Additional manufacturing site for COVID-19 Vaccine Janssen
EMA’s human medicines committee (CHMP) has approved an additional manufacturing site for the production of COVID-19 Vaccine Janssen, developed by Janssen-Cilag International NV.
The site, located in West Point, Pennsylvania in the United States, and operated by Merck Sharp & Dohme Corp, will manufacture finished product.
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 thus the site can become operational immediately.
EMA is in continuous dialogue with all marketing authorisation holders of COVID-19 vaccines as they seek to expand their production capacity for the supply of vaccines. The Agency provides guidance and advice on the evidence required to support and expedite applications to add new sites, or increase the capacity of existing sites for the manufacture of high-quality COVID-19 vaccines.