§360bbb–3. Authorization for medical products for use in emergencies
(b) Declaration of Emergency or Threat Justifying Emergency Authorized Use
(1) In General
The Secretary may make a declaration that the circumstances exist justifying the authorization under this subsection for a product on the basis of-
(A) a determination by the Secretary of Homeland Security that there is
a domestic emergency, or
a significant potential for a domestic emergency,
involving a heightened risk of attack
with a biological, chemical, radiological, or nuclear agent or agents;
(B) a determination by the Secretary of Defense that there is
a military emergency, or
a significant potential for a military emergency,
involving a heightened risk to United States military forces, including personnel operating under the authority of title 10 or title 50,
of attack with-
(i) a biological, chemical, radiological, or nuclear agent or agents; or
(ii) an agent or agents that may cause, or are otherwise associated with, an imminently life-threatening and specific risk to United States military forces;
(C) a determination by the Secretary that there is
a public health emergency, or
a significant potential for a public health emergency,
that affects, or has a significant potential to affect,
national security or the health and security of United States citizens living abroad, and
that involves a biological, chemical, radiological, or nuclear agent or agents, or a disease or condition that may be attributable to such agent or agents; or
(D) the identification of a material threat pursuant to section 319F–2 of the Public Health Service Act [42 U.S.C. 247d–6b] sufficient to affect national security or the health and security of United States citizens living abroad.
(2) Termination of Declaration
(A) In General
A declaration under this subsection shall terminate upon the earlier of-
(i) a determination by the Secretary, in consultation as appropriate with the Secretary of Homeland Security or the Secretary of Defense, that the circumstances described in paragraph (1) have ceased to exist; or
(ii) a change in the approval status of the product such that the circumstances described in subsection (a)(2) have ceased to exist.
(B) Disposition of Product
If an authorization under this section with respect to an unapproved product ceases to be effective as a result of a termination under subparagraph (A) of this paragraph, the Secretary shall consult with the manufacturer of such product with respect to the appropriate disposition of the product.
(c) Criteria for Issuance of Authorization
The Secretary may issue an authorization under this section with respect to the emergency use of a product only if, after consultation with the Assistant Secretary for Preparedness and Response,
the Director of the National Institutes of Health, and
the Director of the Centers for Disease Control and Prevention
(to the extent feasible and appropriate given the applicable circumstances described in subsection (b)(1)),
the Secretary concludes-
(1) that an agent referred to in a declaration under subsection (b) can cause a serious or life-threatening disease or condition;
(2) that, based on the totality of scientific evidence available to the Secretary, including data from adequate and well-controlled clinical trials, if available, it is reasonable to believe that-
(A) the product may be effective in diagnosing, treating, or preventing-
(i) such disease or condition; or
(ii) a serious or life-threatening disease or condition caused by a product authorized under this section, approved or cleared under this chapter, or licensed under section 351 of the Public Health Service Act [42 U.S.C. 262], for diagnosing, treating, or preventing such a disease or condition caused by such an agent; and
(B) the known and potential benefits of the product, when used to diagnose, prevent, or treat such disease or condition, outweigh the known and potential risks of the product, taking into consideration the material threat posed by the agent or agents identified in a declaration under subsection (b)(1)(D), if applicable;
(3) that there is no adequate, approved, and available alternative to the product for diagnosing, preventing, or treating such disease or condition;
(4) in the case of a determination described in subsection (b)(1)(B)(ii), that the request for emergency use is made by the Secretary of Defense; and
(5) that such other criteria as the Secretary may by regulation prescribe are satisfied.
(d) Scope of Authorization
An authorization of a product under this section shall state-
(1) each disease or condition that the product may be used to diagnose, prevent, or treat within the scope of the authorization;
(2) the Secretary's conclusions, made under subsection (c)(2)(B), that the known and potential benefits of the product, when used to diagnose, prevent, or treat such disease or condition, outweigh the known and potential risks of the product; and
(3) the Secretary's conclusions, made under subsection (c), concerning the safety and potential effectiveness of the product in diagnosing, preventing, or treating such diseases or conditions, including, to the extent practicable given the circumstances of the emergency, an assessment of the available scientific evidence.
(e) Conditions of authorization
(1) Unapproved Product
(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.
(B) Authority for Additional Conditions
With respect to the emergency use of an unapproved product, the Secretary may, 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 on which entities may distribute the product with respect to the emergency use of the product (including limitation to distribution by government entities), and on how distribution is to be performed.
(ii) Appropriate conditions on who may administer the product with respect to the emergency use of the product, and on the categories of individuals to whom, and the circumstances under which, the product may be administered with respect to such use.
(iii) Appropriate conditions with respect to collection and analysis of information concerning the safety and effectiveness of the product with respect to the use of such product during the period when the authorization is in effect and a reasonable time following such period.
(iv) For persons other than 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.
(g) Review and Revocation of Authorization
(1) Review
The Secretary shall periodically review the circumstances and the appropriateness of an authorization under this section.
As part of such review, the Secretary shall regularly review the progress made with respect to the approval, conditional approval under section 360ccc of this title, licensure, or clearance of-
(A) an unapproved product for which an authorization was issued under this section; or
(B) an unapproved use of an approved product for which an authorization was issued under this section.
(2) Revision and Revocation
The Secretary may revise or revoke an authorization under this section if-
(A) the circumstances described under subsection (b)(1) no longer exist;
(B) the criteria under subsection (c) for issuance of such authorization are no longer met; or
(C) other circumstances make such revision or revocation appropriate to protect the public health or safety.
A. Per CDC
1) People aged under 70 have >99% survival rate
2) 40% of infected would be asymptomatic i.e. have immunity!
B. Per Studies: https://c19ivermectin.com
3) COVID is treatable - there are so many options to choose from
The jab s/b
-only b for ppl at risk (<1% popn)
-decided on individual risk v benefit
Per the CDC's "COVID-19 Pandemic Planning Scenarios"
Under "Scenario 5: Current Best Estimate"
Infection fatality ratio
ie Estimated number of deaths per 1,000,000 infections:
0–17 years old: 20 or 0.002%
18–49 years old: 500 or 0.05%
50–64 years old: 6,000 or 0.6%
65+ years old: 90,000 or 9.0%
1 People aged < 65 have infection fatality ratio of < 1%
2 30% of infected w/b asymptomatic
& others mildly affected -ie we have immunity!
Per Studies: https://ivmmeta.com
3 Covid is v. curable
The jab s/b
-only for ppl at risk (<1% population)
-decided on individual risk v benefit
EUAs for the vax may have been justifiable
but only for people at risk (<1%) (ie 99% should be excluded!)
IF
1) cures: none at the time of the EUA
2) benefits > risks
3) each at risk person allowed to decide w their doctor
AND Post-EUA, (1) & (2) are reported to inform (3)
Post-EUA
1) Vax Passport: jab is forced on the 99% not at risk
No one is allowed any choice
2) Effective cures actively suppressed
3) Adverse effects (incl. on people not at risk) suppressed
The EUA is no longer justifiable!
Stop forcing the jabs on everyone!
StopTheAgenda!
there doesn't seem to be anything here