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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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0:00:33 --> 0:00:[privacy contact redaction]ors, 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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0:01:09 --> 0:01:[privacy contact redaction]oration and discovery.
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0:01:17 --> 0:01:[privacy contact redaction]and 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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0:01:26 --> 0:01:[privacy contact redaction] 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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0:01:51 --> 0:01:[privacy contact redaction]rictly and Russia.
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0:01:55 --> 0:01:[privacy contact redaction] 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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0:02:02 --> 0:02:[privacy contact redaction], if any country you haven't mentioned, please put in the chat, because
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0:02:06 --> 0:02:[privacy contact redaction] that we are a global group.
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0:02:10 --> 0:02:[privacy contact redaction]e who come here is anything from 40 to 140.
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0:02:15 --> 0:02:[privacy contact redaction]e's timetables, but they know that they can get a recording.
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0:02:19 --> 0:02:[privacy contact redaction]ings afterwards.
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0:02:23 --> 0:02:[privacy contact redaction] 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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0:02:40 --> 0:02:[privacy contact redaction] 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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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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0:03:39 --> 0:03:[privacy contact redaction]e, 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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That's my principle.
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0:03:57 --> 0:04:[privacy contact redaction] to live.
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0:04:00 --> 0:04:[privacy contact redaction] 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 they're the ground rules for this group.
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0:04:27 --> 0:04:[privacy contact redaction]ors for Covid ethics.
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0:04:30 --> 0:04:[privacy contact redaction] 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 over to you.
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Hi, some people know me.
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0:04:51 --> 0:05:[privacy contact redaction]or 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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0:05:41 --> 0:05:[privacy contact redaction]arted 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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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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0:06:21 --> 0:06:[privacy contact redaction]arted during the Clinton regime and then it and and in fact, the military
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0:06:27 --> 0:06:[privacy contact redaction]an 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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0:07:10 --> 0:07:[privacy contact redaction] 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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not particularly well looked at, not not well evaluated, very little regulatory action on
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0:07:43 --> 0:07:[privacy contact redaction]ill use them in an emergency because of this law.
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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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0:08:12 --> 0:08:[privacy contact redaction]en'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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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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0:09:10 --> 0:09:[privacy contact redaction] case ever identified in any kind of animal was only 1958, which is rather remarkable.
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0:09:18 --> 0:09:[privacy contact redaction] human case, 1970.
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There was very little outside of Africa.
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0:09:24 --> 0:09:[privacy contact redaction]ates, 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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But they caught something which we're calling monkeypox.
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monkeypox.
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There were 47 cases.
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0:10:10 --> 0:10:[privacy contact redaction]ion 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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0:10:32 --> 0:10:[privacy contact redaction], 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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0:10:58 --> 0:11:[privacy contact redaction], 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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0:11:22 --> 0:11:[privacy contact redaction] 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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0:12:11 --> 0:12:[privacy contact redaction] to realize that in Africa it was really impossible to distinguish monkeypox.
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0:12:16 --> 0:12:[privacy contact redaction] PCRs from other things, particularly chickenpox, but potentially other
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So those data are not really reliable about mortality rates.
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0:12:31 --> 0:12:[privacy contact redaction] 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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0:12:51 --> 0:13:[privacy contact redaction]ing to the New England Journal, in Africa monkeypox was mostly due to hunting, skinning,
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0:13:00 --> 0:13:[privacy contact redaction]ed animals.
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0:13:03 --> 0:13:[privacy contact redaction] 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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0:13:20 --> 0:13:[privacy contact redaction] 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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0:13:45 --> 0:13:[privacy contact redaction]ices at the end of June.
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0:13:50 --> 0:13:[privacy contact redaction] 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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0:14:12 --> 0:14:[privacy contact redaction] a connection to Africa or to an infected animal.
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0:14:21 --> 0:14:[privacy contact redaction]e who had just flown in from Nigeria.
