EMA and FDA Washing Hands? We Have Receipts
EMA and FDA Washing Hands? We Have Receipts
The proof EMA and FDA are lying that they did not authorize the mRNA jabs for use to prevent infections with SARS-CoV2.
We all have regrets. It seems like the FDA and the EMA also have them, when it comes to giving the pretext and the cover to tyrannical governments, back in 2020, in the name of Science, to subject their citizen to bioweapon mRNA genetic treatments.
To recap my previous post, “EMA and FDA Are Washing Their Hands…”, both FDA and EMA claimed recently that they did not authorize mRNA jabs to prevent the spread of Covid-19-causing SARS-CoV-2 virus, but only to mitigate the consequences of contracting the virus:
“FDA response to Coalition Advocating for Adequately Licensed Medicines, Apr. 18, 2023”
…the Pfizer and Moderna COVID-19 vaccines have been licensed or authorized for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2. This is directly stated in the relevant labeling for each product—in the Indications and Usage section of the Prescribing Information for the approved products, and on the first page of the healthcare provider and recipient Fact Sheets for the authorized products. The vaccines are not licensed or authorized for prevention of infection with the SARS-CoV-2 virus or for prevention of transmission of the virus, nor were the clinical trials supporting the approvals and authorizations designed to assess whether the vaccines prevent infection or transmission of the virus.
“EMA response to Marcel de Graaff MEP, European Parliament, Oct. 18, 2023”
You are indeed correct to point out that COVID-19 vaccines have not been authorised for preventing transmission from one person to another. The indications are for protecting the vaccinated individuals only. The product information for COVID-19 vaccines clearly states that the vaccines are for active immunisation to prevent COVID-19. In addition, EMA’s assessment reports on the authorisation of the vaccines note the lack of data on transmissibility.
So, what did happen in Mozambique?
I. Let’s start with the term “active immunization”. According to Wikipedia:
Active immunization is the induction of immunity after exposure to an antigen.
Induction of immunity. And, according to many medical sources, including NIH’s National Cancer Institute:
In medicine, the immune system’s way of protecting the body against an infectious disease. The three types of immunity are innate, adaptive, and passive. Innate immunity includes barriers, such as skin and mucous membranes, that keep harmful substances from entering the body. It is the first response of the body’s immune system to a foreign substance. Adaptive immunity occurs in response to being infected with or vaccinated against a microorganism. The body makes an immune response, which can prevent future infection with the microorganism. Adaptive immunity can last a person’s entire life.
Thus, “active immunization” with something against a microogranism implies bestowing on the recipient of this something the immunity that will prevent the recipient from future infection with the microogranism. And, as the recipient won’t be infected with the microorganim, the recipient can’t spread the microornanism with which the recipient isn’t infected. Logical?
II. According to the “Comirnaty, INN-COVID-19 mRNA Vaccine (nucleoside-modified)” information provided by EMA:
What Comirnaty is and what it is used for
Comirnaty is a vaccine used for preventing COVID-19 caused by SARS-CoV-2 virus.
The vaccine causes the immune system (the body’s natural defences) to produce antibodies and blood cells that work against the virus, so giving protection against COVID-19.
A bit vague, I agree. But you can definitely conclude, in 2020, that it would provide the immunity against the pathogen, if it “works against the virus”?
III. And here’s the EMA’s summary of its authorization decision from Dec. 21, 2020: “CHMP summary of positive opinion for Comirnaty”:
Comirnaty is a vaccine for preventing coronavirus disease 2019 (COVID-19) in people aged 16 years and older.
How does Comirnaty work?
Comirnaty works by preparing the body to defend itself against COVID-19. It contains a molecule called mRNA which has instructions for making the spike protein. This is a protein on the surface of the SARS-CoV-2 virus which the virus needs to enter the body’s cells.
When a person is given the vaccine, some of their cells will read the mRNA instructions and temporarily produce the spike protein. The person’s immune system will then recognise this protein as foreign and produce antibodies and activate T cells (white blood cells) to attack it.
If, later on, the person comes into contact with SARS-CoV-2 virus, their immune system will recognise it and be ready to defend the body against it.
So, the recipient’s immune system will recognize the virus, not “the disease”, and will defend the recipient’s body against the virus, not “the disease”. Black on white?
IV. That’s not all the incriminating evidence. The EMA also issued a more technical document as part of the EUA for Prizer/Biontech jab, “Comirnaty : EPAR - Public assessment report” (2020.12.23), that keeps repeating the term “active immunization” and tooting the prevention of infection:
1. Background information on the procedure
1.1. Submission of the dossier
The applicant applied for the following indication:
“Active immunisation to prevent COVID-19 disease caused by SARS-CoV-2 virus, in individuals 16 years of age and older. The use of Comirnaty vaccine should be in accordance with official guidance.”
2.1.3. Aetiology and pathogenesis
SARS-CoV-2 is an RNA virus with four structural proteins. One of them, the Spike protein is a surface protein which binds the angiotensin-converting enzyme 2 (ACE-2) present on host cells. Therefore, the Spike protein is considered a relevant antigen for vaccine development. It has been shown that antibodies against the Spike protein neutralise the virus and prevent infection.
2.1.5. Management
About the product
Intended indication: ‘Active immunisation to prevent COVID-19 disease caused by SARS-CoV-2 virus, in individuals 16 years of age and older’.
