35 minute read
The Current Moment
from The Vaccine
Claudia González De Vicenzo
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A Vaccine for the Plan
I propose that we go and investigate whether this is a vaccine for the virus or if the plan is a vaccine. Join us.
The first two weeks of this "pandemic," I believed the story. From the third week on, I began to investigate. Little by little, I was tying up loose ends until I concluded what I present to you at the end of this writing.
So, like you, I wondered...
What is going on?
What virus is it?
Where did it appear?
Who is it attacking?
What effects does it produce?
Are there drugs to treat it?
What about vaccines?
Throughout this process, which began in March 2020, I went through many ideas. All of them led me to THE VACCINE.
Today, May 2021, I can tell you that this process's only purpose was to implement a vaccine. That is why this magazine is about it. Although I anticipate that the June edition will deal with THE VIRUS.
Thus, little by little, we will be dismantling the plan in which we are immersed in order to enable you to make decisions with information and not with dogma.
Let's suppose that we reach a moment in which, without the vaccine, you cannot move from the place where you are, nor travel, nor buy, nor get documents or driving licenses, or whatever. Still... I WILL NEVER GET THIS VACCINE.
I'll tell you why...
The Vaccine
Let's review a bit of the vaccine's history and the background that brought us to this point.
To get into the topic of this edition, we are going to have to adopt some definitions. I'm not going to use scientific language for what I'm going to tell you now. I am going to explain it as it comes to me. I am also going to share some questions that need to be investigated to decide on this concept that concerns us. This is a very personal decision, not one that tries to impregnate you with an official story according to the global criterion intended to be implanted. I leave it to you. The mission of this writing is to inform. Research is an individual decision.
Before I begin, I would like to leave you with three antecedents.
Background 1. Change of denomination of pandemic according to WHO.
What is a pandemic according to WHO?
Published on the WHO website on February 24, 2010
A pandemic is the worldwide spread of a new disease.
An influenza pandemic occurs when a new influenza virus emerges and spreads worldwide, and most people have no immunity to it. Typically, viruses that have caused pandemics in the past have come from influenza viruses that infect animals.
In some respects, pandemic flu resembles seasonal flu, but it can be very different in others. For example, both can affect all age groups and, in most cases, cause an illness that subsides spontaneously and is followed by complete recovery without treatment. However, seasonal influenzarelated mortality generally affects the elderly, while other severe cases involve people with various underlying diseases and conditions.
In contrast, the most severe or fatal cases of pandemic flu have been seen in younger people, whether previously healthy or chronically ill. This flu has caused many more cases of viral pneumonia than is usually the case with seasonal flu.
In both seasonal and pandemic flu, the number of people who become seriously ill can vary. The severity tends to be more frequent in the latter due in part to the much larger number of people who lack immunity to the new virus. When a large proportion of the population is infected, even if the percentage of those who become severely ill is small, the total number of severe cases can be very high.
Both seasonal and pandemic influenza are most active during the regular influenza season in a particular area. In temperate climate areas, for example, this usually occurs in the winter months. But as has been observed with the current H1N1 pandemic, pandemics can have different epidemiological characteristics, and large outbreaks can occur in the summer months.
After the 2009 flu, the WHO decided to change the criteria to define a pandemic.
The World Health Organization (WHO) has presented new guidelines on the management of influenza pandemics which will be based on factual evidence of risk of contagion and severity of the virus.
The previously applied guidelines established a series of criteria that "had to be met" to move up the severity scale to the point of declaring a global pandemic, for instance, like automatically declaring a pandemic as a systematic contagion between humans in a community, in two countries from the same region, and in a nation from another area.
There will be no criteria to meet from now on, but rather based on the national assessments of each country, the WHO will decide that it is appropriate to convene an emergency committee of experts. This committee, in turn, will assess the available information, calculate the risks and estimate the need to declare a global pandemic or not.
The guidelines have been revised after detecting that in 2009 with the H1N1 influenza crisis, known as influenza A, and a pandemic was declared based on estimates that never occurred.
The criterion has been changed, accepting that the declaration of a pandemic will not depend on the number of deaths, but on the number of infected people spreading through different countries, according to the WHO decision. I remind you that the Covid19 mortality rate is 0.27% of those infected.
Background 2. Event 201
It was a meeting held in October 2019 in New York, attended by John Hopkins University (USA), the Bill and Melinda Gates Foundation, the US Centers for Disease Control and Prevention (CDC), and the World Economic Forum. At this meeting, "a pandemic simulation exercise" was carried out.
