Tag: fda

FDA approves Gates-backed bird flu vaccine trial: ‘Disaster waiting to happen’

The FDA has approved the first phase of human trials for a self-amplifying mRNA bird flu vaccine developed by Arcturus Therapeutics, funded by the US government and the Gates Foundation. This vaccine, targeting the H5N1 virus, introduces an enzyme prompting cells to produce more mRNA, leading to sustained antigen production, which experts warn could lead to prolonged immune activation and unknown health risks.

Epidemiologist Dr. Nicolas Hulscher described the FDA’s approval as an opportunity for Arcturus to “experiment with injecting humans with H5N1 bird flu replicon mRNA.” The clinical study is funded by the Biomedical Advanced Research and Development Authority (BARDA), a division of HHS focused on pandemic preparedness. Arcturus also recently received a $928,563 grant from the Gates Foundation, which has long supported mRNA research.

Arcturus claims self-amplifying mRNA vaccines can provide immunity with smaller doses. However, Hulscher warned that even a small dose might be more hazardous due to the vaccine’s self-replicating nature, as the extent of antigen production cannot be precisely measured or controlled.

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Arcturus Therapeutics is seeking approval from the FDA to go ahead with self-replicating bird flu vaccine trials

Self-amplifying RNA (“saRNA”), also termed self-replicating RNA (“srRNA”), and self-amplifying mRNA (“sa-mRNA” or “samRNA”) are synonymous terms. Both refer to a synthetic mRNA molecule engineered to replicate itself within host cells.  Vaccines using this self-replicating technology are also called “replicon” vaccines.

In November 2023, Japan approved the use of the first saRNA vaccine against covid.  The vaccine is called Kostaive and is also known as ARCT-154 or, in Vietnam, VBC-COV19-154. It is a CSL and Arcturus Therapeutics vaccine.  At the time of the approval, researchers were hopeful that this was only the beginning for saRNA treatments for infectious diseases and even cancers.  The vaccine, which the Japanese are referring to as the “third atomic bomb,” began to be rolled out in Japan in October 2024 as part of its autumn covid vaccination programme.

There is only explicit mention of Kostaive using STARR mRNA technology. However, it is likely that the Kostaive “vaccine” uses both of Arcturus Therapeutics’ proprietary technologies: STARR (self-transcribing and replicating RNA) mRNA technology and LUNAR (lipid-mediated universal RNA delivery) delivery system.

LUNAR is a nanoparticle delivery system that enables the efficient and targeted delivery of mRNA to cells. STARR is a self-replicating RNA platform that combines with LUNAR to drive “therapeutic” protein expression.

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FDA Greenlights New Bill Gates-Funded ARCT-2304 Self-Replicating samRNA ‘Pandemic’ H5N1 Bird Flu Jab

Arcturus Therapeutics, a company specializing in mRNA-based pharmaceuticals, quietly announced Monday that the U.S. Food and Drug Administration (FDA) has granted approval for its Investigational New Drug (IND) application for ARCT-2304, a self-amplifying mRNA (sa-mRNA) injection targeting the H5N1 avian influenza “bird flu” virus.

The FDA has recently come under fire for “failing to meet safety requirements” and “failing to prioritize scientific data quality delivered from FDA laboratories,” according to the U.S. House of Representatives Committee on Energy and Commerce.

The new Arcturus trial, funded by the Biomedical Advanced Research and Development Authority (BARDA), aims to assess ARCT-2304’s efficacy in preventing pandemic influenza and plans to enroll around 200 healthy adults across the United States.

“Arcturus is actively engaged with the U.S. government to prepare for the next pandemic, and clearance to proceed into the clinic with our STARR® self-amplifying mRNA technology is a key step in this important process,” said Joseph Payne, President & CEO of Arcturus Therapeutics in a press release.

“The Phase 1 clinical trial is designed to evaluate the safety, reactogenicity, and immunogenicity of ARCT-2304 as a potential vaccine to protect against the highly pathogenic H5N1 avian influenza.”

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Big Pharma CEO’s Call Emergency Meeting After RFK Jr. Vows To Gut Corrupt FDA

The top five CEOs of major pharmaceutical companies appear to be in ‘panic mode’ and have reportedly convened an emergency meeting following Donald Trump’s historic election win.

Following Trump’s election victory, RFK Jr warned that entire departments of the Food and Drug Administration would “have to go”.

Jamel Holley, a New Jersey assemblyman and advisor to Robert F. Kennedy, Jr. said: “Sources tell me top five CEOs of pharmaceutical companies are holding an emergency teleconference at 1 PM. A lawyer has confirmed that everyone is in a state of panic!”

InfoWars reports: Additionally, Holley noted that major pharma stocks are sliding due to an “increasing threat environment” thought to be represented by Kennedy’s role in reforming public health agencies during the next Trump administration.

