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$3,000 and a Toy: Novavax Dangles Incentives to Fill Clinical Trials on COVID Shots for Babies, Kids

By Brenda Baletti, Ph.D. | The Defender | August 29, 2024

Novavax is offering parents up to $3,000 to enroll their children in the vaccine maker’s Phase 2/3 COVID-19 vaccine trial for infants and children ages 6 months to 11 years. The offer also includes a stuffed animal for each child.

The “Hummingbird” trial is testing two primary shots and a booster shot of Novavax’s adjuvanted recombinant spike protein nanoparticle vaccine in children. The study, which began in 2022, is enrolling 3,600 children.

The study, which began in the U.S., is expected to run through 2025 and will be conducted in the U.S. and other countries.

The children will receive three injections and visit the clinic eight times. Parents will participate in three phone calls and keep an e-diary of the vaccine’s effects on their child. Some children will receive two additional injections, for a total of five shots.

The study website promises, “You will be compensated for your time and travel regardless of your immigration status. Transportation to the study site may also be provided, as available. No health insurance is required to participate.”

Recruitment materials from Be Well Clinical Studies, which is running one of the U.S. trials, state that compensation can be more than $3,000 over two years.

A 2023 video explaining the study also promises incentives for the children, including “a Covid stuffed animal.”

In the video, a pastor from Louisiana who has four children enrolled in the study said incentives like the stuffed animal made the kids even “more excited than the parents” to participate.

The video features Dr. Jibran Atwi who is running a Hummingbird trial in Lafayette, Louisiana. He encouraged people to participate in the study, because COVID-19 severely affected kids, particularly through lockdowns and lost schooling.

Atwi also said that COVID-19 can be “very disruptive” because if a child has to stay home from school, parents may not be able to go work and the child may have to be isolated from their grandparents.

“Prevention,” he said, “is the best medicine.” He added that there had been an “impressive response” from parents who wanted to participate.

Research shows that young children rarely get sick from COVID-19 and that the illness is typically mild in older kids.

Atwi received over $2 million in research funding in 2023 from Big Pharma, according to the Open Payments website.

Most of that funding came from Genzyme — a Sanofi subsidiary — and from Sanofi, which shares the co-exclusive licensing agreement with Novavax to commercialize its COVID-19 vaccine.

In 2022, Atwi received over $1 million, largely from AstraZeneca and Genzyme.

Last week, the U.S. Food and Drug Administration (FDA) granted emergency use authorization to Pfizer and Moderna’s 2024-2025 mRNA COVID-19 shots, but Novavax’s 2024-2025 formula has not yet been authorized.

The FDA has authorized previous versions of the Novavax vaccine, but only for children ages 12 and up.

High payments place children ‘at risk of coercion’

Other pharmaceutical companies that have paid research subjects large sums of money have come under scrutiny. In the United Kingdom (U.K.), Moderna was criticized for initially offering children’s families 1,505 pounds ($1,984 dollars) to participate in its NextCOVE clinical trial, which is testing Moderna’s mRNA vaccine in children ages 12 and up.

The Children’s Covid Vaccine Advisory Council submitted a complaint to the U.K.’s Prescription Medicines Code of Practice Authority (PMCPA) — an industry trade group that regulates ethical practices — raising concerns about “inappropriate financial inducement” offered to children and their parents to participate in the trial.

The council cited concerns raised by the research ethics committee (REC) that approved the clinical study. Regarding the 1,500-pound payment they wrote:

“This amount seems much higher than what would be considered a reasonable reimbursement and therefore would contravene clinical trial regulations. The Medicines for Human Use (Clinical Trials) Regulations (2004) explicitly prohibit the giving of incentives or financial inducements to children… or their parents.”

The REC said the amount, “placed the children at risk of coercion,” and the organization required that Moderna reduce the offer before recruitment could begin. Moderna reduced the amount to 185 pounds ($244 dollars).

Yet, according to the complaint, at least one pediatrician continued to offer the high enrollment compensation.

The PMCPA sanctioned Moderna, and the case report on the issue is currently pending.

