Arcturus Therapeutics and CSL Report EMA’s Validation of MAA for ARCT-154 Vaccine to Prevent COVID-19
- The EMA has validated the MAA for ARCT-154, a next-generation mRNA vaccine for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals aged ≥18yrs. The EC is expected an approval decision in 2024
- The submission was based on the P-III clinical results of ARCT-154 against the ancestral D614G variant as a primary series and booster. The primary efficacy EP was met and ARCT-154 as a primary series resulted in 56.6% & 95.3% efficacy for prevention of symptomatic COVID-19 & sev. COVID-19 incl. COVID-19 related deaths
- The additional P-III booster study showed non-inferiority of immune response over Comirnaty & superiority of ARCT-154 in neutralizing Ab response against SARS-CoV-2 Omicron BA.4/5 variant
Ref: Businesswire | Image: Arcturus Therapeutics
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