Before I continue with presenting my research, I would ask that you please be liberal with your approach to what I am about to share. I am not a lawyer and I am not proficient with the legalese surrounding the COVID-19 vaccines, law, and DoD regulations. With your knowledge and expertise, may we together discern fact and fiction.
Note: I have highlighted and commented on all pertinent information in attached PDFs. If not attached, then please search for the titled PDFs and reference the cited links.
The Secretary of Defense memorandum states:
"Mandatory vaccination against COVID-19 will only use COVID-19 vaccines that receive full licensure from the Food and Drug Administration (FDA), in accordance with FDA-approved labeling and guidance." (Please see attached. "Mandatory COVID Vaccination of DoD Service Members")
All COVID-19 vaccines that are "available" for vaccination in the USA are currently only issued EUA from the FDA.
EUA, Emergency Use Authorization, is: "Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), when the Secretary of HHS declares that an emergency use authorization is appropriate, FDA may authorize unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN threat agents when certain criteria are met, including there are no adequate, approved, and available alternatives." https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization
COVID-19 vaccines that are issued EUA will have their liabilities covered by the PREP Act: "The Public Readiness and Emergency Preparedness Act (PREP Act) authorizes the Secretary of Health and Human Services (the Secretary) to issue a Declaration to provide liability immunity to certain individuals and entities (Covered Persons) against any claim of loss caused by, arising out of, relating to, or resulting from the manufacture, distribution, administration, or use of medical countermeasures (Covered Countermeasures), except for claims involving “willful misconduct” as defined in the PREP Act."
"The PREP Act states that a “Covered Countermeasure” must be a “qualified pandemic or epidemic product,” or a “security countermeasure,” as described immediately below; or a drug, biological product or device authorized for emergency use in accordance with Sections 564, 564A, or 564B of the FD&C Act." https://www.federalregister.gov/documents/2020/03/17/2020-05484/declaration-under-the-public-readiness-and-emergency-preparedness-act-for-medical-countermeasures
COVID-19 vaccines that receive full licensure from the FDA, unlike EUA, will lack protections provided by the PREP Act, which is an important distinction when determining reparations for vaccine related injuries, an individual's risk-benefit ratio, and full informed consent.
On December 11, 2020, FDA issued the EUA for Pfizer-BioNTech COVID-19 Vaccine. Since then, the FDA issued several letters of authorization, LOA, to extend the EUA with the latest being on August 23, 2021. It was in the LOA that the COMIRNATY (COVID-19 Vaccine, mRNA) was approved the biologics license application (BLA), FDA's full approval. COMIRNATY (COVID-19 Vaccine, mRNA) is marketed as the brand name of the Pfizer-BioNTech COVID-19 Vaccine. One has full licensure while the other only has EUA and therefore still enjoys liability protection under the PREP Act.
"The licensed vaccine has the same formulation as the EUA-authorized vaccine and the products can be used interchangeably to provide the vaccination series without presenting any safety or effectiveness concerns. The products are legally distinct with certain differences that do not impact safety or effectiveness." https://www.comirnaty.com/ (Please see attached. "FDA-Letter-Final_Pfizer-LOA-to-issue-with-BLA-approval-08.23.21_v2" and "Final_EUA Fact sheet for Recipients - Pfizer-BioNTECH COVID-19 Vaccine")
It is very important to emphasize "legally distinct" concerning liabilities and legal protections. Although COMIRNATY (COVID-19 Vaccine, mRNA) and the Pfizer-BioNTech COVID-19 Vaccine may be used interchangeably, it is still "legally distinct".
"The Pfizer-BioNTech COVID-19 Vaccine vial label and carton labels are clearly marked for “Emergency Use Authorization.” The Pfizer-BioNTech COVID‑19 Vaccine is authorized to be distributed, stored, further redistributed, and administered by emergency response stakeholders when packaged in the authorized manufacturer packaging (i.e., vials and cartons), despite the fact that the vial and carton labels may not contain information that otherwise would be required under the FD&C Act." (Please see attached. "FDA-Letter-Final_Pfizer-LOA-to-issue-with-BLA-approval-08.23.21_v2")
Furthermore, COMIRNATY (COVID-19 Vaccine, mRNA) is not offered in the USA. BioNTech's headquarters is in Germany and COMIRNATY (COVID-19 Vaccine, mRNA) is currently only offered in Europe and possibly Australia.
