28L BLA 125742 0 07 20 2021 Memo Review
Document text
Data Fitness Findings Report IND27034 BioNTech SE and Pfizer , April 2021 Findings Notes C4591001 EUA Amendment (12 -15 Years of Age) Title: A Phase 1/2/3 Study to Evaluate the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID - 19 in Healthy Individuals. Document / Standard Version Notes annotated CRF Seems fine SDTM Implementation Guide SDTM -IG v3.2 SDTM Controlled Terminology 2020-03-27 SDTM define.xml V2.0 Seems fine Medications Dictionary WHODD GLOBALV3Mar20, WHO DDE v202003 Medical Events Dictionary (MedDRA) V23.1 SDTM Reviewer’s Guide PhUSE template Seems fine FDA-CBER-2021-5683-1066331 Data Issues Adverse event marked as AEREL = RELATED, but subject didn’t receive dose yet • USUBJID = C4591001 1226 12261520, AETERM = Pain at injection site , AESTDTC = 2020- 09-02T21:00 o 2 EX records: EXSTDTC = 2020- 09-03T15:06:00 and 2020- 09-22T10:22:00 Subjects have AE records with AEACN = DRUG WITHDRAWN but no ADVERSE EVENT record in DS • 20 subjects – see report “ IND27034 - 12-15years - AEACN of DRUG WITHDRAWN but no DS ADVERSE EVENT record.xlsx ” Value for CEHLGT n ot found in MedDRA dictionary • 1 record (0%) • cSDRG explanation: “Manually coded as "Virus infectious disorders". ” • The correct value per the MedDRA dictionary is: Viral infectious disorders Inconsistent coding of MHTERM mhterm mhdecod mhhlt mhhlgt mhbodsys STUDYID count_of _mhs meddrav SKIN CANCER SKIN CANCER SKIN NEOPLASMS MALIGNANT AND UNSPECIFIED (EXCL MELANOMA) SKIN NEOPLASMS MALIGNANT AND UNSPECIFIED NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) C4591001 2 23.1 SKIN CANCER SKIN NEOPLASM EXCISION SKIN LESION EXCISIONS SKIN AND SUBCUTANEOUS TISSUE THERAPEUTIC PROCEDURES SURGICAL AND MEDICAL PROCEDURES C4591001 1 23.1 FDA-CBER-2021-5683-1066332