EU Regulators Recommend Not Releasing Batches of Janssen COVID-19 Vaccine

The European Medicines Agency (EMA) announced on June 11, 2021 that supervisory authorities in the European Union have recommended not releasing batches of Janssen’s COVID-19 that contain API manufactured at Emergent BioSolution’s Maryland facility around the same time as a known contaminated batch. According to EMA, batches of the vaccine that have been released in the EU are not contaminated, and the recommendation is a precaution to safeguard supplies.

Vaccine production was suspended at Emergent’s Bayview, Md. facility in April 2021 after a manufacturing error caused loss of product and an FDA inspection found good manufacturing practice violations.

EMA stated in a press release that it is working with FDA and international partners to ensure the quality of COVID-19 vaccines.