Experimental Nasal sprays are being developed that appear to reduce nasal viral load considerably

From a preprint:

This one has not been tested in humans but looks great in the lab.  Might be used for prophylaxis when entering enclosed spaces.  It is an OTC sinus nasal spray whose active ingredients are xylitol and grapefruit seed extract.

Xylitol has a long history of being safe and beneficial in preventing bacterial pathogen infections.14 It is considered a prebiotic due to its positive effect on the microbiome, reducing pathogenic proliferation.15 The use of xylitol in oral health to prevent dental caries and periodontal disease has been well documented as safe and effective...  Because there are no risk factors in using the X/GSE combination therapy, and the nasal spray is over the counter available without prescription, and the spray allows for comfortable long term mask wearing, adoption of this preventive anti-viral therapy should be encouraged.

 Here's one other nasal spray, nitric oxide, that has been tested on humans, but the press release never says whether it improved their clinical course.  It did reduce viral load.  Since the product is applying for an EUA, it does not need to show clinical benefit, only that its net effect is presumed to be better than nothing. 

If the vaccines are effective, how long do they work?/ MedPageToday

From MedPageToday:  Maybe you will need those 6-monthly boosters Netanyahu promised if you lack natural immunity...

"neutralizing activity in the older groups declined approximately 10-fold at 6 months from the peak 14 days after the second vaccine dose; in those 18-55, activity was down by roughly half. But activity levels in the older groups remained more than 10-fold above pre-vaccination baseline at the 6-month mark."

Moderna's COVID Vax Produces Antibody Responses 6 Months Later

— But neutralizing activity declined over time, and not equally among age groups

by Molly Walker, Associate Editor, MedPage Today April 6, 2021

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"Antibodies persisted 6 months after the second dose of Moderna's COVID-19 vaccine in younger and middle-age adults, but were diminished in older adults when using more sensitive assays, according to data from an ongoing phase I trial.

Antibody activity was high across groups at day 209, but assessment with a "live virus" neutralization test found geometric mean titers declined more over time in participants ages 56 and older compared with adults ages 18-55, reported Mehul Suthar, PhD, of Emory University School of Medicine in Decatur, Georgia, and colleagues in a correspondence piece in the New England Journal of Medicine.hey noted the durability of protection is currently unknown, and examined binding and neutralizing antibodies elicited by the Moderna COVID-19 vaccine in 33 healthy adult participants in an ongoing phase I trial, who were stratified by age. They measured responses at 180 days after the second dose of vaccine, or day 209, using three distinct serologic assays.

Suthar's group found nearly all participants "had detectable activity in a pseudovirus neutralization assay," and all participants had detectable activity on the "more sensitive live-virus focus-reduction neutralization mNeon-Green test," but it was this assay for which geometric mean titers were lower in older adults compared with adults ages 18-55.

In that assay, neutralizing activity in the older groups declined approximately 10-fold at 6 months from the peak 14 days after the second vaccine dose; in those 18-55, activity was down by roughly half. But activity levels in the older groups remained more than 10-fold above pre-vaccination baseline at the 6-month mark.

The researchers estimated a half-life of binding antibodies of 52 days after day 43 for all participants using a model assuming a steady decay rate over time, and the neutralizing antibody half-life was 202 days for live-virus neutralization using a model that assumed decay rates decrease over time. The model with the steady decay rate was the best fit for binding, and the one with the decreasing decay rate was best for neutralization, which was "consistent with published observations of convalescent patients with COVID-19 through 8 months after symptom onset," Suthar and colleagues wrote.

Suthar and colleagues noted that "the antibody titers and assays that best correlate with vaccine efficacy are not currently known," and ongoing studies continue to monitor immune response beyond 6 months, as well as examine the impact of a potential booster dose against COVID-19 variants."

Investigating the origin of SARS-CoV-2: Interview with Professor Richard Ebright/Independent Science News

This interview is from late March, but has not gotten the attention it deserves.  Professor Ebright is extremely knowledgeable about the issue of biosafety in high containment labs and about high risk (aka Gain of Function aka biological warfare research).

