H5N1 Bird Flu Jab: Accelerated Approval, Immune From Liability, & Already Purchased by US Government
McCullough & Leake bury the lede.
*Edited to provide introductory clarity*
Friends…keep your wits about you. The intensity of the psyop-ery cannot be overstated. Good grief.
There is a clear path to creating emergency situations which ostensibly necessitates countermeasures that are absolved of liability. We just experienced an example of this with the Covid-19 “pandemic”. There are several clear factors involved which I will review in a moment, however one of them happens to be the availability of “trusted experts”. These experts help direct the population toward acceptance of the countermeasures. There currently seems to be no shortage of these experts within the MFM, who deliver some truth and helpful information dissolved into a great deal of propaganda and approved narrative verbiage. Let’s take a look at one of these experts and some of the oversights I noticed in his report.
Recipe for Fake Pandemics review:
Novel germs, big scary ones - species jumpers, perhaps made more deadly by Gain Of Function, that can rapidly spread and cause a global pandemic. Preferably with asymptomatic transmission to amplify the “need” for testing.
PCR TESTS (the lynchpin, in my opinion). And lots of them. A pandemic cannot pop off if there aren’t numbers to tell people it’s happening, especially if “asymptomatic infection” is being pushed.
Fear. This can be pushed by computer modeling, falsified numbers/deaths, and of course the MEDIA.
Trusted Experts to peddle the narrative and the countermeasures.
Structural Legal Framework in place.
I did you a solid and listened to Peter McCullough and his handler, John Leake’s, “Hot Zone” podcast earlier this week. They apparently decided to do an early broadcast due to the “rapidly progressing” bird flu…thing.
::sigh::
Let’s look at this. But first, a definition.
BURYING THE LEDE (from Merrian-Webster):
A lede is the introductory section in journalism and thus to bury the lede refers to hiding the most important and relevant pieces of a story within other distracting information.
This report managed to deliver some truth, which happens to be the lede, nestled in with a lot of approved narrative messaging. I’ll give you a quick overview with timestamps.
Narrative Messaging
Within the first 5 minutes, Dr McCullough highlights several familiar features of fake pandemics:
The necessity for PCR tests (3:20)
Species jumping virus (3:36)
This is cause for alarm (5:20)
Over the next 3 minutes he addressed two more throwback points:
The Biopharmaceutical Complex (8:09)
Gain of Function that’s happening and making it more deadly
Now for the partially informative BURIED LEDE …
BARDA has already funded the development of an H5N1 Influenza vaccine, it’s already approved, and the United States Government has already purchased it (9:38).
THIS IS THE STORY. Part of it.
The story is not fear porning about a species jumping, mad scientist gain of functioning, scary virus that might be the next thing. Disease X.
Also not that we need better and more PCR tests so that the globalist aligning US government can justify the deployment of “vaccines” that they’ve already paid to develop, accelerated approval of, and purchased.
Dr McCullough goes on to encourage preparedness (EARLY TREATMENT with antivirals and antibiotics) and says that he will be aggressive in treatment, especially with the olds.
Hey guys, alternative treatments are being marketed and sold to the alternative health and wellness vaccine decliners. Maybe it’s all great stuff, I don’t know. But I’m increasingly dubious with every promo code. And there’s no shortage of promo codes.
A reader sent me a link to this ZeroHedge article yesterday.
See that little bit at the VERY bottom ↑? That means Zerohedge is getting PAID to promote The Wellness Company.
By the way, anywhere you see a promo code or a hyperlink to purchase products, it means that the person or entity associated is getting compensated for their promotion.
Like The Liberty Daily.
And WND.
Moving on.
Let’s address that buried lede and why I consider McCullough’s “Hot Zone” report to be a glaringly partial report. He left out some important components involving the legal structure of the situation.
This legal structure and regulatory process coupled with emergency conditions, is exactly what matters. The synergistic relationship existing between these components allows bioweapons to be deployed on citizens with very nearly ZERO liability. Folks, this just happened. And it appears that it’s happening again. LET’S REPORT ON THAT.
* Please refer to the work of
and and their extensive archives regarding the legal and regulatory structures in place.Turns out the FDA has already approved the avian flu vaccine “under 21 CFR 601 Subpart E for Accelerated Approval of Biological Products for Serious or Life-Threatening Illnesses” .
You know what I love in my biological products? Accelerated approval.
See how that said “Accelerated approval…FOR SERIOUS OR LIFE THREATENING ILLNESSES” under section blah blah blah. Let’s look at exactly what that means.
