Data from the World Health Organization (WHO) shows only 837 "Covid" fatalities in Haiti since the start of the alleged pandemic in 2020. For more than 2 years, the world has been unceasingly lectured on the dangers of a "new virus" with a diffuse disease syndrome and a constantly fluctuating definition. An experimental vaccination programme, we are told, is the only safe prophylactic against the phantasm. Yet the impoverished Caribbean island nation of Haiti has singlehandedly given the lie to this narrative. Of the country's 11.6 million-strong population, only a tiny fraction has so far received the vaunted Pfizer "vaccine". The feared contagion, however, has had no discernible impact on the island.
Official data shows:
“In Haiti, from 3 January 2020 to 5:03 pm CEST, 7 July 2022, there have been 31,703 confirmed cases of COVID-19 with 837 deaths, reported to WHO. As of 24 June 2022, a total of 342,724 vaccine doses have been administered,” according to the data from WHO.
And:
"As
of June 24, only 1.4% of the population was fully vaccinated. Haiti had
a population of 11,681,526 as of Thursday, July 7, 2022, according to
Worldometers data."
Haiti is the poorest country in the Americas, and its citizens eke out a living amidst a shambolic infrastructure and enduring political violence. In the past 12 years, the country has suffered two major hurricanes and two magnitude 7 earthquakes. It was still recovering from all of this when the lockdown era began. During the consequent economic spiral, political
instability led to the assassination of President Jovenel
Moise. Haiti also had to deal with a severe drought during this period, which severely undermined the nation’s water resources.
It is hardly surprising then, that addressing a new flu was low on the Port-au-Prince government's list of priorities.
Haiti was the last country in the Americas to adopt a Covid vaccine, doing so finally about one week after the assassination of its then President Jovenal
Moise in July, 2021. And yet even in such a chaotic, conflict-ridden and highly malnourished country as this, where appproximately 40% of the population suffer serious food insecurity, no significant mortality increase has been observed since 2020.
Vaccine pushers are quick to cite Haiti's young median age (24). And we know, of course, that the fictional Covid is "rarely fatal for anyone under the age of 40."
However, a cursory examination of statistics in the neighbouring Dominican Republic (RD) upsets their handy excuse. The two countries share the same island and the Dominican Republic also happens to have a population of 11 million, like Haiti. The RD also shares a low median age (28) like Haiti. And yet, according to Worldometres, the Dominican Republic has recorded some 4,383 "Covid" deaths as of July 30th, 2022. That is to say, more than 5 times the rate of Haiti. Unlike Haitians, the Dominicans are almost 67% vaccinated (55% "fully vaccinated" as of July 2022).
But the incongruences don't end there for the vaccine pushers. The Dominican Republic's per capita income was $ 7,268.20 in 2020, i.e., almost 7 times that of Haiti ($ 1,176.76 in 2020). And unlike Haiti, the richer half of this island does not suffer the same political violence as Haiti, nor does is it burdened with such a poor infrastructure or the same catastrophic levels of food insecurity.
So why does the heavily vaxxed and heavily "protected" Republica Dominicana suffer from "Covid" so much more acutely than poor, unvaxxed Haiti?
The data below was provided by the Gateway Pundit. The article assumes the existence of both "Sars CoV-2" and the amorphous "Covid" syndrome. But when we ponder Haiti's 837
"Covid" deaths and how these measure against the results of other nations, we must always keep in mind that no adequate test exists for the purported Sars CoV-2 (a particle that has
never been purified or otherwise demonstrated to exist). These figures, then, must depend upon largely on-the-spot medical judgements in each country. Yet, even if we discards these observations and trust blindly in the official fable, the data coming from Haiti (and so many other countries) clearly do not support it. So, we will leave it to Gateway Pundit to present a comparison of charts from multuiple countries. Readers can draw their own conclusions:
Israel – 72% vaccinated
Israel doesn’t have a high rate of full vaccination (66%), but the
country eagerly embraced all proposed boosters: four. Despite all that,
Israel experienced the highest COVID-19 death rate on record this year.
All Scandinavian countries except Sweden have recently been obliterated by COVID-19. Finland, Denmark, Iceland and Norway have documented their highest death rates, some beating their records several times in recent weeks.
What is worrisome is how long the waves are lasting. Last year, the Denmark wave lasted from mid-November to mid-March. This year started in early November and it doesn't seem to be slowing down. This year's footprint is quite problematic in all four countries. See the graphic here
Canada – 86% vaccinated
Canada hasn't beaten its mortality record, but the latest wave started a month earlier and so far has left a similar number of casualties to last year. In other words, vaccines did absolutely nothing… See the graphic here
Japan – 82% vaccinated
Japan recently experienced its worst death rate this year, doubling its all-time high. Masks and isolation didn't help either. See the graphic here
Australia – 87%
Vaccination Covid-19 is running through Australia like wildfire. The country recently experienced a record four times higher deaths than at any other time in the pandemic, and the fire is still blazing. Maybe a 100% vaccination rate will help, or mandatory booster shots every time someone wants to go out? See the graphic here
New Zealand – 84% vaccinated
Whenever I see the numbers for New Zealand, I shake my head. What a beautiful country; what an inept government. They recently pulverized their all-time death rate. Perhaps they are more successful containing cow farts. See chart here
South Korea – 88% vaccinated
Once a shining beacon on how to deal with Covid-19, today South Korea is on the cusp of monster death. It achieved this with 86.95% of the population fully vaccinated. See chart here
Hong Kong – 89%
The graphic speaks for itself. Either the vaccines didn't work, or the lockdowns only delayed the inevitable. See chart here
Malta – 92%
Another country that beat its all-time record. Malta even imposed new lockdowns in January while the population was over 90% vaccinated. See chart here
Singapore - 92%
Singapore is one of the most vaccinated countries on the planet and it recently shattered its all-time COVID-19 death record…twice. See chart here
***
And finally, of course, there is Haiti - a country with the highest hunger rates in the Western Hemisphere, skyrocketing food prices, record inflation and a worsening fuel crisis. Here, with only a 1.4% vaccination rate, "Covid" is essentially invisible.
Curious, no?
Few nations deserve a break as much as Haiti does. So we can be thankful for this small mercy at least. And let us hope that the island's well-documented distrust in vaccines continues to spare its people from a mass-injection of poisonous nanoparticles.
Recently I joined a group of 20 doctors and scientists around the world who put their names to the “Settling the Virus Debate” statement. In
this two-page document we suggested, “rather than engaging in wasteful
verbal sparring, let us put this argument to rest by doing clear,
precise, scientific experiments that will, without any doubt, show
whether these claims are valid.” Some of the individuals who believe
that the existence of pathogenic viruses is an established fact,
proceeded to immediately disagree. One was Steve Kirsch,
who attempted to distract from the central tenet of our statement,
being that virology had failed to carry out scientific control
experiments. In reality, it is clear that the virologists have not
shown that their techniques of “viral” cultures, genomics, and clinical
diagnostics are valid even on their own terms. Indeed, I have not seen
Kirsch or anyone else provide evidence that the appropriately-controlled
experiments we suggested in the statement have been performed.
