They Don’t Know What They’re Doing: The Vaccine Paradigm’s Shaky Assumptions

07-16-20-Dr-Peter-Aaby-Featured-Image-800x417

JULY 16, 2020
They Don’t Know What They’re Doing: The Vaccine Paradigm’s Shaky Assumptions

They Don’t Know What They’re Doing: The Vaccine Paradigm’s Shaky Assumptions


By the Children’s Health Defense Team

As the endlessly reassuring pronouncements about high-risk Covid-19 vaccines indicate, vaccine scientists are nothing if not confident. Underlying their overweening confidence is a paradigm that has remained essentially unchanged since vaccination’s inception, notwithstanding seismic changes in vaccine technology and vaccine schedules. This paradigm narrowly evaluates a given vaccine’s effects against the target illness but pays little (if any) heed to vaccinated individuals’ overall health or to overall mortality. Adherents of the prevailing paradigm also display a surprising lack of curiosity about whether vaccines have different impacts on boys versus girls or whether the sequence and combination in which vaccines are given matter.

Individuals who teach the scientific method have pointed out that a scientific paradigm represents a “lens” that can be “recognized by the set of assumptions that an observer might not realize he or she is making, but which imply many automatic expectations and simultaneously prevent the observer from seeing the issue in any other fashion.” The authors of a July 2020 commentary in Lancet Infectious Diseases (titled “Vaccinology: time to change the paradigm?”) make this very point, arguing that decades of vaccine research not only have failed to address important inconsistencies but also contradict many of the assumptions that drive global vaccine policies and programs. As one of the authors (Danish scientist Peter Aaby) stated in 2019, “most of you think that we know what all our vaccines are doing—we don’t.”

… they report that 17 different studies examining all-cause mortality in DTP-vaccinated children found higher mortality in girls than boys, whereas in the pre-vaccination era in west Africa, there was no excess mortality in girls at all.
“Non-specific effects” and excess mortality
Aaby and coauthors are staunch advocates of vaccination. However, over the course of 40-plus years of health surveillance in west Africa, they have gathered enough observations and data to be persuaded that vaccines have “non-specific effects” on the immune system—in other words, effects “other than the intended effect of reducing disease from the specific vaccination.” In their Lancet commentary, they outline six principles to explain these effects.

Some non-specific effects, in the Aaby group’s view, are beneficial. The researchers believe, for example, that live virus vaccines can “enhance resistance towards unrelated infections” (Principle 1) and—in the presence of existing maternal or prior vaccine-induced immunity—may enhance other beneficial non-specific effects (Principle 5). On the other hand, some researchers (Aaby and also others) are willing to cop to the fact that certain non-specific effects are plainly deleterious. In 2017, Australian researchers who looked into non-specific (“heterologous”) effects described undesirable outcomes ranging from decreased resistance to infection to “altered susceptibility to allergy, autoimmunity, and malignancy.” These are bad enough, but what the Australians emphasized most strongly—citing the Aaby group’s large body of research—were alarming sex differentials in deaths from all causes, particularly with reference to diphtheria, tetanus and whole-cell pertussis (DTP) vaccines. In the Lancet commentary, Aaby and coauthors encapsulate this observation as Principle 2, stating that “non-live vaccines enhance susceptibility towards unrelated infections for females.” More powerfully, they report that 17 different studies examining all-cause mortality in DTP-vaccinated children found higher mortality in girls than boys, whereas in the pre-vaccination era in west Africa, there was no excess mortality in girls at all.

According to Aaby and colleagues, girls also have fared worse—in terms of non-specific effects and excess all-cause mortality—with a number of other vaccines, including the inactivated polio (IPV), hepatitis B (HepB) and H1N1 influenza vaccines as well as a widely used pentavalent vaccine that contains DTP, HepB and Haemophilus influenzae type b (Hib) components. In addition, Phase 3 trials in Africa of GlaxoSmithKline’s experimental malaria vaccine in 2015 were associated with two times higher all-cause mortality in girls and a higher risk of fatal malaria in girls. Commenting on this latter finding and the fact that GSK’s malaria vaccine was “the first recombinant viral nanoparticle vaccine to show heterologous effects,” the Australian researchers warned in 2017 “that engineered vaccines, and not just pathogen-derived vaccines, may need to be carefully evaluated for non-specific as well as specific effects before wide-scale implementation.” They further noted the lack of any research assessing whether pentavalent vaccines “have similar heterologous effects to the component vaccines contained in them.”

