Pfizer vidste allerede 28. februar 2021,
at vi ville se et massivt antal bivirkninger og dødsfald,
helt specifikt 42.086 rapporter indeholdende
158.893 hændelser(herunder 1223 dødsfald).
FDA har frigivet den første omgang af dokumenter, som de har gennemgået, inden de licenserede Pfizers "vaccine". Efter at en gruppe på mere end 30 professorer og videnskabsmænd fra universiteter, herunder Yale, Harvard, UCLA og Brown, anlagde sag i septemberFDA har produceret de første 91+ sider med dokumenter fra Pfizers COVID-19-vaccinefil, og foreslår en gradvis udgivelse på 500 sider om måneden indtil færdiggørelsen af udgivelsen i år 2076.
Et af de fremlagte dokumenter er en kumulativ analyse af rapporter om uønskede hændelser efter autorisation modtaget til og med 28. februar 2021, to en halv måned efter, at vaccinen modtog nødgodkendelse. Dette dokument afspejler uønskede bivirkninger efter "vaccination", både i og uden for USA, frem til den 28. februar 2021.
Pfizer forklarer på side 6, at "På grund af det store antal spontane bivirkninger, der er modtaget for produktet, har Pfizer prioriteret behandlingen af alvorlige sager...", og at Pfizer "også har truffet flere handlinger for at hjælpe med at afhjælpe den store stigning i rapporter om uønskede bivirkninger", herunder "øgning af antallet af dataindtastning og sagsbehandlingskolleger" og "har indsat ca. [antal fjernet fra dokumenet] yderligere fuldtidsansatte."
Hvad angår mængden af indrapporterede bivirkningr, modtog Pfizer i de 2½ måned efter deres nødgodkendelse i alt 42.086 rapporter indeholdende 158.893 hændelser (herunder . De fleste af disse rapporter var fra USA og uforholdsmæssigt involverede kvinder (29.914 mod 9.182 leveret af mænd) og dem mellem 31 og 50 år (13.886 mod 21.325 for alle andre aldersgrupper tilsammen, med yderligere 6.876, hvis alder var ukendt). 25.957 af hændelserne blev klassificeret som "nervesystemlidelser"
Fuld download af dokumenterne
pd-production-111721
5.2-listing-of-clinical-sites-and-cvs-pages-1-41.pdf
5.2-tabular-listing.pdf
5.3.6-postmarketing-experience.pdf
BATES-92_adc19ef-ve-cov-7pd2-wo-eval-sas.txt
BATES-93_tv.xpt
pd-production-120121
Pages-42-289-Section-5.2-listing-clinical-sites-cvs_Part-A.pdf
Pages-42-289-Section-5.2-listing-clinical-sites-cvs_Part-B.pdf
pd-production-121321
BATES-FDA-CBER-2021-5683-0002372_adc19ef-ve-cov-7pd2-eval-sas.txt
BATES-FDA-CBER-2021-5683-0002373_adc19ef-ve-sev-cov-7pd2-eval-sas.txt
BATES-FDA-CBER-2021-5683-0002374_adc19ef-ve-sev-cov-7pd2-wo-eval-sas.txt
BATES-FDA-CBER-2021-5683-0002375_addv-sas.txt
BATES-FDA-CBER-2021-5683-0002376_relrec.xpt
BATES-FDA-CBER-2021-5683-0002377_supppr.xpt
BATES-FDA-CBER-2021-5683-0002378_ta.xpt
