US FDA Nears Emergency Approval of Moderna Vaccine... "Highly Effective" (Comprehensive)

Positive Review Released Ahead of Approval Review on the 17th
80.2% Effectiveness After First Dose, 94.1% After Second Dose
Distribution to Start Immediately Upon Approval... "20 Million Doses to Be Distributed by Year-End"

[Image source=Reuters Yonhap News]

[Asia Economy Reporter Hyunwoo Lee] The U.S. Food and Drug Administration (FDA) announced on the 15th (local time) that the COVID-19 vaccine developed by pharmaceutical company Moderna is highly effective, signaling that emergency approval is imminent. If the final approval for the Moderna vaccine is granted, it will become the second vaccine available for use in the U.S., following the Pfizer vaccine, which has already begun distribution. The U.S. government plans to start shipping the vaccine immediately after approval and distribute up to 20 million doses by the end of the year alongside the Pfizer vaccine.

According to foreign media including the Associated Press (AP) on the 15th, the FDA advisory committee for vaccines and biological products (VRBPAC), which reviews emergency use authorizations for vaccines, stated in its review report on the Moderna vaccine released that day, "Moderna's vaccine is highly effective against COVID-19 and meets the FDA guidelines for emergency use authorization." The positive review report from VRBPAC ahead of the Moderna vaccine approval hearing scheduled for the 17th is interpreted as a sign that approval is near.

According to Stat News, a U.S. pharmaceutical media outlet, the FDA's review report revealed that the Moderna vaccine guarantees high immunity when administered twice with a 4-week interval. A single dose provides an immunity effect of 80.2%, while two doses result in a 94.1% prevention rate. Among clinical trial participants aged 18 to 65, the immunity effect was 95.6%, and for those over 65, the prevention effect was 86.4% based on the two-dose regimen.

The report noted that among the clinical trial participants, facial paralysis was reported as a side effect in four individuals: three who received the vaccine and one who received a placebo. The three vaccine recipients naturally recovered from the side effects. The FDA also stated that no severe allergic reactions were found with the Moderna vaccine, with hypersensitivity reactions occurring in 1.5% of vaccine recipients and 1.1% of placebo recipients. Other side effects reported included mild symptoms such as fever, fatigue, and pain, which are common with other vaccines. Stat News reported that there were no special side effect factors that would delay the FDA approval process.

The U.S. government is expected to begin shipping immediately after FDA approval. According to The New York Times (NYT), the FDA's final approval is expected to be granted on the 18th, the day after the review, and distribution across the U.S. will likely begin that day under the government's "Operation Warp Speed," which oversees vaccine development and distribution. Previously, Moncef Slaoui, the chief of Operation Warp Speed, stated in an interview with Fox News that "distribution of Moderna's vaccine will begin immediately after approval, and up to 20 million doses will be distributed by the end of the year alongside the Pfizer vaccine," adding, "We hope to increase the vaccination rate to 75-80% by May or June next year to achieve herd immunity."

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