As COVID-19 vaccines become available globally, it is important for countries to put measures in place to help ensure the quality of the vaccine products being used in their countries, especially those procured outside of authorized vaccine programs. There are a growing number of reports of substandard or falsified (SF) COVID-19 medical products.
The WHO recommends that countries accept vaccines received directly through COVAX without the need for additional testing, As the pandemic continues, however, there will be other avenues for vaccines acquisition, and it is advisable to perform some in-country testing on these vaccines to ensure their quality. For some countries receiving vaccines, there may be additional local requirements for testing. Although some countries are taking measures to control the entry of SF COVID-19 vaccine products, more work needs to be done.
Quality Assessment Toolkits for COVID-19 Vaccines
United States Pharmacopeia (USP) has documentary resources, (official chapters) contained in the United States Pharmacopeia-National Formulary (USP-NF), to support the development and validation of analytical tests for release of vaccine products. These resources have been categorized into four toolkits to support the assessment of COVID-19 vaccine product quality and facilitate the supply of and access to quality-assured COVID-19 vaccines. These resources are important tools that can be used by countries to develop and validate analytical tests to safeguard their populations. As part of these toolkits, USP will offer complimentary access to the select USP-NF chapters that support the toolkits. The four toolkits currently available include General Vaccine Chapters and Compendial Assays; mRNA Vaccines; Viral Vector Vaccines; and Inactivated Vaccines.
Upon completion of this course, you will be able to:
- Understand what is included on the USP COVID-19 Quality Assessment Toolkits
- Understand the quality attributes for COVID-19 vaccine products and common tests used to ensure their quality.
- Know where to access and download the toolkit on the USP website.
- Know how to access the USP-NF using the complimentary subscription.
Who should participate:
- National regulatory authority staff
- National control laboratory staff
- Vaccine manufacturing quality control and assurance staff
- Analytical laboratory scientists