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I'm Charles Covess, I'm your moderator.

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I am wearing my red jacket because I am Australasia's passion provocateur.

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Red is the colour of passion.

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Sam, I love you in your lovely red top, looks very impressive.

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So I'm about passion people here on this call.

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Passionate, this is medical doctors for COVID ethics.

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There are lots of professionals here for those of you who don't know, welcome particularly

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if this is your first time.

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There are doctors, retired doctors, lawyers, philosophers.

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Leo from Borneo will call him a gosh naturalist and explorer of animals.

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He's an expert on primates.

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Leo, you are our only primates expert.

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We've got journalists, philosophers, troublemakers and people from lots of countries around the world.

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So welcome.

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We are here in a true spirit of exploration and discovery.

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And most of us understand that we're in World War Three, although Jerry Brady would say

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that we're in the ongoing continuation of World War Two.

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This is not just a medical science conversation.

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Charles, we've got Craig Bartekuper from Central Africa as well.

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Well, no, he's from the UK, I think, but he's in Central Africa.

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Central Africa, we've got sometimes Finland, Norway, Czech Republic.

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So we go for two and a half hours quite strictly and Russia.

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And we have a telegram.

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Stephen?

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Russia.

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Yes, Russia and any other.

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Put your word, if any country you haven't mentioned, please put in the chat, because

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I love the fact that we are a global group.

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The number of people who come here is anything from 40 to 140.

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It depends on people's timetables, but they know that they can get a recording.

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A lot of people ask for recordings afterwards.

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We do record.

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We do record this because it's a valuable learning experience.

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We don't have censorship.

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This is a free speech environment, because, as you all know, the beginning of the end

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of freedom is the end of free speech.

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But we have proper moderation.

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And that means that because we're in a tight time frame of two and a half hours,

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where I make sure that you're efficient with your questions and your comments.

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It is not censorship when I say we're moving on to the next speaker.

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That's proper moderation.

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And if we try to apply the rules of parliament, you can say something once,

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but it's not an ongoing debate, generally speaking.

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That's what that's what we try to do.

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Now, the other big thing in science is please become aware of your beliefs,

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because some heated debates happen, which is fantastic, because I'm all about passion.

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But your beliefs are not necessarily true for each one of us.

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And we hold on to beliefs.

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And it's holding on to these beliefs that causes the conflict.

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Now, we're here in science.

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We are here to discover.

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There are so many challenges that we've got to overcome.

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That's why we're here.

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And an important principle, we come from love, not fear.

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We are here because we're putting our lives on the line by not accepting the narrative.

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Stephen has done that.

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I certainly do it.

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And fear is a shitty way to live.

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That's my principle.

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Fear is a shitty way to live.

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And Dr. Lee Vleet on her Truth for Health Foundation is running a wonderful weekly

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programme on resilience.

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And it's all about let go of fear.

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And this twice a week is your opportunity to not be driven by fear and have an open mind.

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And they're the ground rules for this group.

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We are medical doctors for Covid ethics.

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So hopefully we behave ethically.

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So Meryl Nass, now I'm not going to introduce you, Meryl, because we always let our presenters

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introduce themselves and tell us what you would like.

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We're delighted to have you here.

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And thank you for addressing us.

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And over to you.

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Hi, some people know me.

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I am an internal medicine doctor and I was the sort of lead doctor in the fight against

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anthrax vaccine mandates, which began about 25 years ago and has been ongoing to an

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extent ever since.

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Now, so I was very aware of what was going on in the bio defence vaccine field.

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And in the late 1990s, when President Clinton was our president, it was claimed that he

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read a book that scared him about biological warfare and decided to create programmes that

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would defend Americans against biological warfare threats.

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And he started buying up, you know, I think these were boondoggles and that the area of

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bioterrorism was basically a new frontier.

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America is all about new frontiers, like Australia.

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And so if you can claim that something is a bioterrorism threat, there is no limit on

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what you need to defend against it.

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That could be vaccines, drugs, it could be for one person or it could be for three hundred

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and thirty four million Americans.

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And so you can spend an awful lot of money on preparing for bioterrorism.

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So this started during the Clinton regime and then it and and in fact, the military

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had a plan to develop up to seventy five vaccines for biological warfare threats.

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When Bush, the second, took over in 2001, he continued this, particularly after 9-11

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and the anthrax letters.

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So the anthrax letters were sort of a watershed moment.

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And Congress then allocated about seven billion dollars a year for preparing for for pandemics

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and bioterrorism.

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And we've been living with the results ever since.

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So the first slide I got is a bill that was passed by Congress in 2003.

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It's the Bioshield Act.

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And so this was a way to provide emergency use authorized or, in other words, unlicensed,

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not particularly well looked at, not not well evaluated, very little regulatory action on

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But you could still use them in an emergency because of this law.

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And so that this was the start.

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And next slide.

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There were three authorities, as I said, relaxing regulatory requirements, guaranteed, you know,

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a guaranteed market.

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That's very important for the pharmaceutical industry.

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They have that for children's vaccines as well, and they had it for COVID.

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And then permitting the use of unapproved countermeasures using a very low bar for approval.

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Next slide.

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So I'm telling you this to give you a flavor, give you the background of how our Congress

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and our president look at pandemics and biological threats.

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They look at them as an opportunity to spend money while guaranteeing their constituents

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that they're protecting them, but actually, you know, getting contracts to their friends

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and potentially we don't, I can't prove this, you know, funneling money back into campaign

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coffers, because there's a lot of money involved in these products.

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So what did we know about monkeypox before 2022?

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The first case ever identified in any kind of animal was only 1958, which is rather remarkable.

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First human case, 1970.

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There was very little outside of Africa.

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In the United States, the first human cases occurred in 2003 as a result of a variety

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of rodents, different kinds of rodents that had been transferred from Ghana to become

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pets and they were housed close to other animals in an American warehouse for pets.

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And some of the prairie dogs and other animals then developed this same virus.

