Phase 3 RCT protocols for those doubting adequate "testing" of the vaccine.

in covid •  4 years ago 

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https://pfe-pfizercom-d8-prod.s3.amazonaws.com/2020-11/C4591001_Clinical_Protocol_Nov2020.pdf

I thought twice about posting this because it's not immediately clear to me that Pfizer/BioNTech intended to make this publicly available. It looks to me like the document I'm about to link could be from an S3 with potentially mis-configured AWS security settings.

Given the number of people I've seen claiming the the SARS-CoV-2 vaccine "wasn't tested enough!", I think it's important to counter that particular bit of glurge, and that's my sole purpose in sharing this document.

At the link is the complete Pfizer/BioNTech RCT protocol for all three phases.

This will be more useful to folks who are accustomed to reading/writing study protocols, but even to folks unaccustomed to reading those protocols, it gives an inkling of how thorough the testing was.

I've seen a portion of Moderna's in a thread claiming they excluded everybody except perfectly healthy athlete types. The document included their inclusion/exclusion criteria that specifically contradicted the poster's claims.

Very similar scope and thorougness.

https://www.nejm.org/doi/suppl/10.1056/NEJMoa2028436/suppl_file/nejmoa2028436_protocol.pdf

There are several parts. After the 1st 70 pages of so there's another section on planned stats analysis, etc.

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