Consent and Exemptions

Consent
The US Version of the Nuremburg Code
"An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. The information that is given to the subject or the representative shall be in language understandable to the subject or the representative."
Source: Code of Federal Regulations, Title 21 Subpart B: "Informed Consent of Human Subjects"
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=50&showFR=1&subpartNode=21:1.0.1.1.20.2
https://archive.ph/1Sbz6
Universal Declaration on Bioethics and Human Rights
http://portal.unesco.org/en/ev.php-URL_ID=31058&URL_DO=DO_TOPIC&URL_SECTION=201.html
https://archive.ph/o9wXt
Review the Ethical Considerations in Pandemic Plans from the WHO, UK, and others
You can’t sue Pfizer or Moderna if you have severe COVID vaccine side effects. The government likely won’t compensate you for damages, either.
https://www.cnbc.com/2020/12/16/covid-vaccine-side-effects-compensation-lawsuit.html
https://archive.ph/xRu8U
Lawyers are saying they won't take your case to sue vaccine manufacturers for a vaccine injury, as they're completely protected.
https://www.reuters.com/legal/government/black-hole-covid-vaccine-injury-claims-2021-06-29/
https://archive.ph/43PZg
Legal Conditions of Emergency Use Authorization
"(ii) Appropriate conditions designed to ensure that individuals to whom the product is administered are informed—(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."
Source: 21 U.S. Code § 360bbb–3 - Authorization for medical products for use in emergencies
https://www.law.cornell.edu/uscode/text/21/360bbb-3
https://archive.ph/0jkIj
"the statute requires that FDA ensure that recipients are informed to the extent practicable given the applicable circumstances:
"-That FDA has authorized emergency use of the product;
"-Of the significant known and potential benefits and risks associated with the
emergency use of the product, and of the extent to which such benefits and risks are
unknown;
"-That they have the option to accept or refuse the EUA product and of any
consequences of refusing administration of the product; and
"-Of any available alternatives to the product and of the risks and benefits of available
alternatives."
2017-01: Emergency Use Authorization of Medical Products and Related Authorities: Guidance for Industry and Other Stakeholders
https://www.fda.gov/media/97321/download
https://web.archive.org/web/20190917050449/https://www.fda.gov/media/97321/download
"Organizations, such as hospitals, with licensed products do have capability of asking their workers to get the vaccine. But in the setting of an EUA, patients and individuals will have the right to refuse the vaccine."
2020-10-22: Dr. Amanda Cohn, Executive Secretary of the CDC’s Advisory Committee on Immunization Practices, at the FDA's Center for Biologics Evaluation and Research 161st Vaccines and Related Biological Products Advisory Committee Meeting
https://www.fda.gov/media/143982/download
https://web.archive.org/web/20201130131854/https://www.fda.gov/media/143982/download
"Dr. Cohn reminded everyone that under an EUA, vaccines are not allowed to be mandatory. Therefore, early in the vaccination phase individuals will have to be consented and cannot be mandated to be vaccinated."
2020-08-26: CDC Advisory Committee on Immunization Practices Summary Report
https://www.cdc.gov/vaccines/acip/meetings/downloads/min-archive/min-2020-08-508.pdf
https://web.archive.org/web/20210227142416/https://www.cdc.gov/vaccines/acip/meetings/downloads/min-archive/min-2020-08-508.pdf
"This is a much tougher one, I think, than we had expected coming into it. The data show that this vaccine works and it’s pretty safe …. And yet, we’re worried about a side effect that we can’t measure yet, but it’s probably real. And we see a benefit that isn’t the same as it is in older age groups," he said.
Dr. Eric Rubin, adjunct professor of immunology and infectious diseases at Harvard University, editor-in-chief of the New England Journal of Medicine, and member of a FDA committee which voted for emergency use authorization of the mRNA vaccines
"Dr. Eric Rubin on why he voted to approve Pfizer's vaccine for emergency use"
https://www.boston25news.com/news/dr-eric-rubin-why-he-voted-approve-pfizers-vaccine-emergency-use/5d26f16f-ef3e-4dc9-b0d9-afc313f63bed/
2021-10-21: Advisory Committee on Immunization Practices (ACIP), COVID-19 Vaccine Safety Updates
https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2021-10-20-21/06-COVID-Shimabukuro-508.pdf
https://web.archive.org/web/20211206140042/https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2021-10-20-21/06-COVID-Shimabukuro-508.pdf
https://www.politifact.com/article/2021/nov/01/context-never-going-learn-how-safe-vaccine-unless-/
https://archive.ph/dIjsS
https://rwmalonemd.substack.com/p/were-never-going-to-learn-about-how
https://archive.ph/QHSx7
Operation Warp Speed
"Operation Warp Speed (OWS)—a partnership between the Departments of Health and Human Services (HHS) and Defense (DOD)—aimed to help accelerate the development of a COVID-19 vaccine."