If the PMCPA determines a pharmaceutical company has breached the industry code, it can require the company to pay administrative charges or issue a corrective statement. Or, it may request a compulsory audit of the company.

In the U.S., Be Well is also advertising that it will pay parents $2,400 for enrolling their infants and toddlers, ages 5-23 months, in Moderna’s Rhyme Trial for an mRNA RSV and a human metapneumovirus (hMPV) vaccine.

According to the clinicaltrials.gov website, Be Well withdrew from the Moderna RSV study, but the website is still advertising to recruit participants.

Be Well is run by founder and director Dr. Mark Carlson, a geriatrician, who has taken nearly $3 million in research funding from Big Pharma, mostly from Moderna, since 2021.

Moderna did not respond to The Defender’s inquiry about compensation offered to children’s families to participate in these studies.

This article was originally published by The Defender — Children’s Health Defense’s News & Views Website under Creative Commons license CC BY-NC-ND 4.0. Please consider subscribing to The Defender or donating to Children’s Health Defense.

August 30, 2024 Posted by | Corruption, Video | , , | Leave a comment

CDC, Pharma Giants Angle for Annual COVID Shots Despite ‘Unclear’ Science

By Monica Dutcher | The Defender | August 7, 2023

The U.S. House of Representatives Select Subcommittee on the Coronavirus Pandemic wants to know more about plans by the Centers for Disease Control and Prevention (CDC) to recommend annual COVID-19 vaccines.

During a July interview with Spectrum News, CDC Director Mandy Cohen said she “anticipate[s] that COVID will become similar to flu shots, where … you get your annual flu shot and you get your annual COVID shot.”

As part of the House investigation into federal COVID-19 vaccination mandates and policies, Rep. Brad Wenstrup (R-Ohio) last week sent a letter to Cohen, stating:

“It is unclear if the science supports such a recommendation. If this anticipated CDC recommendation occurs, it will mark a significant change in federal policy and guidance regarding COVID-19 vaccines and the way in which they are utilized.”

Wenstrup requested all documents and communications about any annual — “or any other time-based iteration” — recommendation for COVID-19 booster shots, including correspondence between or among the CDC, U.S. Department of Health and Human Services (also under the subcommittee’s investigation), the White House, the CDC Foundation, CDC contractors and any other CDC stakeholders.

Pfizer, Moderna and Novavax are slated in September to release new single-strain COVID-19 shots targeting the Omicron subvariant XBB.1.5. These vaccines are not yet approved by the U.S. Food and Drug Administration (FDA), but manufacturers are following the June 15 recommendations of the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC).

The committee of 21 independent advisers in June voted unanimously that any new vaccine should protect against just one strain of the virus — a departure from the available bivalent vaccines — and should target one of the three Omicron subvariants currently circulating, including XBB.1.5.

The XBB.1.5 variant spread globally in the first quarter of 2023, reaching dominance in North America, and other parts of the world by April, according to the FDA’s briefing document for the June meeting.

‘We really don’t know what the COVID season is’

FDA advisers in January raised concerns about shifting to a yearly schedule for COVID-19 vaccines. Unlike the flu, which thrives in the winter months, COVID-19’s spread has proved erratic, consistently mutating into new variants.

Dr. Mark Sawyer, professor of clinical pediatrics at the University of California, San Diego, told CNBC that describing COVID-19 as seasonal “could be problematic” because “we really don’t know what the COVID season is.”

Dr. Peter McCullough, author of “The Courage to Face COVID-19: Preventing Hospitalization and Death While Battling the Bio-Pharmaceutical Complex,” told The Defender :

“COVID-19 respiratory illness is now like a mild head cold. There is no seasonal pattern. The COVID-19 vaccines have failed to stop transmission or protect against hospitalization and death.

“The products on the market have theoretical efficacy of less than six months. Annual COVID-19 shots have no clinical indication, medical necessity, are not durable for 12 months and have never been tested for use on a yearly schedule.

