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

SUBMITTER: Jo M 

PROVIDER: S-EPMC12412394 | biostudies-literature | 2025 Aug

REPOSITORIES: biostudies-literature