Pfizer 16+ Documents
Four days after the Pfizer vaccine was approved for ages 16+, PHMPT submitted a Freedom of Information Act Request to the FDA for all of the data within Pfizer’s COVID-19 vaccine biological product file. PHMPT has now sued the FDA for not releasing the data. Click below for court documents and for productions of Pfizer’s documents from the FDA.
| Title | Date | File Size | Link |
|---|---|---|---|
| 125742 0_20219001.P0.pdf | November 1, 2023 | 912 KB | |
| 125742_S112_S2_M3_32s2_control critical steps manuf process.pdf | November 1, 2023 | 2 MB | |
| 125742_S116_M1_lab 1448 1 0.pdf | November 1, 2023 | 1 MB | |
| 125742_S112_M1_cover.pdf | November 1, 2023 | 2 MB | |
| 125742_S111_M1_cover.pdf | November 1, 2023 | 2 MB | |
| 125742_S111_M1_letter of authorization.pdf | November 1, 2023 | 739 KB | |
| 125742_S111_M1_356h.pdf | November 1, 2023 | 4 MB | |
| 125742_S80_M1_cover.pdf | November 1, 2023 | 734 KB | |
| 125742_S63_M1_response 18aug2021.pdf | November 1, 2023 | 2 MB | |
| 125742_S61_M1_response 17aug2021.pdf | November 1, 2023 | 2 MB | |
| 125742_S63_M1_cover.pdf | November 1, 2023 | 2 MB | |
| 125742_S60_M3_32s2_control critical steps manuf process.pdf | November 1, 2023 | 2 MB | |
| 125742_S61_M1_cover.pdf | November 1, 2023 | 668 KB | |
| 125742_S60_M1_response 17aug2021.pdf | November 1, 2023 | 2 MB | |
| 125742_S59_M1_response 17aug2021.pdf | November 1, 2023 | 1 MB | |
| 125742_S60_M1_cover.pdf | November 1, 2023 | 2 MB | |
| 125742_S57_M3_32p3_manufacturer diluent.pdf | November 1, 2023 | 2 MB | |
| 125742_S59_M1_cover.pdf | November 1, 2023 | 672 KB | |
| 125742_S57_M1_response 16aug2021.pdf | November 1, 2023 | 2 MB | |
| 125742 0_20219009.P0.pdf | November 1, 2023 | 889 KB | |
| FDA CBER 2021 5683 1150835 1200874_Slipsheet.pdf | November 1, 2023 | 69 KB | |
| STN 124742_Courtesy Copy_Pfizer BioNTech Comirnaty STN 125742 COVID 19 Vaccine Lot Notifications (2021).pdf | November 1, 2023 | 200 KB | |
| 125742 0_20219007.P0.pdf | November 1, 2023 | 832 KB | |
| 125742 0_20219008.P0.pdf | November 1, 2023 | 882 KB | |
| 125742 0_20219006.P0.pdf | November 1, 2023 | 902 KB | |
| 125742 0_20219006.PC1.pdf | November 1, 2023 | 902 KB | |
| 125742 0_20219004.P0.pdf | November 1, 2023 | 903 KB | |
| 125742 0_20219005.P0.pdf | November 1, 2023 | 898 KB | |
| 125742 0_20219003.P0.pdf | November 1, 2023 | 897 KB | |
| 125742 0_20219003.PC1.pdf | November 1, 2023 | 898 KB | |
| 125742 0_20219002.P0.pdf | November 1, 2023 | 905 KB | |
| 125742 0_20219002.PC1.pdf | November 1, 2023 | 905 KB | |
| 125742 0_20219001.PC1.pdf | November 1, 2023 | 912 KB | |
| 125742_S56_M1_response 13aug2021.pdf | November 1, 2023 | 2 MB | |
| 125742_S55_M3_32p8_stability summary.pdf | November 1, 2023 | 3 MB | |
| 125742_S56_M1_cover.pdf | November 1, 2023 | 672 KB | |
| 125742_S55_M3_32p8_stability data long term.pdf | November 1, 2023 | 3 MB | |
| 125742_S55_M2_introduction.pdf | November 1, 2023 | 11 MB | |
| 125742_S55_M2_drug product stability.pdf | November 1, 2023 | 3 MB | |
| 125742_S55_M2_32p8_stability data accelerated.pdf | November 1, 2023 | 3 MB | |
| 125742_S53_M1_response 13aug2021.pdf | November 1, 2023 | 1 MB | |
| 125742_S55_M1_cover.pdf | November 1, 2023 | 767 KB | |
| 125742_S50_M3_32r_comirnaty lot release template.pdf | November 1, 2023 | 2 MB | |
| 125742_S53_M1_cover.pdf | November 1, 2023 | 675 KB | |
| 125742_S50_M1_response 13aug2021.pdf | November 1, 2023 | 2 MB | |
| 125742_S48_M1_response 06aug2021.pdf | November 1, 2023 | 2 MB | |
| 125742_S50_M1_cover.pdf | November 1, 2023 | 2 MB | |
| 125742_S48_M1_cover.pdf | November 1, 2023 | 2 MB | |
| 125742_S47_M1_response 11aug2021.pdf | November 1, 2023 | 2 MB | |
| 125742_S47_M3_32p3_manufacturer diluent.pdf | November 1, 2023 | 2 MB | |
| 125742_S47_M1_cover.pdf | November 1, 2023 | 2 MB | |
| 125742_S44_M1_response 10aug2021.pdf | November 1, 2023 | 2 MB | |
| 125742_S43_M3_32p3_manufacturers.pdf | November 1, 2023 | 2 MB | |
| 125742_S44_M1_cover.pdf | November 1, 2023 | 2 MB | |
| 125742_S43_M1_response 05aug2021.pdf | November 1, 2023 | 2 MB | |
| 125742_S42_M3_32r_comirnaty lot release template.pdf | November 1, 2023 | 709 KB | |
| 125742_S43_M1_cover.pdf | November 1, 2023 | 2 MB | |
| 125742_S42_M1_response 04aug2021.pdf | November 1, 2023 | 4 MB | |
| 125742_S40_M1_response 06aug2021.pdf | November 1, 2023 | 2 MB | |
| 125742_S42_M1_cover.pdf | November 1, 2023 | 2 MB | |
| 125742_S40_M1_cover.pdf | November 1, 2023 | 2 MB | |
| 125742_S37_M1_cover.pdf | November 1, 2023 | 2 MB | |
| 125742_S37_M1_response 05aug2021.pdf | November 1, 2023 | 2 MB | |
| 125742_S36_M1_response 02aug2021.pdf | November 1, 2023 | 2 MB | |
| 125742_S35_M1_response 04aug2021.pdf | November 1, 2023 | 1 MB | |
| 125742_S36_M1_cover.pdf | November 1, 2023 | 2 MB | |
| 125742_S35_M1_cover.pdf | November 1, 2023 | 2 MB | |
| 125742_S34_M1_response 03aug2021.pdf | November 1, 2023 | 1 MB | |
| 125742_S34_M3_32a3_excipient information nomenclature alc 0315.pdf | November 1, 2023 | 2 MB | |
| 125742_S57_M1_cover.pdf | November 1, 2023 | 2 MB | |
| 125742_S26_M1_fda bnt cl.pdf | November 1, 2023 | 996 KB | |
| 125742_S30_M1_cover.pdf | November 1, 2023 | 671 KB | |
| 125742_S26_M1_andover 483 response.pdf | November 1, 2023 | 1 MB | |
| 125742_S26_M1_cover.pdf | November 1, 2023 | 718 KB | |
| 125742_S25_M1_response 26jul2021.pdf | November 1, 2023 | 1 MB | |
| 125742_S22_M1_response 16jul2021.pdf | November 1, 2023 | 1 MB | |
| 125742_S25_M1_cover.pdf | November 1, 2023 | 668 KB | |
| 125742_S19_M1_response 02jul2021.pdf | November 1, 2023 | 2 MB | |
| 125742_S22_M1_cover.pdf | November 1, 2023 | 678 KB | |
| 125742_S19_M1_cover.pdf | November 1, 2023 | 2 MB | |
| 125742_S17_M1_cover.pdf | November 1, 2023 | 674 KB | |
| 125742_S17_M1_reponse 09jul2021.pdf | November 1, 2023 | 2 MB | |
| 125742_S15_M1_response 16jul2021 lrp samples.pdf | November 1, 2023 | 1 MB | |
| 125742_S15_M3_32r_comirnaty lot release 16jul2021.pdf | November 1, 2023 | 1 MB | |
| 125742_S11_M3_32r_pf 07302048 dp rm coa.pdf | November 1, 2023 | 634 KB | |
| 125742_S15_M1_cover.pdf | November 1, 2023 | 675 KB | |
| 125742_S11_M3_32r_fc3184 coa.pdf | November 1, 2023 | 836 KB | |
| 125742_S11_M3_32r_fd0809 coa.pdf | November 1, 2023 | 836 KB | |
| 125742_S11_M3_32r_677365 1g a 010 coa.pdf | November 1, 2023 | 636 KB | |
| 125742_S11_M3_32r_fc3181 coa.pdf | November 1, 2023 | 840 KB | |
| 125742_S11_M3_32r_677100p 1g a 010 coa.pdf | November 1, 2023 | 636 KB | |
| 125742_S11_M3_32r_677159p 1g a 010 coa.pdf | November 1, 2023 | 636 KB | |
| 125742_S11_M3_32r_677315o 1g a 010 coa.pdf | November 1, 2023 | 635 KB | |
| 125742_S11_M3_32r_21y513c2401 coa.pdf | November 1, 2023 | 1 MB | |
| 125742_S11_M3_32r_21y513c2501 coa.pdf | November 1, 2023 | 636 KB | |
| 125742_S11_M1_response 25jun2021 cmc.pdf | November 1, 2023 | 2 MB | |
| 125742_S11_M3_32r_21y513c2301 coa.pdf | November 1, 2023 | 1 MB | |
| 125742_S11_M1_cover.pdf | November 1, 2023 | 2 MB | |
| 125742_S5_M1_cover.pdf | November 1, 2023 | 725 KB | |
| 125742_S5_M1_response 20 may 2021 facilities.pdf | November 1, 2023 | 1 MB | |
| 125742_S2_M3_32s4_specification.pdf | November 1, 2023 | 2 MB | |
| 125742_S2_M3_32s4_validation analyt procedure overview.pdf | November 1, 2023 | 2 MB | |
| 125742_S2_M3_32s4_analytical procedure overview.pdf | November 1, 2023 | 2 MB | |
| 125742_S30_M1_response 26jul2021.pdf | November 1, 2023 | 1 MB | |
| 125742_S34_M1_cover.pdf | November 1, 2023 | 668 KB | |
| 125742_S2_M3_32r_reg info manufacturing schedules.pdf | November 1, 2023 | 2 MB | |
| 125742_S2_M3_32r_reg info lot release documentation package.pdf | November 1, 2023 | 4 MB | |
| 125742_S2_M3_32p53_validation analytical procedure rt pcr.pdf | November 1, 2023 | 2 MB | |
| 125742_S2_M3_32p53_validation analytical procedures overview.pdf | November 1, 2023 | 2 MB | |
| 125742_S2_M3_32p52_analytical procedure subvis particulate matter.pdf | November 1, 2023 | 2 MB | |
| 125742_S2_M3_32p53_validation analytical procedure cap gel electro.pdf | November 1, 2023 | 2 MB | |