“On Dec. 7, 2022 in a U.S. Senate panel on vaccines, I called for all COVID-19 vaccines to be removed from the market because they are not safe for human use. There has been no objection to that testimony from public health officials.”

NBC News reported that Dr. Peter Marks, the FDA’s top vaccine regulator, acknowledged during an FDA advisory committee meeting in January that “simplifying the COVID-19 vaccine schedule to be exactly like the flu may not be possible.”

Pfizer hopes otherwise. The drug company’s chief scientific officer, Dr. Mikael Dolsten, thinks an annual COVID-19 vaccine would improve vaccine sentiment, telling CNBC the public grew dissatisfied with mandates during the earlier stages of the pandemic.

He said:

“Unfortunately some people see vaccines as part of that [the mandates].

“I think of it like the introduction of seat belts for cars. People didn’t want to wear them at first, but over time they realized how much seat belts protect them. Now everyone uses them today. That’s kind of how the vaccine story needs to be reimagined.”

An annual schedule, Dolsten added, may help people view COVID-19 shots as another “very natural part” of protecting their health.

CDC director ‘very worried about parents not vaccinating kids’

In addition to the ambiguity surrounding COVID-19 vaccine scheduling, there is no consensus among medical experts on which patients would be recommended for an annual jab.

Dr. Paul Offit, a vaccine scientist, professor of pediatrics in the Division of Infectious Diseases at the Children’s Hospital of Philadelphia and a member of VRBPAC, took issue with not only the annual model but also with administering COVID-19 vaccines to low-risk groups.

Offit told CNN:

“If the goal of the vaccine is the stated goal, which is protection against severe disease, do you really need a yearly vaccine for otherwise healthy people less than 75? I mean, is this the flu model? Because I would argue it shouldn’t be.”

Health advocacy groups and doctors argue against authorizing mRNA shots in young children and babies. As of July 28 — when data were last updated in the Vaccine Adverse Event Reporting System (VAERS) — there were 6,591 reports of adverse events following COVID-19 vaccination in children under age 6.

Cohen said she is “very worried about parents not vaccinating kids,” telling Spectrum News, “There’s plenty of other things that are hard as parents that we can’t do. This is one we can do to protect our kids.”

McCullough described Cohen as “fully entrenched in the bio-pharmaceutical complex” and “on the wrong side of every pandemic public health intervention.”

Jeffrey A. Tucker, founder and president of the Brownstone Institute, said Cohen’s career has been punctuated by “heartbreaking fear-mongering, pseudo-science, and propaganda,” adding that “she passed with flying colors all three tests of compliance: closures, masking, and vaccine mandates.”

Reduced trust in vaccines and the CDC concerns Cohen, who plans to rehabilitate that trust by focusing on “transparency, execution and building relationships with the public, health leaders and politicians.”

A survey by the Harvard T.H. Chan School of Public Health published in the journal Health Affairs found that roughly a quarter of Americans have little to no trust in the CDC for health information, including 10% who do not trust the agency at all.

The CDC currently recommends the primary series of mRNA shots, or the first two doses of the updated vaccine be given weeks apart, followed months later by a booster shot. The FDA updated its guidance for these shots in August 2022 to contain a bivalent formulation targeting the original viral strain plus the BA.4 and BA.5 Omicron subvariants.

Pfizer is working on a combined flu/COVID-19 vaccine, expected to be available after 2024. Moderna is also working on a “next-gen flu-COVID combo” vaccine. Other vaccine makers are following suit.

Monica Dutcher is a Maryland-based senior reporter for The Defender.

This article was originally published by The Defender — Children’s Health Defense’s News & Views Website under Creative Commons license CC BY-NC-ND 4.0. Please consider subscribing to The Defender or donating to Children’s Health Defense.

August 7, 2023 Posted by | Science and Pseudo-Science | , , , , , , | 1 Comment

What to Know Before Deciding to Take The Novavax Injection

Accepting an injection of spike protein hoping it is safe or effective is absurd. Yet, many are again forced to make a decision threatening their health and ability to support their family.

