Vaccine lmmunogenicity & the Validation of a Pseudovirus Neutralization Assay in Emerging SARS-CoV-2 Variants

The purpose of my project was to develop and validate a SARS-CoV-2 pseudovirus neutralization assay in various emerging strains of SA RS-CoV-2. The assay allows Novavax to test the immunogenicity of their COVfD-19 vaccine against different variants of the virus by means of quantifying neutralizing antibody response. The SARS-CoV-2 pseudovirus neutralization assay is unique in that it can be run in a BSL-2 environment in contrast to the BSL-3 requirement of comparable live virus neutralization assays. A small part of the goal of this project was to compare different immunological assays used to test vaccine efficacy, most notably those which are validated at Novavax. Further, a primary objective was to demonstrate the process of validating an assay and describe the different parameters and acceptance criteria the assay must meet to be considered validated, and what “validation” really signifies.