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And I'm just going to assume it's a virus for now because I'm not getting into the discussion

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of whether viruses exist.

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But they caught something which we're calling monkeypox.

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So people in the pet business and also people who purchased these infected animals developed

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monkeypox.

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There were 47 cases.

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Every single case had a connection to an infected animal.

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So while it's possible there was secondary spread from human to human, none could be

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absolutely identified.

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And in Africa it was also thought that it rarely, there was rare secondary spread from

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person to person.

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In the West, up until 10 days ago, there were no deaths reported at all associated with

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monkeypox.

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And I'm saying associated with rather than due to deliberately.

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So as of today, there have been five deaths associated with monkeypox in the West that

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were reported and four reported in Nigeria during this year.

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Of the five deaths in the West, two, the one from Peru that was only reported yesterday,

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apparently they're saying this person died from an underlying condition.

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The one in Brazil was a 41 year old with lymphoma, which is cancer.

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Presumably that person also died of their underlying condition, primarily.

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The other three in the West and the four in Nigeria, we don't know anything about underlying

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conditions or what they died or who they were, what they died from.

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Curiously, so there had been a clade identified in West Africa, primarily in Nigeria and Central

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Republic and the country between them.

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And another clade in what was Zaire and is now Democratic Republic of the Congo.

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And it was said, but there really wasn't much data to back up any of this, that the Congo

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monkeypox caused 10% mortality and the Nigerian monkeypox caused 1% mortality.

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But you have to realize that in Africa it was really impossible to distinguish monkeypox.

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They did not have PCRs from other things, particularly chickenpox, but potentially other

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illnesses.

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So those data are not really reliable about mortality rates.

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Most of the deaths reported in Africa were in children and usually when children die

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it's because of dehydration or other secondary consequences when they don't have access to

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fluids or modern medical care.

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According to the New England Journal, in Africa monkeypox was mostly due to hunting, skinning,

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preparing infected animals.

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Just the way we get Lyme disease here, if you shoot a deer or a moose and prepare the

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carcass you're lucky to get a case of Lyme disease as a result.

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And of course we don't call Americans who go deer hunting bushmeat eaters, but that

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is the way we like to define Africans.

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Next slide.

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So in four and a half years, all the slides that are dark blue that look kind of like

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this are CDC slides which I've adapted mostly from a talk that was given to the advisory

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committee on immunization practices at the end of June.

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So CDC said in terms of cases in the west of monkeypox, in four and a half years there

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were only nine cases identified.

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There was apparently secondary spread.

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So three cases, one health care worker and two family members did develop monkeypox from

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an initial case.

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The initial cases all were thought to have a connection to Africa or to an infected animal.

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The two cases in the US were people who had just flown in from Nigeria.

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When the CDC says no flight contacts because most of these people had just traveled back

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home to their country from Africa and nobody on the flights got monkeypox as far as we

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know.

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Next slide.

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So there have been three, in the United States and probably in most of the world, there have

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been only three available vaccines for smallpox.

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We used the New York Department of Health strain which brand name was Dryvax for many

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years that's probably what I received.

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It was made by scraping the virus onto the belly of calves and then collecting the pus

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and developing the vaccine from that pus.

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There were multiple viral strains.

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It was considered a very dirty vaccine and it was considered the most reactogenic both

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local and systemic reactions.

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It was claimed to kill one in a million babies that got it but that number could well have

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been higher and caused a lot of reactions in adults.

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So the vast majority of people who got this vaccine felt ill afterwards.

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And currently the CDC actually admits on its website that one in 100 people who received

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this vaccine developed myocarditis or pericarditis.

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So the United States had a large stockpile of this frozen and they decided to throw it

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away again at the end of the Clinton, beginning of the Bush administrations and get something

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more safe and potentially better in other ways.

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So the first contract went to a startup company, a canvas, and they just basically plucked

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one strain out of this multi strain mess of the New York Department of Health's vaccine

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and they grew it and they could make cheap vaccine.

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It cost about $3 a dose and they made a huge stockpile for the United States of about 300

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million doses.

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However, it wasn't acknowledged at the time.

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So in 2003, the United States decided to make war on Iraq for the second time.

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And in the run up to that war, there was a lot of posturing by the United States about

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the threat of biological warfare from Iraq, particularly smallpox and anthrax.

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Now I don't know what strain of smallpox Iraq may have had or strains, but I can tell you

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that one anthrax strain they had was actually sold to them by the United States by the American

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type culture collection, which at the time was located in Manassas, Virginia.

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They had to get permission from the, what's it called, from one of the federal agencies,

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the Department of Commerce.

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And this was an anthrax strain that the United States had weaponized for use in World War

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II.

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So we actually had a company in Indiana, Terrahot, making cattle cakes made of this strain of

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anthrax for potential use on Germany during World War II.

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That's the strain we sold to Iraq.

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So we knew they had something that was a killer strain for anthrax.

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And again, I don't know what they had for smallpox, but the United States government

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decided, and it's not clear how this was decided, they decided they would vaccinate at least

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10 million Americans against smallpox in 2003.

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So if you can remember, smallpox was eradicated from the planet around 1977.

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It was reported at that time by the WHO there was no more smallpox.

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Ring vaccinations had succeeded and many countries had already ceased vaccinating their children

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for smallpox because there were so little of it, only a few cases popping up in the

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world for that last 10 years.

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But the United, and it was such a dangerous vaccine, why would you want to use it?

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However, the US government decided they were going to start vaccinating people and they

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had some of this ACAM2000 and so they began vaccinating people.

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And immediately people started getting ill and there were a bunch of heart attacks, episodes

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of myocarditis, heart failure and other problems.

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And there was no program to, because this was at the time, I think it was still unlicensed,

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but it did get a license around that time.

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There was no federal program for paying people who were injured by the vaccine.

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So they only got about 30,000 doctors, nurses and first responders to accept the vaccine

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because word got out quickly of all the problems and the program died in 2003, 2004.

