The U.S. Department of Health and Human Services plans to end the federal COVID-19 Public Health Emergency on May 11, but ensuring access to novel vaccines to meet future needs continues to be imperative. The COVID-19 pandemic showed that in the case of another global health emergency, multi-stakeholder collaboration, knowledge transfer, technical assistance, and partnerships with global health agencies are crucial to facilitating manufacture, supply, and access to quality assured vaccines. As new SARS-CoV-2 and influenza strains emerge, pharmaceutical manufacturers need to be prepared to develop innovative vaccines and treatments in an accelerated timeline.

"We are using the learnings from the COVID-19 pandemic to expand our work to support the development, production and supply of quality vaccines," said Jaap Venema, Chief Science Officer for the U.S. Pharmacopeia (USP). "Through our work with USP's independent expert volunteers and collaborations with industry and regulatory stakeholders, we are developing and facilitating adoption of technical and scientific methods, standards and best practices and thereby promote the supply of innovative treatments in support of public health."

As new vaccines are developed to address emerging needs, USP is focused on applying lessons learned from this experience to solve shared challenges related to vaccine quality, equity and access. The organization is focusing its attention on three key areas:

• Common analytical methods for assessing the quality of biologics: mRNA and viral vector-based platforms have risen to the surface as promising solutions for addressing future pandemics. However, the global capacity to develop, manufacture, distribute, regulate, and ensure quality of these innovative products is limited. A set of common methods for assessing and monitoring the quality of biologics will help developers and manufacturers focus their attention and resources on optimizing the successful application of these technologies. To address this need, USP developed tools for the assessment of quality to support vaccine manufacturers by creating shared understanding and building the analytical and regulatory capabilities that are critical for advancing adoption of new vaccine technologies.

• Country-level technical assistance and capacity building for vaccine manufacturers: Increased technical understanding and strong global health regulatory capabilities are critical for improving access to vaccines. However, many countries lack resources, know-how and a regulatory framework that allows public health officials to prepare for new and emerging viral interventions. USP released the quality assessments toolkits to help nations build a framework that adheres to quality standards for COVID-19 vaccines, ensures resources and training, and strengthens surveillance systems. USP is also strengthening regulatory, laboratory, and manufacturing capabilities in low- and middle-income countries (LMICs) through its Global Health Programs, including Promoting the Quality of Medicines Plus, and partnerships in LMICs.

• Optimization of vaccines development and administration: During the COVID-19 pandemic, USP established vital working relationships with U.S. government agencies, task forces, healthcare practitioners and a panel of USP volunteers to maximize the limited supplies of the COVID-19 vaccine. By conducting dose maximization studies that were validated through collaborative testing with local health systems and working with syringe/needle supply parameters specified by the U.S. Centers for Disease Control and Prevention, USP was able to identify optimal needle/syringe combinations that could maximize vaccine volume in the preparation stage of COVID-19 vaccine vials. USP aims to leverage the findings from these studies to inform a vaccine program with national and international partners with the intent to maximize the available dosages of vaccines of trusted, quality vaccines. Finally, identifying supply chain vulnerabilities and related risks that may lead to substandard or falsified medical products from shipping of vaccines to administration helped increase available doses and accelerate the pace of vaccination.

"The vaccine and treatment landscape continues to evolve as new medicines come onto the market, offering more solutions," said Fouad Atouf, Senior Vice President, Global Biologics at USP. "The landscape is complex, and trust in vaccines is paramount to protecting public health. We need to leverage technology to stay ahead of emerging threats and ensure quality medicines are at the core of our response."

Building trust in vaccines requires collaboration across the supply chain starting with developers and manufacturers to regulators and practitioners. USP will continue to provide standards and tools that help ensure the quality and safety of drug and vaccine ingredients and finished products.