In the face of speculation on the matter, John Hopkins University was forced to issue a press release clarifying
that it was not a forecast but a simulation.
"For the scenario, we modeled a fictional coronavirus pandemic, but we explicitly stated that it was not a prediction. Instead, the exercise served to highlight preparation and response challenges that would likely arise in a very severe pandemic. We are not now predicting that the nCoV-2019 outbreak will kill 65 million people. Although our tabletop exercise included a mock novel corona virus, the inputs we used for modeling the potential impact of that fictional virus are not similar to nCoV-2019." the institution explained.
Personally, I have nothing to add. Where there is a confession, no proof is required.
Background 3. Ted talk Bill Gates - March 2015 Ted Vancouver
In 2015, Microsoft co-founder Bill Gates appeared on stage in Vancouver, Canada, pushing a large black barrel with the U.S. Department of Defense seals on a wheelbarrow.
The barrel, he explained, was what many families kept in the basement of their homes when he was a child. It was filled with canned food, water, and other items needed to survive the significant threat of the time: a nuclear war.
This time, however, Gates was not talking about an atomic apocalypse, but about what he predicted would be the subsequent significant risk of a global catastrophe: a pandemic caused by a highly infectious virus that would spread rapidly around the world and against which we would not be ready to fight.
That is precisely the situation we find ourselves in now: a threat "not from missiles, but microbes," as he put it.
To me, this background leaves me, at the very least, in reasonable doubt. I do not believe in chance nor fate. I believe in human will. But let's go to the questions I asked myself during my research.
Having presented the background, let's go to the concepts.
What is disease?
The WHO defines disease as "Alteration or deviation from the physiological state in one or more parts of the body, due to generally known causes, manifested by characteristic symptoms and signs, and whose evolution is more or less foreseeable."
In these terms, we can consider that one of the causes of diseases, in medical terms, is the physiological alteration produced by viruses and bacteria.
What is a virus, and how is it treated?
Viruses are small pieces of genetic material (DNA or RNA) with no cellular structure and they do not reproduce by themselves. Therefore, they are not considered to be alive. They vampirize cells (considered active) to replicate themselves.
According to the National Human Genome Research Institute, a virus is a particle of genetic code, DNA or RNA, encapsulated in a protein vesicle. Viruses cannot replicate on their own. They need to infect cells and use components of the host cell to make copies of themselves. Often, the virus damages or kills the host cell in the process of multiplication. Viruses have been found in every ecosystem on Earth. Scientists estimate that they outnumber bacteria by 1 to 10. Since viruses do not have the same biology as bacteria, they cannot be fought with antibiotics. Only vaccines or antiviral medications can eliminate or reduce the severity of viral diseases, including AIDS, Covid-19, measles, and smallpox (they say they didn't know Dr. Hammer). National Human Genoma Research Institute
What is a bacterium, and how is it treated?
According to Wikipedia, bacteria are prokaryotic microorganisms that are a few micrometers in size (usually between 0.5 and 5 µm in length) and various shapes, including spheres (coccus), rods (bacillus), curved filaments (vibrio), and helical (spirillum and spirochetes).
Bacteria are prokaryotic cells, so unlike eukaryotic cells (of animals, plants, fungi, etc.), they do not have a defined nucleus, nor do they generally have internal membranous organelles. There are approximately ten times more bacterial cells in the human body than human cells, with a large number of bacteria in the skin and digestive tract.
Although the protective effect of the immune system renders the vast majority of these bacteria harmless or beneficial, some pathogenic bacteria can cause infectious diseases, including cholera, diphtheria, scarlet fever, leprosy, syphilis, typhoid, etc.
The most common fatal bacterial diseases are respiratory infections, with tuberculosis alone of about 1.5 million people in 2018. Antibiotics are used worldwide to treat bacterial infections. Antibiotics are effective against bacteria as they inhibit cell wall formation or stop other processes in their life cycle. They are also used extensively in agriculture and animal farming in the absence of disease, resulting in widespread bacterial resistance to antibiotics.
What methods do exist to identify viruses?
The genome of any organism, including viruses, is the molecular instructions in the form of nucleotides, necessary for its functioning and transmission to offspring. Most organisms (including bacteria and many viruses) have a genome with a code consisting of 4 nucleotides. The wellknown DNA bases: A, C, G, and T.
Some viruses, including significant pathogens such as influenza, hepatitis C or HIV, have an RNA genome. That is, with a different base: U instead of T.
