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
Pharmaceutical Tariffs Are Imminent: How Industry is Bracing for Impact
April 16th 2025On April 14, 2025, the Trump Administration launched a national security-driven investigation into pharmaceuticals, a move that will likely result in tariffs being placed on pharmaceutical drugs, ingredients, and other components that are imported from outside of the United States.
