Gearing up for a phase 3 clinical trial of its coronavirus vaccine candidate, mRNA-1273, Moderna (MRNA -0.58%) is apparently butting heads with federal government officials. Tensions between the company and the officials have delayed the start of the trial. This is according to a report on Tuesday by Reuters that cited three sources familiar with the vaccine project.
The sources say that Moderna and the government, specifically the National Institutes of Health (NIH) and the Food and Drug Administration (FDA), plus outside medical experts brought in by the NIH are at odds over numerous elements of the testing. These include the protocols of the trials, patient monitoring, and information sharing.
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According to the article's sources, Moderna was several weeks late in submitting those protocols due to a dearth of employees to handle the work. This is apparently a key reason the start of the trial has been delayed, although the company insists that it will occur this month as planned. One of the interviewees said that Moderna "could be on schedule if they were more cooperative."
Both Moderna and government entities involved in the mRNA-1273 project have denied strains in the relationship. The Department of Health and Human Services, the NIH's parent agency, characterized its work with Moderna and other parties involved in the project as "extremely cooperative."
Moderna acknowledged "differences of opinion," but denied it was being difficult.
Moderna, a young biotech considered to be a leading coronavirus stock these days, was granted $483 million in funding from the government to develop and produce mRNA-1273. The company is part of the federal Operation Warp Speed program aimed at rapidly developing an effective coronavirus vaccine, and its mRNA-1273 is the first candidate to be entering a phase 3 trial.