But the code with which the instructions are interpreted is the same, changing only the T for the U. This makes it possible for an RNA virus to "hijack" the molecular machinery of a human cell and force it to copy and execute its instructions instead of those of the cell itself.
What are Koch's postulates?
Koch's postulates (or Henle-Koch postulates) were formulated by Robert Koch as a list of rigorous requirements to validate the existence of a virus and a disease. These postulates were developed in 1884 to establish the etiology of tuberculosis and were later redefined and published by Koch in 1890.
The postulates, used to confirm the etiological role in other diseases, were modified throughout the 20th century according to the state of knowledge, the problems encountered, and the appearance of new techniques. Since the 1980s, the postulates have been adapted based on molecular methods.
The postulates were formulated from R. Koch's experiments with Bacillus anthracis.
He showed that by injecting a small amount of blood from a diseased mouse into a healthy one, anthrax appeared in the latter. By taking blood from the second animal and injecting it into another, he again obtained the symptoms of the disease.
After repeating the operation about twenty times, he succeeded in culturing the bacterium in nutrient broths outside the animal. He showed that, even after many culture transfers, the bacterium could cause the disease when re-inoculated into a healthy animal. They were applied to establish the etiology of anthrax but have been generalized to all other infectious diseases to determine the agent involved. The postulates are as follows:
1. 1. The pathogenic agent must be present in diseased animals and absent in healthy animals.
2. 2. The agent must be grown in a pure axenic culture isolated from the animal's body.
3. 3. The agent isolated in an axenic culture must cause disease in a susceptible animal when inoculated.
4. 4. The agent must be re-isolated from lesions produced in experimental animals and be precisely the same as that isolated initially.
These points have not been applied to decipher Covid 19 virus. Although the virus is said to have been isolated in Wuhan in late 2019 and is apparently from a bat.
Continuing with the description of disease…
There are other definitions of disease. If you are interested, you can investigate the theory of Dr. Hammer and his disciples. The five biological laws. These show that disease is a unique program with a clear biological meaning. Also, there is another theory that assures that viruses do not exist. That they are simply exosomes.
I leave you with that question.
What are the symptoms of Covid-19?
From the definition of disease, it is clear that it is necessary to have symptoms and signs of being considered sick.
According to the CDC (Center for Disease Control and Prevention of the United States), the official symptoms of Covid 19 are:
Symptoms reported by people with COVID-19 range from those with mild symptoms to those who become severely ill. Symptoms may appear 2 to 14 days after exposure to the virus. People with these symptoms may have COVID-19:
ˋ Fever or chills
ˋ Cough
ˋ Difficulty to breath (feeling short of breath).
ˋ atigue
ˋ Muscle and body aches
ˋ Headache
ˋ Recent loss of sense of smell or taste
ˋ Sore throat
ˋ Congestion or runny nose
ˋ Nausea or vomiting
ˋ Diarrhea
This list does not include all possible symptoms. CDC will continue to update this list as we learn more about Covid-19.
And it clarifies that you should call 911 immediately if you have these symptoms:
ˋ Difficulty to breath
ˋ Persistent chest pain or pressure
ˋ Confusion
ˋ Inability to wake up or stay awake
ˋ Pale, bluish-gray skin, lips, or nail beds, depending on skin tone
According to one of the articles in El Clarín newspaper, it adds other symptoms:
"The precise neurological repercussions of the corona virus (highlights the president of the Neurosciences Foundation) can be headaches, dizziness, impaired
consciousness, coordination disorders (ataxia), stroke,
and epilepsy. In the peripheral nervous system (PNS), also the loss of smell and taste (hyposmia, hypogeusia), because, as the former president of the Association of Otorhinolaryngology of the City of Buenos Aires, Stella Cuevas, said, the olfactory cells are the only neurons that are outside the brain!!! As for the difficulty in moving, the neurologist continues, the virus causes muscle pain and an elevation of muscle enzymes detected in studies".
Considering the idea that associates disease with the symptom, and the specific symptomatic definition associated with the disease as well as the profound emphasis on the need for particular symptoms and the urgency of 911 in specific cases, the concept of asymptomatic, to consider Covid-19 patients, is somewhat contradictory and even suspicious. At least for me.
What is a vaccine?
According to Wikipedia, a vaccine is a preparation intended to generate acquired immunity against disease by stimulating the production of antibodies. Typically, a vaccine contains an agent that resembles a disease-causing microorganism and is often made from weakened or killed forms of the microbe, its toxins, or one of its surface proteins.
