patrick.net

Lol, I know. It was kind of a joke.

But I do think that the DoD was experimenting on the public with all this.

richwicks says

No. Nothing does.

I suspect that ivermectin may cure colds. It would be good if someone tested this.

Patrick says

I suspect that ivermectin may cure colds.

Yes, ivermectin is effective against RNA virus like flu and covid.

From the National Library of Medicine:

From 2012 onwards, there have multiple reports that ivermectin has antiviral properties [4,5,7,8,9,10,11,12,13,14,15,16,17] towards a growing number of RNA viruses, including human immunodeficiency virus (HIV)-1, influenza, flaviruses such as dengue virus (DENV) and Zika virus (ZIKV) and, most notably, SARS-CoV-2 (COVID-19) [17]. Evidence for activity against DNA viruses is more limited, but encompasses Pseudorabies, polyoma and adenoviruses [18,19,20]. The basis of ivermectin’s broadspectrum antiviral activity appears to relate to the fact that ivermectin binds to, and inhibits, the nuclear transport role of the host importin α (IMPα) protein [11,18,20], which is known to mediate nuclear import of various viral proteins and key host factors, but other possible antiviral actions of ivermectin have been proposed (e.g., [12]), including in the case of SARS-CoV-2 (e.g., [21,22]). This mini-review will summarise the weight of evidence for ivermectin’s broad-spectrum antiviral activity and the basis of its IMPα-directed activity in light of the possibility that ivermectin could be a critically useful antiviral in the current SARS-CoV-2 crisis [6,17].

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7564151/

Patrick says

I suspect that ivermectin may cure colds. It would be good if someone tested this.

Ivermectin inhibits viral replication. If you feel like you're coming down with a cold, start taking ivermectin at 0.4 mg/Kg daily. After 2-3 days, all your symptoms will disappear. This doesn't mean that you're cured; rather, ivermectin has kept the virus essentially in stasis, so that your immune system can catch up and do mop up. This means take it for the full 7-10 days over the course of a regular infection.

I have personally experienced the ability of ivermectin to inhibit cold sores. I was already taking it for another viral infection, and then noticed that I had a cluster of tiny scabs on my lip. This would normally have been a major outbreak, but it was completely nipped in the bud. It did take about a week to finally disappear, but this was so much better than a big honking canker.

Just last week, I felt another outbreak, and hit the 'mectin. Sure enough, the outbreak was stopped in its tracks. I continue to be amazed by the versatility and effectiveness of this drug.

Thanks @sterotomy where did you buy it?

Patrick says

Thanks sterotomy where did you buy it?

You can get it on Amazon for veterinarian purposes, but you must recalculate dosage for your weight. Easy and relatively cheap.

Any online pharmacy getting their drugs from India or Asia usually has it, quality has been good so far. You need to take it at the onset though or better even before if you know someone in close contact is infected. Many viruses reach their max replication within days.

Patrick says

richwicks says

No. Nothing does.

I suspect that ivermectin may cure colds. It would be good if someone tested this.

I think it might be able to prevent them. The data indicates that Ivermectin prevents replication of a virus. That would mean you can stop the replication and avoid the disease, if you detect it early enough. But once you're sick, you're sick.

Bd6r says

Patrick says

Thanks sterotomy where did you buy it?

You can get it on Amazon for veterinarian purposes, but you must recalculate dosage for your weight. Easy and relatively cheap.

I want to point out that medicine is medicine.

First drugs go through animal trials, and they progress to human trials. There's nearly NO DRUGS available for animals that aren't available for humans, although a FEW exist.

So Ivermectin for horses, fine for you, unless they intentionally adulterate it to be dangerous to humans. Be careful with dosage. Check, double check, take a few hours off, and check again. Ivermectin is a very safe drug, but you still don't want to fuck it up.

Bd6r says

You can get it on Amazon for veterinarian purposes, but you must recalculate dosage for your weight. Easy and relatively cheap.

I'm not sure where I found it but there was at least one website that helped people calculate the dosage. I still have half a tube in the refrigerator. Probably time to replace it.

Patrick says

Thanks sterotomy where did you buy it?

Drive down to Tijuana and you can get it without a prescription

Patrick says

Thanks sterotomy where did you buy it?

alldaychemist . com

https://www.alldaychemist.com/austro-ivermectin-on-sale-12mg.html

Takes six to eight weeks but have never had an issue.

https://www.coffeeandcovid.com/p/remarkably-consistent-tuesday-september

A new eye-popping FOIA disclosure was making the rounds this week. The FDA three emails evidenced a perfect storm of government bungling and corruption. The short version is that right while federal jab mandates were lifting off in the fall of 2021, top government officials already knew that the jabs “waned,” meaning they didn’t protect anybody.

But that’s not all. Not even close.

Here’s the first email in the thread. It’s a doozy. It was sent from a Department of Defense contractor to FDA top official Marion Gruber in advance of the September 2021 vaccine committee meeting. Marion Gruber was the Director of the Office of Vaccines Research and Review at the FDA.




First of all, notice the email explained that the Department of Defense hired Humetrix in March 2020 to analyze Medicare claims data related to covid:

This study has been conducted by my company under contract with the DoD JAIC (Joint Artificial Intelligence Center) since March 2020, when we were tasked to analyze Medicare claim data to monitor, map and conduct Covid-19 predictive analytics for the military.

