New COVID vaccine approved by FDA for emergency use, but there's no emergency
On Thursday, August 22, the United States Food and Drug Administration (FDA) approved a new COVID-19 vaccine under emergency use authorization, even though there is no emergency. In fact, President Joe Biden ended the national emergency more than a year and a half ago, in the spring of 2023.
Nonetheless, the FDA has granted emergency use authorization for updated mRNA COVID-19 vaccines (a 2024-2025 formula) from Moderna and Pfizer, featuring a “monovalent component” targeting the “Omicron variant KP.2 strain.”
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They say that this updated formula will “more closely target currently circulating variants and provide better protection against serious consequences of COVID-19, including hospitalization and death,” but the evidence supporting that is negligible and researchers have repeatedly sounded the alarm that prevention of hospitalization or death wasn’t the studied endpoint in clinical trial outcomes.
Instead, the endpoints were whether or not people who take the vaccines test positive for COVID-19 less often.
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Every new approval, or authorization, of updated formulations or new variant development is based on the safety and efficacy (or lack thereof) of the original injections' six-month clinical trial data which revealed the COVID-19 injections caused more harm than good, with misrepresented data, misleading demographics, and procedural flaws.
Frontline COVID Critical Care Alliance (FLCCCA) senior fellow Dr. Mary Talley Bowden explains that this is possible because the Public Readiness and Emergency Preparedness (PREP) Act is still in effect until December 2024.
Yesterday, the @US_FDA approved new COVID shots under Emergency Use Authorization (EUA). FLCCC Senior Fellow Dr. Mary Talley Bowden @MdBreathe shares her thoughts on this update.
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The FDA’s path from Research to Emergency Use Authorization explicitly notes that the manufacturer must submit an “Investigational New Drug” application, and without it “clinical trial in humans (are) not permitted to proceed.”
This clearly designates these new injections as investigational drugs, effectively turning the public into test subjects for the investigation.
The FDA makes these unfounded claims about reducing hospitalizations and deaths even though it was well-known by spring 2022 that the more injected and boosted one was, the more likely they were to end up in hospital. These were initially labelled “breakthrough” infections in the summer of 2021, as skewed data and flawed science were twisted to claim the vaccines were effective, despite evidence of the contrary.
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The company's new product, called BNT116, uses the same technology as the COVID-19 vaccine and aims to help treat non-small cell lung cancer.https://t.co/RiqbVMjvvI
The shots worked so well that the vaccinated were still being hospitalized and dying in amounts greater than the unvaccinated, as dissected by independent analysts using official government of Ontario data.
It's important to note, however, that the "unvaccinated" category is misleading, as it was based on the definition of being fully vaccinated. The fully vaccinated designation only applied to those who “received their final dose of the COVID-19 vaccine at least 14 days ago.”
So, if one was hospitalized, died, or tested positive for COVID-19 within two weeks of their dose, they were marked as unvaccinated or partially vaccinated, thereby painting a skewed picture of the data from the onset.
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Yet the fact that provincial data across Canada was showing that the shots weren’t stopping infection, preventing hospitalizations or death
remains true.
The data from public health jurisdictions were painting a similar picture at the time — that more doses equated to poorer outcomes — but these data sets and visualization were swiftly removed when they didn’t align with the safe and effective mantra.
While the US FDA clings to the benefits of the novel injections outweighing their risk, Rebel News has repeatedly inquired with Health Canada, the federal health regulator, to ascertain the same.
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In 2020 the government championed unprecedented lockdowns and societal shuttering while hailing vaccines as the only escape from the pandemic’s grip.
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Those requests, asking what exactly the benefit is to Canadians and how they’re calculating risk, continually fall on deaf ears. So will Health Canada follow in the oh-so-to-be-expected FDA’s footsteps and rubberstamp the new formulation(s)?
The ongoing approval of investigational drugs under emergency use, despite evidence showing they cause more harm than good, highlights a troubling pattern. This persistent push for questionable injections, driven by profit rather than safety, reveals a significant failure to uphold public health standards.
Tamara Ugolini
Senior Editor
Tamara Ugolini is a human rights activist turned journalist. Motherhood introduced her to parental rights advocacy and what it means to have true, informed consent. She critiques the shortcomings of "Big-Policy" on the individual and questions mainstream narratives.