Kennedy said Wednesday he aims to drastically cut “entire departments” in the Food and Drug Administration, which regulates products related to public health and safety in the U.S.

“The nutrition department of the FDA has to go. They’re not doing their job. They’re not protecting our kids. Why do we have Froot Loops in this country that have 18 or 19 ingredients, and you go to Canada and it’s got two or three?” he asked MSNBC.

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RFK Jr. Declares War on Big Pharma: Vows to Clear Out ‘Entire Departments’ at the FDA in Push for Health Reform

Robert F. Kennedy Jr., known for his relentless stance against corporate influence in health policy, is now taking direct aim at the entrenched bureaucracies within the U.S. health agencies.

As a possible future Trump administration appointee, RFK Jr. has laid out a plan to rid the FDA and other key federal agencies of the deeply-rooted corruption that prioritizes corporate profits over public health.

Recall that Trump said that if he is elected, Kennedy will work on “health and women’s health ” and the nation’s food supply.

“Robert F. Kennedy Jr. we have. And he’s going to work on health and women’s health and all of the different reasons, because we’re not really a wealthy or a healthy country,” Trump said during his rally in Nevada.

“I told Bobby, ‘I want you to take care of health, I want you to look at the food and the food supply and what we put on the food and all sorts of — you can look at, but let me handle the oil and gas, Bobby,’” Trump added.

In Kennedy’s crosshairs are not only the FDA but also the Department of Health and Human Services (HHS), the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), and the Department of Agriculture (USDA).

On Saturday, Robert Kennedy Jr. announced that the Trump administration would advise all U.S. water systems to remove fluoride from tap water on day one.

“On January 20, the Trump White House will advise all U.S​. water systems to remove fluoride from public water,” Kennedy wrote. “Fluoride is an industrial waste associated with arthritis, bone fractures, bone cancer, IQ loss, neurodevelopmental disorders, and thyroid disease. President ​Donald Trump and First Lady Melania Trump want to Make America Healthy Again.”

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FDA Knows That China and India Drug Quality Is Poor, But Independently Collects and Tests Only about 0.001%

Quality control errors during pharmaceutical manufacturing are unfortunately common occurrences. The majority (around 50%) of employees that work in pharmaceutical manufacturing tend to have duties which are safety/quality-control related, but apparently even that isn’t enough. 

Even with a major focus on quality, there is still an estimated 2-3σ (sigma) level of imprecision when it comes to pharmaceutical manufacturing. That corresponds to 66,807 to 308,537 defects per 1,000,000 opportunities. But with pharmaceutical development being so complicated, there could be more than 1,000,000 “opportunities” for error. 

The above listed error calculation – while alarming enough – was referenced in small-molecule pharmacology. However, increasingly complex pharmaceuticals (such as today’s widely used biotechnological products, including GLP-1 diabetes/weight loss or mRNA products for Covid-19) have molecular weights that can be thousands times larger than small molecule compounds. That could mean an even greater opportunity for error. 

The FDA is abundantly aware of pharmaceutical fragility and potential quality shortcomings, including at the highest levels of its leadership. 

In fact, Dr. Michael Kopcha, the current Director of the FDA’s Office of Pharmaceutical Quality (OPQ), wrote and published the above published Six Sigma calculation, lamenting the imprecise nature of pharmaceutical manufacturing – back in 2017. 

Any alteration in structure that occurs during manufacturing has the potential to vastly change a compound’s clinical activity, including a change from therapeutic drug into a poison.

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FDA Approves AstraZeneca No-Needle At-Home ‘Live’ Virus Flu Vaccine with 90% Shed Rate

AstraZeneca subsidiary MedImmune, LLC, the manufacturer of FluMist, anticipates that FluMist will be available for the 2026 influenza season as well.

FluMist, which is sprayed into the nose, is now approved for the alleged prevention of influenza disease caused by influenza virus subtypes A and B in individuals 2 through 49 years of age.

Each refrigerated FluMist sprayer contains a single 0.2 mL dose with “live” attenuated influenza virus (10^6.5–7.5 FFU) from three strains: A/Norway (H1N1), A/Thailand (H3N2), and B/Austria (B/Victoria lineage).

Alarmingly, the FDA package insert indicates that the vaccinated can shed (or transmit) the vaccine virus onto the unvaccinated, potentially infecting them.

“Vaccine viruses capable of infection and replication can be cultured from nasal secretions obtained from vaccine recipients,” the document reads.

Vaccine virus shedding within 28 days of FluMist vaccination was studied in two multi-center trials: Study MI-CP129 (200 healthy participants aged 6 to 59 months) and Study FM026 (344 healthy participants aged 5 to 49 years).

In both studies, nasal samples were collected daily for the first 7 days, then every other day through Day 28.

