Moderna reiterates July start for Phase III COVID-19 vaccine trial following report of delay

Shares in Moderna fell as much as 9.4% on Thursday after a report indicated that the company’s late-stage trial for potential COVID-19 vaccine mRNA-1273 will be delayed. According to the report in STAT News citing unnamed investigators involved in running the trial, which was slated to begin July 9, it is unclear how long the delay will last.

Investigators indicated that the start date has been pushed back because Moderna is working on amendments to the study protocol. "My understanding was that they wanted to get the first vaccines given in July, and they say they're still committed to do that," one investigator is quoted as saying, and "as best I can tell, they're close to being on target for that."

'I confirm July': CEO

In response to the report, Moderna CEO Stéphane Bancel suggested the study was on track, but did not offer a specific start date, noting "we have always said July and I confirm July." Moderna also issued a tweet saying that it expects to be the first to start a Phase III trial for a COVID-19 vaccine. "We have worked closely with NIH/OWS (US National Institutes of Health/Operation Warp Speed) to align on the final protocol in order to begin the trial on time," the company added.

Moderna is one of several companies selected to participate in the US government's Operation Warp Speed initiative, which aims to have substantial quantities of a safe and effective COVID-19 vaccine available for Americans by January 2021.

The Phase III trial will enrol approximately 30,000 people in the US who will be randomised to receive mRNA-1273 at a 100-mcg dose or placebo. The study, conducted in partnership with the NIH, will assess the prevention of symptomatic COVID-19 disease as its primary endpoint, while key secondary goals include prevention of severe COVID-19 disease and prevention of infection by SARS-CoV-2.

Results due 'in a few months'

At a US Senate hearing on Thursday, NIH director Francis Collins seemed to back Bancel's remarks, saying "the furthest along in US testing is an experimental vaccine from NIH's vaccine research centre in partnership with Moderna." Collins added "this month we'll seek to enroll 30,000 volunteers with results expected in a few months."

In May, Moderna reported preliminary data from a Phase I trial showing that mRNA-1273, which encodes for a prefusion stabilised form of the Spike protein that protrudes from the coronavirus surface, elicited neutralising antibody titer levels in all eight initial participants in the low- and mid-dose cohorts.

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