| 125742_S2_M3_32p52_analytical procedure rt pcr.pdf | November 1, 2023 | 2 MB | |
| 125742_S2_M3_32p52_analytical procedure osmometry.pdf | November 1, 2023 | 2 MB | |
| 125742_S2_M3_32p52_analytical procedure overview.pdf | November 1, 2023 | 2 MB | |
| 125742_S2_M3_32p52_analytical procedure endotoxin.pdf | November 1, 2023 | 2 MB | |
| 125742_S2_M3_32p8_stability summary.pdf | November 1, 2023 | 2 MB | |
| 125742_S2_M3_32p52_analytical procedure cap gel electro.pdf | November 1, 2023 | 2 MB | |
| 125742_S2_M3_32p8_stability data thermal stress cycling.pdf | November 1, 2023 | 3 MB | |
| 125742_S2_M3_32p8_stability data photostability.pdf | November 1, 2023 | 2 MB | |
| 125742_S2_M3_32p8_stability data long term.pdf | November 1, 2023 | 2 MB | |
| 125742_S2_M3_32p8_stability data accelerated.pdf | November 1, 2023 | 2 MB | |
| 125742_S2_M3_32p8_postapproval stability.pdf | November 1, 2023 | 2 MB | |
| 125742_S2_M3_32p5_batch analyses.pdf | November 1, 2023 | 3 MB | |
| 125742_S2_M3_32p5_specifications.pdf | November 1, 2023 | 2 MB | |
| 125742_S2_M3_32p4_novel excipients.pdf | November 1, 2023 | 2 MB | |
| 125742_S2_M3_32p4_excipients human animal.pdf | November 1, 2023 | 2 MB | |
| 125742_S2_M3_32p3_control critical steps in process mon control overview.pdf | November 1, 2023 | 2 MB | |
| 125742_S2_M3_32p3_manufacturers.pdf | November 1, 2023 | 2 MB | |
| 125742_S2_M3_32p3_batch formula.pdf | November 1, 2023 | 2 MB | |
| 125742_S2_M3_32p1_description and composition.pdf | November 1, 2023 | 2 MB | |
| 125742_S2_M3_32p2_pharmaceutical development introduction.pdf | November 1, 2023 | 2 MB | |
| 125742_S2_M3_32a3_excipient information structure alc 0159.pdf | November 1, 2023 | 2 MB | |
| 125742_S2_M3_32a3_excipient information structure alc 0315.pdf | November 1, 2023 | 2 MB | |
| 125742_S2_M3_32a3_excipient information nomenclature alc 0315.pdf | November 1, 2023 | 2 MB | |
| 125742_S2_M3_32a3_excipient information nomenclature alc 0159.pdf | November 1, 2023 | 2 MB | |
| 125742_S2_M3_32a3_excipient information excipients alc 0159.pdf | November 1, 2023 | 2 MB | |
| 125742_S2_M3_32a3_excipient information excipients alc 0315.pdf | November 1, 2023 | 2 MB | |
| 125742_S2_M3_32a2_adventitious agents kalamazoo.pdf | November 1, 2023 | 2 MB | |
| 125742_S2_M3_32a2_adventitious agents puurs.pdf | November 1, 2023 | 2 MB | |
| 125742_S2_M3_32a2_adventitious agents andover.pdf | November 1, 2023 | 2 MB | |
| 125742_S2_M2_drug product stability.pdf | November 1, 2023 | 2 MB | |
| 125742_S2_M2_introduction.pdf | November 1, 2023 | 2 MB | |
| 125742_S2_M2_drug product reference stand or materials.pdf | November 1, 2023 | 2 MB | |
| 125742_S2_M2_appendices adv agen safe val.pdf | November 1, 2023 | 2 MB | |
| 125742_S2_M2_drug product description composition drug prod.pdf | November 1, 2023 | 2 MB | |
| 125742_S1_M1_financial cert 3455.pdf | November 1, 2023 | 2 MB | |
| 125742_S1_M1_financial cert summary.pdf | November 1, 2023 | 715 KB | |
| 125742_S1_M1_1.9.4_ipsp agreed.pdf | November 1, 2023 | 2 MB | |
| 125742_S1_M1_1.9.2_ped studies deferral req.pdf | November 1, 2023 | 11 MB | |
| 138_BLA_125742_STN125742 release test (pH) lots FD7220, FE3592, FF2587.pdf | November 1, 2023 | 1 MB | |
| 137_BLA_125742_Endotoxin release tests lots FD7220, FE3592, FF2587.pdf | November 1, 2023 | 813 KB | |
| 125742_S2_M3_32s2_control critical steps manuf process.pdf | November 1, 2023 | 2 MB | |
| 125742_S2_M3_32s2_manufacturer.pdf | November 1, 2023 | 2 MB | |
| 133_Courtesy Copy_BLA 125742 0_Benefit Risk Assessment Review Memo COMIRNATY.pdf | November 1, 2023 | 3 MB | |
| 131_Courtesy Copy_BLA 125742 0_Clinical Review Memo, August 23, 2021 COMIRNATY.pdf | November 1, 2023 | 1 MB | |
| 132_BLA 125742 0_09 13 2021_Memo_Committee Memo_Review (1).pdf | November 1, 2023 | 1 MB | |
| 127_Courtesy Copy_BLA 125742 0_CBER Sentinel Program Sufficiency Memo COMIRNATY.pdf | November 1, 2023 | 164 KB | |
| 128_BLA 125742 0_08 30 2021_Telecon_Other (1).pdf | November 1, 2023 | 637 KB | |
| 129_BLA 125742 0_08 30 2021_Telecon_Other.pdf | November 1, 2023 | 638 KB | |
| 125_BLA 125742 0_08 23 2021_Memo_Committee Memo_Toxico.pdf | November 1, 2023 | 4 MB | |
| 123_Courtesy Copy_BLA 125742 0_August 23, 2021 Approval Letter Comirnaty.pdf | November 1, 2023 | 157 KB | |
| 124_BLA 125742 0_08 23 2021_Memo_Committee Memo_SBRA.pdf | November 1, 2023 | 1 MB | |
| 120_Courtesy Copy_BLA 125742 0_CBER CMC BLA Review Memo COMIRNATY.pdf | November 1, 2023 | 1 MB | |
| 121_Courtesy Copy_BLA 125742 0_Employee Officer List Memo, August 22, 2021 COMIRNATY.pdf | November 1, 2023 | 25 KB | |
| 122_BLA 125742 0_08 22 2021_Telecon_Labeling via FAX_e.pdf | November 1, 2023 | 775 KB | |
| 118_1_BLA 125742 0_08 22 2021_Inspection Related_Inspect.pdf | November 1, 2023 | 659 KB | |
| 119_Courtesy Copy_BLA 125742 0_Real World Evidence BLA Memo COMIRNATY.pdf | November 1, 2023 | 63 KB | |
| 116_BLA 125742 0_08 21 2021_Inspection Related_Establi.pdf | November 1, 2023 | 2 MB | |
| 117_2_BLA 125742 0_08 22 2021_Inspection Related_Inspect.pdf | November 1, 2023 | 1 MB | |
| 111_BLA 125742 0_08 21 2021_Telecon_Advice.pdf | November 1, 2023 | 660 KB | |
| 115_1_BLA 125742 0_08 21 2021_Telecon_Labeling via FAX_e.pdf | November 1, 2023 | 789 KB | |
| 136_BLA_125742_RNAcontent_InSupportTesting.pdf | November 1, 2023 | 739 KB | |
| 109_Courtesy Copy_2_BLA 125742 0_CMC Review Memo, August 21, 2021 COMIRNATY.pdf | November 1, 2023 | 839 KB | |
| 110_1_Courtesy Copy_BLA 125742 0_Analytical Method Review Memo COMIRNATY.pdf | November 1, 2023 | 308 KB | |
| 134_Courtesy Copy_BLA 125742 0_Toxicology Review COMIRNATY.pdf | November 1, 2023 | 4 MB | |
| 135_Courtesy Copy_BLA 125742 0_November 8, 2021_Summary Basis for Regulatory Action COMIRNATY.pdf | November 1, 2023 | 540 KB | |
| 107_1_BLA 125742 0_08 20 2021_Telecon_Labeling via FAX_e.pdf | November 1, 2023 | 806 KB | |
| 103_2_BLA 125742 0_08 20 2021_Memo_Test Results.pdf | November 1, 2023 | 1 MB | |
| 105_BLA 125742 0_08 20 2021_Telecon_Advice_Information.pdf | November 1, 2023 | 761 KB | |
| 101_Courtesy Copy_BLA 125742 0_Pharmacovigilance Plan Review Addendum Memo COMIRNATY.pdf | November 1, 2023 | 145 KB | |
| 102_1_BLA 125742 0_08 20 2021_Memo_Test Results.pdf | November 1, 2023 | 1 MB | |
| 100_BLA 125742 0_08 20 2021_Memo_Other.pdf | November 1, 2023 | 1 MB | |
| 100A_BLA 125742 0_08 20 2021_Memo_Other.pdf | November 1, 2023 | 1 MB | |
| 95_BLA 125742 0_08 19 2021_Memo_Compliance Check Acce.pdf | November 1, 2023 | 2 MB | |
| 99_BLA 125742 0_08 20 2021_Memo_Committee Memo_Labeli.pdf | November 1, 2023 | 2 MB | |
| 93_Courtesy Copy_2_BLA 125742 0_Statistical Review COMIRNATY.pdf | November 1, 2023 | 301 KB | |
| 94_Courtesy Copy_1_BLA 125742 0_Statistical Review COMIRNATY.pdf | November 1, 2023 | 261 KB | |
| 89_1_BLA 125742 0_08 18 2021_Telecon_Information Reques.pdf | November 1, 2023 | 743 KB | |
| 92_BLA 125742 0_08 19 2021_Inspection Related_Inspect.pdf | November 1, 2023 | 2 MB | |
| 86_BLA 125742 0_08 18 2021_Telecon_Advice.pdf | November 1, 2023 | 984 KB | |
| 87_3_BLA 125742 0_08 18 2021_Telecon_Information Reques.pdf | November 1, 2023 | 1 MB | |
| 84_BLA 125742 0_08 18 2021_Memo_Committee Memo_Review.pdf | November 1, 2023 | 706 KB | |
| 85_Courtesy Copy_BLA 125742 0_Statistical Review COMIRNATY.pdf | November 1, 2023 | 127 KB | |
| 79_3_BLA 125742 0_08 17 2021_Telecon_Information Reques.pdf | November 1, 2023 | 753 KB | |
| 81_1_BLA 125742 0_08 17 2021_Telecon_Information Reques.pdf | November 1, 2023 | 760 KB | |
| 83_BLA 125742 0_08 17 2021_Telecon_Other.pdf | November 1, 2023 | 770 KB | |
| 74_3_BLA 125742 0_08 16 2021_Telecon_Information Reques.pdf | November 1, 2023 | 746 KB | |
| 75_1_BLA 125742 0_08 16 2021_Telecon_Information Reques.pdf | November 1, 2023 | 717 KB | |
| 68B_5_BLA 125742 0_08 13 2021_Telecon_Information Reques.pdf | November 1, 2023 | 690 KB | |
| 73_2_BLA 125742 0_08 16 2021_Telecon_Information Reques.pdf | November 1, 2023 | 1 MB | |