Here is a taste of the interview:

... The Open Letter explains in detail the structural and functional limitations of the WHO-China Wuhan collaborative team: exclusive Chinese field work, lack of complete access to lab installations or databases, consensus process in report making…

A credible investigation would have had Terms of Reference that: 1) Acknowledged the possibility of laboratory origin, 2) Ensured access of investigators to records, samples, personnel, and facilities at the Wuhan laboratories that handle bat SARS-related coronaviruses, 3) Enabled collection of evidence, not mere meet-and-greet photo-ops, 4) Authorized an investigation of months, not mere days. And 5) A credible investigation also would have had conflict-of-interest-free investigators, not persons who were subjects of the research and/or closely associated with subjects of the investigation.

You have said several times that this WHO mission was literally “a charade”.

Yes, its members were willing –and, in at least one case, enthusiastic– participants in disinformation.

The pre-negotiated “Terms of Reference” for the WHO study did not even acknowledge the possibility of a laboratory origin of the virus and did not even mention the Wuhan Institute of Virology (WIV), the Wuhan Center for Disease Control (CDC) or the Wuhan Institute of Biological Products....

------------------

The reason the origin story has gotten so much attention lately is due to the indefatigable work of about a dozen people originally.  The group has slowly expanded to 28, some of whom are identified only by their Twitter handles.

These people, who openly and collaboratively solved many pieces of the Covid origin puzzle, are the DRASTIC group of armchair researchers (and some are academics) from around the world.  Here is an easy read about these heroes of mine.

Alina J Chan, a well-spoken post-doc at the Broad Institute of MIT, has been invaluable at conveying information about what is being learned to the public.

While the well-paid academic virologists buttoned their lips to avoid the risk of future reductions in grant monies to their field, the above heroes often risked their careers to bring the truth to light.  Careers have been lost. The heroes knew they were working on something that is bigger than themselves. 

Let's not take all the gains from this year of investigation and settle on the most likely narrative, which seems to be a lab leak from Wuhan.  We need to continue to struggle for every nugget of truth and keep travelling down this rabbit hole to its very source, wherever it leads, in order that something like this pandemic never happens again.

Emergent BioSolutions to be Called to Account by Congress on May 19

A few short months ago, Emergent Biosolutions was riding high.  Their stock was at $125/share.  They were a $7 billion dollar company.  They were the epitome of how to turn failure into success:

• never bringing a product they created to market  
• selling almost exclusively to the government; 
• selling single-source products, which meant no-bid contracts; 
• making products that were mostly stockpiled, with a short expiration period, so they had to continuously re-supply the buyer;
• selling products that were stockpiled but never used, the quality of the stockpiled products could be very low;
• asking the government for bailouts, and getting them, when manufacturing problems were identified;
• even when thousands of soldiers were sickened by their anthrax and smallpox vaccines, the Defense Department covered up for the company;
• most of their products were intended for pandemics or bioterrorism, and were thus "covered countermeasures"--which meant they fell under a government PREP Act near-total liability shield;
• because the only way liability could be assigned to the company was by proving "willful misconduct," i.e., knowing of a product's faults but selling it anyway, the company was incentivized not to properly test its products.  By avoiding proper testing, the company could not be accused of knowing about their products' flaws;
• Emergent BioSolutions practically cornered the market on insider, crony deals--which is saying quite a lot when you are talking about the pharmaceutical industry

Naturally this company flubbed its Covid vaccine manufacturing.  The company's M.O. is to screw up the manufacuring of a single-source, necessary product, then cry poor and get the government to bail them out.

Now Congress is paying attention.  The CEO Robert Kramer and Board Chairman/majority owner Fuad el Hibri have been asked to pony up documents and appear for questioning on May 19.  Hopefully Congress will review the prior investigation of this company, performed by the GAO and Government Reform Committee in 1999-2000.  There is quite a lot of history, and Fuad el-Hibri and Robert Kramer have been involved with numerous questionable deals since the company was formed in 1998.  Hopefully the Congress will also look into the acquisition of Narcan nasal spray (an opioid antidote) by Emergent, and the massive increase in Narcan purchases by public agencies after EBS acquired the product.

