COVID-19 “Vaccine” – FACT SHEET, USA & EU

USA Specific Data

  1. The current Pfizer and Moderna covid-19 vaccines have not been approved or licensed by the US government.

“The Pfizer-BioNTech COVID-19 Vaccine is an unapproved vaccine that may prevent COVID-19. There is no FDA-approved vaccine to prevent COVID-19.” Link: https://www.fda.gov/media/144414/download

“The Pfizer-BioNTech COVID-19 vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA)” Link: https://www.pfizer.com/health/coronavirus

“The Moderna COVID-19 Vaccine is an unapproved vaccine that may prevent COVID-19. There is no FDA-approved vaccine to prevent COVID-19.” Link: https://www.fda.gov/media/144638/download

“The Moderna COVID-19 Vaccine has been authorized for emergency use by the FDA in individuals 18 years of age and older. It has not been approved or licensed by FDA.” Link: https://www.modernatx.com/blog/moderna-mrna-vaccine-against-covid-19-receives-fda-emergency-use

  1. The FDA (“Food and Drug Administration” – fda.gov) has only granted “Emergency Use Authorization”

“The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of the unapproved product, MODERNA COVID-19 VACCINE, for active immunization to prevent COVID-19 in individua ls 18 years of age and older.” Link: https://www.fda.gov/media/144637/download

“The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of the unapproved product, Pfizer-BioNTech COVID-19 Vaccine, for active immunization to prevent COVID-19 in individuals 16 years of age and older.” Link: https://www.fda.gov/media/144413/download

  1. These “Emergency Use Approvals” (EUA) allow temporary use of an unapproved medical product. Significantly less data is required, compared to the requirements for standard approval, clearance or licensing.

“The EUA process is different than FDA approval, clearance, or licensing because the EUA standard may permit authorization based on significantly less data than would be required for approval, clearance, or licensing by the FDA.” Link: https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-frequently-asked-questions 

  1. The main criteria for the product properties for getting “Emergency Use Approval” (EUA), is: “may be effective”. In other words, no definite “proof of effectiveness” has been required for either of these two medical products.

From section “Criteria for Issuance of Authorization”: “Based on the totality of scientific evidence available to FDA, it is reasonable to believe that ModernaCOVID‑19 Vaccine may be effective in preventing COVID-19,..” Link: https://www.fda.gov/media/144636/download

From section “Criteria for Issuance of Authorization”: “Based on the totality of scientific evidence available to FDA, it is reasonable to believe that Pfizer-BioNTech COVID‑19 Vaccine may be effective in preventing COVID-19” Link: https://www.fda.gov/media/144412/download 

  1. There is no, or insufficient, evidence that these medical products will make those receiving the vaccine either immune to contracting covid-19 or prevent them from spreading covid-19 to others.

The World Health Organization (see who.org) Chief Scientist, Soumya Swaminathan: “I don’t believe we have the evidence on any of the vaccines to be confident that it’s going to prevent people from actually getting the infection and therefore being able to pass it on,” Swaminathan said. 29 Dec 2020. Link: https://www.skynews.com.au/details/_6218725393001

“None of the trials currently under way are designed to detect a reduction in any serious outcome such as hospital admissions, use of intensive care, or deaths. Nor are the vaccines being studied to determine whether they can interrupt transmission of the virus.” Link: https://www.bmj.com/content/371/bmj.m4037

  1. The Pfizer and Moderna covid-19 vaccines are currently (14 Feb 2021) still in clinical trials and are thus not completed products yet. They are still in the research stage. and they are therefore, by definition, “experimental”.

“Pfizer-BioNTech COVID-19 Vaccine is still being studied in clinical trials.” Link: https://www.fda.gov/media/144414/download

“The Moderna COVID-19 Vaccine is still being studied in clinical trials.” Link: https://www.fda.gov/media/144638/download

NIH Definition of a Clinical Trial – A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.” Link: https://grants.nih.gov/policy/clinical-trials/definition.htm

World Health Organization (WHO) definition of “Clinical Trial”: “Clinical trials are a type of research that studies new tests and treatments and evaluates their effects on human health outcomes.” Link: https://www.who.int/health-topics/clinical-trials/#tab=tab_

  1. These two experimental medical products are called “vaccines” – however they are not “vaccines” according to the US CDC’s (Center for Disease Control) own definition.

