MFDS "Pfizer COVID-19 Vaccine Approved for Ages 16 and Older"…Second Approval in Korea (Update)

On the 26th, the initial shipment of Pfizer vaccines secured through the international vaccine supply organization 'COVAX facility' was unloaded from a Korean Air cargo plane at the Incheon International Airport Cargo Terminal in Yeongjongdo and transported.
The quantity received that day amounted to a total of 58,500 doses, and these vaccines are scheduled to be delivered directly to five central and regional vaccination centers without passing through the logistics center in Pyeongtaek, Gyeonggi Province.
Pfizer vaccine administration will begin the following day, on the 27th, at the Central Vaccination Center set up at the National Medical Center in Jung-gu, Seoul. / Yeongjongdo - Photo by Airport Press Photographers Group

[Asia Economy Reporter Seo So-jeong] Pfizer's 'Comirnaty' has become the second COVID-19 vaccine in South Korea to receive product approval from the Ministry of Food and Drug Safety (MFDS).

The MFDS (Commissioner Kim Gang-lip) announced on the 5th that it held a final review committee meeting including external experts and decided to approve the COVID-19 vaccine 'Comirnaty' imported by Pfizer Korea, which applied for import product approval on January 25, on the condition of submitting the final clinical trial report.

The final review committee also judged that it is appropriate to approve the vaccine for those aged 16 and older, consistent with the results of two previous advisory meetings regarding efficacy and effectiveness for this age group.

Comirnaty is a messenger ribonucleic acid (mRNA) vaccine jointly developed by Pfizer in the United States and BioNTech in Germany. It injects the COVID-19 virus antigen gene in mRNA form to synthesize antigen proteins in the body, which induce the production of neutralizing antibodies, thereby neutralizing and eliminating the virus when it invades the human body.

The efficacy and effectiveness of this drug is the prevention of COVID-19 in individuals aged 16 and older. After dilution, 0.3 mL is administered once, followed by an additional dose three weeks later. Storage conditions are between -60 to -90℃ for six months. Comirnaty is the first mRNA vaccine approved domestically and has received conditional approval or emergency use authorization in 59 countries including Europe (EMA), the United States, Japan, and from the World Health Organization (WHO).

Earlier, the MFDS received advice from the verification advisory group on the 22nd of last month and from the Central Pharmaceutical Affairs Deliberation Committee on the 25th of the same month, and finally decided on product approval at today's meeting, the last stage of the approval review process. The meeting held this morning was attended by three external experts including Chairman Oh Il-hwan of the Central Pharmaceutical Affairs Deliberation Committee and five internal members including the MFDS Commissioner.

The final review committee stated, "The overall safety of the vaccine is good," but added, "However, close monitoring is necessary after approval for individuals with a history of hypersensitivity including anaphylaxis, and adverse events reported in the future will be additionally reflected in the approval details."

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