Moderna’s heavily anticipated trial for a coronavirus vaccine, which was set to begin next week, has been delayed.
“Moderna has previously disclosed that the Phase 3 trial of its COVID-19 vaccine candidate mRNA-1273 is expected to begin in July. The trial is still expected to begin in July and we expect to be the first to start a Phase 3 trial,” read a company statement sent to The New York Daily News Thursday. “We have worked closely with NIH/OWS to align on the final protocol in order to begin the trial on time.”
The Phase 3 study, which includes 30,000 patients, was initially supposed to begin on July 9, but changes to the trial plan have altered the schedule, investigators who spoke anonymously told STAT earlier Thursday.
Although such changes are reportedly common, Moderna did not elaborate on what the particular alterations are.
“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 of the investigators told the health and medicine publication. “As best I can tell, they’re close to being on target for that.”
Also on Thursday, Dr. Francis Collins, the Director of the National Institutes of Health, testified to lawmakers that Moderna is working with the National Institute of Allergy and Infectious Diseases and the Biomedical Advanced Research and Development Authority to launch the trial “as early as this month, pending positive results from this Phase 2 trial,” which began in late May.
Moderna isn’t the only horse in the race to develop and manufacture a COVID-19 vaccine.
Partnering with BioNTech, Pfizer’s own 30,000-patient study is slated to start this month. AstraZeneca and Oxford University have their own trial of similar proportions scheduled to begin in August, and Johnson & Johnson plans to start one in September.
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