Read on Twitter
I went through the whole Pfizer protocol today for the mRNA vaccine trial.
Aside form the trial reaching at data with little statistical significance, the protocol is full of holes and questions. See below, why.
@RichieAllenShow @MattHancock
https://pfe-pfizercom-d8-prod.s3.amazonaws.com/2020-09/C4591001_Clinical_Protocol.pdf
Aside form the trial reaching at data with little statistical significance, the protocol is full of holes and questions. See below, why.
@RichieAllenShow @MattHancock
https://pfe-pfizercom-d8-prod.s3.amazonaws.com/2020-09/C4591001_Clinical_Protocol.pdf
1/ Phase 1 of the trial included a massive 15 participants, receiving varying doses of 2 types of mRNA vaccine.
BNT162b1 (a modRNA encoding glycoprotein receptor binding domain)
and BNT162b2 (P2 mutant perfussion spike protein)
Both using lipid nanoparticle composition.
BNT162b1 (a modRNA encoding glycoprotein receptor binding domain)
and BNT162b2 (P2 mutant perfussion spike protein)
Both using lipid nanoparticle composition.
2/ Off the basis of the results of all 15 participants, the study decided to go with BNT162b2 at 30 microgram doses, 2 doses spaced 21 days apart. 12 received the vaccines/ the other 3 received the placebo.
Phase 1 included ages 18-55 and 65-85.
Phase 2/3 includes 16-55 years
Phase 1 included ages 18-55 and 65-85.
Phase 2/3 includes 16-55 years
3/ Phase 1 looked at: local and systemic reactions at 7 days, adverse events at 1 month after second dose and serious adverse events at 6/12.
Immune response at: 7 and 21 days, 1 month, 6 months and 24 months after second dose.
Immune response at: 7 and 21 days, 1 month, 6 months and 24 months after second dose.
4) Question to ask: did all Phase 1 candidates have full follow up to 24 months already? I think we know the answer to that one.
5) Phase 2&3: Efficacy of prophylactic ay 7 days. Safety profile of only the first 360 participants (statistically significant??)
Local and systemic effects at 7 days, immune response at 1/6/12 and 24 months
Adverse event 1 month, serious adverse events 6 months.
Again??
Local and systemic effects at 7 days, immune response at 1/6/12 and 24 months
Adverse event 1 month, serious adverse events 6 months.
Again??
6) Authors of protocol admits " the sample size for phase 1 study is NOT based on any statistical hypothesis testing"
Total participants 43,998= 21,999 received the vaccine, the rest the placebo (Saline 0.9%).
Total participants 43,998= 21,999 received the vaccine, the rest the placebo (Saline 0.9%).
7) Study outcomes are based upon an ASSUMPTION of 1.3% per year incidence of Covid 19 in the placebo group.
Although the trial included those with stable HIV/HBV or HCV infections, the data will not be included in the study. Why? (Pg 31)
Although the trial included those with stable HIV/HBV or HCV infections, the data will not be included in the study. Why? (Pg 31)
8) Rationale for the study is based upon:
" A prophylactic RNA based SARS CoV2 vaccine provides one of the most flexible and reliable approaches to immunise against an emerging virus"
and
"ongoing pandemic with NO preventative or therapeutic options available"
???
" A prophylactic RNA based SARS CoV2 vaccine provides one of the most flexible and reliable approaches to immunise against an emerging virus"
and
"ongoing pandemic with NO preventative or therapeutic options available"
???
9) On page 27 they acknowledge " Disease enhancement has been seen following vaccination with respiratory
syncytial virus (RSV), feline coronavirus,
and Dengue virus vaccines. There is no rationale for this statement or evidence.
syncytial virus (RSV), feline coronavirus,
and Dengue virus vaccines. There is no rationale for this statement or evidence.
10) The primary target was to reach 164 SARS Cov 2 infections, confirmed by one of the listed symtpoms and PCR or other NAAT test, occuring at 7 days post second dose.
This is the basis of their 90% effectiveness claim.
It does not at all consider the accuracy of these tests
This is the basis of their 90% effectiveness claim.
It does not at all consider the accuracy of these tests
11) This statement is concerning " additional surveillance for Covid 19 will be conducted as [art of the study given the potential risk of disease enhancement.
As yet, I have not seen any results regarding disease enhancement nor an explanation as to why in protocol.
As yet, I have not seen any results regarding disease enhancement nor an explanation as to why in protocol.