"some clinical trial phases overlapped with each other and with animal studies to accelerate development"
2021-02: Operation Warp Speed: Accelerated COVID19 Vaccine Development Status and Efforts to Address Manufacturing Challenges, Report to Congressional Addressees
https://www.gao.gov/assets/gao-21-319.pdf
https://web.archive.org/web/20210308195652/https://www.gao.gov/assets/gao-21-319.pdf
Timeline of Operation Warp Speed
https://populartimelines.com/timeline/Operation-Warp-Speed
https://archive.ph/yntFG
COVID-19 Vaccine Milestones
https://www.hhs.gov/coronavirus/covid-19-vaccines/index.html
https://archive.ph/Q5Nsk
Operation Warp Speed Trials Outline
https://media.defense.gov/2020/Aug/12/2002475961/-1/-1/1/WARP-SPEED-VACCINE-TIMELINE.PDF
https://web.archive.org/web/20210812221839/https://media.defense.gov/2020/Aug/12/2002475961/-1/-1/1/WARP-SPEED-VACCINE-TIMELINE.PDF
Anthony Fauci testimony at a Senate Health, Education, Labor & Pensions Committee hearing: "We predict that sometime by the end of this year, let's say November or December, we will know whether or not these are safe and effective. . . Early studies in animals and in human Phase 1 and Phase 2 indicate that individuals induce a response that is comparable to, if not better, than natural infection . . . Right now, doses of this vaccine are being produced so they'll be ready to be distributed."
2020-09-23: Fauci 'cautiously optimistic' about coronavirus vaccine approval by end of 2020
https://www.foxnews.com/politics/coronavirus-vaccine-timeline-dr-fauci-covid-19
https://archive.ph/q6gv4
“I know many pin their hopes on a vaccine—but let’s be clear: there is no panacea in a pandemic. A vaccine alone cannot solve this crisis; certainly not in the near term.”
2020-09: Secretary-General António Guterres, First Access to COVID-19 Tools (ACT) Accelerator Facilitation Council Meeting
https://www.un.org/sg/en/content/sg/statement/2020-09-10/secretary-generals-remarks-the-first-access-covid-19-tools-%28act%29-accelerator-facilitation-council-meeting-delivered
https://archive.ph/Y4S0Y
2020-03-20: President Donald Trump declares a national emergency
https://trumpwhitehouse.archives.gov/presidential-actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/
https://web.archive.org/web/20210120155452/https://www.whitehouse.gov/presidential-actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/
"[Operation Warp Speed ] is the most remarkable achievement in modern medicine, made possible by following the model of the World War II mobilization effort."
2021-02-01: Why Operation Warp Speed Worked, Wall Street Journal
https://www.wsj.com/articles/why-operation-warp-speed-worked-11612222129
https://archive.ph/2jSF5
"Instead of entering into contracts directly with vaccine makers, more than $6 billion in Operation Warp Speed funding has been routed through a defense contract management firm called Advanced Technologies International, Inc. ATI then awarded contracts to companies working on COVID-19 vaccines."
"As a result, the contracts between the pharmaceutical companies and ATI may not be available through public records requests, and additional documents are exempt from public disclosure for five years."
"Vaccine contracts awarded this way include $1.6 billion for Novavax, $1.95 billion for Pfizer, $1.79 billion for Sanofi and $1 billion for Johnson & Johnson."
2020-09-29: How Operation Warp Speed's Big Vaccine Contracts Could Stay Secret, NPR
https://www.npr.org/sections/health-shots/2020/09/29/917899357/how-operation-warp-speeds-big-vaccine-contracts-could-stay-secret
https://archive.ph/m10oy
Additional info: https://childrenshealthdefense.org/news/operation-warp-speed-cia-linked-contractor-covid-vaccine/
https://archive.ph/ePwni
EUA Documents and Fact Sheets
Pfizer-BioNTech EUA
https://www.fda.gov/media/144413/download
https://web.archive.org/web/20201212022810/https://www.fda.gov/media/144413/download
"Under the EUA, it is your choice to receive or not receive the vaccine. Should you decide not to receive it, it will not change your standard medical care."
Source: Pfizer Fact Sheet for Recipients and Caregivers
https://labeling.pfizer.com/ShowLabeling.aspx?id=14472&format=pdf
https://web.archive.org/web/20210211204640/http://labeling.pfizer.com/ShowLabeling.aspx?id=14472&format=pdf
Moderna EUA
https://www.fda.gov/media/144637/download
https://web.archive.org/web/20201219003854/https://www.fda.gov/media/144637/download
"It is your choice to receive or not receive the Moderna COVID-19 Vaccine. Should you decide not to receive it, it will not change your standard medical care."