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Now, this entity, BARDA, had been set up to distribute money from Project Bioshield and

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other money that was allocated by Congress.

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So they settled on a newer vaccine, which now is called JYNNEOS, then it was called

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Modified Vaccinia Anchora, based on a non or poorly replicating virus, the vaccinia virus.

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Now, I haven't figured out how you can make a live virus that doesn't replicate, but

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apparently you can or it doesn't replicate very much.

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And this was felt to be in terms of acute local and systemic reactions, it was a lot

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less reactogenic than the ACAM2000 or the dry-vax New York strain.

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And so BARDA and later other federal agencies started putting lots of money into this vaccine

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after the Akanbus had already made their billion on the ACAM2000 vaccine.

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But it turned out there were a lot of problems with this one too, which I would say the federal

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government has been loath to acknowledge because they've spent so much damn money on

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these things and they don't care, they want to get these into arms.

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So right now the US has a supply of both these two, the ACAM2000, lots of vaccine, and the

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JYNNEOS, and we'll talk about how much they have later.

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Next slide.

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Coming.

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Thank you.

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All right, change the subject.

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The current monkeypox has apparently too many mutations compared to what you would expect

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for a double-stranded DNA virus because the current strain in the West is fairly close

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to a strain that was isolated in 2008 in Israel, Singapore, and the UK, I think the UK in 2009.

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So it's thought that this current strain is derived in some way from that one, but it's

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too different to, some people say, to have changed naturally, but others say that no,

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it underwent accelerated adaptation to humans and they have come up with some arguments

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which I don't, I'm not a virologist, I can't comment on those arguments, but what I can

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comment on is the fact that two of the people who are pushing the natural origin of the

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current monkeypox are known for having pushed the natural origin of COVID or SARS-CoV-2.

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Andrew Rambeau, who signed the original article that Tony Fauci had encouraged to be written

263
0:23:19 --> 0:23:27
in early February of 2020 to say that it didn't make sense, it couldn't have been a lab origin

264
0:23:27 --> 0:23:35
for COVID, and Michael Waraby, who has written subsequently about the natural origin of COVID

265
0:23:35 --> 0:23:38
most recently in Science Magazine.

266
0:23:38 --> 0:23:44
And both these two guys, by the way, also had challenged Ed Hooper, who wrote the book

267
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The River, about the origin of AIDS being likely from a polio vaccine made on monkey

268
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kidneys.

269
0:23:54 --> 0:24:00
They challenged that origin story as well a couple of decades ago.

270
0:24:00 --> 0:24:07
So I think they are professional naysayers who the system uses.

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Next slide.

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0:24:08 --> 0:24:20
I don't know if John Lukasz is talking about my obfuscating, but I hope not.

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This is simply a very curious thing that, as you know, before the COVID pandemic, there

274
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was a tabletop exercise to plan how to deal with a coronavirus outbreak.

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And before this monkeypox outbreak last year, there was also a tabletop exercise.

276
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And it wasn't just some little thing.

277
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This was really a big deal.

278
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Ernest Moniz is the head of the Nuclear Threat Initiative, former Secretary of Energy, former

279
0:24:59 --> 0:25:00
MIT professor.

280
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Sam Nunn, George Gao, who is the head of the Chinese CDC, and Michael Ryan, who's one of

281
0:25:07 --> 0:25:11
the top people at the WHO for handling emergencies.

282
0:25:11 --> 0:25:12
Next slide.

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Am I missing?

284
0:25:18 --> 0:25:21
Next slide.

285
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Here's a list of some of the other people.

286
0:25:23 --> 0:25:30
Chris Elias, who is again the president of the global group at Bill and Melinda Gates

287
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Foundation.

288
0:25:31 --> 0:25:35
Margaret Hamburg, former FDA commissioner.

289
0:25:35 --> 0:25:41
She has been at a lot of these tabletop exercises for pandemics.

290
0:25:41 --> 0:25:43
So keep your eye on her.

291
0:25:43 --> 0:25:51
Jeremy Farrar, who collaborated with Fauci to hide the natural or the lab origin of COVID.

292
0:25:51 --> 0:25:53
He was one of the participants.

293
0:25:53 --> 0:26:00
The people from National Security Council, CHEPI, UN, WHO, African CDC, and two pharmaceutical

294
0:26:00 --> 0:26:01
companies.

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0:26:01 --> 0:26:06
Can we go back one slide, please?

296
0:26:06 --> 0:26:14
So this just gives you the website for the report that was written about this event.

297
0:26:14 --> 0:26:16
Of course, it was fictional.

298
0:26:16 --> 0:26:21
And they thought that there was a high mortality rate.

299
0:26:21 --> 0:26:26
Let's go forward a couple of slides.

300
0:26:26 --> 0:26:32
To be very quick, the recommendations in the report on this tabletop exercise regarding

301
0:26:32 --> 0:26:38
monkeypox are exactly what you would expect, which is, of course, get the international

302
0:26:38 --> 0:26:44
organizations involved and have them manage the pandemics for us.

303
0:26:44 --> 0:26:48
Next slide.

304
0:26:48 --> 0:26:50
This is scary.

305
0:26:50 --> 0:26:52
Early proactive pandemic response.

306
0:26:52 --> 0:26:55
No regrets approach.

307
0:26:55 --> 0:27:00
That means even if you have to do rather draconian things, just do them and don't worry about

308
0:27:00 --> 0:27:02
the consequences.

309
0:27:02 --> 0:27:04
At least that's how I read this.

310
0:27:04 --> 0:27:07
I think it's very worrisome.

311
0:27:07 --> 0:27:09
Next slide.

312
0:27:09 --> 0:27:19
Yes, again, create an international entity, of course, through the WHO, ideally, or create

313
0:27:19 --> 0:27:24
another one, which will tell us all what to do.

314
0:27:24 --> 0:27:26
Next slide.

