls out rival service
Twitter is limiting any tweets that include links to Substack in an apparent response to the blogging platform’s launch of a competitor.
Users reported on Friday that any tweets with Substack links in them could not be liked, retweeted, or replied to.
The restrictions were imposed shortly after Substack, a platform for newsletters, announced Notes, its own Twitter competitor. Twitter also restricted the ability of users to embed tweets onto Substack the day before.
“We’re investigating reports that Twitter embeds and authentication no longer work on Substack,” Substack stated on Thursday after users reported that embedding tweets into Substack posts did not work. “We are actively trying to resolve this and will share updates as additional information becomes available.” The Washington Examiner tested the feature and found that direct Substack links were limited, while those with custom URLs were unaffected.
“We’re disappointed that Twitter has chosen to restrict writers’ ability to share their work. Writers deserve the freedom to share links to Substack or anywhere else,” Substack founders Chris Best, Hamish McKenzie, and Jairaj Sethi said in a statement sent to the Washington Examiner. “This abrupt change is a reminder of why writers deserve a model that puts them in charge, that rewards great work with money, and that protects the free press and free speech. Their livelihoods should not be tied to platforms where they don’t own their relationship with their audience, and where the rules can change on a whim.”
Federal Agencies Again Resist a Likely COVID Preventative and/or Treatment?
Are Government Health Agencies acting in the best interest of the public?
Dr. Peter McCullough has a new, interesting post regarding a study about a safe and effective, simple, inexpensive nasal spray for the treatment or prevention of COVID-19. This study was a relatively large, double-blind, Randomized Control Trial (RCT).
I haven’t seen or heard a word about this in the mainstream media, even though it was published back in October of 2022. Maybe it’s me.
So, I did a brief investigation, and found out a few surprising things…
The actual spray used in the above study is a product called pHOXBIO. This doesn’t seem to be approved yet by the FDA (surprise), or available in the US. However, the multiple ingredients of pHOXBIO are listed in the study (section 2.1).
An existing US product that you can buy, Xlear, seems to be comparable, and may also provide similar benefits. It contains Xylitol, which is likely the active agent (see below).
Why haven’t you heard more about this US product? Here is a rough chronological history of the interesting story of Xlear and COVID-19…
01-01-20: Very early on it was understood by the medical community that COVID-19 was an upper respiratory affliction.
05-01-20: An in vitro (e.g., lab petri dish) study concluded that Xlear was effective as a COVID preventative and treatment. (Note: For ailments like COVID-19, treating upper respiratory passages with an anti-viral nasal spray makes logical sense.)
06-01-20: Xlear approached the FDA about doing clinical trials on their nasal spray for COVID-19. Initially, the FDA was responsive, but that was short-lived.
07-23-20: A medical commentary (JAMA) enumerated some likely benefits of an appropriate nasal spray for the treatment of COVID-19.
07-29-20: The FTC sent the Xlear company a Warning Letter. It cites several examples of what they say are unsupported assertions about Xlear and COVID-19. For example, the FTC faulted Xlear for making claims without adequate human studies, etc.
It’s puzzling that this complaint came from the FTC, rather than the FDA.
The claims the FTC objects to appear not to have been made by the Xlear company, but by others. Xlear cited scientific research.
For my scientifically mixed audience, I’m saying that the Xlear nasal spray prevented or treated COVID-19. The Xlear company is using the more technically accurate term: that an appropriate nasal spray can block the COVID-19 virus.
I was told that most of Xlear’s nasal spray competitors (e.g., Nielmed, Navage, Blue Willow Biologics, Halodyne) also received FTC or FDA warning letters.
Apparently, Xlear is the only company that is fighting back.
12-02-20: There was another in vitrostudy that concluded that Xlear was effective as a COVID preventative. It seemed to say that Xylitol was the main active agent.
12-30-20: Evidently the Xlear company continued to go along with the publicity of others about the possible benefits of using Xlear regarding COVID, like this.
10-28-21: The FTC (again, not the FDA!) filed this lawsuit against Xlear for purportedly making claims about it being a COVID preventative or treatment.
Based on how government medical agencies have treated HCL, IVM, etc, this lawsuit could be construed as a back-handed endorsement of Xlear.