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0:14:28 --> 0:14:[privacy contact redaction]s 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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0:14:46 --> 0:14:[privacy contact redaction] 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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0:15:14 --> 0:15:[privacy contact redaction]rains.
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It was considered a very dirty vaccine and it was considered the most reactogenic both
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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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0:15:29 --> 0:15:[privacy contact redaction]ions in adults.
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0:15:34 --> 0:15:[privacy contact redaction]e who got this vaccine felt ill afterwards.
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0:15:41 --> 0:15:[privacy contact redaction]ually admits on its website that one in [privacy contact redaction]e who received
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0:15:47 --> 0:15:[privacy contact redaction]itis or pericarditis.
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0:15:52 --> 0:15:[privacy contact redaction]ockpile 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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0:16:14 --> 0:16:[privacy contact redaction]artup company, a canvas, and they just basically plucked
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0:16:21 --> 0:16:[privacy contact redaction]rain 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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0:16:33 --> 0:16:[privacy contact redaction] about $[privacy contact redaction]ockpile 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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0:17:18 --> 0:17:[privacy contact redaction]ually sold to them by the United States by the American
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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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0:17:40 --> 0:17:[privacy contact redaction]ed States had weaponized for use in World War
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II.
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0:17:49 --> 0:17:[privacy contact redaction]ually 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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0:18:19 --> 0:18:[privacy contact redaction] 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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0:18:52 --> 0:18:[privacy contact redaction] 10 years.
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0:18:56 --> 0:19:[privacy contact redaction]ed, 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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0:19:11 --> 0:19:[privacy contact redaction]arted getting ill and there were a bunch of heart attacks, episodes
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0:19:16 --> 0:19:[privacy contact redaction]itis, 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,[privacy contact redaction]ors, nurses and first responders to accept the vaccine
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0:19:49 --> 0:19:[privacy contact redaction] 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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0:20:51 --> 0:20:[privacy contact redaction]ogenic than the ACAM2000 or the dry-vax New York strain.
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0:20:59 --> 0:21:[privacy contact redaction]A 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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0:21:33 --> 0:21:[privacy contact redaction]y 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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0:22:16 --> 0:22:[privacy contact redaction]rain 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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0:22:41 --> 0:22:[privacy contact redaction]ation 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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0:22:55 --> 0:23:[privacy contact redaction] 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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0:23:11 --> 0:23:[privacy contact redaction]ew Rambeau, who signed the original article that Tony Fauci had encouraged to be written
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in early February of 2020 to say that it didn't make sense, it couldn't have been a lab origin
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for COVID, and Michael Waraby, who has written subsequently about the natural origin of COVID
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0:23:35 --> 0:23:[privacy contact redaction] recently in Science Magazine.
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And both these two guys, by the way, also had challenged Ed Hooper, who wrote the book
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The River, about the origin of AIDS being likely from a polio vaccine made on monkey
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kidneys.
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0:23:54 --> 0:24:[privacy contact redaction]ory as well a couple of decades ago.
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So I think they are professional naysayers who the system uses.
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Next slide.
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I don't know if John Lukasz is talking about my obfuscating, but I hope not.
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0:24:20 --> 0:24:[privacy contact redaction]y a very curious thing that, as you know, before the COVID pandemic, there
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0:24:31 --> 0:24:[privacy contact redaction]an how to deal with a coronavirus outbreak.
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0:24:41 --> 0:24:[privacy contact redaction] year, there was also a tabletop exercise.
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And it wasn't just some little thing.
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This was really a big deal.
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0:24:51 --> 0:24:[privacy contact redaction] Moniz is the head of the Nuclear Threat Initiative, former Secretary of Energy, former
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MIT professor.
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Sam Nunn, George Gao, who is the head of the Chinese CDC, and Michael Ryan, who's one of
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0:25:07 --> 0:25:[privacy contact redaction]e at the WHO for handling emergencies.
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Next slide.
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Am I missing?
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Next slide.
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Here's a list of some of the other people.
