Hi Seb, you (and us, we hope) are excused from being confused. What I quoted were the relevant exclusions criteria to Vivian’s comment.
The list is from CLINICAL TRIAL PROTOCOL INCLUDING AMENDMENTS NOS. 01 TO 06
BNT162-01 Version: 9.0 Date: 05 OCT 2020. So they have progressed from a Phase I to Phase I/II presumably on a rolling basis, but the exclusion criteria are virtually the same for asthma, although phrased differently.
We are making the protocol available in Part 3 (4 January).
On your second point this will be dealt with in subsequent posts.
Reconstructing what went on is not an easy task because of the secrecy, fragmentary nature of the evidence and politics surrounding the whole issue.
Yes Vivian, these are the EXCLUSION criteria for the Phase I study. I had a look at the exclusion criteria for the subsequent trial (the timeline is not that clear), Phase I/II protocol and got this at page 14 and 15:
For older volunteers: Have a condition known to put them at high risk for severe
COVID-19, including those with any of the following risk factors:
− Hypertension
− Diabetes mellitus
− Chronic obstructive pulmonary disease
− Asthma
− Chronic liver disease
− Known Stage 3 or worse chronic kidney disease (glomerular filtration rate
<60 mL/min/1.73 m2)
− Serious heart conditions, such as heart failure, coronary artery disease, or
cardiomyopathies
− Sickle cell disease
− Cancer (except for Cohort 13).......etc
But earlier they listed:
Regular receipt of inhaled/nebulized corticosteroids (except for Cohort 13).
Did I get this right: people with Asthma were excluded from the test pages of yon vaccine? How come then that, once the vaccines were available, patients with asthma were told to get vaccinated because having asthma means they're at 'greater risk'?
I'm puzzled - but that might be due to my faulty understanding ...
Immuno compromised also, Bourla, on video, said anyone immunocompromised should not get "the vaccine", but have monoclonal?? , think that's the word, antibodies, instead. My friend, who'd experienced childhood asthma, had a recurrence after her Pfizer jabs. There's so many body parts affected by these jabs, and, the people with the least robust health were targetted for multiple injections, knowing no toxicity studies undertaken.
My hubs only has one fully operative lung, thanks to a brush with pneumonia in January 2018. He's on a then vert new drug, NACYS as well as steroids for asthma. Yes, his name was one of the first out of the hat when the jabbers came calling. He survived one dose of AZ. I have asthma, I declined obstinately. My two boys are autistic and they are still pestering us to jab them.
There in plain sight. Astonishing. Terrifying. Most people I know who rushed to get vaccinated - many several times - on Phase 1 study exclusions should have been excluded or at the very least offered a personal risk versus benefit consultation. Every one of them was badgered ad infinitum on the basis Covid 19 presented a severe risk to them. INCREDIBLE. I am non medical so am concerned I am making a fool of myself…..if so, please forgive this ignorant unvaxxed Hobbit.
"The company (Astra Zeneca') confirmed that the vaccine’s mechanism of action is expected to induce lymphopenia, and all events in phase I were transient and resolved entirely."
...but "The EWG (MHRA's COVID-19 Vaccines Benefit Risk Expert Working Group) noted the potential signal of lymphadenopathy in the clinical trial data: 44 events in the vaccine arm related to upper limb lymph nodes compared to 4 in the placebo group."
'The EWG also noted a potential linkage to the 6 cases of appendicitis in the vaccine arm compared to one in the placebo group'
"The lymphopenia issue should have been a wake-up call, as lymphocytes are our guardians against viral disease....... but, testing for lymphopenia was not conducted in phase II/III of the trial."
I'm thinking those that came down with appendicitis, or similar condition, in the days or weeks following treatment with Astra Zeneca might have some pause for thought.
Since I'm not a medic I may be missing the point, but one can't help noticing the sentence "44 events in the vaccine arm related to upper limb lymph nodes compared to 4 in the placebo group " is seriously ambiguous. Is 48 the total of "events"? In which case, does "related to" mean "were restricted to" ? So are we meant to conclude that the nunbers are trivially small?
I agree things are not crystal clear but I think it means 44 people in the vaccine study treatment group suffered lymphadenopathy close to the vaccination site compared to 4 people in the control group. I don't know how many subjects were in each group.
I'm a bit confused by your transition from discussing one trial (BNT162b2), to looking at the exclusion criteria for a ?different? study (C4591001). Important issues come out from looking at each of them: the 36 Secret Questions from the first, and the exclusion of anyone "at high risk" from the second. But I don't understand how they're related.
