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CHMP Approves Manufacturing Scale-Up for Spikevax

August 5, 2021


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.

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