"Although COMIRNATY (COVID-19 Vaccine, mRNA) is approved to prevent COVID-19 in individuals 16 years of age and older, there is not sufficient approved vaccine available for distribution to this population in its entirety at the time of reissuance of this EUA." (Please see attached. "FDA-Letter-Final_Pfizer-LOA-to-issue-with-BLA-approval-08.23.21_v2")
Even Vaccines.gov, which https://www.comirnaty.com/ homepage provides a link to, only show 3 possible EUA vaccines and locations that have it in stock to offer: https://www.vaccines.gov/search/
Therefore, DoD service members cannot fulfill the exact requirements of the Secretary of Defense's COVID-19 mandatory vaccination of COVID-19 vaccines that receive full licensure from the Food and Drug Administration (FDA).
If a DoD service member requests the COMIRNATY (COVID-19 Vaccine, mRNA) but was instead given the vaccine vial labeled Pfizer-BioNTech COVID‑19 Vaccine, then that service member is a victim of medical negligence, malpractice, and/or suffered serious personal injuries as a result of the negligence of a federal employee and may be able to bring a claim against a federal agency, like the Department of Veterans Affairs, the Department of the Army, the Department of the Navy, or the Department of the Air Force. This is considered medical treatment without full informed consent. https://nationaltriallaw.com/can-i-sue-the-army-navy-or-air-force/
If the COVID-19 vaccine mandate cannot be fulfilled then it could not and should not be enforced. Therefore, it would be, by extension, unnecessary to require invasive medical testing to screen for COVID-19 as an alternative to complying with the vaccine mandate. Also, according to the Safer Federal Workforce Task Force COVID-19 Workplace Safety: Agency Model Safety Principles document that was referenced in Force Health Protection Guidance (Supplement 23) - Department of Defense Guidance for Coronavirus Disease 2019 Vaccination Attestation and Screening Testing for Unvaccinated Personnel document, government agencies are not required to test their employees.
"With the government-wide adoption and implementation of these vaccination requirements, agencies are no longer required to establish a screening testing program for employees or onsite contractor employees who are not fully vaccinated, although they may do so." (Please see attached. "Safer Federal Workforce Task Force, COVID-19 Workplace Safety Agency Model Safety Principles, July 29, 2021")
Furthermore, if COVID-19 diagnostic testing is to continue then the agency may have to cover the costs of the COVID-19 test kits.
"Requirements for Obtaining Self-Collection Kits and Self-Tests
- COVID-19 self-tests must have Instructions for Use and FDA Approval, 510(K) clearance or have an FDA Emergency Use Authorization, and will be made available through the Defense Logistics Agency.
- Cost reporting for the purchase of testing materials or reimbursement for member tests should be in accordance with reference (h).
- Funding for COVID-19 testing: If self-collection kits or self-tests are not available: a. DoD Components are responsible for funding required COVID-19 screening tests. b. Each DoD Component will establish procedures to reimburse Service members and DoD civilian employees for COVID-19 screening tests that require payment for purposes of meeting the screening testing requirement (e.g., if the screening test is not available through the DoD Component and must be administered by a facility who charges for the test). c. For COVID-19 testing ofDoD contractor employees with CRA, DoD Components will offer COVID-19 testing similar to that offered to DoD civilian employees at the DoD Component's expense and at no cost to the employee or their employer." (Please see attached. "FHP Supp 23 DOD Guidance for COVID 19 vaccination attestation and screening")
Besides not having the option to be vaccinated with a fully licensed COVID-19 vaccine, I do not fully trust the vaccines, its manufacturers, mainstream media bias and misinformation, and censorship of opposing scientific studies and proven cheap and effective treatment of COVID-19 symptoms. Science is meant to be questioned, to be challenged. If such treatments were given any merit, then there will no longer be a need for the issued EUAs and no pressure to push for full licensure. I speculate that COMIRNATY (COVID-19 Vaccine, mRNA) will not be available until they successfully lobby for the same liability protections that EUA COVID-19 vaccines enjoy under the PREP Act and/or when they finalize their post marketing clinical trials possibly by 2024.
Pharmaceutical companies are habitual felons. Please excuse my use of Wikipedia. I have checked its cited sources: https://en.wikipedia.org/wiki/List_of_largest_pharmaceutical_settlements
I cannot, in good faith, convince myself or the people I care for into taking the COVID-19 vaccine without full informed consent and having answers to its many questions it requires. I may not always exercise or maintain the most healthy diet. I may not be a peak human specimen but with what little control I have in my life, I would like to be in control of what goes into my body.
I thank you very much for your time and I welcome everyone's expertise and insight.