… the DTP vaccine—heavily promoted by both the World Health Organization (WHO) and its leading donor, Bill Gates—is killing more children than the diseases that the vaccine targets.
Which vaccines, when?
The analyses carried out by Aaby and colleagues have not focused solely on excess female mortality but also on vaccinated versus unvaccinated comparisons. Ten studies that examined all-cause mortality in DTP-vaccinated versus DTP-unvaccinated African children showed higher mortality (an average of two times higher across the 10 studies) for the vaccinated group. The disturbing take-home message of this meticulous body of research is that the DTP vaccine—heavily promoted by both the World Health Organization (WHO) and its leading donor, Bill Gates—is killing more children than the diseases that the vaccine targets.

Why this is the case has to do with the Aaby group’s somewhat broadly worded Principle 3 (“the most recent vaccination has the strongest non-specific effects”) and Principle 4 (“combinations of live and non-live vaccines given together have variable [non-specific effects]”). The researchers explain:

[I]n all studies exploring [sequence and combination], the incidence of all-cause mortality increases if the DTP vaccine is administered after the measles vaccine compared with inverse order. Likewise, administering the measles vaccine and DTP vaccine together is associated with higher incidence of all-cause mortality than only receiving the measles vaccine. [. . . ] In the USA, receiving live vaccines together with non-live vaccines was associated with higher risk of hospital admission for non-targeted infections than having a live vaccine only. [emphases added]

With Principle 6 (“vaccines might interact with other interventions affecting the immune system”), Aaby and coauthors also consider the interaction between vaccines and other health interventions. They note a study showing that whereas vitamin A supplementation benefited children who had not been vaccinated, “[i]n children who had been vaccinated, supplementation with vitamin A was associated with a tendency for increased mortality in girls.”

Dangerous—or scientific?
To evolve with integrity, science requires “paying attention to anomalous, strange or unwelcome observations.” This is exactly what the Aaby group has done, but for most vaccinologists—content to leave their assumptions untouched—the Danish researchers’ findings about non-specific effects and excess mortality are probably “unwelcome” indeed. A writer for the American Council on Science and Health (which claims that it has been “promoting science and debunking junk since 1978”) admits as much, describing the Lancet article as a “dangerous paper” and worrying about its potential to serve as “ammunition” for anti-vaxxers and “those who have nefarious purposes”—individuals who might willingly “hijack” the findings to “claim that vaccines and the CDC’s recommended vaccine schedule aren’t safe.” In reality, the Aaby group’s findings about vaccination and mortality—and their remarkable consistency—can stand on their own two feet, no hijacking required. As Covid-19 vaccines continue to hurtle toward a rushed rollout, the true dangers come from allowing rigid, complacent and dishonest vaccine scientists to keep pretending that their flawed vaccine paradigm is safe.

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Aurobindo Pharma USA, Inc. Issues Voluntary Nationwide Recall of Mirtazapine Tablets Lot Number 03119002A3 Due to Label Error on Declared Strength

*When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company’s announcement as a public service. FDA does not endorse either the product or the company.

Image-1-73

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/aurobindo-pharma-usa-inc-issues-voluntary-nationwide-recall-mirtazapine-tablets-lot-number?utm_campaign=Aurobindo%20Pharma%20USA%2C%20Inc.%20Issues%20Voluntary%20Nationwide%20Recall%20of%20Mirtazapine%20Tablets&utm_medium=email&utm_source=Eloqua

Summary
Company Announcement Date:
December 30, 2019
FDA Publish Date:
December 31, 2019
Product Type:
Drugs
Reason for Announcement:
Due to a label error on declared strength-bottles labeled as Mirtazapine 7.5 mg
Company Name:
Aurobindo Pharma USA, Inc.
Brand Name:
Aurobindo Pharma USA, Inc.
Product Description:
Mirtazapine Tablets 7.5 mg
Company Announcement
Aurobindo Pharma USA, Inc. is voluntarily recalling lot number 03119002A3 of Mirtazapine Tablets to the consumer level. The product is being recalled due to a label error on declared strength; bottles labeled as Mirtazapine 7.5 mg may contain 15 mg tablets.