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FDA Brushed Off Concerns About DNA Fragments in Gardasil’s HPV Vaccine

Over the last two years, cancer genomic experts have raised concerns about the presence of residual DNA fragments in the mRNA COVID-19 vaccines, saying that it has the potential to increase the risk of developing cancer.

This mirrors the concerns raised several years ago about the safety of the Gardasil human papillomavirus (HPV) vaccine, manufactured by Merck & Co.

In 2011, Sin Hang Lee, a pathologist and 30-year veteran in DNA analysis, made the startling discovery of synthetic DNA fragments in several vials.

“I was shocked to find DNA fragments in the HPV vaccine because DNA is not supposed to be there,” Lee recalls.

“They use DNA to make the vaccine, but then it is supposed to be chopped up and removed in the manufacturing process,” he said.

Lee, an internationally recognized expert in molecular gene detection, carefully documented his findings in a report that was sent to the U.S. Food and Drug Administration (FDA) for review.

The FDA investigated.

On Sept. 23, 2011, the FDA’s Center for Biological Evaluation and Research (CEBR) responded by saying it had evaluated the concerns in Lee’s report, and determined that the Gardasil vaccine was “safe and effective.”

The FDA did acknowledge that Lee found residual DNA in the vaccine, but said it was “expected” and “inevitable” in products that are manufactured using recombinant technology.

The agency also said it remained confident that the residual DNA was “not a risk to vaccine recipients.”

“The presence of residual DNA is not a safety factor as defined by US regulations, and is not required to be included in Gardasil’s labeling,” wrote the FDA.

The following month (Oct. 21, 2011) the FDA quietly updated its website to reflect the presence of DNA fragments in the vaccine, assuring the public there was “no safety risk.”

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Millions Of Americans With Depression Could Be Eligible For Psilocybin Therapy If Approved By FDA, Study Shows

As many as 6 in 10 people currently receiving treatment for depression in the U.S. could qualify for psilocybin-assisted therapy if the treatment were approved by the Food and Drug Administration. That’s according to a recent study in the journal Psychedelics that highlights the broad impact that could result from wider clinical availability of the entheogen.

“Our findings suggest that if the FDA gives the green light, psilocybin-assisted therapy has the potential to help millions of Americans who suffer from depression,” Syed Fayzan Rab, an MD candidate at Emory University, and the study’s lead author, said in statement about the report. “This underscores the importance of understanding the practical realities of rolling out this novel treatment on a large scale.”

The study, authored by a three-person team from Emory, the University of Wisconsin and UC Berkeley and published last month, sought to estimate the upper, midrange and lower boundaries of current depression patients—including both major depressive disorder (MDD) and treatment-resistant depression (TRD)—who would likely be eligible for the psychedelic treatment. Its low-end figure is 24 percent, the midrange estimate is 56 percent and the upper boundary is 62 percent of current patients.

Overall, the report gives a range of estimates on the number of depression patients who’d qualify for psilocybin therapy, with between 4.7 million and 6.6 million MDD patients and between 1.4 million and 1.9 million TRD patients potentially eligible.

“These ranges highlight the potential variability in our estimates based on changes in the assumptions underlying comorbidity prevalence, emphasizing both the robustness and the uncertainty inherent in our projections,” the paper says.

Behind the wide range of estimates are open questions about who would be eligible for psilocybin-assisted therapy (PSIL-AT). For example, authors said the variance was “largely influenced by the removal of alcohol and substance use disorders as exclusion criteria” as well as analysis of other comorbidities that may or may not affect patient eligibility.

Other issues involve the degree to which healthcare providers would dispense psilocybin for off-label use (meaning for conditions other than depression), whether treatment is covered by insurance and whether other psychedelics—for example LSD—become available as alternatives to psilocybin.

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Court Confirms Merck Lied on Mumps Vaccine Label — But Lets Drugmaker Off the Hook in Antitrust Lawsuit

An appeals court this week ruled that even though Merck misrepresented critical data to the U.S. Food and Drug Administration (FDA) to gain approval for its updated mumps vaccine — and even though the FDA knew about the false claims — because the agency approved the vaccine anyway, Merck can’t be held responsible for unfairly hurting competitors.

The ruling stems from a class action lawsuit brought by a group of physicians and physicians groups who alleged Merck violated the Sherman Antitrust Act by making false claims about the efficacy of its mump vaccine on the product’s label in order to stifle competition and maintain a monopoly in the marketplace.

The Sherman Antitrust Act prohibits companies from conspiring to create a monopoly.

The U.S. 3rd Circuit Court of Appeals didn’t dispute the plaintiffs’ allegations that Merck lied to the FDA about the vaccine’s efficacy.

However, citing the Noerr-Pennington doctrine, the court ruled that because the FDA took no action against Merck after discovering the false claims, it was the FDA’s decision — not Merck’s fraud — that injured competitor GSK and the physicians and physicians groups who bought the ineffective vaccine at inflated prices.

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