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Chris Elias, who is again the president of the global group at Bill and Melinda Gates
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Foundation.
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Margaret Hamburg, former FDA commissioner.
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She has been at a lot of these tabletop exercises for pandemics.
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So keep your eye on her.
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Jeremy Farrar, who collaborated with Fauci to hide the natural or the lab origin of COVID.
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He was one of the participants.
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0:25:53 --> 0:26:[privacy contact redaction]e from National Security Council, CHEPI, UN, WHO, African CDC, and two pharmaceutical
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companies.
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Can we go back one slide, please?
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0:26:06 --> 0:26:[privacy contact redaction] gives you the website for the report that was written about this event.
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Of course, it was fictional.
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And they thought that there was a high mortality rate.
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Let's go forward a couple of slides.
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To be very quick, the recommendations in the report on this tabletop exercise regarding
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0:26:32 --> 0:26:[privacy contact redaction]ly what you would expect, which is, of course, get the international
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0:26:38 --> 0:26:[privacy contact redaction] them manage the pandemics for us.
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Next slide.
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This is scary.
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0:26:50 --> 0:26:[privacy contact redaction]ive pandemic response.
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No regrets approach.
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0:26:55 --> 0:27:[privacy contact redaction] to do rather draconian things, just do them and don't worry about
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the consequences.
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0:27:02 --> 0:27:[privacy contact redaction] that's how I read this.
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I think it's very worrisome.
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Next slide.
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Yes, again, create an international entity, of course, through the WHO, ideally, or create
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another one, which will tell us all what to do.
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Next slide.
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0:27:27 --> 0:27:[privacy contact redaction]s, always these organizations have an idea that you can create money for nothing
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and chicks for free.
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A catalytic global health security fund.
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What does that mean?
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It's going to just make its own money.
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So you're going to pull in development banks, et cetera, and they're all going to give money
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Next slide.
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0:28:00 --> 0:28:[privacy contact redaction]y chain issues.
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Yeah, that's going to be a big one.
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Next slide.
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So I'm changing subjects again.
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0:28:09 --> 0:28:[privacy contact redaction] want to show you that the European Center for Disease Prevention put out a fact
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sheet two months ago on monkeypox in which they said, while the virus is not considered
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basically a biological warfare agent, according to the US CDC, it is considered an agent with
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high threat for deliberate release, according to the EU task force on bioterrorism.
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So the Europeans are saying, the Americans are trying to say it couldn't be biological
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warfare or terrorism, but we think it's possible.
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0:28:48 --> 0:28:50
Next slide.
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Again, changing course.
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0:28:56 --> 0:29:[privacy contact redaction] want you to know, the CDC told its advisory committee a lot of things, most of which were
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true in June.
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Next slide.
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Brett Peterson was the briefer on the next set of slides, and I want you to remember
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his name.
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Next slide.
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All right.
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It's a mild self-limiting disease.
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Doesn't need any specific therapy.
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And of course, the prognosis is going to depend on whether you have other preexisting conditions.
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Next slide.
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So well, I'll get into that later.
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The issue is these vaccines were made for smallpox.
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They weren't made for monkeypox, but there is no smallpox.
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And so you can't test them in humans for smallpox.
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0:29:58 --> 0:30:[privacy contact redaction]ually, it's very hard to test them in humans for monkeypox also, because there's
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very little monkeypox.
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But monkeypox was one of the viruses used in animals to test this JYNNEOS vaccine.
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Now, there was a paper published about some of these 47 Americans who got monkeypox in
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2003 in the New England Journal.
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And they were able to say that in the [privacy contact redaction]udied in this paper, five of them were old
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0:30:32 --> 0:30:[privacy contact redaction] received a smallpox vaccination as children, and they still got
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monkeypox.
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They didn't go into any more detail.
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Next slide.
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Yeah, we saw this one.
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Next slide.
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So again, supportive care, not easily transmitted.
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Next slide.
