mRNA Vaccines for Rapid and Adaptable Pandemic Response

The recent emergence of the Omicron variant highlights the necessity of pandemic responses which can be rapidly adapted to changing needs. mRNA technology is uniquely suited to meet this urgent need both by virtue of the high degree of characterization attainable and the potential for sequence-agnostic manufacturing. Moderna has established a vaccine technology platform by combining established methods for vaccine process development based on Quality by Design (QbD) with advanced process control strategy and analytical characterization methods. Once a product is initially developed, the technology can be readily adapted to respond to variants. The strategy will be illustrated with examples from the development of mRNA-1273 and follow-on products addressing variants.