Given the 23 year history of malfeasance of this company (previously named Bioport), what probably needs to happen is that it should be barred from federal and state contracting in future.

Here is today's MSNBC article talking about this latest twist in the saga of Emergent BioSolutions, the cardboard "powerhouse" that has contracts to produce nine different medical products in response to the Covid pandemic. Nine products that might be injected into any of us. 

https://www.cnbc.com/2021/04/20/congressional-investigation-launched-into-emergent-biosolutions-federal-vaccine-contracts-.html

The letter my local newspapers have refused to print

 

Letter to All California County Supervisors Regarding Illegal Mandates of EUA Products, fake school openings/ Alix Mayer, Children's Health Defense-California

Alix Mayer at Children's Health Defense, California wrote this excellent letter to all California county supervisors, warning them to obey the law or risk litigation. Since the letter is 11 pages long, but could be useful for many other regions, I reproduced the first part, but invite readers to copy and save the entire letter.

Letter to All California County Supervisors Regarding Illegal Mandates of EUA Products

March 26, 2021

Dear Supervisor,

I am the President of the California Chapter of Children’s Health Defense, a 501(c)(3), and I write on behalf of our organization on this urgent matter regarding your County’s COVID-19 programs. We are a non-profit organization concerned with medical science, law, public policy, medical ethics and now more than ever, impingements on our personal freedoms from both the public and private sectors. One way we are doing this is by taking steps to protect the health of children by ensuring all medical interventions, such as vaccines and COVID-19 testing, are ethical, necessary, voluntary, and only offered with fully informed consent. Over many years, our non-profit has identified the environmental and iatrogenic causes of chronic illness in children, has brought corporate offenders to justice, and has enacted safeguards to prevent future transgressions.

As you may recall, we copied you on a Notice of Liability which we sent to all school districts in California, regarding the legal and ethical need to make COVID testing and vaccines voluntary as they are only authorized for use under federal Emergency Use Authorization (EUA) and are thus illegal to mandate under Federal and CA state law.[1]

Our letter dated January 29, 2020[2] served as a Notice of Liability regarding schools and school districts’ plans to impose illegal mandates of certain EUA products on students and employees.  A number of districts contacted us after receiving that letter, including large urban districts such as the San Jose Public School District, to inform us they have elected to follow the law and science, rather than risk being sued. We applaud these districts’ decisions.

However, a number of other school districts, as well as public agencies, counties, cities, and private entities across the state and nation, continue to roll out plainly illegal and dangerous mandates imposed on employees, customers, students, constituents and others.  We are rapidly descending into a society in which blatantly criminal and legally-suspect actions are being imposed on us to simply participate in many normal aspects of life. Your County has possibly been operating in violation of multiple sections of federal and state law, as are most entities that do public business.

The EUA Statute authorizes the Secretary of the U.S. Department of Health and Human Services (HHS) to declare a health emergency and authorize the use of drugs, treatments, or other products that may be beneficial but have not yet been demonstrated to be safe or effective and are thus only available for use under the EUA. The federal COVID EUA was declared by HHS Secretary Azar on April 1, 2020[3] and includes numerous authorizations for a wide range of products, none of which are fully approved, and all of which may be offered only on a voluntary — not a mandatory — basis.

The large clinical trials for the EUA mRNA injectables and recombinant vaccines in the U.S. will not conclude until late 2022 and early 2023.[4] [5] [6] Full licensure may be considered after the trial results are in, and after government agencies such as FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) and CDC’s Advisory Committee on Immunization Practices (ACIP) have reviewed safety and efficacy data from the trials and experimental usage on the population.

