Explo-CRD-004: early HZ/su safety and cellular immunity Locked Explo-CRD-004: early HZ/su safety and cellular immunity
Zoster-003: gE antigen dose selection Locked Zoster-003: gE antigen dose selection P
Zoster-010: AS01 adjuvant dose selection Locked Zoster-010: AS01 adjuvant dose selection P
Zoster-001: early autoHCT safety/immunogenicity and schedule selection Locked Zoster-001: early autoHCT safety/immunogenicity and schedule selection
Zoster-006 (ZOE-50): pivotal HZ efficacy in adults ≥50 Locked Zoster-006 (ZOE-50): pivotal HZ efficacy in adults ≥50
Zoster-022 (ZOE-70): pivotal HZ efficacy in adults ≥70 Locked Zoster-022 (ZOE-70): pivotal HZ efficacy in adults ≥70
Zoster-015: HIV safety and immunogenicity Locked Zoster-015: HIV safety and immunogenicity
Zoster-002 (ZOE-HSCT): pivotal IC efficacy after autoHCT Locked Zoster-002 (ZOE-HSCT): pivotal IC efficacy after autoHCT
Zoster-039: hematologic malignancy safety/immunogenicity and post hoc efficacy Locked Zoster-039: hematologic malignancy safety/immunogenicity and post hoc efficacy P P
Zoster-028: solid tumors receiving chemotherapy Locked Zoster-028: solid tumors receiving chemotherapy
Zoster-026: dosing-interval study Locked Zoster-026: dosing-interval study
Zoster-004: concomitant influenza vaccination Locked Zoster-004: concomitant influenza vaccination
Zoster-041: renal transplant recipients Locked Zoster-041: renal transplant recipients
Zoster-007: lot-to-lot consistency Locked Zoster-007: lot-to-lot consistency
IND 13857: healthy older-adult HZ/su program Locked
IND 13879: immunocompromised-adult HZ/su program Locked
Initial Pediatric Study Plan Locked Initial Pediatric Study Plan
PeRC supports pediatric full waiver Locked
FDA multidisciplinary review of original BLA Locked FDA multidisciplinary review of original BLA
Original BLA 125614/0 Locked Original BLA 125614/0
FDA IR/clarification: ISS narrative, ISE datasets and SAE narratives Locked
FDA IR: endotoxin-test recalculation Locked
FDA IR: Statistical Analysis Plans for five clinical studies Locked
FDA IR follow-up: resubmission of SAP revisions and final versions Locked
FDA IR: clinical, BIMO and assay-SOP issues Locked
FDA IR: clinical study conduct, disposition and demographics Locked
FDA IR: clinical assay cross-references and HAI validation Locked
FDA IR: pivotal efficacy, safety and statistical analyses Locked
FDA IR: secondary efficacy analyses and SAS code Locked
FDA IR: manufacturing and quality controls Locked
FDA IR: Shingrix in-use stability after reconstitution Locked
FDA IR: container closure and leachables Locked
FDA IR: pharmacovigilance plan and Zoster-022 ALS case Locked
FDA IR: safety results across AS01B-containing products Locked
FDA IR: DBSQC validation reports Locked
FDA IR follow-up: expand AS01 safety review beyond AS01B Locked
FDA IR: pIMD classification discrepancy for Zoster-022 eczema SAE Locked
FDA IR: microbial retention and cleaning validation Locked
FDA IR: quality-control assay validation and system suitability Locked
FDA IR: optic ischaemic neuropathy reporting discrepancy Locked
FDA IR: overall demographic safety totals Locked
FDA IR: process-related impurities Locked
FDA IR: Zoster-033 neuralgia adverse-event narratives Locked
FDA IR: certificate of analysis for QS-21 manufacturing material Locked
FDA IR: DBSQC validation data Locked
FDA IR: gE potency-ratio calculation Locked
VRBPAC recommendation Locked
FDA IR: post-licensure Targeted Safety Study design Locked
FDA approval: SHINGRIX original BLA Locked
Efficacy sBLA 125614/398: immunocompromised adults Locked Efficacy sBLA 125614/398: immunocompromised adults
FDA multidisciplinary review of sBLA 125614/398 Locked FDA multidisciplinary review of sBLA 125614/398
FDA approval: GBS safety labeling supplement Locked
PeRC supports pediatric waiver for new regimen Locked
FDA approval: immunocompromised-adult indication expansion Locked
Pre-IND meeting: U.S. development strategy Locked
Type C meeting: pivotal statistical strategy Locked
Type B EOP2 meeting: pivotal Phase 3 program Locked
EOP2 teleconference: autoHCT Phase 3 plan Locked
Type C meeting: Zoster-039 hematologic malignancy study Locked
Type B EOP2 request: HIV Phase 3 plan (withdrawn) Locked Type B EOP2 request: HIV Phase 3 plan (withdrawn)
Type C meeting: immunocompromised interim data and labeling Locked
Type C meeting: clinical assays and correlate-of-protection strategy Locked
Type B pre-BLA: clinical package and labeling Locked
Type B pre-BLA: CMC readiness Locked
Type C meeting: immunocompromised indication expansion and CoP Locked
Pre-BLA meeting: immunocompromised indication supplement Locked
Prevent herpes zoster with a non-live adjuvanted recombinant vaccine Locked
Separate PHN-prevention indication not independently supported Locked
Fallback label: prevention of HZ without separate PHN indication Locked
Original U.S. indication: prevention of HZ in adults ≥50 Locked
Original dosing: two IM doses, second dose 2–6 months later Locked
Original BLA nonclinical package Locked
VRBPAC unanimously supported licensure Locked
Original approval postmarketing commitments Locked
Anti-gE antibody was not a validated correlate of protection Locked
Expanded indication: IC adults ≥18 at increased HZ risk Locked
Full-human-dose AS01B rabbit DART study Locked
IC dosing option: second dose 1–2 months after first Locked
IC heterogeneity and limited population-specific safety data Locked
Postmarketing Guillain-Barré syndrome signal and labeling update Locked
Integrated evidence supported broad immunocompromised-adult indication Locked
Pregnancy postmarketing commitment: EPI-ZOSTER-039 VS Locked
Pregnancy safety data gap after IC expansion Locked
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