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FDA CBER 2022 1614 1228760 1228762_125752_S37_M1_draft labeling text patient info cleandocxAugust 1, 202430 KBdocx
FDA CBER 2022 1614 1228720 1228735_125752_S35_M1_draft spikevax labeling text pidocxAugust 1, 2024107 KBdocx
FDA CBER 2022 1614 1228680 1228696_125752_S24_M1_draft spikevax labeling text pidocxAugust 1, 2024101 KBdocx
FDA CBER 2022 1614 1228624 1228639_125752_S3_M1_draft labeling text pidocxAugust 1, 202491 KBdocx
FDA CBER 2022 1614 1228618 1228620_125752_S3_M1_draft labeling text patient infodocxAugust 1, 202428 KBdocx
FDA CBER 2022 1614 1228584 1228600_125752_S3_M1_annotated draft labeling textdocxAugust 1, 202493 KBdocx
FDA CBER 2022 1614 1228803 1228819_125752_S48_M1_draft labeling text patient info cleandocxAugust 1, 2024110 KBdocx
FDA CBER 2022 1614 1228767 1228783_125752_S43_M1_draft labeling text patient info cleandocxAugust 1, 2024110 KBdocx
125752_S35_M1_spikevax 7 5ml vial label blapdfAugust 1, 20241 MBpdf
125752_S35_M1_spikevax 7 5ml vial carton blapdfAugust 1, 20241 MBpdf
125752_S35_M1_spikevax 5 5ml vial label blapdfAugust 1, 20241 MBpdf
125752_S35_M1_spikevax 5 5ml vial carton blapdfAugust 1, 20241 MBpdf
125752_S35_M1_draft spikevax labeling text pipdfAugust 1, 2024910 KBpdf
125752_S24_M1_spikevax 7 5ml vial label blapdfAugust 1, 20241 MBpdf
125752_S24_M1_spikevax 7 5ml vial carton blapdfAugust 1, 20241 MBpdf
125752_S24_M1_spikevax 5 5ml vial label blapdfAugust 1, 20241 MBpdf
125752_S24_M1_spikevax 5 5ml vial carton blapdfAugust 1, 20241 MBpdf
125752_S24_M1_draft spikevax labeling text pipdfAugust 1, 20244 MBpdf
125752_S48_M1_draft labeling text patient info cleanpdfAugust 1, 20242 MBpdf
125752_S43_M1_draft labeling text patient info cleanpdfAugust 1, 20241 MBpdf
125752_S37_M1_draft labeling text patient info cleanpdfAugust 1, 2024697 KBpdf
125752_S3_M5_54_zhou 2020pdfAugust 1, 202421 MBpdf
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125752_S3_M5_54_puntmann 2019pdfAugust 1, 20242 MBpdf
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125752_S3_M5_54_benotmane 2021pdfAugust 1, 20242 MBpdf
125752_S3_M5_54_baden 2021pdfAugust 1, 2024760 KBpdf
125752_S3_M5_54_anderson 2020pdfAugust 1, 2024991 KBpdf
125752_S3_M5_54_agrawal 2016pdfAugust 1, 20243 MBpdf
125752_S3_M1_splpdfAugust 1, 2024786 KBpdf
125752_S3_M1_spikevax 7 5ml vial label blapdfAugust 1, 20241 MBpdf
125752_S3_M1_spikevax 7 5ml vial carton blapdfAugust 1, 20241 MBpdf
125752_S3_M1_spikevax 5 5ml vial label blapdfAugust 1, 20242 MBpdf
125752_S3_M1_spikevax 5 5ml vial carton blapdfAugust 1, 20242 MBpdf
125752_S3_M1_draft labeling text pipdfAugust 1, 2024841 KBpdf