“For the military.” Why was DoD involved right from March 2020? Was covid a military operation or a health emergency? What do they know that they aren’t saying?

"Salus" was the name of a pagan Roman goddess associated with health, well-being, and prosperity. Hopefully someone will follow up and FOIA everything related to “Project Salus.”

And … the JAIC? A DoD joint artificial intelligence center? What is that? How and why did the JAIC get involved in covid from day one? Why haven’t we ever heard of its role in the pandemic? Unanswerable questions.

At least, unanswerable so far. We’re getting there, drop by painful drop.

Patrick says

Thanks sterotomy where did you buy it?

alldaychemist.com

I've ordered 4 times, none of the shipments were intercepted. Shipping takes a while - over a month. They have a shipment guarantee in case your order is confiscated.

For payment I've done ACH transfer. They have some credit card thing, but it charges some outrageous fee.

FYI - if you initiate an ACH transfer, and things go south, you can request an investigation under Regulation E - basically, send a letter CMRR to the bank, they have 30 days to conclude the investigation or refund your money.

Ivermectin is kind of expensive - $1 per 12mg pill. Hydroxychloroquine and most antibiotics are pretty cheap. I recommend HCQ, which is more effective than quercetin when you're infected. If you tolerate penicillin-based antibiotics, I recommend amoxicillin. Amoxicillin actually kills bacteria, while ivermectin, cephalexin and doxycycline only inhibit viral and bacterial replication. That being said, amoxicillin will have you peeing out of your butt because it will exterminate all your gut bacteria. There's some amoxicillin that has lactobacillus included to mitigate GI issues.

So far, I've taken ivermectin about 6 times in the last 2 years. Every time, my symptoms disappeared after 72 hours. I even take ivermectin when I'm starting to get a cold sore - it shuts it down before it gets too big and ugly.

I appreciate now why ivermectin won the Nobel Prize for its discoverer. It really is the best goddamn fucking medication I've ever used.

I drove down with the family to TX en route through TN. The chain pharmacies didn't have ivermectin, period, despite the law. Fuck them, at least I scored primers and #8 shot.

https://sashalatypova.substack.com/p/memo-sent-to-sen-johnson-and-his?r=6gdz

Americans were misled about all Covid-19 “countermeasures,” including those products marketed as “vaccines.” Covid policy was managed by the National Security Council (NSC) acting on war footing and countermeasures were contracted for by the Department of Defense (DoD) and Biomedical Advanced Research and Development Authority (BARDA) without any effective regulatory oversight at any stage along the process.

The activities passing as “regulatory processes” appear to have been fraudulent attempts to create color of law and avoid liability for what were clearly criminal acts. These multiple overlapping and mutually reinforcing violations of federal law have imposed serious harms on the American people, including severe injury and death.

Fact pattern background:

Under Stafford Act authority, President Trump declared a Public Health Emergency (PHE) on March 13, 2020 (Stafford Act, P.L. 93-288 as amended).

Under a PHE, medical “countermeasures” are not regulated or safeguarded as normal pharmaceutical products (21 USC 360bbb-3(k).[1]

According to Operation Warp Speed / Administration for Strategic Preparedness and Response (ASPR) reports, the United States Department of Defense (DoD) directed, oversaw and managed the development, manufacture and distribution of nearly all Covid countermeasures,[2] largely utilizing DoD’s previously established network of military contractors and consortia.[3]

DoD, the Biomedical Advanced Research and Development Authority (BARDA) and the Department of Health and Human Services (HHS) contracted for Covid countermeasures, including “vaccines,” as “prototype demonstrations” of “large-scale manufacturing.”[4]

These agencies avoided nearly all relevant legal and transparency requirements by using Other Transaction Authority (OTA) contracts.[5]

Although the DoD/BARDA contracts refer to “safety and efficacy requirements” and mention cGMP compliance, these items are explicitly carved out as not being paid for or ordered by the U.S. Government.

The contracts for countermeasures include a liability shield for manufacturers and contractors along the supply and distribution chains, under the PREP Act.

As prototypes under Emergency Use Authorization (EUA) during a PHE, Covid countermeasures need not comply with laws governing clinical trials, manufacturing quality, safety or labeling (21 USC 360bbb-3(k)). The result: we have a chaotic mess of everything from sham injections that may be mostly just saline all the way to extremely dangerous/deadly shots, all of which are being distributed under the same product brands and labels.[6]

The underlying FDA authorizations and approvals under EUA statutory authority and Investigational New Drug regulatory frameworks all violated drug safety laws governing clinical trials, product labeling, product serialization, importation, product distribution, product quality control testing, dispensing and other parts of the national drug supply oversight system.[7]

The implications of the above can not be overstated. Senior Executive Service officials within the U.S. Government authorized and funded the deployment of noncompliant biological materials on Americans and others without clarifying their “prototype” and “large scale demonstration” legal status, making the materials not subject to normal regulatory oversight, all while knowingly and willfully maintaining a fraudulent pseudo-“regulatory” presentation to the public.

These materials have harmed and killed and continue to harm and kill Americans and other people around the world. ...

https://babylonbee.com/cleanArticle/trump-says-he-totally-would-have-fired-fauci-if-only-hed-had-some-sort-of-cool-catchphrase-to-get-the-job-done

https://sashalatypova.substack.com/p/update-on-chd-lawsuit-challenging

Update on CHD Lawsuit Challenging Government's License to Kill (PREP Act)

Or, why you should not expect Donald Trump speaking the truth about hospital murders or vax death/injury any time soon...

