Public Health and Medical Professionals for Transparency Documents

Pfizer’s Documents

File NameDate ProducedFile SizeLink
BATES-92_adc19ef-ve-cov-7pd2-wo-eval-sas.txtNovember 17, 20219 KB
BATES-93_tv.xptNovember 17, 202116 KB
5.3.6 postmarketing experience.pdfNovember 17, 2021984 KB
5.2 tabular listing.pdfNovember 17, 20212 MB
5.2 listing of clinical sites and cvs pages 1-41.pdfNovember 17, 20218 MB
Pages 42-289-Section 5.2 – listing-clinical-sites-cvs_Part A.pdfDecember 1, 202112 MB
Pages 42-289-Section 5.2 – listing-clinical-sites-cvs_Part B.pdfDecember 1, 202114 MB
BATES-FDA-CBER-2021-5683-0002372_adc19ef-ve-cov-7pd2-eval-sas.txtDecember 13, 20219 KB
BATES-FDA-CBER-2021-5683-0002373_adc19ef-ve-sev-cov-7pd2-eval-sas.txtDecember 13, 20219 KB
BATES-FDA-CBER-2021-5683-0002374_adc19ef-ve-sev-cov-7pd2-wo-eval-sas.txtDecember 13, 20219 KB
BATES-FDA-CBER-2021-5683-0002375_addv-sas.txtDecember 13, 20215 KB
BATES-FDA-CBER-2021-5683-0002377_supppr.xptDecember 13, 202172 KB
signed F21-5683 CBER Dec 13 2021 Response Letter.pdfDecember 13, 2021207 KB
BATES-FDA-CBER-2021-5683-0002378_ta.xptDecember 13, 20218 KB
BATES-FDA-CBER-2021-5683-0002379_te.xptDecember 13, 20213 KB
BATES-FDA-CBER-2021-5683-0002380_ti.xptDecember 13, 202137 KB
BATES-FDA-CBER-2021-5683-0002376_relrec.xptDecember 13, 2021567 KB
CFRs for site 1055.pdfDecember 13, 20216 MB
STN 125742_0_0 Section 2.5 Clinical Overview.pdfDecember 13, 20214 MB
STN 125742_0_0 Section 2.7.3 Summary of Clinical Efficacy.pdfDecember 13, 20213 MB
STN 125742_0_0 Section 2.7.4 summary-clin-safety.pdfDecember 13, 20216 MB
Supplemental Index 12-22-21.pdfDecember 22, 20212 MB
CRFs for site 1081.pdfDecember 30, 202113 MB
CRFs for site 1096.pdfJanuary 18, 202211 MB