Moderna Seeks European Nod For Updated COVID-19 Vaccine Shot To Tackle New Dominant Strain

Moderna Inc MRNA submitted a regulatory application to the European Medicines Agency (EMA) for its updated COVID-19 vaccine encoding the spike protein for the XBB.1.5 sublineage of SARS-CoV-2.

The application is based on guidance from the European Centre for Disease Prevention and Control (ECDC) and the EMA, which recommended that COVID-19 vaccines be updated to a monovalent XBB.1.5 composition. 

This aligns with other regulators and global public health agencies recommending a monovalent XBB.1.5 composition. 

Additionally, Moderna has generated preliminary clinical data of its monovalent XBB.1.5 vaccine candidate showing an immune response against XBB descendent sublineages such as XBB.1.5, XBB.1.16, and XBB.2.3.2.

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In June, Moderna completed the submission of a regulatory application to the FDA for its updated COVID-19 vaccine.

The company also initiated rolling submission for its updated monovalent COVID-19 vaccine.

The company is prepared to deliver updated COVID-19 vaccines for this year's fall vaccination season.

The FDA's Vaccines and Related Biological Products Advisory Committee all 21 members voted "Yes," recommending that updated monovalent COVID shots in the fall and winter targeting the XBB variants, now the dominant strains of the SARS-CoV-2 virus.

Price Action: MRNA shares closed at $121.50 on Friday.