The first US clinical trial for a Covid-19 vaccine will likely not start until the end of the month or the beginning of August, according to a researcher involved in the trials with Moderna.
“It’s been delayed,” said Dr. Carlos del Rio, an infectious disease expert at Emory University School of Medicine and one of the investigators for the Moderna vaccine.
On June 15, one of vaccine trial centers, the University of Illinois at Chicago, said it expected the trial to start July 9.
“We won’t start until July 27, probably,” del Rio said. “But July 27 would still be absolutely amazing. Even if it happens in early August, that’s still amazing. This is going at a speed no other vaccine has ever gone.”
He added that there are many steps involved in putting together a large clinical trial.
“We still need to get FDA approval. We still need to get IRB approval,” del Rio said, referring to the US Food and Drug Administration and institutional review boards at specific centers where the trials will be done.
In addition, he said there are logistical matters, such arranging for enough doses of the vaccine, as well as doses of the placebo that will be given to about half the patients as a comparison.
“This is not an easy trial to get out there. It’s a 30,000 person trial,” del Rio said.
The news of a delay was first reported by STAT. After the article was published, Moderna put out a statement on Twitter.
“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,” according to the statement.
The University of Oxford in England has already started Phase 3 trials in the UK.