By Pierre Kory, MD, MPA | August 17, 2022

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

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

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

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

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

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

So, conceptually, I think the idea of getting any coronavirus vaccine at this point is preposterous. However, let’s try to do a more traditional informed consent using the structure of risks/benefits/alternatives. The following is what I think other providers (or pharmacists egads) should be telling people prior to offering them Novavax, or more accurately, in order to get them to avoid it.

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

RISKS

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

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

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

SHORT TERM RISK DATA

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

Click for full size

Here is how I interpret the data:

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

Conversely, a dose-response in terms of side effects is a pillar of the measure of toxicity. The more you give, the sicker you get. Not cool. Now take a look at Pfizers published chart above, keeping in mind, these are only the short term systemic side effects.

  1. Pfizer: fatigue goes from 47% after the 1st to 59% after the 2nd in young folks and 34% up to 51% in older folks. Chills: 14% to 35% in young, 6% to 23% in old. Same pattern and increases with muscle pains and also joint pains and use of anti-pyretic medications.
  2. Now, take a look at Novavax. Note how they don’t give you the numeral percentages and instead make you crane your neck and use a ruler to estimate the actual incidences and increases. But just looking at the height of the bars from shot 1 to shot 2 and the increases in the yellow at the tops of the bars (yellow = “Grade 3” reactions – i.e. more severe), you see again what looks like a scary shot to me with some of the local and systemic events reported even higher than with Pfizer’s mRNA shot! So, is Novavax safer?

LONG TERM SIDE EFFECTS. Unknown. Remember the famous, “I guess we will just have to give it to see how safe it is” by one of the nations top vaccine experts. I swear, again, and I say this often, you just cannot make this stuff up. So, an informed consent discussion should relate that long term side effects are unknown. Remember as well, we are not in a supposed “emergency” anymore, despite the fact our government keeps renewing its emergency powers. If the person conducting this discussion tries to argue that in terms of long term effects, it is safe and effective because the mRNA vaccines were safe and effective, that is so categorically ridiculous it does not even bare addressing. Again, read my “Vaccine Exemption Letter” post for the data on toxicity and lethality of those vaccines. Do not proceed. My caution would be that spike protein is a pathogen with sequences that we know generate antibodies that then are capable of attacking many tissues (what are called autoantibodies which cause a category of diseases called “auto-immune” diseases). Also, spike protein, when broken down by the body is known to generate amyloid like fragments which are highly thrombogenic (i.e. cause clotting). Spike protein also stimulates immune cells called monocytes and macrophages which disturb numerous organ functions. Spike protein is also toxic to mitochondria which are the energy producing parts of each cell. In summary, don’t sign up for any more spike protein than is already circulating in the world.

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

EFFICACY

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

ALTERNATIVES TO VACCINATION

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

Hope this helps.

P.S. I opened a tele-health clinic providing care not only in the prevention and treatment of acute COVID, but with a specialized focus on the study and treatment of both Long-Haul and Post-Vaccination injury syndromes. If anyone needs our help, feel free to visit our website at www.drpierrekory.com.

P.P.S. I am getting professional help (hah!) to write a book about what I have personally witnessed and learned during Pharma’s historic Disinformation war on ivermectin. Pre-order here for:

August 17, 2022 Posted by | Science and Pseudo-Science, Timeless or most popular, War Crimes | , , | Leave a comment

What You Don’t Know Could Hurt You: Novavax’s ‘Loud-and-Clear’ Nanoparticle Adjuvant

The Defender | July 20, 2022

In recent months, COVID-19 vaccination in the U.S. has “slowed to a crawl” as an increasingly distrustful public says “no thanks” to primary shots and boosters.

Still, U.S. public health agencies continue to authorize, approve and recommend COVID-19 vaccines — even for infants.

On Tuesday, advisors to the Centers for Disease Control and Prevention (CDC) — perhaps believing they can reverse the slowdown in “vaccine uptake” and without admitting to the ravages caused by the Pfizer/BioNTech, Moderna and Johnson & Johnson (J&J) shots — unanimously recommended the “Novavax COVID-19 Vaccine, Adjuvanted.”

