COVGOZE JN.1-Adapted Recombinant Protein COVID-19 Vaccine Receives Approval
核心洞察
Shionogi has obtained approval in Japan for a partial change to the manufacturing and marketing authorization of COVGOZE for Intramuscular Injection (JN.1-Adapted).
The approval adds a booster dose indication to the recombinant protein COVID-19 (搜索) vaccine, which was previously authorized for initial immunization.
Shionogi said the approval establishes the foundation of its strain-adapted vaccine platform, which it aims to fully establish by fiscal year 2026.
Shionogi & Co., Ltd. has obtained approval in Japan for a partial change to the manufacturing and marketing authorization of COVGOZE for Intramuscular Injection (JN.1-Adapted), a recombinant protein vaccine against COVID-19 (搜索), adding a booster dose indication. The vaccine was developed to address the continuously evolving SARS-CoV-2 virus, following earlier approvals of the original-strain vaccine and the JN.1-adapted formulation.
The company said the approval establishes the foundation of a platform intended to enable rapid development and manufacturing of vaccines tailored to the strains recommended for each vaccination season. Shionogi plans to fully establish the platform by fiscal year 2026 and to advance development toward approval of a vaccine adapted to the recommended strain. Under that platform, vaccines matched to the latest recommended strains could be supplied rapidly through a review process based primarily on quality evaluations and non-clinical study data, subject to collection of post-marketing data.
Shionogi stated that the approved vaccine differs from the strain-adapted vaccine designated for use in Japan during the 2026/2027 vaccination season, and that it does not plan to supply this vaccine. COVGOZE is produced using BEVS (Baculovirus Expression Vector System) technology, in which a purified antigen protein expressed from viral genetic information is combined with an adjuvant. The financial impact of the approval was already reflected in the earnings forecast announced on May 12, 2026.
Source: Shionogi & Co., Ltd.