Canadians are constantly told that these gene therapy “vaccines” are safe, and have undergone strict testing in order to be allowed on the market. But what exactly are those standards? And is it normal practice to include a clause making authorization mandatory?
People should know that if the product injures or kills them, indemnification agreements prevent the manufacturers from getting sued. A vaccine injury compensation program was announced back in December, but appears to have gone nowhere.
As a reminder, Interim Authorization and Approval are quite different, and cannot be used interchangeably.
(a) Approved: Health Canada has fully reviewed all the testing, and steps have been done, with the final determination that it can be used for the general population
(b) Interim Authorization: deemed to be “worth the risk” under the circumstances, doesn’t have to be fully tested. Allowed under Section 30.1 of the Canada Food & Drug Act. Commonly referred to as an emergency use authorization.
If you read the inserts provided by Health Canada (see below), they will all claim to be “authorized under Section 5 of an Interim Order”. Fine, but what is that Order, and what does it actually say?
Issuance
5 The Minister must issue an authorization in respect of a COVID-19 drug if the following requirements are met:
(a) the applicant has submitted an application to the Minister that meets the requirements set out in subsection 3(1) or 4(2);
(b) the applicant has provided the Minister with all information or material, including samples, requested under subsection 13(1) in the time, form and manner specified under subsection 13(2); and
(c) the Minister has sufficient evidence to support the conclusion that the benefits associated with the drug outweigh the risks, having regard to the uncertainties relating to the benefits and risks and the necessity of addressing the urgent public health need related to COVID-19.
Several of these “vaccines”, and I use the term loosely, were given Interim Authorization under Section 5 of an Interim Order signed by Health Minister Patty Hajdu on September 16, 2020. The above criteria is all that is required.
Note: Section 5 starts out with “The Minister must” issue and authorization. It’s not that “The Minister should”, or “The Minister may” issue one, but the Minister MUST.
Also, the above requirements are not very strict. 3(1) or 4(2) must be met, along with 13(1) and 13(2). And all that’s needed is the very subjective standard that the “Minister has sufficient evidence to support the conclusion”. It doesn’t specify what, if any, standard there is. The Minister only needs to see is as “worth the risk” given the uncertainties there are.
It’s worth noting that Health Canada doesn’t do the testing themselves. Instead, they rely heavily on the documentation provided. Quite the trust system.
Application for authorization
3 (1) Subject to section 4, an application for an authorization in respect of a COVID-19 drug must be in a form established by the Minister and contain sufficient information and material to enable the Minister to determine whether to issue the authorization, including
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(a) the applicant’s name and contact information and, in the case of a foreign applicant, the name and contact information of their representative in Canada;
(b) a description of the drug and a statement of its proper name or its common name if there is no proper name;
(c) a statement of the brand name of the drug or the identifying name or code proposed for the drug;
a list of the ingredients of the drug, stated quantitatively;
(d) the specifications for each of the drug’s ingredients;
(e) a description of the facilities and equipment to be used in the manufacture, preparation and packaging of the drug;
(f) details of the method of manufacture and the controls to be used in the manufacture, preparation and packaging of the drug;
(g) details of the tests to be applied to control the potency, purity, stability and safety of the drug;
(h) the names and qualifications of all the investigators to whom the drug has been sold;
(i) a draft of every label to be used in connection with the drug, including any package insert and any document that (j) is provided on request and that sets out supplementary information on the use of the drug;
(k) a statement of all the representations to be made for the promotion of the drug respecting
(i) the recommended route of administration of the drug,
(ii) the proposed dosage of the drug,
(iii) the drug’s indications, and
(iv) the contra-indications and side effects of the drug;
(l) a description of the dosage form that is proposed for the sale of the drug;
(m) evidence that all test batches of the drug used in any studies conducted in connection with the application were manufactured and controlled in a manner that is representative of market production;
(n) in the case of a drug intended for administration to food-producing animals, the withdrawal period of the drug; and
(o) the known information in relation to the quality, safety and effectiveness of the drug.