Before I continue with presenting my research, I would ask that you please be liberal with your approach to what I am about to share. I am not a lawyer and I am not proficient with the legalese surrounding the COVID-19 vaccines, law, and DoD regulations. With your knowledge and expertise, may we together discern fact and fiction.
Note: I have highlighted and commented on all pertinent information in attached PDFs. If not attached, then please search for the titled PDFs and reference the cited links.
The Secretary of Defense memorandum states:
"Mandatory vaccination against COVID-19 will only use COVID-19 vaccines that receive full licensure from the Food and Drug Administration (FDA), in accordance with FDA-approved labeling and guidance." (Please see attached. "Mandatory COVID Vaccination of DoD Service Members")
All COVID-19 vaccines that are "available" for vaccination in the USA are currently only issued EUA from the FDA.
EUA, Emergency Use Authorization, is: "Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), when the Secretary of HHS declares that an emergency use authorization is appropriate, FDA may authorize unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN threat agents when certain criteria are met, including there are no adequate, approved, and available alternatives." https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization
COVID-19 vaccines that are issued EUA will have their liabilities covered by the PREP Act: "The Public Readiness and Emergency Preparedness Act (PREP Act) authorizes the Secretary of Health and Human Services (the Secretary) to issue a Declaration to provide liability immunity to certain individuals and entities (Covered Persons) against any claim of loss caused by, arising out of, relating to, or resulting from the manufacture, distribution, administration, or use of medical countermeasures (Covered Countermeasures), except for claims involving “willful misconduct” as defined in the PREP Act."
"The PREP Act states that a “Covered Countermeasure” must be a “qualified pandemic or epidemic product,” or a “security countermeasure,” as described immediately below; or a drug, biological product or device authorized for emergency use in accordance with Sections 564, 564A, or 564B of the FD&C Act." https://www.federalregister.gov/documents/2020/03/17/2020-05484/declaration-under-the-public-readiness-and-emergency-preparedness-act-for-medical-countermeasures
COVID-19 vaccines that receive full licensure from the FDA, unlike EUA, will lack protections provided by the PREP Act, which is an important distinction when determining reparations for vaccine related injuries, an individual's risk-benefit ratio, and full informed consent.
On December 11, 2020, FDA issued the EUA for Pfizer-BioNTech COVID-19 Vaccine. Since then, the FDA issued several letters of authorization, LOA, to extend the EUA with the latest being on August 23, 2021. It was in the LOA that the COMIRNATY (COVID-19 Vaccine, mRNA) was approved the biologics license application (BLA), FDA's full approval. COMIRNATY (COVID-19 Vaccine, mRNA) is marketed as the brand name of the Pfizer-BioNTech COVID-19 Vaccine. One has full licensure while the other only has EUA and therefore still enjoys liability protection under the PREP Act.
"The licensed vaccine has the same formulation as the EUA-authorized vaccine and the products can be used interchangeably to provide the vaccination series without presenting any safety or effectiveness concerns. The products are legally distinct with certain differences that do not impact safety or effectiveness." https://www.comirnaty.com/ (Please see attached. "FDA-Letter-Final_Pfizer-LOA-to-issue-with-BLA-approval-08.23.21_v2" and "Final_EUA Fact sheet for Recipients - Pfizer-BioNTECH COVID-19 Vaccine")
It is very important to emphasize "legally distinct" concerning liabilities and legal protections. Although COMIRNATY (COVID-19 Vaccine, mRNA) and the Pfizer-BioNTech COVID-19 Vaccine may be used interchangeably, it is still "legally distinct".
"The Pfizer-BioNTech COVID-19 Vaccine vial label and carton labels are clearly marked for “Emergency Use Authorization.” The Pfizer-BioNTech COVID‑19 Vaccine is authorized to be distributed, stored, further redistributed, and administered by emergency response stakeholders when packaged in the authorized manufacturer packaging (i.e., vials and cartons), despite the fact that the vial and carton labels may not contain information that otherwise would be required under the FD&C Act." (Please see attached. "FDA-Letter-Final_Pfizer-LOA-to-issue-with-BLA-approval-08.23.21_v2")
Furthermore, COMIRNATY (COVID-19 Vaccine, mRNA) is not offered in the USA. BioNTech's headquarters is in Germany and COMIRNATY (COVID-19 Vaccine, mRNA) is currently only offered in Europe and possibly Australia.
