Moderna Inc MRNA 4.56%'s CEO said last week that it will not seek emergency use authorization for its coronavirus vaccine candidate mRNA-1273 before the Nov. 3 U.S. presidential election.
Trial Enrollment Hits 94% Of Target: Moderna's vaccine candidate is in a large-scale Phase 3 trial dubbed COVE with a target enrollment of 30,000 participants.
About 28,043, or 93.5%, of the targeted participants have been enrolled into the study, Moderna said in a late Friday tweet.
Of those people, 19,369 have been administered a second dose.
As of Friday, October 2, 2020, 28,043 participants have been enrolled in the Phase 3 COVE study and approximately 33% of participants enrolled cumulatively are from diverse communities. 19,369 participants have received their second vaccination.
— Moderna (@moderna_tx) October 2, 2020
The study protocol calls for administering two doses of mRNA-1273 — the first on day one and the second on day 29.
About 33% of the participants were from diverse communities, Moderna said. The company announced the dosing of the first patient in the trial on July 27.
Slowing Enrollment Behind The Delay? Moderna's muted expectations concerning an expedited rollout under an emergency use authorization is partly attributable to the slowdown in enrollment in recent weeks, according to one sell-side analyst.
"Moderna's slower enrollment rate (partially due to an effort to include more diverse demographics) will likely push their earliest possible timeline for positive first interim efficacy readout until after the U.S. election," Raymond James analyst Steven Seedhouse said in a note.
The analyst said he expects Pfizer Inc. PFE 0.96%/BioNTech SE – ADR BNTX 9.5% to be first with an interim efficacy readout before the election and probably before the Oct. 22 general vaccine Adcom meeting.
Hard numbers substantiate the conjecture concerning the reason for the potential delay in Moderna's vaccine program. 
Source: Moderna
Nov. 25 is likely the date when enough safety data will become available to be included in an emergency use authorization application, Moderna CEO Stéphane Bancel told the Financial Times last week.
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.