Development of an identity test for COVID-19 mRNA vaccines using SARS-CoV-2 NAT standard

Abstract

Despite the development of messenger ribonucleic acid (mRNA) vaccines for the infectious novel coronavirus 2 (SARS-CoV-2), further research on test methods is required to ensure their quality as well as rapid and effective approval for release to the market. During the current national lot release testing, identity tests cannot be conducted on other products using primers, probes, and in-house reference materials provided by the manufacturer and specific to one vaccine, because their sequences do not match. When key reagents and reference materials are dependent on the manufacturer in this way, difficulties in national lot release approval—which serves as an additional step for the government to verify product quality—arise if the manufacturer does not provide them. In this study, we aimed to develop a quantitative polymerase chain reaction (qPCR) assay by using commercially available nucleic acid amplification test (NAT) reference material and a dye instead of a probe along with primers that were newly designed in this study. It can be applied to both vaccines. This study suggests a test method that can be applied when the in-house reference standard for the identity test, a major step to confirm the quality of vaccines, is not secured.