125752_S3_M1_draft labeling text patient infopdfAugust 1, 2024646 KBpdf
125752_S3_M1_annotated draft labeling textpdfAugust 1, 2024847 KBpdf
125752_S3_M5_54_bolles 2011pdfAugust 1, 202420 MBpdf
FDA-CBER-2022-1614-1357253-1411136_125752_S3_M5_mrna-1273-p301_S_vs.zipzipAugust 1, 202452 MBzip
FDA-CBER-2022-1614-1236424-1357252_125752_S3_M5_mrna-1273-p301_S_face.zipzipAugust 1, 202470 MBzip
FDA-CBER-2022-1614-1228838-1236423_125752_S3_M5_mrna-1273-p301_A_D_adtteb.zipzipAugust 1, 20248 MBzip
FDA-CBER-2022-1614-1036150-1162722_125752_S3_M5_mrna-1273-p301_A_D_adar.zipzipJuly 1, 2024105 MBzip
FDA-CBER-2022-1614-1162723-1189136_125752_S3_M5_mrna-1273-p301_A_D_adsymp.zipzipJuly 1, 202430 MBzip
FDA-CBER-2022-1614-1189137-1227196_125752_S3_M5_mrna-1273-p301_A_D_adtte.zipzipJuly 1, 202437 MBzip
125752_S37_M1_pvp spikevax 16dec2021 trkpdfJuly 1, 2024902 KBpdf
125752_S37_M1_pvp spikevax 16dec2021pdfJuly 1, 2024837 KBpdf
125752_S37_M1_cover 0037pdfJuly 1, 20241 MBpdf
125752_S34_M1_rsp fda cmts info req31 10dec2021pdfJuly 1, 2024746 KBpdf
125752_S34_M1_cover 0034pdfJuly 1, 20241 MBpdf
125752_S31_M1_rsp fda cmts ir27 clinical 06dec2021pdfJuly 1, 20241 MBpdf
125752_S31_M1_cover 0031pdfJuly 1, 20241 MBpdf
125752_S25_M1_rsp fda cmts post mrktng stud 19nov2021pdfJuly 1, 20241 MBpdf
125752_S48_M1_cover 0048pdfJuly 1, 20241 MBpdf
125752_S45_M1_rsp fda on info req44 12jan2022pdfJuly 1, 20241 MBpdf
125752_S45_M1_cover 0045pdfJuly 1, 20241 MBpdf
125752_S22_M1_cover 0022pdfJuly 1, 20241 MBpdf
125752_S19_M5_5354_mrna 1273 p903 covid 19 safety protocolpdfJuly 1, 20244 MBpdf
125752_S19_M5_5354_mrna 1273 p902 preg outcome studypdfJuly 1, 20241 MBpdf
125752_S17_M1_cover 0017pdfJuly 1, 20241 MBpdf
125752_S13_M1_rsp fda cmts clin 24sept2021pdfJuly 1, 2024689 KBpdf
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125752_S10_M1_rsp fda cmts clinical 28sept2021pdfJuly 1, 2024743 KBpdf
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125752_S24_M1_rsp fda cmts labeling 15nov2021pdfJuly 1, 20243 MBpdf
125752_S24_M1_rsp fda cmts clin 12nov2021pdfJuly 1, 20244 MBpdf
125752_S22_M1_rsp fda cmts safety 05nov2021pdfJuly 1, 2024774 KBpdf
125752_S10_M5_CRF_mrna 1273 p301 us3392287pdfJune 3, 20245 MBpdf
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125752_S3_M2_27_summary clin pharmpdfJune 3, 2024784 KBpdf
125752_S3_M2_27_summary clin efficacypdfJune 3, 20242 MBpdf
125752_S3_M2_27_literature referencespdfJune 3, 2024710 KBpdf
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125752_S1_M4.2.3.2 report body 5002400pdfFebruary 1, 202411 MBpdf
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125752_S1_M4.2.3.2 report body 5002158pdfFebruary 1, 202455 MBpdf
125752_S12_M1_rsp fda cmts ir7 cmc 05oct2021pdfJanuary 2, 2024622 KBpdf