Kirsch
admitted, “this is not my field of expertise at all. I rely on other
people around me who I trust.” I have written a previous article about
why I think Kirsch should be careful about trusting other
“experts.” However, he continues to favour this approach and one of his
trusted parties includes the pathologist/virologist Dr Sin Lee. Lee
wrote, “Tom Cowan claimed the virus has not been isolated. But the virus
has been isolated by the CDC and marketed by ATCC as the control
materials. I bought the virus as the control for my CLIA tests. Many
others do.” We have covered the follies concerning these claims of
“isolation” many times and the CDC certainly have no studies
demonstrating the existence of a pathogenic particle termed
‘SARS-CoV-2’. The ATCC simply repeat the claim by the CDC that their
listed product contains a “virus” – however as I outlined in my first
“Warning Signs” article, following the trail back to the start does not lead to any evidence of a virus in the biological potions being passed around.
On 18 July 2022, Lee sent the following email to Dr Tom Cowan:
I have a Preprint manuscript currently under peer review as follows.
://www.preprints.org/manuscript/202206.0192/v1
There is irrefutable Sanger sequencing evidence that the virus exists
and keeps mutating. If Dr. Tom Cowan disagrees, please write a critique
to challenge my data and interpretation online in the open. I will
respond. Other scientists can join in for the debate.
The preprint paper is
titled, “Implementation of the eCDC/WHO Recommendation for Molecular
Diagnosis of SARS-CoV-2 Omicron Subvariants and Its Challenges.” To
expose the problems of virology it is crucial to examine the methodology
section of any publication and in this case it is no different. In the
“material and methods” section Lee stated that, “five (5) selective
nasopharyngeal swab specimens collected from non-hospitalized patients
with respiratory infection, which were confirmed to be true-positive for
SARS-CoV-2 Omicron variant by Sanger sequencing.” Here we are straight
into the deep end of virology’s circular reasoning: the “virus” has
been confirmed to exist on the basis of detected sequences from some
nasopharyngeal swabs. There is nowhere in the paper that any evidence
is provided for the existence of an actual virus, that is, a tiny
particle that acts as an obligate intracellular parasite and is capable
of causing disease in a host.
The claim that the specimens were,
“true-positive[s] for SARS-CoV-2 Omicron variant,” simply means some
sequences that were previously deposited on genetic databases, and
fraudulently declared to be “viral,” were being detected again. It
doesn’t make any difference which sequencing technique is used, in this
case bidirectional Sanger sequencing because the crucial issue is the
provenance and clinical relevance of these detected sequences. This is
the foundational issue in the entire COVID-19 fraud: there is no virus,
simply sequences falsely claimed to be evidence of an actual virus. The
World Health Organisation helped orchestrate the deception when it
declared that a confirmed ‘case’ of infection with the invented virus is
simply the detection of some of these sequences. We have covered this
absurd circular reasoning in much of our work including in Sam’s 2020 video “What Is A Covid-19 Case?” (And rapid antigen tests are covered here.)
Back
to Lee’s paper and in the following paragraph of the “material and
methods” section, he described the, “RNA Extraction from Nasopharyngeal
Swab Specimens,” as follows:
As previously reported [25-27], the cellular pellet derived
from about 1 mL of the nasopharyngeal swab rinse along with 0.2 mL
supernatant after centrifugation was first digested in a buffered
solution containing sodium dodecyl sulfate and proteinase K. The
digestate was extracted with phenol. The nucleic acid was precipitated
by ethanol and redissolved in 50 μL of DEPC-treated water.
In other words, there was no step to demonstrate: (a) there were any
“viral” particles contained within the samples, or (b) that the RNA came
from such imagined viral particles. A reverse transcription polymerase
chain reaction was then applied to these undifferentiated samples to
generate amplicons ranging from 398 to 707 nucleotides in length. Most
of these sequences spanned the so-called ‘Spike protein’ gene of the
alleged SARS-CoV-2 genome, as that was the area of interest for the
study. In the next step it was stated:
The crude nested PCR products showing an expected amplicon at
agarose gel electrophoresis were subjected to automated Sanger
sequencing without further purification.
In fact, at no stage was an attempt undertaken to purify any entity
from the crude nasopharyngeal specimens. The entire basis of the study
was built on the unestablished premise that the genetic sequences
detected were already known to come from inside a pathogenic particle.
The
“results” section then detailed the nucleotide sequences of the various
amplicons that were generated from the crude samples. Some of the
codons (three-nucleotide units that encode a particular amino acid or
stop signal) were described as “mutated” on the basis of comparisons to
other sequences previously deposited on the genetic databanks. The use
of the word ‘mutation’ is problematic in itself, because it implies that
a genome has been altered. A genome must belong to a discrete
biological entity, so virology is once again misusing terminology to
imply that a certain proof has been established. Lee’s study was simply looking at RNA sequences in uncontrolled experiments.
Those
of us that dispute the virus narrative point out that no RNA (or DNA)
sequences have ever been shown to come from inside any specific
identifiable particle that fulfils the definition of a virus. Thus all
RNAs can only be said to be expressed by a known organism, introduced
artificially (e.g. synthetic mRNA injections) or be of unknown
provenance. The “mutations” only exist within in silico models
that have not been shown to be independent entities in nature. There
are other reasons why RNA sequences can and do vary in dynamic
biological systems and I can’t imagine that any virologist would
disagree with this fact. Simply detecting RNAs is not enough to draw
conclusions about their provenance. Other experiments are required to
make this determination.
In our first COVID-19 Fraud essay we documented the original invention of SARS-CoV-2 by Fan Wu’s team who assembled an in silico “genome”
from genetic fragments of unknown provenance, found in the crude lung
washings of a single ‘case’ and documented in, “A new coronavirus
associated with human respiratory disease in China.” Their in silico construct
served as a reference for others to then “find” the same “virus” around
the world, without evidence that such a particle actually existed.
In
our soon to be published follow-up COVID-19 Fraud essay we will provide
a more detailed explanation as to why detecting nucleic acid sequences per se in
crude specimens or cell cultures does not provide the required evidence
for “viruses.” In the essay we will also follow the trail back to the
first ever declarations of “coronavirus genomes” in the 1980s and show
that no viruses were demonstrated in any part of the trail. However,
such sequence data is used to promulgate the illusion of “virus” family
trees, or claimed “mutations” as discussed above.
