Moderna "COVID-19 Vaccine, Emergency Approval Application If Efficacy Proven by November"

Phase 3 Clinical Trial with 30,000 Participants, Currently Conducted on 10,000
Data Expected by November Could Enable Year-End Distribution
Trump's Claim of Vaccination After Mid-October Seems Unlikely

[Image source=Reuters Yonhap News]

[Asia Economy Reporter Hyunwoo Lee] Moderna, a U.S. pharmaceutical company developing a vaccine for the novel coronavirus infection (COVID-19), stated that the results of the ongoing Phase 3 clinical trial are expected to be available as early as November, and if high efficacy is demonstrated, it will apply for Emergency Use Authorization (EUA).

According to foreign media including CNBC on the 17th (local time), Moderna CEO St?phane Bancel said at a press conference on the 17th (local time), "An independent safety monitoring committee will analyze the initial Phase 3 data, and if preliminary results show the vaccine is 70, 80, or 90% effective, we will request a review for EUA approval." He added, "If the vaccine shows that level of efficacy, we expect it can save the lives of many people in high-risk groups, and we will also request approval for vaccination targeting a limited number of people."

However, he forecasted that the vaccine launch in October, as suggested by some within the Donald Trump administration, would be difficult. CEO Bancel said, "We expect to have sufficient data by November at the earliest to confirm the vaccine's effectiveness in the final Phase 3 clinical trial," and added, "It is unlikely that we will have enough results by October." He also stated, "As of the previous day, 25,296 participants have been enrolled in the ongoing Phase 3 trial involving 30,000 people, and 10,000 have received two doses of the vaccine."

Moderna anticipates that if the interim results confirming efficacy from the Phase 3 trial are available in November, the vaccine could be released by the end of the year. Earlier, President Trump suggested that "the vaccine could be approved as early as next month and immediately distributed to the public," raising the possibility of availability after October 14.