A warm welcome to today’s talk is Wednesday the 9th of march now I’ve been asked for a long time to look into these Pfizer documents and the food and drug administration documents released as a result of the freedom of information request and it’s taken a while to work out what’s going on here but I’m not saying I’m there yet but I’m going to show you what I’ve got and it looks like in the first three
Months there was 42 000 adverse events reported after the marketing of the FISA vaccine and 1223 deaths now this is just quite alarming really so so let’s look at this now this starts off as far as I can tell here public health and medical professionals for transparency and this is a group that seems to be wanting just that they want
Transparency and there’s a large list of uh prestigious highly qualified signatories on that group now what seems to have happened is they’ve put in this information or freedom of information uh act request using the solicitors and uh these documents uh are now in the public domain they’re all on this on this website here so I’ve put the link in so you can see all of these for yourself and a lot of these have.
Just been released as a result of this freedom of information request itself so that was the request and I’m not quite sure what that is I think that’s uh that’s an application to the court but what is fairly clear is this uh the united states district court for the northern district of texas um and this is uh the plaintiff which I believe is is the public health and medicines.
Uh public health and medical transfer professionals for transparency group against the food and drug administration and the judge here has ordered the food and drug administration rolling uh productions of each due to the first business day of each month instead of every 30 days okay that’s administrative things but the point is there uh the FDA will produce 10 000 pages from the first two productions
The FDA will produce eighty thousand pages on or before the second of May first of June and first of July so it’s ordering a huge amount of data release now the immediate question in my mind is why wasn’t this data in the public domain already surely we want to know this information to make informed health care decisions anyway this group the um this group here if you click on thereon.
Their website goes into their website and you can click on uh Pfizer’s documents there that take you through to this and the one I’m looking at here today is this one here post-marketing experience and these are now all uh fully uh downloadable uh courtesy of uh courtesy of the courtesy of this site they can now be downloaded which is great and this is the one we want to.
Look at particularly so that’s kind of the convoluted story so far why has it been so difficult to get this information court orders we’re talking about a health issue here this should surely this should have been public domain information from the start so that we could have been well informed um but let’s look at it anyway um so that’s the group there that’s their link
Uh, freedom of information all those things I’ve just shown you are all there and that’s the court order so you can actually download these for yourself and that’s the list of downloadable documents which as we’ve said is is extensive so what we’re looking at here is this one this is where most of this information is coming from and this was originally confidential to Pfizer before it had.
Been released and it’s quite an extensive document and I must say it’s not a particularly easy read it’s quite difficult to make sense of what there are a lot of abbreviations and things they do give you a list of abbreviations that helps anyway a cumulative analysis of post-authorization adverse events reporting so this is putting together the analysis of the post-authorization.
This is post marketing after the emergency authorization of the FISA vaccine as I say check on it for yourself so this is adverse events reporting and it’s only a very early stage it’s only from the 1st of December 2020 and of course the Pfizer wasn’t approved I don’t think it was in the states until the 11th of December through to the 28th of February so it’s three months at most.
Uh so through to the 28th of February a total of forty-two thousand and eighty-six cases reported some medically confirmed or there’s none medically confirmed but that’s the data set this into working off forty-two thousand and eighty-six adverse events it would have been good to know about this at the time wouldn’t it um.
Containing 158 000 different events so obviously some people having more than one event most cases were received from the united states uh 13739 but also from the united kingdom also from Italy also from Germany also from France also from Portugal also from Spain and from 53 other countries as well so um quite an impressive piece of.
Post-marketing data gathering really so obviously we want to take these and we want to what we should do now really is take these numbers the uh 1223 associated uh fatalities and the 42 000 and a few um associated adverse events and relate that to the number of vaccines given but this is the part that deals with the vaccines given and it seems to me that this is redacted now if that is redacted why on earth.
Would they want to redact that information because that means we could work out the percentages of people getting adverse reactions and the percentage of people dying due to vaccination but we can’t because we don’t actually know how many vaccines were given out why would they want to reduce that information why wouldn’t we be able to access those percentages unless i’m wrong and that means something else but I think it means.
Redacted do let me know since the 11th of December 2020 Pfizer biotech vaccine has been available under emergency use authorization in the united states which we’re looking at as today’s example now this the final approval wasn’t given until the 21st of August and at that point uh Janet Woodcock, Dr. Janet Woodcock acting FDA commissioner said this and this is on that site there check it out
This is as reference space as I can make it while millions of people have already safely received covered 19 vaccines we recognize that for some time the FDA approval of a vaccine may now install additional confidence to get vaccinated so in other words, this is the move from emergency use approval to formal approval now she’s saying safely here
But this time my understanding is she would have had access to this document so how would you say it’s safe when this document is indicating uh there’s been 1223 associated deaths that’s that bit there with the redacted bitten
Um you can download this you can get your own pdf version of this of packed full of use very very uh useful information but as I say not that easy to access personally for me it took quite a bit of effort to get into it uh today’s milestone this is talking on the 21st of august uh put us one step closer to altering the course of this pandemic in the united states consequently Janet Wilcock.
