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Interim Report: Objective Safety Proof Rescinded

Day 3 · 3:40:31 · Dean Allison · Ken Drysdale · James Thorp

  • 📜 September 2023 interim report urged rescinding Food and Drug Regulation changes that permanently exempted COVID vaccines from objective proof of safety and efficacy.
  • 🔄 Drysdale says rules shifted from objective manufacturer proof to subjective 'may allow' ministerial comfort, mandatory acceptance if 'reasonable,' and a one-year bar on rescinding authorization.
  • 💰 He flags conflict of interest after government bought millions of doses of unapproved product then had to approve it, and questions welding emergency rules into permanent law for six-month-olds.

NCI interim recommendations on vaccine authorization rules.

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Transcript

Dean Allison · 3:40:31

You talked about an interim report, and this is very germane. So this, um, this interim report is September 14th, 2023. I actually think— I could be wrong— I, I thought it was a week before Health Canada approved the vaccine for kids, but maybe it's a week after.

Ken Drysdale · 3:40:50

No, it was two days.

Dean Allison · 3:40:51

Two days.

Ken Drysdale · 3:40:52

Two days after.

Dean Allison · 3:40:54

Okay.

Dean Allison · 3:40:54

But you had already— you guys had already written this interim report, and I just want you to speak to— you guys had four recommendations in an interim report released September 14th, 2023. And the first one is newly implemented revisions to the Food and Drug Regulations related to the authorization of COVID-19 vaccines must be rescinded as they permanently exempt COVID-19 vaccine from the requirement to objectively prove the safety and efficacy as required under the Food and Drug Regulations. Why was that an important—.

Ken Drysdale · 3:41:27

Well, the significant thing that happened, and it was, you know, I'll keep that to myself. What they did was they went into the Food and Drug Regulations and Before COVID the Food and Drug Regulations I would describe as having an objective text as to whether a drug is safe and effective, and it was on the manufacturers to prove that it was safe and effective objectively. They changed the regulation and they essentially turned it into a subjective review. And what's the difference? An objective, uh, uh, example might be 2+ 2= 4. That's objective. 2+ 2= 4. A subjective will be, how do you feel about 2+ 2= 4? So they changed it from objective to subjective. So the new regulation only required the manufacturers to submit enough information that may— would allow the Minister of Health to, to decide that it was safe, but not proved.

Ken Drysdale · 3:42:33

And if there was information missing, it would allow the manufacturer to submit that later. So they didn't have to prove safety and efficacy. And the other thing that this did is it created a huge, in my opinion, conflict of interest because the government then on the, on this basis started to import in all millions and millions and millions of, of, of dollars of, of this drug that wasn't approved. Okay, so think about that. The government spent millions and millions of dollars on a drug that wasn't approved, and they're expected to approve it later. You think if something goes wrong, they're gonna be able to say, well, you know, sorry, we spent all this money and we shouldn't have.

Dean Allison · 3:43:20

So this is a little bit of a preamble to this.

Ken Drysdale · 3:43:23

So during this emergency authorization, they changed that. They also forced the minister to accept the application as long as it would be reasonable to conclude that it was safe and effective. So it didn't say the minister may accept, it said must accept. And the last little part of that was it also removed the ability of the minister for a period of 1 year from rescinding the authorization. So the minister's hands were tied First, by the, in my opinion, conflict of interest. Second, by this must approve if he could reasonably make the assumption or reasonably come to the conclusion it was safe. And then the third would be because of— I just lost my train of thought. I'm sorry.

Dean Allison · 3:44:17

Well, no, that's, that's fine. And we're, you know, we've got to wrap it up for time reasons. But the interesting thing is, is at the time The four commissioners at the National Citizens Inquiry had heard more witnesses under oath than any other people in the world. That's correct. And then had been tasked with coming up with positive recommendations. But you guys felt compelled in September 2023, before the full report, to at least say, wait a second, we should put the brakes on this until safety and efficacy is proven. And obviously we're out of any crisis in 2023. Yes. So why not require proof of safety and efficacy?

Ken Drysdale · 3:44:56

Absolutely. And why weld this into the permanent regulation after the emergency had passed? It just didn't make any sense. And again, considering this was now going to go into children as young as 6 months old when there was pretty much a 0% risk to these children of the vaccine.

Dean Allison · 3:45:18

Thank you.

Dean Allison · 3:45:22

Any questions at all from my colleagues? Okay, Mr. Geisel, thank you for being here and thank you for that update and letting Canadians know of an additional resource that they have available to them. We appreciate you being here.

Ken Drysdale · 3:45:35

Thank you. Appreciate being able to be here.

James Thorp · 3:45:37

Thanks.