Dr Lee’s paper
does not even appear to be designed to demonstrate the existence of a
postulated disease-causing particle. I sent him several questions
including, “I have read the preprint and there does not appear to be a
hypothesis presented – is that correct?”, “In your study there did not
appear to be any controls (e.g. checking for selected sequences in other
nasopharyngeal specimens from humans said not to have the alleged
virus) – presumably that was by design?” and “What is your definition of
a ‘virus’ in the paper?” Lee responded, “your questions are irrelevant
to you [sic] intention to write a comment or critique on the manuscript
involved,” and suggested I write something in the preprint website’s
comment section.
Lee has provided a descriptive paper that omits
a falsifiable hypothesis so it is unclear why he would present it as
experimental evidence, let alone “irrefutable” evidence of the existence
of SARS-CoV-2. His paper is inappropriately designed for this purpose
and his claim engages in a circular reasoning fallacy: the genetic
sequences are proffered as evidence of the virus, because it was
presupposed that they come from the virus. We are asking, “where is the
virus?”
Virology has a problem: It needs to show that "A" actually exists
It’s back to the drawing board for virology: it invented the theory
of viruses, so whatever method it employs to prove their existence, it
must satisfy that definition. In fact, do the virologists even have a
theory? The definition of a scientific theory is:
an explanation of an aspect of the natural world and universe that has been repeatedly tested and corroboratedin accordance with the scientific method, using accepted protocols of observation, measurement, and evaluation of results.
Our “Settling the Virus Debate”
statement proposes that the virologists need to employ the required
scientific method as a starting point. It is not looking good for them
because they have not even demonstrated any internal validity on their
own terms. According to science they may not even have a theory. If
they have a hypothesis, they need to specify an independent variable (in
this case the postulated “virus”) and a dependent variable for
analysis. Moreover, to even get started, the independent variable must first be shown to physically exist. I
would implore Steve Kirsch to reconsider taking advice from these
“experts” and to commence his own investigations into the house of
virology. By scientific accounts, it is a house of cards.
Postscript
(Derived from: A. F. Chalmers, What is this thing called Science?, 2nd ed, 1982)
‘Observational statements are frequently presupposed by theory. Such
statements are always made in the language of some theory and will be as
precise as the theoretical or conceptual framework that they utilise is
precise’. In this instance, a virus particle was not observed first and
subsequently viral theory and pathology developed. Scientists of the
mid and late nineteenth century were preoccupied with the identification
of imagined contagious pathogenic entities.
‘The observations of the naïve inductionist did not identify a virus a priori,
and then set about studying its properties and characteristics. The
extant presupposition of the time was that a very small germ particle
existed that may explain contagion. What came thereafter arose to fulfil
the presuppositional premise’.
‘A popular view of scientific
knowledge is that it is proven knowledge and scientific theories are
derived in some righteous way from the facts of experience acquired by
observation and experiment. Science is based upon what we can see, hear,
measure and touch. Science is objective and explicit. Scientific
knowledge is reliable knowledge because it is objectively proven
knowledge’.
‘A realistic scientific theory will consist of a
complex of universal statements rather than a single statement. Further a
theory will need to be augmented by auxiliary assumptions, such as laws
and theories governing the use of any instruments used, for instance’.
‘The
premises from which the prediction is derived must also include the
interconnected statements that constitute the theory under test, the
initial conditions, and the auxiliary assumptions. Falsification of the
theory also indicates the possibility of a failure of any number of the
associated assumptions and conditions, and not necessarily of the theory
itself’.
Acknowledgement
I would like to express my gratitude to Dr M. C. McGrath (New Zealand) for his constructive criticisms and inspiration for the postscript.
PURITY: Relative freedom from extraneous matter in the finished product, whether or not harmful to the recipient or deleterious to the product. (21 CFR 600.3(r))
FDA Guidance Definition for vaccine purity
The above definition for purity is taken from the FDA’s Guidance for Industry. According to the FDA, purity is considered relative freedom from extraneous matter. What is “relative
freedom?” Relative implies that something is true to a certain degree.
In other words, there is freedom from extraneous matter to a certain
degree. However, in relation to purity, there can be no degrees of
freedom from extraneous matter. A substance is either pure, meaning that
it is free of all contaminants and foreign matter, or it is impure,
meaning it is mixed with contamination and foreign matter. There is no
such thing as purity to a certain extent yet you will commonly find
discussions of purity within the “scientific” papers as if this can be
the case. Terminology such as low purity, partially purified, somewhat purified, relatively purified, highly
purified, etc. are thrown about as vague descriptors used to wiggle
around a concept that is so simple and straight forward that most
children can understand it. Something is either pure or impure. There is
no in-between.
The issue of purification
is absolutely vital to the foundational problems regarding virology. In
order to prove the very existence of the fictional creations we are
supposed to fear, it must be shown that “viruses” exist in a purified
and isolated state. However, purification is mostly ignored in any
original “virus” study when it should be a prominent focus. If we are to
believe that these invisible intracellular parasitic entities exist, we
need to be able to observe them alone. As we can not observe “viruses”
in nature nor with our own eyes, this means that it is essential that
the particles assumed to be “viruses” are taken directly from the fluids
of a sick human and then purified free of any contaminants, pollutants,
foreign materials, etc. contained within so that nothing else remains
other than the assumed “viral” particles. Only then could pathogenicity
be proven by having a valid independent variable separated from
everything else in order to establish a cause-and-effect relationship
for the particles claimed as the causative agent. Only then would electron microscope images of just those particles with nothing else contained within the sample be valid as evidence.
However, as you will see, virologists have admitted numerous times
that “viruses” can not be purified and isolated directly from the fluids
of a sick human. They state that “viruses” must be cultured with a host
cell first before purification and isolation can occur. This creates
many problems as:
The methods used to purify and isolate “viruses” are ineffective
“Viruses” can not be separated from exosomes and other MVB’s within the sample
The cell culture method is impure and the media and host cell DNA can not be purified away from the invisible “viruses”
In this article, I will break these various problems down and show
that, from their own sources, virology admits that complete purification
and isolation of the assumed “viral” particles is an impossibilty.
Ineffective Methods
A big hindrance to obtaining evidence of purification of the
particles assumed to be “viruses” is that there is no standardized
universal purification method. The techniques used vary by “virus” and
the researchers performing the study. What “works” for one “virus” may
not work for another as noted in this source on purifying plant
“viruses:”
“Purification refers to the separation of virus particles
from host components in a biologically active state. Purified virus is
required for the production of antibodies, physical, biochemical and
molecular characterization of virus isolates. Purification of
virus involves several steps such as propagation of the virus in the
host, extraction of sap, clarification, concentration and further
purification. Purity of purified preparation can be checked through UV
absorption spectra and its infectivity by inoculating to a susceptible
host under optimal environmental conditions in an insect-proof
glasshouse. Purification methods vary with different viruses,
and there are no universal methods of virus purification. Procedures
that are effective for one virus may not work with the other.”
