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CSL and Arcturus Therapeutics Report the EC’s Approval of Kostaive Against COVID-19

Shots:

  • The EC has approved Kostaive (ARCT-154) for active immunization to prevent COVID-19 in subjects of age ≥18yrs in the EU & EEA states following CHMP positive opinion in Dec 2024
  • Approval was based on Kostaive’s clinical data incl. P-I/II/III showing its efficacy & tolerability, plus P-III COVID-19 booster trial depicting superior immunogenicity vs mRNA comparator. Also, follow-up analysis of booster dose showed higher immunogenicity & antibody response for ~12mos. in adults
  • Kostaive is a self-amplifying mRNA vaccine that codes for the SARS-CoV-2 spike protein to provide active immunization against COVID-19

Ref: Prnewswire | Image: CSL & Arcturus

Related News:- Arcturus and Meiji Seika Pharma Report the EMA’s Positive Opinion of Kostaive for COVID-19

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