The agent stimulates the body's immune system to recognize the agent as a threat, destroy it and keep a record of it so that the immune system can more easily recognize and destroy any such microorganisms it encounters later. Vaccines are used prophylactically, that is, to prevent or lessen the effects of a future infection by some natural or "wild" pathogen.
According to the World Health Organization (WHO),
a vaccine is any preparation intended to generate immunity against disease by stimulating the production
of antibodies. It can be, for example, a suspension of killed or attenuated microorganisms or products or derivatives of microorganisms. The most common method of administering vaccines is by injection, although some are administered by nasal or oral spray.
Vaccines are the most effective way to prevent millions
of cases of illness, disability, or death. Thanks to vaccines, in addition to eradicating smallpox - the 40th anniversary was celebrated in 2020 - it has been possible to control others such as rabies, cholera, tetanus, diphtheria, plague, tuberculosis, typhoid, poliomyelitis, measles, mumps, rubella, meningitis, hepatitis A and B and influenza.
There are also vaccines against toxins, such as snake venoms, or for allergens such as pollen.
Origin and history of vaccines
According to an educational resource produced by the College of Physicians of Philadelphia, the oldest medical society founded in 1787, vaccines originated in China with a technique called variolization. This technique, which sought to prevent smallpox, consisted of pulverizing the scabs of a sick person with mild symptoms and blowing them into the noses of healthy people to immunize them. It is estimated that this practice may be more than a thousand years old, but the first record is found in several accounts from the 16th century.
For the American Academy of Pediatrics, the era of vaccines was initiated by the physician Edward Jenner. The Briton observed that people who milked cows and contracted cowpox were protected against human smallpox. In 1796 he inoculated an eight-year-old boy with pus from bovine cowpox blisters. When he subsequently injected him with the human smallpox virus, the child neither became infected nor showed any symptoms.
In the 19th century, the French physician Louis Pasteur developed the second generation of vaccines, among others, against cholera or rabies and introduced the term vaccine in honor of Jenner's cow experiments
What is herd immunity?
Group immunity, also called collective immunity or herd immunity, is a biostatistical phenomenon observed in a population when part of it has become immune to a disease by the previous contagion or because it has been vaccinated. The epidemiological chain between its individuals is interrupted, causing an indirect form of protection against infection by preventing non-immunized individuals from becoming infected.
In diseases transmitted from individual to individual, it is more challenging to maintain a chain of infection when a large part of the population is immune. The more significant the proportion of immune individuals, the less likely it is that a susceptible individual will contact an infected individual.
Vaccinated or previously infected individuals act as a kind of firewall to spread the disease, slowing or preventing transmission of the disease to other individuals.
Vulnerable individuals are indirectly protected by immunized individuals since they will neither contract the disease from infected individuals nor transmit it to susceptible ones. Thus, a public health policy of herd immunity can be assumed to reduce the spread of an illness and provide a level of protection to a vulnerable or unvaccinated subgroup.
How are vaccines developed and tested?
According to WHO, the most widely used vaccines have been administered for decades, and millions of people receive them safely each year. Like medicines, each vaccine must go through a series of extensive and rigorous tests to ensure its safety before it can be introduced into a country.
The first trial of an experimental vaccine is carried out on animals to evaluate its safety and potential to prevent disease.
Subsequently, human clinical trials are conducted in three phases
ˋ En In phase I, the vaccine is administered to a small number of volunteers to evaluate its safety, confirm that it generates an immune response, and determine the correct dose.
ˋ In Phase II, the vaccine is usually administered to hundreds of volunteers, who are closely monitored for any side effects and to assess their ability to generate an immune response. In addition, if possible, diseaserelated outcome data are obtained in this phase, but usually in insufficient numbers to have a clear picture of the effect of the vaccine on disease. Participants in this phase have the same characteristics (e.g., age and sex) as the people targeted for vaccination. In this phase, some volunteers receive the vaccine, and some do not, allowing comparisons to be made and conclusions to be drawn about the vaccine.
ˋ In Phase III, the vaccine is administered to thousands of volunteers, some of whom receive the experimental vaccine and some do not, as in Phase II trials. Data from both groups are carefully compared to determine whether the vaccine is safe and effective against the disease in question.
Once the results of clinical trials are available, a series of steps, including efficacy, safety, and manufacturing reviews, must be taken to obtain regulatory and public health approvals before introducing the vaccine into a national immunization program.