315
0:27:27 --> 0:27:36
Always, always these organizations have an idea that you can create money for nothing

316
0:27:36 --> 0:27:39
and chicks for free.

317
0:27:39 --> 0:27:41
A catalytic global health security fund.

318
0:27:41 --> 0:27:42
What does that mean?

319
0:27:42 --> 0:27:43
It's going to just make its own money.

320
0:27:43 --> 0:27:50
So you're going to pull in development banks, et cetera, and they're all going to give money

321
0:27:50 --> 0:27:55
to finance this new international project.

322
0:27:55 --> 0:28:00
Next slide.

323
0:28:00 --> 0:28:02
Supply chain issues.

324
0:28:02 --> 0:28:04
Yeah, that's going to be a big one.

325
0:28:04 --> 0:28:06
Next slide.

326
0:28:06 --> 0:28:09
So I'm changing subjects again.

327
0:28:09 --> 0:28:16
I just want to show you that the European Center for Disease Prevention put out a fact

328
0:28:16 --> 0:28:24
sheet two months ago on monkeypox in which they said, while the virus is not considered

329
0:28:24 --> 0:28:31
basically a biological warfare agent, according to the US CDC, it is considered an agent with

330
0:28:31 --> 0:28:38
high threat for deliberate release, according to the EU task force on bioterrorism.

331
0:28:38 --> 0:28:44
So the Europeans are saying, the Americans are trying to say it couldn't be biological

332
0:28:44 --> 0:28:48
warfare or terrorism, but we think it's possible.

333
0:28:48 --> 0:28:50
Next slide.

334
0:28:51 --> 0:28:56
Again, changing course.

335
0:28:56 --> 0:29:05
Just want you to know, the CDC told its advisory committee a lot of things, most of which were

336
0:29:05 --> 0:29:07
true in June.

337
0:29:07 --> 0:29:11
Next slide.

338
0:29:11 --> 0:29:16
Brett Peterson was the briefer on the next set of slides, and I want you to remember

339
0:29:16 --> 0:29:18
his name.

340
0:29:18 --> 0:29:22
Next slide.

341
0:29:22 --> 0:29:24
All right.

342
0:29:24 --> 0:29:27
It's a mild self-limiting disease.

343
0:29:27 --> 0:29:31
Doesn't need any specific therapy.

344
0:29:31 --> 0:29:36
And of course, the prognosis is going to depend on whether you have other preexisting conditions.

345
0:29:36 --> 0:29:42
Next slide.

346
0:29:42 --> 0:29:45
So well, I'll get into that later.

347
0:29:45 --> 0:29:49
The issue is these vaccines were made for smallpox.

348
0:29:49 --> 0:29:53
They weren't made for monkeypox, but there is no smallpox.

349
0:29:53 --> 0:29:58
And so you can't test them in humans for smallpox.

350
0:29:58 --> 0:30:02
And actually, it's very hard to test them in humans for monkeypox also, because there's

351
0:30:02 --> 0:30:04
very little monkeypox.

352
0:30:04 --> 0:30:14
But monkeypox was one of the viruses used in animals to test this JYNNEOS vaccine.

353
0:30:14 --> 0:30:24
Now, there was a paper published about some of these 47 Americans who got monkeypox in

354
0:30:24 --> 0:30:26
2003 in the New England Journal.

355
0:30:26 --> 0:30:32
And they were able to say that in the 11 people studied in this paper, five of them were old

356
0:30:32 --> 0:30:37
enough that they should have received a smallpox vaccination as children, and they still got

357
0:30:37 --> 0:30:39
monkeypox.

358
0:30:39 --> 0:30:41
They didn't go into any more detail.

359
0:30:41 --> 0:30:44
Next slide.

360
0:30:44 --> 0:30:48
Yeah, we saw this one.

361
0:30:48 --> 0:30:52
Next slide.

362
0:30:52 --> 0:30:57
So again, supportive care, not easily transmitted.

363
0:30:57 --> 0:31:02
Next slide.

364
0:31:02 --> 0:31:03
Prolonged close interaction.

365
0:31:03 --> 0:31:13
So this post-exposure prophylaxis is of interest to people who are bioterrorism folk, because

366
0:31:14 --> 0:31:19
they want to be able to come up with some remedy after you have already been exposed

367
0:31:19 --> 0:31:23
to whatever agent is being used.

368
0:31:23 --> 0:31:31
And so it has been believed that the old vaccines for smallpox could be used up to four days

369
0:31:31 --> 0:31:36
after a smallpox exposure and prevent you from getting smallpox.

370
0:31:36 --> 0:31:38
That's sort of the belief.

371
0:31:38 --> 0:31:41
And it's probably true.

372
0:31:42 --> 0:31:48
That doesn't mean it holds for these newer vaccines, and it doesn't mean it holds for

373
0:31:48 --> 0:31:51
monkeypox.

374
0:31:51 --> 0:31:59
But of course, the CDC is very interested in using the vaccines available for both what

375
0:31:59 --> 0:32:07
they call post-exposure prophylaxis as well as pre-exposure prophylaxis.

376
0:32:07 --> 0:32:12
And they're interested in giving information to health care workers who may have come in

377
0:32:12 --> 0:32:16
contact with a patient, and do they need to be vaccinated?

378
0:32:16 --> 0:32:20
What precautions do they need to take?

379
0:32:20 --> 0:32:21
Next slide.

380
0:32:21 --> 0:32:25
So they said the health care workers should be okay as long as they wear gloves.

381
0:32:25 --> 0:32:28
There should not be a problem.

382
0:32:28 --> 0:32:36
Now, CDC has been recommending since the start of this outbreak that you can give the JYNNEOS

383
0:32:36 --> 0:32:41
vaccine between four and 14 days after the date of exposure, although you're better off

384
0:32:41 --> 0:32:42
within four days.

385
0:32:42 --> 0:32:46
They have no data that we know of to support this claim.

