guess who just got into the EMA clinical data publication system :) you have to go all digital citizen but then you get clinical study reports! hundreds of megabytes of files per entry. https://t.co/nsyRSqMp8mclinicaldata.ema.europa.eu/web/cdp/home
for example: here's the final C4591001 protocol amendment!
nope lol there's another final protocol amendment?
i know im gonna be spending hours making sense of this stuff. the top two entries have 10 and 17 documents respectively? weird as hell
my browser crashed, but there's lots of material on C4591007, the kids study, including the narrative-sensitive file listing serious adverse events. dozzens of seizures and ICU treatment led to postponement of study intervention in a 3yo.
there's also an interim study report, and they were really using one of the OG C4591001 batches 👀
why do 6/17 comirnaty authorizations not have "tozinameran" as active substance, instead "COVID-19 mRNA vaccine (nucleoside-modified)", including the first four and the most recent two?
c4591044 is the hilarious bivalent trial. like 800 participants, the first entire cohort is just left out of the data and there are precisely 7 days post-dose safety data available. ~30% of the 3x jabbed study population had already had covid 😂
👀 ab titres 1 week after dose 2 was higher than 1 month after dose 2, but 1 week after dose 3 was LOWER than 1 month after dose 3. also note this graph is LOG scale. 23 c4591001 patients were boostered. that's the science behind dose 3.
also, how directly to jail will i go if i just upload all the documents to ? they're guaranteed watermarked to my account. maybe i should read the T&C 🤔mega.nz
an average of 2.3 weeks of safety data for C4591007. mRNA for kids was based on two weeks of safety data. jesus christ
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#rkifiles ein inkohärenter strang mit entdeckungen aus dem leck. "nCoV hat eine zusätzliche multibasische furin-spaltstelle", zusatzmaterial 5.2.2020 🤔download hat für mich nur über diesen mirror geklappt: (h/t @DerCheapi ) dercheapi.de/files/rki/
10.2.2020 zusatzmaterial, risikobewertung für DE. sehr interessant wie "anhaltende viruszirkulation" ausschlaggebender bestandteil der gefährdung gemacht wird und gleichzeitig der letzte kontaktmanagement-satz gestrichen wird.
13.2. ergebnisprotokoll - asymptomatische sollen nicht getestet werden?
wanna see something funny? final CSR for sanofi-moderna booster+flu jab study was released on EMA CDP. 3 groups with 100 patients each, 1) mrna 1273 50 ug + sanofi, 2) sanofi only 3) moderna only. all 60+, 90%+ 2020-2021 flu jab rate, inclusion criterium 2x moderna.
link didnt fit in the previous post, this is study QHD00028. so! of the six medically attended cases of covid, there were three in group 1 and three in group 3 and none in group 2😬imagine how salty bancel must have been, just imagine! mega.nz/folder/rBgl0Jy…
this group dynamic remains remarkably constant throughout the safety reporting. i find the breakdown tables pretty interesting to look at given the split in group 1. also showcases neatly that pfizer-biontech are the only sponsors to have diarrhea as a solicited sytemic event
🚨FINAL MODERNA STUDY REPORT 🚨 uploaded on EMA CDP 30.5. 15k words with no end in sight into my pfizer CRF writeup, so im just gonna do a brief flyover of this 8500-page monstrosity. unlike AZ a few days ago, this is the pivotal phase 3 mega.nz/folder/nNAg3DZ…
page 11: yeah so because incidence rates were similar in vaxed-months-ago and vaxed-just-now, there is duration of protection. but because BOTH groups got more covid later, gotta boost 😵💫
page 12: and the reason we gotta boost is becaaaauuuuussseee boosties had more covid than un-boosties. what?
the very first goddamn email: daszak says baric is working on nanoparticles, and baric is asked about sars glycoproteins he's making for a DARPA grant and they're trying to get them into bats
ADSYMPT - covid signs and symptoms
ADAE - adverse events
these are the symptoms that can lead to a "covid illness visit" except for 7 days after each dose.
these are the scraped results from both files. some of the "signs and symptoms of disease" from ADSYMPT don't translate directly to ADAE MedDRA terminology, for example fever=pyrexia, sore throat=oropharyngeal pain. take a good long look at it and let me know if it makes sense.
been looking at the latest pfizer puff piece. this is going to be a dump thread of links and files. both C4591031 and C4591007 are heavily represented on the EMA CDP portal. already did a thread on C4591031:
firstly, c4591031 has results on the EU CTR. results have been updated three times by now 👀 this includes substudies A-E so it's REALLY really long. c4591007 only has a protocol posted clinicaltrialsregister.eu/ctr-search/tri…
the US CTR entry for c4591007 lists spanish sites, yet the EU CTR only has finland and poland 🤔