The U.S. Food and Drug Administration (FDA) last week granted Novavax Emergency Use Authorization (EUA) for its COVID-19 vaccine, for adults age 18 and up.

Back in 2020, Operation Warp Speed awarded Novavax — another company that like Moderna, never brought a product to market before COVID-19 — a secret contract worth $1.6 billion (now being reported as $1.8 billion).

It was one of the largest taxpayer handouts channeled through Operation Warp Speed.

The media’s obliging sales pitch is that the Novavax injection is a “game changer” in comparison to the mRNA and adenovirus-vectored gene therapy shots, and should be “reassuring to those who are hesitant.”

In fact, according to the CDC’s advisors, the unvaccinated represent the “primary target population for Novavax.”

To further entice the unvaccinated, headlines feature the misleading claim that Novavax’s EUA jab — featuring recombinant moth-cell-based nanoparticle technology, the problematic surfactant polysorbate 80 and a never-before-approved nanoparticulate adjuvant called Matrix-M — is “free of side effects.”

However, the day after the FDA issued its Novavax authorization, the European Medicines Agency (EMA) made its own announcement, stating it was updating its product information for the Novavax COVID-19 shot to disclose “new” side effects.

The EMA’s list of side effects included “severe allergic reaction [anaphylaxis] and unusual or decreased feeling in the skin” (called paresthesia and hypoesthesia, respectively).

In addition, the EMA said it is assessing myocarditis and pericarditis as Novavax side effects — safety signals that also were on display in the FDA’s briefing document.

And in clinical trials, older adults who received the Novavax vaccine experienced an increased incidence of hypertension compared to those in the placebo group.

In short, as reported last week and last month by The Defender, the evidence contradicts Novavax’s downplaying of its vaccine’s association with heart problems and other side effects.

Apparently unaware of any potential cardiac risks, die-hards who have swallowed the slanted Novavax messaging blithely suggested in online comments that they would take bizarre skin problems over the heart problems they associate with other COVID-19 vaccines any day.

Adjuvants — ‘leave them out if you can’

Adjuvants, sometimes referred to as “the immunologist’s dirty little secret,” are components of at least 80% of all vaccines. They are supposed to “stimulate and enhance the magnitude and durability of the immune response.”

Additional adjuvant actions include modifying or broadening the immune response in certain age groups (such as infants and older adults) who tend not to respond to vaccines as strongly as vaccine makers would like, and increasing the body’s uptake of the vaccine antigen and protecting the antigen “from degradation and elimination.”

Less often admitted is the sordid association between adjuvants’ tenacious and “immunostimulatory” properties and systemic adverse events — such as neurotoxicity, “enigmatic” autoimmune issues (dubbed “autoimmune/inflammatory syndrome induced by adjuvants” or “ASIA” by Israeli autoimmunity expert Yehuda Shoenfeld), narcolepsy, infertility and other wild-card effects.

For these reasons, Dr. Martin Friede — lead scientist at the World Health Organization’s (WHO) Initiative for Vaccine Research — candidly remarked to other global vaccine insiders in late 2019, “We do not add adjuvants to vaccines because we want to do so” but out of perceived necessity.

Friede added:

“The first lesson is, while you’re making your vaccine, if you can avoid using an adjuvant, please do so. Lesson two is, if you’re going to use an adjuvant, use one that has a history of safety. And lesson three is, if you’re not going to do that, think very carefully.”

Undermining these seeming appeals to safety, Friede has since gone on to shill for Pfizer’s COVID-19 shot and for mRNA vaccine technology more broadly.

Nanoparticles times two

For many decades, aluminum-based adjuvants were the only game in town.

However, with the burgeoning of nanotechnology and encouragement from sponsors like the National Institutes of Health, manufacturers shifted gears toward a new generation of “novel” nanotech adjuvants designed to not only amplify vaccine responses but also to serve as carrier systems that distribute the vaccine’s payload to “key cells of the immune system.”

