Janssen COVID-19 Vaccine EUA FDA Review Memorandum
Emergency Use Authorization (EUA) for an Unapproved Product Review Memorandum Identifying Information Application Type EUA (Event-driven EUA request) Application Number 27205 Sponsor Janssen Biotech, Inc. Submission Date February 4, 2021 Receipt Date February 4, 2021 Signatory Authority Marion F. Gruber, Ph.D., Director, CBER/OVRR Principal Discipline Reviewers Sudhakar Agnihothram, Ph.D., Committee chair, OVRR/DVRPA; from the Review Team Bharat Khurana, DVM, Ph.D., MBA, Regulatory Project Manager, OVRR/DVRPA; Rachel Zhang, M.D., Clinical reviewer, OVRR/DVRPA; Yosefa Hefter, M.D., Clinical reviewer, OVRR/DVRPA; Claudia Wrzesinski, Ph.D., Toxicology reviewer, OVRR/DVRPA; Ye Yang, Ph.D., Biostatistics reviewer, OBE/DB; Lei Huang, Ph.D., Biostatistics reviewer, OBE/DB; Marian Major, Ph.D., CMC/Product reviewer, OVRR/DVP; Alla Kachko, Ph.D., CMC/Product reviewer, OVRR/DVP; Pankaj (Pete) Amin, B.S., CMC/Facility reviewer; OCBQ/DMPQ; Holly Brevig, Ph.D., CMC/Facility reviewer; OCBQ/DMPQ; Jane Woo, M.D., Pharmacovigilance reviewer, OBE/DE; Brenda Baldwin, Ph.D., Data Integrity reviewer, OVRR/DVRPA; Haecin Chun, M.S., BIMO reviewer, OCBQ/DIS/BMB; Bhanu Kannan, M.S., BIMO reviewer, OCBQ/DIS/BMB; Oluchi Elekwachi, Pharm.D., MPH, Labeling reviewer, OCBQ/DCM/APLB Review Completion Date February 27, 2021 Established Name/Other names Janssen COVID-19 vaccine (Ad26.COV2.S) used during development Dosage Forms/Strengths and A 0.5 mL suspension administered as a single intramuscular Route of Administration injection at the dose level of 5×1010 virus particles (vp) Intended Use for EUA Active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Intended Population Individuals 18 years of age and older Janssen Ad26.COV2.S (COVID-19) Vaccine VRBPAC Briefing Document Table of Contents List of Tables ................................................................................................................................
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