| 68_5_BLA 125742 0_08 13 2021_Telecon_Information Reques.pdf | November 1, 2023 | 753 KB | |
| 68A_5_BLA 125742 0_08 13 2021_Telecon_Information Reques.pdf | November 1, 2023 | 710 KB | |
| 65_BLA 125742 0_08 13 2021_Memo_Request For Complianc.pdf | November 1, 2023 | 864 KB | |
| 66_4_BLA 125742 0_08 13 2021_Telecon_Information Reques.pdf | November 1, 2023 | 794 KB | |
| 62_BLA 125742 0_08 12 2021_Memo_Committee Memo_Requir.pdf | November 1, 2023 | 1 MB | |
| 64_Courtesy Copy_BLA 125742 0_Bioresearch Monitoring Discipline Review Memo, August 13, 2021 COMIRNATY.pdf | November 1, 2023 | 81 KB | |
| 107A_1_BLA 125742 0_08 20 2021_Telecon_Labeling via FAX_e.pdf | November 1, 2023 | 815 KB | |
| 108_BLA 125742 0_08 21 2021_Inspection Related_Inspect.pdf | November 1, 2023 | 1 MB | |
| 47_1_BLA 125742 0_08 05 2021_Telecon_Information Reques.pdf | November 1, 2023 | 755 KB | |
| 45_BLA 125742 0_08 05 2021_Telecon_Advice.pdf | November 1, 2023 | 801 KB | |
| 46_2_BLA 125742 0_08 05 2021_Telecon_Information Reques.pdf | November 1, 2023 | 789 KB | |
| 43A_STN 125742.0 4AUG21 LRP FU IR 2.pdf | November 1, 2023 | 2 MB | |
| 44_3_BLA 125742 0_08 04 2021_Telecon_Information Reques.pdf | November 1, 2023 | 767 KB | |
| 40_2_BLA 125742 0_08 03 2021_Telecon_Information Reques.pdf | November 1, 2023 | 772 KB | |
| 42_1_BLA 125742 0_08 04 2021_Telecon_Information Reques.pdf | November 1, 2023 | 773 KB | |
| 33_1_BLA 125742 0_07 27 2021_Telecon_Information Reques.pdf | November 1, 2023 | 734 KB | |
| 39_2_BLA 125742 0_08 02 2021_Telecon_Information Reques.pdf | November 1, 2023 | 784 KB | |
| 27_BLA 125742 0_07 19 2021_Telecon_Advice.pdf | November 1, 2023 | 746 KB | |
| 32_1_BLA 125742 0_07 26 2021_Telecon_Information Reques.pdf | November 1, 2023 | 890 KB | |
| 25_1_BLA 125742 0_07 16 2021_Telecon_Information Reques.pdf | November 1, 2023 | 794 KB | |
| 26_2_BLA 125742 0_07 16 2021_Telecon_Information Reques.pdf | November 1, 2023 | 789 KB | |
| 15_BLA 125742 0_07 02 2021_Telecon_Information Reques.pdf | November 1, 2023 | 819 KB | |
| 18_BLA 125742 0_07 09 2021_Telecon_Information Reques.pdf | November 1, 2023 | 765 KB | |
| 21_BLA 125742 0_07 15 2021_Letter_Filing Notification.pdf | November 1, 2023 | 722 KB | |
| 9_IND_19736_491_29 Sep 2021_DEBORAH_DEBORAH__RO_ The Summary Monthly Safety Report has been reviewed. No furthe.pdf | November 1, 2023 | 716 KB | |
| 10_BLA 125742 11_12 22 2021_Memo_Committee Memo_CMC.pdf | November 1, 2023 | 757 KB | |
| 8_1_BLA 125742 0_06 25 2021_Telecon_Information Reques.pdf | November 1, 2023 | 1 MB | |
| 8_IND_19736_453_26 Aug 2021_DEBORAH_DEBORAH__RO_.pdf | November 1, 2023 | 717 KB | |
| 6_IND_19736_366_24 Jun 2021_DEBORAH_DEBORAH__RO_.pdf | November 1, 2023 | 717 KB | |
| 7_IND_19736_409_26 Jul 2021_DEBORAH_DEBORAH__RO_.pdf | November 1, 2023 | 718 KB | |
| 4_IND_19736_289_27 Apr 2021_DEBORAH_DEBORAH__RC_.pdf | November 1, 2023 | 717 KB | |
| 5_IND_19736_335_19 May 2021_DEBORAH_DEBORAH__RC_.pdf | November 1, 2023 | 716 KB | |
| 2_IND_19736_214_03 Mar 2021_KERRY_KERRY__RO_.pdf | November 1, 2023 | 698 KB | |
| 3_BLA 125742 0_05 20 2021_Telecon_Information Reques.pdf | November 1, 2023 | 747 KB | |
| 3_IND_19736_243_19 Mar 2021_KERRY_KERRY__RO_.pdf | November 1, 2023 | 696 KB | |
| 1_BLA 125742 0_05 13 2021_Letter_Acknowledgement Let.pdf | November 1, 2023 | 713 KB | |
| 1_IND_19736_185_23 Feb 2021_KERRY_KERRY__RO_.pdf | November 1, 2023 | 697 KB | |
| 60_BLA 125742 0_08 11 2021_Telecon_Information Reques.pdf | November 1, 2023 | 764 KB | |
| 61_BLA 125742 0_08 11 2021_Telecon_Other.pdf | November 1, 2023 | 719 KB | |
| 55_BLA 125742 0_08 09 2021_Telecon_Advice.pdf | November 1, 2023 | 2 MB | |
| 58_2_BLA 125742 0_08 10 2021_Telecon_Information Reques.pdf | November 1, 2023 | 755 KB | |
| 53_2_BLA 125742 0_08 06 2021_Telecon_Information Reques.pdf | November 1, 2023 | 765 KB | |
| 54_BLA 125742 0_08 09 2021_Inspection Related_Inspect.pdf | November 1, 2023 | 1 MB | |
| 51_Courtesy Copy_BLA 125742 0_Pharmacovigilance Plan Review Memo COMIRNATY.pdf | November 1, 2023 | 279 KB | |
| 52_1_BLA 125742 0_08 06 2021_Telecon_Information Reques.pdf | November 1, 2023 | 1 MB | |
| 49_BLA 125742 0_08 06 2021_Letter_UNII Code Notificat.pdf | November 1, 2023 | 766 KB | |
| 019736_S70_M5_vr mqr 10211 10212 dlq.pdf | October 1, 2023 | 663 KB | |
| 125742_S5_M3_guidelines travel red zone belgium.pdf | October 1, 2023 | 643 KB | |
| 125742_S5_M3_requirements travel belgium.pdf | October 1, 2023 | 635 KB | |
| 019736_S157_M1_cover.pdf | October 1, 2023 | 668 KB | |
| 019736_S387_M5_c4591012 interim sponsor signature.pdf | October 1, 2023 | 664 KB | |
| 19736_S0289_M1_cover.pdf | October 1, 2023 | 687 KB | |
| 019736_S387_M5_c4591008 interim excluded subjects.pdf | October 1, 2023 | 684 KB | |
| 19736_S0369_M1_cover.pdf | October 1, 2023 | 704 KB | |
| 019736_S70_M1_cover.pdf | October 1, 2023 | 689 KB | |
| 19736_S0185_M1_cover.pdf | October 1, 2023 | 687 KB | |
| 19736_S0214_M1_cover.pdf | October 1, 2023 | 716 KB | |
| 019736_S70_M5_vr mqr 10211 10212 pq.pdf | October 1, 2023 | 708 KB | |
| 19736_S0243_M1_cover.pdf | October 1, 2023 | 733 KB | |
| 3_PM_S89_BLA 125742 5_09 21 2021_Telecon_Other.pdf | October 1, 2023 | 724 KB | |
| 19736_S0408_M1_cover.pdf | October 1, 2023 | 736 KB | |
| 19736_S0335_M1_cover.pdf | October 1, 2023 | 735 KB | |
| 19736_S0453_M1_cover.pdf | October 1, 2023 | 739 KB | |
| 19736_S0366_M1_cover.pdf | October 1, 2023 | 736 KB | |
| 125742_S2_M5_5.4_who 2005.pdf | October 1, 2023 | 747 KB | |
| 19736_S0491_M1_cover.pdf | October 1, 2023 | 742 KB | |
| 125742_2_BLA 125742 0_05 18 2021_Telecon_Information Reques.pdf | October 1, 2023 | 742 KB | |
| 019736_S414_M1_cover.pdf | October 1, 2023 | 753 KB | |
| 125742_S2_M5_5.4_who 2019.pdf | October 1, 2023 | 747 KB | |
| 019736_S488_M1_cover.pdf | October 1, 2023 | 756 KB | |
| 019736_S222_M1_cover.pdf | October 1, 2023 | 754 KB | |
| 5_PM_S102_1_BLA 125742 8_09 21 2021_Memo_600.81 Lot Distributi.pdf | October 1, 2023 | 782 KB | |
| 019736_S444_M5_c4591007 p2 3 older child assent lower dose eval.pdf | October 1, 2023 | 773 KB | |
| 019736_S196_M1_cover.pdf | October 1, 2023 | 759 KB | |
| 019736_S444_M5_c4591007 p1 older children assent lower dose eval icd.pdf | October 1, 2023 | 786 KB | |
| 6_PM_S102_2_BLA 125742 8_09 21 2021_Memo_600.81 Lot Distributi.pdf | October 1, 2023 | 783 KB | |
| 019736_S387_M5_c4591008 interim protocol deviations.pdf | October 1, 2023 | 633 KB | |
| 125742_S2_M1_356h.pdf | October 1, 2023 | 813 KB | |
| 7_PM_S102_BLA 125742 8_09 29 2021_Letter_Waiver Request.pdf | October 1, 2023 | 830 KB | |
| 19736_S0185_M1_1571.pdf | October 1, 2023 | 827 KB | |
| 019736_S387_M5_c4591008 interim sponsor signature.pdf | October 1, 2023 | 824 KB | |
| 019736_S488_M5_c4591007 p2 3 older children assent troponin icd.pdf | October 1, 2023 | 837 KB | |
| 11_PM_S136_BLA 125742 31_10 30 2021_Memo_Final Review Memo.pdf | October 1, 2023 | 835 KB | |
| 019736_S488_M5_c4591007 p2 3 parent icd pbo controlled selected dose.pdf | October 1, 2023 | 880 KB | |
| 019736_S222_M5_c4591020 informed consent form.pdf | October 1, 2023 | 867 KB | |
| 019736_S444_M5_c4591007 p2 3 adult participant icd lower dose eval.pdf | October 1, 2023 | 966 KB | |
| 9_PM_S105_BLA 125742 9_09 20 2021_Telecon_Advice.pdf | October 1, 2023 | 941 KB | |
| 4_PM_S89_BLA 125742 5_09 22 2021_Telecon_Advice.pdf | October 1, 2023 | 983 KB | |
| 019736_S444_M5_c4591007 p1 adult participant icd lower dose eval.pdf | October 1, 2023 | 974 KB | |
| 019736_S444_M5_c4591007 p1 parent icd lower dose eval.pdf | October 1, 2023 | 995 KB | |
| 019736_S444_M5_c4591007 p2 3 parent icd lower dose eval.pdf | October 1, 2023 | 988 KB | |
| 1_PM_S85_BLA 125742 4_09 30 2021_Telecon_Advice.pdf | October 1, 2023 | 1,014 KB | |
| 019736_S488_M5_c4591007 p2 3 younger children assent troponin icd.pdf | October 1, 2023 | 1,013 KB | |
| 019736_S70_M5_vr sop lc 11120.pdf | October 1, 2023 | 1,020 KB | |
| 8_PM_S102_BLA 125742 8_09 29 2021_Telecon_Other.pdf | October 1, 2023 | 1,016 KB | |
