// May 21, 2024

Quality is a foundation for global vaccine preparedness

vaccine preparedness

The emergence of COVID-19 almost five years ago forced us all to face the realities of containing and mitigating a highly transmissible, deadly pandemic. With the lessons learned from that global health crisis, we share responsibility for building a world better prepared and protected against future biological threats.

Toward this goal, the 2024 World Vaccine Congress opened with a day-long Biodefense & Preparedness workshop, led by Dr. Matthew Hepburn and Nikki Romanik (White House Office of Pandemic Preparedness and Response Policy), along with Dr. Bassam Hallis (UK Health Security Agency). Each session throughout the day featured experts from various disciplines, brought together to discuss the latest research in pandemic preparedness. I was honored to speak on the panel titled, “Innovation in Vaccine Manufacturing”, moderated by James Coburn (FDA) and including Dr. Mike Stebbins of the CBRN Defense Consortium and Dr. Chris Earnhart from JPEO-CBRND (Department of Defense).

The panelists aligned on several themes during the discussion. Globally, our health care readiness is not where it needs to be, but it is improving. Post-COVID momentum is at risk of waning without sustained governmental funding, while the private sector faces insufficient financial incentives for coordinated action. Speakers throughout the day praised the Coalition for Epidemic Preparedness Innovations (CEPI) 100 Days Mission. CEPI and the global health leaders who support this mission aim to accelerate the development of safe, effective, globally accessible vaccines within a timeframe of just over three months from threat recognition to a vaccine being ready for initial authorization and manufacturing at scale.

The panelists agreed on the core challenge in achieving the 100 Days goal: how do we build quality, standardization, and predictability into our vaccine manufacturing process in a way that enables rapid response and scalability, when needed?

As a standard-setting organization, USP plays a critical role in this pursuit by supporting the quality of new modalities and medicines. By building consensus on best practices and providing standards, tools, and training, USP helps to advance quality assessment of both new and existing vaccine modalities. Quality standards and standardized methods and processes provide the baseline for consistency, predictability, and scalability in vaccine manufacturing to help meet the most ambitious timelines.

Emerging platforms require new thinking (see, for example, USP’s latest mRNA draft guidelines) around how we assess and assure vaccine quality. Since the successful application of mRNA technology is relatively new, regulatory guidelines and industry standards are still evolving. Building consensus on best practices and standardized analytical methods for assessing mRNA quality can support developers, manufacturers, regulatory agencies, and national control laboratories.

New technologies, processes and modalities may also require different supply chain approaches, from qualification of raw materials to transportation and storage conditions. By building consensus on quality requirements as a foundation for the vaccine supply chain, product developers and regulators can more seamlessly bring online new or alternative manufacturing partners when scale or redundancy is needed.

The best time to build consensus on establishing and maintaining quality is before we need it. As a standard-setting public health organization and member of the Biopharmaceutical Manufacturing Preparedness Consortium (BioMaP-Consortium), USP stands ready to help advance global biomanufacturing preparedness and resilience. We invite you to email us at FederalPractice@usp.org, or to visit our Federal Government Solutions page, to learn more about our work to help foster supply chain resiliency, improve health equity and patient safety, and sustainably deploy advanced manufacturing and quality testing processes.