CHMP Approves Manufacturing Scale-Up for Spikevax

EMA’s CHMP has approved the increased manufacturing capacity and supply of Moderna’s COVID-19 vaccine active substance in its US manufacturing site.

The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) has approved the increased manufacturing capacity and supply of Moderna’s COVID-19 vaccine (Spikevax) active substance in its United States manufacturing site.

CHMP’s decision is expected to impact the supply of Spikevax within the European Union (EU) as it is estimated that the US supply chain will provide 40 million doses of Spikevax for the EU in the third quarter of 2021. Furthermore, the recommendation reaffirms that the two US facilities—ModernaTX in Norwood, Mass., and Lonza Biologics in Portsmouth, NH—that were recently approved are able to produce high-quality active substances consistently.

So far, CHMP has authorized four manufacturing sites for the production of the active substance for Spikevax. Two sites in the US, as mentioned earlier, and two sites located in Visp, Switzerland.

CHMP’s recommendation on this matter does not require any further decision from the European Commission.

Source: EMA