EDQM publishes document to support COVID-19 recombinant viral vectored vaccine development
The EDQM notes the rapid development of newer technologies – such as recombinant viral vectored vaccines – and says only limited guidance has been available for these thus far.
Released today, the new text – ‘Recombinant viral vectored vaccines for human use’ - covers both replication-competent and replication-defective viral vectored vaccines.
The document provides a series of analytical strategy options for the control of recombinant viral vectored vaccines. It includes recommendations on tests that may be conducted at different manufacturing stages of viral vectored vaccines and can be used by COVID-19 vaccine developers as an aid in building appropriate analytical strategies during the development of their candidate vaccines.
The guidance has been put together by the EDQM with experts from the European Pharmacopoeia Commission, who come from licensing authorities, control laboratories, academia and industry across Europe, the US, Canada and Australia.
While the document is written in the context of COVID-19, the principles can also be applied to other recombinant viral vectored vaccines.
The document is not an official binding text; but rather will be updated to adapt to the evolving situation or reflect new learnings as development of vaccine candidates progresses. As such, stakeholders are invited to give their feedback on the document with relevant comments and data.
The EDQM’s role is to protect public health by enabling the development, supporting implementation, and monitoring application of quality standards for safe medicines and their safe use. The standards it sets are recognised scientific benchmarks and are applied in Europe as well as beyond.