“COVID-19 Vaccines Are Not Associated with Sudden Death” – FDA Response to an American’s Concerns About COVID Vaccines
Every day Americans who had no record of medical issues are suddenly dropping dead. Many people believe these sudden deaths are due to the COVID vaccines.
Morbidity and mortality rates in working-age Americans are on the rise as these deaths continue. The Twitter thread in the below article provides information and examples of healthy individuals dropping dead and mortality and morbidity rates rising worldwide.
MUST SEE – Historic Increase in Working Class Disabilities and Deaths after COVID Vaccine Mandates – Athletes and Media Personalities Are Dropping Before Our Very Eyes (VIDEOS)
A concerned American shared with us that he sent the following email to the FDA discussing his concerns with the COVID Vaccine. Here is the letter:
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?
In response to the letter the Health Communications Specialist at the Center for Biologics Evaluation and Research in the Office of Communications, Outreach and Development at the U.S. Food and Drug Administration, provided the following response [emphasis added]:
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 firstname.lastname@example.org 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 is very difficult to believe that the totality of scientific evidence supports continuing with the COVID vaccines at this time. This is frightening coming from the FDA – the one organization that is mandated to protect Americans.
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