386
0:32:46 --> 0:32:52
And given that the incubation period has been variously suggested as between the average

387
0:32:52 --> 0:33:00
incubation period, eight to 12 days with a range of about three to 20 something, it suggests

388
0:33:00 --> 0:33:05
to me that the CDC is trying to get vaccine into an awful lot of people.

389
0:33:05 --> 0:33:11
So they're trying to get it quickly, probably many of whom too late when it won't do any

390
0:33:11 --> 0:33:17
good, but then again, possibly it will do some good later if they get exposed again.

391
0:33:17 --> 0:33:18
Next slide.

392
0:33:18 --> 0:33:28
So JYNNEOS, you need two doses, whereas ACAM2000, you only need one.

393
0:33:28 --> 0:33:32
You're believed to become immune six weeks after the first dose.

394
0:33:32 --> 0:33:42
There is no evidence, there's no data that the CDC and the other health agencies have

395
0:33:42 --> 0:33:48
provided the public with absolutely no data to show effectiveness of JYNNEOS in the current

396
0:33:48 --> 0:33:51
outbreak.

397
0:33:51 --> 0:33:58
And CDC added onto its recommendations just a couple of weeks ago, not even that long

398
0:33:59 --> 0:34:04
ago, that they're finally telling people that they're basically part of an experiment and

399
0:34:04 --> 0:34:07
they will be following them to try to find out whether the vaccine works.

400
0:34:07 --> 0:34:14
Next slide.

401
0:34:14 --> 0:34:19
There is a limited supply of JYNNEOS, although more is expected in the coming weeks and months.

402
0:34:19 --> 0:34:21
This again is from the CDC.

403
0:34:21 --> 0:34:26
This is scary because they're telling people basically that they're willing to break out

404
0:34:26 --> 0:34:35
the ACAM2000 and they're willing to give it to people unless they have eczema, pregnancy

405
0:34:35 --> 0:34:40
or possibly some other immune compromising conditions.

406
0:34:40 --> 0:34:49
So we've got to be concerned about this willingness because of the one in 175 people risk of myocarditis

407
0:34:49 --> 0:34:52
from ACAM2000.

408
0:34:52 --> 0:34:56
Next slide.

409
0:34:56 --> 0:35:00
When I say what did CDC leave out, they left out this.

410
0:35:00 --> 0:35:11
CDC conducted a study, conducted an open label clinical trial of the JYNNEOS vaccine in Democratic

411
0:35:11 --> 0:35:13
Republic of Congo.

412
0:35:13 --> 0:35:18
They started it more than five years ago.

413
0:35:18 --> 0:35:25
And Brett Peterson, the guy who was briefing the advisory committee, is the principal investigator

414
0:35:25 --> 0:35:27
of this trial.

415
0:35:27 --> 0:35:31
I don't believe he informed the advisory committee about it.

416
0:35:31 --> 0:35:36
It's only by chance that I was able to discover this.

417
0:35:36 --> 0:35:41
They were planning to enroll 1,600 participants.

418
0:35:41 --> 0:35:47
Estimated completion date was this month, five and a half years since they started.

419
0:35:47 --> 0:35:51
The idea was to give it to healthcare workers and see if they got monkeypox and see what

420
0:35:51 --> 0:35:53
the side effects were.

421
0:35:53 --> 0:36:00
CDC probably has a boatload of data on this vaccine in Africa, some of whom were exposed

422
0:36:00 --> 0:36:02
to monkeypox.

423
0:36:02 --> 0:36:05
And so far, it's a big secret.

424
0:36:05 --> 0:36:12
And by September 2020, they were no longer recruiting for the trial.

425
0:36:12 --> 0:36:13
So that's all I can tell you.

426
0:36:13 --> 0:36:15
Two years ago, they had stopped recruiting.

427
0:36:15 --> 0:36:19
So they must have collected all the data by now.

428
0:36:19 --> 0:36:20
Next slide.

429
0:36:23 --> 0:36:33
So as I said, BARDA gave out about a million and a half, a billion and a half dollars a

430
0:36:33 --> 0:36:39
year for products for bioterrorism and pandemics.

431
0:36:39 --> 0:36:42
And other federal agencies gave out more money.

432
0:36:42 --> 0:36:48
This was the first start to finish vaccine that BARDA and Project BioShield were involved

433
0:36:48 --> 0:36:49
with.

434
0:36:49 --> 0:36:57
And that is perhaps the reason why they continued with it, even though it has some significant

435
0:36:57 --> 0:36:59
problems.

436
0:36:59 --> 0:37:02
And I'm not sure why, but the name keeps changing.

437
0:37:02 --> 0:37:06
It's had three names since I have known it in the last 20 years.

438
0:37:06 --> 0:37:09
It was called MVA.

439
0:37:09 --> 0:37:11
Then it became InfImmune.

440
0:37:11 --> 0:37:16
And suddenly when it got licensed by FDA two years ago, it was called GENIOS.

441
0:37:16 --> 0:37:17
Next slide.

442
0:37:20 --> 0:37:29
So you don't have to read all these things, but I pulled all this information from a series

443
0:37:29 --> 0:37:38
of about 35 press releases that this company has put out over the last 13, 14 years, because

444
0:37:38 --> 0:37:43
there's been a lot of questions about how much of the vaccine is available to Americans

445
0:37:43 --> 0:37:45
as well as others in the world.

446
0:37:45 --> 0:37:51
And there has been claimed to be a tremendous shortage of this vaccine.

447
0:37:51 --> 0:37:53
And let's just look at what we bought.

448
0:37:53 --> 0:38:03
And so by 2013, the company had completed delivery of 20 million doses that were frozen

449
0:38:03 --> 0:38:06
liquid vaccine.

450
0:38:06 --> 0:38:13
And over the next three years, it delivered 8 million more doses.

451
0:38:13 --> 0:38:18
And then it continued to get contracts from the US government, mostly from BARDA, but

452
0:38:18 --> 0:38:25
also others, to develop a freeze-dried version rather than a liquid vaccine that was alleged

453
0:38:25 --> 0:38:28
to have a longer shelf life.