After the introduction of a vaccine, close monitoring is maintained to detect any unanticipated adverse side effects and to further evaluate its efficacy under normal use conditions, including in more significant numbers of people, as well as to further evaluate how best to use the vaccine and achieve the maximum protective effect.
How long does it take to achieve a vaccine? I share with you an article taken from this link:
Read the article here
Science has been in a frantic race against time to find a vaccine against the coronavirus. The extremely high number of infections and deaths made it urgent to see it, and records have been broken. It is enough to compare the time it took to develop the coronavirus vaccine with other diseases.
The Oxford University has made the comparison, which is also reported in a BBC report. It is pointed out that only ten months have elapsed since the Pfizer/BioNtech vaccine was conceived until it became a reality.
The Oxford study compares the time that elapsed between identifying the bacteria or viruses that cause 16 diseases and the year in which a vaccine to combat that disease was approved in the United States. The researchers chose this country because it is where most immunizations were first licensed.
ˋ Malaria: discovered in 1880, still no vaccine.
ˋ Tuberculosis: discovered in 1882, vaccine found in 1927 - 45 years.
ˋ Typhoid Fever: found in 1884, vaccine found in 2017 - 133 years.
ˋ Meningitis: identified in 1889, vaccine approved in 1981 - 92 years. ˋ Whooping cough: identified in 1906, vaccine not found until 1948 - 42 years.
ˋ Dengue fever: virus identified in 1907, vaccine created in 2019 - 112 years
ˋ Polio: identified in 1908, vaccine dates back to 1955 - 47 years
ˋ Zika virus: identified in 1947, still no vaccine yet.
ˋ Varicella: identified in 1953, vaccine exists since 1995 - 42 years.
ˋ Measles: found in 1953 vaccine found already in 1963 - 10 years
ˋ CMV infection: found in 1960, still no vaccine.
ˋ Hepatitis B: identified in 1965, vaccine found in 1981 - 16 years.
ˋ Rotavirus infection: found in 1973, vaccine disseminated in 2006 - 33 years.
ˋ Ebola: identified in 1976, vaccine found last 2019 - 43 years.
ˋ HPV infection: discovered in 1981, vaccine found in 2006 - 25 years.
ˋ AIDS: identified in 1983, still no vaccine.
ˋ Coronavirus: identified in 2019, vaccine arrived in 2020 - 1 year
I want to share with you what the WHO says about the flu vaccine. Textually copied from the WHO website.
Stages in the manufacturing of the pandemic flu vaccine 6 de august 2009, Geneve (OMS).- WHO stated that it takes approximately five to six months for the first supplies of approved vaccine to become available once a new strain of influenza virus with pandemic potential is identified and isolated. These months are needed because the process of producing a new vaccine involves many sequential steps, and each of these steps requires a certain amount of time to complete.
The vaccine development process from the start (obtaining a virus sample) to end (availability of vaccine for use) is summarized below.
Activities at WHO Collaborating Centers 1. Identification of a new virus. As part of a network set up for surveillance, laboratories worldwide routinely collect samples of circulating influenza viruses and submit these to WHO Collaborating Centers for
Reference and Research on Influenza for analysis. The first step towards producing a pandemic vaccine starts when a Centre detects a novel influenza virus that differs significantly from circulating strains and reports this finding to WHO. Vaccine virus is grown in eggs because the flu virus grows well, and eggs are readily available.
2. Preparation of the vaccine strain (called vaccine virus):.The virus must first be adapted for use in manufacturing vaccine. To make the vaccine virus less dangerous and better able to grow in hen's eggs (the production method used by most manufacturers), the virus is mixed with a standard laboratory virus strain.
The two are allowed to grow together. After a while, a hybrid is formed, which contains the inner components of the laboratory strain and the outer components of the pandemic strain. It takes roughly three weeks to prepare the hybrid virus.
3. Verification of the vaccine strain. After its preparation, the hybrid virus needs to be tested to ensure that it indeed produces the outer proteins of the pandemic strain, is safe, and grows in eggs. Upon completing this process, which takes roughly another three weeks, the vaccine strain is distributed to vaccine manufacturers.
4. Preparation of reagents to test the vaccine (with reference reagents). In parallel, WHO Collaborating
Centers produce standardized substances (called reagents) that are given to all vaccine manufacturers to enable them to measure how much virus they are producing and to ensure they are all packaging the correct dose of vaccine. This requires at least three months and often represents a bottleneck for manufacturers.
