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$3,000 and a Toy: Novavax Dangles Incentives to Fill Clinical Trials on Covid Shots for Babies, Kids
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.
åThe 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.
‘I Will Kill You and Your Families’ – Somali Migrant Stabs German Man in the Neck in Small Town, 30 Police Officers Make Arrest
In yet another knife attack involving a foreigner, a Somali man stabbed a 46-year-old man in the neck outside a supermarket in the small town of Waltershausen. Thirty police officers arrived on scene and took him into custody.
At 5:30 p.m., the incident started with the 27-year-old Somali man purposefully coughing on customers at random inside the “Netto” discount supermarket. He then began threatening them and randomly entering into arguments with various customers.
When a 46-year-old man asked the Somali man to stop, the Somali man allegedly threatened to kill him. The victim then told the Somali to calm down, at which point the Somali stabbed him in the neck, according to the Welt newspaper.
??‼️ “Germany is no longer a safe country… The migration crisis is first and foremost a crime crisis.”
— Remix News & Views (@RMXnews) August 28, 2024
German police union (DPoIG) chairman Manuel Ostermann makes a major statement following the Solingen terror attack by a Syrian Islamist. pic.twitter.com/ZolmrLnMHa
The victim was able to evade the attacker, thus preventing further stab wounds, and other witnesses nearby intervened to stop the Somali. The victim was able to escape with only minor injuries, despite suffering a stab wound to the neck.
The incident triggered a major police operation, with 30 police officers arriving on scene to arrest the Somali man, who was intoxicated. He is now being charged with attempted manslaughter, violent disorder, and threats. He is known for previous crimes as well and has convictions on his record.
“The accused reportedly said to the victim and other people, ‘I will kill you and your families.’ He is then said to have stabbed the victim in the neck with a knife and knowingly accepted his death,” said a public prosecutor.
He faces 15 years in prison.
The small town, which is 50 kilometers west of Erfurt in the eastern state of Thuringia, is one of the strongholds of the Alternative for Germany (AfD) party in the country. Voters will elect a new state government there on Sunday, with the AfD expected to get at least 30 percent of the vote.
The stabbing attack follows a wave of knife crimes involving migrants, including the Solingen knife attacks which killed three Germans at the Festival of Diversity a week ago. Foreigners now account for a record share of violent crimes in the country, as per government statistics from 2023.
?? Germans say they’re “shocked” about the mass stabbing by a Syrian national at the “Festival of Diversity” in Solingen.
— Remix News & Views (@RMXnews) August 28, 2024
But there is nothing to be shocked about. Knife crime in Germany is soaring, predominately due to mass immigration.
That is a statistical fact. pic.twitter.com/NWAxJp2gBe
UK: Starmer Moves One Step Closer to Reversing Brexit
Sir Keir Starmer, Britain’s new and unpopular Labour prime minister, travelled to Germany yesterday to tell Chancellor Olaf Scholz that he wants to “turn a corner” on Brexit.
As with his previous calls to “reset” relations with the European Union, his speech alongside Scholz hinted at even weaker borders and more rule-taking from Brussels under a Starmer government.
Never mind the fact that more Britons voted to leave the EU in 2016 than have voted for any other electoral option in the nation’s history—and that the vote was deeply tied to the all-important issue of immigration. Nor that the electorate doubled down on this in both the 2019 European elections and general election, during which the then-prime minister Boris Johnson promised to “get Brexit done.” Nor, indeed, that the Tory failure to properly see Brexit through played a large part in the party being thrown out of office in July.
Even as Starmer tries to deny it—just as senior Labour figures spent months talking down the idea they would implement (now-incoming) major tax rises—Brussels officials have been quite clearthat the EU will only agree to Starmer’s “reset” plans if he agrees to ease immigration controls for young Europeans to come to the UK.
Adding insult to injury, Starmer even used a catchphrase repeated ad nauseam during the 2016 referendum campaign when describing his intention to effectively undo parts of Brexit as a “once-in-a-generation opportunity.” Of course, he never did believe that phrase when it was used in 2016, since he later went on to campaign for a second referendum on EU membership.
On the morning of Starmer’s talks with Scholz, an SPD spokesman pointed to the “constant push by the German government to bring the UK closer to Europe and to facilitate cooperation between Great Britain and the EU in as many fields as possible, ranging from trade to student mobility rights to defence.” Most notably, he added that regarding all this, the two leaders are “more or less on the same page.”
In order to keep up the momentum, Starmer is today, on August 29th, in France to discuss closer UK-EU relations—“closer,” said the PM, “than ever before”—with President Emmanuel Macron. The BBC reports that some form of treaty with EU leaders will be signed within the next six months.
