Increased manufacturing capacity for COVID-19 Vaccine Janssen

EMA’s committee for human medicines (CHMP) has approved a scale-up of the active substance manufacturing process at Janssen Biologics B.V. The plant, which is located in Leiden, the Netherlands, produces all active substance for the manufacture of the EU supply of COVID-19 Vaccine Janssen, the COVID-19 vaccine developed by Janssen-Cilag International NV.

The approved modifications to the Janssen Biologics B.V. facility include a newly constructed building, new equipment and the introduction of additional process optimizations. This will enable an increase of the active substance manufacturing capacity and frequency.

The site is expected to support the continued supply of COVID-19 Vaccine Janssen in the European Union.

This recommendation does not require a European Commission decision and the new building can become operational immediately.