MODERNA SPARS WITH US SAVANTS OVER COVID VACCINE TRIALS

As the United States accelerates the search for a coronavirus vaccine, tensions have erupted between government scientists and Moderna, Inc, one of the leading developers, Marisa Taylor and Tobin Respaut wrote for Reuters late in July 7, 2020.

The federal government is supporting Moderna’s vaccine project with nearly half a billion dollars and has chosen it as one of the first to enter large-scale human trials. But the company - which has never produced an approved vaccine or run a large trial - has squabbled with government scientists over the process, delayed delivering trial protocols and resisted experts’ advice on how to run the study, according to three sources familiar with the vaccine project. The sources said those tensions, which have not been previously reported, have contributed to a delay of more than two weeks in launching the trial of the Moderna’s vaccine candidate, now expected in late July.

Moderna “could be on schedule if they were more cooperative,” one of the sources told Reuters. Some of the disagreements have stoked concerns over the young biotech firm’s relative inexperience and what the sources described as its lack of staff and expertise to oversee the most critical phase of human trials. The U.S. government is not facing similar problems with established drug makers, such as AstraZeneca Plc and Johnson & Johnson, working on other leading vaccine candidates, the sources said.

Moderna and other vaccine developers are working with the US National Institutes of Health (NIH) and the Food and Drug Administration (FDA), along with networks of immunologists and other vaccine experts tasked by the NIH to help oversee trial design. The company denied any misstep on its part but acknowledged “differences of opinion” with experts involved in the unprecedented effort to deliver on the Trump administration’s pledge to find a vaccine within months. It typically takes about a decade to develop a vaccine - and many efforts fail to produce one at all. Moderna said it has an experienced team that includes people who have run multiple large-scale trials.