EMA Approves Manufacturing Site for Janssen COVID-19 Vaccine

The European Medicines Agency (EMA) announced on Oct. 7, 2021 that its Committee for Medicinal Products for Human Use (CHMP) has approved a manufacturing site operated by Merck Sharp & Dohme for the production of Janssen’s COVID-19 vaccine. The site is located in West Point, Pa. in the United States and will manufacture finished product to support supply to the European Union.

Because CHMP’s recommendation does not require a decision from the European Commission, 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,” the agency stated in a press release.