Late last week, it came out that Moderna would delay the phase 3 study of its COVID-19 vaccine, thanks to changes to the trial’s protocols, one investigator told Stat. Such changes are not uncommon, highlighting just how closely watched anti-COVID-19 efforts are, but the delay is part of a trend of tensions in the biotech’s relationship with the U.S. government.
Those tensions include resisting government experts’ advice on how to run the study and seeking a lower bar than proposed by the FDA to prove the vaccine works, as well as turning in trial protocols late, three sources familiar with the vaccine project told Reuters.
Moderna, which has a pipeline of more than 20 mRNA vaccines and treatments, has not yet brought a medicine to market. It is one of five drug developers selected under the U.S. government’s Operation Warp Speed, an initiative that aims to deliver a COVID-19 vaccine to Americans by the end of this year.
Although Moderna has already secured up to $483 million for its mRNA vaccine from the Biomedical Advanced Research and Development Authority (BARDA), Warp Speed can set it up with additional funding, clinical trial assistance and manufacturing help. The other four finalists—Pfizer, Merck, AstraZeneca and Johnson & Johnson—are all established drugmakers that have experience running large, late-stage trials and with whom the government is not “facing similar problems.”
Moderna, like its peers, has been given “significant control” over its phase 3 program, but it has been “less forthcoming” with the government about its plans, Reuters reported. As for the trial launch, Moderna said it “made the call” to delay it, but the sources told Reuters that the biotech did not have enough staff to finish the trial protocols on time. Before it started work on a COVID-19 vaccine, Moderna’s largest clinical trial involved about 250 patients, according to ClinicalTrials.gov. It plans to test its vaccine in 30,000 people.
It has also sought a lower threshold for proving if its vaccine worked and resisted the government scientists’ insistence on monitoring trial participants’ oxygen levels, a marker that could indicate dangerous complications, Reuters reported. Although it said monitoring could be a “hassle” that slowed down development, the company eventually aligned with the agency on both points.
Moderna dismissed the hiccups as “differences of opinion” in a mission to do something completely unprecedented.
“No one has ever done anything like this before—not Moderna, not the NIH, and not any of the other companies,” Moderna spokesman Ray Jordan told Reuters.
“There have, of course, been differences of opinion, but we believe there has always been good intent,” he said.
For its part, the Department of Health and Human Services (HHS), which oversees BARDA, told Reuters that the government’s collaboration with all companies in the project, including Moderna, has been “extremely cooperative.” HHS declined to answer other questions and the National Institutes of Health and the FDA declined to comment.
In the meantime, other Warp Speed finalists are going full speed ahead. Pfizer and partner BioNTech plan to start a phase 2b/3 study later this month that will enroll 30,000 patients, while AstraZeneca and Oxford University aim to follow suit in August. Johnson & Johnson initially planned to start human trials of its candidate in November but revised that to September when it joined forces with BARDA to commit $1 billion to the development of a COVID-19 vaccine.