The biotech firm Moderna Therapeutics announced Monday that all 45 participants in the first phase of its COVID-19 vaccine trial who received one of three dose levels of the vaccine developed some antibodies. The company is expected to begin the second phase soon, and its president, Stephen Hoge, said their goal is to have the vaccine ready for distribution by early next year.
Hoge said 30 of those 45 participants, who received two doses of the vaccine at the 25-microgram dose level or the 100-microgram dose level, the low and the middle levels, had developed “antibodies in their blood that bound the virus.”
“When we characterized eight of those subjects and said, would it neutralize the virus, in a viral replication assay, it showed that those same antibodies that those people had developed actually could neutralize the virus and prevent its ability to infect human cells,” Hoge said on “CBS This Morning” Monday. “All together, we’re very pleased by that result because it suggests we’re on the right path with this vaccine.”
Phase 2 of the trials will “expand the safety and immunogenicity database,” he said.
“The Phase 1, the vaccine was generally safe and well tolerated, but 45 people is still a relatively small number. And so we’ll be looking across 600 people in the Phase 2 study, which will start any day now, and that will be to both confirm that we’ve got the right idea of the dose where we believe we’re going to see protective immunity, as well as that the safety profile continues to hold up,” he said.
After Phase 2, Moderna expects to start Phase 3 by early summer, Hoge said.
“Our goal is to have a vaccine available for broad distribution by year-end or early next year,” he said. “If we and others build data that shows that the vaccine has a potential for benefit, that it’s safe and has a potential for efficacy, then, of course, there are circumstances where the vaccine could be deployed to high-risk populations earlier under something called an Emergency Use Authorization. Really though, that’s a decision that regulators, in particular the FDA, have to make.”
While the latest results are “a small step” in the right direction, CBS News medical contributor Dr. David Agus said there is a long way to go.
Responding to Health and Human Services Secretary Alex Azar’s comment that the country’s goal is to create 300 million doses of a vaccine by the end of the year, Agus said, “I don’t think it’s likely that we’re going to have 300 million doses of a vaccine at the end of the year. … We’re going to need 600 million doses as a country. I think we’ll have millions of doses by the end of the year.”