BATES-FDA-CBER-2021-5683-0002379_te.xpt
BATES-FDA-CBER-2021-5683-0002380_ti.xpt
CRFs-for-site-1055.pdf
signed-F21-5683-CBER-Dec-13-2021-Response-Letter.pdf
STN-125742_0_0-Section-2.5-Clinical-Overview.pdf
STN-125742_0_0-Section-2.7.3-Summary-of-Clinical-Efficacy.pdf
STN-125742_0_0-Section-2.7.4-summary-clin-safety.pdf
pd-production-122221
Supplemental-Index-12-22-21.pdf
pd-production-123021
pd-production-123021/CRFs-for-site-1081.pdf
pd-production-011822
CRFs-for-site-1096.pdf
pd-production-013122
CRFs-for-site-1128.pdf
pd-production-030122
125742_S1_M1_356h.pdf
125742_S1_M1_3674.pdf
125742_S1_M1_cover.pdf
125742_S1_M1_debarment.pdf
125742_S1_M1_exclusivity-claim.pdf
125742_S1_M1_fast-track-designation.pdf
125742_S1_M1_financial-cert-3454.pdf
125742_S1_M1_financial-cert-bias.pdf
125742_S1_M1_ipsp-agreed-letter.pdf
125742_S1_M1_priority-review-request.pdf
125742_S1_M1_trans-of-oblig.pdf
125742_S1_M1_us-agent-authorization.pdf
125742_S1_M1_userfee.pdf
125742_S1_M1_waiver-req-designated-suffix.pdf
125742_S1_M2_22_introduction.pdf
125742_S1_M2_24_nonclinical-overview.pdf
125742_S1_M2_26_pharmkin-tabulated-summary.pdf
125742_S1_M2_26_pharmkin-written-summary.pdf
125742_S1_M2_27_literature-references.pdf
125742_S1_M2_27_synopses-indiv-studies.pdf
125742_S1_M4_4223_185350.pdf
125742_S1_M4_4223_R-20-0072.pdf
125742_S1_M5_5351_c4591001-ad-hoc-label-tables.pdf
125742_S1_M5_5351_c4591001-fa-interim-compliance-sensitive.pdf
125742_S1_M5_5351_c4591001-fa-interim-compliance.pdf
125742_S1_M5_5351_c4591001-fa-interim-efficacy-response.pdf
125742_S1_M5_5351_c4591001-fa-interim-errata.pdf
125742_S1_M5_5351_c4591001-fa-interim-excluded-patients-sensitive.pdf
125742_S1_M5_5351_c4591001-fa-interim-excluded-patients.pdf
125742_S1_M5_5351_c4591001-fa-interim-lab-measurements-sensitive.pdf
125742_S1_M5_5351_c4591001-fa-interim-lab-measurements.pdf
125742_S1_M5_5351_c4591001-fa-interim-oversight-committees.pdf
125742_S1_M5_5351_c4591001-fa-interim-protocol.pdf
125742_S1_M5_5351_c4591001-interim-mth6-oversight-committees.pdf
125742_S1_M5_5351_c4591001-interim-mth6-protocol.pdf
125742_S1_M5_c4591001-A-201114-hiv-preferred-terms.pdf
125742_S1_M5_c4591001-A-adrg.pdf
125742_S1_M5_c4591001-A-bmi-12-15-scale.pdf
125742_S1_M5_c4591001-A-c4591001-phase-1-subjects-from-dmw.pdf
125742_S1_M5_c4591001-A-c4591001-subject-list-for-12-25-immuno-analysis-27jan2021.pdf
125742_S1_M5_c4591001-A-comorbidity-categories.pdf
125742_S1_M5_c4591001-A-first-c4591001-360-participants-enrolled-v1-13aug20-update.pdf
125742_S1_M5_c4591001-A-newlist-c4591001-6k-participants-enrolled-v3-17sep2020.pdf
125742_S1_M5_c4591001-A-report-cci-aids-hiv.pdf
125742_S1_M5_c4591001-A-report-cci-any-malignancy.pdf
