On February 27, 2021, the Superintendent of the Los Angeles Unified School District (LAUSD), Austin Buetner, sent out an email containing the following order to his employees: “Please Schedule an Appointment to Receive a COVID-19 Vaccination.”
That is a direct order from the superintendent to his LAUSD employees to schedule an appointment to receive a COVID-19 vaccination.
It is clear that the superintendent intends the vaccine as a requirement for teachers and staff. U.S. News and World Report reported on January 12, 2021, that L.A. School District Superintendent Austin Buetner stated that once a coronavirus vaccine is widely available for children, immunization will be required for students in Los Angeles to attend classes, the district’s superintendent.
KCRW reported on February 4, 2021, that “LA Unified School District and United Teachers Los Angeles (UTLA) both say schools can’t reopen until teachers are vaccinated. But the Centers for Disease Control and a group of local pediatricians disagree.”
Los Angeles Daily News, on February 8, 2021, reported that “[t]he superintendent [Austin Beutner] has maintained that three things must happen for schools to reopen: COVID-19 cases must come down in the county, schools must have proper safety protocols in place and staff who work on campuses must be vaccinated.”
In the email itself, the superintendent states: “Vaccinating school staff is a critical part of reopening school campuses in the safest way possible.” The superintendent views school staff vaccination as “critical” to reopening schools. Clearly, the superintendent intends to convey that LAUSD teachers and other staff are required to get vaccinated when he said in the email: “Please Schedule an Appointment to Receive a COVID-19 Vaccination.”
That order in the email was the first sentence in the email and placed in bold typeface. The superintendent’s order violates the Nuremberg Code and Federal law.
The Los Angeles Unified School District (LAUSD) has selected the Moderna COVID-19 vaccine.
The Moderna COVID-19 vaccine fact sheet for vaccine providers explicitly states that:
INFORMATION TO PROVIDE TO VACCINE RECIPIENTS/CAREGIVERS
As the vaccination provider, you must communicate to the recipient or their caregiver, information consistent with the “Fact Sheet for Recipients and Caregivers” (and provide a copy or direct the individual to the website www.modernatx.com/covid19vaccine-eua to obtain the Fact Sheet) prior to the individual receiving the Moderna COVID-19 Vaccine, including:
• FDA has authorized the emergency use of the Moderna COVID-19 Vaccine, which is not an FDA-approved vaccine.
• The recipient or their caregiver has the option to accept or refuse the Moderna COVID-19 Vaccine.
• The significant known and potential risks and benefits of the Moderna COVID-19 Vaccine, and the extent to which such risks and benefits are unknown.
• Information about available alternative vaccines and the risks and benefits of those alternatives.
Id. at 4 (emphasis added)
Why is Moderna saying that the recipient of the vaccine should be told that they have the option of accepting or refusing the vaccine? Because the vaccine is an investigational vaccine (i.e., experimental vaccine).
The Moderna COVID-19 vaccine (and all COVID-19 vaccines) are unapproved vaccines. The FDA has not approved any COVID-19 vaccines. The Moderna recipient fact sheet explicitly admits:
The COVID-19 vaccines are being administered to the public on what is known as an Emergency Use Authorization (EUA) by the FDA. The gravamen 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.
While the COVID-19 vaccines have been authorized for emergency use, they remain experimental vaccines. As experimental vaccines, they cannot be required by an employer or the government. Indeed, any person who offers a vaccine under an EUA must obtain informed consent from the recipient before administering the experimental vaccine. To require someone to take part in any medical experiment is a violation of the Nuremberg Code.
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 in pertinent part:
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.
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.
Where did the FDA come up with that? It is required by the EUA statute. While the statute offers a watered-down informed consent requirement; it nonetheless requires informed consent for experimental vaccines being administered under an EUA. The FDA acknowledges that it is not exempt from the Federal law that requires a watered-down informed consent for an EUA under 21 U.S. Code § 360bbb–3, which is the law governing the emergency use authorizations of experimental vaccines. That statute requires the following before administration of a vaccine under an EUA:
Appropriate conditions designed to ensure that individuals to whom the product is administered are informed—
(I) that the Secretary has authorized the emergency use of the product;
(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.
21 U.S. Code § 360bbb–3(e)(1)(A)(i) (emphasis added)
The FDA thinks that providing a fact sheet to the recipients of the COVID-19 vaccines is sufficient. “Therefore, FDA recommends that a request for an EUA include a “Fact Sheet” for recipients that includes essential information about the product.”
Below are the recipient fact sheets provided by each of the vaccine manufacturers.