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0:31:02 --> 0:31:[privacy contact redaction]ion.
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0:31:03 --> 0:31:[privacy contact redaction]-exposure prophylaxis is of interest to people who are bioterrorism folk, because
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they want to be able to come up with some remedy after you have already been exposed
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to whatever agent is being used.
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And so it has been believed that the old vaccines for smallpox could be used up to four days
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after a smallpox exposure and prevent you from getting smallpox.
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That's sort of the belief.
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And it's probably true.
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That doesn't mean it holds for these newer vaccines, and it doesn't mean it holds for
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monkeypox.
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But of course, the CDC is very interested in using the vaccines available for both what
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0:31:59 --> 0:32:[privacy contact redaction]-exposure prophylaxis as well as pre-exposure prophylaxis.
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0:32:07 --> 0:32:12
And they're interested in giving information to health care workers who may have come in
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0:32:12 --> 0:32:[privacy contact redaction] with a patient, and do they need to be vaccinated?
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0:32:16 --> 0:32:20
What precautions do they need to take?
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0:32:20 --> 0:32:21
Next slide.
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0:32:21 --> 0:32:25
So they said the health care workers should be okay as long as they wear gloves.
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0:32:25 --> 0:32:28
There should not be a problem.
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Now, CDC has been recommending since the start of this outbreak that you can give the JYNNEOS
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vaccine between four and 14 days after the date of exposure, although you're better off
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within four days.
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0:32:42 --> 0:32:[privacy contact redaction] no data that we know of to support this claim.
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And given that the incubation period has been variously suggested as between the average
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incubation period, eight to 12 days with a range of about three to 20 something, it suggests
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to me that the CDC is trying to get vaccine into an awful lot of people.
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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
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0:33:11 --> 0:33:17
good, but then again, possibly it will do some good later if they get exposed again.
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0:33:17 --> 0:33:18
Next slide.
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0:33:18 --> 0:33:28
So JYNNEOS, you need two doses, whereas ACAM2000, you only need one.
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You're believed to become immune six weeks after the first dose.
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There is no evidence, there's no data that the CDC and the other health agencies have
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provided the public with absolutely no data to show effectiveness of JYNNEOS in the current
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outbreak.
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And CDC added onto its recommendations just a couple of weeks ago, not even that long
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ago, that they're finally telling people that they're basically part of an experiment and
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they will be following them to try to find out whether the vaccine works.
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0:34:07 --> 0:34:14
Next slide.
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0:34:14 --> 0:34:[privacy contact redaction]y of JYNNEOS, although more is expected in the coming weeks and months.
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0:34:19 --> 0:34:21
This again is from the CDC.
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0:34:21 --> 0:34:26
This is scary because they're telling people basically that they're willing to break out
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0:34:26 --> 0:34:35
the ACAM2000 and they're willing to give it to people unless they have eczema, pregnancy
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0:34:35 --> 0:34:40
or possibly some other immune compromising conditions.
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0:34:40 --> 0:34:49
So we've got to be concerned about this willingness because of the one in [privacy contact redaction]itis
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from ACAM2000.
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0:34:52 --> 0:34:56
Next slide.
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0:34:56 --> 0:35:[privacy contact redaction] out, they left out this.
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0:35:00 --> 0:35:[privacy contact redaction]udy, conducted an open label clinical trial of the JYNNEOS vaccine in Democratic
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0:35:11 --> 0:35:13
Republic of Congo.
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0:35:13 --> 0:35:[privacy contact redaction]arted it more than five years ago.
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0:35:18 --> 0:35:25
And Brett Peterson, the guy who was briefing the advisory committee, is the principal investigator
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of this trial.
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I don't believe he informed the advisory committee about it.
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It's only by chance that I was able to discover this.
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0:35:36 --> 0:35:[privacy contact redaction]anning to enroll 1,600 participants.
418
0:35:41 --> 0:35:[privacy contact redaction]etion date was this month, five and a half years since they started.