125742_S1_M5_c4591001-A-report-cci-cerebrovascular.pdf
125742_S1_M5_c4591001-A-report-cci-chf.pdf
125742_S1_M5_c4591001-A-report-cci-dementia.pdf
125742_S1_M5_c4591001-A-report-cci-diabetes-with-comp.pdf
125742_S1_M5_c4591001-A-report-cci-diabetes-without-comp.pdf
125742_S1_M5_c4591001-A-report-cci-hemiplegia.pdf
125742_S1_M5_c4591001-A-report-cci-leukemia.pdf
125742_S1_M5_c4591001-A-report-cci-lymphoma.pdf
125742_S1_M5_c4591001-A-report-cci-metastatic-tumour.pdf
125742_S1_M5_c4591001-A-report-cci-mi.pdf
125742_S1_M5_c4591001-A-report-cci-mild-liver.pdf
125742_S1_M5_c4591001-A-report-cci-mod-sev-liver.pdf
125742_S1_M5_c4591001-A-report-cci-peptic-ulcer.pdf
125742_S1_M5_c4591001-A-report-cci-periph-vasc.pdf
125742_S1_M5_c4591001-A-report-cci-pulmonary.pdf
125742_S1_M5_c4591001-A-report-cci-renal.pdf
125742_S1_M5_c4591001-A-report-cci-rheumatic.pdf
125742_S1_M5_c4591001-T-S-final-reacto-tables-track.pdf
125742_S1_M5_c4591001-T-S-roadmap.pdf
125742_S1_M5_c4591001-T-S-summary-differences-csr-vs-update.pdf
125742_S1_M5_c4591001-T-S-suppl-arg.pdf
125742_S1_M5_c4591001-T-S-updated-reacto-tlf.pdf
125742_S1_M5_CRF_c4591001-1085-10851018.pdf
125742_S1_M5_CRF_c4591001-1085-10851116.pdf
125742_S1_M5_CRF_c4591001-1085-10851129.pdf
125742_S1_M5_CRF_c4591001-1085-10851216.pdf
125742_S1_M5_CRF_c4591001-1085-10851246.pdf
FDA-CBER-2021-5683-0021888 to -0021901_125742_S1_M5_c4591001-A-P-adae-s091-all-pd2-p3-saf1-sas.txt
/FDA-CBER-2021-5683-0021902 to -0021915_125742_S1_M5_c4591001-A-P-adae-s091-all-pd2-p3-saf2-sas.txt
FDA-CBER-2021-5683-0021916 to -0021929_125742_S1_M5_c4591001-A-P-adae-s092-all-unb-p3-saf-sas.txt
FDA-CBER-2021-5683-0021930 to -0021943_125742_S1_M5_c4591001-A-P-adae-s092-cr-cut-p3x-saf-sas.txt
FDA-CBER-2021-5683-0021944 to -0021963_125742_S1_M5_c4591001-A-P-adae-sas.txt
FDA-CBER-2021-5683-0021964 to -0021980_125742_S1_M5_c4591001-A-P-adae-vax-tier2-p3-saf-sas.txt
FDA-CBER-2021-5683-0021981 to -0022027_125742_S1_M5_c4591001-A-P-adc19ef-sas.txt
FDA-CBER-2021-5683-0022028 to -0022040_125742_S1_M5_c4591001-A-P-adc19ef-ve-cov-7pd2-sg-eval-sas.txt
FDA-CBER-2021-5683-0022041 to -0022053_125742_S1_M5_c4591001-A-P-adc19ef-ve-cov-7pd2-wo-sg-eval-sas.txt
FDA-CBER-2021-5683-0022054 to -0022062_125742_S1_M5_c4591001-A-P-adc19ef-ve-sev-cov-pd1-aai-sas.txt
FDA-CBER-2021-5683-0022063 to -0022135_125742_S1_M5_c4591001-A-P-adce-s010-lr-p3-saf-sas.txt
FDA-CBER-2021-5683-0022136 to -0022325_125742_S1_M5_c4591001-A-P-adce-s020-se-p3-saf-sas.txt
FDA-CBER-2021-5683-0022326 to -0022345_125742_S1_M5_c4591001-A-P-adcevd-sas.txt
FDA-CBER-2021-5683-0022346 to -0022364_125742_S1_M5_c4591001-A-P-adcm-sas.txt
FDA-CBER-2021-5683-0022365 to -0022560_125742_S1_M5_c4591001-A-P-adds-s002-all-p3-rand-sas.txt