FDA may grant marketing approval for a biological product on the basis of adequate and well-controlled clinical trials establishing that the biological product has an effect on a surrogate endpoint that is reasonably likely, based on epidemiologic, therapeutic, pathophysiologic, or other evidence, to predict clinical benefit or on the basis of an effect on a clinical endpoint other than survival or irreversible morbidity. Approval under this section will be subject to the requirement that the applicant study the biological product further, to verify and describe its clinical benefit, where there is uncertainty as to the relation of the surrogate endpoint to clinical benefit, or of the observed clinical benefit to ultimate outcome. Postmarketing studies would usually be studies already underway. When required to be conducted, such studies must also be adequate and well-controlled. The applicant shall carry out any such studies with due diligence.
Oh cool. So it actually means they can just approve a BIOLOGICAL PRODUCT to treat serious or life threatening illnesses based on something else entirely. Literally. 🤯 On the basis “of an effect on a clinical endpoint other than survival or irreversible morbidity”.
So if the FDA was accelerating approval for life jackets for the treatment of the severe and life threatening illness known as drowning, we could approve them based on something other than whether people drowned while wearing them.
Makes sense.
Audenz™ Avian Influenza H5N1 (Bird Flu) Vaccine Clinical Trials, Dosage, Indication, News
Anywho… that’s how this vaccine adjuvanted (with squalene), cell-based (grown on Madin-Darby canine kidney cells) biological product came about. Accelerated approval and based on three studies. Want to hear some of the disclosures and acknowledgments from the studies?
(Psssssttt…. Novartis was acquired by CSL Group and is now Seqirius)
NCT01776541
Sponsored by: Novartis
Investigators
Study Chair: Novartis Vaccines and Diagnostics,Novartis Vaccines
NCT01766921
Conflict of interest statement
J.P. received study fees paid to his Institution by Seqirus, Inc.; E.V., M.H., are employees of Seqirus, USA; E.V.T. is an employee of Seqirus, The Netherlands.
We also acknowledge Debaditya Das, PhD (Novartis Healthcare Pvt. Ltd., India), Nicola West, PhD (Parexel Ltd., Uxbridge, UK), Melanie Meister-Broekema, MSc (Parexel Ltd., Uxbridge, UK), and Jamie Stirling, PhD (OLC Bioscience Ltd., London, UK), for providing support in manuscript preparation, revision, and editing.
Financial support. This work was supported by Novartis Vaccines and Diagnostics Inc. (Novartis’ influenza vaccine business was acquired by the CSL Group on July 31, 2015, and is currently operating as Seqirus Inc.) and by Federal funds from the US Office of Public Health Emergency Preparedness, Office of Research and Development Coordination (Contract No. HHSO100200600012C).
Potential conflicts of interest. Authors C.K., P.J., Z.M., B.V., and N.K-T. were permanent employees of Novartis Group companies at the time the study was conducted (Novartis’ influenza vaccine business was acquired by the CSL Group on July 31, 2015, and is currently operating as Seqirus Inc.). M.H. is a permanent employee of Seqirus Inc. (f/k/a Novartis’ influenza vaccine business), Cambridge, MA. PR has served on advisory boards for GlaxoSmithKline, Sanofi, and Janssen and has received institutional funding to undertake multicenter vaccine trials from Novartis, GlaxoSmithKline, CSL, and Janssen. S.F., S.S., E.S., T.S., P.C., and T.T. do not have any conflicts of interest to declare. MF59 is a registered trademark of Novartis International AG, Basel, Switzerland. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed.
NCT01776554
Approval for children 6 months and up was based on 4 studies. I pulled the conflict of interest statement from the first and the acknowledgments from the second.
Conflict of interest statement
Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: [Pornthep Chanthavainich reports equipment, drugs, or supplies was provided by Novartis Vaccines and Diagnostics. Pornthep Chanthavanich reports a relationship with Seqirus USA inc that includes: non-financial support. Eve Versage, Esther Van Twuijver, Matthew Hohenboken are the employees of Seqirus].
The authors would like to thank all of the study participants and investigators; Zenaida Morajes, MD, MPH for her contributions in conducting the study and data acquisition; Claudia Kittel, MSc for statistical expertise; David Lee, MD, MBA; David Hering, MBA; Heather Clouting, MSc and Robin Wallace, BSN for their operational support in conducting the study. The authors also acknowledge D Das PhD (Novartis Healthcare Pvt. Ltd., Hyderabad, India), Parexel International (IRL) Ltd., Dublin, Ireland, and J Stirling PhD (OLC Bioscience Ltd., London, UK) for providing support in the preparation, revision and editing of this manuscript. MF59 is a registered trademark of Novartis AG.