There are substantial known and unknown risks associated with using any EUA product, including in the context of COVID. EUA products are, by definition, experimental and investigational; anyone administering or receiving an EUA product is participating in a medical experiment. That is precisely why EUA products cannot be mandated.[7]

Among the key product types authorized for COVID-related EUAs are:

1. devices, systems and procedures that may detect the possible presence of some viral material in a person (i.e., “tests” or “RT-PCR tests” or “antigen tests” or “antibody tests”);
2. wearable devices that may have some effect on reducing transmission (i.e., “masks” or “Personal Protective Equipment (PPE)”); and
3. two different manufacturers’ mRNA injectable drug treatments delivered via two consecutive shots (i.e., “vaccines”).
4. one manufacturer’s recombinant single-shot vaccine.

For these — or any other EUA products — to be distributed and used, disclosure documents published by the FDA for each product must be provided at the time of distribution to all potential users, detailing the potentially significant risks and benefits associated with use of that specific product.  Additionally, extensive protocols are required by federal law for assessing the effectiveness and safety of EUA products, while also protecting users’ medical health, privacy and other guaranteed rights.

Emergency Use Authorization (EUA) Law[8]

Mandating employees, students or others to use products that have been approved only conditionally for emergency use violates federal and state law.[9] Federal and state law are clear:  mandates are illegal for EUA products. The prohibition on EUA mandates has been upheld in court.[10] The RT-PCR test, COVID vaccines, and certain face coverings are not FDA-approved; they are available only under an EUA.[11]

The EUA statute explicitly states that administration of all EUA products must “ensure that individuals to whom the product is administered are informed … of the option to accept or refuse administration of the product.”[12]  21 U.S.C. Sec. 360bbb-3(e)

Federal and state law on this rests on the first principle of the Nuremberg Code, requiring that the human subject be “so situated as to be able to exercise free power of choice without undue inducement or any element of force, fraud, deceit, duress or other forms of constraint or coercion.” This is a bright line that cannot be blurred. The consent of the individual is “absolutely essential.”[13]

In the letter we sent to schools, we officially put them on notice that if they illegally or irresponsibly mandate products on students or employees, we may take legal action. Children’s Health Defense has initiated a suit in New York against the NYC Department of Education and Mayor de Blasio for coerced PCR testing as a condition to in-person learning privileges.[14] (Aviles, et al. V. de Blasio, et al. 20-CV-09829 (PGG))...

Johnson & Johnson suffers another setback as FDA tells Md. vaccine maker to suspend production/ WaPo

From the WaPo our fears are confirmed--vaccine has been leaking out of this plant despite the fact that the plant was never authorized by FDA.  Still wondering if this was related to some of those clinic shut-downs?The storyline is that the unapproved vaccine went to Canada and Mexico.  Are you relieved yet?  From the WaPo:

Emergent BioSolutions has shut down new manufacturing of Johnson & Johnson’s coronavirus vaccine at its Baltimore plant at the request of the Food and Drug Administration after an inspection of the troubled facility last week, Emergent said Monday... 

"Emergent’s brief statement Monday said the FDA began a new inspection of its Bayview facility on April 12. On Friday, at the FDA’s request, “Emergent agreed not to initiate the manufacturing of any new material at its Bayview facility and to quarantine existing material manufactured at the Bayview facility pending completion of the inspection and remediation of any resulting findings,’’ the company said...

AstraZeneca and Johnson & Johnson have not disclosed how many doses of vaccine have previously been shipped from the Emergent plant and put into vials by other manufacturers.

The quarantine of packaged vaccine could delay millions of doses further down the distribution pipeline. But none of those doses have yet been administered in the United States, U.S. officials have said.

Emergent’s manufacturing of Johnson & Johnson vaccine has not been certified by the FDA, so vaccines made there cannot be used. Johnson & Johnson has been forced to turn to imported vaccine produced in the Netherlands for early supplies of shots for American arms.

AstraZeneca vaccine has not been approved for emergency use in the United States, although the Biden administration has sent a few million doses to Mexico and Canada...

Who pays for Covid vaccine injuries? Is anybody out there?

 In Ireland, nobody pays.

I updated my knowledge of the United States' CICP on April 16, through a seminar put on by the RAND Corporation's Justice Policy program.

In the US, you have the right to apply to the Countermeasures Injury Compensation Program.  Of the 700 plus people who have applied, 500 cases have been adjudicated and 200 are pending.  The program found in favor of 39.  