Complicating the issues related to the lack of any standardized
methods or procedure to achieve purification is the existence of various
methods virologists can choose from in order to attempt to obtain
purification. These include but are not limited to:
Centrifugation
Filtration
Precipitation
Chromatography
Adsorption
However, you will be hard pressed to find much mention of any of
these methods being used in “virus” studies at all. If you do happen to
find purification methods being performed, it is typically just a spin
on the ol’ centrifugation for a bit. While this may separate some of the
larger substances from the smaller ones, it does not offer complete
purification of all particles.
“Viruses”/Exosomes: Inseparable “Cousins”
How can we be sure that we are isolating and quantifying extracellular vesicles rather than enveloped viruses present in the sample? Equally, how can viral researchers know that they are not detecting similarly sized non-viral vesicles or empty vectors during vaccine production?”
We can easily find this lack of complete purification to be the case for all of the methods used for “viruses” if we look to exosome
research as it shares the exact same procedures as those used in
virology. For those who may not know, exosomes are “viruses” in every
sense of the word. They share the same biochemical and morphological
characteristics. The main difference (beyond the name) is that exosomes
are considered “non-infectious” and they are assumed to play a role in
intracellular communication. In other words, they are the exact same
particles as “viruses” but they were given different names and different
functions than their “viral” cousins. Fortunately, as I noted earlier,
the same methods of purification are used for these identical particles.
If the purification methods are unable to completely purify exosomes,
the same can be said of “viruses.” For instance, in this 2020 study on
the attempts to separate “viruses” from exosomes, we can see that
ultracentrifugation, the “gold standard” method of purification for both
entities, is considered inadequate:
“The method is not ideally suited for the separation of EV and viruses, particularly from infected cultures and/or body fluids
and it is difficult to adopt ultracentrifugation to large-scale
production environments or to environments that present biosafety
concerns.”
This inability to purify exosomes from “viruses” does not stop with
ultracentrifugation. No matter what method is utilized, each one has its
own drawbacks and limitations which lead to a lack of complete
purification and the inability to separate “viruses” from exosomes.
These next two sources show that the same methods shared between
“viruses” and exosomes are all equally unable to successfully purify and
isolate these particles from each other:
Exosomes and viruses
“Because of their similar physical properties, the techniques used by researchers for purification of exosomes and virions are also similar.
Ultracentrifugation at greater than 100,000 x g is used to
concentrate both exosomes and viruses. This technique retains intact,
functional viruses and exosomes. Because exosomes and viruses are similar in size and density, separation of the two is not possible using this technique.
Polyethylene glycol (PEG) can be used to precipitate both exosomes
and viral particles. PEG precipitation is commonly used in commercially
available exosome isolation kits and has been harnessed for isolation of
many different viruses for many years. Again, you cannot separate viruses and exosomes with this protocol.
Exosomes and viruses can also be purified using chromatography
techniques based on size, affinity, hydrophobicity, or other
characteristics. Size exclusion chromatography (SEC) purification such
as Exo-spin can be used to isolate both exosomes and viral particles. Again, exosomes and virions cannot be distinguished from one another using this method.”
Review on Strategies and Technologies for Exosome Isolation and Purification
“A method that can efficiently provide intact and pure exosomes
samples is the first step to both exosome-based liquid biopsies and
therapeutics. Unfortunately, common exosomal separation techniques suffer from operation complexity, time consumption, large sample volumes and low purity, posing significant challenges for exosomal downstream analysis.”
“At present, common exosome isolation technologies, such as
ultrafiltration, immunoaffinity, ultracentrifugation (“gold standard”
for the isolation of exosomes) are expensive instruments, large volumes
of sample, possible protein contamination, complete isolation steps, but they result in low isolation efficiency, sample loss, low exosome recovery and purity (LeBleu and Kalluri, 2020).”
“Although exosomes play an irreplaceable role in early detection and treatment, they
are small in size (30–150 nm), low in density (1.13–1.19 g/ml), and
mixed with similar components (e.g., cell fragments, proteins) in the
body fluids, which pose tremendous challenges for their separation (Cui et al., 2018; Lin et al., 2020). In addition, the biological activity of exosomes will be affected by different separation techniques (Paolini et al., 2016).”
“Although the above-mentioned traditional separation methods are the
most widely used, there are also many disadvantages, such as large
sample consumption, risk of damage to exosomes, low purity, and long time consuming, which are hard to meet the current increasing scientific research needs.”
As can be seen, the methods listed above do not offer the ability to
actually separate the particles believed to be exosomes from those
believed to be “viruses.” This is a major problem as purification is
absolutely necessary not only in order to prove cause and effect but
also to characterize the “virus” physically, molecularly, and
biochemically. Without having just the assumed “viral” particles alone,
the “virus” can not be studied independently nor differentiated from the
millions of similar and/or identical particles within the sample. There
can be no direct proof for the existence of any “virus” as there are
numerous other microorganisms, substances, and contaminants within a
sample that could also be the potential cause of the disease rather than
the assumed-yet-never-seen “virus.” Exosome literature is rife with
papers explaining the impossibility of separating these particles from
their “viral” cousins. As exosomes and “viruses” are the same size and
shape, this means that complete purification and isolation of any
“virus” is impossible. There will always be exosomes and/or any other
particle that is either the same size or smaller than the assumed
“virus” particles left remaining. Highlights from the below article from
2019 presents further evidence to this effect:
How are Exosomes Isolated?
“Exosomes are extracellular vesicles that are believed to play a role in communication between cells by transporting materials inside the vesicle.
Exosomes can be isolated from cells using typical methods for purifying cell fractions. The
challenge in isolating vesicles is differentiating them from other
types of membrane material in the cell culture supernatant.
This is done through successive steps of centrifugation at increasing speeds.
The final supernatant is ultracentrifuged at 100,000g to pellet the
exosomes. This is then washed to remove contaminating proteins and
centrifuged at high speed one more time.
However, that type of preparation is more an enrichment of the sample than a purification. Further analysis of the sample through biochemistry or microscopy is still required to characterize the vesicles.
Characterization
In addition to exosomes, the extracellular milieu contains
extracellular RNA, other types of vesicles, protein complexes, and
lipoproteins. These are not fully separated from exosomes through the
centrifugation protocol. There are also commercial kits
available to isolate exosomes that make use of polymers, but these kits
tend to co-isolate other molecules, particularly RNA-protein complexes.
The Executive Committee of the International Society for
Extracellular Vesicles (ISEV) proposed criteria for characterizing
exosomes to aid in consisting reporting of experimental results.
The criteria are that all exosome samples must adhere to are given below:
Be isolated from extracellular fluids like cell culture medium or body fluids. The
collection should be gentle to minimize cell wall disruption that could
contaminate the sample with intracellular compartments.