Taking a higher dose than expected, may increase risk of sedation, agitation, increased reflexes, tremor, sweating, dilated pupils, gastrointestinal distress, nausea, constipation and more. Unexpected levels of sedation in particular can contribute to falls in the elderly or motor vehicle accidents in adults.

Mirtazapine tablets are indicated for the treatment of major depressive disorder and are packaged in 500 count bottles. The affected lot number for both Mirtazapine Tablets 7.5 mg and Mirtazapine Tablets 15 mg are 03119002A3 Exp 03/2022. The product can be identified by checking the product name, manufacturer details and batch or lot number on the bottle containing these products.

Aurobindo Pharma USA, Inc. is notifying its distributors by letter and is arranging for return of all of the recalled product. Distributors/retailers that have product which is being recalled should return the bottle(s) to place of purchase.

Consumers with medical questions regarding this recall or to report an adverse event can contact Aurobindo Pharma USA, Inc. at:

1-866-850-2876 Option 2
pvg@aurobindousa.com
Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Any general questions regarding the return of this product please contact Qualanex at 1-888-504-2014 or email mecall@qualanex.com(live calls received 7:00 am to 4:00 pm M-F CST).

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report OnlineExternal Link Disclaimer
Regular Mail or Fax: Download formExternal Link Disclaimer or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Company Contact Information
Consumers:
Aurobindo Pharma USA
1-866-850-2876 Option 2
pvg@aurobindousa.com

Bill Clinton’s Unforgivable Sin: Tells Truth about ObamaCare!

AND THAT TRUTH has outraged supporters of Hillary Clinton who would prefer that Bill Clinton stifle his desire to confuse the electorate with unfounded “truths!”

Bill Clinton’s Unforgivable Sin: Tells Truth about ObamaCare!


John Lillpop imageBy —— Bio and Archives October 6, 2016

Canadafreepress.com

Former President and disgraced perjurer Bill Clinton, the second most prolific congenital liar in the Clinton household, was recently caught in a boo-boo of epic proportions in this, the most volatile election cycle in American political history, in which his corrupt, criminal addicted wife is attempting to steal the White House and destroy American liberty and Democracy,

Either unwittingly or with racist intent to sabotage the legacy of America’s first African-American president, Slick Willy was recently caught inadvertently telling the truth about Barack Obama’s coveted signature achievement: Slick correctly labeled the Obama travesty and world-class failure(aka,OBAMACARE) as the “craziest thing in the world!—-.

Slick’s political torpedo, fired at the Holy Grail of Progressive thought, reverberated wildly throughout the heathen world of leftists who regard Obamacare as a precious, permanent monument to the use of corruption, lying, and hijacking of democratic principles to advance progressive ideas, regardless of how flawed and how against the best interests of the American people such programs may be.

In the muddled minds of liberals, it matters not one whit whether or not ObamaCare actually provides Affordable Care to the unwashed masses—-all that really matters is the adoption of a hugely unworkable and costly program that will usher even more unsuspecting millions into utter dependency on big government, and the tyranny of the Democrat Party.

It is in this tangled environment that Bill Clinton had his epic meltdown,. His words as reported:

“You’ve got this crazy system where all of a sudden, 25 million more people have health care, and then the people who are out there busting it, sometimes 60 hours a week, wind up with their premiums doubled and their coverage cut in half and it’s the craziest thing in the world,” the former president railed at a rally in Michigan on Monday.

“Clinton also said the system is hurting moderately successful small businesses — ones that aren’t doing poorly enough to be subsidized and fall just above the line.”

“On the other hand, the current system works fine if you’re eligible for Medicaid, if you’re a lower-income working person, if you’re already on Medicare or if you get enough subsidies on a modest income that you can afford your health care,” Clinton said.