| 2_PM_S89_BLA 12572 5_09 10 2021_Telecon_Advice.pdf | October 1, 2023 | 1 MB | |
| 019736_S444_M5_c4591007 p2 3 parent icd pbo controlled selected dose.pdf | October 1, 2023 | 1 MB | |
| 019736_S488_M5_c4591007 p2 3 parent troponin icd.pdf | October 1, 2023 | 1 MB | |
| 019736_S470_M1_cover.pdf | October 1, 2023 | 795 KB | |
| 019736_S268_M5_wi255886 sap.pdf | October 1, 2023 | 1 MB | |
| 019736_S268_M5_wi255886 protocol.pdf | October 1, 2023 | 1 MB | |
| 019736_S387_M5_c4591008 interim withdrawn subjects.pdf | October 1, 2023 | 1 MB | |
| 019736_S387_M5_c4591008 interim unplanned hospitalization.pdf | October 1, 2023 | 1 MB | |
| 019736_S196_M5_c4591008 protocol.pdf | October 1, 2023 | 1 MB | |
| 019736_S70_M5_vr mqr 10214 att01 shi sop 10011.pdf | October 1, 2023 | 1 MB | |
| 019736_S387_M5_c4591008 interim sample icd.pdf | October 1, 2023 | 1 MB | |
| 019736_S31_M1_response ir 06jul2020 c4591001.pdf | October 1, 2023 | 1 MB | |
| 019736_S70_M5_vr tm 10293.pdf | October 1, 2023 | 2 MB | |
| 019736_S444_M5_c4591007 p2 3 younger child assent lower dose eval.pdf | October 1, 2023 | 1 MB | |
| 125742_S1_M5_5351_c4591001 interim mth6 investigators.pdf | October 1, 2023 | 2 MB | |
| 125742_S1_M5_5351_c4591001 fa interim investigators.pdf | October 1, 2023 | 2 MB | |
| 019736_S387_M5_c4591008 interim non hospitalization.pdf | October 1, 2023 | 2 MB | |
| 019736_S70_M5_vr tm 10294.pdf | October 1, 2023 | 2 MB | |
| 125742_S75_M1_356h.pdf | October 1, 2023 | 2 MB | |
| 019736_S444_M5_c4591007 p1 younger children assent lower dose eval icd.pdf | October 1, 2023 | 2 MB | |
| 019736_S488_M5_c4591007 p2 3 parent icd pbo controlled selected dose track.pdf | October 1, 2023 | 2 MB | |
| 019736_S387_M5_c4591008 interim demographics.pdf | October 1, 2023 | 2 MB | |
| 019736_S444_M5_c4591007 p2 3 children assent cont select dose icd.pdf | October 1, 2023 | 2 MB | |
| 019736_S398_M1_cover.pdf | October 1, 2023 | 2 MB | |
| 019736_S70_M5_vr mqr 10214 att03.pdf | October 1, 2023 | 2 MB | |
| 019736_S70_M5_vr mqr 10214 att02.pdf | October 1, 2023 | 2 MB | |
| 019736_S70_M5_vr mqr 10214 att01.pdf | October 1, 2023 | 2 MB | |
| 019736_S444_M5_c4591007 p2 3 parent icd pbo controlled selected dose track.pdf | October 1, 2023 | 2 MB | |
| 019736_S31_M1_cover.pdf | October 1, 2023 | 2 MB | |
| 019736_S444_M5_c4591007 p2 3 children assent pbo cont select dose icd track.pdf | October 1, 2023 | 2 MB | |
| 019736_S70_M5_vr mqr 10212 att01.pdf | October 1, 2023 | 2 MB | |
| 019736_S70_M5_vr mqr 10211 att01.pdf | October 1, 2023 | 2 MB | |
| 019736_S70_M5_vr mqr 10212.pdf | October 1, 2023 | 2 MB | |
| 019736_S31_M5_vr mqr 10214 att01 shi sop 10011.pdf | October 1, 2023 | 2 MB | |
| 019736_S470_M5_c4591009 protocol.pdf | October 1, 2023 | 2 MB | |
| 019736_S488_M5_c4591007 p2 3 parent addendum icd pbo cont selected dose.pdf | October 1, 2023 | 2 MB | |
| 019736_S222_M5_c4591020 protocol.pdf | October 1, 2023 | 1 MB | |
| 125742_S6_M5_5351_c4591001 sequencing report.pdf | October 1, 2023 | 2 MB | |
| 019736_S31_M1_1571.pdf | October 1, 2023 | 2 MB | |
| 019736_S325_M1_cover.pdf | October 1, 2023 | 2 MB | |
| 019736_S470_M1_1571.pdf | October 1, 2023 | 2 MB | |
| 19736_S0491_M1_1571.pdf | October 1, 2023 | 2 MB | |
| 019736_S488_M1_1571.pdf | October 1, 2023 | 2 MB | |
| 19736_S0366_M1_1571.pdf | October 1, 2023 | 2 MB | |
| 19736_S0335_M1_1571.pdf | October 1, 2023 | 2 MB | |
| 019736_S398_M1_1571.pdf | October 1, 2023 | 2 MB | |
| 019736_S296_M1_1571.pdf | October 1, 2023 | 2 MB | |
| 19736_S0369_M1_1571.pdf | October 1, 2023 | 2 MB | |
| 19736_S0408_M1_1571.pdf | October 1, 2023 | 2 MB | |
| 19736_S0289_M1_1571.pdf | October 1, 2023 | 2 MB | |
| 19736_S0243_M1_1571.pdf | October 1, 2023 | 2 MB | |
| 19736_S0453_M1_1571.pdf | October 1, 2023 | 2 MB | |
| 019736_S196_M1_1571.pdf | October 1, 2023 | 2 MB | |
| 019736_S268_M1_1571.pdf | October 1, 2023 | 2 MB | |
| 019736_S444_M1_1571.pdf | October 1, 2023 | 2 MB | |
| 019736_S427_M1_1571.pdf | October 1, 2023 | 2 MB | |
| 019736_S325_M1_1571.pdf | October 1, 2023 | 2 MB | |
| 019736_S414_M1_1571.pdf | October 1, 2023 | 2 MB | |
| 019736_S222_M1_1571.pdf | October 1, 2023 | 2 MB | |
| 019736_S387_M1_1571.pdf | October 1, 2023 | 2 MB | |
| 19736_S0214_M1_1571.pdf | October 1, 2023 | 2 MB | |
| 019736_S70_M1_1571.pdf | October 1, 2023 | 2 MB | |
| 019736_S70_M5_vr mqr 10214.pdf | October 1, 2023 | 2 MB | |
| 019736_S157_M1_1571.pdf | October 1, 2023 | 2 MB | |
| 019736_S325_M5_c4591020 sap.pdf | October 1, 2023 | 3 MB | |
| 019736_S31_M5_vr mqr 10214.pdf | October 1, 2023 | 2 MB | |
| 019736_S31_M5_vr tm 10294.pdf | October 1, 2023 | 3 MB | |
| 019736_S31_M5_vr tm 10293.pdf | October 1, 2023 | 3 MB | |
| 019736_S70_M5_vr mqr 10211.pdf | October 1, 2023 | 3 MB | |
| 019736_S325_M5_c4591020 sap track.pdf | October 1, 2023 | 3 MB | |
| 019736_S444_M1_cover.pdf | October 1, 2023 | 3 MB | |
| 019736_S387_M5_c4591008 interim abstract.pdf | October 1, 2023 | 3 MB | |
| 019736_S470_M5_c4591012 protocol track.pdf | October 1, 2023 | 3 MB | |
| 125742_S2_M5_5.4_sedic m 2020.pdf | October 1, 2023 | 3 MB | |
| 019736_S387_M5_c4591012 interim abstract.pdf | October 1, 2023 | 3 MB | |
| 019736_S268_M5_c4591014 protocol.pdf | October 1, 2023 | 3 MB | |
| 125742_S1_M5_5351_c4591001 fa interim interlab standard.pdf | October 1, 2023 | 3 MB | |
| 125742_S2_M1_environmental analysis.pdf | October 1, 2023 | 3 MB | |
| 019736_S268_M1_cover.pdf | October 1, 2023 | 3 MB | |
| 019736_S70_M1_response ir 29jul2020 clin assay qual.pdf | October 1, 2023 | 3 MB | |
| 019736_S398_M1_response 30june2021 icd myo peri.pdf | October 1, 2023 | 3 MB | |
| 019736_S157_M5_vr mvp 10074.pdf | October 1, 2023 | 3 MB | |
| 019736_S31_M5_vr mqr 10211.pdf | October 1, 2023 | 3 MB | |
| 019736_S31_M5_vr mqr 10212.pdf | October 1, 2023 | 3 MB | |
| 125742_S6_M5_5314_vr vtn 10436.pdf | October 1, 2023 | 2 MB | |
| 125742_S29_M1_356h.pdf | October 1, 2023 | 3 MB | |
| 125742_S3_M1_356h.pdf | October 1, 2023 | 3 MB | |
| 125742_S40_M1_356h.pdf | October 1, 2023 | 3 MB | |
| 125742_S37_M1_356h.pdf | October 1, 2023 | 3 MB | |
| 125742_S6_M1_356h.pdf | October 1, 2023 | 3 MB | |
| 125742_S32_M1_356h.pdf | October 1, 2023 | 3 MB | |
| 125742_S44_M1_356h.pdf | October 1, 2023 | 3 MB | |
| 125742_S34_M1_356h.pdf | October 1, 2023 | 3 MB | |
| 125742_S14_M1_356h.pdf | October 1, 2023 | 3 MB | |
| 125742_S8_M1_356h.pdf | October 1, 2023 | 3 MB | |
| 125742_S36_M1_356h.pdf | October 1, 2023 | 3 MB | |
| 125742_S35_M1_356h.pdf | October 1, 2023 | 3 MB | |
| 125742_S4_M1_356h.pdf | October 1, 2023 | 3 MB | |
| 125742_S42_M1_356h.pdf | October 1, 2023 | 3 MB | |
| 125742_S12_M1_356h.pdf | October 1, 2023 | 3 MB | |
| 125742_S10_M1_356h.pdf | October 1, 2023 | 3 MB | |
| 125742_S7_M1_356h.pdf | October 1, 2023 | 3 MB | |
| 125742_S9_M1_356h.pdf | October 1, 2023 | 3 MB | |
| 125742_S5_M1_356h.pdf | October 1, 2023 | 3 MB | |
| 125742_S13_M1_356h.pdf | October 1, 2023 | 3 MB | |
| 125742_S24_M1_356h.pdf | October 1, 2023 | 3 MB | |
| 125742_S16_M1_356h.pdf | October 1, 2023 | 3 MB | |
| 125742_S43_M1_356h.pdf | October 1, 2023 | 3 MB | |
| 125742_S21_M1_356h.pdf | October 1, 2023 | 3 MB | |
| 125742_S30_M1_356h.pdf | October 1, 2023 | 3 MB | |
| 125742_S23_M1_356h.pdf | October 1, 2023 | 3 MB | |
| 125742_S19_M1_356h.pdf | October 1, 2023 | 3 MB | |
| 125742_S26_M1_356h.pdf | October 1, 2023 | 3 MB | |
| 125742_S27_M1_356h.pdf | October 1, 2023 | 3 MB | |
| 125742_S31_M1_356h.pdf | October 1, 2023 | 3 MB | |
| 125742_S22_M1_356h.pdf | October 1, 2023 | 3 MB | |
| 125742_S25_M1_356h.pdf | October 1, 2023 | 3 MB | |
| 125742_S11_M1_356h.pdf | October 1, 2023 | 3 MB | |
| 125742_S46_M1_356h.pdf | October 1, 2023 | 4 MB | |
| 125742_S45_M1_356h.pdf | October 1, 2023 | 4 MB | |
| 125742_S33_M1_356h.pdf | October 1, 2023 | 4 MB | |
| 125742_S41_M1_356h.pdf | October 1, 2023 | 4 MB | |
| 125742_S38_M1_356h.pdf | October 1, 2023 | 4 MB | |
| 125742_S20_M1_356h.pdf | October 1, 2023 | 4 MB | |
| 125742_S18_M1_356h.pdf | October 1, 2023 | 4 MB | |
