The pandemic caused an unprecedented surge in demand for the development of vaccines that could control the spread of COVID-19 using diverse technologies. To continue to build public trust and confidence in these innovative products we need to ensure they are of good quality, safe and effective. As regulatory guidelines and industry standards for these new technologies continue to evolve, ensuring the quality of vaccines for COVID-19 as well as other new therapies based on these technologies through development, manufacturing, packaging, transportation, and administration will be critical to increasing access and building trust.

As new COVID-19 vaccines were developed and distributed, USP made widely available any existing public quality standards that applied to the vaccines in production, providing benchmarks to ensure that medicine quality remained consistent from manufacturing through administration. USP also looked for new ways to create a shared understanding of what quality looked like, with the goals of accelerating product development, guiding successful scale-up of manufacturing and fueling regulatory confidence.

vaccine infographic

USP continues to build on this work to support manufacturers as they develop these vaccines and other new modalities to solve public health needs. In collaboration with scientific experts from the academic, industry, healthcare practitioner and regulatory communities, USP is finding ways to help solve some of the most critical and challenging problems in the industry and strengthen the supply chain of quality medicines, ultimately ensuring patients have access to the medicines that they need.

USP Standards in Support of the Manufacturing and Distribution of Quality Vaccines

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