“But the people getting killed in this deal are the small-business people and individuals who make just a little bit too much to get any of these subsidies,” he added.

After the scathing attack, Clinton sought to tone down some of his ObamaCare criticism while stumping for his wife in Ohio on Tuesday. Like Hillary, he said the health-care law is a positive first step that needs improving.

“The Affordable Health Care Act did a world of good and the 50-something efforts to repeal it that the Republicans have staged were a terrible mistake,” Clinton said.”

“But there’s a group of people — mostly small-business owners, and employees who make just a little too much money to qualify for Medicaid expansion or for the tax incentives — who can’t get affordable health-insurance premiums in a lot of places,” he said.”

Just how radical has Hillary become on illegal immigration?

AND THAT TRUTH has outraged supporters of Hillary Clinton who would prefer that Bill Clinton stifle his desire to confuse the electorate with unfounded “truths!”

How Long Has It Been Since Anything Was Said About Ebola? Fresh From the CDC In Atlanta: CDCEbola (Ebola Virus Disease)U.S. Healthcare Workers and SettingsPersonal Protective Equipment (PPE)


CDCEbola (Ebola Virus Disease)U.S. Healthcare Workers and SettingsPersonal Protective Equipment (PPE)
For U.S. Healthcare Settings: Donning and Doffing Personal Protective Equipment (PPE) for Evaluating Persons Under Investigation (PUIs) for Ebola Who Are Clinically Stable and Do Not Have Bleeding, Vomiting, or Diarrhea
http://www.cdc.gov/vhf/ebola/healthcare-us/ppe/guidance-clinically-stable-puis.html

Who this is for: Healthcare providers in the U.S. evaluating PUIs for Ebola who are clinically stable AND do not have bleeding, vomiting, or diarrhea

What this is for: Provides guidance on the processes for donning and doffing PPE for healthcare workers and staff who are evaluating a PUI who is clinically stable and does not have bleeding, vomiting, or diarrhea

How to use this, how it relates to other guidance documents: Use this guidance with frontline and assessment healthcare facilities described in Interim Guidance for U.S. Hospital Preparedness for Patients Under Investigation (PUIs) or with Confirmed Ebola Virus Disease (EVD): A Framework for a Tiered Approach. It offers step-by-step processes for donning and doffing PPE described in Identify, Isolate, Inform: Emergency Department Evaluation and Management for Patients Under Investigation (PUIs) for Ebola Virus Disease (EVD). These procedures do NOT apply to healthcare workers caring for patients with confirmed Ebola or to healthcare workers caring for PUIs who have bleeding, vomiting, diarrhea, or who are clinically unstable and/or will require invasive or aerosol-generating procedures (e.g., intubation, suctioning, active resuscitation). In those cases, use the Guidance on Personal Protective Equipment (PPE) To Be Used By Healthcare Workers during Management of Patients with Confirmed Ebola or Persons under Investigation (PUIs) for Ebola who are Clinically Unstable or Have Bleeding, Vomiting, or Diarrhea in U.S. Hospitals, Including Procedures for Donning and Doffing PPE.

http://www.cdc.gov/vhf/ebola/healthcare-us/preparing/hospitals.html

http://www.cdc.gov/vhf/ebola/healthcare-us/emergency-services/emergency-departments.html

http://www.cdc.gov/vhf/ebola/healthcare-us/ppe/guidance.html

Recommended PPE:

While evaluating and managing PUIs who are clinically stable and do not have bleeding, vomiting, or diarrhea, healthcare providers should at a minimum wear:

Single-use (disposable) fluid-resistant gown that extends to at least mid-calf or single-use (disposable) fluid-resistant coveralls without integrated hood
Single-use (disposable) full face shield
Single-use (disposable) facemask
Single-use (disposable) gloves with extended cuffs. Two pairs of gloves should be worn. At a minimum, outer gloves should have extended cuffs.
In this guidance, fluid-resistant means a gown that has demonstrated resistance to water or a coverall that has demonstrated resistance to water or synthetic blood. The specific test methods that assess resistance are listed in Table 1. When purchasing gowns and coveralls, facilities should follow specifications in this table to ensure they select recommended gowns and coveralls.

