Ministry of Food and Drug Safety Approves National Shipment of COVID-19 Variant Response Vaccines

The Ministry of Food and Drug Safety announced on September 20 that it had approved national shipment of 5.63 million doses of the COVID-19 variant response vaccine.

National shipment approval is a system in which the Ministry of Food and Drug Safety comprehensively evaluates the results of inspection tests conducted by each manufacturing unit and the manufacturing and testing results of the manufacturer before vaccines are distributed on the market to reconfirm the quality.

The products that received national shipment approval this time include 5 million doses of Korea Pfizer’s ‘Comirnaty JN Oneju’ and 630,000 doses of Moderna Korea’s ‘Spikevax JN Oneju’. Both products are designed to express the COVID-19 JN.1 variant antigen and are vaccines with mRNA (messenger ribonucleic acid) as the active ingredient.

Among these, Spikebox JNJ is produced by Samsung BioLogics as a finished drug product using raw pharmaceutical ingredients supplied by Moderna.

On this day, the Ministry of Food and Drug Safety Commissioner Oh Yoo-kyung visited Samsung BioLogics in Yeonsu-gu, Incheon, and inspected the manufacturing and quality control status of ‘Spikebox JNJ’.

Commissioner Oh expressed his gratitude to the executives and staff of Samsung BioLogics and Moderna Korea, who are responsible for the production and supply of Spikevax JNJ, which will be used for COVID-19 vaccination during the winter season this year.

He emphasized the importance of thorough management of the vaccine manufacturing process and quality inspection, ensuring that the public can receive the vaccine with confidence.