First, let me answer the burning question about Trump - no, it’s not because he is not a scientist and Fauci and Birx lied to him.

It’s the PREP Act, silly! In order to maintain his immunity from liability, he must push the genocidal HHS narrative (a “covered countermeasure”), or else he is not a “covered person” and then can be prosecuted for real crimes, not the fake made-up ones he is currently indicted for and fundraises from. Note that not a single hard-hitting investigative journalist (I mean real ones like Carlson and Beck) are even allowed to ask him pointed questions, because otherwise they would not be allowed “access” to Trump’s campaign. Which Tucker Carlson acknowledged and explained as a standard operating procedure in media. ...



Readers in other countries can look up similar relevant law, search for keywords “countermeasures”, “public health emergency” and “pandemic preparedness”. This is especially relevant for NATO allied regions.

The only case currently challenging the constitutionality of PREP Act is this one - Watts v DOD:



... Counsel for the Estate of George Watts, Jr., filed an opposition to the Department of Defense's Motion to Dismiss for failure to state a claim based primarily on the Rex non potest peccare defense. (the king can do no wrong- that eventually became doctrine of sovereign immunity in this country.)

However sovereign immunity is not written into the U.S. Constitution. The Countermeasures Injury Compensation Program's 4 payments of approximately $2,200 each for death or serious bodily injury combined with the PREP Act's foreclosing all remedies, makes sovereign immunity the unconstitutional icing on the cake and the black letter of the PREP Act allows for severing an unconstitutional provision. ... The DOD argued in its motion to dismiss that the department cannot be sued in this case because it has “sovereign immunity,” which is a legal doctrine asserting the state cannot commit legal wrongdoing and therefore cannot be sued without its consent.

The DOD also argued that even if the state did not have sovereign immunity, the complaint’s allegations were not sufficient to claim the DOD engaged in “willful misconduct” when it made public statements about the safety and efficacy of the COVID-19 vaccine. ...

PREP Act is a governments’ license to kill, and it must be repealed. Yet, not a single Congress person speaks about it. I don’t know when/if material progress toward this goal will be made. In the meantime, we must educate everyone around us about this atrocity. The problem is that most people, even those who are now awake to the vaccine and hospital murders still think that “if fraud can be proven” than the perps can be prosecuted. The fraud has not only been definitively proven, it hasn’t been really hidden to begin with! Vast majority of the fraud was visible from the start, I and hundreds of others have published clear evidence of fraud from publicly available documents.

https://sashalatypova.substack.com/p/transcript-of-my-interview-for-the

Basically, the U.S. government is representing to the public that this is a response to a health event. But in fact, what they are doing is a military operation. These so-called vaccines aren’t really vaccines, but have been manufactured under defense contracts, utilizing the Defense Production Act, other transaction authority, and emergency use authorization under a public health emergency. When these things are used together, then good manufacturing practices don’t apply to these products at all.

Mr. Jekielek: Even legally?

Ms. Latypova: Even legally. There’s a law on the books, 21-USC-360bbb, that says, “Emergency use authorized countermeasures under public health emergency can’t constitute clinical investigation.” Clinical investigation is actually not possible for these countermeasures. If clinical investigation isn’t possible, then you can’t have clinical trials, informed consent, clinical trial subjects, or clinical trial investigators.

Utilizing the structure of emergency use authorization, public health emergency, other transaction authority, and the Defense Production Act, the government was able to commandeer pharmaceutical companies to produce these noncompliant injectable products and distribute them, calling them a medicine, when in fact, they’re not a medicine.

It’s an act of war. They’re using the Defense Production Act, its machinery, and the U.S. military. Even internationally, this is being distributed from this military to overseas militaries, not through the pharmaceutical distribution chain. They’re using the military machinery to distribute these noncompliant products—including biologicals, chemicals, and all kinds of ingredients we don’t really understand very well—and then calling it public health and medicine. ...

Pfizer produced its DOD contract, and since then, hundreds of Department of Defense contracts for COVID countermeasures were released through FOIA [Freedom of Information Act], although they’re partially redacted. They’re all online, and they’re all essentially similar. They’re utilizing the structure of ordering countermeasures, prototypes, with the Department of Defense ordering them from the pharmaceutical manufacturers under the Defense Production Act and other transaction authority. Good manufacturing practices aren’t part of it at all.

Another additional part of this scheme is the public health emergency announcement. When a public health emergency happens, essentially the executive branch of the government absorbs power from [the] legislative and judicial [branches]. A public health emergency, by various legal amendments and acts over a long period of time, triggers this whole system in which the HHS secretary becomes a de facto dictator. ...

Mr. Jekielek: I’ve had a number of people on this show who have had pretty serious vaccine injuries. That these people could be harmed is denied by society and certainly denied by the authorities.

There are admissions from the NIH [National Institutes of Health], but that’s rare. Mostly they say there’s no signal. Most of these people are diagnosed with anxiety and things like that. I don’t know what your thoughts are on this.