Table 1. Specifications for fluid-resistant gowns and coveralls
Gown Coverall
Fluid-resistant
Surgical or isolation* gown that passes:

ANSI/AAMI PB70 Level 3 requirements
or
EN 13795 high performance surgical gown
Coverall* made of fabric that passes:

AATCC 42 ≤ 1 g and AATCC 127 ≥ 50 cm H20 or EN 20811 ≥ 50 cm H20
or
ASTM F1670 (13.8kPa)
or
ISO 16603 ≥ 3.5 kPa
*Testing by an ISO 17025 certified third party laboratory is recommended

For more details, refer to technical document Considerations for Selecting Protective Clothing used in Healthcare for Protection against Microorganisms in Blood and Body Fluids, which provides a more detailed explanation of the scientific evidence and national and international standards, test methods, and specifications for fluid-resistant and impermeable protective clothing used in health care settings.

http://www.cdc.gov/niosh/npptl/topics/protectiveclothing/default.html

http://www.cdc.gov/vhf/ebola/healthcare-us/ppe/guidance.html

Facilities should ensure that healthcare providers are trained and able to demonstrate competency in donning and doffing recommended PPE before being allowed to care for PUIs. Facilities should also designate areas for PPE donning and doffing as specified below (for more information, refer to the Guidance on Personal Protective Equipment (PPE) To Be Used By Healthcare Workers during Management of Patients with Confirmed Ebola or Persons under Investigation (PUIs) for Ebola who are Clinically Unstable or Have Bleeding, Vomiting, or Diarrhea in U.S. Hospitals, Including Procedures for Donning and Doffing PPE.

Ensure that areas for donning and doffing are separate from the patient care area (e.g., patient’s room) and that there is a predominantly one-way flow of movement of healthcare providers from the donning area to the patient care area or room to the doffing area.
Confirm that the doffing area is large enough to allow freedom of movement for safe doffing, has space for waste containers, a new glove supply, and alcohol-based hand rub (ABHR) for use during the doffing process.
Donning PPE

Donning PPE – This donning procedure applies to PPE recommended for evaluating and managing PUIs who are clinically stable and do not have bleeding, vomiting, or diarrhea. There is a lower risk of splashes and contamination in these situations. An established protocol, combined with proper training of the healthcare worker (HCW), helps to facilitate compliance with PPE guidance.

Remove Personal Clothing and Items: The HCW should wear surgical scrubs (or disposable garments) and dedicated washable (plastic or rubber) footwear. No personal items (e.g., jewelry [including rings], watches, cell phones, pagers, pens) should be worn under PPE or brought into the patient room. Long hair should be tied back. Eye glasses should be secured with a tie.

Inspect PPE Prior to Donning: Visually inspect the PPE ensemble to ensure that it is in serviceable condition (e.g., not torn or ripped), that all required PPE and supplies are available, and that the sizes selected are correct for the HCW.
Perform Hand Hygiene: Perform hand hygiene with alcohol-based hand rub (ABHR). When using ABHR, allow hands to dry before moving to next step.
Put on Inner Gloves: Put on first pair of gloves.
Put on Gown or Coverall: Put on gown or coverall. Ensure gown or coverall is large enough to allow unrestricted movement. Ensure cuffs of inner gloves are tucked under the sleeve of the gown or coverall.
Put on Facemask: Put on facemask.
Put on Outer Gloves: Put on second pair of gloves (with extended cuffs). Ensure the cuffs are pulled over the sleeves of the gown or coverall.
Put on Face Shield: Put on full face shield over the surgical facemask to protect the eyes, as well as the front and sides of the face.
Verify: After completing the donning process, the integrity of the ensemble should be verified by the HCW (e.g., there should be no cuts or tears in the PPE). The HCW should be comfortable and able to extend the arms, bend at the waist, and go through a range of motions to ensure there is sufficient range of movement while all areas of the body remain covered. A mirror in the room can be useful for the HCW while donning PPE.
Doffing PPE

Doffing PPE – PPE is doffed in the designated PPE removal area in the healthcare facility. As with all PPE doffing, meticulous care should be taken to avoid self-contamination. Place all PPE waste in a leak-proof infectious waste container.