Generally left unmentioned in the hype surrounding these next-generation, nanoparticle-based adjuvants is the abundant evidence of nanoparticle toxicity.

Well before COVID-19 vaccines came along, researchers warned about nanomaterials’ ability to “cross biological membranes and access cells, tissues and organs” — such as the brain, heart, liver, kidneys, spleen, bone marrow and nervous system — “that larger-sized particles normally cannot.”

They also cautioned that in the cells, “nanomaterials may be taken up by cell mitochondria and the cell nucleus,” with the potential for DNA mutation, structural damage to mitochondria and cell death.

Moreover, researchers identified extensive biotoxic impacts of nanoparticles on the cardiovascular system, including “cardiac damage and dysfunction, vascular dysfunction, EC [epithelial cell] abnormities [sic], atherosclerosis, abnormal angiogenesis, platelet activation, blood coagulation and thrombosis.”

Nevertheless, in pre-COVID-19 studies of experimental vaccines containing Novavax’s Matrix-M, researchers waxed enthusiastic about the nanoparticle-based adjuvant’s “significant” and “potent” action — including its strong “immunostimulatory properties” even without any accompanying antigen.

And, where nanoparticles are concerned, the Novavax COVID-19 shot actually delivers a double whammy, combining Matrix-M with genetically engineered spike protein nanoparticles.

As Novavax explains it (for some reason putting the word “adjuvant” in quotes), “The spike protein is the ‘signal,’ but … we want your immune system to hear that signal loud and clear [and] that signal boost comes from our Matrix-M ‘adjuvant.’”

Phospholipids and autoimmunity

Not unlike the lipid nanoparticle “carrier systems” in the Pfizer and Moderna COVID-19 injections, the “immunostimulant” Matrix-M adjuvant includes two types of fat molecules — cholesterol and phospholipids — bundled with detergent-like saponins.

In human biology, phospholipids are essential for properly functioning cell membranes. But in the vaccine laboratory, synthetic versions are viewed as “essential components of advanced vaccines.”

Unheeded by the pharmaceutical industry is the fact that up to 5% of healthy individuals are estimated to harbor antiphospholipid antibodies, produced in a “mistaken” autoimmune response.

Researchers have linked the autoantibodies to the risk of antiphospholipid syndrome (APS), an autoimmune disorder characterized by recurring blood clots as well as fetal loss, fetal growth retardation and other obstetric complications.

Although researchers claim to be baffled as to why some people develop APS, studies have noted the emergence of APS and other autoimmune conditions following receipt of numerous vaccines, including those against tetanus, influenza, human papillomavirus (HPV) — and now COVID-19.

In a study published in August 2021, the authors suggested that in people with preexisting antiphospholipid antibodies, both the mRNA and adenovirus-vectored COVID jabs — and presumably other types such as the Novavax injection — could plausibly function as “the straw that breaks the camel’s back,” triggering “aberrant activation of the coagulation pathway.”

Rheumatologists are also reporting surges in blood clotting disorders, including APS.

Will the unvaccinated public take the bait?

In 2005, the EMA mused that while new adjuvants often had trouble gaining approval due to safety concerns such as “acute toxicity and the possibility of delayed side effects … an increased level of toxicity may be acceptable if the benefit of the vaccine is substantial.”

In a 2017 study, investigators studying Matrix-M approvingly noted that “rapid activation” of the immune system “is highly desirable in adjuvants used for emergency vaccination.”

With its authorization of Novavax’s souped-up COVID-19 jab, the FDA appears to have endorsed both of these views.

Outside the U.S., Novavax’s potent adjuvant also is being test-driven in children in the African nation of Burkina Faso, where almost 1 in 10 of the unfortunate toddlers who received an experimental Matrix-M-containing malaria vaccine withdrew or were “lost to follow-up” before or just after the third dose.

Acknowledging only seven serious adverse events, the researchers concluded, “None … were attributed to the vaccine.”

Does Novavax even take its product seriously?