Welp, that sounds legit and barely conflicted at all!
And excellent news, the US government has already purchased the vaccine after they funded its development! Gotta love dem public-private-partnerships. It’s like a circle jerk. But with drugs and money and lives.
I mean, it’s almost like they knew this was going to happen.
Were you just sitting there thinking that you sure wish there was a self amplifying mRNA vaccine ready to go?
Great news.
There is a self amplifying mRNA vaccine that’s ready to go. In Japan, approved November 2023.
So here’s the other important piece that Dr. McCullough didn’t mention at all.
After that STELLAR evidence produced and funded by the company and government that will profit from the injectable product they producing and approving…you’ll be happy to know that BULLSHIT is free from liability.
PREP Act Declaration → ((Poof)) → Liability be gone
Recently I posted about the Avian Flu, Influenza A(HPAI) A(H5N1)A, being declared a threat to national security under the PREP Act declaration that was amended on December 23, 2022:
The PREP Act declaration removes liability for all covered countermeasures associated with emergency response. That means individuals, companies, vaccines, therapeutics, diagnostics, and the list goes on and on….literally everyone and everything involved.
The Public Readiness and Emergency Preparedness Act (PREP Act) authorizes the Secretary of Health and Human Services (the Secretary) to issue a Declaration to provide liability immunity to certain individuals and entities (Covered Persons) against any claim of loss caused by, arising out of, relating to, or resulting from the administration or use of medical countermeasures (Covered Countermeasures), except for claims that meet the PREP Act’s definition of willful misconduct. The Secretary may, through publication in the Federal Register, amend any portion of a Declaration.
Thank you
for pointing me to the other threats that were added to the PREP Act amendment that day.Just a friendly heads up for all the other shit that was added to that amendment and thus will enjoy countermeasures free from any pesky liability:
Botulism, Anthrax, Zika, nerve agents, and insecticides were also added to the Federal Register by the HHS Secretary (Becerra) on December 23, 2022.
The Secretary is now amending the Republished Declaration to extend the time period for which liability immunity is in effect for all of the Covered Countermeasures to December 31, 2027. Botulinum Toxin continues to pose a national security threat to the United States and has the potential to cause significant morbidity and mortality in the event of large-scale exposures. There is a lack of a commercial market for countermeasures against Botulinum Toxin, making PREP Act coverage critical to the engagement with potential product sponsors. Vaccines, therapeutics, and diagnostics. Notices for Botulinum Toxin will continue to be a part of the preparedness posture for the United States, both in terms of stockpiling current products and developing next-generation candidates. Extension of the PREP Act Declaration including vaccines, therapeutics, and diagnostics for Botulinum Toxin is essential. Unless otherwise noted, all statutory citations below are to the U.S. Code.
Botulinum toxin (abbreviated either as BTX or BoNT) is produced by Clostridium botulinum, a gram-positive anaerobic bacterium. [1] The clinical syndrome of botulism can occur following ingestion of contaminated food, from colonization of the infant gastrointestinal tract, or from a wound infection.
I. Determination of Public Health Emergency or Credible Risk of Future Public Health Emergency 42 U.S.C. 247d–6d(b)(1)
I have determined that there is a credible risk that the spread of Bacillus anthracis and/or the spores of Bacillus anthracis and the resulting disease or conditions may in the future constitute a public health emergency
Anthrax is a serious infectious disease caused by gram-positive, rod-shaped bacteria known as Bacillus anthracis. It occurs naturally in soil and commonly affects domestic and wild animals around the world. People can get sick with anthrax if they come in contact with infected animals or contaminated animal products. Anthrax can cause severe illness in both humans and animals.
Zika Virus continues to pose a public health threat. Current epidemiologic data indicates that despite the steep decline in cases since the 2016 peak in Brazil, the virus is circulating in low levels in Latin America and South and Southeast Asia. Notably, India had an outbreak of Zika in late 2021 that largely went unreported because COVID–19 stressed the country’s public health systems and currently the virus may be spreading across the country undetected. PREP Act coverage of Zika Virus vaccines is critical to enable continuation of ongoing programs for development of these products and accomplish established preparedness goals. Unless otherwise noted, all statutory citations below are to the U.S. Code.
Zika virus is a mosquito-borne virus first identified in Uganda in 1947 in a Rhesus macaque monkey followed by evidence of infection and disease in humans in other African countries in the 1950s.