125752_S11_M1_rsp fda cmts ir6 cmc 28sept2021pdfJanuary 2, 2024717 KBpdf
125752_S15_M1_loa bla 0700 accpdfJanuary 2, 20241 MBpdf
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125752_S39_M1_form 356h 0039pdfJanuary 2, 20244 MBpdf
125752_S49_M1_form 356h 0049pdfJanuary 2, 20244 MBpdf
125752_S52_M1_form 356h 0052pdfJanuary 2, 20244 MBpdf
125752_S38_M1_form 356h 0038pdfJanuary 2, 20244 MBpdf
125752_S40_M1_form 356h 0040pdfJanuary 2, 20244 MBpdf
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125752_S23_M1_form 356h 0023pdfJanuary 2, 20244 MBpdf
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125752_S20_M1_form 356h 0020pdfJanuary 2, 20244 MBpdf
125752_S50_M1_form 356h 0050pdfJanuary 2, 20244 MBpdf
125752_S28_M1_form 356h 0028pdfJanuary 2, 20244 MBpdf
125752_S21_M1_form 356h 0021pdfJanuary 2, 20244 MBpdf
125752_S18_M1_form 356h 0018pdfJanuary 2, 20244 MBpdf
125752_S33_M1_form 356h 0033pdfJanuary 2, 20244 MBpdf
125752_S46_M1_form 356h 0046pdfJanuary 2, 20244 MBpdf
125752_S51_M1_form 356h 0051pdfJanuary 2, 20244 MBpdf
125752_S5_M1_form 356h 0005pdfJanuary 2, 20244 MBpdf
125752_S7_M1_form 356h 0007pdfJanuary 2, 20244 MBpdf
125752_S6_M1_form 356h 0006pdfJanuary 2, 20244 MBpdf
125752_S9_M1_form 356h 0009pdfJanuary 2, 20244 MBpdf
125752_S12_M1_form 356h 0012pdfJanuary 2, 20244 MBpdf
125752_S8_M1_form 356h 0008pdfJanuary 2, 20244 MBpdf
125752_S16_M1_form 356h 0016pdfJanuary 2, 20244 MBpdf
125752_S11_M1_form 356h 0011pdfJanuary 2, 20244 MBpdf
125752_S1_M1_form 356h 0001pdfJanuary 2, 20244 MBpdf
125752_S4_M1_form 356h 0004pdfJanuary 2, 20244 MBpdf
125752_S15_M1_form 356h 0015pdfJanuary 2, 20244 MBpdf
125752_S3_M5_CRF_mrna 1273 p301 us3082051pdfJanuary 2, 20244 MBpdf
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125752_S3_M5_CRF_mrna 1273 p301 us3012171pdfJanuary 2, 20246 MBpdf
125752_S9_M1_cover 0009.pdfpdfDecember 4, 20231 MBpdf
125752_S9_M1_rsp fda cmts clin 28sep2021 ir6.pdfpdfDecember 4, 2023746 KBpdf
125752_S1_M1_cover 0001.pdfpdfDecember 4, 20231 MBpdf
125752_S1_M1_form 3397.pdfpdfDecember 4, 20231 MBpdf
125752_S4_M1_cber rqstd tables.pdfpdfDecember 4, 20231 MBpdf
125752_S4_M1_cover 0004.pdfpdfDecember 4, 20231 MBpdf
125752_S5_M1_cover 0005.pdfpdfDecember 4, 20231 MBpdf
125752_S5_M1_form 3674.pdfpdfDecember 4, 20231 MBpdf
125752_S5_M1_rsp fda cmts clinical 17sept2021.pdfpdfDecember 4, 2023730 KBpdf
125752_S5_M1_rsp ir1 14sept2021.pdfpdfDecember 4, 2023690 KBpdf
125752_S6_M1_cover 0006.pdfpdfDecember 4, 20231 MBpdf
125752_S6_M1_rsp ir1 14sept2021.pdfpdfDecember 4, 20231 MBpdf
125752_S7_M1_cover 0007.pdfpdfDecember 4, 20231 MBpdf
125752_S7_M1_rsp fda cmts ir2 clinical 17sept2021.pdfpdfDecember 4, 2023782 KBpdf
