Europe – Euro Regulatory Roundup

The European Directorate for the Quality of Medicines (EDQM) has published advice on developing COVID-19 vaccines using viral vector platforms. The text covers analytical strategies for recombinant viral vectored vaccines such as AstraZeneca’s AZD1222 and Johnson & Johnson’s JNJ-78436735 (also known as Ad26.COV2.S).

Viral vectored vaccines are a relatively unproven and untested modality. Yet, the need to act quickly in response to the coronavirus outbreak means viral vectored vaccines are among the most advanced COVID-19 prophylactics. The prospect of an emerging modality being used in hundreds of millions of people has created a need for guidance on ensuring safety, performance and quality.

EDQM has responded with a document detailing the tests manufacturers can perform at each step of the production process. For example, EDQM suggests testing to confirm the absence of viruses that can replicate when producing replication-deficient vaccines. EDQM proposes running different tests at the seed lot, propagation, harvest, final bulk and final lot stages…