Ms. Latypova: I understand why the government denies it, but I can’t wrap my head around the denial by regular physicians. I know there’s a monetary structure that incentivizes this behavior. There are payments from Medicare and Medicaid to the doctors to vaccinate, and bonuses for the number of vaccinations that they administered. There are especially high bonuses to vaccinate somebody who hasn’t been vaccinated. And there’s not only a huge monetary compensation and incentive, but there’s also liability protection through the PREP Act [Public Readiness and Emergency Preparedness Act].

That liability exemption is also explicit in the DOD contracts with vaccine manufacturers. Not just vaccines, it actually goes with the entire COVID countermeasures production, which includes vaccines, therapeutics, monoclonal antibodies, blood products, diagnostics, masks, swabs, and even staffing. All of them have the PREP Act Liability Exemption Clause, which states that if you are in compliance with all of this and follow procedure, then you are exempt from liability. The last sentence of that clause says, “This is both civil and military application.” ...

In addition to seeing huge adverse events and death rates overall, we saw huge variability from batch to batch. But that variability was also not random, meaning that they aren’t just producing random outputs. There’s some sort of a design going on as far as what’s in those vials in different batches.

For example, we saw clustering by alphanumeric codes, both in Pfizer and Moderna. The letters used in the alphanumeric numbering, which should be just random, should be just some sort of a manufacturing tactic to keep track of things. But depending on the letters, we know that one set of letters produced higher toxicity and another set lower toxicity. That should never happen.

Patrick says

Ms. Latypova: I understand why the government denies it, but I can’t wrap my head around the denial by regular physicians. I know there’s a monetary structure that incentivizes this behavior. There are payments from Medicare and Medicaid to the doctors to vaccinate, and bonuses for the number of vaccinations that they administered. There are especially high bonuses to vaccinate somebody who hasn’t been vaccinated. And there’s not only a huge monetary compensation and incentive, but there’s also liability protection through the PREP Act [Public Readiness and Emergency Preparedness Act].

That's my beef with medical "professionals" - admit you're wrong, you gaslit me and you prefer money to the Hippocratic Oath.

Fuck them and everyone who looks like them. My wife suffered for 6 months because the blood supply was contaminated with spike protein and she had to rebuild her hemoglobin levels the hard way.

If my accident happened a year ago instead of 14 years ago (when I had to get 5 pints of blood), I probably would be dead from spike protein contaminated blood.

I agree. The medical establishment cannot recover any credibility until it admits that it lied to the public wholesale about the toxxine, resulting in a large number of deaths.

Patrick says

I agree. The medical establishment cannot recover any credibility until it admits that it lied to the public wholesale about the toxxine, resulting in a large number of deaths.

They will do what the government does, wait until the public forgets.

That is absolutely their plan.

I expected a fallout from the Bush administration lying the nation into the Iraq war. It didn't happen. Watch people forget and and move on from being poisoned by the medical industry.

Personally, I'm kind of happy that finally the US government is murdering its own citizens instead of people of another nation. At least in this nation, we could have resisted. We deserve what we get now.

Patrick said:

"The medical establishment cannot recover any credibility until it admits that it lied to the public wholesale about the toxxine, resulting in a large number of deaths."

richwicks says

"They will do what the government does, wait until the public forgets."

-------------------
My take is that it is downright impossible for the public to forget some 300,000 deaths and over 1,000,000 debilitating injuries.

Huge mistake.

Women should never be allowed in such top military positions. They simply do not have the same interest in defending borders than men do, and that is genetic all the way back to chimpanzees. Male chimps defend borders, but female chimps do not.

Patrick says

Women should never be allowed in such top military positions. T

True, but it may be comforting to know that CNO has no real wartime command authority. The command goes from the President, through the Secretary of Defense, to the Major Commands. A female SecDef would be worse, or a female general running Air Combat Command or Special Operations Command.

The_Deplorable says

I remember that 18 year old service members were allowed to buy beer at on base clubs.

https://welcometheeagle.substack.com/p/attorney-tom-renz-drops-the-biggest#media-1dfd5743-0f1b-4549-b555-7994194077ab

Covid-19 jab was administered to a soldier in Fort Riley Kansas in 2014!!??

https://www.2ndsmartestguyintheworld.com/p/us-government-confirms-1433x-increase

https://brownstone.org/articles/covid-mrna-vaccines-required-no-safety-oversight/

When everyone from the President to your primary care doctor declared loudly and wholeheartedly in December 2020 that the newly FDA-authorized Covid mRNA vaccines were “safe and effective” – what were those claims based on?

In this article, I will review the contractual and regulatory framework applied by the US government to the initial development, manufacture, and acquisition of the Covid mRNA shots. I will use the BioNTech/Pfizer agreements to illustrate the process.

The analysis will show that:

The Covid mRNA vaccines were acquired and authorized through mechanisms designed to rush medical countermeasures to the military during emergencies involving weapons of mass destruction.

These mechanisms did not require the application of, or adherence to, any laws or regulations related to vaccine development or manufacturing.

The FDA’s Emergency Use Authorization for the vaccines was based on clinical trials and manufacturing processes conducted with no binding legal standards, no legally proscribed safety oversight or regulation, and no legal redress from the manufacturer for potential harms. (This last point is being challenged in multiple court cases, so far to no avail.)

What all of this means is that none of the laws or regulations that we count on to protect us from potentially harmful, or deadly, medical products was applied to the Covid mRNA vaccines. The assertion of “safe and effective” was based entirely on aspirations, opinions, beliefs, and presumptions of government employees.