Have an overview of protein composition included in its description. The amount of 3 or more relevant proteins should be reported in a semi-quantitative manner in any exosome preparation.
Have levels of proteins not expected to be enriched to determine the extent of co-isolation of intracellular vesicles.
Have single vesicles characterized as an indication of heterogeneity.
Have a quantitative analysis of dose-function relationships in the case that in vitro functional studies are carried out.
Have demonstration of association of molecules with the exosome, in the case that functional changes are ascribed to single molecules or clusters of molecules.
Study of exosomes is a rich area of research due to the large number of unanswered questions, including exactly how they are formed, what their functions are, how they communicate with acceptor cells, and their role in various diseases.
Consistent methods for isolating and characterizing exosomes anddistinguishing them from other types of extracellular and intracellular vesicles are needed to enable these advances.”
There are no consistent methods used for purifying (i.e. “isolating”)
exosomes nor ways for distinguishing them from other extracellular and
intracellular organisms. In other words, exosomes (the “non-infectious
virus”) can not be completely separated from everything else nor can
they be differentiated from everything else within the cell culture
supernatant. This should tell you everything you need to know regarding
the impossibility of complete purification and isolation of these
entities.
Purifying “Viruses” from Culture forVaccines?
Beyond being unable to completely purify and isolate exosomes (cough
“viruses” cough) from everything contained within a sample, it is also
admitted that “viruses” can not be completely purified from the cell culture materials
that they are supposedly grown in. Take, for instance, the Jynneos
vaccine for monkeypox. It is claimed that the vaccine, which utilized
chicken embryo fibroblast cells for culturing the assumed “virus,” was
purified and that it contained no animal material. However, it is later
revealed within the same paragraph that not only does the vaccine
contain host-DNA (i.e. chicken DNA from the CEF cell), it contains other
proteins (source unknown) as well as antibiotics used for culturing and
an enzyme used for purification:
Benzonase – a genetically engineeredendonuclease from Serratia marcescens produced and “purified” from E. coli strain
Gentamicin – an antibiotic that can cause severe damage to the kidneys
Ciprofloxacin – another antibiotic used to treat urinary bacterial infections
“JYNNEOS is a live vaccine produced from the strain Modified Vaccinia
Ankara-Bavarian Nordic (MVA-BN), an attenuated, non-replicating
orthopoxvirus. MVA-BN is grown in primary Chicken Embryo
Fibroblast (CEF) cells suspended in a serum-free medium containing no
material of direct animal origin, harvested from the CEF cells, purified
and concentrated by several Tangential Flow Filtration (TFF) steps
including benzonase digestion. Each 0.5 mL dose is formulated
to contain 0.5 x 108 to 3.95 x 108 infectious units of MVA-BN live virus
in 10 mM Tris (tromethamine), 140 mM sodium chloride at pH 7.7. Each
0.5 mL dose may contain residual amounts of host-cell DNA (≤ 20 mcg),
protein (≤ 500 mcg), benzonase (≤ 0.0025 mcg), gentamicin (≤ 0.163 mcg)
and ciprofloxacin (≤ 0.005 mcg).”
This is also seen in the Johnson & Johnson “Covid” vaccine which
contains trace amounts of host DNA belonging to the PER.C6 TetR cell
line derived from human embryonic retinal cells from an aborted fetus
supposedly genetically modified with “adenovirus.” This cell line is
known to cause tumors in mice:
“The Ad26 vector expressing the SARS-CoV-2 S protein is grown in PER.C6 TetR cells, in media containing amino acids and no animal-derived proteins. After propagation, the vaccine is processed through several purification steps, formulated with inactive ingredients and filled into vials.
Each 0.5 mL dose of Janssen COVID-19 Vaccine is formulated to contain
5×10^10 virus particles (VP) and the following inactive ingredients:
citric acid monohydrate (0.14 mg), trisodium citrate dihydrate (2.02
mg), ethanol (2.04 mg), 2-hydroxypropyl-β-cyclodextrin (HBCD) (25.50
mg), polysorbate-80 (0.16 mg), sodium chloride (2.19 mg). Each dose may also contain residual amounts of host cell proteins (≤0.15 mcg) and/or host cell DNA (≤3 ng).”
Antibiotics and trace components remain in the “purified” vaccines.
Remember, purification means to free from contaminants, pollutants,
foreign materials, etc. Do these vaccines sound like purified
concoctions to you? If they can not separate out the cell culture
additives as well as the benzonase substance used for “purification” as
in the Jynneos vaccine, how can they purify a “virus” to study for cause
and effect, let alone for use in a vaccine? If they can not separate
the host cell DNA as noted in both vaccines, whatever cell line they
use, from cancer cells to aborted fetuses to monkey kidneys, will remain
within the vaccine and injected into the body. This is why it is
imperative to be able to show that these assumed “virus” particles exist
directly in the fluids of a sample from a sick human first before it is
subjected to the cell culture process and mixed with all sorts of
outside contaminants and foreign materials that are subsequently unable
to be purified away from the assumed “viral” particles.
We can gain further insight into this inability to separate the
“virus” from the culture materials in these highlights from a 270-page
“virus” purification manual:
VIRUS PURIFICATION, DETECTIONAND REMOVAL
“In vaccine manufacturing, the cell culture is commonly
accompanied with cellular debris, unwanted media proteins, adventitious
agents, residual DNA, nucleic acid and many process related leachable
contaminants. As per the FDA vaccine approval requires the
freedom from extraneous material whether or not harmful to the recipient
[12]. Viruses have a unique size, shape and surface chemistry, i.e.
hydrophobicity and charge. Most often a series of unit operations are
required to increase the yield of virus particles. The currently used
operations involve a combination of precipitation, centrifugation,
filtration and chromatography [13, 14].”
“Vaccine production in therapeutic industry is currently performed on a case-by-case basis for each virus and a single platform system to purify viruses is still lacking. A traditional ATPS system was used for virus precipitation but lack of selectivity for virus against protein contaminants and difficulty in separation from polymer phase inhibited ATPS progress towards vaccine development systems.”
“Traditionally, virus is purified by ultracentrifugation on cesium
chloride (CsCl) or sucrose gradients [10, 11]. However, the shear force
has been known to reduce virus infectivity and moreover, it is time
consuming, labor intensive and difficult to scale up [12]. Virus
precipitation with modest results have been obtained using salts
ammonium sulfate [13] or calcium phosphate [14]. Polyethylene glycol (PEG)/aqueous
two-phase system has also been studied for virus purification [15], but
the technique lacks the ability to purify virus from many cell culture
contaminants.
