Emergent Manufacturing Operations Baltimore LLC — EU GMP NCR (EudraGMDP) Findings

The site fails to demonstrate full control of the manufacturing process of Janssen’s viral vector drug substance with repeated contamination issues as well as a history of cross contamination with another viral vector vaccine drug substance. After 14 batches manufactured (7 of which were terminated), the site has failed to provide 3 successful consecutive PPQ batches. In light of the recent contamination issues (notified on the 7th of February and updated on the 18th of March 2022) and the unsuccessful PPQ runs, it is concluded that the site has failed to demonstrate consistent production of viral vector vaccine drug substance in accordance to the EU GMP requirements and that contamination issues are still present and are not under control which presents a risk to the quality of the vaccines and public health. Action taken/proposed by the NCA: Recall of batches already released Consideration for recall of vaccines produced with drug substance originating from the Emergent facility Prohibition of supply No further supplies of Janssen’s COVID vaccine’s drug substance should be allowed in the Union