In a comment posted at Yahoo!Finance, a person who signed up for the Novavax clinical trials and then, after researching the untried company, decided to withdraw, noted the doctor running the trial responded, “Oh sure, that’s fine. You want to wait and get one of the real vaccines.”

In another sign of Novavax’s lackadaisical corporate attitude, the labels on the COVID-19 vaccine vials will contain no information about expiration dates, forcing healthcare providers into using an “online expiry date checker tool,” which CDC advisors acknowledge could be both burdensome and a source of “confusion.”

The Merriam-Webster dictionary defines a “nova” as “a star that suddenly increases its light output tremendously and then fades away to its former obscurity in a few months or years.”

Will we say the same for “Nova”-vax’s shot in a few months’ or years’ time?

© 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.

July 21, 2022 Posted by | Aletho News | , , | Leave a comment

COVID-19: RDIF Points to Absence of Long-Term Studies on Vaccines Based on Monkey Adenoviral Vectors

By Aleksandra Serebriakova – Sputnik – 09.09.2020

The third round of trials for the AstraZeneca anti-COVID-19 drug is now on pause over “potentially unexplained illness” in a participant in the UK. On 11 August, Russia registered its own Sputnik V anti-coronavirus vaccine, which is said to have been developed in a different way.

The Russian Direct Investment Fund (RDIF) the investor which has funded the development of Russia’s Sputnik V anti-coronavirus vaccine, could not comment on the halt of AstraZeneca trials, it said in a statement.

However, RDIF pointed out that the fund’s CEO Kirill Dmitriev had previously discussed the differences between the human adenoviral vector-based platform used in Russia’s Sputnik V vaccine and those used by some of their international colleagues, that rely on “novel unproven technologies such as monkey adenoviral vectors or mRNA”.

“The safety of the human adenoviral vector used in Sputnik V has been proven over decades in over 250 clinical studies, as human adenovirus has been shown to be the safest vaccine delivery mechanism and the most ‘organic for humans’, as human adenovirus has coexisted with humans for over 100,000 years,” RFID said.

Meanwhile, “mRNA and monkey adenoviral vector-based platforms have not been studied over a long period of time,” RDIF CEO Dmitriev pointed out this Tuesday.

Commenting on the so-called “pledge of safety” earlier voiced by the CEOs of AstraZeneca, BioNTech, GlaxoSmithKline, Johnson & Johnson, Merck, Moderna, Novavax, Pfizer and Sanofi in relation to the development of the first COVID-19 vaccines, Dmitriev stressed that this plea was “insufficient” as it did not “discuss the lack of long-term studies on the carcinogenic effects and impact on fertility of newly-developed vaccine technologies”.

“Since some of the companies developing these vaccines have taken the ‘pledge of safety’, we would like to stress that public health and safety requires not only short-term evidence of a lack of serious adverse effects, but also the safety and efficacy proved by the results of long-term studies,” Dmitriev added.

AstraZeneca COVID-19 Vaccine Trials on Pause

It was revealed this week that the third round of trials for the AstraZeneca anti-COVID-19 vaccine has been halted due to a “potentially unexplained illness” which had developed in a participant in the United Kingdom, without further specifications about the nature of possible side effects. The vaccine in question was developed in partnership with Oxford University and has reportedly involved around 30,000 participants in the UK, US, Brazil and South Africa. AstraZeneca described the pause as “routine” so as to allow for a “standard review process” of “safety data”.

Russia’s First Anti-Coronavirus Vaccine

On 11 August, Russia registered the world’s first vaccine against COVID-19, called Sputnik V, which was developed by the Gamaleya National Research Centre of Epidemiology and Microbiology and the RDIF after several rounds of clinical trials. On Monday, the vaccine was made available to the public.

According to RDIF, Russia has now received requests for 1 billion doses of the vaccine; at least 20 countries, including the UAE, Saudi Arabia, Indonesia, Philippines, Mexico, Brazil and India, have expressed an interest in obtaining Sputnik V.

September 9, 2020 Posted by | Aletho News | , , , , , , , , , | Leave a comment