| 125742_S28_M1_356h.pdf | October 1, 2023 | 4 MB | |
| 125742_S39_M1_356h.pdf | October 1, 2023 | 3 MB | |
| 125742_S17_M1_356h.pdf | October 1, 2023 | 4 MB | |
| 125742_S80_M1_356h.pdf | October 1, 2023 | 4 MB | |
| 125742_S78_M1_356h.pdf | October 1, 2023 | 4 MB | |
| 125742_S67_M1_356h.pdf | October 1, 2023 | 4 MB | |
| 125742_S72_M1_356h.pdf | October 1, 2023 | 4 MB | |
| 125742_S59_M1_356h.pdf | October 1, 2023 | 4 MB | |
| 125742_S74_M1_356h.pdf | October 1, 2023 | 4 MB | |
| 125742_S79_M1_356h.pdf | October 1, 2023 | 4 MB | |
| 125742_S60_M1_356h.pdf | October 1, 2023 | 4 MB | |
| 019736_S387_M5_c4591008 interim sap.pdf | October 1, 2023 | 4 MB | |
| 125742_S15_M1_356h.pdf | October 1, 2023 | 4 MB | |
| 019736_S196_M5_c4591011 protocol.pdf | October 1, 2023 | 4 MB | |
| 125742_S56_M1_356h.pdf | October 1, 2023 | 4 MB | |
| 125742_S105_M1_356h.pdf | October 1, 2023 | 4 MB | |
| 125742_S89_M1_356h.pdf | October 1, 2023 | 4 MB | |
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| 125742_S112_M1_356h.pdf | October 1, 2023 | 4 MB | |
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| 125742_S102_M1_356h.pdf | October 1, 2023 | 4 MB | |
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| 125742_S58_M1_356h.pdf | October 1, 2023 | 4 MB | |
| 125742_S136_M1_356h.pdf | October 1, 2023 | 4 MB | |
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| 125742_S85_M1_356h.pdf | October 1, 2023 | 4 MB | |
| 125742_S70_M1_356h.pdf | October 1, 2023 | 4 MB | |
| 125742_S68_M1_356h.pdf | October 1, 2023 | 4 MB | |
| 125742_S64_M1_356h.pdf | October 1, 2023 | 4 MB | |
| 125742_S82_M1_356h.pdf | October 1, 2023 | 4 MB | |
| 019736_S387_M5_c4591008 interim protocol.pdf | October 1, 2023 | 4 MB | |
| 125742_S55_M1_356h.pdf | October 1, 2023 | 4 MB | |
| 019736_S470_M5_c4591012 protocol.pdf | October 1, 2023 | 4 MB | |
| 125742_S50_M1_356h.pdf | October 1, 2023 | 4 MB | |
| 125742_S49_M1_356h.pdf | October 1, 2023 | 4 MB | |
| 125742_S47_M1_356h.pdf | October 1, 2023 | 4 MB | |
| 125742_S48_M1_356h.pdf | October 1, 2023 | 4 MB | |
| 125742_S52_M1_356h.pdf | October 1, 2023 | 4 MB | |
| 125742_S51_M1_356h.pdf | October 1, 2023 | 4 MB | |
| 125742_S53_M1_356h.pdf | October 1, 2023 | 4 MB | |
| 125742_S2_M5_5.4_singh dk 2020.pdf | October 1, 2023 | 8 MB | |
| 19736_S0185_M1_smsr 01dec2020 31dec2020.pdf | October 1, 2023 | 9 MB | |
| 019736_S387_M1_cover.pdf | October 1, 2023 | 11 MB | |
| 019736_S196_M5_c4591012 protocol.pdf | October 1, 2023 | 13 MB | |
| 19736_S0214_M1_smsr 01jan2021 31jan2021.pdf | October 1, 2023 | 15 MB | |
| 019736_S268_M5_wi235284 protocol.pdf | October 1, 2023 | 16 MB | |
| 019736_S414_M5_c4591001 amendment 17 clean.pdf | October 1, 2023 | 16 MB | |
| 019736_S414_M5_c4591001 amendment 17 track.pdf | October 1, 2023 | 16 MB | |
| 019736_S387_M5_c4591012 interim protocol.pdf | October 1, 2023 | 17 MB | |
| 019736_S387_M5_c4591012 interim report body.pdf | October 1, 2023 | 5 MB | |
| 019736_S387_M5_c4591008 interim report body.pdf | October 1, 2023 | 6 MB | |
| 019736_S387_M5_c4591008 interim compliance.pdf | October 1, 2023 | 7 MB | |
| 019736_S488_M5_c4591007 protocol amend3 track.pdf | October 1, 2023 | 23 MB | |
| 19736_S0369 dsur 22apr2020 21apr2021.pdf | October 1, 2023 | 23 MB | |
| 019736_S444_M5_c4591007 protocol amend2 track.pdf | October 1, 2023 | 23 MB | |
| 019736_S444_M5_c4591007 protocol amend2.pdf | October 1, 2023 | 24 MB | |
| 19736_S0243 smsr 01feb2021 28feb2021.pdf | October 1, 2023 | 31 MB | |
| 19736_S0289_M1_smsr 01mar2021 31mar2021.pdf | October 1, 2023 | 37 MB | |
| 125742_S1_M1_meeting correspondence.pdf | October 1, 2023 | 21 MB | |
| 019736_S488_M5_c4591007 protocol amend3.pdf | October 1, 2023 | 22 MB | |
| 125742_S1_M5_5351_bnt162 01 interim3 reports.pdf | October 1, 2023 | 73 MB | |
| 19736_S0408_M1_smsr 01jun2021 30jun2021.pdf | October 1, 2023 | 76 MB | |
| 19736_S0335 M1_smsr 01apr2021 29apr2021.pdf | October 1, 2023 | 59 MB | |
| 19736_S0366_M1_smsr 30apr2021 31may2021.pdf | October 1, 2023 | 67 MB | |
| 19736_S0491_M1_smsr-01aug2021-31aug2021.pdf | October 1, 2023 | 100 MB | |
| 19736_S0453_M1_smsr-01jul2021-31jul2021.pdf | October 1, 2023 | 100 MB | |
| 125742_S0136_M5_smsr-01sep2021-30sep2021.pdf | October 1, 2023 | 112 MB | |
| FDA CBER 2021 5683 1053274 1058198_125742_S1_M5_C4591001 S D mh.zip (xpt) | September 1, 2023 | 11 MB | |
| FDA CBER 2021 5683 1049660 1051265_125742_S1_M5_C4591001 S D ho.zip (xpt) | September 1, 2023 | 734 KB | |
| FDA CBER 2021 5683 1051266 1053273_125742_S1_M5_C4591001 S D lb.zip (xpt) | September 1, 2023 | 2 MB | |
| FDA CBER 2021 5683 1045840 1049564_125742_S1_M5_C4591001 S D co.zip (xpt) | September 1, 2023 | 1 MB | |
| FDA CBER 2021 5683 1049565 1049659_125742_S1_M5_C4591001 S D faho.zip (xpt) | September 1, 2023 | 80 KB | |
| FDA CBER 2021 5683 1040915 1045839_125742_S1_M5_C4591001 A D admh.zip (xpt) | September 1, 2023 | 23 MB | |
| FDA CBER 2021 5683 1071968 1071995_125742_S6_M5_c45941001 S D xb.zip (xpt) | September 1, 2023 | 25 KB | |
| FDA CBER 2021 5683 1040914_125742_S1_M5_bnt162 01 S D mh.zip (xpt) | September 1, 2023 | 6 KB | |
| FDA CBER 2021 5683 1067563 1070765_125742_S6_M5_c4591001 S D ex.zip (xpt) | September 1, 2023 | 2 MB | |
| FDA CBER 2021 5683 1070766 1071967_125742_S6_M5_c45941001 S D dm.zip (xpt) | September 1, 2023 | 1 MB | |
| FDA CBER 2021 5683 1066333 1067534_125742_S6_M5_c4591001 A D adsl.zip (xpt) | September 1, 2023 | 7 MB | |
| FDA CBER 2021 5683 1067535 1067562_125742_S6_M5_c4591001 A D adxb.zip (xpt) | September 1, 2023 | 47 KB | |
| FDA CBER 2021 5683 1058199 1058203_125742_S1_M5_C4591001 S D suppie.zip (xpt) | September 1, 2023 | 7 KB | |
| FDA CBER 2021 5683 1058209 1060003_28A_2 c4591001 safety fa eff.xlsx | September 1, 2023 | 3 MB | |
| FDA CBER 2021 5683 1060004 1060071_28B_3 bnt162 01.xlsx | September 1, 2023 | 133 KB | |
| FDA CBER 2021 5683 1060085_28E_IND27034 BNT162 01 AEACN is DRUG WITHDRAWN but no ADVERSE EVENT record in DS.xlsx | September 1, 2023 | 11 KB | |
| FDA CBER 2021 5683 1071996 1072061_125742_S6_M5_define.xml | September 1, 2023 | 283 KB | |
| FDA CBER 2021 5683 1072062 1072080_125742_S6_M5_define 1.xml | September 1, 2023 | 74 KB | |
| FDA CBER 2021 5683 1064475 1066330_28K_Part III CoreDF IND27034 c4591001 subset 2021 04 19T10 50.xlsx | September 1, 2023 | 3 MB | |
| FDA CBER 2021 5683 1060090 1064473_28I_Part II CoreDF IND27034 12 15years.xlsx | September 1, 2023 | 7 MB | |
| FDA CBER 2021 5683 1064474_28J_Part II IND27034 12 15years AEACN of DRUG WITHDRAWN but no DS ADVERSE EVENT record (1).xlsx | September 1, 2023 | 16 KB | |
| FDA CBER 2021 5683 1060089_28H_IND27034 c4591001 safety fa eff AEACN is DRUG WITHDRAWN but no ADVERSE EVENT record in DS.xlsx | September 1, 2023 | 14 KB | |
| FDA CBER 2021 5683 1060086 1060087_28F_IND27034 BNT162 01 Multiple baseline records in LB.xlsx | September 1, 2023 | 26 KB | |
| FDA CBER 2021 5683 1060088_28G_IND27034 BNT162 01 Multiple baseline records in VS.xlsx | September 1, 2023 | 16 KB | |
| 125742_S1_M5_CRF_c4591001 1095 10951228.pdf | September 1, 2023 | 3 MB | |
| 125742_S1_M5_CRF_c4591001 1095 10951206.pdf | September 1, 2023 | 2 MB | |
| 125742_S1_M5_CRF_c4591001 1095 10951197.pdf | September 1, 2023 | 5 MB | |
| 125742_S1_M5_CRF_c4591001 1095 10951204.pdf | September 1, 2023 | 1 MB | |
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| 125742_S1_M5_CRF_c4591001 1095 10951125.pdf | September 1, 2023 | 2 MB | |
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| 125742_S1_M5_CRF_c4591001 1095 10951107.pdf | September 1, 2023 | 2 MB | |
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| 125742_S1_M5_CRF_c4591001 1093 10931141.pdf | September 1, 2023 | 3 MB | |
| 125742_S1_M5_CRF_c4591001 1095 10951009.pdf | September 1, 2023 | 3 MB | |
| 125742_S1_M5_CRF_c4591001 1093 10931128.pdf | September 1, 2023 | 1 MB | |
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| 125742_S1_M5_CRF_c4591001 1093 10931067.pdf | September 1, 2023 | 1 MB | |
| 125742_S54_M1_vial rl 7302 rocky mount hospira.pdf | September 1, 2023 | 695 KB | |
