18 Nov, 5 tweets, 2 min read
Still haven't heard back from the @US_FDA on the mathematical errors in the Comirnaty BLA docs

The difference of 154 cases, (8 vax, 162 placebo) from which the VE was based on, could be completely wrong, based on this error

Putting the whole world wide roll out into question
When adding 2,285 + 2,636 that = 4,921

Also, when subtracting the neg results, that would leave:
Vax 2,285 - 2,026 = 259 -- Which is dif than the 303 referred to later
Placebo 2,636 - 2,305 = 331 -- Which is dif than the 396 referred to later

Total then would be 590 vs. 699
Swab was not taken = Vax 210, Placebo 267 = 477
Swab was taken outside symptom window = Vax 80, Placebo 88 = 168
Swab was taken but results not available - Vax 13, Placebo 41 = 54

Total Vax 303, Placebo 396 = 699
With the article in the BMJ, regarding the sloppiness that whistleblower observed, along with this mathematical error, not caught by the FDA, how can the documents and authorization be trusted?

Still waiting on an answer from the FDA.

bmj.com/content/375/bm…
And now FDA is requesting to not present the data for 55 years?!

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# More from @JeanRees10

17 Nov
MIS-C post vax

Most of these cases would be considered:
"C19 hospitalization, unvaccinated"

per CDC definitions of 14 days post 2nd dose is "Vaxxed"

Is priming/immune suppression post dose making kids more susceptible to C19?

Pfizer had 18.2% VE up to 11 days post 1st dose
#1825618
12 yo female
13 days post 2nd dose developed MIS-C
4 Days in Hosp
Not stated whether prev C19 inf
wonder.cdc.gov/controller/sav…

#1822149
16 yo female
9 days post 2nd dose
Active C19 inf - 9 days after 2nd dose of 💉
Diagnosed w/MIS-C
6 days in Hosp
wonder.cdc.gov/controller/sav…
#1813648
12 yo female
26 days post 1st dose
Developed MIS-C in tandem w/C19 inf
5 days in hosp
wonder.cdc.gov/controller/sav…

#1804422
16 yo male
3 days post 2nd dose
C19 infection
Thrombocytopenia
MIS-C susp, but Ecoli found as well
Unknown days in hosp
wonder.cdc.gov/controller/sav…
16 Nov
Highly recommend @GirardotMarc 's articles. He makes complex immunological processes understandable.

It should be noted in the FDA EUAs & at the 9/17/21 VRBPAC, Pfizer's Jansen could not establish a "correlate of protection" to Abs

At the 5:37 mark

🧵
The case being made for boosters is based on waning antibodies. Something that vaccine manufacturers can't establish if there is a "correlate of protection" to.
Pfizer's Jansen quote:

“We actually looked at our breakthrough cases in our placebo-controlled phase 3 study, and have compared the antibody titers where we had the opportunity in individuals that got the disease versus the ones that didn’t,
15 Nov
Pfizer 5-11 yo trial contained the buffer PBS

FDA allowed Pfizer to change the buffer to Tris for the public 5-11 yos. Never trialed

Now, let me take you on a thread where this gets super interesting, esp, in light of the administration errors, that @BearGauss highlighted

1/6
Here are the slides from the 10/26/21 VRBPAC where they say they used PBS for the Trial, but that the orange cap formulation coming out for 5-11 yos will contain Tris.

Tris is not in the 12+ Pfizer vaccines that has been deployed in the purple cap, PBS is.

2/6
In the FDA updated BLA/EUA they make a special point to say that PBS is not approved for 5-11 yos, only Tris is. So they trialed 5-11 yos with PBS, are sending untrialed Tris to the public 5-11 yos.

3/6
14 Nov
FDA said "NO!" on 8/22/21
BLA issued on 8/23/21

"We also call on FDA to require a more thorough assessment of spike proteins produced in-situ by the body following vaccination—including studies on their full biodistribution, pharmacokinetics, & tissue-specific toxicities."

1/2
"We ask the FDA to demand manufacturers complete proper biodistribution studies that would be expected of any new drug and request additional studies to better understand the implications of mRNA translation in distant tissues"

2/2

bmj.com/content/371/bm…
Do the FDA Regulators seem like serious scientists?

They don't ask questions on a novel "vaccine" that has never made it to market.

They don't know how/what/why/how much spike is generated, and aren't interested in knowing. Why?
13 Nov
Coming back to this, thinking about the primary clinical endpoint of the vax, "reduce symptomatic infection".

That Pfizer's Kathrin Jansen at the VRBPAC meeting could not establish "correlates of protection" to Abs. Yet, the FDA allowed children's vaxxes to be EUA'd off of them
At the ~5:37 mark:

“We actually looked at our breakthrough cases in our placebo-controlled phase 3 study, and have compared the antibody titers where we had the opportunity in individuals that got the disease versus the ones that didn’t, (con'd)
and we were also unable to really come up with an antibody threshold. So I think there’s probably a much more complex story and not easily just addressed with neutralizing antibodies.”
13 Nov
Dr. Peter's Doshi (Univ of MA, and editor at BMJ) @ 11/2/21 Roundtable - 💉 injuries and mandates

?ing what:
"EVERYBODY KNOWS"

Asking if we really know that from what was demonstrated in the clinical trials or if that is what is what PHOs purported

faculty.rx.umaryland.edu/pdoshi/files/2…

🧵
"Or why would the statistics be so different in the UK, where most covid hospitalizations and deaths are among the fully vaccinated? There’s a disconnect there -there’s something to be curious about - there’s something not adding up (con'd)"
and we should all be asking “is it true that this is a pandemic of the unvaccinated? What does that even
mean?”