EMA’s human medicines committee (CHMP) has approved a scale-up of the active substance production process at Moderna’s COVID-19 vaccine manufacturing sites in the United States (US).
This recommendation is expected to have significant impact on the supply of Spikevax, the COVID-19 vaccine developed by Moderna, in the European Union. It is estimated that in the third quarter of 2021, the US supply chain will provide 40 million doses of vaccine for the European market.
EMA’s decision reaffirms that the two recently approved US facilities, ModernaTX, Inc. in Norwood, Massachusetts and Lonza Biologics, Inc. in Portsmouth, New Hampshire, are capable of consistently manufacturing high-quality active substance and will enable Moderna to increase production capacity at these sites.
Since the granting of a conditional marketing authorisation for Spikevax, the CHMP authorised a total of four manufacturing sites for the production of active substance for this vaccine, two in the US as mentioned above, and two in Visp, Switzerland.
This recommendation does not require a European Commission decision.