Moderna COVID-19 Vaccine Receives Product Approval... Fourth in South Korea

Post-Approval Submission Requirements Including Final Clinical Trial Result Reports

[Image source=Yonhap News]

[Asia Economy Reporter Kim Ji-hee] The Ministry of Food and Drug Safety (MFDS) has approved the COVID-19 vaccine developed by Moderna, USA.

On the 21st, the MFDS held the final review committee meeting, the last stage of the COVID-19 vaccine approval process, and decided to grant marketing authorization for the 'Moderna COVID-19 Vaccine' on the condition that the final clinical trial report and other documents be submitted after approval. This decision was made after a comprehensive review of the clinical trials and other necessary data for approval, recognizing the vaccine's safety and efficacy. The meeting was attended by three external experts, including Chairperson Oh Il-hwan of the Central Pharmaceutical Review Committee, and five internal members including the MFDS Commissioner.

Regarding safety, the final review committee judged that most of the reported adverse events were expected reactions related to vaccine administration and were generally mild. Common adverse events (occurring in 1% or more of cases) included injection site pain, fatigue, headache, muscle pain, joint pain, chills, nausea/vomiting, lymphadenopathy, fever, injection site swelling, and flushing. Most symptoms were mild to moderate and resolved within a few days after vaccination.

Among all 30,351 registered clinical trial participants, serious adverse events were reported in 1.0% (147 individuals) of the vaccine group and 1.0% (153 individuals) of the control group. Of these, nine cases of serious adverse drug reactions possibly related to the vaccine, such as facial swelling, were reported, and most were recovering at the time of clinical data submission. Facial swelling has been reflected in the precautions for use.

Based on these results, the final review committee noted that while the vaccine's safety is generally favorable, there is a tendency for increased occurrences of expected reactions such as pain, fatigue, and chills after the second dose, which has been incorporated into the precautions for use.

Furthermore, consistent with the results of two previous advisory meetings, the final review committee found the vaccine's preventive efficacy sufficient based on the submitted clinical trial data. In the clinical trial conducted in the United States, 11 confirmed COVID-19 cases occurred in the vaccine group (out of 14,134 participants) and 185 cases in the control group (out of 14,073 participants), demonstrating approximately 94.1% preventive efficacy.

The final review committee determined that the overall safety management measures are appropriate and decided to continuously monitor neurological safety, including peripheral neuropathy and demyelinating diseases, as a preventive measure through a post-approval risk management plan. They will also continuously collect and evaluate adverse events occurring during ongoing clinical trials and post-market use.

With this approval, the Moderna vaccine became the fourth COVID-19 vaccine authorized in South Korea, following AstraZeneca, Pfizer, and Janssen vaccines. The Moderna vaccine has also received conditional approval or emergency use authorization in 39 countries including Europe and the United States, as well as from the World Health Organization (WHO).

Meanwhile, on the same day, the MFDS additionally approved the imported product manufactured in Italy, which is the same as the AstraZeneca COVID-19 vaccine approved domestically on February 10.

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