Shionogi announced that it has filed for manufacturing and sales approval of S-268019, a recombinant protein-based preventive vaccine, for use in priming and booster (3rd) doses, against COVID-19, caused by the novel coronavirus (SARS-CoV-2) infection.
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S-268019 is produced using a unique and reliable recombinant protein vaccine technology, “BEVS”, established by UMN Pharma Inc., a subsidiary of Shionogi.
The recombinant protein vaccine contains the purified target antigen protein, produced using genetic information from the virus, and produced by the BEVS technology, which is used in already approved and marketed vaccines, such as an influenza prophylactic vaccine.
The filing is based on the positive results of five clinical trials conducted in Japan.
In the main clinical trial, which tested priming dose administration, the Phase 3 neutralizing antibody titer comparison trial met the criteria for primary endpoint.
The primary endpoint in this study was a superiority comparison of the geometric mean antibody titer (GMT) of SARS-CoV-2 neutralizing antibody titer at 28 days following the 2nd vaccination of S-268019 compared to the group receiving ChAdOx1 nCoV-19.
Regarding the booster dose (3rd dose) administration clinical study, the primary endpoint was also achieved, with non-inferiority of the S-268019 group to the COMIRNATY (original strain) group confirmed in a comparison of the GMT of the neutralizing antibody titer, as well as the seroresponse rate of the SARS-CoV-2 neutralizing antibody titer, measured on the 29th day (28 days after inoculation) between groups in which S-268019 or COMIRNATY was administered as the 3rd vaccine dose in adults, 6 months or more after receiving two inoculations of COMIRNATY.
Regarding safety, there were no major clinical concerns in any of the five trials.
Starting in February 2022, they initiated prior consultation with the Pharmaceuticals and Medical Devices Agency (PMDA) in preparation for the approval application in Japan and Shionogi has already been submitting non-clinical and clinical data for review, and will continue to do so as further information is obtained. ■