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OK folks I can't put this off any longer.
You aren't getting the #CoronavirusVaccine that is being sold to you by @Pfizer because the story isn't what you are being told.
And I don't care if @POTUS believes in it.
There is no #Covid19 vaccine. Let's unpick it.
You aren't getting the #CoronavirusVaccine that is being sold to you by @Pfizer because the story isn't what you are being told.
And I don't care if @POTUS believes in it.
There is no #Covid19 vaccine. Let's unpick it.
OK so @Pfizer are telling you that they have a new mRNA vaccine that they have tested on 43,000 people and with a 90% efficacy.
It's not true.
The @guardian pretend to play it down whilst whetting your appetite. Standard #mockingbirdmedia tactics. https://www.theguardian.com/world/2020/nov/09/what-has-pfizers-covid-vaccine-trial-found-and-is-this-a-breakthrough
It's not true.
The @guardian pretend to play it down whilst whetting your appetite. Standard #mockingbirdmedia tactics. https://www.theguardian.com/world/2020/nov/09/what-has-pfizers-covid-vaccine-trial-found-and-is-this-a-breakthrough
So what's the study?
It's supposed to be a concurrent phase 1-2-3 study.
We don't do those. Why? Because you need the phase 1 study to see if your new drug is not going to kill people.
Remember what happened in the UK? That was phase 1 study gone wrong.
It's supposed to be a concurrent phase 1-2-3 study.
We don't do those. Why? Because you need the phase 1 study to see if your new drug is not going to kill people.
Remember what happened in the UK? That was phase 1 study gone wrong.
There was huge publicity for this and this prompted big changes in the way phase 1 studies are conducted. Not just in the UK.
Phase 1 studies are highly controlled, particularly for new classes of drugs - like *mRNA VACCINES*
https://www.lexology.com/library/detail.aspx?g=c827f92c-2bb9-4276-a160-75a415788ddc
Phase 1 studies are highly controlled, particularly for new classes of drugs - like *mRNA VACCINES*
https://www.lexology.com/library/detail.aspx?g=c827f92c-2bb9-4276-a160-75a415788ddc
But, hey, we have "Operation Warp Speed" so that doesn't matter I guess...
So what is the Pfizer study?
Here is the European registry entry. Note it was first registered in the EudraCT in August - 3 months ago.
https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-002641-42/DE
So what is the Pfizer study?
Here is the European registry entry. Note it was first registered in the EudraCT in August - 3 months ago.
https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-002641-42/DE
The protocol is here if you want to read it...
https://pfe-pfizercom-d8-prod.s3.amazonaws.com/2020-11/C4591001_Clinical_Protocol_Nov2020.pdf
It's 146 pages. That's pretty typical for a drug study.
https://pfe-pfizercom-d8-prod.s3.amazonaws.com/2020-11/C4591001_Clinical_Protocol_Nov2020.pdf
It's 146 pages. That's pretty typical for a drug study.
You'll notice it's a phase 1-2-3 together, so there is no way to ascertain the safe dose of the drug before rolling it out to phase 2 and 3.
The protocol should be clearly dated with version number and it isn't. It's a document-in-flux (contravenes #ICHGCP)
7th November 2020?
The protocol should be clearly dated with version number and it isn't. It's a document-in-flux (contravenes #ICHGCP)
7th November 2020?
Maybe Nick Kitchin can take a break from his work at Pfizer and comment. Anyway getting back to the subject...
Pfizer reported the Phase 1 part of the study in August, hence why the European phase was initiated then (US regs less stringent) https://pubmed.ncbi.nlm.nih.gov/32785213/
Pfizer reported the Phase 1 part of the study in August, hence why the European phase was initiated then (US regs less stringent) https://pubmed.ncbi.nlm.nih.gov/32785213/
Briefly a couple of interesting points.
First, that there was a toxic dose - 100mcg.
That's fine. That's what phase 1 studies are for and why they specifically must be on fit healthy young people (unless you are trying to kill your subjects)
First, that there was a toxic dose - 100mcg.
That's fine. That's what phase 1 studies are for and why they specifically must be on fit healthy young people (unless you are trying to kill your subjects)
Second - and importantly - confirmation that the drug is stored at -80C.
It has to be if it's mRNA because mRNA degrades outside of a biological host at any higher temperature. Anybody that's worked in a lab with this stuff will confirm how unstable it is.
It has to be if it's mRNA because mRNA degrades outside of a biological host at any higher temperature. Anybody that's worked in a lab with this stuff will confirm how unstable it is.
Why so important? I'll come back to it later but storing at -80c is no mean feat.
It usually requires liquid nitrogen or heavy duty freezers. You can't do it in a standard clinic.
Dry ice will get you down to -78C, and evaporates. https://nypost.com/2020/11/10/why-pfizers-covid-19-vaccine-will-be-a-nightmare-to-distribute/
It usually requires liquid nitrogen or heavy duty freezers. You can't do it in a standard clinic.
