Notice at the 2:50 mark of the video below, the pharmacist opens one of the vaccine inserts provided by the pharmaceutical companies to the pharmacies that is supposed to provide safety and efficacy information for the COVID-19 vaccines only to discover that it is blank. He furtively throws the insert into the trash and nervously explains that he is going to have to go online to get the information. Wow!
The COVID-19 vaccines are experimental vaccines that are “authorized” for emergency use but they are NOT “approved” by the FDA. They have not been demonstrated to be safe or effective. The essence of the EUA standard is that the known and potential benefits of the COVID-19 vaccines when used to prevent COVID-19 outweigh their known and potential risks.
That benefit vs. risk analysis is very low. It allows for a vaccine to be used before the trials for safety and effectiveness are completed. The safety and effectiveness are being monitored. That means that all who get a COVID-19 vaccine are taking part in an experiment to determine the safety and effectiveness of the COVID-19 vaccines. They are unwitting test subjects.
It is unconscionable to trick people into receiving an experimental vaccine. To not inform a person that he is taking part in an experiment violates the Nuremberg Code, which requires that “the voluntary consent of the human subject is absolutely essential” before they take part in a medical experiment.
The Nuremberg Code requires that the consent be knowing consent. The person must be informed that he is taking part in an experiment involving the COVID-19 vaccine that has not been demonstrated to be safe or effective. But the COVID-19 vaccine test subjects are not being told this. Indeed, they should be told that the vaccine manufacturers are so unsure of the safety and effectiveness of the vaccine, the test subjects will be monitored to determine if they suffer any dangerous side effects from the experimental vaccine. But nobody is being told this.
The gravamen of the Nuremberg Code has been adopted as the law in the United States under 45 C.F.R. § 46.111, et seq. and 21 C.F.R. § 50.20, et seq. Section 50.20 states:
Except as provided in §§ 50.23 and 50.24, no investigator may involve a human being as a subject in research covered by these regulations unless the investigator has obtained the legally effective informed consent of the subject or the subject’s legally authorized representative.
21 U.S. Code § 360bbb–3 provides, in pertinent part, that when an unapproved medical product is authorized for emergency use, the product may be administered provided that the following conditions are met:
(ii) Appropriate conditions designed to ensure that individuals to whom the product is administered are informed—
(II) of the significant known and potential benefits and risks of such use, and of the extent to which such benefits and risks are unknown; and
(III) of the option to accept or refuse administration of the product, of the consequences, if any, of refusing administration of the product, and of the alternatives to the product that are available and of their benefits and risks.
The FDA has taken the official position that compliance with the above statutory requirements is sufficient to dispense with the need to obtain informed consent from the EUA vaccine recipient. The FDA alleges:
Although informed consent as generally required under FDA regulations is not required for administration or use of an EUA product, section 564 [21 U.S. Code § 360bbb–3] does provide EUA conditions to ensure that recipients are informed about the MCM [Medical Countermeasure] they receive under an EUA.
The FDA further states:
FDA must ensure that recipients of the vaccine under an EUA are informed, to the extent practicable given the applicable circumstances, that FDA has authorized the emergency use of the vaccine, of the known and potential benefits and risks, the extent to which such benefits and risks are unknown, that they have the option to accept or refuse the vaccine, and of any available alternatives to the product. Typically, this information is communicated in a patient “fact sheet.” The FDA posts these fact sheets on our website.
Customers cannot give informed consent because the pharmaceutical companies are purposely keeping the patients ignorant about the safety and efficacy studies performed by the pharmaceutical companies. The pharmacist admitted that the customers are being given a “truncated” fact sheet that does not contain all of the safety and efficacy studies and information. The customers are NOT being fully informed. And, indeed, the safety and efficacy information is NOT provided to the pharmacies administering the vaccines as evidenced by the blank vaccine insert.
The COVID-19 vaccine program is not being administered in accord with the FDA’s watered-down informed consent requirement of providing a fact sheet containing “the significant known and potential benefits and risks of such use.”
While the pharmacist indicates that patients are being given truncated fact sheets, I question whether that is truly being done. One proof of that is that when the woman asked for the vaccine insert, the pharmacy worker could not provide even the patient fact sheet to the woman and had to call on the pharmacist to assist the lady. Furthermore, this writer has spoken with many persons who have received the COVID-19 vaccine. And none of those to whom I have spoken received a COVID-19 vaccine fact sheet. It seems that the common practice is that customers are not being given the required “fact sheet.”
The pharmaceutical companies are even keeping the pharmacies ignorant of the safety and efficacy of the vaccines so that they cannot inform their customers. They provide the pharmacies with a blank fact sheet! Thus, the COVID-19 vaccine program seems to be illegally administered.
Furthermore, President Biden’s vaccine mandate violates the statutory requirement that the patient be given “the option to accept or refuse administration of the product.”
The pharmacist in the video admits that customers receiving the COVID-19 vaccine are not giving full information upon which to make informed consent as required by law for all experimental drugs being administered under emergency use. The pharmacist could not cite any study upon which he based his opinion that the COVID-19 vaccines are safe and effective. Upon realizing the illegality and immorality of the COVID-19 vaccine program, the pharmacist stated that he could no longer advocate taking the vaccine.
Informed consent means the patient is fully informed about the potential dangers and benefits of the vaccine and then voluntarily agrees to take part in the medical experiment. Informed consent means that the patient has the option to decline to participate in the administration of the vaccine.