December 2020 | America’s Front Line Doctors |
AFLDS WHITE PAPER: CIVIL LIBERTIES SURROUNDING MEDICAL EXPERIMENTATION
THE CIVIL LIBERTIES & HUMAN RIGHTS IMPLICATIONS OF MANDATING COVID-19 VACCINE CANDIDATES
Informed Consent of Emergency Use Authorization Products
Since an Emergency Use Authorization (EUA) means the products are investigational and experimental only, products approved for emergency use are prohibited from being mandated by federal law, and an individual must consent to the use of the experimental product. An EUA is very specific: “…individuals to whom the product is administered are informed … of the option to accept or refuse the product …”6
21 U.S.C. §360bbb-3 “Authorization for medical products for use in emergencies”
- (e) (conditions of authorization)
- (1) unapproved product
- (A) required conditions
- (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
1. “The FDA has an obligation to ensure that recipients of the vaccine under an EUA are informed, to the extent practicable under 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.”7
At the regular August 2020 CDC Advisory Committee on Immunization Practices (ACIP) weekly meeting held at the CDC in Atlanta Georgia, the CDC-ACIP Executive Secretary Amanda Cohn, MD stated:8
“I just wanted to add that, just wanted to remind everybody, that under an Emergency Use Authorization, an EUA, vaccines are not allowed to be mandatory. So, early in this vaccination phase, individuals will have to be consented and they won’t be able to be mandated.” (Emphasis added) – p.4
Link To Document_AFLD_white paper_CIVIL LIBERTIES SURROUNDING MEDICAL EXPERIMENTATION