BRIEF—Increased manufacturing capacity for COVID-19 Vaccine Janssen

The European Medicine Agency’s committee for human medicines CHMP has approved a scale-up of the active substance manufacturing process at Janssen Biologics BV.

The plant, which is located in Leiden, the Netherlands, produces all active substances for the manufacture of the European Union supply of COVID-19 Vaccine Janssen, the COVID-19 vaccine developed by Janssen-Cilag International, a unit of Johnson & Johnson.

The approved modifications to the Janssen Biologics 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 EU.

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