Moderna COVID-19 Vaccine Passes 'Second Approval Gate' (Update)

"Acceptable Level of Adverse Events and Other Cases"

[Image source=Yonhap News]

[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).

On the 13th, the MFDS held the second expert advisory meeting, the Central Pharmaceutical Affairs Deliberation Committee (Central Pharmaceutical Committee), at its headquarters in Osong, Chungbuk, and announced that it gave an advisory opinion that approval is possible. This is the second of three expert advisory processes for the MFDS's COVID-19 vaccine approval review. The Central Pharmaceutical Committee meeting included 14 external experts: 10 standing members of the Biologics Subcommittee, a specialized subcommittee for reviewing vaccine safety and efficacy; 3 members of the verification advisory group; and 1 expert recommended by the Korean Medical Association. In addition, 8 members from the MFDS's 'COVID-19 Crisis Response Support Headquarters' vaccine review teams, including the overall review team, clinical review team, and quality review team, attended.

The Central Pharmaceutical Committee advised, "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 advisory group, approval can be granted." Previously, the verification advisory group, which held the first advisory meeting, also expressed an opinion that approval of the Moderna vaccine is possible.

Regarding safety, it was judged that "adverse events occurring in clinical trials are at an acceptable level." However, it added, "As with the COVID-19 mRNA vaccines approved domestically, there is a tendency for an increase in expected adverse events such as more pain, fatigue, and chills after the second dose, so guidance is necessary."

Regarding efficacy, it stated, "Since efficacy was confirmed 14 days after two doses in individuals aged 18 and over based on the submitted data, the preventive effect for approval is acceptable," and recommended "tracking and monitoring data on long-term efficacy for more than six months."

The MFDS plans to review additional submitted materials necessary for the final inspection, such as quality data of the Moderna vaccine, and then hold a final inspection committee meeting to decide on approval.

Meanwhile, the government has secured 20 million doses (40 million shots) of the Moderna vaccine, with some quantities expected to be introduced as early as the second quarter. GC Green Cross is responsible for domestic approval and distribution.