VAXNEUVANCE Development and Commercialization Team
For seamless, reactive, and resilient teamwork; for managing steep technical challenges while meeting critical deadlines; and for bringing a new, lifesaving vaccine to a global population.
VAXNEUVANCE is a vaccine intended to prevent invasive pneumococcal disease caused by any of 15 strains of pneumococcal bacteria. VAXNEUVANCE received its first regulatory approval from the U.S. Food and Drug Administration in 2021 for use in adults and in 2022 for use in infants and children.
The VAXNEUVANCE Development and Commercialization Team (DCT) was a cross-functional team spanning Merck’s research, manufacturing, and marketing divisions. The team was responsible for the late-stage product development, process development, technology transfer to manufacturing, and regulatory approvals in major worldwide markets. The DCT innovated to meet the global challenges, often turning distances into strengths by efficiently and effectively collaborating across time zones.
The team consisted of approximately 40% to 60% women engineers, including leadership from two United States-based, women-identifying leads: Jessica Sinacola (serving from 2016 to 2020) and Tracie Spangler (serving from 2020 to 2022). In Ireland, Matt Maher served as co-lead during a time of significant technology transfer to European-based manufacturing sites in 2017-2018.
The DCT also employed subject matter experts leading work streams in project management, regulatory sciences, analytics, process development, and manufacturing sites for intermediates (i.e., raw materials), drug substance, drug product, combination product, and packaging. Most team members were based in the United States and Ireland, with others representing sites in Japan, Italy, and the Netherlands.
VAXNEUVANCE is a complex vaccine with multiple manufacturing steps. Each step faced technical challenges requiring collaboration across geographical and functional groups. Team members had to respond quickly with innovative solutions to implement changes and updates while meeting key milestones from process development through filing and subsequent launch.
In some cases, technical challenges arose when moving from laboratory scale to manufacturing scale. For example, mixing speed was demonstrated to be critical at a particular process step. The team collaborated with subject matter experts for that step to design novel equipment to ensure the required rate of mixing could be achieved at large scale. This novel equipment received a U.S. patent.
Key achievements of the VAXNEUVANCE Development and Commercialization Team included manufacturing of materials to support phase-three clinical trials, process development, technology transfer, and process demonstration of new intermediates, drug substance and drug product, and packaging. The team’s success was demonstrated by reliable, robust production of a high-quality vaccine.
Close collaboration among global colleagues included strong in-person engagement across technical and operational teams. This enabled innovation and resilience in the face of challenges, resulting in the successful completion of all planned conjugation manufacturing batches. The vaccine stands as a milestone that will improve the health of babies, children, and adults worldwide.