FDA Stealth Approval of mRNA Technology through Pfizer Covid-19 Vaccines, No Core Safety Evaluation

Updated: Aug 25

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Update: Many readers are writing in to state FDA letter does NOT constitute full use authorization.. Videos and articles have surfaced stating the approval violates existing FDA standards for full FDA licensure of pharmaceuticals. The authorization appears to only authorize 2 doses of vaccination and keeps additional doses under EUA (so any booster would retain liability protection for Pfizer) This article sheds some clarification on the manipulations involved in current FDA Pfizer approval:


2 Things Mainstream Media Didn’t Tell You About FDA’s Approval of Pfizer Vaccine


The determination of legal standing of current approval is beyond the expertise of this blog, however, relevant information related to this topic will be included in future posts.


Companion Blog (full documentation showing Covid-19 vaccines induce severe risks with NO substantive benefit through the vaccine trial and public health organization own data:


FDA Grants Full Approval Pfizer Covid-19 Vaccine for Over 16s, In Act of Medical & Scientific Fraud


The Story:


The FDA approval of Pfizer Covid-19 mRNA therapy drug (not traditional 'vaccine') occurred without ANY evaluation of the core safety concerns for mRNA therapies (per package insert). A entirely NEW technology has been approved with NO safety evaluation for CENTRAL RISKS of this technology.


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Researchers have emphasized development of mRNA drug therapies requires study of safety risks inherent to the use of this technology:

An Evidence Based Perspective on mRNA-SARS-CoV-2 Vaccine Development


"Although these beneficial features of mRNA vaccines provide some hope for the development of the first clinically applicable SARS-CoV-2 mRNA vaccine, recent reports regarding rare cases of moderate or severe reactions for different mRNA vaccines have raised concerns about safety and immunogenicity, including in the primary outcome findings of the phase I trial on mRNA-1273 [20,48]. Therefore, it is important to clearly understand the potential risks of this type of mRNA-based vaccine, which include local and systemic inflammatory responses, the biodistribution and persistence of the induced immunogen expression, possible development of autoreactive antibodies and toxic effects of any non-native nucleotides and delivery system components".


mRNA technology work by gene line editing RNA code to retrain cellular immune response:


“It uses a sequence of genetic RNA material produced in a lab that, when injected into your body, must invade your cells and hijack your cells’ protein-making machinery called ribosomes to produce the viral components that subsequently train your immune system to fight the virus.”


Many experts have disingenuously claimed mRNA vaccines do not alter DNA because RNA and not DNA are the targets for alteration. However, this is not accurate since alternation of RNA has. a DIRECT effect on DNA.


Pfizer vaccination contains a modified MESSENGER RNA (some articles have attempted to state mRNA vaccines do not contain messenger RNA (only modified) to falsely claim this finding does not apply to vaccines however Pfizer ingredient list CLEARLY states vaccine contains messenger RNA):


The vaccine contains a nucleoside-modified messenger RNA (modRNA) (pg 11)


Per Institute of Basic Medical Sciences:


Modified RNA has a direct effect on DNA stability


Normally, epigenetic gene regulation is studied by examining dynamic modifications of DNA and proteins – so-called epigenetic modifications. The modifications can turn genes on or off without changing the underlying genetic code.


Less than 10 years ago, it was discovered that dynamic modifications also exist in RNA and that these have an important role to play in gene regulation

Important modification

The most common modification is on mRNA is 6-metyladenin (m6A). It has now been shown that this modification is essential for the survival of cells and model (non-human) organisms".


Modification of RNA, therefore, has HUGE potential to impact stability of cellular DNA with serious implications for potential genotoxicity and mutagenesis NOT evaluated in Pfizer Covid-19 mRNA 'vaccine trials:


Per Package Insert:


13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility COMIRNATY has not been evaluated for the potential to cause carcinogenicity, genotoxicity, or impairment of male fertility.


The FDA approved gave FULL approval to a new technology mRNA therapy drug, and did NOT evaluate for the CORE safety risks posed by modified messenger mRNA drugs.


This is likely due to the fact that direct safety trials of mRNA technology could NOT bypass traditional safety review processes:


Lavishly funded Moderna hits safety problems in bold bid to revolutionize medicine


(Moderna uses same mRNA technology as Pfizer 'vaccination):


In need of a Hail Mary


"Founded in 2012, Moderna reached unicorn status — a $1 billion valuation — in just two years, faster than Uber, Dropbox, and Lyft, according to CB Insights. The company’s premise: Using custom-built strands of messenger RNA, known as mRNA, it aims to turn the body’s cells into ad hoc drug factories, compelling them to produce the proteins needed to treat a wide variety of diseases.


But mRNA is a tricky technology. Several major pharmaceutical companies have tried and abandoned the idea, struggling to get mRNA into cells without triggering nasty side effects.


Bancel has repeatedly promised that Moderna’s new therapies will change the world, but the company has refused to publish any data on its mRNA vehicles, sparking skepticism from some scientists and a chiding from the editors of Nature.


The indefinite delay on the Crigler-Najjar project signals persistent and troubling safety concerns for any mRNA treatment that needs to be delivered in multiple doses, covering almost everything that isn’t a vaccine, former employees and collaborators said"


mRNA drug makers received 'hail mary' when the FDA allowed technology which could not bypass traditional safety review through under pretense of national emergency unsupported by Covid-19 attributed mortality & symptom presentation risk, and now has approved the technology through Pfizer Covid-19 mRNA drugs without ANY evaluation of core risks. This is a betrayal of science and public health.

For full history of mRNA 'vaccination' developed as funded through DARPA and military grants, please see this companion blog:


Pfizer /Moderna Military Funding For Vaccines, Decade of Headlines In Lead Up to Covid-19 Vaccines



Additional Safety Violations:


Pfizer package insert confirms insufficient data for safe use in pregnancy:


"Available data on COMIRNATY administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy".


This means the risks are UNKNOWN and every single health expert is misrepresenting safety of Covid-19 vaccines on the premise of lack of data, an unacceptable standard to ascertain risk.


Additionally, the results of a New England Journal of Medicine Study were falsified by the study authors, the CDC, and the media to misrepresent study findings.


New England Journal of Medicine Study Found:


127 women before twenty weeks were enrolled in trial and vaccinated before 20 weeks, of which 104 women or 82% lost their pregnancies.


This finding was buried in the data by including women experiencing spontaneous abortion in the first three months with ALL trial outcomes (after 20 weeks loss of pregnancy is classified as still birth and would not apply to women after 20 week term)


84.6% of trial participants were in third trimester when vaccinated who were included in the pregnancy loss assessment group:


"Data on pregnancy loss are based on 827 participants in the v-safe pregnancy registry who received an mRNA Covid-19 vaccine (BNT162b2 [Pfizer–BioNTech] or mRNA-1273 [Moderna]) from December 14, 2020, to February 28, 2021, and who reported a completed pregnancy. A total of 700 participants (84.6%) received their first eligible dose in the third trimester. Data on neonatal outcomes are based on 724 live-born infants, including 12 sets of multiples.


‡ A total of 96 of 104 spontaneous abortions (92.3%) occurred before 13 weeks of gestation".


The study lumped the data in with total pregnancy outcomes thus misrepresenting early trimester pregnancy outcomes as the same as women in early pregnancy whom did not receive the vaccine.


This data should have been included SEPARATELY to determine risks for early pregnancy outcomes as goal of study was to determine safety in different terms of pregnancy and spontaneous abortion does not apply to women post 20 weeks.



Serious Side Effects: Not Enough Data:


A cursory review of package insert information reveals Pfizer lacks substantive data to assess for serious risk:


8.2 Lactation Risk Summary


It is not known whether COMIRNATY is excreted in human milk. Data are not available to assess the effects of COMIRNATY on the breastfed infant or on milk

production/excretion.


The Package ADMITS Safety and Effectiveness have NOT been established for children under 16 (nor older age groups due to lack of data), yet EUA was granted for children as young as 12 despite the group not being at risk from Covid-19 attributed infection:


The safety and effectiveness of COMIRNATY in individuals younger than 16 years of age have not been established


FDA Approval Contingent on Myocarditis Safety Study Not Due for Completion until 2025:


"We have determined that an analysis of spontaneous postmarketing adverse events reported under section 505(k)(1) of the FDCA will not be sufficient to assess known serious risks of myocarditis and pericarditis and identify an unexpected serious risk of subclinical myocarditis. Furthermore, the pharmacovigilance system that FDA is required to maintain under section 505(k)(3) of the FDCA is not sufficient to assess these serious risks. Therefore, based on appropriate scientific data, we have determined that you are required to conduct the following studies: 4. Study C4591009, entitled “A Non-Interventional Post-Approval Safety Study of the Pfizer-BioNTech COVID-19 mRNA Vaccine in the United States,” to evaluate the occurrence of myocarditis and pericarditis following administration of COMIRNATY. We acknowledge the timetable you submitted on August 21, 2021, which states that you will conduct this study according to the following schedule:


Final Protocol Submission: August 31, 2021

Monitoring Report Submission: October 31, 2022

Interim Report Submission: October 31, 2023

Study Completion: June 30, 2025

Final Report Submission: October 31, 2025


Package Insert Disclosure on Myocarditis:


5.2 Myocarditis and Pericarditis Postmarketing data demonstrate increased risks of myocarditis and pericarditis, particularly within 7 days following the second dose. The observed risk is higher among males under 40 years of age than among females and older males. The observed risk is highest in males 12 through 17 years of age. Although some cases required intensive care support, available data from short-term follow-up suggest that most individuals have had resolution of symptoms with conservative management.

Information is not yet available about potential longterm sequelae. The CDC has published considerations related to myocarditis and pericarditis after vaccination, including for vaccination of individuals with a history of myocarditis or pericarditis (https://www.cdc.gov/vaccines/covid-19/clinical-considerations/myocarditis.html).


The FDA granted approval 18 months before ANY trial were set for completion and ordered additional studies due to severe cardiac risks.


This approval is fraud. By the approval letter documentation and Pfizer package insert data, the risks of severe vaccine safety risks remain unstudied and unknown. This approval violates basic previous FDA safety standards for full approval of new drugs and, in no way provides sufficient documentation to demonstrate safety/efficacy of this drug.


This study establishes as a highly dangerous precedent standard for drug approval in the United States.


The FDA deserves no deference as an institutional authority to protect citizen health. The FDA has completely abdicated its duty to provide safety oversight for drug demonstrating serious health risks. The agency is nothing more than a rubber stamp for pharmaceutical companies and no citizen is obliged to defer to mandates based on fraudulent approval standards.


Irish Physician Whistleblower Reveals SERIOUS vaccine harm is COMMON and being covered by attribution to Covid-19:


Notice:


New videos added to compilation post of protests and citizen pushback. You may view the updated post HERE.


Love to all. Remember, stay united, stay peaceful, stay strong. The tide IS turning.




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