Moderna’s UK manufacturing facility receives license from MHRA to produce mRNA vaccines
Vaccine maker Moderna has received a Manufacturer’s/Importer’s Authorization (MIA) from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for its manufacturing facility in Harwell, Oxfordshire, the Moderna Innovation and Technology Center (MITC).
The license allows Moderna to move forward with commercial mRNA vaccine production in the UK, pending standard regulatory approvals. The company said the milestone “marks a pivotal step toward producing mRNA vaccines in the UK in 2025.”
The authorization follows a successful inspection confirming the site’s compliance with Good Manufacturing Practice. Moderna says the facility is now fully operational and represents a step toward strengthening the UK’s domestic supply of mRNA vaccines.
The MITC is part of a 10-year strategic partnership between Moderna and the UK government aimed at boosting pandemic preparedness. The agreement includes the ability to produce up to 250 million doses during a pandemic and provides the UK with priority access to mRNA vaccines.
“This significant achievement marks a major step forward in our mission to establish end-to-end mRNA manufacturing capabilities in the UK, and we are proud to have reached it in less than two years since breaking ground on the site,” Darius Hughes, UK General Manager of Moderna, said in a statement, bringing the company “closer to ensuring a reliable, onshore supply of mRNA vaccines within the UK.”
Moderna’s UK facility joins similar sites in Australia and Canada, forming a global network designed to improve rapid response to health emergencies. The company says these hubs will help reduce distribution times and enhance resilience in future public health crises.
In February 2025, Moderna announced financial results for the fourth quarter and full-year 2024, including a loss of $238 million on a non-cash charge related to its manufacturing resizing. The company, which has struggled with declining COVID-19 vaccine sales, launched a strategic cost initiative in the third quarter of 2023 to resize manufacturing operations.