Chromatography a popular technique
for biomolecular purification has been seldom used for virus recovery
due to diffusional limitations and large virus size, restricting access
to internal surface area of beads. The technique has not
provided high virus yield but it is known to work well for protein
biomolecules < 5 nm in size [16]. Chromatography has gained wide
spread attention due to its ability to create specificity for a
biomolecule based on several variables as charge, size and
hydrophobicity [17-19]. The virus produced in the lab is heavily contaminated with cell media proteins
and our goal is to consider each variable individually (charge, size
and hydrophobic) for maximum protein removal with best possible
recoverable virus. The purified virus can be very useful to analyze cell
protein and contaminant interference during lab scale experimentation.”
“Purification of virus is usually performed from density gradient centrifugation or salt or polymer precipitation techniques. The methods are difficult to scale up or lackspecificity from co-precipitating impurities.
Filtration is another technique for virus purification but this may
cause virus degradation from shear stress, especially in tangential flow
filtration conditions. An efficient and fast paced system to achieve high purity virus is required.”
It should be clear from the above passages that it is an
impossibility to purify “viruses” from the cell culture supernatant and
the material used for propagation. This should be the final nail in the
coffin for both cell culture and virology as it has been admitted
numerous times that the only way virologists can “isolate” a “virus” is
by means of cell culture.
“Viruses are basically inanimate objects which need a culture to activate in. But
the way they are phrasing the requests is that the sample must be
completely unadulterated and not be grown in any culture – and you can’t
do that,” she told AAP FactCheck in a phone interview.
“You can’t isolate a virus without using a cell culture, so by using their definition it hasn’t been isolated. But it has been isolated and cultivated using a cell culture multiple times all around the world.”
For more on this impossibility of purifying the “virus” from the cell culture supernatant, let’s look at the FDA’s Guidance for Industry for vaccines
which you will find highlights for below. The FDA states that live
attenuated “viruses” can not be purified as rigorously as subunit
vaccines (a vaccine that contains “purified” parts of the pathogen that
are used to elicit an immune response) which leads to greater
contamination. Due to this, it is not possible to validate the clearance
of adventitious agents in the live “virus” vaccines which means that
purification is impossible. For inactivated “virus” vaccines, there is
the possibility that not all of the adventitious agents are inactivated
as was seen in the case of the polio vaccine.
The FDA admits to numerous sources of contamination just from the cell culturing process itself such as:
Exposure to the person or animal from which the “virus” was “isolated”
The cells and raw materials (e.g., serum or trypsin) used
Materials used in banking and propagation of cells for “viral” seed growth
Other materials used during production and filling of the seed
Any infectious “viruses” (including those that infect nonhuman species)
Retroviruses that may either be endogeneous (coming from within the host) or exogenously acquired
The FDA’s laundry list of sources of contamination establishes that
culturing the sample immediately invalidates any claims of purity. Even
when checking for contamination, the FDA allows for the use of
“non-infected control” cultures to establish whether or not the culture
is free of contamination rather than checking the actual “infected”
culture to be used for the vaccine. While it should be obvious that a
stand-in culture should not be used to judge whether or not a separate
culture is free of contamination, the conditions used for the control
culture only need to be similar to the “infected” culture rather than identical which immediately invalidates this process as a control.
It is also admitted by the FDA that cell lines such as the Vero cells
used in culturing many “viruses” (including “SARS-COV-2”) have
biochemical, biological, and genetic characteristics that are different
from primary cell lines which may be a result of transformation caused
by an adventitious agent. There also may be potential risks from
residual DNA within the vaccine as well. As the mechanism by which most
cell lines become immortal is unknown, and due to the fact some cell
lines cause tumors in inoculated mice, there are many concerns with
using these cell lines in vaccines. This is yet another example which
shows that complete purification of “viruses” coming from these cell
lines is an impossibilty.
Finally, it is admitted by the FDA that the cytopathogenic effect,
which is used to determine whether or not a “virus” is present in the
culture, can in fact be caused by substances other than a “virus:”
Obviously, if other factors can cause the same effect
ascribed to a “virus,” there is no need for the vitus” to enter into
the equation as a possible explanation as the cause of the effect,
especially when the particles assumed to be “viruses” are unable to be
seen in a completely purified and isolated state without culturing
first:
Characterization and Qualification ofCell Substrates and Other BiologicalMaterials Used in the Production of Viral Vaccines for Infectious DiseaseIndications
“Live attenuated viruses, whole inactivated virions, or virus-like particles often cannot be purified as rigorously as viral subunit vaccines; as a consequence, the potential for contamination is greater than that of subunit vaccines. Generation of live viral vaccines often involves cell disruption, which may add cellular components to the vaccine bulk. In addition, such vaccines often are minimally purified
and are not subjected to inactivation steps. Comprehensive testing and
qualification of the biological starting materials and lot-by-lot
testing for adventitious agents are particularly important because
it is not possible for a manufacturer of live viral vaccines to
validate the process for clearance of adventitious agents.
In contrast, for more highly purified products where viral clearance
can be demonstrated during downstream processing, you can place more
reliance on process validation (Ref. 2). For inactivated
vaccines, the concern is that the process used to inactivate the vaccine
virus may not inactivate all adventitious agents potentially present
(as occurred with early inactivated poliovirus vaccines[Ref. 4]).
Therefore, you should validate your process for inactivation of
adventitious agents using different model viruses (Ref. 2). The choice
of tests and the stages at which the tests are applied will depend on
your inactivation process. The degree of viral clearance that is
feasible may influence the sensitivity of the testing you should
perform to demonstrate the absence of contaminants in your product.”
2. Potential Sources of Contamination
“It is important that you identify and examine all potential
sources of contamination of your product. For example, a viral seed
could be exposed to the following potential sources of contamination:
the person or animal from which it was isolated; the cells and raw
materials (e.g., serum or trypsin) used in its isolation and
attenuation; materials used in banking and propagation of cells for
viral seed growth; and other materials used during production and
filling of theseed. You should also consider
the species of origin of your cell substrates, viral seeds, and other
biological starting materials in selecting your tests to ensure the
absence of contaminants. Furthermore, you should consider any
infectious viruses (including those that infect nonhuman species) as
potential contaminants if there is the possibility of contact with your
product or cell substrate at any timeduring
development or production. Retroviruses may be either endogeneous (i.e.,
encoded by the cell substrate genome) or exogenously acquired.
Retrovirus testing should address the possibility that either type of
retrovirus could contaminate a product. Finally, you should consider the
possibility of contamination from unusual sources, as exemplified by
the reported presence of minute virus of mice (MVM) in some lots of
recombinant proteins (Ref. 5). The susceptibility of the cell
substrate to infection by agents of potential concern can influence the
tests needed to assure absence of contamination.”
4. Use of Control-Cell Cultures
“We recommend the use of control cells when it is not feasible to
directly test cells or product at various stages of manufacture. For
example, if you are using primary cell cultures to propagate your
vaccine virus, complete testing of the primary culture might not be feasible prior to inoculation of virus. In this situation, when possible, you should produce and test uninfected control-cell cultures that are derived in parallel with, and handled in the same manner as, the production culture.”
