Document text
BNT162b2
2.7.1 Summary of Biopharmaceutic Studies and Associated Analytical Methods
CONFIDENTIAL
Page 12.7.1 SUMMARY OF BIO PHARMACEUTIC STUDIES AND ASSOCIATED
ANALYTICAL METHODS
090177e19671a370\Approved\Approved On: 17-Mar-2021 14:08 (GMT)
FDA-CBER-2021-5683-0142288
BNT162b2
2.7.1 Summary of Biopharmaceutic Studies and Associated Analytical Methods
CONFIDENTIAL
Page 2SUMMARY OF BIOPHARMACEUTIC STUDIES AND ASSOCIATED
ANALYTICAL METHODS
COVID -19 diagnostic and severe acute respiratory syndrome coronavirus 2 (SARS -CoV -2)
human serological assay s were utilized in support of the Phase 1 and 2/3 clinical evaluation
of BNT162b2 (BioNTech code number BNT162, Pfizer code number PF- 07302048) ,an
investigational vaccine intende d to prevent COVID -19, which is caused b y SARS -CoV -2.
Assay descriptions and summaries of the qualification or validation studies performed for
each assay method are included in Section 5.3.1.4 Reports of Bioanaly tical and Anal ytical
Methods for Human Studies or Section 5.3.5.1 Study Reports and Related Information of
Controlled Clinical Studies Pertinent to the Claimed Indication. Per communications with the
Center for Biologics Evaluation and Research, primary endpoint assay s used in the Phase 2/3
studies are validated; whereas assay s used for exploratory endpoints are qualified.
Table 1lists each bioanaly tical method, the location of its corresponding assay summary , and
the assay parameters, including limit of detection (LOD), the lower and upper range, and/or
the assay ’s lower limit of quantitation (LLOQ).
Table 1.Summary of Bioanalytical Methods for Human Studies
Bioanalytical Method Title and
Section
LocationAssay Param eters
LOD Lower
RangeUpper
RangeLLOQ
Cepheid Xpert®
Xpress SARS -CoV -2a5.3.1.4
VR-MVR -100800.01
FFU/mL N/A N/A N/A
Roche Elecsys
SARS -CoV- 2
N-Binding Antibody
Assaya5.3.1.4
VR-MVR -10081N/A N/A N/A N/A
Single -plex Direct
Luminex Assay for
Quantitation of SARS -
CoV- 2 S1-binding IgG
in Human Serumb5.3.1.4
VR-MQR -10211N/A 0.002533
U/mL well
concentration0.128000
U/mL well
concentration1.2665
Dilution adjusted
U/mL
Single -plex Direct
Luminex Assay for
Quantitation of SARS -
CoV- 2
RBD -binding IgG in
Human Serumb5.3.1.4
VR-MQR -10212N/A 0.002301
U/mL well
concentration0.128000
U/mL well
concentration1.1505
Dilution adjusted
U/mL
090177e19671a370\Approved\Approved On: 17-Mar-2021 14:08 (GMT)
FDA-CBER-2021-5683-0142289
BNT162b2
2.7.1 Summary of Biopharmaceutic Studies and Associated Analytical Methods
CONFIDENTIAL
Page 3Table 1.Summary of Bioanalytical Methods for Human Studies
Bioanalytical Method Title and
Section
LocationAssay Param eters
LOD Lower
RangeUpper
RangeLLOQ
mNeonGreen
SARS -CoV- 2
Microneutralization
Assayb5.3.1.4
VR-MQR -1021420 N/A N/A N/A
mNeonGreen SARS -
CoV- 2
Microneutralization
Assaya,c5.3.1.4
VR-MVR -1008320 41 3187 41
ELISpot Assayb5.3.5.1
BNT 162 -01,
Appendix
16.1.14
R-20-0244N/A N/A N/A N/A
5.3.5.1
BNT 16 2-01,
Appendix
16.1.14
GA-RB-022-
01AN/A N/A N/A N/A
Intracellular Cytokine
Staining (ICS) for
BNT162b1b5.3.5.1
BNT 162 -01,
Appendix
16.1.14
R-20-0235N/A N/A N/A N/A
Intracellular Cytokine
Staining (ICS) for
BNT162b2b5.3.5.1
BNT 162 -01,
Appendix
16.1.14
R-20-0241N/A N/A N/A N/A
a. Validation performed on method
b. Qualification performed on method
c.NT50 ranges shown.
Abbreviations: FFU = focus forming units; ICS = intracellular cytokine staining; LOD = limit of detection;
LLOQ = lower limit of quantitation; N/A = not applicable; NT = neutralizing titer; U = units
090177e19671a370\Approved\Approved On: 17-Mar-2021 14:08 (GMT)
FDA-CBER-2021-5683-0142290