The European Medicines Agency (EMA)
In addition to the new manufacturing facility for this vaccine, the CHMP has also given a positive opinion for the addition of several alternative sites responsible for batch control/testing.
Already on 4 June 2021, two new sites for the manufacturing of active substance and finished product intermediates, located in the US (ModernaTX, Inc., Norwood, Massachusetts and Lonza Biologics, Inc., Portsmouth, New Hampshire), were approved by CHMP. Together, these changes are expected to allow the production of an additional one to two million vials of ready-to-use vaccine for the European Union market every month. This will increase the supply of the vaccine in the European Union.
This recommendation does not require a European Commission decision and the site in Monts can become operational immediately.
The changes described will be included in the publicly available information on this vaccine.