However, this DHHS program only pays for medical expenses and lost wages.  Only 29 of the 39 claimants had unreimbursed medical expenses or wages.

So, the opportunity to obtain benefits exists, but the chance of obtaining benefits currently is 29/500 or 5.8%.

There is no transparency to the program, and no rules have been written regarding the adjudication of Covid injury cases.

I wonder what % of the population is aware of this?

Dr. Charles Hoffe describes what happened to 900 of his patients after they were given the Moderna shot. Please watch or listen

I found this video incredibly compelling.  Yes, he was told to shut up and threatened, and that is a story.  But what truly stunned and sickened me were the number of vaccine injuries in this small population, many who are from the First Nations.  If these rates of injury are broadly representative, we are seeing a major crime against humanity taking place.

When doctors who are just trying to inform public health authorities about their own patients' injuries are being muzzled, something is indeed very rotten.

https://brandnewtube.com/watch/dr-charles-hoffe-reveals-the-devastating-impact-of-the-moderna-jab_w5Bj9xDPqJ8E1qr.html

Yet another $10 billion to expand vaccine access and build vaccine confidence?/US News

From US News:

"Officials say the nation will soon reach a point where the supply of vaccine outpaces demand. At that point, the biggest challenge will be convincing still skeptical Americans to get the shots, and deciding what to do with a growing stockpile, the Times reported.
Vaccine hesitancy is particularly prominent among minorities and Republicans, the Times said."
Three weeks ago, "White House officials said the administration would spend $10 billion on congressionally-appropriated money to expand access to COVID-19 vaccines and build vaccine confidence in the hardest-hit and highest-risk communities."

EUA Vaccines, Mandates and the US Military: Legal and Historical Issues/Meryl Nass

1.  Are Americans who receive vaccines under EUA experimental subjects?

·        Definitely yes.  An EUA product is not a law unto itself.  According to 21CFR Subchapter D Part 312:  "an experiment is any use of a drug except for the use of a marketed drug in the course of medical practice."

·       FDA Commissioner Stephen Hahn told USA Today.

·        Medicines and vaccines are either licensed products or experimental products. There is no gray area between them in US law. Whether or not research is explicitly conducted, the use of experimental products (including those issued under an Emergency Use Authorization) falls under the Nuremberg Code and under US law regulating experimental drugs.  

·        Vaccines are drugs under FDA law:  "[V]accines are a unique class of pharmaceutical products that meet the statutory definition of both a drug and biological product," according to Marion Gruber, the current Director of FDA's Office of Vaccines Research and Review.

2.  US regulations (45 CFR 46 Subpart A) for the use of experimental products require: 

•  informed consent, in which there must be full disclosure of risks and benefits of the product and the absence of coercion, and 
• approval by an Institutional Review Board.  

·        Neither of these requirements have been met for Covid-19 vaccines supplied to Americans by the US government, even for civilians. This suggests that the federal government may be trying to carve out a gray area in which the laws governing investigational products do not apply.

3.  US law (10 USC 1107) and Executive Order 13139, issued in 1999, although not the Nuremberg Code, permit the President of the United States to mandate the use of experimental drugs for military servicemembers "participating in particular military operations." Why did this law and EO come about?

·        Just prior to the first Gulf War, the FDA granted a waiver of informed consent to the Defense Department, enabling it to use experimental drugs without disclosure or consent and there was no adequate recordkeeping.  The result was Gulf War syndrome, a disabling condition that could not be clearly linked to particular drugs or exposures, and which occurred in 30% (200,000) of the returning soldiers.

·        Congress took this matter very seriously. Faced with the possibility that troops might encounter chemical, biological or radiological risks "during particular military operations," during which unlicensed drugs might be beneficial, Congress gave the Defense Department one method for their use.  This required the Secretary of Defense to formally request and receive from the President a waiver of informed consent, in writing, under EO 13139. Clearly, Congress' intention was to avoid frivolous use of this waiver.  Until now, it has never been used.

