One of the companies in the lead to develop a vaccine to prevent infection with the virus that causes Covid-19 has sent its application to regulators to start a larger trial to determine efficacy.
Cambridge, Massachusetts-based Moderna said Monday that it had submitted an investigational new drug application to the Food and Drug Administration to start a Phase II study of mRNA-1273, its messenger RNA-based vaccine against SARS-CoV-2. Initiation is contingent on supportive safety data from the ongoing Phase I study, which the company said would be released once they become available.
Shares of Moderna fell 5.8% on the Nasdaq when markets opened Tuesday.
The company said the original three cohorts of the Phase I study, enrolling healthy volunteers aged 18-55 who receive the vaccine at 25, 100 and 250 micrograms, has finished enrolling 45 participants, and the trial is now enrolling six additional cohorts of people aged 56-70 and 71 and older. Data from the initial patient cohort will be reported once it’s available, the company said. The Phase II study will enroll 600 participants, divided in half between those aged 18-55 and those 55 and older, all of whom will be followed through 12 months after the second vaccination.
“Submitting this IND is an important next step in the clinical development of our mRNA vaccine against SARS-CoV-2, and we are moving rapidly to potentially address this global health emergency,” Moderna chief medical officer Tal Zaks said in a statement. “We look forward to launching this Phase II study as soon as possible, which will provide important information about the safety, reactogenicity and immunogenicity of mRNA-1273.”
Immunogenicity refers to the ability of a foreign body such as a vaccine to provoke an immune system response, while reactogenicity refers to a vaccine’s ability to produce adverse reactions related to the body having an inflammatory response to it.
The announcement comes less than two weeks after Moderna received a funding commitment of up to $483 million from the Biomedical Advanced Research and Development Authority to support its development of mRNA-1273 through Phase III testing and potential licensing by the Food and Drug Administration. The company said in its Monday announcement that depending on results from the Phase I and Phase II studies, a Phase III trial could begin this fall.
Moderna is one of several companies developing vaccines against Covid-19. The first to move a candidate into Phase II testing was CanSino Biologics, based in Tianjin, China, which said in a regulatory filing earlier this month that it would start a Phase II study of its vaccine candidate, Ad5-nCoV.
Photo: FDA, via Flickr (free of copyright protection)