FDA-CBER-2021-5683-0022561 to -0022567_125742_S1_M5_c4591001-A-P-adds-sas.txt
FDA-CBER-2021-5683-0022568 to -0022600_125742_S1_M5_c4591001-A-P-adfacevd-sas.txt
FDA-CBER-2021-5683-0022601 to -0022617_125742_S1_M5_c4591001-A-P-admh-sas.txt
FDA-CBER-2021-5683-0022618 to -0022691_125742_S1_M5_c4591001-A-P-adsl-demo-7d-eval-eff-sas.txt
FDA-CBER-2021-5683-0022692 to -0022765_125742_S1_M5_c4591001-A-P-adsl-demo-7d-wwo-eval-eff-sas.txt
FDA-CBER-2021-5683-0022766 to -0022792_125742_S1_M5_c4591001-A-P-adsl-fu-d2-p3-saf-sas.txt
FDA-CBER-2021-5683-0022793 to -0022866_125742_S1_M5_c4591001-A-P-adsl-s005-demo-all-p3-saf-sas.txt
FDA-CBER-2021-5683-0022867 to -0023006_125742_S1_M5_c4591001-A-P-adsl-sas.txt
FDA-CBER-2021-5683-0023007 to -0023031_125742_S1_M5_c4591001-A-P-adsympt-sas.txt
FDA-CBER-2021-5683-0023032 to -0023065_125742_S1_M5_c4591001-A-P-adva-sas.txt
FDA-CBER-2021-5683-0023150 to -0023454_125742_S1_M5_c4591001-A-define.xml
FDA-CBER-2021-5683-0023455 to -0023486_125742_S1_M5_c4591001-A-define-2-0-0.xsl
FDA-CBER-2021-5683-0023490 to -0023491_125742_S1_M5_c4591001-A-bmi-12-15-scale.xlsx
FDA-CBER-2021-5683-0023500 to -0023507_125742_S1_M5_c4591001-A-c4591001-phase-1-subjects-from-dmw.xlsx
FDA-CBER-2021-5683-0023523 to -0023538_125742_S1_M5_c4591001-A-c4591001-subject-list-for-12-25-immuno-analysis-27jan2021.xlsx
FDA-CBER-2021-5683-0023540_125742_S1_M5_c4591001-A-comorbidity-categories.xlsx
FDA-CBER-2021-5683-0023550 to -0023569_125742_S1_M5_c4591001-A-first-c4591001-360-participants-enrolled-v1-13aug20-update.xlsx
FDA-CBER-2021-5683-0023711 to -0023875_125742_S1_M5_c4591001-A-newlist-c4591001-6k-participants-enrolled-v3-17sep2020.xlsx
FDA-CBER-2021-5683-0023878_125742_S1_M5_c4591001-A-report-cci-aids-hiv.xlsx
FDA-CBER-2021-5683-0023895 to -0023915_125742_S1_M5_c4591001-A-report-cci-any-malignancy.xlsx
FDA-CBER-2021-5683-0023919 to -0023921_125742_S1_M5_c4591001-A-report-cci-cerebrovascular.xlsx
FDA-CBER-2021-5683-0023924_125742_S1_M5_c4591001-A-report-cci-chf.xlsx
FDA-CBER-2021-5683-0023926_125742_S1_M5_c4591001-A-report-cci-dementia.xlsx
FDA-CBER-2021-5683-0023928_125742_S1_M5_c4591001-A-report-cci-diabetes-with-comp.xlsx
FDA-CBER-2021-5683-0023930_125742_S1_M5_c4591001-A-report-cci-diabetes-without-comp.xlsx
FDA-CBER-2021-5683-0023932_125742_S1_M5_c4591001-A-report-cci-hemiplegia.xlsx
FDA-CBER-2021-5683-0023936 to -0023937_125742_S1_M5_c4591001-A-report-cci-leukemia.xlsx
FDA-CBER-2021-5683-0023944 to -0023950_125742_S1_M5_c4591001-A-report-cci-lymphoma.xlsx
FDA-CBER-2021-5683-0023955 to -0023958_125742_S1_M5_c4591001-A-report-cci-metastatic-tumour.xlsx
FDA-CBER-2021-5683-0023960_125742_S1_M5_c4591001-A-report-cci-mi.xlsx