“Control cell cultures should be propagated under conditions
similar to conditions of manufacture for a time appropriate to the
reason for performing the cultures. This time period may be 14
days or more, when needed to allow for detection of potential
adventitious agents that may be latent, endogenous, or
poorly replicating. Control-cell cultures should be processed simultaneously with your production culture, but left uninfected.
Control cells should be evaluated for the presence of adventitious
agents using the same tests that would have been performed on the
production cultures, if it were feasible. Tests for adventitious agents
should be performed on control cells at times at which you would perform
similar tests on your manufactured product.”
5. Special Considerations for Continuous Cell Lines
“Some continuous cell lines, including Vero cells and CHO cells, have been used as substrates for licensed biologicals. Cell lines might have biochemical, biological, and genetic characteristics that differ from primary or diploid cells (e.g., they are typically aneuploid and have accumulated genetic changes). Because the mechanism by which most cell lines become immortal is generally unknown, and because some cell lines form tumors when inoculated into immunodeficient rodents, there
are additional concerns for continuous cell lines compared with diploid
cells, including the potential that transformation was caused by an
adventitious agent and potential risks from residual DNA.
Products prepared in cell lines (including viral vaccines) should be purified to be free (see Section V. Glossary) of adventitious agents and residual cells and should have low levels of cell-substrate DNA. When potential biological activity of residual cell substrate DNA is a concern, you should introduce procedures that extensively remove or degrade DNA. If you are considering the use of cell lines, we
encourage you to develop and evaluate efficient methods for the
purification of your product as an essential element of any product
development program.”
“Your biological starting materials should be characterized sufficiently to ensure that they do not contaminate the final product with extraneous infectious organisms, such
as bacteria, fungi, cultivatable and non-cultivatable mycoplasmas and
spiroplasma, mycobacteria, viruses, and the agent(s) responsible for transmissible
spongiform encephalopathies (TSEs). For a substance to be considered
free of a contaminant, your assay should demonstrate, at a predefined
level of sensitivity, that a certain quantity of the substance is free of that contaminant. Alternatively, a validated process that is known to remove a contaminant to a defined level may be used to demonstrate the absence of that contaminant.”
“An appropriate volume should be inoculated onto monolayer cultures
of at least 3 cell types. The sample to be tested should be diluted as
little as possible. The cell cultures should be observed for at least 2 weeks. After 2weeks
of observation, the original cultures of supernatants or lysates from
cell banks are subcultured onto fresh cells and observed for at least an
additional 2 weeks. This subculture onto fresh cells might help to
distinguish between non-specific CPE and virus-induced CPE, as toxic
effects of the initial specimen or length in culture will be diluted,
whereas virus-induced CPE should be amplified.”
Purification refers to the separation of “virus” particles from host components in a biologically active state
Purified “virus” is required for the production of antibodies, physical, biochemical and molecular characterization of “virus” isolates
Purification methods vary with different “viruses,” and there are no universal methods of “virus” purification
Procedures that are effective for one “virus” may not work with the other
As the most common purification method, ultracentrifugation is not ideally suited for the separation of exosomes (i.e. non-infectious “viruses”) and “viruses,” particularly from infected cultures and/or body fluids
The techniques used by researchers for purification of exosomes and “virions” are similar
None of the methods, including ultracentrifugation, precipitation, and chromatography, can separate exosomes from “viruses”
Common exosomal separation techniques suffer from operation complexity, time consumption, large sample volumes and low purity
At
present, common exosome isolation technologies, such as
ultrafiltration, immunoaffinity, ultracentrifugation (“gold standard”
for the isolation of exosomes) are expensive instruments, large volumes
of sample, possible protein contamination, complete isolation steps, but they result in low isolation efficiency, sample loss, low exosome recovery and purity
Like “viruses,” exosomes are small in size (30–150 nm), low in density (1.13–1.19 g/ml), and
mixed with similar components (e.g., cell fragments, proteins) in the
body fluids, which pose tremendous challenges for their separation
Exosomes are extracellular vesicles that are believed to play a role in communication between cells by transporting materials inside the vesicle
The challenge in isolating vesicles is differentiating them from other types of membrane material in the cell culture supernatant
This is done through successive steps of centrifugation at increasing speeds
However, that type of preparation is more an enrichment of the sample than a purification
In addition to exosomes, the extracellular milieu contains extracellular RNA, other types of vesicles, protein complexes, and lipoproteins
These are not fully separated from exosomes through the centrifugation protocol
The Executive Committee of the International Society for Extracellular Vesicles (ISEV) proposed criteria for characterizing exosomes to aid in consisting reporting of experimental results and within these criteria, they state:
Be isolated from extracellular fluids like cell culture medium or body fluids. The collection should be gentle to minimize cell wall disruption that could contaminate the sample with intracellular compartments
Have levels of proteins not expected to be enrichedto determine the extent of co-isolation of intracellular vesicles
In other words, it is well-known that other intracellular components will be “isolated” along with the exosomes
Study of exosomes is a rich area of research due to the large number of unanswered questions, including:
Exactly how they are formed
What their functions are
How they communicate with acceptor cells
Their role in various diseases
Consistent methods for isolating and characterizing exosomes and distinguishing them from other types of extracellular and intracellular vesicles are needed to enable these advances
In vaccine manufacturing, the cell culture is commonly accompanied with:
Cellular debris
Unwanted media proteins
Adventitious agents
Residual DNA
Nucleic acid
Many process related leachable contaminants
Vaccine production in therapeutic industry is currently performed on a case-by-case basis for each “virus” and a single platform system to purify “viruses” is still lacking
A traditional ATPS system was used for “virus” precipitation but lack of selectivity for “virus” against protein contaminants and difficulty in separation from polymer phase inhibited ATPS progress towards vaccine development systems
Polyethylene glycol (PEG)/aqueous two-phase system has also been studied for “virus” purification, but the technique lacks the ability to purify “virus” from many cell culture contaminants
Chromatography a popular technique for biomolecular purification has been seldom used for “virus” recovery due to diffusional limitations and large “virus” size, restricting access to internal surface area of beads
The “virus” produced in the lab is heavily contaminated with cell media proteins
Purification of “virus” is usually performed from density gradient centrifugation or salt or polymer precipitation techniques
The methods are difficult to scale up or lack specificity from co-precipitating impurities
An efficient and fast paced system to achieve high purity “virus” is required
According
to University of Auckland associate professor and microbiologist
Siouxsie Wiles, “Viruses are basically inanimate objects which need a
culture to activate in. But the way they are phrasing the
requests is that the sample must be completely unadulterated and not be
grown in any culture – and you can’t do that. You can’t isolate a virus without using a cell culture, so by using their definition it hasn’t been isolated. But it has been isolated and cultivated using a cell culture multiple times all around the world.”
