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The FDA's Center for Biologics Evaluation and Research (CBER) has sent an email to Pfizer regarding the Validation Report (VR-MVR-10077) for a vaccine. The email poses 11 questions and requests clarification on various aspects of the report, including:

1. The immunoassay used for assessing binding antibodies in Phase 2 and 3 studies.
2. Data for specificity analysis, including inhibition experiments.
3. Evaluation of assay robustness.
4. Information on the source, preparation, and titer assignment for reference standards and quality control samples.
5. Validation of the assay using incurred samples from vaccine trials.
6. Inclusion of the WHO SARS-CoV-2 International Antibody Standard.
7. Support for the proposed lower limit of quantitation (LLOQ).
8. Verification of numbers in Table 10 of the report.
9. Clarification on mean, standard deviation, and other statistical values.
10. Submission of data sets used for linearity and precision analyses.
11. Resubmission of Figure 4 in higher quality.

The email requests a response to confirm receipt and to address any questions or concerns.