Pfizer/BioNTech C4591001 Trial - Phase 1 Antibodies. Where haven't they cheated exactly?
ADVA tests have likely been falsified to avoid showing disturbing drops in the measurements as early as 21 days post dose 1.
This article is the product of another joint effort with Christine Cotton1, who made the original discovery of the major issue we highlight here. Both authors contributed equally to this paper.
As usual, we must also thanks Geoff Pain2 for his cautious rereading & precious lights on technicalities.
Introduction
There are 332 Phase 1 subjects in the ADSL File (Subject Level Analysis Dataset)3 corresponding to the Phase 1.
195 of them were selected to receive either a dose of Placebo, or a dose of one of the active products tested.
After a brief overview on the general demographic conditions of the phase 1, we applied ourselves to demonstrate most concerning anomalies, this time on the tests performed to measure if the subject was developing the antibodies (supposed to protect him from the COVID-19 disease).
Specifically - the results of the “50% Neutralization titer” tests, stored in the ADVA file (Immunogenicity Analysis Dataset)4, are showing considerable differences between simultaneous tests - affecting deeply the alleged efficacy at producing antibodies lasting more than a few short months.
Phase 1 Demographics & population focused
Demographics of the phase 1 - which we verified as corresponding to the ADSL data - are summarized page 4 of the NEJM study by Edward E. Walsh et al., “Safety and Immunogenicity of Two RNA-Based Covid-19 Vaccine Candidates”5.
195 subjects received, according to the study, two doses at an interval of 21 days apart between dose 1 and dose 2 (the protocol6 doesn't include any mention of the 19 to 42 days "allowed window" which would later apply in phase 3, but does plan for a 19 to 23 days window).
Let’s quickly note, as did Geoff Pain7 re-reading this paper prior publication, that the age group which saw 14 of the 38 deaths registered in phase 2-3 in March 20218, namely the 56 - 64, wasn’t studied here. But they didn’t know it would be the most impacted, right?
The subjects received their injections as scheduled for the BNT162b2 Phase 1 (10 mcg), BNT162b2 Phase 1 (20 mcg), BNT162b2 Phase 1 (30 mcg), BNT162b1 Phase 1 (10 mcg), BNT162b1 Phase 1 (20 mcg), and BNT162b1 Phase 1 (30 mcg).
The 12 BNT162b1 Phase 1 (100/10 mcg) subjects received their second doses between 85 to 105 days after dose 1. 3 subjects from the placebo arm (10021041, 10011021, 10011013 - those assigned to the 100/10 mcg group) received their second dose in a similar window. This wasn’t specified in the protocol9 which only includes the mention of a scheduled 22 days between two doses of 100 µg.
In any case, our goal being to study the antibodies with a primary focus on the 30 µg, we disregarded the 100 µg group, which would have required specific code.
From 195 subjects, discarding those who received the BNT162b1 100 µg and those who received a Placebo brings the sample we wish to study here to 144 subjects (24 subjects in each arm of BNT162b1 & BNT162b2 at 10, 20 & 30 µg).
How were antibodies measured ?
Various tests were performed on the subjects, on predetermined intervals:
SARS-CoV-2 serum neutralizing titer 50 (titer) - Virus Neutralization Assay
SARS-CoV-2 serum neutralizing titer 90 (titer) - Virus Neutralization Assay
N-binding antibody - N-binding Antibody Assay
COVID-19 RBD IgG (U/mL) - Luminex Immunoassay
COVID-19 S1 IgG (U/mL) - Luminex Immunoassay
As we mentioned in introduction, we shall focus in this analysis on the first assay, “SARS-CoV-2 serum neutralizing titer 50 (titer) - Virus Neutralization Assay”.
The 144 subjects had their antibodies measured - as described above, at regular intervals, using the 50% titer test, labelled “SARS-CoV-2 serum neutralizing titer 50 (titer) - Virus Neutralization Assay”.
These tests were recorded in the ADVA table. While some tables have been re-ordered at export time (for example the “S1_M5_c4591001-S-D-suppdv.xpt” table10), the data appears to be incremental here: every row of tests results concerns either the same subject / visit number pair, or the visit number is superior to the last observed.
The ADVA rows have a few important variables in that analysis:
“VISIT” (the name of the visit on which the test is performed) concatenated from another table at export time.
“AVISIT” (the label of the visit as registered in the ADVA table - for example “1 Month after Vaccination 2”)
“AVISITN” (the visit’s incremental occurrence number)
“ISDTC” (the date of the visit)
“PARAM” (the type of test performed)
“AVALC” (the test result)
The study’s subjects were submitted to this test on recurring visits:
Visit 1 (“Day 1”, AVISITN = 1, VISIT = V1_DAY1_VAX1_S), the day of the first dose
Visit 3 (Day 7, AVISITN = 2, VISIT = V3_WEEK1_POSTVAX1_S), one week after the first dose
Visit 4 (“Day 21”, AVISITN = 3, VISIT = V4_WEEK3_VAX2_S), the day of the second dose - 19 to 23 days post dose 1
Visit 5 (“Day 28”, AVISITN = 4, VISIT = V5_WEEK1_POSTVAX2_S), one week after the second dose
Visit 6 (“Day 35”, AVISITN = 5, VISIT = V6_WEEK2_POSTVAX2_S), two weeks after the second dose
Visit 7 (“Day 49”, AVISITN = 6, VISIT = V7_MONTH1_S), a month after the second dose
Visit 8 (“Day 183”, AVISITN = 7, VISIT = V8_MONTH6_S), 6 months after the first dose.
