The public is clamoring for a vaccine before coming out of lockdown and quarantine. Many new vaccines are under development and will reportedly receive licensure from the Food & Drug Administration. By law, any medical intervention requires informed consent.
Informed consent is legally defined by the Title 21 of the Code of Federal Regulations for any medical treatment offered to you that includes:
- Opportunity to opt out of vaccination (refuse immunization) without penalties or recrimination.
- Alternatives to vaccination, if any.
- Privacy (confidentiality) so immunization will not be used against you.
- Knowledge of known risks involved and any proposed benefits
Other provisions in a consent form should include:
- A copy of the consent form to take home
- Name of vaccine manufacturer, type of vaccine, lot number
- Number needed to vaccinate to prevent 1 COVID-19 infection; the number needed to vaccinate to prevent 1 COVID-19 related death
- Information on whether the vaccine was approved by comparison with an inactive placebo or comparison with an existing vaccine.
- Opportunity to refuse a waiver of liability in cases of malpractice
- List of health factors that predispose you to a poor response to vaccination
- Acknowledgment the vaccine you are about to receive has been rushed to market and has not undergone customary testing
- Concession that all the side effects posed by a new vaccine will not be known until months or years after the vaccine is licensed and approved for use by the Food & Drug Administration. The vaccine you receive may be recalled at a later date.
- Assurance by your health practitioner who administers the vaccine that in his/her assessment of you as an individual that the proposed benefits of the vaccine exceed known side effects.
Protect yourself and your loved ones. An 18-page model consent form has been written by investigative health journalist Bill Sardi and legally reviewed by The National Health Federation (NHF) and is available for $12.95 (shipping included). The consent form is intended for vaccine candidates to bring to their healthcare providers. Proceeds go towards the NHF legal defense fund. Send your check or money order, payable to Knowledge of Health, 1502 Foothill Blvd., Suite 103, La Verne, CA 91750. Or order online at https://covid19consent.com
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