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0:35:47 --> 0:35:51
The idea was to give it to healthcare workers and see if they got monkeypox and see what
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0:35:51 --> 0:35:[privacy contact redaction]s were.
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0:35:53 --> 0:36:00
CDC probably has a boatload of data on this vaccine in Africa, some of whom were exposed
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0:36:00 --> 0:36:02
to monkeypox.
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0:36:02 --> 0:36:05
And so far, it's a big secret.
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And by September 2020, they were no longer recruiting for the trial.
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So that's all I can tell you.
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Two years ago, they had stopped recruiting.
427
0:36:15 --> 0:36:[privacy contact redaction]ed all the data by now.
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0:36:19 --> 0:36:20
Next slide.
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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
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0:36:33 --> 0:36:[privacy contact redaction]s for bioterrorism and pandemics.
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0:36:39 --> 0:36:[privacy contact redaction] out more money.
432
0:36:42 --> 0:36:[privacy contact redaction]art to finish vaccine that BARDA and Project BioShield were involved
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0:36:48 --> 0:36:49
with.
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0:36:49 --> 0:36:57
And that is perhaps the reason why they continued with it, even though it has some significant
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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.
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0:37:06 --> 0:37:09
It was called MVA.
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0:37:09 --> 0:37:11
Then it became InfImmune.
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0:37:11 --> 0:37:16
And suddenly when it got licensed by FDA two years ago, it was called GENIOS.
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0:37:16 --> 0:37:17
Next slide.
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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
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0:37:29 --> 0:37:38
of about 35 press releases that this company has put out over the last 13, 14 years, because
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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.
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0:38:13 --> 0:38:[privacy contact redaction]s from the US government, mostly from BARDA, but
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0:38:18 --> 0:38:25
also others, to develop a freeze-dried version rather than a liquid vaccine that was alleged
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0:38:25 --> 0:38:[privacy contact redaction] a longer shelf life.
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0:38:28 --> 0:38:31
And they got lots of money for different things.
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0:38:31 --> 0:38:38
They got money to perform clinical trials and money to take the vaccine through FDA
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0:38:38 --> 0:38:39
licensure.
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0:38:39 --> 0:38:40
Next slide.
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0:38:43 --> 0:38:[privacy contact redaction]ory.
459
0:38:47 --> 0:38:[privacy contact redaction], say, [privacy contact redaction]s was only
460
0:38:55 --> 0:39:[privacy contact redaction]ure 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
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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
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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
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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:[privacy contact redaction] 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
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the fill and finish facility had not been approved by the FDA.
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0:40:25 --> 0:40:29
Next slide.
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0:40:29 --> 0:40:[privacy contact redaction] that they had from 2017.
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0:40:34 --> 0:40:[privacy contact redaction]d it.
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We're halfway through at the top and at the bottom.
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You can see that over 1.[privacy contact redaction] amount of which 675 million
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has already been obligated.
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0:40:53 --> 0:40:55
Next slide.
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0:40:56 --> 0:41:00
Okay.
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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:[privacy contact redaction]ing to the label, it looks like over 1% had a cardiac event of special interest.
488
0:41:42 --> 0:41:[privacy contact redaction]ayed in the label and in some FDA documents, but there was some degree
489
0:41:50 --> 0:41:[privacy contact redaction]iac enzyme elevation in 10% of the subjects in one sub-study and in 18%
490
0:41:58 --> 0:42:[privacy contact redaction]s in another sub-study.
491
0:42:02 --> 0:42:06
So these were not very high, apparently.
492
0:42:06 --> 0:42:[privacy contact redaction]ing to the label, they weren't very high, but they did exist.
493
0:42:10 --> 0:42:[privacy contact redaction]e with EKG changes.
494
0:42:13 --> 0:42:[privacy contact redaction]e 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:[privacy contact redaction] in animals, but it's probably completely different than the monkeypox virus
497
0:42:32 --> 0:42:[privacy contact redaction]culating.