But “who,” asked journalist Mick Hume in the Mail, “voted for that?”
Certainly not the 17.4 million citizens who put their X in the box marked “Leave” in the 2016 referendum, which was billed as a “once-in-a-generation” chance to “take back control.” That’s getting on for twice as many as the 9.7 million who voted Labour in July. Or, to put it another way, just 20 per cent of the electorate.
Journalist Patrick O’Flynn added that to “kibosh” developing plans “would require pro-Brexit political parties also to get their acts together: a strong Tory revival under a charismatic new leader; some kind of sensible accommodation with Nigel Farage’s Reform party.”
And we are, alas, a very long way away from that.
BREAKING: Brazil’s Top Tyrant Threatens to Charge Elon Musk with Obstruction of Justice & Ban X
On Thursday Alex Jones covered how Brazilian Supreme Court Justice Alexandre de Moraes, a dracule, is threatening Elon Musk over his X platform.
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Recycled Plastics are a Nightmare Concoction of BPA & Phthalates, But Recycling Makes a Great Cover Story for ‘Greenwashing’ the Plastics Industry
Keeping plastic bottles out of the landfills and waterways is a conscious, sustainable pursuit; however, these plastic chemicals are often recycled into new packaging materials, creating an unknown blend of synthetic chemicals that leech into the food supply, harming human health. While trying to protect the environment, we may inadvertently be harming ourselves, and the regulatory agencies are asleep at the wheel on the issue.
The U.S. Food and Drug Administration (FDA) is facing mounting criticism over its lack of oversight concerning the recycled plastics that are used in new food packaging. Researchers warn that chemical companies are practically regulating themselves, incorporating a nightmare concoction of phthalates and BPA into recycled plastics. Unknown combinations of synthetic chemicals are being intermixed into new food packaging materials, ensuring that the current food supply is full of endocrine-disrupting carcinogens. To make matters worse, the FDA’s approval process does not adequately safeguard against the potential risks of toxic chemicals leaching into food products.
FDA’s review of recycled plastics is a voluntary process that allows companies to do whatever they want
Since the early 1990s, the FDA has approved over 340 voluntary applications for food contact materials made from recycled plastics, with the number of approvals increasing significantly in recent years. Approvals for recycled plastic products have tripled since 2019, going from 7-8 approvals per year prior to 2019 to an average of 23 approvals per year since.
For example, major companies like Coca-Cola and General Mills have adopted recycled plastics for their products, including Coca-Cola’s 100% recycled PET (polyethylene terephthalate) bottles and General Mills’ Annie’s cereal boxes with 35% recycled plastic liners.
Companies that seek approvals include some of the biggest petrochemical companies around, including Eastman Chemicals, DuPont and Indorama. These manufacturers, along with companies from India and China, exert significant influence over regulators, especially when so much money is put into plastic recycling in the first place. Moving new products in the cheapest recycled plastic is the ultimate goal, as companies want to appear sustainable, while reaping max profits.
This is why the FDA’s approval process for these materials has been criticized for its lack of rigor and transparency. Unlike other regulatory processes, the FDA’s review of recycled plastics is voluntary, meaning companies are not required to submit comprehensive safety data or undergo mandatory testing unless they choose to. The FDA’s reliance on industry-provided data is insufficient for identifying potential health hazards.
Recycled plastics are a BPA and phthalate nightmare
Researchers have pointed out that recycled plastics may contain a cocktail of toxic chemicals that may leach into food products. Studies indicate that recycled PET, commonly used in bottles, can harbor substances like bisphenol-A (BPA), phthalates and other hazardous chemicals at higher levels than virgin PET. These substances are linked to various health issues, including endocrine disruption, cancer and developmental problems.
Dr. Maricel Maffini, a scientist with Environmental Health News, argues that the FDA’s approach to approving recycled plastics is “very lax.” The agency primarily concerns itself with pathogen contamination rather than the complex chemical mixtures present in recycled materials.
The recycling process itself introduces additional complexities. Recycled plastics are often collected from mixed sources, including potentially hazardous items like pesticide containers. Furthermore, the degradation of plastics during recycling may necessitate the addition of stabilizers and other chemicals, increasing the risk of harmful substances leaching into food.
FDA spokesperson Enrico Dinges, defends the agency’s review process for having “stringent scientific guidelines” and says the agency has the capability to conduct spot tests if necessary. However, Professor Tom Zoeller from the University of Massachusetts Amherst says the FDA’s approach is outdated, noting that its safety standards are based on evaluating single chemicals rather than the complex mixtures found in recycled plastics. Zoeller and others suggest that the FDA should adopt more modern testing methodologies that consider endocrine-disrupting chemicals and the cumulative effects of chemical exposures.