Activities at vaccine manufacturers 1. Optimization of virus growth conditions. The vaccine manufacturer takes the hybrid vaccine virus that it has received from the WHO laboratories and tests different growth conditions in eggs to find the best conditions.
This process requires roughly three weeks.
2. Vaccine bulk manufacture. This is performed in nine to twelve-days old fertilized hen's eggs for most influenza vaccine production. The vaccine virus is injected into thousands of eggs, and the eggs are then incubated for two to three days, during which time the virus multiplies. The egg white, which now contains many millions of vaccine viruses, is then harvested, and the virus is separated from the egg white.
The partially pure virus is killed with chemicals. The outer proteins of the virus are then purified, and the result is several hundred or thousand liters of purified virus protein that is referred to as antigen, the active ingredient in the vaccine. Producing each batch, or a lot, of antigen, takes approximately two weeks, and a new set can be started every few days. The size of the cluster depends on how many eggs a manufacturer can
obtain, inoculate and incubate. Another factor is the yield per egg. When one batch has been produced, the process is repeated as often as needed to generate the required amount of vaccine.
3. Quality control. This can only begin once the reagents for testing the vaccine are supplied by WHO laboratories, as described above. Each batch is tested, and the sterility of bulk antigen is verified. This process takes two weeks.
4. Vaccine filling and release. The batch of vaccines is diluted to give the desired antigen concentration and put into vials or syringes and labeled. A number of these are then tested:
• for sterility • to confirm the protein concentration and • for safety by testing in animals. This process takes two weeks.
5. Clinical studies. In certain countries, each new influenza vaccine must be tested in a few people to show that it performs as expected. This requires at least four weeks. This may not be necessary for some countries as many clinical trials were done with similar annual vaccine preparation. The assumption is that the new pandemic vaccine will behave similarly.
Activities at regulatory agencies: regulatory approval
Before the vaccine can be sold or administered to people, regulatory approval is required. Each country has its own regulatory agency and rules.
If the vaccine is made with the same processes as the seasonal influenza vaccine and in the same manufacturing plant, this can be very rapid (one to two days). Regulatory agencies in some countries may require clinical testing before approving the vaccine, which adds to the time before the vaccine is available.
The entire process, in a best-case scenario, can be completed in five to six months. Then the first final pandemic vaccine lot would be available for distribution and use.
Safety of pandemic vaccines
WHO is aware of some media reports that have expressed concern about the safety of vaccines for pandemic influenza. The public needs to be reassured that regulatory procedures in place for the licensing of pandemic vaccines, including strategies for expediting regulatory approval, are rigorous and do not compromise safety or quality controls.
Vaccines are among the most essential medical interventions for reducing illness and deaths during a pandemic. However, to have the most significant impact, pandemic vaccines need to be available quickly and in large quantities.
During the 1957 and 1968 pandemics, vaccines arrived too late to be used as an effective mitigation tool during the more severe phases of the pandemics. Influenza vaccines had not yet been developed when the 1918 pandemic swept around the world, eventually killing an estimated 50 million people.
In 2007, as part of preparedness for an influenza
pandemic, WHO worked together with health officials, regulatory authorities, and vaccine manufacturers to explore a broad range of issues surrounding the regulatory approval of pandemic vaccines.
Ways were sought to shorten the time between the emergence of a pandemic virus and the availability of safe and effective vaccines. Different regulatory pathways were assessed, and precautions needed to ensure quality, safety, and effectiveness were set out in detail.
Fast-track procedures for approval
Regulatory authorities have shown great flexibility in developing procedures for fast-tracking the approval and licensing of pandemic vaccines.
In some cases, pandemic vaccines are not regarded by regulatory authorities as entirely "new" vaccines, as they build on the technology used to produce vaccines for seasonal influenza, established procedures for testing and regulatory control, and an extensive body of safety data.
In such cases, approval procedures are similar to those applied to "strain changes" made each year when seasonal vaccines are modified to match circulating viruses in the Northern and Southern Hemispheres.
Specific regulatory procedures have been devised to expedite the approval of pandemic vaccines. In the USA, for example, fewer data are required when the manufacturer already has a licensed influenza vaccine and intends to use the same manufacturing process for its pandemic vaccine.
In the European Union, the European Medicines Agency uses a rolling review procedure whereby manufacturers can submit sets of data for regulatory review as they become available without waiting until all data can be submitted together in a single formal application.