Dry ice will get you down to -78C, and evaporates. https://nypost.com/2020/11/10/why-pfizers-covid-19-vaccine-will-be-a-nightmare-to-distribute/
Something else a bit fishy about the Phase 1 study report. The accession number.
The group say that they have deposited MN908947.3 with GenBank. This should be an RNA fragment.
This is what GenBank says...
https://www.ncbi.nlm.nih.gov/nuccore/MN908947.3
@Ayjchan @flavinkins @LynnFynn3
The group say that they have deposited MN908947.3 with GenBank. This should be an RNA fragment.
This is what GenBank says...
https://www.ncbi.nlm.nih.gov/nuccore/MN908947.3
@Ayjchan @flavinkins @LynnFynn3
The fact that they have *reported* the whole #SARSCOV2 genome as their "drug" might be important later. It certainly isn't what I would consider mRNA.
Maybe it explains the cold storage anomaly. Viral ss-RNA (i.e. the virus genome) is a lot more stable than mRNA....
Maybe it explains the cold storage anomaly. Viral ss-RNA (i.e. the virus genome) is a lot more stable than mRNA....
Anyway back to the main study - the phase 2/3 study.
Pfizer report that 43,000 patients have received the "vaccine"
OK let's unpick that. Back to the protocol. Here is the schedule for a single patient. 3 pages
Pfizer report that 43,000 patients have received the "vaccine"
OK let's unpick that. Back to the protocol. Here is the schedule for a single patient. 3 pages
Most people don't realise how intensive these studies are. They require multiple attendances and for each attendance a form needs to be filled in and all the protocols checked.
Each person involved has to know the 146-page protocol inside out.
Each person involved has to know the 146-page protocol inside out.
For a study like this a small unit with doctor, research nurse and administrator could handle maybe 20 patients. A large centre maybe 100 patients. Beyond that this paperwork is unmanageable.
Pfizer said 43000 people have been recruited....
Pfizer said 43000 people have been recruited....
So there should be 400 - 4000 recruiting centres around, all with -80C storage facilities in the same place that there are nurses, doctors and established clinical researchers.
If you belong to one of these centres please join the conversation. I have some questions for you...
If you belong to one of these centres please join the conversation. I have some questions for you...
Just as an aside some of these apparently highly advanced medical centres are in the World Bank "Tier 2" category.
I have medical and scientific colleagues from these countries who tell me what the health systems are like.
I have medical and scientific colleagues from these countries who tell me what the health systems are like.
I guess it's *possible* that they have many health centres with all these facilities and -80C freezers in these places.
Just like's it possible to catch a live cicada.
Anything is possible.
On the subject of statistics let's look at why a #covid19 vaccine study is problematic
Just like's it possible to catch a live cicada.
Anything is possible.
On the subject of statistics let's look at why a #covid19 vaccine study is problematic
Let's assume that there are 100,000 cases a day (so we are being told) of #covid19 in the US, a population of 350m, with a disease that lasts about a week.
At the peak therefore:
700,000 infected at any one time = 0.2%
Transmission rate (various studies) <= 10%
At the peak therefore:
700,000 infected at any one time = 0.2%
Transmission rate (various studies) <= 10%
This gives a susceptible prevalent population of 0.02%.
At 0.2% (peak) the numbers needs to show a 50% effect are around the magical Pfizer numbers
At 0.2% (peak) the numbers needs to show a 50% effect are around the magical Pfizer numbers
But this is a dwindling disease in most regions (actually it probably dwindled months ago but that's a thread for another day).
Add in the limited transmission rate and you now need 10x or more patients - possibly millions
Add in the limited transmission rate and you now need 10x or more patients - possibly millions
Most people don't realise that the "epidemic" that you are seeing on TV still has a prevalence of less than 0.1% in most regions.
It's impossible to recruit this many patients in a short time. enough to see a difference.
You'll need fewer patients for a 90% effect...
It's impossible to recruit this many patients in a short time. enough to see a difference.
You'll need fewer patients for a 90% effect...
But very few vaccines have that kind of effectiveness in *real world use*, i.e. out in the community.
We saw this in the HPV studies - which BTW took years to conclude - for a super effective vaccine with 98% efficacy to only have 44% effectiveness in the population
We saw this in the HPV studies - which BTW took years to conclude - for a super effective vaccine with 98% efficacy to only have 44% effectiveness in the population
[taking a break here]
OK resuming now. In case you don't believe me about the prevalence issue check out Brazil - another "hotspot". Averages 30000 cases/day = 210,000 cases/wk
Population 213m
Prevalence = 0.1%
Susceptible population = 0.01%
Most other countries have a lower prevalence.
Population 213m
Prevalence = 0.1%
Susceptible population = 0.01%
Most other countries have a lower prevalence.
There is another factor. Pfizer are one of many in a race to produce a working vaccine. Reportedly there are 157 vaccine candidates.
So you don't just need 100,000 (phase 3) trial patients.
You need 15.7m
Well that's a lot of forms.
#notachance
So you don't just need 100,000 (phase 3) trial patients.
You need 15.7m
Well that's a lot of forms.