So 21st of august and remember this data that we’re looking at here uh this data here only goes through to the was the one was at the end of February wasn’t it 28th of February so what did she have access to this data then if so how can she say it’s uh safely let me know if you understand that
Because it doesn’t make too much sense to me so um moving on from this statement here from dr woodcock about the safety of the vaccines that have been received by millions of people let’s move on to the adverse offensive events reported as of the 28th of February so that’s a march April May June July or basically six months before and of course the data
In between times um I don’t think that’s been released yet it’s going to be released as we saw on this rolling basis um anyway um so information that was presumably available uh this is in the information that was available to those who were allowed to see it at the end of February we believe um that contains the greatest number so
These are greater than uh two or greater than two percent of events uh where general disorders and administrative site conditions they accumulated uh 51 000 adverse reactions adverse events there I think that’s adverse events nervous system disorders so these uh vaccines that have been safely administered were associated with 25 957 nervous system disorders these vaccines that have been safely
Administered according to the FDA statement there were associated with 17 283 musculoskeletal events these vaccines that have been safely administered are associated with 1000 with 14 096 gastrointestinal disorders these vaccines that have been safely administered I could go on couldn’t you can read the numbers there skin 8 400 respiratory thoracics mediastinal the mediastinum is a little bit in the
Middle there between the lungs 884 infections and infestations six thousand foot four thousand six hundred and ten um sometimes I read these numbers wrong so if I read the numbers wrong the number that’s written down is the correct one so I just um have difficulty reading numbers sometimes while making videos
So it’s a number that’s written down is accurate I do check those um injury poisoning and procedural complications as well that as well cardiovascular this is adverse events of uh special interest an e s is adverse events of special interest a number of uh number of cases uh because of course we talked to kyle and adam and people about adverse
Cardiac events or presumed no associated adverse cardiac events number of cases 1 403 3.3 of the total and post-marketing adverse events data set not 3.3 of people that had the vaccine 3.3 of the adverse events dating said and that is all available there um obviously you can’t see it on your phone on your screen but if you download it all the information’s there
Or broken down really quite uh nicely about the adverse events of special interest uh that had been noted during the safe administration of this vaccine um I think you can tell I’m not a happy man um summary um just before yeah there we go um
Oh yeah that’s just the ones that are medically confirmed and not medically confirmed right summary in conclusion now this is the summary and conclusion of this report uh so long report lots of information there and I just want to check actually because the summary and conclusion here on my notes say that um review of the available data for this
Cumulative post-marketing experience confirms a favorable benefit-risk balance for the FISA vaccine that seems to be the conclusion of this report I’m just struggling to see if it really says that I know it does say that because I cut and pasted this I mean uh having said all this is is that they’re uh
Is that their conclusion there we go no I got it right there it is you won’t be able to see it very well but that’s what it says there they conclude there’s a good risk-benefit analysis now addition in addition to this it also covers um additional events adverse events of special interests and here’s the list here now again you won’t be able to see it
But this is I can’t remember how many it’s listed here it looks like hundreds I think they do say somewhere but all these are uh syndromes or conditions of special interest associated with the period of time after the vaccine now to be fair some of these probably only occurred once or twice we don’t know but um
That is one heck of a long list of medical uh conditions and again I certainly wasn’t aware of all these until I uh until I read this and even then I’m still I still don’t know what a lot of them means um the the the list is is is long
Uh quite incredible really um why weren’t we made available but made aware of these at the time if we were aware of them at the time we could have had an index of suspicion for them and kept an eye out for them peter marks md phd director of the FDA center for biological evaluation and research says this and I think this is from the FDA site i
Showed you the reference for before so um so this if I’m right this will be written on the 21st of august or published on the 21st of August and as we say this data set is six months before our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine we evaluated scientific data and information including in hundreds of thousands of pages so it
Looks like they’ve looked through it all hundreds of thousands of pages conducted through our own analysis of the FISA vaccine safety and effectiveness and performed detailed assessments of the manufacturing processes okay he says this the public is counting on the on a safe and effective vaccine which it now transpires it wasn’t as safe as we’ve been led to as it has had been intimated
The public and the medical community can be confident can we confident that although we approve this vaccine expeditiously it was fully in keeping with existing high standards for vaccines in the united states so they are saying that the vaccines between um the 11th of December when it was first given emergency authorization and this report on the 21st of august