| 125742_S79_M1_cover.pdf | September 1, 2023 | 2 MB | |
| 125742_S54_M1_diluent carton fresenius kabi.pdf | September 1, 2023 | 730 KB | |
| 125742_S54_M1_diluent vial fresenius kabi.pdf | September 1, 2023 | 717 KB | |
| 125742_S38_M1_response 22jul2021.pdf | September 1, 2023 | 2 MB | |
| 125742_S54_M1_carton ca 7114 rocky mount hospira.pdf | September 1, 2023 | 679 KB | |
| 125742_S38_M1_cover.pdf | September 1, 2023 | 2 MB | |
| 125742_S6_M5_adrg.pdf | September 1, 2023 | 776 KB | |
| 125742_S6_M5_csdrg.pdf | September 1, 2023 | 814 KB | |
| 125742_S1_M5_CRF_c4591001 1095 10951256.pdf | September 1, 2023 | 1 MB | |
| 125742_S6_M5_acrf.pdf | September 1, 2023 | 3 MB | |
| 106_2_BLA 125742 0_08 20 2021_Telecon_Labeling via FAX_e.pdf | September 1, 2023 | 822 KB | |
| 104A_BLA 125742 0_08 20 2021_Telecon_Information Reques.pdf | September 1, 2023 | 675 KB | |
| 104B_BLA 125742 0_08 20 2021_Telecon_Information Reques.pdf | September 1, 2023 | 675 KB | |
| 97_1_BLA 125742 0_08 19 2021_Telecon_Information Reques.pdf | September 1, 2023 | 785 KB | |
| 98_BLA 125742 0_08 19 2021_Telecon_Labeling via FAX_e.pdf | September 1, 2023 | 784 KB | |
| 104_BLA 125742 0_08 20 2021_Telecon_Information Reques.pdf | September 1, 2023 | 747 KB | |
| 91_2_BLA 125742 0_08 18 2021_Telecon_Labeling via FAX_e.pdf | September 1, 2023 | 754 KB | |
| 96_2_BLA 125742 0_08 19 2021_Telecon_Information Reques.pdf | September 1, 2023 | 756 KB | |
| 88_2_BLA 125742 0_08 18 2021_Telecon_Information Reques.pdf | September 1, 2023 | 746 KB | |
| 90_1_BLA 125742 0_08 18 2021_Telecon_Labeling via FAX_e.pdf | September 1, 2023 | 810 KB | |
| 76_BLA 125742 0_08 16 2021_Telecon_Labeling via FAX_e.pdf | September 1, 2023 | 793 KB | |
| 80_2_BLA 125742 0_08 17 2021_Telecon_Information Reques.pdf | September 1, 2023 | 782 KB | |
| 82_BLA 125742 0_08 17 2021_Telecon_Labeling via FAX_e.pdf | September 1, 2023 | 731 KB | |
| 71_6_BLA 125742 0_08 13 2021_Telecon_Information Reques.pdf | September 1, 2023 | 790 KB | |
| 72_BLA 125742 0_08 13 2021_Telecon_Labeling via FAX_e.pdf | September 1, 2023 | 753 KB | |
| 69_1_BLA 125742 0_08 13 2021_Telecon_Information Reques.pdf | September 1, 2023 | 802 KB | |
| 70_2_BLA 125742 0_08 13 2021_Telecon_Information Reques.pdf | September 1, 2023 | 792 KB | |
| 125742_S1_M5_5351_c4591001 interim mth6 narrative sensitive.pdf | September 1, 2023 | 22 MB | |
| 67_3_BLA 125742 0_08 13 2021_Telecon_Information Reques.pdf | September 1, 2023 | 866 KB | |
| 125742_S1_M5_5351_c4591001 interim mth6 compliance.pdf | September 1, 2023 | 94 MB | |
| 114_2_BLA 125742 0_08 21 2021_Telecon_Labeling via FAX_e.pdf | September 1, 2023 | 784 KB | |
| 112A_1_BLA 125742 0_08 21 2021_Telecon_Information Reques.pdf | September 1, 2023 | 766 KB | |
| 113_2_BLA 125742 0_08 21 2021_Telecon_Information Reques.pdf | September 1, 2023 | 874 KB | |
| 112_1_BLA 125742 0_08 21 2021_Telecon_Information Reques.pdf | September 1, 2023 | 747 KB | |
| 59_1_BLA 125742 0_08 10 2021_Telecon_Information Reques.pdf | September 1, 2023 | 759 KB | |
| 50_BLA 125742 0_08 06 2021_Memo_Committee Memo_APLB.pdf | September 1, 2023 | 771 KB | |
| 56_BLA 125742 0_08 09 2021_Telecon_Information Reques.pdf | September 1, 2023 | 755 KB | |
| 57_BLA 125742 0_08 09 2021_Telecon_Labeling via FAX_e.pdf | September 1, 2023 | 789 KB | |
| 48A_BLA 125742 0_08 05 2021_Telecon_Labeling via FAX_e.pdf | September 1, 2023 | 3 MB | |
| 43_2_BLA 125742 0_08 04 2021_Telecon_Information Reques.pdf | September 1, 2023 | 1 MB | |
| 48_BLA 125742 0_08 05 2021_Telecon_Labeling via FAX_e.pdf | September 1, 2023 | 750 KB | |
| 37_BLA 125742 0_07 29 2021_Telecon_Information Reques.pdf | September 1, 2023 | 804 KB | |
| 38_1_BLA 125742 0_08 02 2021_Telecon_Information Reques.pdf | September 1, 2023 | 785 KB | |
| 41_1_BLA 125742 0_08 03 2021_Telecon_Information Reques.pdf | September 1, 2023 | 757 KB | |
| 35_BLA 125742 0_07 28 2021_Telecon_Information Reques.pdf | September 1, 2023 | 776 KB | |
| 36_BLA 125742 0_07 28 2021_Telecon_Labeling Target Cl.pdf | September 1, 2023 | 746 KB | |
| 31_2_BLA 125742 0_07 26 2021_Telecon_Information Reques.pdf | September 1, 2023 | 810 KB | |
| 34_2_BLA 125742 0_07 27 2021_Telecon_Information Reques.pdf | September 1, 2023 | 742 KB | |
| 29_BLA 125742 0_07 20 2021_Telecon_Information Reques.pdf | September 1, 2023 | 748 KB | |
| 30_BLA 125742 0_07 22 2021_Telecon_Information Reques.pdf | September 1, 2023 | 787 KB | |
| 30A_BLA 125742 0_07 22 2021_Telecon_Information Reques.pdf | September 1, 2023 | 946 KB | |
| 28D_BLA 125742 0_07 20 2021_Memo_Review.pdf | September 1, 2023 | 864 KB | |
| 28L_BLA 125742 0_07 20 2021_Memo_Review.pdf | September 1, 2023 | 744 KB | |
| 28_BLA 125742 0_07 20 2021_Memo_Review.pdf | September 1, 2023 | 697 KB | |
| 28C_BLA 125742 0_07 20 2021_Memo_Review.pdf | September 1, 2023 | 783 KB | |
| 23_1_BLA 125742 0_07 15 2021_Telecon_Information Reques.pdf | September 1, 2023 | 739 KB | |
| 24_2_BLA 125742 0_07 15 2021_Telecon_Information Reques.pdf | September 1, 2023 | 733 KB | |
| 20_1_BLA 125742 0_07 13 2021_Telecon_Information Reques.pdf | September 1, 2023 | 734 KB | |
| 22_BLA 125742 0_07 15 2021_Meeting Summary_Committee.pdf | September 1, 2023 | 1 MB | |
| 16_BLA 125742 0_07 06 2021_Telecon_Information Reques.pdf | September 1, 2023 | 735 KB | |
| 17_BLA 125742 0_07 06 2021_Telecon_Advice_PNR Accepta.pdf | September 1, 2023 | 728 KB | |
| 19_2_BLA 125742 0_07 13 2021_Telecon_Information Reques.pdf | September 1, 2023 | 748 KB | |
| 12_BLA 125742 0_07 01 2021_Memo_Filing Checklist_RPM.pdf | September 1, 2023 | 1 MB | |
| 14_BLA 125742 0_07 02 2021_Telecon_Advice.pdf | September 1, 2023 | 770 KB | |
| 9_2_BLA 125742 0_06 25 2021_Telecon_Information Reques.pdf | September 1, 2023 | 812 KB | |
| 11_BLA 125742 0_06 29 2021_Telecon_Information Reques.pdf | September 1, 2023 | 701 KB | |
| 5_BLA 125742 0_06 08 2021_Telecon_Information Reques.pdf | September 1, 2023 | 766 KB | |
| 6_BLA 125742 0_06 09 2021_Telecon_Information Reques.pdf | September 1, 2023 | 732 KB | |
| 63_BLA 125742 0_08 12 2021_Telecon_Other.pdf | September 1, 2023 | 691 KB | |
| FDA CBER 2021 5683 1072126 1072170_125742_S6_M5_define2 0 0 2.zip (xsl) | September 1, 2023 | 27 KB | |
| FDA CBER 2021 5683 1072081 1072125_125742_S6_M5_define2 0 0.zip (xsl) | September 1, 2023 | 27 KB | |
| FDA-CBER-2021-5683-1007285-1007313_125742_S2_M1_lab-1448-0-1-pkg-insert-clean.doc | August 1, 2023 | 533KB | |
| 125742_S1_M5_CRF_c4591001 1089 10891182.pdf | August 1, 2023 | 4 MB | |
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| 125742_S1_M5_CRF_c4591001 1077 10771137.pdf | August 1, 2023 | 2 MB | |
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| 125742_S1_M5_CRF_c4591001 1079 10791228.pdf | August 1, 2023 | 1 MB | |
| 125742_S1_M5_CRF_c4591001 1080 10801006.pdf | August 1, 2023 | 3 MB | |
| 125742_S1_M5_CRF_c4591001 1080 10801013.pdf | August 1, 2023 | 3 MB | |
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| 125742_S1_M5_CRF_c4591001 1080 10801059.pdf | August 1, 2023 | 1 MB | |
| 125742_S1_M5_CRF_c4591001 1080 10801152.pdf | August 1, 2023 | 2 MB | |
| 125742_S1_M5_CRF_c4591001 1082 10821076.pdf | August 1, 2023 | 1 MB | |
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| 125742_S1_M5_CRF_c4591001 1082 10821149.pdf | August 1, 2023 | 1 MB | |
| 125742_S1_M5_CRF_c4591001 1083 10831029.pdf | August 1, 2023 | 4 MB | |
| 125742_S1_M5_CRF_c4591001 1083 10831050.pdf | August 1, 2023 | 3 MB | |
| 125742_S1_M5_CRF_c4591001 1083 10831060.pdf | August 1, 2023 | 5 MB | |
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| 125742_S1_M5_CRF_c4591001 1083 10831173.pdf | August 1, 2023 | 3 MB | |
| 125742_S1_M5_CRF_c4591001 1084 10841141.pdf | August 1, 2023 | 2 MB | |
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| 125742_S1_M5_CRF_c4591001 1084 10841219.pdf | August 1, 2023 | 2 MB | |
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| 125742_S1_M5_CRF_c4591001 1084 10841470.pdf | August 1, 2023 | 3 MB | |
| 125742_S1_M5_CRF_c4591001 1084 10841480.pdf | August 1, 2023 | 2 MB | |