^^^^^^^^^^^^^^^^^^^
THIS

Our own military is killing us under the justification that because of technology:

"Anybody can create a 99.999999% fatal pathogen in their back yard, so we have to create a mechanism which is 0% effective" against the insane paranoid dreams of our MIC overlords.

They don't care how many experimental subjects (AKA the population of the USA, sans rapefugee immigrants and homeless) die because they are trying to figure out a silver bullet for protecting the remaining WASP/EA people. If the useless eaters (slaves, "people of color") die from the clot shot, then that's a two-fer while the WASPS/WEP hangers-on get their saline shots.

"Wake up Irish people!" (Nod to Stern with the KKK dude).

I'm learning how to reload; just sayin' . . .

The_Deplorable says

What kind of losers "can't affod groceries" in a basically full-employment economy? Fucking Chick-Fil-A is fucking paying fucking $20/hr and they always have "help wanted" in their fucking window and I bet they feed their employess for fucking free too.

https://sashalatypova.substack.com/p/short-testimony-with-links

I later found that covid vaccines are promoted as compliant pharmaceutical products, but they are indeed medical countermeasures that were contracted for by the Department of Defense (DoD) and Biomedical Advanced Research and Development Authority (BARDA). Some of the contracts released via FOIA are here. Medical countermeasures lack any effective regulatory consumer safety oversight at any stage of the process. This is based on 6 key statutes and related federal laws outlined in the memo written for Senator Johnson in December 2022. Bailiwick News Katherine Watt and I discussed these perverted laws here.

1. All covid countermeasures were ordered by the DOD, typically as “demonstrations” via Other Transactions Authority contracts. DOD oversaw the development, manufacture, and distribution of the countermeasures. The contracts include the removal of liability for the manufacturers and any contractors along the supply and distribution chain under the 2005 PREP Act except in case of willful misconduct. The HHS legal opinion of willful misconduct under PREP differs from that generally defined in law, specifically, under PREP Act even proven death and injury caused by a covered countermeasure is not considered willful misconduct by a covered person. While the DOD/BARDA countermeasure contracts refer to safety and efficacy requirements and mention current Good Manufacturing Practices (cGMP) compliance, this language in contract is unenforceable. Judge Truncale (TX) agreed with this interpretation when dismissing Brook Jackson’s case v Pfizer under False Claims Act. The case is now being appealed.

2. Covid “vaccines” were pushed under a “bait and switch” scheme where the actual delivered product always substituted with the Emergency Use Authorized (EUA) version of the product (with exception of tiny amount of 35K doses of Comirnaty). The FDA’s stated position in court is that the recipients of vaccines need not to be given informed consent.

3. Use of Emergency Use Authorized (EUA) covered countermeasures under a declared Public Health Emergency cannot constitute a clinical investigation (21 USC 360bbb-3(k)), therefore these countermeasures could not be tested for safety or efficacy in accordance with US law (21 CFR 312 and 21 CFR 601), nor could compliance with current Good Manufacturing Practices (cGMP) or Good Distribution Practices (GxP in general) be enforced by the FDA. This legal fact was known to the FDA, DOD and BARDA officials and to the pharmaceutical companies signing these contracts. This fact was not known to the public, clinical investigators, clinical trial subjects or most vaccinators.

4. In conclusion, a medical product for which no enforceable liability exists, where all risks are pushed onto recipients, while all profits are privatized, is not a medical product at all. It should be treated as a dangerous substance, stopped, seized, and investigated.

https://sagehana.substack.com/p/i-got-the-fda-to-do-thingsit-was

“But I did it…I was able to get something approved that you know, has…proven to save a LOT OF LIVES. Some people say I saved a hundred million lives worldwide.”

But I was able to get that done in nine months versus five years to twelve years.

If it ever got done.

I got the FDA to do things that they…it was pretty amazing what we were able to do.”

Donald Trump, January 18, 2023

Trump is still FAILING because he refuses to admit that the toxxine is the worst disaster in human history, causing the largest number of deaths.

Trump issued EO 13887 well before the mass death shot campaign:

Executive Order 13887 of September 19, 2019 (Only 5 Pages,… Read It)
Modernizing Influenza Vaccines In The United States To Pro-mote National Security & Public Health

https://www.govinfo.gov/content/pkg/FR-2019-09-24/pdf/2019-20804.pdf

https://www.federalregister.gov/documents/2019/09/24/2019-20804/modernizing-influenza-vaccines-in-the-united-states-to-promote-national-security-and-public-health

Huh, those two official copies of that Executive Order are now missing. Funny.

Here's a copy, prolly legit:

DONALD J. TRUMP
45th President of the United States: 2017 ‐ 2021
Executive Order 13887—Modernizing Influenza Vaccines in the United States To Promote National Security and Public Health
September 19, 2019

By the authority vested in me as President by the Constitution and the laws of the United States of America, including section 301 of title 3, United States Code, it is hereby ordered as follows:

Section 1. Findings. (a) Influenza viruses are constantly changing as they circulate globally in humans and animals. Relatively minor changes in these viruses cause annual seasonal influenza outbreaks, which result in millions of illnesses, hundreds of thousands of hospitalizations, and tens of thousands of deaths each year in the United States. Periodically, new influenza A viruses emerge from animals, including birds and pigs, that can spread efficiently and have sustained transmission among humans. This situation is called an influenza pandemic (pandemic). Unlike seasonal influenza, a pandemic has the potential to spread rapidly around the globe, infect higher numbers of people, and cause high rates of illness and death in populations that lack prior immunity. While it is not possible to predict when or how frequently a pandemic may occur, there have been 4 pandemics in the last 100 years. The most devastating pandemic occurred in 1918–1919 and is estimated to have killed more than 50 million people worldwide, including 675,000 Americans.