Also, in Europe, some manufacturers have conducted advanced studies using a so-called "mock-up" vaccine. Mock-up vaccines contain an active ingredient for an influenza virus that has not circulated recently in human populations and thus mimics the novelty of a pandemic virus. Such advanced studies can greatly expedite regulatory approval.
Special safety concerns
Influenza vaccines have been used for more than 60 years and have an established safety record in all age groups. While some serious adverse events have been reported, these have been rare.
Nonetheless, special safety issues will inevitably arise during a pandemic when the vaccine is administered on a massive scale. For example, adverse events too rare to show up even in a large clinical trial may become apparent when vast numbers of people receive a pandemic vaccine.
Some adverse events will be coincidental – that is, associated in time with vaccine administration, yet not directly caused by the vaccine. Genuine adverse events directly caused by the vaccine may also occur but cannot be predicted in advance. Given the safety record of seasonal vaccines, such events are expected to be rare.
Time constraints mean that clinical data when pandemic vaccines are first administered will inevitably be limited. Further testing of safety and effectiveness will need to take place after administration of the vaccine has begun.
For these reasons, WHO advises all countries administering pandemic vaccines to conduct intensive monitoring for safety and efficacy, and many countries have plans to do so. On the positive side, mass vaccination campaigns can generate significant safety data within a few weeks.
International sharing of data from such post-marketing surveillance will guide risk-benefit assessments and determine whether changes in vaccination policies are needed. WHO has developed standardized protocols for data collection and reporting in real-time and will communicate findings to the international community via its website.
I think we are not asking the right questions. If flu vaccines have been used for 60 years... Why hasn't the flu been eradicated?
What is in the vaccine?
According to the official WHO website, all components of vaccines are essential to ensure their safety and efficacy. These are some of them
ˋ Antigen: this is a killed or weakened form of a pathogen (e.g., a virus or bacteria) that prepares our body to recognize and fight a particular disease in the future.
ˋ Adjuvants: help to boost the immune response and thus facilitate the action of vaccines.
ˋ Preservatives: ensure that the immunization maintains its efficacy.
ˋ Stabilizers: protect the vaccine during transport and storage
Some of the components listed on the label of vaccines are unknown to us, but many of them are naturally present in our bodies, our environment, and the food we eat. To ensure their safety, all vaccines and their ingredients are comprehensively tested and monitored separately.
I want to share with you the content of vaccines according to the book "What Pharmaceutical Companies Don't Want You to Know About Vaccines" - by Dr. Todd M. Elsner
If you vaccinate in the first six years of life, your child receives the following
ˋ 17,500 mcg 2-phenoxyethanol (antifreeze)
ˋ 5,700 mcg aluminum (neurotoxin)
ˋ Unknown amounts of fetal bovine serum (aborted cow blood)
ˋ 801.6 mcg formaldehyde (carcinogen, embalming agent)
ˋ 23,250 mcg gelatin (ground up animal meat)
ˋ 500 mcg human albumin (human blood)
ˋ 760 mcg of monosodium L-glutamate (causes obesity & diabetes) ˋ Unknown amounts of MRC-5 cells (aborted human babies)
ˋ Over 10 mcg neomycin (antibiotic)
ˋ Over 0.075 mcg polymyxin B (antibiotic)
ˋ Over 560 mcg polysorbate 80 (carcinogen)
ˋ 116 mcg potassium chloride (used in lethal injection)
ˋ 188 mcg potassium phosphate (liquid fertilizer agent)
ˋ 260 mcg sodium bicarbonate (baking soda)
ˋ 70 mcg sodium borate (Borax, used for cockroach control)
ˋ 54,100 mcg of sodium chloride (table salt)
ˋ Unknown amounts of sodium citrate (food additive)
ˋ Unknown amounts of sodium hydroxide (Danger
Corrosive!)
ˋ 2,800 mcg sodium phosphate (toxic to any organism)
ˋ Unknown amounts of sodium phosphate monobasic monohydrate (toxic to any organism)
ˋ 32,000 mcg sorbitol (Not to be injected)
ˋ 0.6 mcg streptomycin (antibiotic)
ˋ Over 40,000 mcg sucrose (cane sugar)
ˋ 35,000 mcg yeast protein (fungus)
ˋ 5,000 mcg urea (metabolic waste from human urine)
ˋ Other chemical residuals
The direct relationship between vaccines and autism has not been scientifically proven.