454
0:38:28 --> 0:38:31
And they got lots of money for different things.

455
0:38:31 --> 0:38:38
They got money to perform clinical trials and money to take the vaccine through FDA

456
0:38:38 --> 0:38:39
licensure.

457
0:38:39 --> 0:38:40
Next slide.

458
0:38:43 --> 0:38:47
And money to build a fill and finish factory.

459
0:38:47 --> 0:38:55
So apparently what they had for the first, say, 15 years of these contracts was only

460
0:38:55 --> 0:39:03
a facility that can manufacture bulk liquid vaccine but could not bottle it.

461
0:39:03 --> 0:39:09
And so they've been paid a lot of money to create a fill and finish, which is a bottling

462
0:39:09 --> 0:39:12
facility as well.

463
0:39:12 --> 0:39:21
And in 2017, they got a new nine-year contract for both the freeze-dried and the liquid vaccines

464
0:39:21 --> 0:39:29
that could be, what do they say, contracts, it could involve as much as over a billion

465
0:39:29 --> 0:39:37
dollars after the approximately billion that had already been spent on this vaccine earlier.

466
0:39:38 --> 0:39:43
And two and a half, let me see, three and a half years ago, they got the last 44 million

467
0:39:43 --> 0:39:47
to qualify their new bottling facility.

468
0:39:47 --> 0:39:53
So I'm not sure how long it takes to qualify such a facility, but it wasn't qualified by

469
0:39:53 --> 0:40:02
the FDA until less than two weeks ago.

470
0:40:02 --> 0:40:07
And then again in April, two years ago, they got another new big order.

471
0:40:08 --> 0:40:14
This may have been part of the former contract, but they were putting it out in a press release.

472
0:40:14 --> 0:40:21
And again, the story was that they couldn't ship any vaccine to the United States because

473
0:40:21 --> 0:40:25
the fill and finish facility had not been approved by the FDA.

474
0:40:25 --> 0:40:29
Next slide.

475
0:40:29 --> 0:40:34
This is the contract that they had from 2017.

476
0:40:34 --> 0:40:36
And I have circled it.

477
0:40:36 --> 0:40:40
We're halfway through at the top and at the bottom.

478
0:40:40 --> 0:40:51
You can see that over 1.029 billion is the potential award amount of which 675 million

479
0:40:51 --> 0:40:53
has already been obligated.

480
0:40:53 --> 0:40:55
Next slide.

481
0:40:56 --> 0:41:00
Okay.

482
0:41:00 --> 0:41:07
The label mentions or omits information on some problems with the vaccine.

483
0:41:07 --> 0:41:12
So I'll just mention some of the big ones that you can see right on the label.

484
0:41:12 --> 0:41:23
Again, there's no studies of pregnancy, children, lactation, fertility, carcinogenicity.

485
0:41:23 --> 0:41:27
2% of recipients had a serious adverse event during a trial.

486
0:41:27 --> 0:41:34
They had about 7,000 recipients altogether in a series of trials.

487
0:41:34 --> 0:41:42
According to the label, it looks like over 1% had a cardiac event of special interest.

488
0:41:42 --> 0:41:50
These were downplayed in the label and in some FDA documents, but there was some degree

489
0:41:50 --> 0:41:58
of troponin cardiac enzyme elevation in 10% of the subjects in one sub-study and in 18%

490
0:41:58 --> 0:42:02
of the subjects in another sub-study.

491
0:42:02 --> 0:42:06
So these were not very high, apparently.

492
0:42:06 --> 0:42:10
According to the label, they weren't very high, but they did exist.

493
0:42:10 --> 0:42:13
There were people with EKG changes.

494
0:42:13 --> 0:42:20
There were people pulled out of the trial because of cardiac concerns.

495
0:42:20 --> 0:42:26
And the other thing is that although I don't know what monkeypox virus the vaccine was

496
0:42:26 --> 0:42:32
tested against in animals, but it's probably completely different than the monkeypox virus

497
0:42:32 --> 0:42:36
that is currently circulating.

498
0:42:37 --> 0:42:43
They filed their information with the FDA to get licensed in 2018.

499
0:42:43 --> 0:42:52
And the current monkeypox strain is very different from the strains that existed then.

500
0:42:52 --> 0:42:53
All right, next slide.

501
0:42:57 --> 0:43:02
This is a small trial, but it was reported recently in the New England Journal right

502
0:43:02 --> 0:43:05
after the vaccine was licensed.

503
0:43:05 --> 0:43:12
They acknowledged this was in soldiers, so basically a captive population, yet 47% or

504
0:43:12 --> 0:43:18
11% of them withdrew after apparently getting a dose of vaccine.

505
0:43:18 --> 0:43:22
So there were two arms of this trial.

506
0:43:22 --> 0:43:32
One got two doses of JYNNEOS, and after that, they got a third dose, which was the ACAM2000.

507
0:43:32 --> 0:43:35
The other arm only got an ACAM2000 one dose.

508
0:43:41 --> 0:43:50
I thought this trial was probably unethical because obviously humans don't need to get

509
0:43:52 --> 0:43:59
in rapid succession two different smallpox vaccines, both of which are known to cause

510
0:43:59 --> 0:44:02
cardiac problems and other problems.

511
0:44:03 --> 0:44:06
But anyway, that's how the trial was carried out.

512
0:44:06 --> 0:44:08
And I love the terminology.

513
0:44:08 --> 0:44:15
This is kind of Ezekiel Emmanuel type language.

514
0:44:16 --> 0:44:22
Now we're not going to call our people in our subjects in clinical trials, we're not

515
0:44:22 --> 0:44:26
going to call them volunteers, we're not going to call them subjects.

516
0:44:26 --> 0:44:28
We're going to call them participants.

517
0:44:30 --> 0:44:35
And we're giving them the opportunity to participate in research as if this is something

518
0:44:35 --> 0:44:39
they should be longing to do and enjoy.