About part (n), it says “administration to food-producing animals”. Are we to assume that livestock are going to be vaccinated with these substances at some point? Or are we repurposing drugs that were originally meant for them? That’s a bit unsettling.
Application for authorization – foreign drug
4 (1) An application for an authorization in respect of a COVID-19 drug may be based on a comparison to a foreign drug if the sale of the foreign drug is authorized by a foreign regulatory authority on the basis of information submitted to the authority in relation to the quality, safety and effectiveness of that drug.
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Content
(2) The application must be in a form established by the Minister and contain the following information and material:
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(a) the information and material described in paragraphs 3(1)(a) to (d), (f), (j) to (l) and, if applicable, (n);
(b) an attestation, signed and dated by an individual who has authority to bind the applicant in Canada, certifying that the applicant has access to the information referred to in paragraph 3(1)(o) that was submitted to the relevant foreign regulatory authority in order for the foreign drug to be authorized to be sold;
(c) information that demonstrates that the drug is identical to, and is manufactured, prepared and packaged in the same manner as, the foreign drug;
(d) information that demonstrates that the sale of the foreign drug is authorized by the foreign regulatory authority referred to in paragraph (b); and
(e) any labels that are approved by the foreign regulatory authority referred to in paragraph (b) for use in connection with the foreign drug.
Request for information or material
13 (1) The Minister may request that a person that has submitted an application for an authorization in respect of a COVID-19 drug or the holder of such an authorization provide any information or material, including samples, that is necessary to enable the Minister to determine whether to issue, amend or suspend the authorization.
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Time, form and manner
(2) The person or holder, as the case may be, must provide the information, material or samples in the time, form and manner specified by the Minister.
Section 3(1) lists what documentation needs to be submitted to get authorization. Section 4(2) contains a few extra steps for foreign drugs. Sections 13(1) and (2) state that information and samples must be provided if demanded.
The standard for Interim Authorization under Section 5 appears to be a fairly low one. Keep in mind, the Minister doesn’t even need to be certain the drugs work as advertised. It just has to be determined to be worth the risk. Not quite what we are told on the news.
As for the basis in the law, Section 30.1 of the Canada Food & Drug Act allows the Health Minister to sign such Orders, if it’s believed, (or claimed to be believed), it’s in the public interest. There is no requirement that the Minister have any appropriate education background, or know what he/she is talking about.
Circling back to the top of Section 5, the Health Minister “must issue an authorization” if the conditions in Section 5 are met?!?! So this isn’t discretionary? Our graphic designer Minister must sign off on this?
It’s also unsettling that this Order allows for drugs originally intended for livestock to be repurposed and tested on humans.
WHO Paper On MANDATORY Vaccination April 13, 2021 (Original)
WHO Paper On MANDATORY Vaccination April 13, 2021 (Copy)
Section 30.1 Canada Food & Drug Act
September 2020 Interim Order From Patty Hajdu
https://www.canada.ca/en/public-health/news/2020/12/government-of-canada-announces-pan-canadian-vaccine-injury-support-program.html
https://covid-vaccine.canada.ca/info/pdf/astrazeneca-covid-19-vaccine-pm-en.pdf
https://covid-vaccine.canada.ca/info/pdf/janssen-covid-19-vaccine-pm-en.pdf
https://covid-vaccine.canada.ca/info/pdf/covid-19-vaccine-moderna-pm-en.pdf
https://covid-vaccine.canada.ca/info/pdf/pfizer-biontech-covid-19-vaccine-pm1-en.pdf
Testing Product Insert AstraZeneca Interim Authorization
Testing Product Insert Janssen Interim Authorization
Testing Product Insert Moderna Interim Authorization
Testing Product Insert Pfizer Interim Authorization
Vaccines Supported For Pregnant Women, Despite No Testing
Vaccines Given “Interim Authorization”, Not Approval. Very Different
Call Centers Wrongly Telling People “Vaccines” Are Approved
Ontario Adds, Then Removes Protections Against “No Jab, No Job”
WHO April 13 Paper: Discussion On Mandatory “Experimental Vaxx”
