Moderna on Tuesday confirmed published reports of disagreements it had with government officials over how to run large-scale human trials of the company’s experimental COVID-19 vaccine, but a spokesman for the Cambridge biotech brushed aside the matter, calling the disputes “productive dialogue.“
The disagreements have included how closely Moderna should monitor trial participants who might contract COVID-19 for changes in oxygen levels that could indicate a dangerous complication, as well as Moderna’s initial request for a lower threshold for proving its vaccine works.
All of the disagreements were resolved, according to the company.
“There’s always healthy scientific exchange when you have these kinds of actions,” said Moderna spokesman Ray Jordan. “I call it productive dialogue.”
A spokeswoman for Operation Warp Speed, the multi-agency federal effort seeking to get a COVID-19 vaccine to the American public as quickly as possible, didn’t immediately respond to a request for comment.
Reuters reported early Tuesday that tensions had flared between government scientists and Moderna, which in March got the first potential coronavirus vaccine into an early-stage clinical trial.
Moderna is receiving up to $483 million from the Biomedical Advanced Research and Development Authority, part of the Department of Health and Human Services, to accelerate development of the vaccine. The authority has given billions of dollars to four other drug makers working on their own COVID-19 vaccines.
Moderna, which has never produced an approved drug or vaccine, has squabbled with government scientists over its planned Phase 3 clinical trial, delayed delivering trial protocols, and resisted experts’ advice on how to run the study, three unidentified sources familiar with the vaccine project told Reuters.
Those tensions have contributed to a delay of more than two weeks in launching the Phase 3 trial, said the sources. It is now expected to start in late July. Moderna “could be on schedule if they were more cooperative,” one of the sources told Reuters.
The company’s vaccine was first injected into the arms of 45 healthy volunteers on March 16 in Seattle in an early-stage trial, a mere 63 days after company scientists obtained the genetic sequence for the virus. Moderna’s candidate uses messenger RNA, genetic material that instructs cells to make proteins that provoke an immune response. Researchers have explored that scientific approach for several years, but it has yet to produce an approved vaccine.
Moderna had hoped to start a late-stage trial, involving 30,000 patients, in the first half of July, Jordan said. But it was moved to the second half of the month as the company worked out details with officials from federal agencies, including the Food and Drug Administration, the National Institutes of Health, and the National Institute of Allergy and Infectious Diseases. STAT first reported the trial delay on Thursday.
One of the disagreements concerned monitoring of trial participants for a serious potential symptom of COVID-19 ― decreased oxygen levels ― in the event that the vaccine caused the disease instead of triggering an immune response to the virus.
Federal scientists have insisted on close monitoring of volunteers in coronavirus vaccine trials, and rival companies have complied with the request as they plan their testing. But Moderna questioned the recommendation as a “hassle” that slowed development, one of the sources told Reuters.
Jordan told the Globe that Moderna “wanted to defer decisions about the intensity of monitoring to the qualified physician caring for the patient rather than to dictate,” but “ultimately the company agreed to increased monitoring while still leaving discretion to the physician caring for the patient.”
Moderna has also drawn scrutiny for recent stock trades by some of its executives.
Several, including chief executive Stephane Bancel and chief medical officer Tal Zaks, have made tens of millions of dollars this year by selling company shares that have tripled in value following news of the company’s progress in making a vaccine.
Moderna contends that many of those stock sales were arranged before it began working on a COVID-19 vaccine.
Jonathan Saltzman can be reached at email@example.com.