Moderna Inc. (Nasdaq: MRNA), the developer of the messenger RNA-based vaccine candidate known as mRNA-1273, reports that the independent NIH appointed Data Safety and Monitoring Board (DSMB) for the Phase 3 clinical trial of the vaccine candidate against COVID-19 reports that the trial has met the statistical criteria pre-specified in the study protocol for efficacy, with a vaccine efficacy of 94.5%. This upbeat news actually improves on the Pfizer/BioNTech interim analysis, which came in a 90% effective rate. The news involving vaccines out of the U.S. and Europe continues to stay upbeat. Moderna prepares to submit an application for an emergency use authorization (EUA) with the U.S. Food and Drug Administration (FDA).
TrialSite provides a breakdown of this important update.
What study does the data originate from?
The COVE study, which enrolled over 30,000 participants in the United States, in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services.
What are the key endpoints for this pivotal clinical trial?
The primary endpoint of the COVE is based on the analysis of COVID-19 cases confirmed and adjudicated commencing two weeks following the second dose of vaccine. This first interim analysis was based on 95 cases, of which 90 cases of COVID-19 were observed in the placebo group versus 5 cases observed in the mRNA-1273 group, resulting in a point estimate of vaccine efficacy of 94.5% (P<0.0001).
Did all severe cases only occur in the placebo group?
Yes. This was a second endpoint analysis and included 11 severe cases (as defined in the protocol) in the first interim analysis. All 11 cases occurred in the placebo group and none in the mRNA-1273 vaccinated group.
What are the demographics of the subjects?
The 95 COVID-19 cases included 15 older adults (ages 65+) and 20 participants identifying as being from diverse communities (including 12 Hispanic/LatinX, 4 Black or African Americans, 3 Asian Americans and 1 multiracial).
Were there any severe adverse events?
No. During the interim analysis of this study the DSMB did not observe any significant safety concerns. There were some adverse events of mild to moderate in severity levels. Grade 3 (severe) events greater than or equal to 2% in frequency after the first dose included injection site pain (2.7%) and after the second dose included fatigue (9.7%), myalgia (8.9%), arthralgia (5.2%), headache (4.5%), pain (4.1%) and erythema/redness at the injection site (2.0%). Generally these events were short-lived, reported the trial sponsor Moderna.
Is this safety data subject to change?
Absolutely. This interim analysis is early-on and large amounts of data still need to be analyzed for any conclusive statements.
Will Moderna use this data as a trigger to submit an Emergency Use Authorization like Pfizer/BioNTech?
Yes. They will submit for an EUA with the FDA in the coming weeks and anticipates having the EUA informed by the final safety and efficacy data (with a media duration of two months). The Cambridge, MA-based biotech company will also submit applications for EUAs to other global regulatory agencies.
Who is Moderna working with for purposes of vaccine distribution?
Moderna collaborates with the U.S. Centers for Disease Control and Prevention (CDC), Operation Warp Speed and McKesson (NYSE: MCK), a COVID-19 distributor contracted by the U.S. government as well as global stakeholders to be prepared for distribution of mRNA-1273, in the event that the company receives an EUA and similar global authorizations.
Does the company plan on having doses for distribution ready this year?
Yes. It plans on having up to 20 million doses of mRNA-1273 ready to ship in the United States before the end of the year.
What does the dosage volume look like in 2021?
The company touts in its recent press release that it remains on track to produce 500 million to 1 billion doses globally in 2021.
Will insurance companies pay for this vaccine candidate?
It appears the housekeeping for such potential is now occurring, based on the American Medical Association’s recent issuance of a Current Procedural Terminology (CPT) code to report vaccination with mRNA-1273 (Code: 91301).