·        At the same time, Congress required the Defense Department to establish the Defense Medical Surveillance System, a force-wide database of all medical inpatient and outpatient encounters, all vaccinations administered, and all deployments and their dates, so that in the event of a future tragedy like Gulf War syndrome, there would be a clear record of the possible exposures soldiers had faced, and the diagnoses and treatments they had received.  Data from the Defense Medical Surveillance System were promised to be shared quarterly.  Instead, these data have been withheld from the general public since being provided to the Institute of Medicine in 2001, during its investigation into anthrax vaccine.

·        The language of 10 USC 1107 and EO13139 make clear that Congress' intention was to make drugs available to deployed troops on a particular military mission, for a narrow purpose.  The law's intention was not to mandate a vaccine or drug throughout the military force for the purpose of public health.  From USC 1107:  "The Secretary of Defense may request the President to waive the prior consent requirement with respect to the administration of an investigational new drug or a drug unapproved for its applied use to a member of the armed forces in connection with the member’s participation in a particular military operation." 

4.  What were the specific shortcomings in DOD's handling of investigational drugs during the Gulf War?  

·        The November 9, 1999 Subcommittee on National Security, Veterans Affairs and International Relations:  Testimony of William F. Raub, Deputy Assistant Secretary of DHHS for Science Policy, p 21, makes DOD's shortcomings clear, but also explains that the purpose of the waiver was to alleviate the infeasibility of providing informed consent in the middle of a military operation :

·        "In December 1990, motivated by concerns about potential chemical and biological threats to troops participating in Operation Desert Storm, the Department of Defense requested that FDA waive the informed consent requirement for use of particular investigational products. In response, FDA published an interim rule amending its informed consent regulations such that the Commissioner of Food and Drugs, given appropriate evidence, could determine that obtaining informed consent from military personnel for use of a specific investigational product would not be feasible in certain circumstances and to grant a waiver from the requirement for obtaining consent.  Shortly thereafter, the Commissioner approved waiver requests from DOD for use of pyridostigmine bromide tablets and botulinum toxoid vaccine. The aftermath of these decisions has been subject to intensive examination. The President's Advisory Committee on Gulf War Veterans ' Illness, deliberating during 1996 and 1997, described a number of shortcomings in DOD use of investigational products during the Persian Gulf war and recommended that FDA revisit the interim rule to address, among other thing , the adequacy of information disclosure to service personnel, recordkeeping and long-term follow-up of individuals who received investigational products..."

5.  While the Nuremberg Code is not officially part of the US Code, it is important to remember that it was formulated by American judges at the Nazi Doctors Trial.  It has subsequently been interpreted to have the force of law by US judges. According to the New England Journal of Medicine:

·       "[Nuremberg's] basic requirement of informed consent, for example, has been universally accepted and is articulated in international law in Article 7 of the United Nations International Covenant on Civil and Political Rights (1966).^6,22 Informed consent, with specific reliance on the Nuremberg Code, is also the basis of the International Ethical Guidelines for Biomedical Research Involving Human Subjects, the most recent guidelines promulgated by the World Health Organization and the Council for International Organizations of Medical Sciences (1993).²³ ...Both the Nuremberg Code and the Declaration of Helsinki served as models for the current U.S. federal research regulations." 

6.  What information do we have regarding the safety, efficacy, necessity and manufacturing fidelity of the 3 Covid-19 vaccines currently authorized under EUAs and those expected to be authorized?

·        Safety:  2,216 deaths have been reported to a passive reporting system, VAERS, as of March 22.  CDC says it does not have a method for tracking deaths following vaccination, since most of its safety surveillance relies on vaccines administered within the healthcare system. According to MSN, "The struggle to find a way to complete the key vaccination mortality study highlights a growing frustration among officials working on the pandemic response that the federal government is still falling short in collecting, analyzing, and reporting of COVID-19 data." 

·        Yet CDC has assured the public that not a single death has been shown to be due to a vaccination. According to Elisabeth Rosenthal in the LA Times, "we still don't have a uniform national digital database that can track who is getting the vaccine." The bottom line is that we don't have the safety data we need, after over 100 million doses of unlicensed vaccines have been administered.