#notachance
Not just that, but each mRNA candidate needs to be stored at -80C - for all those hundreds of thousands or millions of potential patients.
This is just not going to be possible.
But, even if we give the benefit of the doubt, there's another problem
This is just not going to be possible.
But, even if we give the benefit of the doubt, there's another problem
mRNA vaccines have never been shown to work in a population. It's a totally experimental drug delivery system.
Papers as recently as *this year* were saying this. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7580817/#CR82
Papers as recently as *this year* were saying this. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7580817/#CR82
There are others but here's a Zika candidate vaccine published last year which failed in an animal model. That is ten years away from getting a functioning vaccine in humans. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6789535/
So, let's say this technique is miraculously made to work in humans (as the test subjects, because there don't seem to be any valid animal models)
What are they trying to do?
The mRNA vaccine attempts to use the cells of the host to produce the antigen...
What are they trying to do?
The mRNA vaccine attempts to use the cells of the host to produce the antigen...
Pfizer says that they are encoding the #SARSCOV2 spike protein (the sticky out bits) using their mRNA.
Remember?
So the idea is that the vaccine makes your cells produce this.
Remember?
So the idea is that the vaccine makes your cells produce this.
There is a bit of a problem with this though. There is one good reason why we have never been able to make a #coronavirus vaccine. We've been trying for 20 years.
ADE and related inflammatory over-responses. https://pubmed.ncbi.nlm.nih.gov/32659783/
ADE and related inflammatory over-responses. https://pubmed.ncbi.nlm.nih.gov/32659783/
Essentially coronavirus vaccines have been plagued with this problem for years.
You give a fragment of the spike protein.
The host mounts an antibody response but it's not a neutralising antibody.
You re-expose.
The host inflammatory system goes crazy - potentially lethal.
You give a fragment of the spike protein.
The host mounts an antibody response but it's not a neutralising antibody.
You re-expose.
The host inflammatory system goes crazy - potentially lethal.
It's a problem that has never been resolved yet the mRNA vaccine delivery system studies have no interest in it.
Strange? https://pubmed.ncbi.nlm.nih.gov/31692019/
Strange? https://pubmed.ncbi.nlm.nih.gov/31692019/
The debate about ADE is still ongoing yet the mRNA vaccine systems (which in theory are merely a delivery system for a viral protein) don't pay any attention to resolving it.
https://www.pnas.org/content/117/15/8218
https://www.pnas.org/content/117/15/8218
Of course there is another aspect to the study sample size of the "huge" 43,000 Pfizer study. At 0.1% prevalence of covid (or less) the probability that the risk of ADE will be tested is low.
If the risk of ADE was 10% you would only see it in 2 patients in their study....
If the risk of ADE was 10% you would only see it in 2 patients in their study....
That risk would be presented as 2/43,000 and the vaccine would be considered "safe" because the risk of ADE was so low.
But it would still be far higher than the risk of an unvaccinated person dying of #SARSCOV2 in a post-covid environment.
But it would still be far higher than the risk of an unvaccinated person dying of #SARSCOV2 in a post-covid environment.
It's a numbers game for @Pfizer and you can guarantee that the numbers will look favourable for them.
Especially the numbers in their bank account.
/END
Especially the numbers in their bank account.
/END
Just to labour the point about storage... Here's how Pfizer say they'll take care of it (without really explaining how)
https://www.supplychaindive.com/news/pfizer-vaccine-supply-chain-BioNTech-fedex-ups-dhl/588784/
h/t @JesseMatchey
https://www.supplychaindive.com/news/pfizer-vaccine-supply-chain-BioNTech-fedex-ups-dhl/588784/
h/t @JesseMatchey
Archived here https://archive.is/836q5
Extra reading for those interested in the storage problem - a very good article here https://www.nakedcapitalism.com/2020/11/the-super-cold-covid-vaccine-distribution-problem.html
Extra stats for the numbers people. The endpoints of these studies are "infection" - not deaths.
According to the #covid19 "data" 3.5% of the US population were "infected". 0.07% death rate....
According to the #covid19 "data" 3.5% of the US population were "infected". 0.07% death rate....
The issue is supposed to be deaths remember?
OK so in the 43,000 nobody is reported to have died of covid. That gives a death rate of less than 0.002%.
To show a 90% reduction you need...
(yes that's >1m people)
OK so in the 43,000 nobody is reported to have died of covid. That gives a death rate of less than 0.002%.
To show a 90% reduction you need...
(yes that's >1m people)
And if your risk of ADE is only 1% your chance of getting ADE following such a vaccine potentially far outweighs the risk of you dying from not having a vaccine.
That's why the death rates and ADE rates are suppressed in the protocols.
Doesn't fit the narrative.
That's why the death rates and ADE rates are suppressed in the protocols.
Doesn't fit the narrative.
Makes the same point.... https://www.creators.com/read/michelle-malkin/11/20/covidgate-the-corruption-of-clinical-trials-part-one
Another illustration of the "numbers of deaths needed" problem... https://twitter.com/Arkancideisreal/status/1336471619330396160?s=20
