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

Pharmaceutical Technology Editors

As a safety measure, supervisory authorities in the European Union have recommended not releasing batches of Janssen’s COVID-19 vaccine with API manufactured at Emergent BioSolutions’ Maryland facility.

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.

Source: EMA