PILOT SPIN

Spin Zone => Spin Zone => Topic started by: Number7 on October 07, 2023, 06:03:01 AM

Title: Vaccine Apoloigsts REALLY Have Their Work Cut Out For Themselves
Post by: Number7 on October 07, 2023, 06:03:01 AM

Pfizer Used Separate Manufacturing Processes for COVID Shots Used in Clinical Trials, Public Distribution

Gee... I wonder how the fda, cdc, and who managed to miss (ignore) this. It had to cost hundreds of millions in bribes to get them all to look the other way.

    Recent calls for more transparency in COVID-19 vaccine clinical trials is particularly relevant for data on the manufacturing process, which is an integral part of the regulatory approval process to ensure consistent safety and efficacy outcomes.

    An October 2020 amendment to the protocol of the pivotal Pfizer/BioNTech BNT162b2 (Comirnaty) clinical trial (C4591001) indicates that nearly all vaccine doses used in the trial came from ‘clinical batches’ manufactured using what is referred to as ‘Process 1’. However, in order to upscale production for large-scale distribution of ‘emergency supply’ after authorization, a new method was developed, ‘Process 2’. The differences include changes to the DNA template used to transcribe the RNA and the purification phase, as well as the manufacturing process of the lipid nanoparticles. Notably, ‘Process 2’ batches were shown to have substantially lower mRNA integrity.

    The protocol amendment states that “each lot of ‘Process 2’-manufactured BNT162b2 would be administered to approximately 250 participants 16 to 55 years of age” with comparative immunogenicity and safety analyses conducted with 250 randomly selected ‘Process 1’ batch recipients. To the best of our knowledge, there is no publicly available report on this comparison of ‘Process 1’ versus ‘Process 2’ doses.

    Two documents obtained through a Freedom of Information Act (FOIA) request[6] describe the vaccine batches and lots supplied to each of the trial sites through November 19, 2020[7] and March 17, 2021,[8] respectively. According to these documents, doses from ‘Process 2’ batch EE8493Z are listed at four trial sites prior to November 19, and four other sites are listed with ‘Process 2’ batch EJ0553Z in the updated document. Both batches were also part of the emergency supply for public distribution. The CDC’s Vaccine Adverse Event Reporting System, known to be underreported. lists 658 reports (169 serious, 2 deaths) for lot EE8493[10] and 491 reports (138 serious, 21 deaths) for lot EJ0553.

https://pjmedia.com/news-and-politics/benbartee/2023/10/06/bombshell-pfizer-used-separate-manufacturing-processes-for-covid-shots-used-in-clinical-trials-public-distribution-n1732965

Title: Re: Vaccine Apoloigsts REALLY Have Their Work Cut Out For Themselves
Post by: Anthony on October 07, 2023, 07:10:00 AM

Separate but equal?   >:(

Title: Re: Vaccine Apoloigsts REALLY Have Their Work Cut Out For Themselves
Post by: Number7 on October 07, 2023, 08:17:16 AM

Now we know at least part of why the vaccine makers were so determined to get 56 years to release their vaccine data and records.