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| 125742_S1_M5_CRF_c4591001 1087 10871070.pdf | August 1, 2023 | 2 MB | |
| 125742_S1_M5_CRF_c4591001 1087 10871029.pdf | August 1, 2023 | 3 MB | |
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| 125742_S1_M5_CRF_c4591001 1087 10871150.pdf | August 1, 2023 | 3 MB | |
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| 125742_S1_M5_CRF_c4591001 1087 10871228.pdf | August 1, 2023 | 3 MB | |
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| 125742_S1_M5_CRF_c4591001 1087 10871289.pdf | August 1, 2023 | 2 MB | |
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| 125742_S1_M5_CRF_c4591001 1088 10881126.pdf | August 1, 2023 | 3 MB | |
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| 125742_S1_M5_CRF_c4591001 1088 10881139.pdf | August 1, 2023 | 2 MB | |
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| 125742_S1_M5_CRF_c4591001 1089 10891042.pdf | August 1, 2023 | 2 MB | |
| 125742_S1_M5_CRF_c4591001 1089 10891073.pdf | August 1, 2023 | 2 MB | |
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| 125742_S1_M5_CRF_c4591001 1089 10891088.pdf | August 1, 2023 | 2 MB | |
| 125742_S1_M5_CRF_c4591001 1089 10891181.pdf | August 1, 2023 | 1 MB | |
| 125742_S1_M5_CRF_c4591001 1089 10891150.pdf | August 1, 2023 | 2 MB | |
| 125742_S1_M5_CRF_c4591001 1142 11421073.pdf | August 1, 2023 | 1 MB | |
| 125742_S1_M5_CRF_c4591001 1142 11421084.pdf | August 1, 2023 | 1 MB | |
| 125742_S1_M5_CRF_c4591001 1089 10891273.pdf | August 1, 2023 | 1 MB | |
| 125742_S1_M5_CRF_c4591001 1089 10891289.pdf | August 1, 2023 | 1 MB | |
| 125742_S1_M5_CRF_c4591001 1094 10941112.pdf | August 1, 2023 | 5 MB | |
| 125742_S1_M5_CRF_c4591001 1094 10941155.pdf | August 1, 2023 | 1 MB | |
| 125742_S1_M5_CRF_c4591001 1097 10971011.pdf | August 1, 2023 | 39 MB | |
| 125742_S1_M5_CRF_c4591001 1097 10971017.pdf | August 1, 2023 | 3 MB | |
| 125742_S1_M5_CRF_c4591001 1097 10971023.pdf | August 1, 2023 | 18 MB | |
| 125742_S1_M5_CRF_c4591001 1097 10971026.pdf | August 1, 2023 | 2 MB | |
| 125742_S1_M5_CRF_c4591001 1097 10971025.pdf | August 1, 2023 | 1 MB | |
| 125742_S1_M5_CRF_c4591001 1097 10971031.pdf | August 1, 2023 | 2 MB | |
| 125742_S1_M5_CRF_c4591001 1097 10971061.pdf | August 1, 2023 | 3 MB | |
| 125742_S1_M5_CRF_c4591001 1097 10971064.pdf | August 1, 2023 | 25 MB | |
| 125742_S1_M5_CRF_c4591001 1097 10971084.pdf | August 1, 2023 | 2 MB | |
| 125742_S1_M5_CRF_c4591001 1097 10971087.pdf | August 1, 2023 | 2 MB | |
| 125742_S1_M5_CRF_c4591001 1098 10981024.pdf | August 1, 2023 | 6 MB | |
| 125742_S1_M5_CRF_c4591001 1101 11011115.pdf | August 1, 2023 | 2 MB | |
| 125742_S1_M5_CRF_c4591001 1107 11071031.pdf | August 1, 2023 | 4 MB | |
| 125742_S1_M5_CRF_c4591001 1107 11071044.pdf | August 1, 2023 | 2 MB | |
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| 125742_S1_M5_CRF_c4591001 1109 11091111.pdf | August 1, 2023 | 3 MB | |
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| 125742_S1_M5_CRF_c4591001 4444 44442304.pdf | August 1, 2023 | 2 MB | |
| 125742_S45_M1_response 09aug2021.pdf | August 1, 2023 | 2 MB | |
| 125742_S2_M1_lab 1448 0 1 annotated.pdf | August 1, 2023 | 1 MB | |
| 125742_S2_M1_lab 1448 0 1 pkg insert clean.pdf | August 1, 2023 | 1 MB | |
| 125742_S2_M1_loa dmf 15209 vials.pdf | August 1, 2023 | 960 KB | |
| 125742_S2_M1_pharmacovigilance plan.pdf | August 1, 2023 | 13 MB | |
| 125742_S6_M1_cover.pdf | August 1, 2023 | 2 MB | |
| 125742_S7_M1_cover.pdf | August 1, 2023 | 671 KB | |
| 125742_S6_M5_c4591001_adxb sas.pdf | August 1, 2023 | 621 KB | |
| 125742_S8_M1_cover.pdf | August 1, 2023 | 2 MB | |
| 125742_S9_M1_cover.pdf | August 1, 2023 | 2 MB | |
| 125742_S9_M1_response 29jun2021.pdf | August 1, 2023 | 714 KB | |
| 125742_S10_M1_response 25jun2021.pdf | August 1, 2023 | 716 KB | |
| 125742_S10_M1_appendix 1.pdf | August 1, 2023 | 730 KB | |
| 125742_S10_M1_cover.pdf | August 1, 2023 | 696 KB | |
| 125742_S13_M1_cover.pdf | August 1, 2023 | 671 KB | |
| 125742_S12_M1_cover.pdf | August 1, 2023 | 668 KB | |
| 125742_S16_M1_cover.pdf | August 1, 2023 | 673 KB | |
| 125742_S13_M1_response 06july2021.pdf | August 1, 2023 | 767 KB | |
| 125742_S16_M1_ped studies deferral req.pdf | August 1, 2023 | 11 MB | |
| 125742_S16_M1_psp agreed clean.pdf | August 1, 2023 | 2 MB | |
| 125742_S16_M1_response 15jul2021.pdf | August 1, 2023 | 1 MB | |
| 125742_S18_M1_cover.pdf | August 1, 2023 | 671 KB | |
| 125742_S18_M1_response 22jul2021.pdf | August 1, 2023 | 749 KB | |
| 125742_S20_M1_cover.pdf | August 1, 2023 | 2 MB | |
| 125742_S20_M1_response 22jul2021.pdf | August 1, 2023 | 1 MB | |
| 125742_S23_M1_response 26jul2021.pdf | August 1, 2023 | 764 KB | |
| 125742_S23_M1_cover.pdf | August 1, 2023 | 673 KB | |
| 125742_S21_M1_cover.pdf | August 1, 2023 | 2 MB | |
| 125742_S24_M1_cover.pdf | August 1, 2023 | 671 KB | |
| 125742_S27_M1_cover.pdf | August 1, 2023 | 672 KB | |
| 125742_S28_M1_cover.pdf | August 1, 2023 | 673 KB | |
| 125742_S24_M1_response 27jul2021.pdf | August 1, 2023 | 1 MB | |
| 125742_S31_M1_cover.pdf | August 1, 2023 | 672 KB | |
| 125742_S29_M1_cover.pdf | August 1, 2023 | 721 KB | |
| 125742_S32_M1_cover.pdf | August 1, 2023 | 1 MB | |
| 125742_S31_M1_response 28jul2021.pdf | August 1, 2023 | 1 MB | |
| 125742_S32_M1_response 02aug2021.pdf | August 1, 2023 | 2 MB | |
| 125742_S33_M1_cover.pdf | August 1, 2023 | 2 MB | |
| 125742_S33_M5_c4591001_adc19ef ve sev 7pd2 cdc wo eval sas.pdf | August 1, 2023 | 608 KB | |
| 125742_S33_M1_response 22jul 03aug.pdf | August 1, 2023 | 2 MB | |
| 125742_S33_M5_c4591001_adc19ef ve sev 7pd2 cdc eval sas.pdf | August 1, 2023 | 608 KB | |
| 125742_S39_M1_cover.pdf | August 1, 2023 | 2 MB | |
| 125742_S41_M1_cover.pdf | August 1, 2023 | 2 MB | |
| 125742_S41_M1_response 10aug2021.pdf | August 1, 2023 | 2 MB | |
| 125742_S41_M5_5354_c4591021 protocol.pdf | August 1, 2023 | 14 MB | |
| 125742_S45_M1_cover.pdf | August 1, 2023 | 2 MB | |
| 125742_S77_M1_response 21aug2021 pmc.pdf | August 1, 2023 | 1 MB | |
| 125742_S78_M1_attachment hcp letter.pdf | August 1, 2023 | 742 KB | |
| 125742_S46_M1_cover.pdf | August 1, 2023 | 2 MB | |
| 125742_S49_M1_cover.pdf | August 1, 2023 | 672 KB | |
| 125742_S49_M1_response 13aug2021.pdf | August 1, 2023 | 1 MB | |
| 125742_S51_M1_cover.pdf | August 1, 2023 | 720 KB | |
| 125742_S54_M1_cover.pdf | August 1, 2023 | 721 KB | |
| 125742_S52_M1_cover.pdf | August 1, 2023 | 671 KB | |
| 125742_S52_M1_response 13aug2021.pdf | August 1, 2023 | 817 KB | |
| 125742_S54_M1_response 16aug2021.pdf | August 1, 2023 | 1 MB | |
| 125742_S58_M1_cover.pdf | August 1, 2023 | 720 KB | |
| 125742_S62_M1_cover.pdf | August 1, 2023 | 671 KB | |
| 125742_S64_M1_carton ca 7114 hospira.pdf | August 1, 2023 | 676 KB | |
| 125742_S64_M1_cover.pdf | August 1, 2023 | 732 KB | |
| 125742_S62_M1_response 17aug2021.pdf | August 1, 2023 | 2 MB | |
| 125742_S64_M1_diluent vial fresenius kabi.pdf | August 1, 2023 | 715 KB | |
| 125742_S64_M1_diluent carton fresenius kabi.pdf | August 1, 2023 | 728 KB | |
| 125742_S65_M1_2253.pdf | August 1, 2023 | 1,024 KB | |
| 125742_S64_M1_vial diluent rl 7302 hospira.pdf | August 1, 2023 | 670 KB | |
| 125742_S65_M1_eua lab 1450 12 0.pdf | August 1, 2023 | 2 MB | |
| 125742_S65_M1_eua lab 1451 8 0.pdf | August 1, 2023 | 700 KB | |
| 125742_S65_M1_lab 1448 1 0.pdf | August 1, 2023 | 1 MB | |
| 125742_S66_M1_2253.pdf | August 1, 2023 | 1 MB | |
| 125742_S66_M1_eua lab 1450 12 0.pdf | August 1, 2023 | 2 MB | |
| 125742_S66_M1_eua lab 1451 8 0.pdf | August 1, 2023 | 697 KB | |
| 125742_S66_M1_lab 1448 1 0.pdf | August 1, 2023 | 1 MB | |
| 125742_S67_M1_attachment hcp letter.pdf | August 1, 2023 | 661 KB | |
| 125742_S67_M1_attachment infographic lots.pdf | August 1, 2023 | 637 KB | |
| 125742_S66_M1_pp cvv usa 0357.pdf | August 1, 2023 | 19 MB | |
| 125742_S67_M1_cover.pdf | August 1, 2023 | 673 KB | |
| 125742_S67_M1_response 18aug2021.pdf | August 1, 2023 | 715 KB | |
| 125742_S68_M1_cover.pdf | August 1, 2023 | 2 MB | |
