Market Overview

How Moderna's Slowing COVID-19 Vaccine Enrollment Could Delay Interim Readout

How Moderna's Slowing COVID-19 Vaccine Enrollment Could Delay Interim Readout

Moderna Inc (NASDAQ: MRNA)'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.

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.

See also: The Week Ahead In Biotech: Avenue's FDA Decision, Alkermes Adcom Meeting, Aziyo Biologics IPO

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. (NYSE: PFE)/BioNTech SE – ADR (NASDAQ: BNTX) 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. mrna.png 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.

MRNA Price Action: Moderna shares gained 4.56% in Monday's session, closing at $71.95.

Related Link: Attention Biotech Investors: Mark Your Calendar For October PDUFA Dates

Latest Ratings for MRNA

Nov 2020SVB LeerinkMaintainsUnderperform
Nov 2020Wells FargoInitiates Coverage OnEqual-Weight
Nov 2020Chardan CapitalMaintainsBuy

View More Analyst Ratings for MRNA
View the Latest Analyst Ratings


Related Articles (MRNA)

View Comments and Join the Discussion!

Posted-In: Coronavirus Covid-19Analyst Color Biotech Health Care Analyst Ratings General Best of Benzinga

Latest Ratings

OCXBTIGInitiates Coverage On5.0
GCMGWilliam BlairInitiates Coverage On
PDCraig-HallumInitiates Coverage On41.0
CAPLWells FargoDowngrades
MMPWells FargoDowngrades
View the Latest Analytics Ratings
Don't Miss Any Updates!
News Directly in Your Inbox
Subscribe to:
Benzinga Premarket Activity
Get pre-market outlook, mid-day update and after-market roundup emails in your inbox.
Market in 5 Minutes
Everything you need to know about the market - quick & easy.
Fintech Focus
A daily collection of all things fintech, interesting developments and market updates.
Thank You

Thank you for subscribing! If you have any questions feel free to call us at 1-877-440-ZING or email us at