FDA-CBER-2021-5683-0023963_125742_S1_M5_c4591001-A-report-cci-mild-liver.xlsx
FDA-CBER-2021-5683-0023965_125742_S1_M5_c4591001-A-report-cci-mod-sev-liver.xlsx
FDA-CBER-2021-5683-0023967_125742_S1_M5_c4591001-A-report-cci-peptic-ulcer.xlsx
FDA-CBER-2021-5683-0023971 to -0023972_125742_S1_M5_c4591001-A-report-cci-periph-vasc.xlsx
FDA-CBER-2021-5683-0023975 to -0023976_125742_S1_M5_c4591001-A-report-cci-pulmonary.xlsx
FDA-CBER-2021-5683-0023979 to -0023980_125742_S1_M5_c4591001-A-report-cci-renal.xlsx
FDA-CBER-2021-5683-0023983 to -0023984_125742_S1_M5_c4591001-A-report-cci-rheumatic.xlsx
FDA-CBER-2021-5683-0023987_125742_S1_M5_c4591001-A-201114-hiv-preferred-terms.xlsx
pd-production-032422
125742_S1_M1_priority-review-request.pdf
pd-production-040122
125742_S1_M5_5351_c4591001-fa-interim-audit-certificates.pdf
125742_S1_M5_5351_c4591001-fa-interim-demographics.pdf
125742_S1_M5_5351_c4591001-fa-interim-iec-irb-consent-form.pdf
125742_S1_M5_5351_c4591001-fa-interim-invest-signature.pdf
125742_S1_M5_5351_c4591001-fa-interim-protocol-deviations.pdf
125742_S1_M5_5351_c4591001-fa-interim-publications.pdf
125742_S1_M5_5351_c4591001-fa-interim-randomization-sensitive.pdf
125742_S1_M5_5351_c4591001-fa-interim-randomization.pdf
125742_S1_M5_5351_c4591001-fa-interim-sample-crf.pdf
125742_S1_M5_5351_c4591001-fa-interim-sponsor-signature.pdf
125742_S1_M5_5351_c4591001-interim-mth6-adverse-events-sensitive.pdf
125742_S1_M5_5351_c4591001-interim-mth6-audit-certificates.pdf
125742_S1_M5_5351_c4591001-interim-mth6-demographics.pdf
125742_S1_M5_5351_c4591001-interim-mth6-invest-signature.pdf
reissue_5.3.6 postmarketing experience.pdf
pd-production-050222
125742_S1_M5_5351_bnt162-01-interim3-adverse-events.pdf
125742_S1_M5_5351_bnt162-01-interim3-compliance.pdf
125742_S1_M5_5351_bnt162-01-interim3-demographics.pdf
125742_S1_M5_5351_bnt162-01-interim3-discontinued-patients.pdf
125742_S1_M5_5351_bnt162-01-interim3-excluded-patients.pdf
125742_S1_M5_5351_bnt162-01-interim3-iec-irb.pdf
125742_S1_M5_5351_bnt162-01-interim3-invest-signature.pdf
125742_S1_M5_5351_bnt162-01-interim3-investigators.pdf
125742_S1_M5_5351_bnt162-01-interim3-lab-measurements.pdf
125742_S1_M5_5351_bnt162-01-interim3-notes-for-reader.pdf
125742_S1_M5_5351_bnt162-01-interim3-patient-batches.pdf
125742_S1_M5_5351_bnt162-01-interim3-protocol-deviations.pdf
125742_S1_M5_5351_bnt162-01-interim3-protocol.pdf
125742_S1_M5_5351_bnt162-01-interim3-report-body.pdf
125742_S1_M5_5351_bnt162-01-interim3-sample-crf.pdf
125742_S1_M5_5351_bnt162-01-interim3-sap.pdf
125742_S1_M5_5351_bnt162-01-interim3-sponsor-personnel-list.pdf
125742_S1_M5_5351_bnt162-01-interim3-sponsor-signature.pdf
