Pfizer's Covid-19 vaccine targeting XBB variant gets emergency approval

The Ministry of Food and Drug Safety (MFDS) said it is pushing for a swift introduction and distribution of a new vaccine developed specifically to counter the XBB 1.5, an Omicron sub-variant, for the 2023-24 winter season.

Responding to a request from the Korea Disease Control and Prevention Agency (KDCA), the MFDS granted emergency use authorization (EUA) for Pfizer Korea's Comirnaty 0.1mg/ml on Tuesday.

Furthermore, the agency is reviewing an EUA for Moderna Korea's Spikevax X, which, like Pfizer's vaccine, has already received EUA or approval in the U.S. and Europe.

The MFDS stressed that it is conducting meticulous reviews on efficacy and safety based on submitted data, seeking counsel from experts across diverse fields, including infectious diseases, pathology, and preventive medicine, and convening various committees before making final decisions for the EUA.

With the EUA approval, the MFDS expressed optimism that the country can swiftly introduce vaccines to tackle the currently prevalent variant strains and be better prepared for potential winter outbreaks.

The MFDS also reassured the public, committing to rigorous quality control, efficient adverse event monitoring, and reinforcing the safety management system to ensure citizens can confidently receive their vaccinations.

Meanwhile, the government had previously ensured that its citizens won't have to dig into their pockets as Covid-19 vaccinations will remain free.

The government had announced that healthy citizens will be vaccinated once annually, whereas immunocompromised individuals will get their shots twice a year.

According to previous reports, the nation is gearing up for this winter's vaccination drive from October.