Discover how integrated bioanalytical testing supported the clinical development of the mRNA-1273 COVID-19 vaccine.

The rapid development of COVID-19 vaccines required scalable, high-quality testing to support global clinical trials. This case study highlights the bioanalytical strategies used to support the Moderna mRNA-1273 clinical program, including assay development, molecular testing, sequencing, and high-throughput laboratory operations.

Key highlights include:

• Development and validation of a sensitive RT-qPCR assay to support the mRNA-1273 clinical program
• Execution of more than 85,000 tests across a Phase III trial involving more than 30,000 participants
• Quantitative viral load testing using nasopharyngeal swab and saliva specimens
• Spike gene and whole genome sequencing to monitor SARS-CoV-2 variants
• Multiplex respiratory pathogen testing to differentiate viral and bacterial respiratory infections
• High-throughput laboratory operations to support large-scale clinical trial testing during the COVID-19 pandemic

This case study demonstrates how integrated bioanalytical capabilities, scalable laboratory operations, and advanced molecular testing supported one of the largest vaccine clinical programs during a global public health emergency.