Basically, the patient is given a fact sheet from each manufacture. Notice that dodge in the Moderna COVID-19 vaccine fact sheet. The fact sheet asks the following question: “ARE OTHER CHOICES AVAILABLE FOR PREVENTING COVID-19 BESIDES MODERNA COVID-19 VACCINE?” Notice that the question only goes to prevention. There is no mention of treatment.
This is the Moderna answer to that question: “Currently, there is no FDA-approved alternative vaccine available for prevention of COVID-19. Other vaccines to prevent COVID-19 may be available under Emergency Use Authorization.” Moderna does not address the question about “other choices” for preventing COVID-19. Moderna limits the response only to vaccines. There is no mention of hydroxychloroquine, ivermectin, or other safe and effective treatment and prevention alternatives. The Pfizer-BioNtech fact sheet contains the same misinformation.
The FDA is reading the statutory requirements under 21 U.S. Code § 360bbb–3 for the administration of an unapproved MCM under an EUA as a waiver of the otherwise required informed consent. There is nothing in the statute that allows for that interpretation. Indeed, it seems that the requirements under 21 U.S. Code § 360bbb–3 for the administration of a vaccine under an EUA are in addition to, and not in lieu of, the informed consent requirements found at 45 C.F.R. § 46.111, et seq. and 21 C.F.R. § 50.20, et seq.
Regardless of the FDA’s interpretation of the EUA vaccine makers’ informed consent obligations, neither the FDA nor the vaccine makers are exempt from the Federal law that requires informed consent for an EUA contained in the EUA statute itself. Indeed, 21 U.S. Code § 360bbb–3, which is the law governing the emergency use authorizations of experimental vaccines requires informed consent that is more limited than in the federal regulations on informed consent for medical experiments, but the statute nonetheless requires certain information be provided to the patient prior to vaccination and the patient has the option of withdrawing consent and refusing to be vaccinated. The statute, 21 U.S. Code § 360bbb–3(e)(1)(A)(i), requires informed consent.
The COVID-19 vaccine is not like other MCMs. A vaccine is always administered to a healthy person. The person is not receiving the experimental COVID-19 vaccine to treat a disease. They are receiving the vaccine in the hope it will prevent a disease. Thus, all who receive an experimental vaccine to prevent disease are by definition taking part in a medical experiment for which they should be given notice so that they can in turn give informed consent.
To the extent that the LAUSA order to “[p]lease Schedule an Appointment to Receive a COVID-19 Vaccination” is taken as mandating a vaccine for which there is any adverse employment consequence for refusal to take the vaccine violates the federal informed consent requirement in 21 U.S. Code § 360bbb–3(e)(1)(A)(i).
The email sends the LAUSD employees to the following informational video from Johns-Hopkins about the COVID-19 vaccines.
The Johns-Hopkins video starts right out with a falsehood. It states that “mRNA vaccines … are now approved to prevent COVID-19.” That is just plain false. The fact sheets from both Moderna and Pfizer-BioNtech state explicitly that their vaccines are “unapproved.” And “there is no FDA-approved vaccine to prevent COVID-19.”
“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.“ Pfizer-BioNTech COVID-19 Vaccine Fact Sheet.
“The Moderna COVID-19 Vaccine is an unapproved vaccine that may prevent COVID-19. There is no FDA-approved vaccine to prevent COVID-19.“ Moderna COVID-19 Vaccine Fact Sheet.
The COVID-19 Vaccines are not approved by the FDA as being safe and effective. The COVID-19 vaccines are experimental vaccines, which are only “authorized” by the FDA under an alleged medical emergency. The COVID-19 vaccines are being administered to the public on what is known as an Emergency Use Authorization (EUA) by the FDA.
The LAUSD employees are being hoodwinked into believing that the COVID-19 vaccine with which they are being injected is an FDA approved vaccine to which they must submit. In fact, the COVID-19 vaccine being pushed on the LAUSD employees is an experimental vaccine that is NOT approved by the FDA.
So far, the vaccines have proven to be ineffective in preventing COVID-19. This ineffectiveness was known by the FDA at the outset. Read this author’s analysis of how Moderna falsely showed effectiveness of their vaccine in the article at the following link.
Indeed, because the experimental COVID-19 vaccines have been proven ineffective in preventing COVID-19 the manufacturers and the FDA are changing the criterion for measuring effectiveness. You can still be infected with COVID-19 after being vaccinated. Thus, they are now claiming that the COVID-19 vaccines are only effective in reducing symptoms of COVID-19.