(b) Vaccination is the most effective defense against influenza. Despite recommendations by the Centers for Disease Control and Prevention (CDC) that nearly every American should receive the influenza vaccine annually, however, seasonal influenza vaccination levels in the United States have currently reached only about 45 percent of CDC goals.

(c) All influenza vaccines presently in use have been developed for circulating or anticipated influenza viruses. These vaccines must be reformulated for each influenza season as well as in the event of a pandemic. Additional research is needed to develop influenza vaccines that provide more effective and longer-lasting protection against many or all influenza viruses.

(d) The current domestic enterprise for manufacturing influenza vaccines has critical shortcomings. Most influenza vaccines are made in chicken eggs, using a 70-year-old process that requires months-long production timelines, limiting their utility for pandemic control; rely on a potentially vulnerable supply chain of eggs; require the use of vaccine viruses adapted for growth in eggs, which could introduce mutations of the influenza vaccine virus that may render the final product less effective; and are unsuitable for efficient and scalable continuous manufacturing platforms.

(e) The seasonal influenza vaccine market rewards manufacturers that deliver vaccines in time for the influenza season, without consideration of the speed or scale of these manufacturers' production processes. This approach is insufficient to meet the response needs in the event of a pandemic, which can emerge rapidly and with little warning. Because the market does not sufficiently reward speed, and because a pandemic has the potential to overwhelm or compromise essential government functions, including defense and homeland security, the Government must take action to promote faster and more scalable manufacturing platforms.

Sec. 2. Policy. It is the policy of the United States to modernize the domestic influenza vaccine enterprise to be highly responsive, flexible, scalable, and more effective at preventing the spread of influenza viruses. This is a public health and national security priority, as influenza has the potential to significantly harm the United States and our interests, including through large-scale illness and death, disruption to military operations, and damage to the economy. This order directs actions to reduce the United States' reliance on egg-based influenza vaccine production; to expand domestic capacity of alternative methods that allow more agile and rapid responses to emerging influenza viruses; to advance the development of new, broadly protective vaccine candidates that provide more effective and longer lasting immunities; and to support the promotion of increased influenza vaccine immunization across recommended populations.

Sec. 3. National Influenza Vaccine Task Force. (a) There is hereby established a National Influenza Vaccine Task Force (Task Force). The Task Force shall identify actions to achieve the objectives identified in section 2 of this order and monitor and report on the implementation and results of those actions. The Task Force shall be co-chaired by the Secretary of Defense and the Secretary of Health and Human Services, or their designees.

(b) In addition to the Co-Chairs, the Task Force shall consist of a senior official from the following executive branch departments, agencies, and offices:

(i) the Department of Defense (DOD);

(ii) the Department of Justice;

(iii) the Department of Agriculture;

(iv) the Department of Veterans Affairs (VA);

(v) the Department of Homeland Security;

(vi) the United States Food and Drug Administration;

(vii) the Centers for Disease Control and Prevention;

(viii) the National Institutes of Health (NIH);

(ix) the Centers for Medicare and Medicaid Services (CMS); and

(x) the Biomedical Advanced Research and Development Authority (BARDA).

(c) The Co-Chairs may jointly invite additional Federal Government representatives, with the consent of the applicable executive department, agency, or office head, to attend meetings of the Task Force or to become members of the Task Force, as appropriate.

(d) The staffs of the Department of State, the Office of Management and Budget (OMB), the National Security Council, the Council of Economic Advisers, the Domestic Policy Council, the National Economic Council, and the Office of Science and Technology Policy (OSTP) may attend and participate in any Task Force meetings or discussions.

(e) The Task Force may consult with State, local, tribal, and territorial government officials and private sector representatives, as appropriate and consistent with applicable law.

(f) Within 120 days of the date of this order, the Task Force shall submit a report to the President, through the Assistant to the President for National Security Affairs, the Assistant to the President for Domestic Policy, the Director of the Office of Management and Budget, and the Director of the Office of Science and Technology Policy. The report shall include:

(i) a 5-year national plan (Plan) to promote the use of more agile and scalable vaccine manufacturing technologies and to accelerate development of vaccines that protect against many or all influenza viruses;

(ii) recommendations for encouraging non-profit, academic, and private-sector influenza vaccine innovation; and (iii) recommendations for increasing influenza vaccination among the populations recommended by the CDC and for improving public understanding of influenza risk and informed influenza vaccine decision-making.

(g) Not later than June 1 of each of the 5 years following submission of the report described in subsection (f) of this section, the Task Force shall submit an update on implementation of the Plan and, as appropriate, new recommendations for achieving the policy objectives set forth in section 2 of this order.

