Health Sciences Council’s subcommittee chair negative on S 217622 vaccine for COVID 19
S 217622 a COVID 19 therapeutic vaccine from Shionogi does not meet the “presumed efficacy” standards set under the proposed emergency approval system, the chair of a health ministry panel said in a parliamentary session on April 12.
Tsuguya Fukui, director of Tokyo Medical University Ibaraki Medical Center, commented on the clinical trial results of the drug, in response to an opposition party lawmaker’s questioning. Dr Fukui serves as chair of the Health Sciences Council’s subcommittee for pharmaceuticals and medical devices regulations and has been involved in the legislation of the proposed amendment of the Pharmaceuticals and Medical Devices (PMD) Law, which embraces the introduction of an emergency approval system.
S 217622, failed to show a statistically significant improvement in clinical symptoms versus placebo while demonstrating reductions in viral loads. Dr Fukui sounded negative about the Shionogi application, saying that he personally thinks that “even if viral loads decrease, you can’t say a drug is clinically effective unless it has an impact on health outcomes.”
Shionogi filed S 217622 in Japan in February, seeking review under the existing conditional early approval pathway.
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