One of the companies in the lead to develop a vaccine against the virus that causes Covid-19 has finished enrolling participants into its mid-stage clinical trial.
Cambridge, Massachusetts-based Moderna said Wednesday that it had completed enrollment in its Phase II study of mRNA-1273, its vaccine against SARS-CoV-2, including both its cohorts of younger and older adults. The company said it plans to start a Phase III study this month and has finished manufacturing the supplies of vaccine required to begin.
Shares of Moderna were down more than 2% on the Nasdaq in late-morning trading Thursday.
The randomized, placebo-controlled Phase II study enrolled participants in two cohorts, consisting of those aged 18-55 and those aged 55 and older. The company said on June 11 that it had completed enrollment of the cohort of younger volunteers, which consisted of 300 participants, plus the sentinel group of 50 older adults, aged 55 and older. As of Wednesday, the company has also completed enrollment of a 300-volunteer cohort of older adults.
The Phase III study is expected to include approximately 30,000 healthy volunteers in the U.S., who will be randomized on a 1:1 basis to receive mRNA-1273 at 100 micrograms or placebo. The company said that it is on track to provide about 500 million and potentially up to 1 billion doses of the vaccine annually starting next year.
Moderna’s vaccine is based on messenger RNA technology, similar to the vaccines that Pfizer is developing under a partnership with Germany-based BioNTech. Other vaccines in clinical development include Inovio’s INO-4800, which was developed using DNA-based technology. Others include Novavax’s NVX-CoV2373, which uses nanoparticle technology, and a vaccine developed by China-based CanSino Biologics that is based on adenoviral vector technology. Several of the vaccines currently in clinical development, including Moderna’s, have already produced data showing antibody responses in volunteers. However, while that has generated significant excitement, it remains to be seen whether that will translate into immunity, and if so, how long that immunity will last.
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