125752_S7_M1_updated rsp ir1 14sept2021.pdfpdfDecember 4, 20231 MBpdf
125752_S8_M1_cber rqstd tables batch2.pdfpdfDecember 4, 20232 MBpdf
125752_S8_M1_cover 0008.pdfpdfDecember 4, 20232 MBpdf
125752_S8_M1_rsp fda cmts clinical 23sept2021.pdfpdfDecember 4, 20233 MBpdf
125752_S20_M1_rsp fda cmts clin 28oct2021.pdfpdfDecember 4, 20231 MBpdf
125752_S20_M1_rsp fda cmts ir11 cmc 22oct2021.pdfpdfDecember 4, 2023866 KBpdf
125752_S21_M1_cover 0021.pdfpdfDecember 4, 20231 MBpdf
125752_S11_M1_cber req tables mrna 1273.pdfpdfDecember 4, 20232 MBpdf
125752_S11_M1_cover 0011.pdfpdfDecember 4, 20231 MBpdf
125752_S11_M1_rsp fda cmts ir3 cmc 23sept2021.pdfpdfDecember 4, 2023665 KBpdf
125752_S11_M1_rsp fda cmts ir5 group1 24sept2021.pdfpdfDecember 4, 2023769 KBpdf
125752_S12_M1_cover 0012.pdfpdfDecember 4, 20231 MBpdf
125752_S15_M1_cover 0015.pdfpdfDecember 4, 20231 MBpdf
125752_S16_M1_cover 0016.pdfpdfDecember 4, 20231 MBpdf
125752_S16_M1_rsp fda cmts ir5 group3 24sept2021.pdfpdfDecember 4, 20231 MBpdf
125752_S18_M1_cover 0018.pdfpdfDecember 4, 20231 MBpdf
125752_S18_M1_rsp fda cmts clin 22oct2021.pdfpdfDecember 4, 2023850 KBpdf
125752_S20_M1_ce mapping.pdfpdfDecember 4, 20231 MBpdf
125752_S20_M1_cover 0020_.pdfpdfDecember 4, 20231 MBpdf
125752_S21_M5_real world effect study v3.pdfpdfDecember 4, 202327 MBpdf
125752_S40_M1_cover 0040.pdfpdfDecember 4, 20231 MBpdf
125752_S23_M1__rsp fda cmts safety 10nov2021.pdfpdfDecember 4, 20231 MBpdf
125752_S23_M1_cover 0023.pdfpdfDecember 4, 20231 MBpdf
125752_S27_M1_cover 0027.pdfpdfDecember 4, 20231 MBpdf
125752_S28_M1_rsp fda cmts info req24 30nov2021.pdfpdfDecember 4, 20231 MBpdf
125752_S32_M1_cover 0032.pdfpdfDecember 4, 20231 MBpdf
125752_S32_M1_rsp fda cmts clin 19nov2021.pdfpdfDecember 4, 20231 MBpdf
125752_S33_M1_cover 0033.pdfpdfDecember 4, 20231 MBpdf
125752_S33_M1_rsp fda cmts info req30 10dec2021.pdfpdfDecember 4, 20231 MBpdf
125752_S38_M1_rsp fda cmts ir32 cmc 10dec2021.pdfpdfDecember 4, 2023693 KBpdf
125752_S39_M1_cover 0039.pdfpdfDecember 4, 20232 MBpdf
125752_S39_M1_rsp fda cmts info req36 16dec2021.pdfpdfDecember 4, 20232 MBpdf
125752_S51_M1_draft labeling text patient info clean.pdfpdfDecember 4, 20232 MBpdf
125752_S51_M1_draft labeling text patient info redline.pdfpdfDecember 4, 20232 MBpdf
125752_S51_M1_rsp fda on info req48 26jan2022.pdfpdfDecember 4, 20231 MBpdf
125752_S52_M1_cover 0052.pdfpdfDecember 4, 20231 MBpdf
125752_S52_M1_draft labeling text patient info clean.pdfpdfDecember 4, 2023911 KBpdf
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125752_S40_M1_rsp fda cmts info req37 16dec2021.pdfpdfDecember 4, 20231 MBpdf
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