50% Neutralization Titer - Antibodies Documented
Our 144 subjects have records for “AVISIT” 1, 3, 4.
Only 24 subjects have records for “AVISIT” 2.
Only 141 underwent “AVISIT” 5, 143 “AVISIT” 6, and we have only 23 “AVISIT” 7 records.
We can chart the evolution of the subjects’ antibodies measurements, calculating the average antibodies measured on each visit (sorting them by “AVISIT” number), for each subject who received the active product, as reflected by the data.
For example, for the BNT162b2 30 µg sub-group, whose antibodies are measured page 10 of the NEJM study, it shows a nice, constant progression on the participants over 65, while the antibodies are slightly descending for the 18-55 (framed in red).
Plotting the ADVA figures for our BNT162b2 participants (the product sustained in phase 2 - 3, without care for age groups as it’s unclear to us why elder people would magically generate more antibodies) would result in the following charts (using means and not geometrical means as above).
All Pfizer showed you in the NEJM study - opportunely published on October 20, 2020, was ending with this slight drop on “Day 35” (have no doubt they knew the “month 6” phenomenon already through the earlier German studies).
That drastic drop in antibodies measured at 180 days was already pointed out by Jikkyleaks11 & Christine Cotton12. That's already bad & tells you why early 2021, human beings started to be ridiculously compared with Duracell's rabbits to be recharged every 2 months (here for example an NHS promotional picture13).
But it gets worse.
“Invalidated Tests” replaced with new results
Some records stand out in the ADVA file. They have no “AVISIT” or “AVISITN” values, while they do have a “VISIT” set, along with all the other values we could expect, among which a date confirming they have been processed at the same time than another test.
To take a practical example, subject 10031065 visit records for the 50% Neutralization titer are represented below:
On his “3 weeks post dose 1” visit, the subject antibodies are at 10 on two measures. 1 month post dose 2 - they are passing from 270.09 to 962.67!
We verified that these “tests without AVISIT” label were systematically inserted in the ADVA table prior to their “reviewed” version.
These “two tests on the same day” often result in very different measurements than the ones used. Aware as we are of the tendency of anomalies to lean in Pfizer/BioNTech’s favor, we reviewed how taking into account these “first tests” instead of their second edition would have affected the end plotting.
This chart excludes the 180 days measurements to better show the data they had when they published in the NEJM. In Orange, what they told you; in Blue what the “first measurements on subjects” were showing.
According to the experts we consulted, antibodies measurements from the same subject, on the same day, on this test, shouldn’t be statistically different.
Here, as shown in the detail below, we have offsets up to 1K in two different results of the same test, on the same subject & day.
We can therefore reasonably assume that the sponsors used fraudulent measures, for example taking another subject’s samples, to “re-run” the “unsatisfying” tests.
The detail of each subjects’ “different measurements” on all their visits, used to generate these charts, can be consulted in the following Google Spreadsheet14.
The ADVA file, as well as the JSON extract from the ADSL file (132 Mo + 33 Mo unzipped, 7.8 Mo zipped15) must be unzipped in your project folder.
The script extracting the data to .JSON while verifying the incremental order of the data and the order of occurrence of the tests records can be accessed here on GitHub.
Other analysis presented in this page can be reproduced using the following script accessible on GitHub.
phmpt.org/pfizers-documents, “S1_M5_C4591001-A-D_adsl.xpt”
phmpt.org/pfizers-documents, “S1_M5_c4591001-A-D-adva.xpt”
Good work (again). Remember we posted about this last year and it only garnered a modicum of interest so I hope your rundown gains traction.
For clarity, in my view the *drop* in antibody titre isn't disturbing - it's normal. You can't just keep producing antibodies. HOWEVER... what was an absolute scam was selling to the world the unsubstantiated (and wrong) claim that flogging the body to produce more and more antibodies for an obsolete spike induced immunity (protection) from a virus. This was a lie.
Another lie was that the claim that you needed more doses to get those antibodies. All the additional doses do is flog the system, producing more antibodies and then immune tolerance. Hence the Cleveland paper.
Now you have a generation of people who are tolerant of the Wuhan spike. Who wants to make a real bioweapon? Just use the Wuhan spike again.
Für Ihre Sicheheit.
Thanks for the great work! I've been able to reproduce the same results fairly quickly using JMP, which can directly import SAS transport files (*.xpt). I'm also seeing very large same-day discrepancies in PARAM "COVID-19 S1 IgG (U/mL) - Luminex Immunoassay" for 20+ of the Phase 1 subjects, including the one you highlighted. Something is fishy with these data.