Perhaps Barnes has Pfizer a bit nervous here, @kgwatt? "Pfizer Shuts Trial Sites for Lyme Disease Jab After Standards Breaches [...] Pfizer said it had learned of potential violations of 'Good Clinical Practice,' a quality standard regulating human trials, and shut down the sites after investigating." ( https://www.barrons.com/articles/pfizer-lyme-disease-trial-closed-shut-vaccine-valneva-38a8b108 )
IIRC, Pfizer shut down 0 sites during the initial COVID-19 vaccine trials (please correct me if I'm wrong)...
Pfizer's 'Base Agreement' (Base Agreement between the Medical CBRN Defense Consortium (MCDC), Consortium Management Firm (CMF), Advanced Technology International (ATI) and the Project Agreement Holder (PAH) [Pfizer]), July 20, 2020
"The PAH will conduct advanced development / pivotal studies including human safety studies, animal efficacy studies or clinical studies required for approval using validated endpoints, and other studies as deemed necessary by the FDA for licensure of the candidate product in adherence to current Good Laboratory Practice regulations, current *Good Clinical Practice regulations*, and all other applicable FDA regulations in the conduct of non-clinical and clinical studies as defined by FDA guidance (21 CFR Parts 210-211)." ( https://www.documentcloud.org/documents/22028603-pfizer-base-agreement ) ... "A regional director who was employed at the research organisation Ventavia Research Group has told The BMJ that the company falsified data, unblinded patients, employed inadequately trained vaccinators, and was slow to follow up on adverse events reported in Pfizer’s pivotal phase III trial. Staff who conducted quality control checks were overwhelmed by the volume of problems they were finding. After repeatedly notifying Ventavia of these problems, the regional director, Brook Jackson, emailed a complaint to the US Food and Drug Administration (FDA). Ventavia fired her later the same day. Jackson has provided The BMJ with dozens of internal company documents, photos, audio recordings, and emails." ( https://www.bmj.com/content/375/bmj.n2635 ; https://www.theepochtimes.com/exclusive-pfizer-trial-whistleblower-presses-forward-with-lawsuit-without-us-governments-help_4277153.html )
IIRC, Pfizer shut down 0 sites during the initial COVID-19 vaccine trials (please correct me if I'm wrong)...
Pfizer's 'Base Agreement' (Base Agreement between the Medical CBRN Defense Consortium (MCDC), Consortium Management Firm (CMF), Advanced Technology International (ATI) and the Project Agreement Holder (PAH) [Pfizer]), July 20, 2020
"The PAH will conduct advanced development / pivotal studies including human safety studies, animal efficacy studies or clinical studies required for approval using validated endpoints, and other studies as deemed necessary by the FDA for licensure of the candidate product in adherence to current Good Laboratory Practice regulations, current *Good Clinical Practice regulations*, and all other applicable FDA regulations in the conduct of non-clinical and clinical studies as defined by FDA guidance (21 CFR Parts 210-211)." ( https://www.documentcloud.org/documents/22028603-pfizer-base-agreement ) ... "A regional director who was employed at the research organisation Ventavia Research Group has told The BMJ that the company falsified data, unblinded patients, employed inadequately trained vaccinators, and was slow to follow up on adverse events reported in Pfizer’s pivotal phase III trial. Staff who conducted quality control checks were overwhelmed by the volume of problems they were finding. After repeatedly notifying Ventavia of these problems, the regional director, Brook Jackson, emailed a complaint to the US Food and Drug Administration (FDA). Ventavia fired her later the same day. Jackson has provided The BMJ with dozens of internal company documents, photos, audio recordings, and emails." ( https://www.bmj.com/content/375/bmj.n2635 ; https://www.theepochtimes.com/exclusive-pfizer-trial-whistleblower-presses-forward-with-lawsuit-without-us-governments-help_4277153.html )
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