COVID-19 Self-Amplifying mRNA Injection Nears European Approval

[Smokin Joe]

COVID-19 Self-Amplifying mRNA Injection Nears European Approval

By Nicolas Hulscher, MPH

On December 12, 2024, the Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending marketing authorization for Kostaive, a self-replicating (replicon) mRNA injection developed by Arcturus Therapeutics. The final decision for regulatory approval now rests with the European Commission:

Japan had already approved these injections last year. In November 2023, Japan's Ministry of Health, Labor and Welfare (MHLW) fully approved CSL and Arcturus Therapeutics' replicon shot, Kostaive ARCT-154. Despite enormous safety concerns, Japan’s MHLW approved the updated booster shot in September 2024 to target the JN.1 lineage of Omicron subvariants.

During the clinical trials for Kostaive, five deaths were reported among participants in the phase 3b study. Across study phases 1, 2, and 3a combined, 90% of injected participants experienced adverse events, with 74.5% reporting systemic reactions and 15.2% requiring medical attention after the first dose. Notably, many of the study authors are full-time employees of Arcturus Therapeutics, raising concerns about bias in their conclusions.

https://www.thefocalpoints.com/p/covid-19-self-amplifying-mrna-injection?utm_source=substack&utm_medium=email