One of the most closely watched Phase III Covid-19 vaccine trials is already more than 80% enrolled, while the vaccine has been fully administered in about 30% of participants, the company sponsoring it said Thursday.
As part of its 2020 R&D day, Cambridge, Massachusetts-based Moderna said Thursday that the Phase III COVE study of its vaccine against the SARS-CoV-2 virus, mRNA-1273, had enrolled 25,296 participants to date toward its 30,000-participant target as of Wednesday. Of those, 10,025 have received their second shot; mRNA-1273 consists of two shots – one delivered on day 1, and a booster shot that participants receive on day 29.
In addition – citing an interest in transparency – the company took the unusual step of publishing the full protocol of the study online.
Shares of Moderna were down 2% on the Nasdaq in afternoon trading Thursday.
Moderna is one of several companies developing vaccines against the Covid-19 virus that have already advanced their product candidates into late-stage development. The Phase III study is being conducted under partnership with the National Institutes of Health and the Department of Health and Human Services’ Biomedical Advanced Research and Development Authority, under HHS’ Operation Warp Speed. Moderna’s vaccine uses messenger RNA technology, similar to the BNT162 vaccines developed by Pfizer and Germany’s BioNTech, though Pfizer has emphasized a policy of not accepting government funding for its project.
The protocol of a trial is distinct from the entry on clinical trial registries such as ClinicalTrials.gov and includes details about patient selection, dosing, measurement of outcomes, adverse event management, study governance and other features that are not typically disclosed to the public until after the study is complete. The protocol for COVE is 135 pages long.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
“The pipeline has matured with our Covid-19 vaccine in a Phase III study and four candidates in Phase II studies,” Moderna CEO Stephane Bancel said in a statement. “We are actively preparing for a potential commercial launch of mRNA-1273, our Covid-19 vaccine, and we continue to expand the breadth of Moderna’s platform.”
Other companies with Covid-19 vaccines in late-stage development include AstraZeneca, which is developing its vaccine, AZD1222, with the University of Oxford. However, that study has run into trouble and partially been placed on hold due to an unexpected adverse event in a participant.
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