Tensions have erupted between US government scientists and Moderna, one of the leading developers.
According to Reuters, the US govt has announced plan to support Moderna’s vaccine project with nearly half a billion US dollars and has chosen it as one of the first to enter large-scale human trials.
The company has, however, been locked in a face-off with the govt scientists over the process, delayed delivering trial protocols and resistance of experts’ advice on how to run the study.
According to sources familiar with the vaccine project, those tensions have contributed to a delay of more than two weeks in launching the trial of the Moderna’s vaccine.
The government scientists have doubted the firm’s experience and availability of staff and expertise to oversee the most critical phase of human trials.
Moderna and other vaccine developers are working with the US National Institutes of Health and the Food and Drug Administration, along with networks of immunologists and other vaccine experts tasked by the NIH to help oversee trial design.
While denying any fault on its part, Moderna stated that there were “differences of opinion” with experts involved in the unprecedented effort to deliver on the Trump administration’s pledge to find a vaccine within months.
Moderna said it has an experienced team that includes people who have run multiple large-scale trials.
“It has not been smooth or easy,” said Moderna spokesman Ray Jordan.
“No one has ever done anything like this before – not Moderna, not the NIH, and not any of the other companies,” Jordan added.
Moderna executives continue to resist experts’ insistence on close monitoring of trial participants who might contract COVID-19 for changes in oxygen levels that could signal dangerous complications.
Stephen Thomas, a vaccine developer who is chief of infectious diseases at SUNY Upstate Medical University, said vaccine development can spark such disagreements even without the pressures of an out-of-control pandemic.
“Those tensions, in and of themselves, don’t indicate that Moderna is incapable of doing it,” Thomas said.