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:[privacy contact redaction]rain 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.
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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:[privacy contact redaction]iac problems and other problems.
511
0:44:03 --> 0:44:[privacy contact redaction], 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:[privacy contact redaction] 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:[privacy contact redaction]itis 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:[privacy contact redaction] 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:[privacy contact redaction]itis.
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And yet, this is what was used to replace dry vaccine.
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And at this point in 2010, we had over 200 million doses of this vaccine in the U.S.
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0:45:49 --> 0:45:[privacy contact redaction]ockpile for use in an emergency.
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Next slide.
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Okay. From Nature, two months ago, I thought this was...
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I wanted to grab this because the CDC was claiming at that point that the
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vaccines were...
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The monkeypox vaccine, JYNNEOS, was going to be 85% effective against a monkeypox infection.
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0:46:16 --> 0:46:22
And I pointed out that then and subsequently that there's no published data to support that.
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And so Nature pointed it out as well.
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It's never been directly tested against that disease in people.
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However, Nature didn't know, and at the time I didn't know, that CDC had been conducting
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0:46:35 --> 0:46:41
a trial for five years in Congo to find out whether the vaccine worked.
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0:46:42 --> 0:46:47
So I think we need to put their feet to their fire about that bit of hidden information.
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0:46:47 --> 0:46:48
Next slide.
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0:46:48 --> 0:46:52
Yeah, this is also from Nature acknowledging again, we don't know if it's going to work
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0:46:52 --> 0:46:[privacy contact redaction]-exposure within four days.
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0:46:55 --> 0:46:59
We certainly don't know if it's going to work within [privacy contact redaction]-exposure, which seems
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ridiculous.
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0:47:00 --> 0:47:01
Next slide.
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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,
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0:47:13 --> 0:47:18
because it's interesting since the government today announced we don't have enough, so they
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0:47:18 --> 0:47:[privacy contact redaction]itting the doses of JYNNEOS.
553
0:47:21 --> 0:47:23
Yeah, I guess I should have told you that.
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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
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0:47:34 --> 0:47:[privacy contact redaction]ering it as an intradermal dose like a vaccine.
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0:47:40 --> 0:47:52
I hope everybody got that.
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0:47:52 --> 0:47:57
You're only going to get 20% as much and it's going to be administered differently within
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0:47:57 --> 0:47:58
the layers of skin.
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0:47:59 --> 0:48:06
And the media claims this then will cause it to have an emergency use authorization.
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0:48:07 --> 0:48:08
Very important.
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0:48:09 --> 0:48:14
See, if they were giving it in the licensed way for the licensed indication, according
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0:48:14 --> 0:48:19
to the license, it would have liability, at least for now.
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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:[privacy contact redaction]urer, 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.
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0:48:40 --> 0:48:47
They claimed they were delivering this year and next year [privacy contact redaction]ates.
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0:48:48 --> 0:48:53
And because of these problems with their fill and finish facility, which nobody's acknowledged
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0:48:53 --> 0:49:00
what those problems are or were, that they're getting a U.S. contract manufacturer to actually
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0:49:01 --> 0:49:07
take the bulk vaccine, which they have stored for us, which is something like 16 million doses,
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0:49:08 --> 0:49:09
and we'll fill it into vials.
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0:49:10 --> 0:49:18
And probably they can also fill it into vials diluted to make up what now the government
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0:49:18 --> 0:49:[privacy contact redaction]e.
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0:49:19 --> 0:49:25
Now note also that in June and July 500,[privacy contact redaction]ered,
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0:49:26 --> 0:49:[privacy contact redaction]ered in 2020 for 1.4 million doses, blah, blah, blah.
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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.
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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.
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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:[privacy contact redaction] the 200 or 300 million ACAM2000 doses because nobody was expecting
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0:50:03 --> 0:50:08
monkeypox was going to be a problem, nor that anyone would need to be vaccinated for monkeypox
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0:50:08 --> 0:50:09
since it's a mild disease.
