EMA approves scale-up of Spikevax manufacturing and supply

The European Medicines Agency’s human medicines committee (CHMP) has approved a scale-up of the active substance production process at US mRNA-based biotech Moderna's (Nasdaq: MRNA) COVID-19 vaccine manufacturing sites in the USA.

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, the EMA noted.

The EMA's decision reaffirms that the two recently approved US facilities, ModernaTX, in Norwood, Massachusetts, and Lonza Biologics, part of Swiss biotech ingredient supplier Lonza (VTX: LONN), in Portsmouth, New Hampshire, are capable of consistently manufacturing high-quality active substance and will enable Moderna to increase production capacity at these sites.