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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 speci c: “...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 bene ts and risks, the extent to which such bene ts
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)
6 https://www.law.cornell.edu/uscode/text/21/360bbb-3
7 https://www.eeoc.gov/wysk/what-you-should-know-about-covid-19-and-ada-rehabilitation-act-and-other-eeo-laws
https://youtu.be/p0zCEiGohJs?t=4420.
“Under an emergency use authorization and EUA Vaccines are not allowed to be mandatory so early in this vaccination phase individuals will have to be consented and they wont be able to be mandated.”
Minute 1:14:40
8
Businesses are Not Shielded from Liability with Experimental Agents
Employers are not shielded from liability like pharmaceutical companies when it comes
to an experimental agent. In 2005, Congress enacted the PREP Act. The PREP Act
authorizes the Secretary of the U.S. Department of Health and Human Services to
issue a PREP Act declaration in response to a public health emergency. “On March 10,
2020 the Secretary of HHS made a public health emergency declaration for COVID-19,
which makes the PREP Act’s protections applicable to the COVID-19 pandemic.” 10 A
PREP Act declaration provides immunity from tort liability claims (except willful
misconduct) to individuals or organizations involved in the manufacture, distribution, or
dispensing of medical countermeasures. Although pharmaceutical companies are not
liable (unless willful misconduct), the PREP Act does not shield employers or
businesses as “covered persons” and should they attempt to mandate vaccination,
they may be liable for resulting harm.” The Covid-19 vaccines are emergency use
products, and as such, as not fully licensed, the law is clear: States may not mandate
the vaccines, and private entities may do so only at the peril of violating federal law. 11
9
https://www.nap.edu/read/2138/chapter2
The Public Readiness and Preparedness Act (PREP): What you need to know – Minnesota Dept. of Health
(state.mn.us)
10
Under Federal Law, Can Your Employer Make You Get the COVID Vaccine?