The European Medicines Agency (EMA) announced on Friday 30 July that it had approved “a scale-up of the active substance production process” of the Covid-19 vaccine Spikevax, developed by the company Moderna.
This “scale-up”—which does not require European Commission approval—involves two US vaccine manufacturing sites: ModernaTX, Inc. in Norwood, Massachusetts, and Lonza Biologics, Inc. in Portsmouth, New Hampshire.
The EMA’s recommendation is intended to confirm that both facilities are capable of “consistently manufacturing high-quality active substance” and will allow Moderna to increase production capacity at both sites, the European Agency said in a statement.
It further asserts that the initiative is expected to have a “significant impact” on the supply of Spikevax in the EU. The US supply chain should indeed be able to provide 40 million doses of vaccine for the European market by the third quarter of 2021, the EMA estimates.
In total, the EMA has already authorised four manufacturing sites dedicated to the production of the active substance of Moderna’s vaccine: in addition to the two sites mentioned above, two sites have been authorised in Visp, Switzerland.
Spikevax is one of a number of vaccines ordered by the European Commission on behalf of the EU-27. The institution recently requested an additional 150 million doses of the vaccine for 2022 (see EUROPE 12746/10). It is now approved for use by 12-17 year olds in the EU (see EUROPE 12768/13). (Original version in French by Agathe Cherki)