125742_S1_M5_5351_bnt162-01-interim3-synopsis.pdf
125742_S1_M5_5351_bnt162-01_10010.pdf
125742_S1_M5_5351_bnt162-01_10075.pdf
125742_S1_M5_5351_bnt162-01_20116.pdf
125742_S1_M5_5351_bnt162-01_20215.pdf
125742_S1_M5_5351_bnt162-01_20242.pdf
125742_S1_M5_5351_c4591001-interim-mth6-randomization-sensitive.pdf
125742_S1_M5_5351_c4591001-interim-mth6-sample-crf.pdf
125742_S1_M5_5351_c4591001-interim-mth6-sponsor-signature.pdf
125742_S1_M5_bnt162-01-A-adrg.pdf
125742_S1_M5_bnt162-01-S-acrf.pdf
125742_S1_M5_bnt162-01-S-csdrg.pdf
125742_S1_M5_c4591001-S-acrf.pdf
125742_S1_M5_c4591001-S-csdrg.pdf
125742_S1_M5_c4591001-S-Supp-acrf.pdf
125742_S1_M5_CRF_c4591001-1001-10011093.pdf
125742_S1_M5_CRF_c4591001-1001-10011100.pdf
125742_S1_M5_CRF_c4591001-1001-10011135.pdf
125742_S1_M5_CRF_c4591001-1003-10031038.pdf
125742_S1_M5_CRF_c4591001-1003-10031065.pdf
125742_S1_M5_CRF_c4591001-1003-10031111.pdf
125742_S1_M5_CRF_c4591001-1003-10031113.pdf
125742_S1_M5_CRF_c4591001-1003-10031149.pdf
125742_S1_M5_CRF_c4591001-1003-10031186.pdf
125742_S1_M5_CRF_c4591001-1003-10031197.pdf
125742_S1_M5_CRF_c4591001-1003-10031207.pdf
125742_S1_M5_CRF_c4591001-1005-10051047.pdf
125742_S1_M5_CRF_c4591001-1005-10051054.pdf
125742_S1_M5_CRF_c4591001-1005-10051069.pdf
125742_S1_M5_CRF_c4591001-1005-10051214.pdf
125742_S1_M5_CRF_c4591001-1005-10051293.pdf
125742_S1_M5_CRF_c4591001-1005-10051347.pdf
125742_S1_M5_CRF_c4591001-1005-10051387.pdf
125742_S1_M5_CRF_c4591001-1005-10051411.pdf
125742_S1_M5_CRF_c4591001-1006-10061020.pdf
125742_S1_M5_CRF_c4591001-1006-10061040.pdf
125742_S1_M5_CRF_c4591001-1006-10061052.pdf
125742_S1_M5_CRF_c4591001-1006-10061094.pdf
125742_S1_M5_CRF_c4591001-1006-10061098.pdf
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125742_S34_M1_response-03aug2021.pdf
125742_S34_M3_32a3_excipient-information-nomenclature-alc-0315.pdf
125742_S35_M1_cover.pdf
125742_S35_M1_response-04aug2021.pdf
125742_S36_M1_cover.pdf
125742_S36_M1_response-02aug2021.pdf
125742_S37_M1_cover.pdf
125742_S37_M1_response-05aug2021.pdf
125742_S40_M1_cover.pdf
125742_S40_M1_response-06aug2021.pdf
125742_S42_M1_cover.pdf
125742_S42_M1_response-04aug2021.pdf
125742_S42_M3_32r_comirnaty-lot-release-template.pdf
125742_S43_M1_cover.pdf
125742_S43_M1_response-05aug2021.pdf
125742_S43_M3_32p3_manufacturers.pdf
125742_S44_M1_cover.pdf
125742_S44_M1_response-10aug2021.pdf
125742_S47_M1_cover.pdf
125742_S47_M1_response-11aug2021.pdf
125742_S47_M3_32p3_manufacturer-diluent.pdf
125742_S48_M1_cover.pdf
125742_S48_M1_response-06aug2021.pdf
125742_S50_M1_cover.pdf
125742_S50_M1_response-13aug2021.pdf
125742_S50_M3_32r_comirnaty-lot-release-template.pdf
125742_S53_M1_cover.pdf
125742_S53_M1_response-13aug2021.pdf