On the second question: I do hope that "high risk" people were included in later phases. Because, in my informed, but hardly qualified - let alone "expert" - opinion, the high risk population (suitably defined, i.e. not as in the document you copied above) is precisely the group who _may_ have gained some benefit from the mRNA 'treatment'. For everyone else, it was all risk and no benefit.
" I do hope that "high risk" people were included in later phases. "
reasonable folks like you Seb would expect that; but ...... for those paid royally as facilitators/enablers, those questions seem far, far away ......
instead you advocate it will save the unwell and compromised; exclude those categories from the only study that you actually do; so you don't get any whoopsies ....... then you triumphantly laud your results in the healthiest souls you could find for your "randomised" study ..... ; (and where you had excluded as best you could anyone could embarrass you by falling unwell);
and having sung your own virtues and your marvellous product, you confidently say now that all the frail and unwell should have this miracle product .... stands to reason, guv ...
A friend of ours had double pneumonia, appendicitis and cancer in the spine..My husband is one of eight retired firefighters and he is the only one with no serious health conditions (including the friend above). He is also the only one who was never jabbed. Their ages range from 60 to 73.
James Roguski's stack has recent articles on the trial data and also post jab AE studies. I know people who survived clots, in lungs, colon and leg, some who didn't, deaths from "turbo" cancers, 3 diabetic type, from new onset, to severe complications, plus numerous debilitating, but not quite lifethreatening illnesses, lots of pains, eye probs, loss of mobility, worse one being finally diagnosed with disautonomia, where all your automatic body reactions to control breathing, blood pressure, heart rate, bladder and bowel functions, muscles, etc., all haywire and she feels totally abandoned by docs. With this taking so long to be diagnosed, no-one is relating to jabs. Whilst majority here are 60+, T1diabetes is another teenage girl. Another one, dead baby, born 32 weeks, lived for a couple of weeks, then died. Mother, young nurse, extended family member, oh, and quite a few dementias now in elderly, too. Terrifying stuff, and I think now, some are at last, wondering if the jabs may have something to do with their health.
an X-Spurt will superiorly wave his effete arm Sandie; and dismiss this as pure coincidence;
in the 2019? study on bempedoic acid, " 2 people died on the placebo: and 13 died taking bempedoic acid" but the statin X-Spurts were airily able to dismiss this as not significant; as they could not see how folks could be dying: no clear reason to them, so just dismiss it ....
Our daughter, healthy, fit, mid-twenties, normal BMI had one Pfizer shot and then ended up with an abdomen with multiple abscesses around ovary, appendix, diagnosed 8 months later. Cultured a normal commensal small intestinal bacteria, but the original focus of this infection was never clear.
I have wondered, as the presentation was so unusual.
Sounds terrible and serious. Hope she's doing ok now. My young, very healthy adult daughter, unbeknown to me, who I begged to wait, took Moderna. I've no idea when, but Christmas 2021, she sought emergency treatment for strep throat, she'd had tonsils removed as a child with no throat probs since. Her partner got bad ear infection requiring treatment too. Later, (after 2nd jab, maybe), got ill with a cold so bad she was laid up in bed for a week and she said she thought she was dying! I am a very worried mum, wondering what's next. Since 2022, no further illnesses, touch wood. I'm hoping their bodies have repaired enough to keep illnesses away.
Myra, there may be a pattern here. My 61 yr old apparently healthy wife became suddenly ill almost exactly a month after receiving her second Pfizer injection.
She was diagnosed as suffering from Typhilitis an inflammation of the cecum, which is a serious illness that affects people who have a weak immune system, often from cancer, AIDS, or organ transplant.
She recovered after five days of inpatient IV antibiotics and a further 6 days of Augmentin as an outpatient.
Despite further investigations no cause was ever found.
If someone is immuno compromised, transplanted organ type, are they "safer" because they aren't making antibodies which attack cells making these foreign proteins, or are they worse off, and filling up with SPs which eventually kill them with so called Covid?
Hi Seb, you (and us, we hope) are excused from being confused. What I quoted were the relevant exclusions criteria to Vivian’s comment.
The list is from CLINICAL TRIAL PROTOCOL INCLUDING AMENDMENTS NOS. 01 TO 06
BNT162-01 Version: 9.0 Date: 05 OCT 2020. So they have progressed from a Phase I to Phase I/II presumably on a rolling basis, but the exclusion criteria are virtually the same for asthma, although phrased differently.