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0:50:09 --> 0:50:16
And the New York Times then admitted we own the equivalent of 16 million doses of bulk vaccine,
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0:50:16 --> 0:50:[privacy contact redaction]ored in Denmark. Okay. But the company had trouble delivering it. Now,
584
0:50:26 --> 0:50:[privacy contact redaction] 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.
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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.
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0:50:55 --> 0:51:[privacy contact redaction]imate that $7 billion in new funding would allow the department to support
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0:51:02 --> 0:51:[privacy contact redaction]ic end-to-end vaccine manufacturing capacity and technology transfer in the United States.
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0:51:07 --> 0:51:[privacy contact redaction]art making the whole thing here, even though we've got 16.5 million
591
0:51:12 --> 0:51:[privacy contact redaction]rophe that these hundreds of thousands of genius doses were
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0:51:24 --> 0:51:30
stranded overseas for weeks, awaiting U.S. inspection and transport. Give me a break.
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0:51:31 --> 0:51:32
Next slide.
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0:51:32 --> 0:51:37
With the $7 billion, officials estimate they could secure 19 million new doses
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0:51:37 --> 0:51:42
of monkeypox vaccine and buy all this other stuff. Next slide.
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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:[privacy contact redaction]ates didn't bottle them because it had the ACAM2000 already,
598
0:52:02 --> 0:52:[privacy contact redaction]ion was scheduled until after the monkeypox outbreak, and the FDA inspection
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0:52:09 --> 0:52:17
did not conclude until July 27th. Well, actually the first case of monkeypox was in the United
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0:52:17 --> 0:52:23
States, and the FDA inspection did not conclude until July 27th. Well, actually the first case
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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:[privacy contact redaction] that is what was holding things up. Next slide.
604
0:52:46 --> 0:52:[privacy contact redaction] in terms of the modified vaccinia anchora as a virus, you need to be aware of this because
605
0:52:53 --> 0:53:[privacy contact redaction]atform for other experimental vaccines that aren't necessarily
606
0:53:00 --> 0:53:[privacy contact redaction] smallpox or monkeypox, but for other pathogens. So somehow it can express its genes,
607
0:53:11 --> 0:53:[privacy contact redaction]icate its genome, but doesn't assemble correctly. And it's been fully approved in Canada
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0:53:18 --> 0:53:25
for smallpox and monkeypox, in the U.S. for both, and in Europe for smallpox. Next slide.
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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:[privacy contact redaction]ory 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,
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0:54:00 --> 0:54:08
I found out the terminology isn't there anymore. And now it's test and trace.
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0:54:12 --> 0:54:20
This in yellow shows you that the disease is already spreading in the community without
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0:54:20 --> 0:54:[privacy contact redaction] many cases are not being reported and therefore
615
0:54:29 --> 0:54:[privacy contact redaction], it's going to maybe slow things down,
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0:54:33 --> 0:54:[privacy contact redaction]op an outbreak. But that of course doesn't stop the people who
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0:54:40 --> 0:54:47
like the idea and the benefit, the surveillance benefits it can provide.
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0:54:49 --> 0:54:57
So next slide is when I looked up track and trace, Google told me it was an error.
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I didn't like track and trace and I went to a different browser and I got the same message.
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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:[privacy contact redaction]ill used in the U.K. But it's not being used by, I couldn't find that it was
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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
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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
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0:55:31 --> 0:55:36
happy to try and answer anything else. So thank you very much.
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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:[privacy contact redaction]ion of liability. But traditionally, Meryl, as you know, Steven, as founder of this
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0:55:59 --> 0:56:05
group, goes first on the questions. For the rest of you with questions, please put your hands up.
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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:[privacy contact redaction]ence 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:[privacy contact redaction]uff 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
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0:56:30 --> 0:56:36
keep having those conversations, but that's not the conversation for today because Meryl's not
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0:56:36 --> 0:56:[privacy contact redaction]even, questions to you?
