Jungangyakshim "Approval Appropriate for Adults 18 and Older with Two-Dose Regimen"
[Asia Economy Reporter Kim Ji-hee] The Moderna COVID-19 vaccine has passed the second expert advisory process of the Ministry of Food and Drug Safety (MFDS). If it passes the final inspection committee, it will become the fourth vaccine approved domestically, following AstraZeneca, Pfizer, and Janssen.
Seo Kyung-won, Director of the Food and Drug Safety Evaluation Institute at the MFDS, stated at a briefing on the 13th, "At today's Central Pharmaceutical Affairs Deliberation Committee, after discussing the safety and efficacy of the Moderna COVID-19 vaccine, it was advised that approving this product based on the currently submitted data is appropriate." Director Seo explained, "The adverse events observed in clinical trials were mild symptoms such as injection site pain, fatigue, headache, and muscle pain, most of which resolved within one to three days, and there were no overall safety concerns. In terms of efficacy, it was demonstrated that the preventive effect was 94.1% when administered twice to 28,207 individuals aged 18 and older."
Based on these results, the advisory opinion was that it is reasonable to approve the vaccine for two doses in adults aged 18 and over.
The Central Pharmaceutical Affairs Deliberation Committee meeting included 14 external experts: 10 standing members of the Biologics Subcommittee, which reviews vaccine safety and efficacy, 3 verification advisory panel members, and 1 expert recommended by the Korean Medical Association. Additionally, 8 members from the MFDS's 'COVID-19 Crisis Response Support Headquarters' vaccine review teams?comprising the overall review team, clinical review team, and quality review team?attended. The committee stated, "The necessity of the Moderna COVID-19 vaccine for domestic COVID-19 prevention is recognized, and considering the advisory results from the COVID-19 vaccine safety and efficacy verification panel, it is possible to grant product approval."
Regarding safety, Oh Il-hwan, Chairman of the Central Pharmaceutical Affairs Deliberation Committee, said, "The trend of safety profiles, including adverse events observed in clinical trials, was judged to be at an acceptable level. However, similar to other COVID-19 mRNA vaccines already approved domestically, there is a tendency for more pain, fatigue, chills, and other predictable adverse events to occur after the second dose compared to the first, so it is necessary to inform recipients about these."
He added, "Unexpected adverse events not related to vaccination occurred in about 8.2% of vaccine recipients during the four-week post-vaccination monitoring period. The main symptoms were fatigue, headache, muscle pain, injection site pain, and injection site redness. The incidence was not higher than that of other mRNA vaccines."
There were also nine serious adverse drug reactions that could not exclude a causal relationship with vaccination. However, Chairman Oh noted, "At the time of submitting the clinical trial data, most were in the process of recovery."
Data submitted confirmed a 94% preventive effect 14 days after two doses in individuals aged 18 and older. However, long-term efficacy data from follow-up beyond six months was recommended for continued observation.
The MFDS plans to review additional submitted materials necessary for the final quality check of the Moderna vaccine and will hold the final inspection committee to decide on approval. The final inspection committee is scheduled to be held on the 21st.
Meanwhile, the government has secured 20 million doses (40 million shots) of the Moderna vaccine, with some supplies expected to be introduced as early as the second quarter. GC Green Cross is responsible for domestic approval and distribution.
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