We are making the protocol available in Part 3 (4 January).
On your second point this will be dealt with in subsequent posts.
Reconstructing what went on is not an easy task because of the secrecy, fragmentary nature of the evidence and politics surrounding the whole issue.
Bear with us please and keep commenting.
Best, Tom
Yes Vivian, these are the EXCLUSION criteria for the Phase I study. I had a look at the exclusion criteria for the subsequent trial (the timeline is not that clear), Phase I/II protocol and got this at page 14 and 15:
For older volunteers: Have a condition known to put them at high risk for severe
COVID-19, including those with any of the following risk factors:
− Hypertension
− Diabetes mellitus
− Chronic obstructive pulmonary disease
− Asthma
− Chronic liver disease
− Known Stage 3 or worse chronic kidney disease (glomerular filtration rate
<60 mL/min/1.73 m2)
− Serious heart conditions, such as heart failure, coronary artery disease, or
cardiomyopathies
− Sickle cell disease
− Cancer (except for Cohort 13).......etc
But earlier they listed:
Regular receipt of inhaled/nebulized corticosteroids (except for Cohort 13).
Best wishes, Tom.
Did I get this right: people with Asthma were excluded from the test pages of yon vaccine? How come then that, once the vaccines were available, patients with asthma were told to get vaccinated because having asthma means they're at 'greater risk'?
I'm puzzled - but that might be due to my faulty understanding ...
Immuno compromised also, Bourla, on video, said anyone immunocompromised should not get "the vaccine", but have monoclonal?? , think that's the word, antibodies, instead. My friend, who'd experienced childhood asthma, had a recurrence after her Pfizer jabs. There's so many body parts affected by these jabs, and, the people with the least robust health were targetted for multiple injections, knowing no toxicity studies undertaken.
My hubs only has one fully operative lung, thanks to a brush with pneumonia in January 2018. He's on a then vert new drug, NACYS as well as steroids for asthma. Yes, his name was one of the first out of the hat when the jabbers came calling. He survived one dose of AZ. I have asthma, I declined obstinately. My two boys are autistic and they are still pestering us to jab them.
There in plain sight. Astonishing. Terrifying. Most people I know who rushed to get vaccinated - many several times - on Phase 1 study exclusions should have been excluded or at the very least offered a personal risk versus benefit consultation. Every one of them was badgered ad infinitum on the basis Covid 19 presented a severe risk to them. INCREDIBLE. I am non medical so am concerned I am making a fool of myself…..if so, please forgive this ignorant unvaxxed Hobbit.
Shocking, isn't it? I don't think one needs to be medical, just critical thinking.
"The company (Astra Zeneca') confirmed that the vaccine’s mechanism of action is expected to induce lymphopenia, and all events in phase I were transient and resolved entirely."
...but "The EWG (MHRA's COVID-19 Vaccines Benefit Risk Expert Working Group) noted the potential signal of lymphadenopathy in the clinical trial data: 44 events in the vaccine arm related to upper limb lymph nodes compared to 4 in the placebo group."
'The EWG also noted a potential linkage to the 6 cases of appendicitis in the vaccine arm compared to one in the placebo group'
"The lymphopenia issue should have been a wake-up call, as lymphocytes are our guardians against viral disease....... but, testing for lymphopenia was not conducted in phase II/III of the trial."
I'm thinking those that came down with appendicitis, or similar condition, in the days or weeks following treatment with Astra Zeneca might have some pause for thought.
Since I'm not a medic I may be missing the point, but one can't help noticing the sentence "44 events in the vaccine arm related to upper limb lymph nodes compared to 4 in the placebo group " is seriously ambiguous. Is 48 the total of "events"? In which case, does "related to" mean "were restricted to" ? So are we meant to conclude that the nunbers are trivially small?
I agree things are not crystal clear but I think it means 44 people in the vaccine study treatment group suffered lymphadenopathy close to the vaccination site compared to 4 people in the control group. I don't know how many subjects were in each group.
I'm a bit confused by your transition from discussing one trial (BNT162b2), to looking at the exclusion criteria for a ?different? study (C4591001). Important issues come out from looking at each of them: the 36 Secret Questions from the first, and the exclusion of anyone "at high risk" from the second. But I don't understand how they're related.
On the second question: I do hope that "high risk" people were included in later phases. Because, in my informed, but hardly qualified - let alone "expert" - opinion, the high risk population (suitably defined, i.e. not as in the document you copied above) is precisely the group who _may_ have gained some benefit from the mRNA 'treatment'. For everyone else, it was all risk and no benefit.
