Trial of Moderna Covid-19 vaccine delayed, investigators say, but July start still possible
Written by Sunlight Radio America on July 3, 2020
A 30,000-patient trial of Moderna’s coronavirus vaccine candidate, expected to start next week, has been delayed, a potential hurdle in the company’s ambitious effort to deliver key data by Thanksgiving.
Moderna is making changes to the trial plan, called a protocol, which has pushed back the expected start date of the Phase 3 study, according to investigators. The investigators, who spoke on condition of anonymity, emphasized that protocol changes are common but said it’s not clear how long the start will be delayed.
“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 said. “As best I can tell, they’re close to being on target for that.”
Investigators at the University of Illinois at Chicago had previously said Moderna’s trial would begin July 9. On Thursday, NIH Director Francis Collins also told lawmakers in Washington that the study would begin this month.
Moderna did not respond to multiple emails asking about how long the delay will last, the nature of the protocol changes, or whether they have anything to do with the vaccine’s safety or manufacturing. After publication, CEO Stéphane Bancel told CNBC that Moderna still intends to start the trial in July. In a statement posted to Twitter on Thursday afternoon, the company said it has “worked closely” with the National Institutes of Health, which is funding the Phase 3 study, “to align the final protocol in order to begin the trial on time.”
Source: Stat News
