The issue of substandard and falsified (SF) COVID-19 vaccines will likely remain a global problem for many years to come, as the world continues to work toward immunization of the global population and as boosters are needed to counter variants as they emerge. While the WHO advises that vaccines procured from assured sources should not tested again by receiving countries as they have been tested and released already by NRAs, individual countries or manufacturers may have need to develop their own laboratory capacity for testing of COVID-19 vaccines.
To support laboratories that need to develop and validate assays for assessment of quality attributes of vaccines, USP has created toolkits that can help navigate USP’s documentary standards to support these assessments. These toolkits are organized based on the various COVID-19 vaccine platforms currently in use for authorized COVID-19 vaccines. The Vaccine Quality Attributes Toolkits include common quality tests, standards and other information to support development and validation of analytical tests commonly used to ensure quality of vaccines. These toolkits can help reduce risks from substandard and falsified vaccines, and, ultimately, increase public trust.