Sec. 4. Agency Implementation. The heads of executive departments and agencies shall also implement the policy objectives defined in section 2 of this order, consistent with existing authorities and appropriations, as follows:

(a) The Secretary of HHS shall:

(i) through the Assistant Secretary for Preparedness and Response and BARDA:

(A) estimate the cost of expanding and diversifying domestic vaccine-manufacturing capacity to use innovative, faster, and more scalable technologies, including cell-based and recombinant vaccine manufacturing, through cost-sharing agreements with the private sector, which shall include an agreed-upon pricing strategy during a pandemic;

(B) estimate the cost of expanding domestic production capacity of adjuvants in order to combine such adjuvants with both seasonal and pandemic influenza vaccines;

(C) estimate the cost of expanding domestic fill-and-finish capacity to rapidly fulfill antigen and adjuvant needs for pandemic response;

(D) estimate the cost of developing, evaluating, and implementing delivery systems to augment limited supplies of needles and syringes and to enable the rapid and large-scale administration of pandemic influenza vaccines;

(E) evaluate incentives for the development and production of vaccines by private manufacturers and public-private partnerships, including, in emergency situations, the transfer of technology to public-private partnerships—such as the HHS Centers for Innovation and Advanced Development and Manufacturing or other domestic manufacturing facilities—in advance of a pandemic, in order to be able to ensure adequate domestic pandemic manufacturing capacity and capability;

(F) support, in coordination with the DOD, NIH, and VA, a suite of clinical studies featuring different adjuvants to support development of improved vaccines and further expand vaccine supply by reducing the dose of antigen required; and

(G) update, in coordination with other relevant public health agencies, the research agenda to dramatically improve the effectiveness, efficiency, and reliability of influenza vaccine production;

(ii) through the Director of NIH, provide to the Task Force estimated timelines for implementing NIH's strategic plan and research agenda for developing influenza vaccines that can protect individuals over many years against multiple types of influenza viruses;

(iii) through the Commissioner of Food and Drugs:

(A) further implement vaccine production process improvements to reduce the time required for vaccine production (e.g., through the use of novel technologies

for vaccine seed virus development and through implementation of improved potency and sterility assays);

(B) develop, in conjunction with the CDC, proposed alternatives for the timing of vaccine virus selection to account for potentially shorter timeframes associated with non egg based manufacturing and to facilitate vaccines optimally matched to the circulating strains;

(C) further support the conduct, in collaboration with the DOD, BARDA, and CDC, of applied scientific research regarding developing cell lines and expression systems that markedly increase the yield of cell-based and recombinant influenza vaccine manufacturing processes; and

(D) assess, in coordination with BARDA and relevant vaccine manufacturers, the use and potential effects of using advanced manufacturing platforms for influenza vaccines;

(iv) through the Director of the CDC:

(A) expand vaccine effectiveness studies to more rapidly evaluate the effectiveness of cell based and recombinant influenza vaccines relative to egg-based vaccines;

(B) explore options to expand the production capacity of cell-based vaccine candidates used by industry;

(C) develop a plan to expand domestic capacity for whole genome characterization of influenza viruses;

(D) increase influenza vaccine use through enhanced communication and by removing barriers to vaccination; and

(E) enhance communication to healthcare providers about the performance of influenza vaccines, in order to assist them in promoting the most effective vaccines for their patient populations; and

(v) through the Administrator of CMS, examine the current legal, regulatory, and policy framework surrounding payment for influenza vaccines and assess adoption of domestically manufactured vaccines that have positive attributes for pandemic response (such as scalability and speed of manufacturing).

(b) The Secretary of Defense shall:

(i) provide OMB with a cost estimate for transitioning DOD's annual procurement of influenza vaccines to vaccines manufactured both domestically and through faster, more scalable, and innovative technologies;

(ii) direct, in coordination with the VA, CDC, and other components of HHS, the conduct of epidemiological studies of vaccine effectiveness to improve knowledge of the clinical effect of the currently licensed influenza vaccines;

(iii) use DOD's network of clinical research sites to evaluate the effectiveness of licensed influenza vaccines, including methods of boosting their effectiveness;

(iv) identify opportunities to use DOD's vaccine research and development enterprise, in collaboration with HHS, to include both early discovery and design of influenza vaccines as well as later-stage evaluation of candidate influenza vaccines;

(v) investigate, in collaboration with HHS, alternative correlates of immune protection that could facilitate development of next-generation influenza vaccines; (vi) direct the conduct of a study to assess the feasibility of using DOD's advanced manufacturing facility for manufacturing cell-based or recombinant influenza vaccines during a pandemic; and

(vii) accelerate, in collaboration with HHS, research regarding rapidly scalable prophylactic influenza antibody approaches to complement a universal vaccine initiative and address gaps in current vaccine coverage.

(c) The Secretary of VA shall provide OMB with a cost estimate for transitioning its annual procurement of influenza vaccines to vaccines manufactured both domestically and with faster, more scalable, and innovative technologies.

Sec. 5. Termination. The Task Force shall terminate upon direction from the President or, with the approval of the President, upon direction from the Task Force Co-Chairs.

Sec. 6. General Provisions. (a) Nothing in this order shall be construed to impair or otherwise affect:

(i) the authority granted by law to an executive department or agency, or the head thereof; or

(ii) the functions of the Director of the Office of Management and Budget relating to budgetary, administrative, or legislative proposals.

(b) This order shall be implemented consistent with applicable law and subject to the availability of appropriations.