| 125742_S69_M1_cover.pdf | August 1, 2023 | 668 KB | |
| 125742_S69_M1_response 19aug2021.pdf | August 1, 2023 | 2 MB | |
| 125742_S70_M1_cover.pdf | August 1, 2023 | 2 MB | |
| 125742_S71_M1_cover.pdf | August 1, 2023 | 672 KB | |
| 125742_S71_M1_response 19aug2021.pdf | August 1, 2023 | 2 MB | |
| 125742_S72_M1_cover.pdf | August 1, 2023 | 696 KB | |
| 125742_S72_M1_letter of authorization.pdf | August 1, 2023 | 654 KB | |
| 125742_S73_M1_cover.pdf | August 1, 2023 | 2 MB | |
| 125742_S74_M1_cover.pdf | August 1, 2023 | 2 MB | |
| 125742_S74_M1_response 20aug2021.pdf | August 1, 2023 | 2 MB | |
| 125742_S75_M1_attachment hcp letter.pdf | August 1, 2023 | 753 KB | |
| 125742_S75_M1_attachment infographic lots.pdf | August 1, 2023 | 4 MB | |
| 125742_S75_M1_cover.pdf | August 1, 2023 | 2 MB | |
| 125742_S76_M1_cover.pdf | August 1, 2023 | 721 KB | |
| 125742_S75_M1_response 20aug2021.pdf | August 1, 2023 | 2 MB | |
| 125742_S77_M1_response 21aug2021 attachment pmc.pdf | August 1, 2023 | 2 MB | |
| 125742_S77_M1_cover.pdf | August 1, 2023 | 671 KB | |
| 125742_S118_M1_pp cvv usa 0426.pdf | August 1, 2023 | 830 KB | |
| 125742_S85_M1_cover.pdf | August 1, 2023 | 779 KB | |
| 125742_S78_M1_cover.pdf | August 1, 2023 | 671 KB | |
| 125742_S82_M1_cover.pdf | August 1, 2023 | 671 KB | |
| 125742_S87_m1_2253.pdf | August 1, 2023 | 1 MB | |
| 125742_S87_M1_2253 multiple product.pdf | August 1, 2023 | 588 KB | |
| 125742_S87_M1_eua lab 1450 12 0.pdf | August 1, 2023 | 2 MB | |
| 125742_S87_M1_lab 0722 9 0.pdf | August 1, 2023 | 753 KB | |
| 125742_S87_M1_eua lab 1451 8 0.pdf | August 1, 2023 | 700 KB | |
| 125742_S87_M1_lab 0469 18 0.pdf | August 1, 2023 | 901 KB | |
| 125742_S87_M1_lab 1436 1 0.pdf | August 1, 2023 | 856 KB | |
| 125742_S87_M1_lab 1448 1 0.pdf | August 1, 2023 | 1 MB | |
| 125742_S87_M1_pp pna usa 4653.pdf | August 1, 2023 | 2 MB | |
| 125742_S88_M1_2253.pdf | August 1, 2023 | 1 MB | |
| 125742_S88_M1_pp cvv usa 0378.pdf | August 1, 2023 | 921 KB | |
| 125742_S89_M1_comments advice req.pdf | August 1, 2023 | 1 MB | |
| 125742_S89_M1_cover.pdf | August 1, 2023 | 696 KB | |
| 125742_S94_M1_eua lab 1451 9 0.pdf | August 1, 2023 | 700 KB | |
| 125742_S94_M1_2253.pdf | August 1, 2023 | 1 MB | |
| 125742_S94_M1_eua lab 1457 13 0.pdf | August 1, 2023 | 2 MB | |
| 125742_S94_M1_lab 1448 1 0.pdf | August 1, 2023 | 1 MB | |
| 125742_S94_M1_pp cvv usa 0408.pdf | August 1, 2023 | 3 MB | |
| 125742_S102_M1_cover.pdf | August 1, 2023 | 1 MB | |
| 125742_S105_M1_req comments advice bpdr.pdf | August 1, 2023 | 689 KB | |
| 125742_S102_M1_request waiver ldr.pdf | August 1, 2023 | 2 MB | |
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| 125742_S105_M1_cover.pdf | August 1, 2023 | 1 MB | |
| 125742_S113_M1_cover.pdf | August 1, 2023 | 2 MB | |
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| 125742_S116_M1_pp cvv usa 0387.pdf | August 1, 2023 | 1 MB | |
| 125742_S116_M1_lab 1457 14 0.pdf | August 1, 2023 | 9 MB | |
| 125742_S116_M1_pp cvv usa 0389.pdf | August 1, 2023 | 748 KB | |
| 125742_S117_M1_2253.pdf | August 1, 2023 | 1 MB | |
| 125742_S117_M1_lab 1448 1 0.pdf | August 1, 2023 | 1 MB | |
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| 125742_S117_M1_lab 1457 14 0.pdf | August 1, 2023 | 9 MB | |
| 125742_S117_M1_pp cvv usa 0422.pdf | August 1, 2023 | 3 MB | |
| 125742_S118_M1_2253.pdf | August 1, 2023 | 1 MB | |
| 125742_S118_M1_lab 1448 1 0.pdf | August 1, 2023 | 1 MB | |
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| 125742_S144_M1_lab 1457 15 0.pdf | August 1, 2023 | 2 MB | |
| 125742_S144_M1_pp cvv usa 0478.pdf | August 1, 2023 | 9 MB | |
| 125742_S123_M1_2253.pdf | August 1, 2023 | 1 MB | |
| 125742_S123_M1_lab 1448 1 0.pdf | August 1, 2023 | 1 MB | |
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| 125742_S123_M1_lab 1457 14 0.pdf | August 1, 2023 | 9 MB | |
| 125742_S123_M1_pp cvv usa 0430.pdf | August 1, 2023 | 5 MB | |
| 125742_S125_M1_2253.pdf | August 1, 2023 | 1 MB | |
| 125742_S125_M1_lab 1451 10 0.pdf | August 1, 2023 | 708 KB | |
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| 125742_S126_M1_2253.pdf | August 1, 2023 | 1 MB | |
| 125742_S125_M1_pp cvv usa 0424.pdf | August 1, 2023 | 1 MB | |
| 125742_S126_M1_lab 1451 10 0.pdf | August 1, 2023 | 708 KB | |
| 125742_S126_M1_lab 1448 1 0.pdf | August 1, 2023 | 1 MB | |
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| 125742_S129_M1_2253.pdf | August 1, 2023 | 1 MB | |
| 125742_S126_M1_pp cvv usa 0429.pdf | August 1, 2023 | 2 MB | |
| 125742_S129_M1_lab 1451 10 0.pdf | August 1, 2023 | 710 KB | |
| 125742_S129_M1_lab 1448 1 0.pdf | August 1, 2023 | 1 MB | |
| 125742_S129_M1_lab 1457 14 0.pdf | August 1, 2023 | 9 MB | |
| 125742_S131_M1_2253.pdf | August 1, 2023 | 1 MB | |
| 125742_S129_M1_pp cvv usa 0442.pdf | August 1, 2023 | 1 MB | |
| 125742_S131_M1_lab 1451 10 0.pdf | August 1, 2023 | 710 KB | |
| 125742_S131_M1_lab 1448 1 0.pdf | August 1, 2023 | 1 MB | |
| 125742_S131_M1_lab 1457 14 0.pdf | August 1, 2023 | 9 MB | |
| 125742_S131_M1_pp cvv usa 0391.pdf | August 1, 2023 | 1 MB | |
| 125742_S131_M1_pp cvv usa 0431.pdf | August 1, 2023 | 1 MB | |
| 125742_S131_M1_pp cvv usa 0432.pdf | August 1, 2023 | 760 KB | |
| 125742_S136_M1_cover.pdf | August 1, 2023 | 732 KB | |
| 125742_S138_M1_lab 1448 1 0.pdf | August 1, 2023 | 1 MB | |
| 125742_S138_M1_2253.pdf | August 1, 2023 | 1 MB | |
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| 125742_S138_M1_lab 1451 11 0.pdf | August 1, 2023 | 703 KB | |
| 125742_S138_M1_pp cvv usa 0416.pdf | August 1, 2023 | 571 KB | |
| 125742_S141_M1_lab 1448 1 0.pdf | August 1, 2023 | 1 MB | |
| 125742_S141_M1_2253.pdf | August 1, 2023 | 1 MB | |
| 125742_S141_M1_lab 1457 15 0.pdf | August 1, 2023 | 2 MB | |
| 125742_S141_M1_lab 1451 11 0.pdf | August 1, 2023 | 703 KB | |
| 125742_S141_M1_pp cvv usa 0473.pdf | August 1, 2023 | 3 MB | |
| 125742_S144_m1_lab 1448 1 0.pdf | August 1, 2023 | 1 MB | |
| 125742_S144_M1_2253.pdf | August 1, 2023 | 895 KB | |
| 125742_S144_M1_lab 1451 11 0.pdf | August 1, 2023 | 703 KB | |
| FDA CBER 2021 5683 1007284_125742_S2_M1_comirnaty 12.jpg | August 1, 2023 | 295 KB | |
| FDA CBER 2021 5683 1007238 1007272_125742_S2_M1_comirnaty.xml | August 1, 2023 | 205 KB | |
| FDA CBER 2021 5683 1007275_125742_S2_M1_comirnaty 03.jpg | August 1, 2023 | 16 KB | |
| FDA CBER 2021 5683 1007273_125742_S2_M1_comirnaty 01.jpg | August 1, 2023 | 14 KB | |
| FDA CBER 2021 5683 1007274_125742_S2_M1_comirnaty 02.jpg | August 1, 2023 | 11 KB | |
| FDA CBER 2021 5683 1007278_125742_S2_M1_comirnaty 06.jpg | August 1, 2023 | 13 KB | |
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| FDA CBER 2021 5683 1007277_125742_S2_M1_comirnaty 05.jpg | August 1, 2023 | 10 KB | |
| FDA CBER 2021 5683 1007282_125742_S2_M1_comirnaty 10.jpg | August 1, 2023 | 56 KB | |
| FDA CBER 2021 5683 1007280_125742_S2_M1_comirnaty 08.jpg | August 1, 2023 | 5 KB | |
| FDA CBER 2021 5683 1007281_125742_S2_M1_comirnaty 09.jpg | August 1, 2023 | 5 KB | |
| FDA CBER 2021 5683 1007283_125742_S2_M1_comirnaty 11.jpg | August 1, 2023 | 344 KB | |
| FDA CBER 2021 5683 1007338_125742_S82_M1_comirnaty 01.jpg | August 1, 2023 | 23 KB | |
| FDA CBER 2021 5683 1007339_125742_S82_M1_comirnaty 02.jpg | August 1, 2023 | 17 KB | |
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| FDA CBER 2021 5683 1007343_125742_S82_M1_comirnaty 06.jpg | August 1, 2023 | 22 KB | |
| FDA CBER 2021 5683 1007347_125742_S82_M1_comirnaty 10.jpg | August 1, 2023 | 458 KB | |
| FDA CBER 2021 5683 1007346_125742_S82_M1_comirnaty 09.jpg | August 1, 2023 | 109 KB | |
| FDA CBER 2021 5683 1007348_125742_S82_M1_comirnaty 11.jpg | August 1, 2023 | 798 KB | |
| FDA CBER 2021 5683 1007314 1007337_125742_S82_M1_comirnaty.xml | August 1, 2023 | 139 KB | |
| FDA CBER 2021 5683 1007349_125742_S138_M1_pp cvv usa 0416.mp3 | August 1, 2023 | 243 KB | |
| 125742_S65_M1_pp cvv usa 0349 01.pdf | August 1, 2023 | 60 MB | |
| 125742_S1_M5_CRF_c4591001 1027 10271191.pdf | July 3, 2023 | 4 MB | |
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