Know Your Rights under the Emergency Use Authorization: Request a Consent Form Before Taking the COVID Vaccine
Not providing informed consent is a violation of human rights.
An Emergency Use Authorization (EUA) under Section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act)1 allows for the special use of drugs and other medical products during certain types of emergencies.2 The EUA authority was added by the Project BioShield Act of 2004, which amended the FD&C Act, among other things.
As of March 2012, Congress is in the process of reauthorizing the Pandemic and All-Hazards Preparedness Act (PAHPA). The U.S. House and Senate have adopted their own versions of reauthorizing legislation, both of which provide greater flexibility for HHS and FDA to approve the use of medical products in emergencies but differ in some specific provisions. Congress is likely to convene a conference committee to reconcile the differences between the bills. The legislation ultimately passed may affect Section 564 and other provisions of the FD&C Act as described below. Please see ASTHO EUA Current Issues Winter 2012 for more information about reauthorization and its potential impact on EUAs and related issues. (Download a printable PDF.)
Conditions of Authorization—The FDA may establish conditions on the use of a product under an EUA. For unapproved products, FD&C Act §564 requires the FDA commissioner (to the extent practicable given the circumstances of the emergency) to establish certain required conditions on an EUA that the commissioner finds necessary or appropriate to protect public health and permits the commissioner to establish other conditions that he or she finds necessary or appropriate to protect public health.
Such conditions include:
A requirement to disseminate information (e.g., fact sheets) to healthcare professionals or authorized dispensers and prospective patients or other consumers regarding the EUA, the product’s significant known and potential benefits and risks, and the extent to which such benefits and risks are unknown.
Available alternatives and their benefits and risks.
For prospective patients and consumers, the option to accept or refuse the product, any consequences of refusal, and alternatives to the product.
Other conditions such as restricted advertising, distribution, and administration; adverse event reporting and monitoring; data collection and analysis; recordkeeping and records access; and compliance with Current Good Manufacturing Practice (CGMP)
All of the above represents important information that you should know before being pressured into taking the covid vaccine under the guise of the EUA. Share it with everyone you know.
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