Moderna’s manufacturing facility in Harwell, Oxfordshire, UK, the Moderna Innovation and Technology Centre (MITC), has been granted a Manufacturer’s/Importer’s Authorisation (MIA) by the Medicines and Healthcare products Regulatory Agency (MHRA).
With the manufacturer’s licence now in place, the US-based biotechnology company, can move forward with commercial mRNA vaccine manufacture, which will be subject to the standard regulatory review processes with the MHRA.
This key milestone follows a successful inspection confirming compliance with the principles and guidelines of Good Manufacturing Practice (GMP), enabling the MITC to become fully operational.
With the manufacturer’s licence now in place, the US-based biotechnology company, can move forward with commercial mRNA vaccine manufacture
Darius Hughes, UK General Manager of Moderna, said: “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,” said Darius Hughes, UK General Manager of Moderna.
“This important step brings the company closer to ensuring a reliable, onshore supply of mRNA vaccines within the UK.”
The establishment of the MITC is part of a ten-year strategic partnership between Moderna and the UK Government, managed by the UK Health Security Agency (UKHSA).
The partnership aims to boost pandemic preparedness by onshoring vaccine production and securing priority access to mRNA vaccines while strengthening the UK’s global leadership in clinical research, scientific innovation, and skills development.
The establishment of the MITC is part of a ten-year strategic partnership between Moderna and the UK Government
This broader collaboration goes beyond manufacturing to strengthen long-term resilience and rapid response capabilities, including the ability to produce at least 250 million doses during a pandemic for the NHS and UK public, according to Moderna.
This UK facility and additional sites in Australia and Canada will also form a network of advanced manufacturing hubs that collectively strengthen global pandemic readiness.
Each site is strategically placed to maximise geographic coverage and minimise response times, ensuring that vaccines and therapeutics can be distributed quickly and efficiently where needed.