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• The approval was based on various clinical data of ARCT-154 studies (NCT05012943) evaluating safety, immunogenicity, and efficacy on COVID-19 Patients
• The result of the study depicted higher immunogenicity & favorable safety profile vs standard mRNA COVID-19 Vaccine. Additionally, results from previous studies b/w Dec 2022 & Feb 2023 on patients who received ARCT-154 (n=420) or Comirnaty (n=408) booster doses in a 1:1 ratio depicted that 4wks. later, ARCT-154 showed higher Wuhan-Hu-1 & anti-Omicron neutralizing antibodies vs Comirnaty with GMT ratios of 1.43 & 1.30, respectively 
• Sa-mRNA, amplifies protein production compared to standard mRNA, potentially leading to more robust cellular immune responses & extended protection with reduced mRNA doses

Ref: PR Newswire | Image: Arcturus Therapeutics

Related News:- Arcturus Therapeutics and CSL Report EMA’s Validation of MAA for ARCT-154 Vaccine to Prevent COVID-19

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