10-01-22: As stated above (at the beginning), this is a relatively large, double-blind, Random Controlled Trial (RCT) of a similar (Xylitol-based) nasal spray. The conclusion was that the nasal spray is highly effective with COVID-19:
“The test agent significantly reduced SARS-CoV-2 infection in healthcare workers, with 62% fewer infections when compared to placebo. It was found to be safe and well-tolerated, and offers a novel treatment option for prophylaxis {prevention} against SARS-CoV-2 infection.”
Note that the FTC is unlikely to give Xlear credit for the positive results in this RCT study, as it used a similar nasal spray, not specifically Xlear.
10-06-22: This intermediate court ruling was against Xlear, denying them some of the information they had asked the government to produce (e.g., FDA data).
01-30-23: The FTC filed a further demand that Xlear pay civil penalties. Xlear has 30 days to respond, and I was unable to find one.
So the question here is: why are medical agencies of the government doing things like this? They automatically say that it is “for the public’s benefit” — but is it?
Yes, there are certain unanswered questions here, but consider that for Xylitol based products like Xlear: a) they have an excellent safety profile, b) it’s likely that an appropriate nasal spray would benefit an upper respiratory infection, c) in vitro tests have demonstrated efficacy years ago, d) now an RCT comes to the same conclusion, e) the consumer cost is small, f) such a product could not only be a treatment but a preventative. So such an option is safeandeffective and inexpensive.
Considering all that, why hasn’t the FDA seen that appropriate RCTs were done in mid-2020? or in 2021? or in 2022? What am I missing here?
The Food and Drug Administration is responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices… FDA is responsible for advancing public health by helping to speed innovations that make medical products more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medical products to maintain and improve their health.
The FTC’s mission is to protect the public from deceptive or unfair business practices and from unfair methods of competition through law enforcement, advocacy, research, and education.
Evidently, I am missing something here, as I don’t see the actions/inactions of either of these government agencies, to be genuinely in the best interest of the public.
PS — I just bought some Xlear and Xlear Max to have on hand. Now that I have a reasonable idea of the claims and evidence, it seems to me that the downsides are tiny.
PPS — Here is a reasonable Petition to the CDC started a while back on this topic. It lists several applicable studies that are interesting. Please sign it and pass it on.
In news that has somehow remained entirely unreported in the United States, Dr Anthony Fauci seems to have inked his first gig outside of U.S. Government Health, where he is reportedly still taking a salary.
According to several Italian press reports, Fauci has agreed to serve in a consulting capacity to a newly created “anti-pandemic” bio lab, which is being run by a high-level Italian scientist and longtime pharmaceutical executive.
“American immunologist Anthony Fauci has agreed to act in an informal capacity as a strategic advisor to Rino Rappuoli, scientific director of the Biotecnopolo biotech hub in Siena, an institution founded by the Ministries of the University, Health, Economy and Industry with the aim of focusing on applied research in biotechnologies and life sciences, the Fondazione Biotecnopolo announced this week.”
The news was also reported by Italy’s L’Eco di Bergamo and others, but there seem to be no reports on the matter outside of the country.
Biotecnopolo, the newfound bio lab that is funded by the Italian government, is self-described as “an anti-pandemic hub with a particular focus on the development and production of vaccines and monoclonal antibodies for the treatment of emerging epidemic-pandemic pathologies.”
Rome has already committed hundreds of millions of Euros to the noticeably below-the-radar state-backed project.
In a press release, a board member declared that Fauci’s new role will be “a fundamental step towards making the Biotecnopolo the Italian hub for the research, study and prevention of pandemics”.
Fauci has not released a statement on the matter. Dr Rappuoli did not reply to a request for comment.
It still remains unclear why Fauci, a lifelong American government bureaucrat, has decided to become a consultant for an entity funded by the Italian government. On several occasions, he has spoken highly about his Italian heritage. In 2020, the Italian government awarded him with the Order of Merit of the Italian Republic.
Italy and the United States share a lot when it comes to the humanitarian catastrophes our governments imposed in the name of a virus. Dr. Fauci, campaigned for coronavirus lockdowns that modeled after Italy’s response. What remained unspoken was that Italy got the idea for its brutal lockdowns from China. Both Fauci and Dr Deborah Birx, his longtime mentee, remained committed to the Italian model for several years, declaring Italy as the gold standard for “the measures.”