Vaccine: A product that stimulates a person’s immune system to produce immunity to a specific disease, protecting the person from that disease. Vaccines are usually administered through needle injections, but can also be administered by mouth or sprayed into the nose.” Link: https://www.cdc.gov/vaccines/vac-gen/imz-basics.htm

“Vaccines contain the same germs that cause disease. (For example, measles vaccine contains measles virus, and Hib vaccine contains Hib bacteria.) But they have been either killed or weakened to the point that they don’t make you sick. Some vaccines contain only a part of the disease germ.

A vaccine stimulates your immune system to produce antibodies, exactly like it would if you were exposed to the disease. After getting vaccinated, you develop immunity to that disease, without having to get the disease first.” Link: https://www.cdc.gov/vaccines/vpd/vpd-vac-basics.html 

  1. The UK government was expecting such a high volume of adverse reactions from the Covid-19 vaccines that, with EU Funding, it was seeking Artificial Intelligence Software as early as 23 Oct 2020.

Short description: The MHRA urgently seeks an Artificial Intelligence (AI) software tool to process the expected high volume of Covid-19 vaccine Adverse Drug Reaction (ADRs) and ensure that no details from the ADRs’ reaction text are missed.” Link: https://ted.europa.eu/udl?uri=TED:NOTICE:506291-2020:TEXT:EN:HTML&src=0

“For reasons of extreme urgency under Regulation 32(2)(c) related to the release of a Covid-19 vaccine MHRA have accelerated the sourcing and implementation of a vaccine specific AI tool.” Link: https://ted.europa.eu/udl?uri=TED:NOTICE:506291-2020:TEXT:EN:HTML&src=0

“Strictly necessary — it is not possible to retrofit the MHRA’s legacy systems to handle the volume of ADRs that will be generated by a Covid-19 vaccine. Therefore, if the MHRA does not implement the AI tool, it will be unable to process these ADRs effectively.” Link: https://ted.europa.eu/udl?uri=TED:NOTICE:506291-2020:TEXT:EN:HTML&src=0

  1. As of 14 Feb 2014 over 12500 adverse effects have been reported (to the national VAERS database) in connection with receiving the covid-19 vaccine from either Pfizer or Moderna. Over 4% of the reported adverse affects were deaths. Over 2200 of the reported adverse effects were “serious” (see below). This is in the VAERS (Vaccine Adverse Effects Reporting System) alone.

“Death                          536                      4.22%” Link: https://wonder.cdc.gov/controller/saved/D8/D117F394

“  Serious AEs regardless of causality. Serious AEs per FDA are defined as:

Death;

A life-threatening AE;

Inpatient hospitalization or prolongation of existing hospitalization;

A persistent or significant incapacity or substantial disruption of the ability to conduct normal life  functions;

A congenital anomaly/birth defect;

An important medical event that based on appropriate medical judgement may jeopardize the individual and may require medical or surgical intervention to prevent one of the outcomes listed above.” Link: https://vaers.hhs.gov/faq.html

  1. A very sobering fact, as reported by numerous studies, is that only 1-10% of adverse reactions are ever reported to the VAER database. Meaning that the figures reported should be multiplied by 10X to 100X to accurately reflect the situation.

“Underreporting” is one of the main limitations of passive surveillance systems, including VAERS.” Link: https://vaers.hhs.gov/data/dataguide.html

  1. Pfizer has paid nearly 5 billion USD in fines in the past decade – earning it the title of second-most fined pharmaceutical company. Moderna has been implicated in manipulating the stock market price of its shares and a watchdog group was urging the SEC to investigate.

Pfizer $4,712,210,359” Link: https://violationtracker.goodjobsfirst.org/industry/pharmaceuticals

“This misconduct was particularly egregious because it involved not only financial fraud and manipulation of the financial markets, but also because it exploited widespread fears surrounding the ongoing COVID-19 pandemic,” Link: https://www.cbsnews.com/news/insider-trading-allegations-moderna-accountable-us-securities-exchange-commission/

EU Specific Data

  1. No vaccine has been granted EU Commission approval. Three vaccines have only been given “Conditional Marketing Authorizations” – which means that they are considered “clinical trials” and the suppliers are required to provide more evidence about the vaccine for another 2 years.