519
0:44:41 --> 0:44:45
So I just wanted to point that out because you'll probably be seeing more of it.

520
0:44:45 --> 0:44:46
Next slide.

521
0:44:49 --> 0:44:51
This is from CDC.

522
0:44:51 --> 0:44:56
This is a slide they showed the advisory committee, and they acknowledged here

523
0:44:56 --> 0:45:02
myopericarditis 5.7 per thousand in the ACAM2000, which is one in 175.

524
0:45:03 --> 0:45:08
And for JYNNEOS, they acknowledged that the risk was believed to be lower.

525
0:45:10 --> 0:45:11
Next slide.

526
0:45:16 --> 0:45:24
This was just a description in a journal in 2010 of the ACAM2000 vaccine.

527
0:45:24 --> 0:45:28
If somebody wanted to learn more about it, I'm giving you a reference.

528
0:45:30 --> 0:45:36
And this is an acknowledgement that it causes a lot of adverse events, an unexpectedly high

529
0:45:36 --> 0:45:40
rate of myocarditis and pericarditis.

530
0:45:40 --> 0:45:43
And yet, this is what was used to replace dry vaccine.

531
0:45:43 --> 0:45:49
And at this point in 2010, we had over 200 million doses of this vaccine in the U.S.

532
0:45:49 --> 0:45:52
strategic stockpile for use in an emergency.

533
0:45:52 --> 0:45:53
Next slide.

534
0:45:54 --> 0:46:01
Okay. From Nature, two months ago, I thought this was...

535
0:46:01 --> 0:46:08
I wanted to grab this because the CDC was claiming at that point that the

536
0:46:08 --> 0:46:09
vaccines were...

537
0:46:09 --> 0:46:15
The monkeypox vaccine, JYNNEOS, was going to be 85% effective against a monkeypox infection.

538
0:46:16 --> 0:46:22
And I pointed out that then and subsequently that there's no published data to support that.

539
0:46:23 --> 0:46:25
And so Nature pointed it out as well.

540
0:46:26 --> 0:46:29
It's never been directly tested against that disease in people.

541
0:46:29 --> 0:46:35
However, Nature didn't know, and at the time I didn't know, that CDC had been conducting

542
0:46:35 --> 0:46:41
a trial for five years in Congo to find out whether the vaccine worked.

543
0:46:42 --> 0:46:47
So I think we need to put their feet to their fire about that bit of hidden information.

544
0:46:47 --> 0:46:48
Next slide.

545
0:46:48 --> 0:46:52
Yeah, this is also from Nature acknowledging again, we don't know if it's going to work

546
0:46:52 --> 0:46:55
post-exposure within four days.

547
0:46:55 --> 0:46:59
We certainly don't know if it's going to work within 14 days post-exposure, which seems

548
0:46:59 --> 0:47:00
ridiculous.

549
0:47:00 --> 0:47:01
Next slide.

550
0:47:05 --> 0:47:13
I'm going back to this issue of how much of this vaccine we actually have and where it might be,

551
0:47:13 --> 0:47:18
because it's interesting since the government today announced we don't have enough, so they

552
0:47:18 --> 0:47:21
are going to be splitting the doses of JYNNEOS.

553
0:47:21 --> 0:47:23
Yeah, I guess I should have told you that.

554
0:47:25 --> 0:47:34
The government is going to be reducing the dose to 20% of the licensed dose and is going to be

555
0:47:34 --> 0:47:39
administering it as an intradermal dose like a vaccine.

556
0:47:40 --> 0:47:52
I hope everybody got that.

557
0:47:52 --> 0:47:57
You're only going to get 20% as much and it's going to be administered differently within

558
0:47:57 --> 0:47:58
the layers of skin.

559
0:47:59 --> 0:48:06
And the media claims this then will cause it to have an emergency use authorization.

560
0:48:07 --> 0:48:08
Very important.

561
0:48:09 --> 0:48:14
See, if they were giving it in the licensed way for the licensed indication, according

562
0:48:14 --> 0:48:19
to the license, it would have liability, at least for now.

563
0:48:20 --> 0:48:27
But by giving it an emergency use authorization, no liability for anyone, not for the government,

564
0:48:27 --> 0:48:32
the manufacturer, the doctor who gives it to you, the facility in which it's given, etc.

565
0:48:32 --> 0:48:38
So this was a press release from the company and I'm emphasizing the date of July 15.

566
0:48:40 --> 0:48:47
They claimed they were delivering this year and next year 7 million doses to the United States.

567
0:48:48 --> 0:48:53
And because of these problems with their fill and finish facility, which nobody's acknowledged

568
0:48:53 --> 0:49:00
what those problems are or were, that they're getting a U.S. contract manufacturer to actually

569
0:49:01 --> 0:49:07
take the bulk vaccine, which they have stored for us, which is something like 16 million doses,

570
0:49:08 --> 0:49:09
and we'll fill it into vials.

571
0:49:10 --> 0:49:18
And probably they can also fill it into vials diluted to make up what now the government

572
0:49:18 --> 0:49:19
wants to get out to people.

573
0:49:19 --> 0:49:25
Now note also that in June and July 500,000 and 2.5 million doses were ordered,

574
0:49:26 --> 0:49:32
and then an order from BARDA had been ordered in 2020 for 1.4 million doses, blah, blah, blah.

575
0:49:32 --> 0:49:38
So this is what we should be getting the 7 million doses this year and next year. Next slide.

576
0:49:41 --> 0:49:45
So is it a real shortage? This is what the New York Times said.

577
0:49:46 --> 0:49:51
So is it a real shortage? This is what the New York Times said on August 3rd.

578
0:49:52 --> 0:49:56
It said, we failed to replenish them. We let the supply dwindle to almost nothing. Well,

579
0:49:56 --> 0:50:03
actually we did have the 200 or 300 million ACAM2000 doses because nobody was expecting

580
0:50:03 --> 0:50:08
monkeypox was going to be a problem, nor that anyone would need to be vaccinated for monkeypox

581
0:50:08 --> 0:50:09
since it's a mild disease.

