The coronavirus vaccine trial that started out in Seattle is progressing well enough to get onto Food and Drug Administration’s fast track for development, with planning well underway for the next two phases of testing.
Seattle’s Kaiser Permanente Washington Health Research Institute kicked off the Phase I clinical trial, which focuses on ensuring that the vaccine is safe for humans.
The first participants got their shots in mid-March, and last month, the trial was expanded to Emory University in Atlanta and the National Institute of Allergy and Infectious Diseases’ Vaccine Research Clinic in Bethesda, Md. NIAID is funding the trial, and the vaccine was developed by Moderna Therapeutics.
Last week, Moderna said the Phase I results were so encouraging that the FDA gave the go-ahead for Phase II trials, which involve administering the vaccine to 600 volunteers and finding out whether it sparks the desired immune response.
Today, Moderna said the FDA issued fast-track authorization, and NIAID director Anthony Fauci gave the vaccine his vote of confidence during a Senate hearing. “If we are successful, we hope to know that in the late fall or early winter,” Fauci said.
Plans are already being made for Phase III trials. “My team is actually spending most of the time now preparing for Phase III that they say could start in early summer,” Moderna CEO Stephane Bancel said during a CNBC interview.
Bancel marveled at how the timetable for Phase II and Phase III is being sped up.
“In normal times, we would have waited for antibody levels, looked at total data, asked experts, and only then start to make the Phase II material,” he said. “So here we say, look, lives are at stake. Let’s make the Phase II material at risk during the Phase I. Let’s not wait … let’s just go into Phase II as soon as we know the safety of Phase I is positive.”
Bancel said it would be up to the National Institutes of Health to decide when the data from the Phase I trials can be shared.
“As soon as we have data that makes sense, we will of course share it,” he told CNBC. “We know everybody is eager to see the data.”
Late in the clinical trial process, vaccinated participants are traditionally exposed to the pathogen they’re supposed to be protected from, to ensure that the vaccine is effective. That’s a complicated issue for COVID-19, since there’s currently no surefire treatment to rescue patients from the effects of the virus if the vaccine doesn’t work.
Bancel said Massachusetts-based Moderna is working out the procedure for challenge trials, beginning with non-human experiments.
Coronavirus Live Updates: The latest COVID-19 developments in Seattle and the world of tech
“If you get the right animal model, you can do a challenge into an animal where you vaccinate them, and then you give them a very high dose of a virus, and you can see, you know, are we getting protection? That sort of clinical work should be published pretty soon now,” he said.
If the vaccine gets far enough, Moderna plans to make it available to thousands of volunteers, thanks to hundreds of millions of dollars in federal funding. The timing just might mesh with what’s expected to be a second wave of the outbreak.
“If you think about it, if we’re going to run thousands and thousands of healthy subjects getting vaccinated, and then into potentially the second wave in the fall, we should be able to get the efficacy rate down actually pretty quickly,” Bancel said. “Maybe even faster than getting a challenge study set up properly.”
Leonard Schleifer, the founder and CEO of Regeneron, told CNBC that ethicists will have to address the thorny questions surrounding such studies. “I’m sure there will be no shortage of people willing to volunteer,” he said. “The question is not whether people would volunteer to do this, the question is how the ethics come out.”
In any case, Bancel hopes there’ll be more than one vaccine approved for use against COVID-19. “I really hope that we have three or four or five vaccines, because no [single] manufacturer can make enough doses for the planet,” he said.
Bancel said the looming vaccine shortage is already sparking discussions with the federal government.
“How do we provide access? How do you prioritize? We believe this is not a company decision,” he said. “This has been done by the clinical community, being coordinated across the country. … We are going to be at least a year, a year and a half, with really a tight, tight supply across the country and across the world.”