From the FDA was saying that millions of doses have been safely administered I’ll let you decide whether the information that’s now been released indicates uh safe administration as we just look at some of those potentially associated conditions um I’m just really quite bemused and
Also, you know we had our politicians and medical leaders telling us that this vaccine’s safe and effective all this time but I can only assume well I don’t I simply don’t know this data was available to the FDA was this data available to the regulatory authorities in the UK in Germany in Canada in Australia I I would assume so I would assume so
Finally, has this changed the risk-benefit analysis of giving vaccines compared to the condition well um Austria this is the relevant minister senior politician in Austria the law passed in January uh for mandatory vaccinations in force since early February for a mandatory vaccination in Austria which
I remember recovered at the time she now says it’s not proportionate because of the relatively mild symptoms experienced by most people who contract omicron so um it looks like Pfizer and the FDA concluded that the risk-benefit analysis was favorable way back in the early part of 21 2021 could argue about that um given that there seems to be 1223
Associated deaths from an unknown vaccinate unknown number of Pfizer vaccinations in the first three months I would question that now um but now with omicron because it’s so much less uh people are getting uh so much less sick so much lower hospitalization rates and lower death rates from micron not gone away but much less
Surely that’s complete well that has I think we can state as a fact that has changed the risk-benefit analysis so really governments like Austria need to be reviewing the situation against the increased risks of vaccination, in this case, the FISA vaccination we don’t have the full details on the other one we need to compare that now risk that we are now learning about due
To this freedom of information activity uh uh come and compare that to the known risk from omicron this may be time for a new the risk-benefit analysis has changed maybe that needs to change through into policy but I must say I just feel so you know why on earth does it take the signature from a just a judge really what is that about
So they go um we’ve learned things here that we didn’t know at the time um at the time we were taking the word of uh these senior people the other thing about this is why hasn’t the mainstream media doesn’t seem to have taken this up at all I would have thought this is a complete scandal perhaps on a par with watergate or
The perfumer crisis or whatever scandal you have in your country um it doesn’t seem to be taken up, of course, everyone’s to some extent rightly preoccupied with the war now but you know there’s still plenty of mental capacity in these countries to ask sensible questions I would have thought and the mainstream media just don’t seem to be taking this up as far as I can as far
As I can see so there we are that’s um that’s the situations I’ve worked it out so far I mean you could argue because there’s a lot of people dying with a lot of people dying with coronavirus of course but then there’s been times um in 40 foot right you know I’ve been
Practicing for about 40 years but there’s a lot of that was teaching but I’ve done a lot of clinical I’ve been a clinical nurse for a long long time and once again recently but then there are times where you don’t manage to save someone’s life, of course, um and that’s
Kind of uh acceptable in a sense because men and men and women are mortal of course we are even children die sometimes so that that happens but if it’s something that I’ve caused then that’s a bit of a different thing and there have been times where I’ve reflected on interventions that I have carried out and
Come to consider that uh perhaps accelerated someone’s death now I was probably doing that for the absolutely right reasons I would hope um and there are times where it’s acceptable so sometimes we give terminal patients analgesia um painkillers knowing that that may well accelerate their death and that that can be acceptable for quality of
Life um but to actually do something that does harm to people that are otherwise healthy you could argue it is a fundamental breach of the Hippocrates idea that first do no harm and it appears it appears we’ve done some harm um as far as we know all of our current
Regulatory bodies are still saying the risk-benefit analysis is favorable but in terms of on we could argue about the past we could argue about delta but in terms of monochrome the risk-benefit analysis has changed and let’s hope that starts feeding through into into into into policies and I think I think maybe the other thing that this has done is just destroyed it in my view it’s just destroyed trust in authority
You know so you’ll get senior people saying this is safe and effective and it turns out to be it turns out that their understanding of the word safe and my understanding of the word safe are really quite different so are we going to trust these people in future it’s a completely separate matter probably waffling a little bit now but the the the reason that most governments didn’t believe that the
Russians were going to invade Ukraine was not because there was poor intelligence there it was because Colin Powell and his mates had said Saddam Hussein and Tony Blair and all these other people at the time said uh Saddam is saying could be reigning weapons of mass destruction down on us in 45 minutes due to fraudulent intelligence so the trust had been lost the trust had been lost
As a pretext as I see it as a pretext for the for the Iraq invasion and um and now when there was genuine intelligence people didn’t believe it so is the situation analogous here you know is there going to be something coming along in future where we really really really need to trust our healthcare leaders and as a result of this maybe some of us