I want to share 13.1 of the vaccine packages insert with you: Has not been evaluated for carcinogenic or mutagenic potential or impairment of fertility.
Nothing to add.
Let me tell you what is happening in the United States with vaccines.
U.S. Court Order by Kennedy Jr. Identified as Case 1:18-cv-03215-JMF Document 18 Filed 07/09/18
In the U.S., the law requires vaccine companies to report to the Department of Health and Human Services (HHS) and Congress every two years, documenting vaccine safety studies and quality control improvements to their products.
However, when in a recent lawsuit Robert F. Kennedy Jr. and Del Bigtree requested that HHS provide these 32 years of vaccine safety studies, the federal government did not respond. Which led Kennedy and Bigtree to file a court order demanding the documents. The Department of Health and Human Services (HHS) replied, "The department's records search did not find any records responsive to their request." This means that HHS has violated the law since 1986 and refuses to hold vaccine companies accountable today.
The takeaway from this lawsuit is that: no vaccine safety studies have been conducted in 32 years. Or that, for more than three decades, if vaccine safety studies were done, absolutely no documentation can be found in the files of the Department of Health and Human Services.
If this documentation does not appear, this case will have generated case law that can be cited in lawsuits by all parents, for 'fraudulent mandate,' against any regulation, governmental, or organizational requirement to vaccinate their children for school or any other activity and to stop the forced vaccination of themselves and their children.
Textual information is taken from this article
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Is there medication against the alleged Covid-19?
A lot of energy has been moved since March 2020. In the face of the confusion, various allopathic, homeopathic, and natural medicines have been used to provide prevention and/or solution beyond the conventional idea according to the official protocol, without isolating the virus or autopsies that have confirmed the cause of death.
During the first years of my daughter's life, I have experienced regular fevers. I always thought they were emotional. However, the doctor always gave me the same procedure. Bring the fever down with antipyretic and after 24 hours, do a laryngeal swab. If it's bacteria, antibiotic prescription. If it's a virus...just wait for the body to settle in.
I am not a doctor. I can't prescribe, nor would I prescribe. I can suggest that you do some research. I recommend you review these items and determine for yourself the appropriateness.
ˋ CDS proposed by Dr. Andreas Kalker.
ˋ Inhalable Ibuprofen (Argentine discovery).
ˋ Human plasma
ˋ Ivermectin (antiparasitic)
ˋ Hydroxychloroquine (used for malaria)
ˋ Some other less conventional preventative (walnut oil,
Ormuz, colloidal silver, seawater, etc.).
I am human. I suggest taking advantage of the human body's design at its best, and I guarantee you that it will not take going through any physical conflict situations of any kind.
An optimal immune system and a review and cleansing of the burdens carried by your energy field will ensure health is available to you for as long as you choose to remain in this human experience.
Covid-19 Death Statistics
If death is your concern, let's talk statistics. In today's state of manipulation, it is tough to get official statistics.
There is a very interesting video by Dr. Acevedo Whitehouse that gives the following scientific conclusions:
The average age of people dying from Covid-19 is 82.
Under the age of 70, you are more likely to die of nonCovid-19 causes.
The most significant number of people dying from Covid-19 are those above the age at which they generally die.
The average mortality is above life expectancy.
According to WHO, the case fatality rate of the infection is, on average, 0.23%.
You can see the partial report of Dr. Acevedo in this link:
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MY CONCLUSION
I just have questions
Considering the minimal background presented would you believe this is a plan?
While we seem to be exposed to a flu virus (that's what coronaviruses are) of high contagiousness and low mortality rate, why are we still locked down?
How scared are you of dying, to the point of no longer living?
If average mortality is above life expectancy, what scares you? You are going to die anyway.
If preventive medication exists, why require a vaccine?
Having read the content of the vaccine, do you still believe that it is an antidote? Or is it a poison?
If the flu vaccine that has been used for 60 years has not made the flu disappear, why do they still administer the flu vaccine every year?
Considering what you have read so far, do you still believe that you need a vaccine?
But then why do they want to give us a vaccine?
I could give you my internal version... but for now, I prefer to paraphrase Bill Clinton.
"The economy, stupid" was a phrase widely used in American politics during Bill Clinton's 1992 election campaign against George H. W. Bush (Sr.), which led him to become President of the United States. Later the phrase was popularized as "it's the economy, stupid," and the structure of the term has been used to highlight the most diverse aspects that are considered essential.
I am Claudia González De Vicenzo.
This is my vision of the current reality