The Commission has so far given 3 conditional marketing authorisations for the vaccines developed by BioNTech and Pfizer, Moderna and AstraZeneca” Link: https://ec.europa.eu/info/live-work-travel-eu/coronavirus-response/safe-covid-19-vaccines-europeans_en

A conditional marketing authorisation (CMA) is an authorisation of medicines on the basis of less complete data required for a normal marketing authorisation.” Link: https://ec.europa.eu/cyprus/news/20201221_4_en

“COVID-19 Vaccine Moderna has been given ‘conditional marketing authorisation’. This means that there is more evidence to come about the vaccine (see below), which the company is required to provide.” Link: https://www.ema.europa.eu/en/medicines/human/EPAR/covid-19-vaccine-moderna

“Since COVID-19 Vaccine Moderna has been given conditional marketing authorisation, the company that markets COVID-19 Vaccine Moderna will continue to provide results from the clinical trial, which is ongoing, for 2 years. This trial and additional studies will provide information on how long protection lasts, how well the vaccine prevents severe COVID-19, how well it protects immunocompromised people, children and pregnant women, and whether it prevents asymptomatic cases.” Link: https://www.ema.europa.eu/en/medicines/human/EPAR/covid-19-vaccine-moderna

  1. The vaccines which have received “Conditional Marketing Authorization” fall under the definition of “genetically modified organism” – since they contain genetically modified material – which were, for all intents and purposes, banned in EU.

“..the ongoing efforts to develop a vaccine against COVID-19 are based on genetically modified attenuated viruses or viral vectors. These products fall under the definition of “genetically modified organism” and are subject to the GMO legislation.” Link: https://ec.europa.eu/commission/presscorner/detail/en/mex_20_1359

  1. The EU has had, what is said to be, the most strict regulations against the use of GMO’s in the world. This changed on 15 July 2020, when an ultra-rapid change of the regulations took place in a 10-day period, with no scientific reports, no hearings, no debate, and no amendments.

Yesterday, the Council adopted the Commission’s proposal to accelerate clinical trials and the supply of medicinal products that contain genetically modified organisms (GMOs) in the fight against COVID-19.” Link: https://ec.europa.eu/commission/presscorner/detail/en/mex_20_1359

Stella Kyriakides, Commissioner for Health and Food Safety said: “I welcome the swift support given by both the European Parliament and Council. This endorsement is another clear signal that, in times of crisis, the EU’s institutions can react quickly and adapt legislation to tackle emergencies. Link: https://ec.europa.eu/commission/presscorner/detail/en/mex_20_1359

  1. In the decision on July 15 2020, the EU parliament agreed to remove the need for risk evaluation required under the GMO regulations. This is relevant since these covid-19 vaccines will be injecting GMO material directly into humans.

The regulation will allow for a temporary derogation for clinical trials with the contained used of GMOs and it also allows for Member States to use medicinal products containing or consisting of GMOs intended to treat or prevent COVID-19 in certain urgent circumstances.” Link: https://ec.europa.eu/commission/presscorner/detail/en/mex_20_1359

  1. As of 14 Feb 2021, over 55 000 adverse reaction reports, connected to the Covid-19 vaccines, have been recorded in the European Union’s “EudraVigilance – European database of suspected adverse drug reaction reports”. Over 16 000 of these reports are categorized as “serious” (see definition below).

Link: http://www.adrreports.eu/

(Note: select language, click on C and scroll down to “Covid-19 MRNA Vaccine” in order to access the report.)

Seriousness provides information on the suspected undesirable effect; it can be classified as ‘serious’ if it corresponds to a medical occurrence that results in death, is life-threatening, requires inpatient hospitalisation, results in another medically important condition, or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a congenital anomaly/birth defect.” Link: http://www.adrreports.eu/docs/Web%20report%20user%20guide%20EN.pdf