November 3, 2020 -- The European Directorate for the Quality of Medicines & Healthcare (EDQM) of the Council of Europe issued a new document on the use of recombinant viral vectored vaccines to support COVID-19 vaccine developers.
The document provides analytical strategy options for the control of recombinant viral vectored vaccines, including suggested tests that should be conducted at each stage in the manufacturing process. The work was accomplished in collaboration with the European Pharmacopoeia Group of Experts on vaccines for human use (Group 15), which is composed of experts from licensing authorities, national control laboratories, academia, and industry in Europe and beyond.
The text was drafted based on knowledge from regulatory documents issued by the European Pharmacopoeia, the European Medicines Agency, the U.S. Food and Drug Administration, and the World Health Organization. The guidance within the document can also be used for other recombinant viral vectored vaccines.
The organization intends to update the document to adapt to the evolving situation and to take into account new constructs or products.
EDQM is an organization that protects public health by enabling the development, supporting the implementation, and monitoring the application of quality standards for safe medicines and their safe use.