By Nicolas Hulscher, MPH Source
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.
As I outlined last month, the Biopharmaceutical Complex's self-amplifying mRNA assault has already begun with at least 33 candidates in development:
Attack of the Replicons
Nicolas Hulscher, MPH
·
7 Nov 2024
By Nicolas Hulscher, MPH
“It's become abundantly clear that the pharmaceutical industry and captured regulatory agencies have zero regard for the massive safety concerns of undefined synthetic mRNA replication resulting in uncontrolled toxic antigen production. These experimental injections must not receive further regulatory approval for humans or animals if we are to prevent another public health disaster. All self-amplifying mRNA injections currently available for humans and animals should be immediately withdrawn until comprehensive, long-term safety studies are conducted.”
The European Commission must make the right decision and REJECT authorization for an experimental injection with a 90% adverse event rate and non existent long-term safety data.
Nicolas Hulscher, MPH
Epidemiologist and Foundation Administrator, McCullough Foundation
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