125742_S55_M1_cover.pdf
125742_S55_M2_32p8_stability-data-accelerated.pdf
125742_S55_M2_drug-product-stability.pdf
125742_S55_M2_introduction.pdf
125742_S55_M3_32p8_stability-data-long-term.pdf
125742_S55_M3_32p8_stability-summary.pdf
125742_S56_M1_cover.pdf
125742_S56_M1_response-13aug2021.pdf
125742_S57_M1_cover.pdf
125742_S57_M1_response-16aug2021.pdf
125742_S57_M3_32p3_manufacturer-diluent.pdf
125742_S59_M1_cover.pdf
125742_S59_M1_response-17aug2021.pdf
125742_S5_M1_cover.pdf
125742_S5_M1_response-20-may-2021-facilities.pdf
125742_S60_M1_cover.pdf
125742_S60_M1_response-17aug2021.pdf
125742_S60_M3_32s2_control-critical-steps-manuf-process.pdf
125742_S61_M1_cover.pdf
125742_S61_M1_response-17aug2021.pdf
125742_S63_M1_cover.pdf
125742_S63_M1_response-18aug2021.pdf
125742_S80_M1_cover.pdf
125_BLA 125742-0_08-23-2021_Memo_Committee Memo_Toxico.pdf
127_Courtesy Copy_BLA 125742-0_CBER Sentinel Program Sufficiency Memo - COMIRNATY.pdf
128_BLA 125742-0_08-30-2021_Telecon_Other (1).pdf
129_BLA 125742-0_08-30-2021_Telecon_Other.pdf
131_Courtesy Copy_BLA 125742-0_Clinical Review Memo, August 23, 2021 - COMIRNATY.pdf
132_BLA 125742-0_09-13-2021_Memo_Committee Memo_Review (1).pdf
133_Courtesy Copy_BLA 125742-0_Benefit-Risk Assessment Review Memo - COMIRNATY.pdf
134_Courtesy Copy_BLA 125742-0_Toxicology Review - COMIRNATY.pdf
135_Courtesy Copy_BLA 125742-0_November 8, 2021_Summary Basis for Regulatory Action - COMIRNATY.pdf
136_BLA_125742_RNAcontent_InSupportTesting.pdf
137_BLA_125742_Endotoxin release tests lots FD7220, FE3592, FF2587.pdf
138_BLA_125742_STN125742 release test (pH) lots FD7220, FE3592, FF2587.pdf
15_BLA 125742-0_07-02-2021_Telecon_Information Reques.pdf
18_BLA 125742-0_07-09-2021_Telecon_Information Reques.pdf
1_BLA 125742-0_05-13-2021_Letter_Acknowledgement Let.pdf
1_IND_19736_185_23-Feb-2021_KERRY_KERRY__RO_.pdf
21_BLA 125742-0_07-15-2021_Letter_Filing Notification.pdf
25_1_BLA 125742-0_07-16-2021_Telecon_Information Reques.pdf
26_2_BLA 125742-0_07-16-2021_Telecon_Information Reques.pdf
27_BLA 125742-0_07-19-2021_Telecon_Advice.pdf
2_IND_19736_214_03-Mar-2021_KERRY_KERRY__RO_ .pdf
32_1_BLA 125742-0_07-26-2021_Telecon_Information Reques.pdf
33_1_BLA 125742-0_07-27-2021_Telecon_Information Reques.pdf
39_2_BLA 125742-0_08-02-2021_Telecon_Information Reques.pdf
3_BLA 125742-0_05-20-2021_Telecon_Information Reques.pdf
3_IND_19736_243_19-Mar-2021_KERRY_KERRY__RO_ .pdf
40_2_BLA 125742-0_08-03-2021_Telecon_Information Reques.pdf
42_1_BLA 125742-0_08-04-2021_Telecon_Information Reques.pdf
43A_STN 125742.0 4AUG21 LRP FU IR 2.pdf
44_3_BLA 125742-0_08-04-2021_Telecon_Information Reques.pdf
45_BLA 125742-0_08-05-2021_Telecon_Advice.pdf
