Moderna Nears Finish Line For Enrollment In Phase 3 Coronavirus Vaccine Study

Coronavirus vaccine developer Moderna Inc MRNA 4.03% is close to achieving 100% enrollment in its Phase 3 COVE study. 

What Happened: After seeing a slowdown in the enrollment rate in recent weeks, the pace of addition picked up in the recent week, according to statistics shared by the company on Twitter.

As of Friday, October 16, 2020, 29,521 participants have been enrolled in the Phase 3 COVE study and approximately 36% of participants enrolled cumulatively are from diverse communities. 24,496 participants have received their second vaccination. https://t.co/ToJWTwNyYa pic.twitter.com/X3O5gFP898

— Moderna (@moderna_tx) October 16, 2020

Moderna said that as of Friday, 29,521 participants have been enrolled into the study, representing 98.4% of the targeted enrollment number of 30,000.

This suggests the addition of 903 participants last week — brisker than the pace seen in the week ended Oct. 9, when the company added 575 participants week-over-week.

The company said about 24,496 participants have received their second vaccination. About 36% of the study population is from diverse communities, Moderna said.

Why It's Important: , Moderna's vaccine timeline is being closely watched given the pause in the studies launched by AstraZeneca plc AZN 1.11% and Johnson & Johnson JNJ 2.43%, and Pfizer Inc. PFE 0.4% giving a late November timeline for an emergency use application.  

Moderna's protocol assumes it will likely see 150 infection events through the trial, and the company has planned for the first interim analysis at 53 events and the second at 106 events.

The company has indicated the first readout could come in November.

Moderna has also started rolling regulatory submissions for mRNA-1273 in the European Union and Canada. The company could shed some light on the vaccine program when it reports its third-quarter earnings Oct. 29.

https://www.benzinga.com/general/biotech/20/10/17961560/moderna-nears-finish-line-for-enrollment-in-phase-3-coronavirus-vaccine-study