12) Exclusion criteria on Pg 39.
Includes: autoimmune disease, suicidal ideation, pregnancy, breastfeeding, anaphylaxis, obesity, those in long term care facilities etc.
Tested on predominantly healthy men and women.
Includes: autoimmune disease, suicidal ideation, pregnancy, breastfeeding, anaphylaxis, obesity, those in long term care facilities etc.
Tested on predominantly healthy men and women.
13) Now to the most concerning part (Pg63)
"Human reproductive data is not available".
"Therefore all men and women are advised to use highly effective contraception".
It is unclear if this is advised through the whole 24 month trial period.
"Human reproductive data is not available".
"Therefore all men and women are advised to use highly effective contraception".
It is unclear if this is advised through the whole 24 month trial period.
14) Exposure during pregnancy:
A female participant is found to be pregnant while receiving or after discontinuing study
intervention.
• A male participant who is receiving or has discontinued study intervention exposes a
female partner prior to or around the time of conception
A female participant is found to be pregnant while receiving or after discontinuing study
intervention.
• A male participant who is receiving or has discontinued study intervention exposes a
female partner prior to or around the time of conception
15)
• A female is found to be pregnant while being exposed or having been exposed to study intervention due to environmental exposure. Below are examples of environmental exposure during pregnancy:
• A female family member or healthcare provider reports that she is pregnant..
• A female is found to be pregnant while being exposed or having been exposed to study intervention due to environmental exposure. Below are examples of environmental exposure during pregnancy:
• A female family member or healthcare provider reports that she is pregnant..
16)
..after having been exposed to the study intervention by inhalation or skin contact.
• A male family member or healthcare provider who has been exposed to the study intervention by inhalation or skin contact then exposes his female partner prior to or
around the time of...
..after having been exposed to the study intervention by inhalation or skin contact.
• A male family member or healthcare provider who has been exposed to the study intervention by inhalation or skin contact then exposes his female partner prior to or
around the time of...
17)
.....conception
I cannot quite understand what this means, but it sounds ominous in terms of pregnancy risk, although the pregnancy risk IS not explained in the study protocl.
I would love to see the informed consent for this in particular.
.....conception
I cannot quite understand what this means, but it sounds ominous in terms of pregnancy risk, although the pregnancy risk IS not explained in the study protocl.
I would love to see the informed consent for this in particular.
18) If a woman is exposed during pregnancy, the baby will be examined at birth or if there is an abortion or miscarraige, a review of the fetus will be carried out.
Sounds ominous again?
Sounds ominous again?
19) I have not been able to find the informed consent information but in the study design it states:
Male participants to abstain from sexual intercourse for 28 days OR use a condom for any sexual act where ejaculation is expected
Females to use a suitable contraceptive
Male participants to abstain from sexual intercourse for 28 days OR use a condom for any sexual act where ejaculation is expected
Females to use a suitable contraceptive
20) Participants are asked to take their own temperature at home using an oral thermometer which can be inaccurate especially if not done properly. I'd like to see how they ensure this? Its an element that introduces BIAS.
21) I think this is a very important point and one that is not considered r/e introduction of further BIAS.
For example: what is the contact the person has with others at work or home. Are they adhering to mask wearing? Are they social distancing? How is their diet? Etc.
For example: what is the contact the person has with others at work or home. Are they adhering to mask wearing? Are they social distancing? How is their diet? Etc.
21) Have they been in direct contact with other known to be SARS Cov2?
In the 164 cases of positive PCR test and 1 symptom, were any of those frontline workers with symptomatic patients, and could the contacts/origin be indentified?
In the 164 cases of positive PCR test and 1 symptom, were any of those frontline workers with symptomatic patients, and could the contacts/origin be indentified?
22) Liver safety is acknolwedged as a risk, but liver function tests will not be as part of the evaluation unless symptoms develop of liver issues. You can have significant changes in your Liver function and not be aware. I question why they left this out.
23) To conclude, firstly we don't have all the data to be able to analyse the statistical significance of the preliminary trial.
Secondly, it seems fertility and pregnancy are a real concern to the researchers but it is not justified as to why.
Secondly, it seems fertility and pregnancy are a real concern to the researchers but it is not justified as to why.
Not sure why all the GIFs I posted, I spent ages choosing them 
have been deleted, please unrolll @threadreaderapp
have been deleted, please unrolll @threadreaderapp