46_2_BLA 125742-0_08-05-2021_Telecon_Information Reques.pdf
47_1_BLA 125742-0_08-05-2021_Telecon_Information Reques.pdf
49_BLA 125742-0_08-06-2021_Letter_UNII Code Notificat.pdf
4_IND_19736_289_27-Apr-2021_DEBORAH_DEBORAH__RC_.pdf
51_Courtesy Copy_BLA 125742-0_Pharmacovigilance Plan Review Memo - COMIRNATY.pdf
52_1_BLA 125742-0_08-06-2021_Telecon_Information Reques.pdf
53_2_BLA 125742-0_08-06-2021_Telecon_Information Reques.pdf
54_BLA 125742-0_08-09-2021_Inspection Related_Inspect.pdf.pdf
55_BLA 125742-0_08-09-2021_Telecon_Advice.pdf
58_2_BLA 125742-0_08-10-2021_Telecon_Information Reques.pdf
5_IND_19736_335_19-May-2021_DEBORAH_DEBORAH__RC_.pdf
60_BLA 125742-0_08-11-2021_Telecon_Information Reques.pdf
61_BLA 125742-0_08-11-2021_Telecon_Other.pdf
62_BLA 125742-0_08-12-2021_Memo_Committee Memo_Requir.pdf
64_Courtesy Copy_BLA 125742-0_Bioresearch Monitoring Discipline Review Memo, August 13, 2021 - COMIRNATY.pdf
65_BLA 125742-0_08-13-2021_Memo_Request For Complianc.pdf
66_4_BLA 125742-0_08-13-2021_Telecon_Information Reques.pdf
68A_5_BLA 125742-0_08-13-2021_Telecon_Information Reques.pdf
68B_5_BLA 125742-0_08-13-2021_Telecon_Information Reques.pdf
68_5_BLA 125742-0_08-13-2021_Telecon_Information Reques.pdf
6_IND_19736_366_24-Jun-2021_DEBORAH_DEBORAH__RO_.pdf
73_2_BLA 125742-0_08-16-2021_Telecon_Information Reques.pdf
74_3_BLA 125742-0_08-16-2021_Telecon_Information Reques.pdf
75_1_BLA 125742-0_08-16-2021_Telecon_Information Reques.pdf
79_3_BLA 125742-0_08-17-2021_Telecon_Information Reques.pdf
7_IND_19736_409_26-Jul-2021_DEBORAH_DEBORAH__RO_.pdf
81_1_BLA 125742-0_08-17-2021_Telecon_Information Reques.pdf
83_BLA 125742-0_08-17-2021_Telecon_Other.pdf
84_BLA 125742-0_08-18-2021_Memo_Committee Memo_Review.pdf
85_Courtesy Copy_BLA 125742-0_Statistical Review -- COMIRNATY.pdf
86_BLA 125742-0_08-18-2021_Telecon_Advice.pdf
87_3_BLA 125742-0_08-18-2021_Telecon_Information Reques.pdf
89_1_BLA 125742-0_08-18-2021_Telecon_Information Reques.pdf
8_1_BLA 125742-0_06-25-2021_Telecon_Information Reques.pdf
8_IND_19736_453_26-Aug-2021_DEBORAH_DEBORAH__RO_.pdf
92_BLA 125742-0_08-19-2021_Inspection Related_Inspect.pdf
93_Courtesy Copy_2_BLA 125742-0_Statistical Review - COMIRNATY.pdf
94_Courtesy Copy_1_BLA 125742-0_Statistical Review-COMIRNATY.pdf
95_BLA 125742-0_08-19-2021_Memo_Compliance Check Acce.pdf
99_BLA 125742-0_08-20-2021_Memo_Committee Memo_Labeli.pdf
9_IND_19736_491_29-Sep-2021_DEBORAH_DEBORAH__RO_ The Summary Monthly Safety Report has been reviewed. No furthe.pdf
FDA-CBER-2021-5683-1150835-1200874_Slipsheet.pdf
STN 124742_Courtesy Copy_Pfizer-BioNTech Comirnaty STN 125742 COVID-19 Vaccine Lot Notifications (2021).pdf
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