·      Meanwhile, the Astra-Zeneca vaccine has been found to cause serious, rare blood clots, especially in the brain, in perhaps one in 25,000 young recipients.

·        Data adequacy:  The Emergency Use Authorizations for the Covid-19 vaccines were issued with only a median of 2 months of data.  Only two months.  While the trials were originally expected to continue for 2 years, when vaccine became publicly available, the vaccine manufacturers offered vaccine to the subjects in their trials who had received placebos. Thus, the anticipated datasets from the clinical trials, in which placebo recipients would be compared to vaccine recipients in terms of long-term side effects and infection rates for 2 years, will be greatly abbreviated.  

  ·      According to Brownlee and Lenzer, "A decision [was] made back in December by the U.S. Food and Drug Administration (FDA). The agency allowed manufacturers to effectively stop their clinical trials as soon as they were authorized to market their vaccines. While the early results from the clinical trials look incredibly promising, we don’t actually know with any precision just how effective and safe they really are – and we probably never will." 

·        Efficacy:  We still do not know to what extent the vaccines are efficacious and to what extent they prevent transmission, both to current strains of Covid-19 and to newer variants.

·        Necessity:  On November 4, 2020, Stars and Stripes revealed that only one active duty servicemember had died as a result of Covid-19.  So had 8 reservists.  There were 59,000 Covid-19 cases documented in the military at that time.  In general, soldiers are young and healthy and unlikely to suffer severe illness or death.

·        Manufacturing fidelity:  The FDA is not required to inspect manufacturers of EUA products, as it is for licensed products.  Whether Good Manufacturing Practices are met is uncertain.  Emergent BioSolutions, which is the subcontractor for the production of the Johnson and Johnson, Astra-Zeneca and Novavax Covid-19 vaccines for the US market, continues to face delays receiving authorization from FDA for its J and J vaccine. This is the company that produces all US anthrax vaccine.  Furthermore, the DHHS Secretary has the authority to waive Good Manufacturing Practice (GMP) requirements for EUA products, and GMP waivers have been issued for other Covid-19 EUA products.

7.  What has the President said previously about Covid-19 vaccine mandates?

·        President Biden told reporters in December that he would not make Covid-19 vaccines mandatory.

8.  What if a soldier has a religious or philosophic objection to the vaccine?  For example, some Catholics were told to avoid the J and J vaccine.

·        From the experience with anthrax vaccine, I can assure you that servicemembers were not given vaccine exemptions for religious, personal belief, or often even valid medical reasons.  Suspected pregnancy, for example, was initially not permitted as a contraindication to vaccination.  That is why there were so many court martials and punishments for vaccine refusals.

9.  What benefits might be available for a soldier who is injured as a result of a Covid-19 vaccination?

·        Under PREPA, Covid vaccines have been designated as "covered countermeasures" by the DHHS Secretary, granting their manufacturers, distributors, healthcare workers and program planners a virtually complete waiver of liability. The single avenue to obtain benefits is the Countermeasures Injury Compensation Program, an administrative program of the DHHS. While benefits are potentially available only for lost wages and medical care, less than 10% of the injured who have applied to the program since it began 11 years ago have received any funds.  There is no court or special master; there is a one-year statute of limitations; and one must be able to prove that one's injury was caused by the vaccine.  The maximum benefit is about $370,000.  The average benefit paid has been about $200,000.  It is funded by Congressional appropriation.

10.  Soldiers do not understand why they lack the same rights as civilians

·        They remember many thousands of injuries caused by mandatory but unnecessary anthrax vaccines during the Gulf War, and subsequently.

·        They know how Federal District Court Judge Emmett Sullivan ruled in Doe v. Rumsfeld in 2004: "The women and men of our armed forces put their lives on the line every day to preserve and safeguard the freedoms that all Americans cherish and enjoy. Absent an informed consent or presidential waiver, the United States cannot demand that members of the armed forces also serve as guinea pigs for experimental drugs."