1. Inspect: Inspect the PPE for visible contamination, cuts, or tears before starting to remove. If any PPE is visibly contaminated, disinfect by using an *EPA-registered disinfectant wipe.
http://www.epa.gov/oppad001/list-l-ebola-virus.html
If the facility conditions permit and appropriate regulations are followed, an *EPA-registered disinfectant spray can be used, particularly on contaminated areas.

2. Disinfect and Remove Outer Gloves: Disinfect outer-gloved hands with either an *EPA-registered disinfectant wipe or ABHR. Remove and discard outer gloves, taking care not to contaminate inner gloves when removing the outer gloves. Dispose of outer gloves into the designated leak-proof infectious waste container.
http://www.cdc.gov/vhf/ebola/healthcare-us/cleaning/hospitals.html

3. Inspect and Disinfect Inner Gloves: Inspect the inner gloves’ outer surfaces for visible contamination, cuts, or tears. If an inner glove is visibly soiled, then disinfect the glove with either an *EPA-registered disinfectant wipe or ABHR, remove the inner gloves, perform hand hygiene with ABHR on bare hands, and don a new pair of gloves. If a cut or tear is seen on an inner glove, immediately review occupational exposure risk per hospital protocol. If there is no visible contamination and no cuts or tears on the inner gloves, then disinfect the inner-gloved hands with either an *EPA-registered disinfectant wipe or ABHR.

4. Remove Face Shield: Remove the full face shield by tilting the head slightly forward, grabbing the rear strap and pulling it over the head, gently allowing the face shield to fall forward. Avoid touching the front surface of the face shield. Discard the face shield into the designated leak-proof infectious waste container.

5. Disinfect Inner Gloves: Disinfect inner gloves with either an *EPA-registered disinfectant wipe or ABHR.

6. Remove Gown or Coverall: Remove and discard.
(a) Depending on gown design and location of fasteners, the HCW can either untie fasteners or gently break fasteners. Avoid contact of scrubs or disposable garments with outer surface of gown during removal. Pull gown away from body, rolling inside out and touching only the inside of the gown.
(b) To remove coverall, tilt head back to reach zipper or fasteners. Unzip or unfasten coverall completely before rolling down while turning inside out. Avoid contact of scrubs with outer surface of coverall during removal, touching only the inside of the coverall. Dispose of gown or coverall into the designated leak-proof infectious waste container.

7. Disinfect and Change Inner Gloves: Disinfect inner gloves with either an *EPA-registered disinfectant wipe or ABHR.
(a) Remove and discard gloves, taking care not to contaminate bare hands during removal process.
(b) Perform hand hygiene with ABHR.
(c) Don a new pair of inner gloves.

8. Remove Surgical Facemask: Remove the surgical facemask by tilting the head slightly forward, grasping first the bottom tie or elastic strap, then the top tie or elastic strap, and remove the front of the surgical facemask without touching it. Discard the surgical face mask into the designated leak-proof infectious waste container.

9. Disinfect and Remove Inner Gloves: Disinfect inner-gloved hands with either an *EPA-registered disinfectant wipe or ABHR. Remove and discard gloves, taking care not to contaminate bare hands during removal process. Dispose of inner gloves into the designated leak-proof infectious waste container.

10. Perform Hand Hygiene: Perform hand hygiene with ABHR.

11. Inspect: The HCW should inspect for any contamination of the surgical scrubs or disposable garments. If there is contamination, shower immediately, and then immediately inform the infection preventionist or occupational safety and health coordinator or their designee.

*EPA-registered disinfectant wipe: Use a disposable wipe impregnated with a U.S. Environmental Protection Agency (EPA)-registered hospital disinfectant with a label claim for a non-enveloped virus (e.g., norovirus, rotavirus, adenovirus, poliovirus); see EPA list of Disinfectants for Use Against the Ebola Virus at http://www.epa.gov/oppad001/list-l-ebola-virus.html.