According to the CDC, purifying “viruses” without cell culturing is outside of what is possible in virology
In
other words, it is impossible to purify “viruses” without culturing and
it is also impossible to purify and isolate them with culturing
From the FDA’s Guidance forIndustry, we learn that live attenuated “viruses,” whole inactivated “virions,” or “virus-like” particles often cannot be purified as rigorously as “viral” subunit vaccines; as a consequence, the potential for contamination is greater than that of subunit vaccines
Generation of live “viral” vaccines often involves cell disruption, which may add cellular components to the vaccine bulk
In addition, such vaccines often are minimally purified and are not subjected to inactivation steps
Comprehensive
testing and qualification of the biological starting materials and
lot-by-lot testing for adventitious agents are particularly important
because it is not possible for a manufacturer of live “viral” vaccines to validate the process for clearance of adventitious agents
For inactivated vaccines, the concern is that the process used to inactivate the vaccine “virus” may not inactivate all adventitious agents potentially present (as occurred with early inactivated poliovirus vaccines)
The degree of “viral” clearance that is feasible may influence the sensitivity of the testing that should be performed to demonstrate the absence of contaminants in the product
It is important to identify and examine all potential sources of contamination of the product such as:
The person or animal from which it was isolated
Tthe cells and raw materials (e.g., serum or trypsin) used in its isolation and attenuation
Materials used in banking and propagation of cells for “viral” seed growth
Other materials used during production and filling of the seed
Furthermore, any infectious “viruses” (including those that infect nonhuman species) should be considered as potential contaminants if there is the possibility of contact with the product or cell substrate at any time during development or production
“Retroviruses” may be either endogeneous(from the host genome) or exogenously acquired
The susceptibility of the cell substrate to infection by agents of potential concern can influence the tests needed to assure absence of contamination
If using primary cell cultures to propagate vaccine “virus,” complete testing of the primary culture might not be feasible prior to inoculation of “virus”
In this situation, when possible, they are to produce and test uninfected control-cell cultures that are derived in parallel with, and handled in the same manner as, the production culture
In
other words, if they decide that they can not check the uninfected
culture used for the vaccine for contamination, using another uninfected
culture as a stand-in suffices
Control cell cultures should be propagated under conditions similar(i.e. not the same) to conditions of manufacture for a time appropriate to the reason for performing the cultures
Control-cell cultures should be processed simultaneously with the production culture, but left uninfected
Cell lines, such as Vero and CHO, might have biochemical, biological, and genetic characteristics that differ from primary or diploid cells (e.g., they are typically aneuploid and have accumulated genetic changes)
Because the mechanism by which most cell lines become immortal is generally unknown, and because some cell lines form tumors when inoculated into immunodeficient rodents, there are additional concerns for continuous cell lines compared with diploid cells, including the potential that transformation was caused by an adventitious agent and potential risks from residual DNA
Products prepared in cell lines (including “viral” vaccines) should be purified to be freeof adventitious agents and residual cells and should have low levels of cell-substrate DNA
When potential biological activity of residual cell substrate DNA is a concern, procedures thatextensively remove or degrade DNAshould be introduced
If considering the use of cell lines, it is encouraged(not required)
to develop and evaluate efficient methods for the purification of the
product as an essential element of any product developmentprogram
Biological starting materials should be characterized sufficiently to ensure that they do not contaminate the final productwith extraneous infectious organisms such as:
Bacteria
Fungi
Cultivatable and non-cultivatable mycoplasmas and spiroplasma
Mycobacteria
“Viruses”
Agent(s) responsible for transmissible spongiform encephalopathies (TSEs)
For a substance to be considered free of a contaminant, the assay should demonstrate, at a predefined level of sensitivity, that a certain quantity of the substance is free of that contaminant (i.e. not all of it has to be shown free of contamination)
Alternatively, a validated process that is known to remove a contaminant to a defined level may be used to demonstrate (i.e. to infer)the absence of that contaminant
The
cell cultures should be observed for at least 2 weeks and after 2 weeks
of observation, the original cultures of supernatants or lysates from
cell banks are subcultured onto fresh cells and observed for at least an additional 2 weeks
This subculture onto fresh cells might help to distinguish between non-specific CPE and “virus-induced” CPE, as toxic effects of the initial specimen or length in culture will be diluted, whereas “virus-induced” CPE should be amplified
In
other words, it is admitted that the CPE used to identify “viruses” can
be caused by factors other than “viruses” thus destroying this effect
as an indirect indicator of the presence of any “virus”
Obviously the main objective in the purification and isolation of viruses is the separation of the virus from the host tissues and cell organelles.”
DOI: 10.1007/978-94-009-5876-0_3
It should be clear by now that virology can not completely purify and
therefore isolate the particles assumed to be “viruses” from everything
else that is sure to be within the sample. Virologists openly admit
that they:
Can not purify directly from the fluids of humans
Can not purify the particles from cell culture supernatant
Can not separate “viruses” from exosomes and other similar MVB’s
Can not separate the “viruses” from the cell culture host material and DNA
Can not separate the cell culture media from the sample
As purification can not be achieved, virology lacks the physical
particles necessary for use as an independent variable to vary and
manipulate in order to determine cause and effect. There is no direct
evidence as to the existence of the particles assumed to be “virus” ever
being found within humans. The only evidence is from indirect cell
culture experimentation citing patterns of cell death known as the
cytopathogenic effect (CPE) seen in the cells after being poisoned and
starved for days which is then blamed on an invisible “virus.” As other
contaminants, chemicals, and impurities remain within the cultured
sample, there can be no certainty that the other substances within may
be the potential cause of the CPE seen within the culture over the
assumed “virus.” It is a fact that other substances will be there within
the fluids, especially in any sample processed through cell culture, as
can be seen from the exosome studies as well as from attempts to purify
“viruses” from cell culture supernatant for vaccine use. The FDA
admitted that there are other factors besides a “virus” which can cause
the CPE seen which is instead blamed on the invisible “virus.” The cell
culture method is by definition an impure process as many foreign
elements, chemicals, and contaminants are added to the culture which can
not be separated out. As virology admits that “viruses” can not be
purified and isolated directly from the fluids of a sick human and must
be cultured, there is no purification that can ever be achieved by
subjection to an impure process.
Without purification, virology can not adhere to the scientific
method and is thus a pseudoscience. We know this and virologists know
this which is why purification methods are rarely performed and why this
criteria is rarely discussed in virology papers. Purification is the
black sheep of the virology family and it will remain as such until
virology can find a way to do what it has been unable to do for well
over 100 years.
Perhaps a psychologist could explain why virologists feel free to abuse the word “isolation” so freely, but are scared to death of even writing the word “purification”
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