This is federal LAW for use of EUA products. Most of it is not being adhered to. You don’t have to go along if your boss breaks the law.

 https://www.law.cornell.edu/uscode/text/21/360bbb-3

21 U.S. Code § 360bbb–3 – Authorization for medical products for use in emergencies

(A)Required conditions

With respect to the emergency use of an unapproved product, the Secretary, to the extent practicable given the applicable circumstances described in subsection (b)(1), shall, for a person who carries out any activity for which the authorization is issued, establish such conditions on an authorization under this section as the Secretary finds necessary or appropriate to protect the public health, including the following:

(i)Appropriate conditions designed to ensure that health care professionals administering the product are informed

(I)

that the Secretary has authorized the emergency use of the product;

(II)

of the significant known and potential benefits and risks of the emergency use of the product, and of the extent to which such benefits and risks are unknown; and

(III)

of the alternatives to the product that are available, and of their benefits and risks.

(ii)Appropriate conditions designed to ensure that individuals to whom the product is administered are informed

(I)

that the Secretary has authorized the emergency use of the product;

(II)

of the significant known and potential benefits and risks of such use, and of the extent to which such benefits and risks are unknown; and

(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.

(iii)

Appropriate conditions for the monitoring and reporting of adverse events associated with the emergency use of the product.

(iv)

For manufacturers of the product, appropriate conditions concerning recordkeeping and reporting, including records access by the Secretary, with respect to the emergency use of the product.

Right now, vaccination forms are being given out that say “Vaccine informed Consent” but are nothing of the kind.  I got one from my local pharmacy, a preferred site for Covid vaccinations–probably because the pharmacists are incapable of discussing side effects with recipients and unlikely to know anything about EUA law.

The so-called Consent Form asks for your address, DOB, gender, allergies, pregnancy status, your doctor and his/her name and address, phone, your race, your ethnicity, your mother’s maiden name (in some states only), whether you want your doctor notified of your vaccination, and information about potential vaccine side effects from an earlier COVID vaccine dose.  That is it.  It provides NO information for you, and you have consented to nothing.

A legal informed consent must give you information about vaccine risks and benefits, what is known and unknown about the vaccine(s) and explain that you have a choice to accept or refuse the vaccine.  It must make sure you have a mechanism to report adverse reactions.  

This form provides none of that.  Instead, it elicits information from you that CDC wants, and mendaciously pretends to be giving you informed consent, so you think you have been given a legal process and so it never occurs to you that you have been cheated.

Because of the extremely broad liability shield given to all “program planners” in the PREP Act (the original text of the Act said “government program planners”) the CDC and its lawyers, who designed these documents and much of the vaccine rollout, think they will get away with pulling the wool over your eyes.

However, because they know what they are doing, and are trying to fool you, it is malfeasance aka willful misconduct–and the liability protection does not cover them for deliberate crimes like these.

——————

Pfizer confirms they are not providing any licensed product (National Library of Medicine announcement)

https://dailymed.nlm.nih.gov/dailymed/dailymed-announcements-details.cfm?date=2021-09-13

SEPTEMBER 13, 2021

Pfizer received FDA BLA license for its COVID-19 vaccine

Pfizer received FDA BLA license on 8/23/2021 for its COVID-19 vaccine for use in individuals 16 and older (COMIRNATY). At that time, the FDA published a BLA package insert that included the approved new COVID-19 vaccine tradename COMIRNATY and listed 2 new NDCs (0069-1000-03, 0069-1000-02) and images of labels with the new tradename.

At present, Pfizer does not plan to produce any product with these new NDCs and labels over the next few months while EUA authorized product is still available and being made available for U.S. distribution. As such, the CDC, AMA, and drug compendia may not publish these new codes until Pfizer has determined when the product will be produced with the BLA labels.

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