·        They have not forgotten over 100 Court Martials and hundreds or thousands of Article 15 punishments faced by servicemembers who refused dangerous anthrax vaccines.

·        They also know there may be other reasons for mandating vaccines in the military; for example, the former Army Surgeon General Sue Bailey, former DHHS Secretary Louis Sullivan, former General George Joulwan and former FDA Director of the Center for Biologics Kathryn Zoon are all currently on the Board of the anthrax vaccine manufacturer.

How can they keep slamming hydroxychloroquine? By pretending the overdose HCQ/CQ studies didn't overdose, and meta-analyzing them/ Nature Communications

Just in case people are starting to wake up and realize there are actually effective drug treatments for Covid, it is important to keep banging the drum that says, not only don't the drugs work, but they are dangerous, to boot. And so we have a new meta-analysis designed to do just that.

This is very easy to do.  Here's how:

1. Never admit there was anything wrong with the trials that overdosed patients with hydroxychloroquine or chloroquine.  In fact, these authors called the Recovery and Solidarity trials that gave patients 4 times the normal dose of HCQ at first, "pragmatic." Odd use of verbiage.

2.  Cherry pick a small number of studies from which to perform your meta-analysis, so that the number of subjects in the overdose studies outweighs the number in all the other trials. In this case 67% of all subjects in this meta-analysis (which included about 14 of 233 total trials) had been enrolled in the Recovery and Solidarity overdose trials. Two other overdose studies were included, PATCH and Remap-CAP. (PATCH abruptly ended after only 5 subjects were enrolled, once the other overdose trials were exposed.)

3.  Because the overdose studies (except PATCH, in which none of the 5 died) had a higher proportion of deaths in the hydroxychloroquine arms than in the placebo arms, and provided more than two thirds of the subjects for this meta-analysis, the authors of the meta-analysis were able to conclude that using HCQ is associated with higher death rates than using nothing at all.  

4.  Incredible that the toxic doses used in 4 of the trials selected are whitewashed by calling them "relatively high doses" and never linking these doses to the increased death rates.

5.  Another odd thing is that investigators from the included trials, whose data were used in this study, are listed as coauthors.  There are 94 coauthors, all of whom signed off on the final paper (i.e., the overdose investigators had the opportunity to craft the language of this paper to cover their butts regarding their overdose trials).

6.  Many of these investigators have financial interests in products and/or companies making new products for which hydroxychloroquine would be a cheap competitor.

Here is the new paper.

Mortality outcomes with hydroxychloroquine and chloroquine in COVID-19 from an international collaborative meta-analysis of randomized trials

• Cathrine Axfors, 
• Andreas M. Schmitt, 
• […]
• Lars G. Hemkens

volume 12, Article number: 2349 (2021)  
https://www.nature.com/articles/s41467-021-22446-z
"Results for hydroxychloroquine are dominated by RECOVERY and WHO SOLIDARITY, two highly pragmatic trials, which employed relatively high doses and included 4716 and 1853 patients, respectively (67% of the total sample size). The combined OR on all-cause mortality for hydroxychloroquine is 1.11 (95% CI: 1.02, 1.20)..."

PLOT TWIST: Toronto police make no arrests, allow anti-lockdown protest to proceed one day after Doug Ford's restrictive lockdown measures/ThePostMillenial

From The Post Millennial, where there is a video of the march:

Protestors once again gathered at Queen's Park in Toronto to speak out against the ongoing lockdowns, the latest amendment of which gives police increased authority to enforce the provincial stay-at-home order.

"I understand you have an opinion that you'd like to express," one officer said to some protestors, adding that "free expression is everything in this country."

Another officer said "There are at least two sides to everything," one said, "and we're always in the middle. We're just trying to make it a safe place for everybody."

Since Doug Ford's announcement that police would now be stopping vehicles in order, several police districts have said they do not intend to enforce the orders.

Travis Dhanraj, Queen's Park Bureau Chief for Global News, reported that as a result of the police's refusal to enforce Ford's harsh measures, Ontario is currently "reconsidering" the playground closures and police stops...