The Ministry of Food and Drug Safety (MFDS) said it has granted emergency use approval (EUA) for Pfizer's Covid-19 bivalent vaccine, an improved vaccine developed to respond to the Omicron variants.
The Emergency Use Approval System allows the urgent manufacture, import, and supply of medical products needed in a public health crisis prior to approval at the request of central government agencies such as the Korea Disease Control and Prevention Agency (KDCA).
The MFDS granted EUA after reviewing the efficacy and safety of the vaccine based on the data submitted by Pfizer and consulting with relevant government committees.
Experts who presided over the committees expressed favor in granting EUA for Pfizer's bivalent vaccine as the submitted data by Pfizer were the same as those reviewed in the U.S. and Europe, where the vaccine has already been approved, and the dosage and manufacturing method of Pfizer's licensed vaccine is the same.
The MFDS said that with the EUA, it will be possible to quickly introduce a vaccine against the Omicron variants and prepare for a possible re-emergence of the virus during the winter.
Korea had also received the 780,000 doses of Pfizer's bivalent vaccine last Thursday.
Professor Jung Ki-suck, head of the National Advisory Committee on Infectious Disease Crisis Response, urged people at a high risk of infection to receive the bivalent vaccines as a new Covid-19 viral wave may occur in early December.
Jung stressed that Korea needs to prepare a mid-to-long-term response in advance and said that the country should consider adjusting the Covid-19 quarantine system.
"In countries with high vaccination rates, such as Italy, Germany, and France, an increasing trend of daily Covid-19 infection is being observed," Jung said during a daily task force meeting on Monday. "In Korea, there is also a possibility that a full-fledged resurgence of the virus will occur around early December."
On Monday, Korea's new COVID-19 cases fell below 20,000, backed by fewer Covid-19 testing over the weekend.
The country added 11,040 new Covid-19 infections, including 81 cases from abroad, bringing the total caseload to 25,131,505, according to the KDCA.
The nation also reported 11 more Covid-19 deaths, raising the death toll to 28,851. The fatality rate stood at 0.11 percent. The number of critically ill patients came to 248, up one from the previous day.
According to the KDCA, about 44.68 million among 52 million Koreans have been fully vaccinated. In addition, about 33.6 million people had received their first booster shots, and 7.49 million had their second booster shots.