Moreover, Fauci’s new “informal” relationship with Dr Rappuoli should raise some eyebrows.
Before becoming the chief scientist for the new bio lab, Dr Rappuoli was the head of vaccine research and development at GSK, the Big Pharma behemoth formerly known as GlaxoSmithKline. He is also the Professor of Vaccines Research at Imperial College, London, the home of the infamous computer model simulations that helped to launch the coronavirus hysteria.
GSK is known for record setting fraudulent activity. In 2012, GSK agreed to pay a $3 billion settlement to the U.S. government, breaking Pfizer’s record for the largest health-care fraud settlement for a drugmaker in U.S. history.
Last year, Fauci spoke at a conference organized by GSK on the “role of vaccines in protecting people and the planet.”
So Fauci has now linked up with Big Pharma heavyweights and he’s an advisor for a clandestine bio lab project being financed by the Italian government. What could possibly go wrong?
So what have we learned after three years? Beside MSM, NIH, CDC,FDA, AMA, WHO, and the Biden administration continues to lie to us. I believe that this Thursday is the three year anniversary of “15 Days To Slow The Spread” campaign.
Without a doubt Tony the Fauch and his boss Collins started this campaign of lies and deceit. And yes Trump bought into this great Hoax of Lockdowns and shutdowns.
Only folks who were really in danger were the seniors and those with existing conditions. The folks who were ignored. The big push was to vaccinate the young, healthy, and children.
So what do we do if this happens again? Ignore folks like the Fauch and hope for the best.
DeSantis on Covid lockdowns: “So I call and say, ‘Deborah [Birx], tell me: when in American history has this been done?’ And she says, ‘It’s kind of our own science experiment that we’re doing in real time.’”
The Moment That Shook the World: "15 Days to Slow the Spread" (March 16, 2020)
Fauci: "In states with evidence of community transmission, bars, restaurants, food courts, gyms, and other indoor and outdoor venues where groups of people congregate should be https://t.co/T9CGrYFNjv… pic.twitter.com/k5oaU36YAR
Part of what’s in this report should have come out the first six months of when COVID HIT. I have disagreements with alot of this, but at least they are starting to see the light.
Don’t get me wrong, the WHO was protecting China as was the NIH. CDC and the FDA went along.
Following its 20-23 March meeting, WHO’s Strategic Advisory Group of Experts on Immunization (SAGE) revised the roadmap for prioritizing the use of COVID-19 vaccines, to reflect the impact of Omicron and high population-level immunity due to infection and vaccination.
The roadmap continues SAGE’s prioritization of protecting populations at the greatest risk of death and severe disease from SARS-CoV-2 infection and its focus on maintaining resilient health systems. The roadmap newly considers the cost-effectiveness of COVID-19 vaccination for those at lower risk – namely healthy children and adolescents – compared to other health interventions. The roadmap also includes revised recommendations on additional booster doses and the spacing of boosters. The current COVID-19 vaccines’ reduction of post-COVID conditions is also considered but the evidence on the extent of their impact is inconsistent.
“Updated to reflect that much of the population is either vaccinated or previously infected with COVID-19, or both, the revised roadmap reemphasizes the importance of vaccinating those still at-risk of severe disease, mostly older adults and those with underlying conditions, including with additional boosters,” stated SAGE Chair Dr Hanna Nohynek. “Countries should consider their specific context in deciding whether to continue vaccinating low risk groups, like healthy children and adolescents, while not compromising the routine vaccines that are so crucial for the health and well-being of this age group.”
The revised roadmap outlines three priority-use groups for COVID-19 vaccination: high, medium, and low. These priority groups are principally based on risk of severe disease and death, and consider vaccine performance, cost-effectiveness, programmatic factors and community acceptance.
The high priority group includes older adults; younger adults with significant comorbidities (e.g. diabetes and heart disease); people with immunocompromising conditions (e.g. people living with HIV and transplant recipients), including children aged 6 months and older; pregnant persons; and frontline health workers.
For the high priority group, SAGE recommends an additional booster of either 6 or 12 months after the last dose, with the timeframe depending on factors such as age and immunocompromising conditions. All the COVID-19 vaccine recommendations are time-limited, applying for the current epidemiological scenario only, and so the additional booster recommendations should not be seen as for continued annual COVID-19 vaccine boosters. The aim is to serve countries planning for the near- to mid-term.