Source: Moderna Fact Sheet for Recipients and Caregivers
https://www.modernatx.com/covid19vaccine-eua/eua-fact-sheet-recipients.pdf
https://web.archive.org/web/20201219064013/http://www.modernatx.com/covid19vaccine-eua/eua-fact-sheet-recipients.pdf
"All descriptive printed matter, advertising, and promotional material relating to the use of the Pfizer-BioNTech COVID‑19 Vaccine clearly and conspicuously shall state that: This product has not been approved or licensed by FDA, but has been authorized for emergency use by FDA, under an EUA to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 16 years of age and older; and The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner. "
2021-05-10: CDC EUA Letter to Ms. Harkins
https://www.fda.gov/media/144412/download
https://web.archive.org/web/20201212022704/https://www.fda.gov/media/144412/download
Related New Zealand FOIA Request
https://fyi.org.nz/request/14712-appropriate-vaccine-warnings
https://archive.md/Oee1J
New Zealand's answer: https://fyi.org.nz/request/14712/response/55283/attach/html/4/H2021001468%20V.Crawford%20Response.pdf.html
https://archive.ph/THDBt
Exemptions
America's Front Line Doctors: Do Not Quit Your Job
https://americasfrontlinedoctors.org/do-not-quit-your-job/
https://archive.md/zssjK
America's Front Line Doctors: Religious Exemptions
https://americasfrontlinedoctors.org/religious/
https://archive.md/aYaW3
COVID Vaccine Religious Exemption Documents for College Students, Military, Employees
https://news.gab.com/2021/07/29/important-download-covid-vaccine-religious-exemption-documents-here/
https://archive.md/JEpUs
Employee Letter Example
https://novaxmandate.org/letter
https://archive.md/XSmEl
Do the COVID-19 vaccines contain aborted fetal cells?
"Pfizer and Moderna did perform confirmation tests (to ensure the vaccines work) using fetal cell lines. And Johnson & Johnson uses fetal cell lines in vaccine development, confirmation and production."
2021-08-18: You asked, we answered: Do the COVID-19 vaccines contain aborted fetal cells?, Nebraska Medicine
https://www.nebraskamed.com/COVID/you-asked-we-answered-do-the-covid-19-vaccines-contain-aborted-fetal-cells
https://archive.md/Hqzos
The Moral Right to Conscientious, Philosophical and Personal Belief Exemption to Vaccination
https://www.nvic.org/informed-consent.aspx
https://archive.ph/nUuvw
Legal information about vaccine exemption status state by state. Know your rights in your state before you approach an employer.
https://www.ncsl.org/research/health/school-immunization-exemption-state-laws.aspx
https://archive.ph/29EO7
Vaccine Attorneys
List of Vaccine Attorneys
https://app.box.com/s/fq9xl1d869ceigpcjxl9yu9cn2j2oqtp
https://web.archive.org/web/20211001164037/https://app.box.com/s/fq9xl1d869ceigpcjxl9yu9cn2j2oqtp
A list of law firms you may call if you believe your rights are being infringed upon by your employer, school, college, or any group that discriminates against you for not complying with their vaccine or mask mandates.
*Advocates For Faith and Freedom: https://faith-freedom.com/
*Alliance Defending Freedom: https://adflegal.org/about-us
*American Center for Law and Justice: https://aclj.org/
*Center for Law and Religious Freedom: https://www.clsreligiousfreedom.org/about-center
*Christ Forgiveness Ministries: https://christsforgivenessministries.org/vaccinations/
*Christian Attorneys of America: https://christianattorneysofamerica.com/
*Christian Law Association: https://www.christianlaw.org/
*Christian Legal Society: https://www.christianlegalsociety.org/
*Liberty Counsel: https://lc.org/
*Liberty Institute: https://www.libertyinstitute.org/about/faq
*National Association of Christian Lawmakers: https://christianlawmakers.com/
*National Legal Foundation: https://nationallegalfoundation.org/
*Pacific Justice Institute: https://www.secure.pacificjustice.org/site/SPageNavigator/contact_us.html
*Pacific Legal Foundation: https://pacificlegal.org/
*Thomas More Law Center: https://www.thomasmore.org/
*Thomas More Society: https://thomasmoresociety.org/
Other Groups with Helpful Resources
*https://americasfrontlinedoctors.org
*https://childrenshealthdefense.org
*https://doctors4covidethics.org/
*https://dreddymd.com
*https://www.c19vaxreactions.com
*https://medpagetoday.com
*https://vaccineimpact.com
Ontario Civil Liberties Association
https://ocla.ca/a-letter-to-the-unvaccinated/
https://archive.ph/iclBQ
Category:COVID-19 Pandemic
Category:Consent and Exemptions
Category:Legal