Emergency Use Authorization Granted for New Omicron Variant Vaccine 'Comirnaty'

The Ministry of Food and Drug Safety announced on the 13th that it has granted emergency use authorization for Pfizer Korea's 'Comirnaty 0.1mg/ml (active ingredient: Raxstozinameran)' to respond to the new Omicron variant XBB 1.5 of COVID-19. Emergency use authorization is a system that allows the manufacture and import of unapproved drugs in Korea upon request from central administrative agencies to appropriately respond to public health crises.

Additionally, the Ministry of Food and Drug Safety is currently reviewing emergency use authorization for Moderna Korea's 'Spikevax X Injection (active ingredient: Andusomeran)'.

According to the Ministry, both Comirnaty and Spikevax X Injection have already received emergency use authorization in the United States. In Europe, Comirnaty has received conditional marketing authorization, and Spikevax X Injection is expected to receive conditional marketing authorization within this month.

The Ministry expects that with this emergency use authorization, vaccines against the currently circulating variant virus can be rapidly introduced, enabling preparation for the winter season outbreak. They plan to strengthen safety management systems such as thorough quality control and adverse event collection so that the public can receive vaccinations with confidence.

Before deciding on emergency use authorization for pharmaceuticals, the Ministry explained that it reviews efficacy and safety, consults experts in fields such as infectious diseases, pathology, and preventive medicine, and then holds the Public Health Crisis Response Medical Product Safety Management and Supply Committee.

COVID-19 Vaccine [Photo by Yonhap News]

This content was produced with the assistance of AI translation services.