(c) This order is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person.

DONALD J. TRUMP

The White House,

September 19, 2019.

This doc is after the death jab mandates were already out, but seems to me likely to have been planned in advance as well:

https://www.dvidshub.net/news/389661/new-domane-pandemic-era

A New DOMANE for the Pandemic Era




Adaptive Trials test multiple treatments against the Standard of Care (SOC)...

FORT BELVOIR, VA, UNITED STATES
02.23.2021
Courtesy Story
Defense Threat Reduction Agency's Chemical and Biological Technologies Department

The Defense Threat Reduction Agency’s (DTRA) Chemical and Biological Technologies Department, in its role as the Joint Science and Technology Office (JSTO), is developing a system-of-systems called DOMANE — Discovery of MCMs (medical countermeasures) Against Novel Entities — an interdisciplinary effort with team members whose expertise include computer science, physics, and medicine. DTRA CB posits that one drug may be insufficient towards countering a threat, so it is developing DOMANE to rapidly identify a combination of drugs to impact the novel biological threat from multiple targets, which may prove effective in promoting a disease-modifying effect to counter the biological threat.

Systems within DOMANE include machine learning, high-throughput screening, in silico predictive tools, cryogenic electron microscopy (cryo-EM), organ-on-a-chip, and other emergent technologies. Machine-learning algorithms greatly reduce the time needed to search vast amounts of data on drugs and diseases. DOMANE is possible, in part, because of research studies that have occurred over the past several decades on biological threat agents and MCMs. The studies resulted in the global availability of a large repository of laboratory and clinical data (“big data”) on how biological threats affect the human body.

The COVID-19 pandemic and the resulting national human and economic toll demonstrate a clear and present vulnerability of the U.S. to emerging and unknown contagious infectious diseases. For Joint Forces on the battlefield, the possibility of illness due to emerging biological threats can impact their mission. Ideally, they should be equipped with the MCMs they need to lessen the influence of emerging biological threats.

DOMANE started in 2019, before the current pandemic, with the goal to shorten the traditional, multi-year timeline for developing MCMs to treat novel diseases. Utilizing drugs already approved by the Food and Drug Administration (FDA), DOMANE will evaluate the feasibility of repurposing them as MCMs to combat emerging threats. Some of the advantages to using FDA-approved drugs are that they are already manufacturable, have well-known toxicological profiles, and can proceed directly to human efficacy or Animal Rule studies. This can reduce or eliminate the time-intensive animal toxicology and human safety studies and enhance current good manufacturing practice to scale up process and ongoing stability assessment.

DTRA-JSTO is testing DOMANE using COVID-19 as a proof of concept to evaluate whether the DOMANE concept can identify drugs that are an effective treatment against the disease. DOMANE has already identified several FDA-approved drugs that can be repurposed to treat COVID-19, and these drugs have shown indications of potential efficacy in numerous case studies.

The next step is setting up randomized clinical trials to fully demonstrate the effectiveness of these repurposed drugs. To do this, adaptive, platform clinical trials will evaluate multiple drug combinations, dosages, and administration schedules performed in parallel. The adaptive nature of the trials enables clinical scientists to react to initial data from the trials. For example, if a drug and its approved dosage are ineffective or are having unanticipated effects, then clinicians can change the dosage or add another drug to the combination to pursue another therapeutic option.

The efficacy of COVID-19 drugs identified by DOMANE will be tested with two inpatient clinical trials and a planned virtual clinical trial. One inpatient trial is evaluating the efficacy of DOMANE-identified drugs for patients with severe, late-stage COVID-19 and the other inpatient trial is assessing the efficacy of drugs in COVID-19 patients newly admitted to hospitals. The virtual clinical trial will include outpatients who are newly diagnosed with COVID-19. Virtual outpatient trials dramatically reduce the cost of clinical trials and offer the Department of Defense (DoD) an opportunity to conduct these studies wherever patients with the disease are located, such as on a military ship or base.

DTRA-JSTO recently held a two-day virtual workshop consisting of subject matter experts in synthetic biology, artificial intelligence and machine learning, organs-on-a-chip, high-throughput screening, microcrystal electron diffraction, cryo-EM, animal model development, and other fields. The goal of the workshop was to bring together a collaborative team with diverse technical capabilities to develop an operational workflow for rapidly discovering MCMs of interest. The workshop included presentations and panel discussions among experts from academia, industry, national laboratories, DoD, and other U.S. government organizations. The workshop identified capability gaps that will need to be addressed as well as collaborative opportunities to advance DOMANE that will begin the process of changing our defense against emerging biological and chemical threats.

The current COVID-19 pandemic has demonstrated the impact of biological diseases on national security and everyday life, which could set the stage for an era when there will be significant temptation for both state and non-state actors to intentionally execute a biological attack to cause pandemic-level devastation. Successful development of DOMANE will produce a discovery and verification engine for identifying MCMs for emerging biological threats. The engine will produce in months, not decades, MCMs ready for pre-clinical and clinical development to protect the Joint Force and the nation against biological threats. With DOMANE, DoD has the capability to fight not only COVID-19 but also diseases that have not yet surfaced, thereby ensuring the maintenance of a strong and lethal force.

POCs: Revell Phillips, Ph.D., l.r.phillips.civ@mail.mil ; Dale Taylor, dale.e.taylor4.civ@mail.mil