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FDA CBER 2022 1614 1860645 1981508_125752_S27_M5_mrna 1273 p301_S_facezipOctober 1, 202467 MBzip
FDA CBER 2022 1614 1841554 1860644_125752_S3_M5_mrna 1273 p301_S_cezipOctober 1, 202411 MBzip
FDA CBER 2022 1614 1796059 1841553_125752_S3_M5_mrna 1273 p301_A_D_adar1zipOctober 1, 202453 MBzip
FDA CBER 2022 1614 1795911 1795927_125752_S24_M1_annotated draft spikevax labeling textdocxOctober 1, 2024114 KBdocx
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125752_S37_M1_draft labeling text patient info redlinepdfOctober 1, 20241 MBpdf
125752_S35_M1_annotated draft spikevax labeling textpdfOctober 1, 20241,018 KBpdf
FDA CBER 2022 1614 1796024 1796040_125752_S48_M1_draft labeling text patient info redlinedocxOctober 1, 2024114 KBdocx
FDA CBER 2022 1614 1795988 1796004_125752_S43_M1_draft labeling text patient info redlinedocxOctober 1, 2024113 KBdocx
FDA CBER 2022 1614 1795981 1795983_125752_S37_M1_draft labeling text patient info redlinedocxOctober 1, 202432 KBdocx
FDA CBER 2022 1614 1795945 1795961_125752_S35_M1_annotated draft spikevax labeling textdocxOctober 1, 2024118 KBdocx
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125752_S3_M5_5314_vsdvac 66 vs adden1 antigen 01pdfOctober 1, 20241 MBpdf
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125752_S3_M5_5314_vsdvac 58 elisa qual rptpdfOctober 1, 2024996 KBpdf
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125752_S3_M5_5314_r1024 reportpdfOctober 1, 202430 MBpdf
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125752_S3_M5_5314_sop 5525pdfOctober 1, 202458 MBpdf
125752_S3_M5_5314_duke 02 mvr covid0002 v1 val reportpdfOctober 1, 20242 MBpdf
125752_S3_M5_5314_duke 02 mvr covid0001 v1 1 val reportpdfOctober 1, 2024913 KBpdf
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125752_S3_M5_5314_clin pharm summ biomarker assayspdfOctober 1, 20241 MBpdf
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125752_S3_M2_27_synopses-indiv-studies.pdfpdfSeptember 3, 2024673 KBpdf
FDA-CBER-2022-1614-1567605-1600616_125752_S3_M5_mrna-1273-p301_S_relrec.zipzipSeptember 3, 20244 MBzip
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FDA-CBER-2022-1614-1411137-1492214_125752_S3_M5_mrna-1273-p301_A_D_adar2.zipzipSeptember 3, 2024zip
125752_S24_M1_annotated draft spikevax labeling textpdfSeptember 1, 20245 MBpdf
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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
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