The medium priority group includes healthy adults – usually under the age of 50-60 – without comorbidities and children and adolescents with comorbidities. SAGE recommends primary series and first booster doses for the medium priority group. Although additional boosters are safe for this group, SAGE does not routinely recommend them, given the comparatively low public health returns.
The low priority group includes healthy children and adolescents aged 6 months to 17 years. Primary and booster doses are safe and effective in children and adolescents. However, considering the low burden of disease, SAGE urges countries considering vaccination of this age group to base their decisions on contextual factors, such as the disease burden, cost effectiveness, and other health or programmatic priorities and opportunity costs.
The public health impact of vaccinating healthy children and adolescents is comparatively much lower than the established benefits of traditional essential vaccines for children – such as the rotavirus, measles, and pneumococcal conjugate vaccines – and of COVID-19 vaccines for high and medium priority groups. Children with immunocompromising conditions and comorbidities do face a higher risk of severe COVID-19, so are included in the high and medium priority groups respectively.
Though low overall, the burden of severe COVID-19 in infants under 6 months is still higher than in children aged 6 months to 5 years. Vaccinating pregnant persons – including with an additional dose if more than 6 months have passed since the last dose – protects both them and the fetus, while helping to reduce the likelihood of hospitalization of infants for COVID-19.
Thanks to Christopher Cook (former executive editor of The Western Free Press) from The Freedom Scale.
If you’ve been paying attention—and if you’re reading this, then chances are you have been!—you know that ivermectin is effective against covid. You know that ivermectin has been maligned, lied about, and mocked by the mainstream narrative-creation machine. You know that orders came down from the top, and then spread down through the entire medical-pharmaceutical establishment, to make ivermectin nearly impossible to get. The government has even gone so far as to confiscate shipments that people have ordered from overseas.
You also likely know that it is extremely safe, with few side effects; that it garnered a Nobel Prize; and that it has been administered several billion times worldwide since its advent.
That said, you may or may not have seen ivermectin work with your own eyes. Facts tell, but stories sell, and seeing it save someone is powerful stuff. So I am going to share one such story about which I have direct personal knowledge, and whose details I can confirm are 100% accurate.
First, some background…
For an as-yet-unknown reason, this patient appears to be more susceptible to severe covid symptoms. Patient had a strong reaction to Alpha in 2020 and severe symptoms, hospitalization, and multi-month recovery from Delta in the second half of 2021. (One hypothesis for this heightened susceptibility involves overactive immune response, but no dispositive determinations have been made.) Fever in 2021 was over 103˚ for 7 days; patient’s history thus gave strong reason for concern as soon as high fever began to manifest with this most recent infection.
And yet, read the details below and observe the rapid recovery as soon as ivermectin was administered:
Saturday:
Patient complained of upper respiratory symptoms culminating in high fever.
Sunday:
Fever reached 102.6 before administering fever-reducing medication (ibuprofen, acetaminophen). Fatigue, upper-respiratory symptoms strong. Covid test negative.
Monday:
Covid test in AM positive. Ivermectin administered mid-morning (0.6mg/kg). Fever reached 102.8 before administering fever-reducing medication. Fatigue, cough, fog, sputum production all severe. Heart rate elevated. Daytime SpO2 low-mid 90s. Covid test repeated to confirm; still positive. Fever-reducing medication taken before sleep (10PM).
Tuesday:
7 AM wakeup, no fever. Ivermectin administered (same dosage). Daytime SpO2 low-mid 90s. Took until 2pm for fever to slowly climb to 100.8. Fever-reducing medication administered. Fatigue, cough, fog, sputum production, heart rate all improved.
Wednesday:
7 AM wakeup, temperature normal. Ivermectin administered (same dosage). Temperature remained normal all day. Daytime SpO2 low-mid 90s. Fatigue, cough, fog, sputum production, heart rate all significantly improved.
Thursday:
Temperature normal. Ivermectin administered (same dosage). All symptoms further improved. Entering pulmonary-inflammatory phase. Daytime SpO2 variable (91–95) Nighttime SpO2 average 91.