2.3.1. Pharmacology
Mechanism of action
SARS-CoV-2 infects the body by the use of the Spike protein (S) to attach to specific cell surface receptors, of which the angiotensin converting enzyme 2 (ACE2) may constitute a major part, as recently suggested. In addition to the initial attachment to a host cell, the S protein is also responsible for viral envelope fusion with the host cell membrane resulting in genome release. Due to its indispensable role, the S protein is a major target of virus neutralizing antibodies and has become a key antigen for vaccine development. By immunisation with the modified RNA (modRNA) product BNT162b2, encoding for the S protein, the intention is to trigger a strong and relatively long-lasting production of high affinity virus neutralizing antibodies, which can act through blocking the S-protein and it’s receptor-binding domain (RBD) interaction with host cell receptors but also by opsonisation mediated virus clearance. In addition, the immunisation with BNT162b2 is also intended to elicit a concomitant T cell response of the Th1 type, supporting the B cells responsible for the production of Sspecific antibodies and cytotoxic T cells that kill virus infected cells.
3.1. Therapeutic Context
3.1.1. Disease or condition
As of 1 December 2020, there have been >63 million globally confirmed COVID-19 cases and >1.4 million deaths, with 191 countries/regions affected. At the time of this marketing application submission, confirmed cases and mortality continue to rise globally. The ongoing pandemic remains a significant challenge to public health and economic stability worldwide.
Comirnaty is intended for active immunisation against SARS-CoV-2, thereby preventing COVID-19.
3.2. Favourable effects
The overall vaccine efficacy against symptomatic laboratory confirmed COVID-19 from 7 days after dose 2 was 95.0% (95% CI 90.0, 97.9) in subjects ≥16 years of age without prior evidence of SARSCoV2 infection and 94.6% (95% CI 89.6, 97.6) in all subjects regardless of prior evidence of SARSCoV-2 infection (primary endpoint). This outcome met the pre-specified success criteria.
Vaccine efficacy after dose 1 to before dose 2 was 52.4% (95% CI 29.5, 68.4). Vaccine efficacy from 10 days after dose 1 to before dose 2 was estimated to be 86.7% (95% CI 68.6, 95).
3.3. Uncertainties and limitations about favourable effects
The pivotal study was not designed to assess the effect of the vaccine against transmission of SARSCoV-2 from subjects who would be infected after vaccination. The efficacy of the vaccine in preventing SARS-CoV-2 shedding and transmission, in particular from individuals with asymptomatic infection, can only be evaluated post-authorisation in epidemiological or specific clinical studies.
4. Recommendations
Outcome
Based on the CHMP review of data on quality, safety and efficacy, the CHMP considers by consensus that the benefit-risk balance of Comirnaty is favourable in the following indication: Comirnaty is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 16 years of age and older.
The use of this vaccine should be in accordance with official recommendations.
“It has been shown that antibodies against the Spike protein neutralise the virus and prevent infection.” Prevent infection: the EMA said it itself, in 2020. And, “Comirnaty is indicated for active immunisation”. I rest my case!
V. The FDA isn’t much better, also tooting “active immunization” as the goal of jabbination with the Pfizer “vaccine” in the USA:
“Active immunization to prevent Covid-19”: not alleviate, mitigate, soften the course of the disease, but outright prevent through active immunization!
So, for all intents and purposes, the mRNA jabs have been authorized by the FDA and the EMA to prevent the infection by and transmission of SARS-CoV-2, and no amount of bending into pretzels now will deny this fact. And the fact that they didn’t have any factual basis for doing that, and here I agree with the EMA and the FDA, is also contained in their EUA documents, for all to behold.
The fallout is just starting to unfold, the FDA tolls the alarm bell:
Maybe it’s due to something you are complicit in, FDA? The actuaries predict the increased death toll among the working population with pension plans to accelerate into 2030:
But that is only if things stay on the same track as they currently are. Geert Vanden Boschee predicts a qualitative change to the worse, a fall off the cliff, as it were, in the very immediate future. Have a read:
Well written evidence and observations vs the clear knowledge obfuscation they continue to perpetually claim didn't happen.
It was clear by the claim they initially made so loudly that it was designed to prevent "serious illness", and "prevent hospitalization" because it is a completely immeasurable quantity. The brainwashing began right then and there, because ANYONE who got jabbed ALWAYS told everyone they were so glad they got the "vaccine" (gene therapy) that they can't imagine how sick they'd have been if they didn't get the shot/s. Nevermind the fact that the unvaccinated around them simply weren't getting sick, but they were absolutely convinced that they would have been in the hospital if they hadn't received every shot and every booster.
The medical malpractice and malfeasance, and medical fraud, not to mention the actual harm caused by these lies is the worst form of Genocide ever seen in the world, yet it still gets national and international prime time TV commercials. Even worse, it's being combined with other actual acclaimed "vaccines" which from combined versions of vaccines like MMR are far more harmful in the combined form than each by itself.
We surpassed the Nuremberg Trial status and necessity a very long time ago, and yet it's still very widely accepted as any normal part of the "vaccine schedule" which is nothing short of obscene. 72 injections by the age of 18 should alone make you question how that suddenly aligns with the huge spike in allergies of all kinds that rarely or never existed before the 70s and 80s. Enter Fauci the Fraud, and his 40-50 years of reign as the supreme poison pusher for all of us, our kids and future generations that will be increasingly unhealthy and brainwashed to keep increasing the human and animal retroviruses included in each dose of vaccines they agree to take. At some point the various Chimera diseases will be an impressive and fearful byproduct, a ticking time bomb of future brainwashed citizens.
never experimental no matter how you look at it: experimental not only implies but requires testing for a result. This onslaught of the genetic shot was never a test, ever, legally . They could care less about the result, which is obvious..here is definition
cambridge dictionary
experimental
adjective
"using new methods, ideas, substances, etc. that have not been tried before, usually in order to find out what effect they have: