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The experimental Covid jab is not responsible for the uptick in sudden deaths following its rollout, the Food and Drug Administration claims.
Responding to an email from a concerned citizen, a rep for the FDA – which gave pharmaceutical companies fast-track approval and granted emergency use authorization green-lighting the jabs – denied links to the unexplained deaths, claiming their robust surveillance and regulatory bureaucracy ensures these types of incidents don’t happen.
“Based on these multiple safety surveillance systems there is no link between sudden death in people and the COVID-19 vaccines,” the agency claimed.
In the email obtained by The Gateway Pundit, the unidentified citizen asked the federal agency whether intramuscular injection of the mRNA vaccine and subsequent spike proteins could be prompting inflammatory reactions that could manifest in the sudden deaths being observed.
Read the email from the concerned American below:
Everyday, more and more stories of sudden death in heretofore healthy people are being reported. Strokes, heart attacks, hemorrhages, even in young children, athletes, otherwise known healthy adults.
The covid vaccine seems to be a common denominator. It is my understanding that the FDA was warned about the significant possibility of these events many many months ago (Steve Kirsch comes readily to mind, Dr. McCullough has also been active). Yet the FDA still approved primary vaccine series, boosters, and these even in infants and children. If it is established that the FDA approved (EUA) the vaccines, as safe and effective, and tens or hundreds of thousands of people subsequently die from effects of the vaccine, how will this ever have been justified approving the vaccine for demographics of people that statistically had very little to fear from covid?
To an outsider, like myself, it seems possible that the FDA is not the independent U.S. Govt Regulatory Agency that I thought, rather they seem more an extension of irresponsible Pharmacological Businesses that offered a product with insufficient testing on animals, and insufficient clinical trials, or testing that indeed showed the tragic results that are being seen, but through some mechanism, was suppressed. A responsible FDA would address these sudden deaths and recommend testing to look for people that may be prone to vaccine injuries and death from the covid vaccine. Ignoring it is beyond the pale.
It is my understanding that the following is not being done routinely:
“Syringe aspiration when vaccinating intramuscularly was not recommended before the pandemic due to the lack of conclusive evidence that it provides any benefit. However, in vivo evidence suggests that intravenous injection of mRNA vaccine can potentially lead to myocarditis, while introducing adenoviral vector to bloodstream can possibly result in thrombocytopenia and coagulopathy. These rare reactions were recorded in humans following the administration of the COVID-19 vaccines. Although the syringe aspiration may increase the level of pain at the injection site, it represents a simple technique to decrease the risk of vaccine introduction into the vascular system and potentially decrease the risk of severe reactions to mRNA and adenoviral vaccines. We are of the opinion that this cannot be disregarded if one considers that the COVID-19 vaccines will continue to be administrated globally in the form of initial and booster doses. Therefore, the aspiration when giving mRNA and adenoviral vaccines appears to be fully in line with the precautionary principle.”
Yet this appears to be the CDC opinion on the topic:
“Aspiration before injection of vaccines or toxoids (i.e., pulling back on the syringe plunger after needle insertion but before injection) is not necessary because no large blood vessels are present at the recommended injection sites, and a process that includes aspiration might be more painful for infants.”
If the mRNA vaccine is to be an IM Injection, isn’t it possible that, with poor syringe techniques, vaccine gets injected into a vessel, at least in part, with the resultant spike protein in the vascular system causing an inflammatory response that destroys the vascular endothelium eventually resulting in the Sudden Death effects we are seeing?
As always,
Best Regards
A Health Communications Specialist for the FDA’s Center for Biologics Evaluation and Research responded that the agency has “analyzed and evaluated safety and effectiveness data,” reassuring “the COVID-19 vaccines are not associated with sudden death.”
“The totality of the available scientific evidence continues to support FDA’s determination that the known and potential benefits of the Authorized COVID-19 Vaccines outweigh their known and potential risks,” the agency wrote in its reply.
The email dismisses the citizen’s concerns about intramuscular injection, saying the technique “is considered practice of medicine and the FDA does not have oversight of practice of medicine.”
Read their email to the concerned citizen below:
Thank you for your inquiry to the Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) regarding the COVID-19 vaccines. CBER, one of seven centers within FDA, is responsible for the regulation of biologically-derived products, including blood intended for transfusion, blood components and derivatives, vaccines, allergenic extracts, and cell, tissue and gene therapy products. We hope the following information will be helpful.
We appreciate the opportunity to provide accurate information about the COVID-19 vaccines, as it appears that you may have heard some inaccurate information. Please be assured that FDA is closely monitoring the safety of the COVID-19 vaccines that we have approved and authorized for emergency use. The U.S. government has a well-established post-authorization/post-approval vaccine safety monitoring infrastructure in place to meet the needs of a large-scale COVID-19 vaccination program. The U.S. government – in partnership with health systems, academic centers, and private sector partners – are using multiple existing vaccine safety monitoring systems to monitor COVID-19 vaccines in the post-authorization/approval period. Based on these multiple safety surveillance systems there is no link between sudden death in people and the COVID-19 vaccines. The technique for intramuscular administration of vaccines to people is considered practice of medicine and the FDA does not have oversight of practice of medicine, and we reiterate, the COVID-19 vaccines are not associated with sudden death.
In addition, the COVID-19 vaccines that FDA has approved and authorized for emergency use are supported by clinical trial data in which we analyzed and evaluated safety and effectiveness data to determine whether to approve or authorize the vaccines for emergency use in the United States.
Furthermore, the totality of the available scientific evidence continues to support FDA’s determination that the known and potential benefits of the Authorized COVID-19 Vaccines outweigh their known and potential risks.
Information on the COVID-19 vaccines that are approved and authorized for emergency use is available on our website at https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-vaccines.
We hope this information is helpful. If you have questions, please feel free to contact us at [email protected] or by phone at 1-800-835-4709.
This informal communication represents my best judgment at this time. It does not constitute an advisory opinion in accordance with 21 CFR 10.85, and does not necessarily represent the formal position of FDA or otherwise obligate the agency to the views expressed.
It’s unclear whether the agency’s response is a custom reply, or a boilerplate email being sent to people with similar inquiries.
The FDA’s claims the jabs are safe and effective have been countered by a slew of politicians, top scientists and medical professionals, including renowned cardiologist Dr. Peter McCullough who has laid blame for the increase in mass deaths squarely on the jabs.
It’s definitely interesting the agency is responding to citizens’ concerns about Covid vaccines, let alone addressing questions about links between the jabs and sudden deaths.
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