582
0:50:09 --> 0:50:16
And the New York Times then admitted we own the equivalent of 16 million doses of bulk vaccine,

583
0:50:16 --> 0:50:26
which is stored in Denmark. Okay. But the company had trouble delivering it. Now,

584
0:50:26 --> 0:50:30
how do you have trouble delivering these doses that are stored in Denmark?

585
0:50:30 --> 0:50:34
Can't you put them on a plane and deliver them? Next slide.

586
0:50:40 --> 0:50:48
But of course, if you don't have them, then you can spend a lot of money and buy more, right?

587
0:50:49 --> 0:50:53
So again, July 26th is 11 days after that press release.

588
0:50:55 --> 0:51:01
Government officials estimate that $7 billion in new funding would allow the department to support

589
0:51:02 --> 0:51:07
domestic end-to-end vaccine manufacturing capacity and technology transfer in the United States.

590
0:51:07 --> 0:51:12
So all of a sudden we want to start making the whole thing here, even though we've got 16.5 million

591
0:51:12 --> 0:51:24
doses there. And what a catastrophe that these hundreds of thousands of genius doses were

592
0:51:24 --> 0:51:30
stranded overseas for weeks, awaiting U.S. inspection and transport. Give me a break.

593
0:51:31 --> 0:51:32
Next slide.

594
0:51:32 --> 0:51:37
With the $7 billion, officials estimate they could secure 19 million new doses

595
0:51:37 --> 0:51:42
of monkeypox vaccine and buy all this other stuff. Next slide.

596
0:51:47 --> 0:51:54
New York Times now acknowledging that the fill-in-finish plan is bottling so many doses per week.

597
0:51:54 --> 0:52:01
And somehow the United States didn't bottle them because it had the ACAM2000 already,

598
0:52:02 --> 0:52:09
and no FDA inspection was scheduled until after the monkeypox outbreak, and the FDA inspection

599
0:52:09 --> 0:52:17
did not conclude until July 27th. Well, actually the first case of monkeypox was in the United

600
0:52:17 --> 0:52:23
States, and the FDA inspection did not conclude until July 27th. Well, actually the first case

601
0:52:23 --> 0:52:32
of monkeypox that anyone got reported was at the end of April. So May, June, July, August,

602
0:52:32 --> 0:52:38
we're talking three and a half months. The FDA could have completed that inspection a long time

603
0:52:38 --> 0:52:42
ago if in fact that is what was holding things up. Next slide.

604
0:52:46 --> 0:52:53
Just in terms of the modified vaccinia anchora as a virus, you need to be aware of this because

605
0:52:53 --> 0:53:00
it is being used as a platform for other experimental vaccines that aren't necessarily

606
0:53:00 --> 0:53:11
against smallpox or monkeypox, but for other pathogens. So somehow it can express its genes,

607
0:53:11 --> 0:53:18
replicate its genome, but doesn't assemble correctly. And it's been fully approved in Canada

608
0:53:18 --> 0:53:25
for smallpox and monkeypox, in the U.S. for both, and in Europe for smallpox. Next slide.

609
0:53:30 --> 0:53:40
Yeah. So again, I'm just writing the same thing here. Next slide.

610
0:53:44 --> 0:53:52
Changing the story again. All right. So now monkeypox is going to be the excuse to start up

611
0:53:52 --> 0:53:59
track and trace all over again. However, when I tried to look up track and trace online,

612
0:54:00 --> 0:54:08
I found out the terminology isn't there anymore. And now it's test and trace.

613
0:54:12 --> 0:54:20
This in yellow shows you that the disease is already spreading in the community without

614
0:54:20 --> 0:54:28
being detected. Officials know that most many cases are not being reported and therefore

615
0:54:29 --> 0:54:33
track and trace is only going to have, it's going to maybe slow things down,

616
0:54:33 --> 0:54:39
but is not going to be able to stop an outbreak. But that of course doesn't stop the people who

617
0:54:40 --> 0:54:47
like the idea and the benefit, the surveillance benefits it can provide.

618
0:54:49 --> 0:54:57
So next slide is when I looked up track and trace, Google told me it was an error.

619
0:54:58 --> 0:55:03
I didn't like track and trace and I went to a different browser and I got the same message.

620
0:55:03 --> 0:55:11
And then I tried again later and it did give me track and trace the third time. And apparently

621
0:55:11 --> 0:55:18
the terminology is still used in the U.K. But it's not being used by, I couldn't find that it was

622
0:55:18 --> 0:55:25
being used by any federal agencies in the U.S. anymore. So I'm sorry to have gone that far down

623
0:55:25 --> 0:55:30
in the weeds with you. I hope I've answered all the questions you may have, but I'm

624
0:55:31 --> 0:55:36
happy to try and answer anything else. So thank you very much.

625
0:55:40 --> 0:55:52
Well done, Meryl. What an amazing survey of the journey. One of the issues I'm going to raise is

626
0:55:52 --> 0:55:59
the question of liability. But traditionally, Meryl, as you know, Steven, as founder of this

627
0:55:59 --> 0:56:05
group, goes first on the questions. For the rest of you with questions, please put your hands up.

628
0:56:05 --> 0:56:11
Meryl has said she's not going into the question. We've had many discussions around it on the

629
0:56:11 --> 0:56:17
existence of viruses or not. That's another topic. That's not today's topic. So whilst you might put

630
0:56:17 --> 0:56:23
some stuff in the chat, we're not going into that question of, you know, there's no virus,

631
0:56:23 --> 0:56:30
the proof of isolation of virus. We've had that conversation. However, it's okay in science to

632
0:56:30 --> 0:56:36
keep having those conversations, but that's not the conversation for today because Meryl's not

633
0:56:36 --> 0:56:40
going there. Steven, questions to you?