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Japan-based Shionogi & Co. has recently announced the results from the Japanese Phase 1/2 clinical trial of S-268019, a recombinant protein-based vaccine for COVID-19.
The side effects after vaccination were the same as that seen in normal vaccination. From 2 weeks after the 2nd injection of S-268019, it was confirmed that the neutralizing antibody titer increased to the same level as that seen in recovered serum. Both Th1 and Th2 reactions were induced, but the Th1 / Th2 balance did not dominate Th2.
The Japanese Phase 1/2 clinical trial was supported by Japan Agency for Medical Research and Development (AMED)
Based on these results, Shionogi is currently conducting a Japanese Phase 2/3 clinical trial. The company will continue to consult closely with the Ministry of Health, Labor and Welfare, Pharmaceuticals and Medical Devices Agency (PMDA) and other organizations for future applications for approval.