Global Vaccine Safety Summit from 2 to 3 December 2019
Prof Janice Graham, Dalhousie University, Canada
41:40 I’d like to bring a governance issue that hasn’t been really emphasized, it’s mentioned through a report, it’s just a sort of conflict of interest. 2.0 places the priority on addressing the rising thread of vaccine hesitancy. It locates the source of hesitancy on anti-vaccination groups and on the public knowledge deficit but neglects knowledge deficit surrounding safety data. The 2.0 neglects to propose governance guidelines for full transparency and disclosure all of the safety data. Including individual case report forms and authorization decision rationals. Without these data remains difficult and sometimes impossible for interdependent and even Cochrane reviewers to obtain the data needed to evaluate vaccines and vaccine components. Regulators often mistakenly believe that they need to protect the manufacturers’ claims of confidential business information. Which several legal scholars have contested. Is it possible for 2.0 to identify full data transparency, full data transparency and require release of all vaccine and vaccine components for interdependent appraisal? This word I’m really getting out is considering models, wider models of open science, for transparency.
Global Vaccine Safety Summit from 2 to 3 December 2019
Prof. Janice Graham, Dalhousie Universitetas, Kanada
41:40 Norėčiau iškelti valdymo problemą, kuri iš tikrųjų nebuvo akcentuojama, paminėta pranešime, tai tik tam tikras interesų konfliktas. 2.0 prioritetas skiriamas vis didėjančiam skiepų dėl vakcinų srautui. Jame surandama dvejonių dėl antivakcinavimo grupių ir visuomenės žinių stokos priežastis, tačiau neatsižvelgiama į žinių, susijusių su saugos duomenimis, trūkumą. 2.0 nepaisoma valdymo gairių pasiūlymo siekiant visiško skaidrumo ir visų saugos duomenų atskleidimo. Įskaitant atskirų atvejų ataskaitų formas ir sprendimo dėl autorizacijos principus. Be šių duomenų tarpusavio priklausomybėms ir netgi „Cochrane“ apžvalgininkams išlieka sunku ir kartais neįmanoma gauti duomenų, reikalingų vakcinoms ir jų dalims įvertinti. Reguliuotojai dažnai klaidingai mano, kad jiems reikia apsaugoti gamintojų teiginius dėl konfidencialios verslo informacijos. Kuris keletą teisės žinovų užginčijo. Ar 2.0 galima nustatyti duomenų skaidrumą, duomenų skaidrumą ir norint, kad tarpusavio vertinimas būtų atliekamas, reikia išleisti visas vakcinas ir vakcinos komponentus? Šis žodis, kurio aš tikrai išlošiu, dėl skaidrumo svarsto modelius, platesnius atvirojo mokslo modelius.
Farmacininkų ir medikų kontrolės įstaiga - CDC (Centers for Disease Control and Prevention) iš tiesų yra vakcinų kompanija, ne tik finansuojama įmonių, kurias turėtų kontroliuoti, bet gaunanti pajamas iš vakcinų pardavimo
51:17 We’re being told that 45 individuals, here it is -
Seattle gets first go at coronavirus vaccine testing
“The initial trial will need 45 healthy adults. Jackson said that no research participants will be given a placebo”<
What? Wait a minute. I thought we just heard Tony Fauci saying to us the gold standard for approving a pharmaceutical product, in the drug trial, you know, that they’re doing, he said, the gold standard is a Placebo based trial, yet with the vaccine, we’re not gonna use a Placebo? You see normally they get away with this and this is what it led me when I was thinking about Paul Offit and Peter Hotez, you see the problem I have? We are now all watching this. Because Of the work that we’we done with the Informed Action Network, because so many of you are sharing the firewire with your friends, you’re all alert to this now. You say wait a minute why aren’t they using a placebo? Especially right now. Even if the study that we know that study is only gonna last about four months. I’ve already pointed out, I don’t know how you’re going to establish safety? Forty-five people with a four-month study. There’ll be no look at long-term side effects. Autoimmune disease, future cancers, or the fact that once these people, if it acts, ends up, being like the animal trials or like RSB trials. What happens if you give these people the vaccine, they look perfectly good for months and then they walk out and they happen to run into somebody’s coronavirus, they get it and they die! Their body, you know, suffers from immune enhancement, they have an absolute, you know, meltdown, as a cytokine storm takes place in their body, which is what this thing can cause and they drop dead. Then what happens? And then I started thinking about the fact that, do you realize that, usually, you know, this stage one type of trial takes place out of sight, out of mind, is happening inside of a pharmaceutical clinic. They happen all the time. Most of them fail. Mostly drugs and vaccines don’t get out of those first trials, because really bad things go down. Now think what Hotez and Otten are thinking. This isn’t going to be good for the program if people watch. What if one of these forty-five people dies? What if ten of them get really sick? What if they all end up having massive upper respiratory problems? Then what are we going to do? How we going to explain that? I mean we could use all use our usual antics and say - “well, you know we didn’t have a placebo group, so it is natural that one of these people would die. Oh, you know, people get upper respiratory, there’s a cold going around, people get the flu, you know, yes they the flu, it happens.” They’ll try to explain it away. But never before has entire world been waiting with bated breath watching forty-five people entering a stage one trial. I think that’s what’s got Paul Offit and Peter Hotez really nervous. The pharmaceutical industry has never, ever wanted to try and do something like this under a microscope. They like being left alone. They like having time to figure out what their talking points are. Are we going to know who these forty-five people are? And better yet. I think we really ought to talk about these individuals. Because in my mind they are making gigantic sacrifice. For us, for whatever this coronavirus is, no matter how deadly it is, or is not. What we know is that attempts at this vaccine have been deadly in animal models. Have been deadly, you know, we know, that RSV killed children we know that Dengue vax killed children, we know that people die. And even though, you’re only testing this on perfectly healthy people. Right? And so, what are we gonna even learn from that? I mean 45 healthy people? We know that healthy people tend to not have any symptoms or very mild symptoms anyway. Why aren’t we testing this on the elderly that seemed to have extreme reactions? Why aren’t they the ones being tested on? Since they’re the ones that need it most? See all these questions should be asked, but what we know is we going to go and get 45 extremely healthy individuals and give them the vaccine that after animal trials there were massive warnings saying - be very, very careful moving forward with human trials. You even heard Hotes say that - it was so devastating what happened with RSV that we bailed out even attempting to create am RSV vaccine. What Bill Gates is working on right now, that should make everybody happy that he’s returning to the cause, but they’d given up on it. Coronavirus is not an easy vaccine. Coronavirus, as they have said with common cold - there’s no cure for the common cold. You have to assume they’ve been attempting for a very, very, very long time to make a Coronavirus vaccine and now, suddenly they’re going to rush into stage one trials. My question is this - these 45 people that are signing up for what appears to be as dangerous to me as being astronauts heading to Mars for the very first time. There is a gigantic risk here for these people. Are they getting informed consent? Are they being told that in animal models there were animals that died and there’s been a lot of warning to say we had to be very careful? Are they being told that that’s the case in this trial?
56:40 I hope so, but I do really want to commend those 45 people that are taking this on and I want to thank you for your service because this is an extremely risky trial and we will all be watching every single step as it unfolds.