Friday:
Temperature normal. Ivermectin administered (same dosage; final dose). All symptoms significantly improved. Daytime SpO2 variable (93–97) Nighttime SpO2 average 93.
Saturday:
Temperature normal. Covid test negative. All symptoms dramatically improved. Daytime SpO2 variable (94–97) Nighttime SpO2 average 94 (which is low-average for patient).
Sunday:
Temperature normal. Covid test negative result confirmed. All symptoms continue to improve. Daytime SpO2 is between low-normal and normal.
Subsequent days:
SpO2 normal. Minor cough and fatigue linger but improve, and no indication of increase in inflammatory risk.
Notes:
This began as a stronger-than-expected reaction to the current strain, based on reports of mild symptoms for most others. Fever ~103 for two days, with no indication of any pending improvement. Given patient’s previous history, there was strong concern and expectation of severe symptoms and continued high fever. After ivermectin administered, fever went from ~103 to ~101 to normal in under 48 hours, and remained normal thereafter. Symptoms showed significant improvement each day.
Vitamins and other supports were administered, but ivermectin was the main player.
There is always the risk of confusing correlation with causation, and obviously this is a single case study and not a broad scientific study. But given the fact that close to 100 studies have been done…and given the patient’s rapid recovery in spite of apparent susceptibility to severe covid reaction, this does appear to be one more data point in ivermectin’s favor.
Given all we know about ivermectin’s effectiveness, we can rightly say that its vilification, and especially its removal as a medical option for millions of people in America and elsewhere, constitute literal
Does my heart good to see the Fauch lies exposed so all can see. Thanks Newsmax for this great article.
https://youtu.be/soMUg_y3sqw
Fauci Emails and Covid Lab Leak Theory
By Nick Koutsobinas
The New Civil Liberties Alliance (NCLA) has released six video depositions taken in a federal lawsuit that sheds light on what role government actors, including Dr. Anthony Fauci, played in censoring or, as revealed in the Twitter Files, the offshoring of government requests to private social media companies or foreign actors to censor speech around COVID-19.
In his deposition for State of Missouri v. Joseph R. Biden Jr., as NCLA outlines, Fauci “testified ‘I do not recall’ 174 times, and ‘I don’t remember,’ at least 212 times.” According to NCLA, evidence from “his own emails and past statements” indicate the former head of the National Institute of Allergy and Infectious Disease (NIAID) “cast substantial doubt” on his claim to a “failing memory.”
According to U.S. Right to Know, Fauci requested Wellcome Trust Director Jeremy Farrar organize a secret teleconference on Feb. 1, 2020, onstensibly to shift concerns from a lab leak to one of natural origin.
Furthermore, NCLA says, “his deposition testimony — that he genuinely believed COVID had natural origins — conflicts with emails he exchanged with scientists in early 2020, indicating that he believed the lab leak hypothesis could be accurate.”
The recent ruling by Judge Terry A. Doughty of the U.S. District Court for the Western District of Louisiana denying the government defendants’ motion to dismiss has paved the way for the case to continue. The judge was unpersuaded by the defendants’ arguments.
Elvis Chan, who has been named in the Twitter Files, said in his deposition that the FBI played a prominent role in working with Big Tech to sway public opinion. In regard to the wider scope of what’s been termed the “censorship industrial complex,” Chan, on the eve of the New York Post’s Hunter Biden laptop story, sent Twitter’s then-head of site integrity, Yoel Roth, 10 documents. “Within hours,” journalist Michael Shellenberger writes, “Twitter and other social media companies” began censoring the story.
Nonetheless, the recently filed Supplemental Preliminary Injunction Brief as well as the Proposed Findings of Fact reveal a damning effort by the Biden administration and federal officials’ in employing “illicit tactics” to silence voices on social media that presented views on COVID-19 that were otherwise deemed inconvenient or disfavored.
Jenin Younes, litigation counsel for NCLA, said, “These depositions further confirm what other discovery in the case has already demonstrated: Dozens of members of the federal government, including unelected bureaucrats like Dr. Fauci, orchestrated a campaign to shut down debate about COVID-19 related subjects; and they deceived the American public on issues ranging from the lab leak theory to efficacy of masks to the protection offered by naturally acquired immunity to whether the vaccines could prevent disease transmission.”