Moderna's Stock Hits New Highs After COVID-19 Vaccine Analysis Confirms 94% Efficacy

Moderna Inc (NASDAQ: MRNA) shares, which closed in record territory Friday, are adding to their gains following the release of primary analysis of the Phase 3 study that evaluated its coronavirus vaccine candidate, RNA-m1273, and a disclosure from the company regarding the timeline for filing for emergency use authorization.

Primary Analysis Pitches Efficacy at 94.1% The Cambridge, Massachusetts-based company said primary efficacy analysis of data from the study, dubbed COVE, conducted on 196 cases showed vaccine efficacy at 94.1%. Interim analysis of efficacy data released in mid-November showed vaccine efficacy of 94.5%.

Of the 196 cases, 185 cases were observed in the placebo groups and 11 in the mRNA-1273 arm. The 196 cases, according to the company, included 33 older adults, ages over 65 years, and 42 participants from diverse communities.

The primary endpoint is based on the analysis of COVID-19 cases confirmed and measured starting two weeks after the second dose of vaccine was administered.

The secondary endpoint of serve cases of COVID-19 included 30 severe cases, which were all in the placebo group. No new serious safety concerns have been identified, with the most common solicited adverse reactions included injection site pain, fatigue, myalgia, arthralgia, headache, and erythema/redness at the injection site.

Safety data continues to accrue and the study continues to be monitored by an independent, NIH-appointed Data Safety Monitoring Board.

"This positive primary analysis confirms the ability of our vaccine to prevent COVID-19 disease with 94.1% efficacy and importantly, the ability to prevent severe COVID-19 disease. We believe that our vaccine will provide a new and powerful tool that may change the course of this pandemic and help prevent severe disease, hospitalizations and death," said Stéphane Bancel, CEO of Moderna.

EUA Filing Monday: Moderna said it will submit on Monday an EUA application with the FDA as well as a conditional marketing authorization application with the European Medicines Agency.

The company also said FDA's Vaccines and Related Biological Products Advisory Committee will likely meet on Dec. 17 to review the safety and efficacy data package for mRNA-1273.

Shipping of mRNA-1273 to designated distribution points throughout the U.S. will occur shortly after an EUA is granted, it added.

https://www.benzinga.com/node/18573749