"Although COMIRNATY (COVID-19 Vaccine, mRNA) is approved to prevent COVID-19 in individuals 16 years of age and older, there is not sufficient approved vaccine available for distribution to this population in its entirety at the time of reissuance of this EUA." (Please see attached. "FDA-Letter-Final_Pfizer-LOA-to-issue-with-BLA-approval-08.23.21_v2")
Even Vaccines.gov, which https://www.comirnaty.com/ homepage provides a link to, only show 3 possible EUA vaccines and locations that have it in stock to offer: https://www.vaccines.gov/search/
Therefore, DoD service members cannot fulfill the exact requirements of the Secretary of Defense's COVID-19 mandatory vaccination of COVID-19 vaccines that receive full licensure from the Food and Drug Administration (FDA).
If a DoD service member requests the COMIRNATY (COVID-19 Vaccine, mRNA) but was instead given the vaccine vial labeled Pfizer-BioNTech COVID‑19 Vaccine, then that service member is a victim of medical negligence, malpractice, and/or suffered serious personal injuries as a result of the negligence of a federal employee and may be able to bring a claim against a federal agency, like the Department of Veterans Affairs, the Department of the Army, the Department of the Navy, or the Department of the Air Force. This is considered medical treatment without full informed consent. https://nationaltriallaw.com/can-i-sue-the-army-navy-or-air-force/
If the COVID-19 vaccine mandate cannot be fulfilled then it could not and should not be enforced. Therefore, it would be, by extension, unnecessary to require invasive medical testing to screen for COVID-19 as an alternative to complying with the vaccine mandate. Also, according to the Safer Federal Workforce Task Force COVID-19 Workplace Safety: Agency Model Safety Principles document that was referenced in Force Health Protection Guidance (Supplement 23) - Department of Defense Guidance for Coronavirus Disease 2019 Vaccination Attestation and Screening Testing for Unvaccinated Personnel document, government agencies are not required to test their employees.
"With the government-wide adoption and implementation of these vaccination requirements, agencies are no longer required to establish a screening testing program for employees or onsite contractor employees who are not fully vaccinated, although they may do so." (Please see attached. "Safer Federal Workforce Task Force, COVID-19 Workplace Safety Agency Model Safety Principles, July 29, 2021")
Furthermore, if COVID-19 diagnostic testing is to continue then the agency may have to cover the costs of the COVID-19 test kits.
"Requirements for Obtaining Self-Collection Kits and Self-Tests
COVID-19 self-tests must have Instructions for Use and FDA Approval, 510(K) clearance or have an FDA Emergency Use Authorization, and will be made available through the Defense Logistics Agency. Cost reporting for the purchase of testing materials or reimbursement for member tests should be in accordance with reference (h). Funding for COVID-19 testing: If self-collection kits or self-tests are not available: a. DoD Components are responsible for funding required COVID-19 screening tests. b. Each DoD Component will establish procedures to reimburse Service members and DoD civilian employees for COVID-19 screening tests that require payment for purposes of meeting the screening testing requirement (e.g., if the screening test is not available through the DoD Component and must be administered by a facility who charges for the test). c. For COVID-19 testing ofDoD contractor employees with CRA, DoD Components will offer COVID-19 testing similar to that offered to DoD civilian employees at the DoD Component's expense and at no cost to the employee or their employer." (Please see attached. "FHP Supp 23 DOD Guidance for COVID 19 vaccination attestation and screening") Besides not having the option to be vaccinated with a fully licensed COVID-19 vaccine, I do not fully trust the vaccines, its manufacturers, mainstream media bias and misinformation, and censorship of opposing scientific studies and proven cheap and effective treatment of COVID-19 symptoms. Science is meant to be questioned, to be challenged. If such treatments were given any merit, then there will no longer be a need for the issued EUAs and no pressure to push for full licensure. I speculate that COMIRNATY (COVID-19 Vaccine, mRNA) will not be available until they successfully lobby for the same liability protections that EUA COVID-19 vaccines enjoy under the PREP Act and/or when they finalize their post marketing clinical trials possibly by 2024.
Pharmaceutical companies are habitual felons. Please excuse my use of Wikipedia. I have checked its cited sources: https://en.wikipedia.org/wiki/List_of_largest_pharmaceutical_settlements
I cannot, in good faith, convince myself or the people I care for into taking the COVID-19 vaccine without full informed consent and having answers to its many questions it requires. I may not always exercise or maintain the most healthy diet. I may not be a peak human specimen but with what little control I have in my life, I would like to be in control of what goes into my body.
I thank you very much for your time and I welcome everyone's expertise and insight.