Renewal of PREP Act declaration for nerve agent and insecticide threats is requested due to the continued national security threat posed by these chemical threats. Nerve agent and insecticide threats have the potential to cause significant morbidity and mortality in the event of large-scale exposures. PREP Act coverage of countermeasures is critical to the engagement with potential product sponsors due to the limited commercial market of products in this threat space. Covered countermeasures for nerve agents and insecticides will continue to be a part of the preparedness posture for the United States, both in terms of stockpiling current products and development next generation candidates. Extension of the PREP Act declaration for countermeasures against nerve agents and insecticides is essential. Unless otherwise noted, all statutory citations below are to the U.S. Code.
Nerve agents are highly poisonous chemicals that work by preventing the nervous system from working properly. This page provides resources on various nerve agents.
Insecticide, any toxic substance that is used to kill insects. Such substances are used primarily to control pests that infest cultivated plants or to eliminate disease-carrying insects in specific areas.
Disease X is a mind virus and your participation is crucial to its pandemic potential.
Do not participate.
Do not test.
https://ko-fi.com/conspiracysarah
Friday Memes coming shortly 😘
The Eye of Sauron eternally seeketh thine cash cow.
Please understand Bird Flu: Part Deux is a supernatural force. At last night's seance the spirit medium relayed the message that Donald Rumsfeld is orchestrating this sequel from the underworld.
No new material from Hollywood or Langley- just reruns.
"A blast from the past and into the present: Donald Rumsfeld, Avian Flu Hoax, Gilead,Tamiflu, Remdesivir"
Donald Rumsfeld has made a killing out of bird flu. The US Defence Secretary has made more than $5m (£2.9m) in capital gains from selling shares in the biotechnology firm that discovered and developed Tamiflu, the drug being bought in massive amounts by Governments to treat a possible human pandemic of the disease.
More than 60 countries have so far ordered large stocks of the antiviral medication - the only oral medicine believed to be effective against the deadly H5N1 strain of the disease - to try to protect their people. The United Nations estimates that a pandemic could kill 150 million people worldwide.
Britain is about halfway through receiving an order of 14.6 million courses of the drug, which the Government hopes will avert some of the 700,000 deaths that might be expected. Tamiflu does not cure the disease, but if taken soon after symptoms appear it can reduce its severity.
The drug was developed by a Californian biotech company, Gilead Sciences. It is now made and sold by the giant chemical company Roche, which pays it a royalty on every tablet sold, currently about a fifth of its price.
Mr Rumsfeld was on the board of Gilead from 1988 to 2001, and was its chairman from 1997. He then left to join the Bush administration, but retained a huge shareholding .
The firm made a loss in 2003, the year before concern about bird flu started. Then revenues from Tamiflu almost quadrupled, to $44.6m, helping put the company well into the black. Sales almost quadrupled again, to $161.6m last year. During this time the share price trebled.
Mr Rumsfeld sold some of his Gilead shares in 2004 reaping - according to the financial disclosure report he is required to make each year - capital gains of more than $5m. The report showed that he still had up to $25m-worth of shares at the end of 2004, and at least one analyst believes his stake has grown well beyond that figure, as the share price has soared.
https://www.independent.co.uk/news/world/americas/donald-rumsfeld-makes-5m-killing-on-bird-flu-drug-6106843.html
In 2001, shares of Gilead Sciences, Inc. traded in a range between $6.64 and $17.93. Between January and April 2006, its price range had been $53.00 to $65.62.
Today, March 3, 2024, shares are at $72.31.
=======
"2024 marks a new era for Gilead. We’re looking forward to innovation, continued growth and making an even greater impact as we advance our leading HIV prevention and treatment portfolio and accelerate cutting-edge treatments for cancer."
https://www.gilead.com/
"On April 25, 2022, the U.S. Food and Drug Administration (FDA) approved a supplemental new drug application (sNDA) for Veklury® (remdesivir) for the treatment of pediatric patients who are older than 28 days, weighing at least 3 kg, and are either hospitalized with COVID-19 or have mild-to-moderate COVID-19 and are considered high risk for progression to severe COVID-19, including hospitalization or death.
This approval removed the need for a previously issued Emergency Use Authorization granted by the FDA enabling the use of Veklury to treat pediatric patients weighing 3.5 kg to less than 40 kg or pediatric patients less than 12 years of age weighing at least 3.5 kg with positive results of direct SARS-CoV-2 viral testing."
https://www.gilead.com/remdesivir
Here's the thing....assuming 10% of the information is accurate (which I would argue is 99% accurate)....Sarah would still be describing a "crime against humanity" worthy of a Nuremberg 2.0. Pax