I may be missing some context here.
" I do hope that "high risk" people were included in later phases. "
reasonable folks like you Seb would expect that; but ...... for those paid royally as facilitators/enablers, those questions seem far, far away ......
instead you advocate it will save the unwell and compromised; exclude those categories from the only study that you actually do; so you don't get any whoopsies ....... then you triumphantly laud your results in the healthiest souls you could find for your "randomised" study ..... ; (and where you had excluded as best you could anyone could embarrass you by falling unwell);
and having sung your own virtues and your marvellous product, you confidently say now that all the frail and unwell should have this miracle product .... stands to reason, guv ...
My neighbour's teenage daughter had to have her appendix removed after one Moderna injection.
A friend of ours had double pneumonia, appendicitis and cancer in the spine..My husband is one of eight retired firefighters and he is the only one with no serious health conditions (including the friend above). He is also the only one who was never jabbed. Their ages range from 60 to 73.
James Roguski's stack has recent articles on the trial data and also post jab AE studies. I know people who survived clots, in lungs, colon and leg, some who didn't, deaths from "turbo" cancers, 3 diabetic type, from new onset, to severe complications, plus numerous debilitating, but not quite lifethreatening illnesses, lots of pains, eye probs, loss of mobility, worse one being finally diagnosed with disautonomia, where all your automatic body reactions to control breathing, blood pressure, heart rate, bladder and bowel functions, muscles, etc., all haywire and she feels totally abandoned by docs. With this taking so long to be diagnosed, no-one is relating to jabs. Whilst majority here are 60+, T1diabetes is another teenage girl. Another one, dead baby, born 32 weeks, lived for a couple of weeks, then died. Mother, young nurse, extended family member, oh, and quite a few dementias now in elderly, too. Terrifying stuff, and I think now, some are at last, wondering if the jabs may have something to do with their health.
"He is also the only one who was never jabbed"
an X-Spurt will superiorly wave his effete arm Sandie; and dismiss this as pure coincidence;
in the 2019? study on bempedoic acid, " 2 people died on the placebo: and 13 died taking bempedoic acid" but the statin X-Spurts were airily able to dismiss this as not significant; as they could not see how folks could be dying: no clear reason to them, so just dismiss it ....
I find this both interesting and disturbing.
Our daughter, healthy, fit, mid-twenties, normal BMI had one Pfizer shot and then ended up with an abdomen with multiple abscesses around ovary, appendix, diagnosed 8 months later. Cultured a normal commensal small intestinal bacteria, but the original focus of this infection was never clear.
I have wondered, as the presentation was so unusual.
We will likely never really know…
Sounds terrible and serious. Hope she's doing ok now. My young, very healthy adult daughter, unbeknown to me, who I begged to wait, took Moderna. I've no idea when, but Christmas 2021, she sought emergency treatment for strep throat, she'd had tonsils removed as a child with no throat probs since. Her partner got bad ear infection requiring treatment too. Later, (after 2nd jab, maybe), got ill with a cold so bad she was laid up in bed for a week and she said she thought she was dying! I am a very worried mum, wondering what's next. Since 2022, no further illnesses, touch wood. I'm hoping their bodies have repaired enough to keep illnesses away.
Myra, there may be a pattern here. My 61 yr old apparently healthy wife became suddenly ill almost exactly a month after receiving her second Pfizer injection.
She was diagnosed as suffering from Typhilitis an inflammation of the cecum, which is a serious illness that affects people who have a weak immune system, often from cancer, AIDS, or organ transplant.
She recovered after five days of inpatient IV antibiotics and a further 6 days of Augmentin as an outpatient.
Despite further investigations no cause was ever found.
"We will likely never really know…"
and they don't want you to know, Myra ......
So in the Phase 1 the lymphopenia resolved? To what? Is that 16% lymph's, or 18 or 20???
Did they run a battery, to see if t-cell exhaustion was present after spiking the IGG??
Very interesting. Thanks for all your hard work and geezering. As a late sixties curmudgeon I appreciate it.
" If you are infected
.. or at significant risk of it
.. and vaccinated, you have little immunity to fight SARS-CoV-2."
.. that does assume it exists;
exactly; the screamingly obvious that no-one was allowed to talk about
If someone is immuno compromised, transplanted organ type, are they "safer" because they aren't making antibodies which attack cells making these foreign proteins, or are they worse off, and filling up with SPs which eventually kill them with so called Covid?