Positive vaccine trial
Moderna developing key cog in virus fight
The highly regarded coronavirus vaccine created by Cambridge-based company Moderna has shown positive results in early participants of its phase 1 study, the company announced on Monday.
After two doses of the vaccine, all healthy participants showed binding antibody levels and neutralizing antibody levels that were at or above those who have recovered from coronavirus, according to Moderna.
The vaccine was safe and welltolerated among the participants and an anticipated dose for phase 3 is expected to start in July.
In all, 45 people have received one or two shots of the vaccine, which was being tested at three different doses. The kind of detailed antibody results needed to assess responses are only available on eight volunteers so far.
“With today’s positive interim Phase 1 data and the positive data in the mouse challenge model, the Moderna team continues to focus on moving as fast as safely possible to start our pivotal Phase 3 study in July,” said Stephane Bancel, chief executive officer at Moderna.
Preclinical results from a viral challenge study in mice also showed the vaccine offered full protection against viral replication in the lungs.
“When combined with the success in preventing viral replication in the lungs of a pre-clinical challenge model at a dose that elicited similar levels of neutralizing antibodies, these data substantiate our belief that mRNA1273 has the potential to prevent COVID-19 disease and advance our ability to select a dose for pivotal trials,” said Dr. Tal Zaks, chief medical officer at Moderna.
A phase 2 study is expected to begin soon, according to a presentation delivered by Moderna in a Monday morning conference call.
That study will evaluate the safety and effectiveness of the vaccine after two doses are given to participants 28 days apart.
The study will include 600 healthy participants of middleaged adults and older adults.
The presentation highlighted the impressive timeline Moderna was able to follow, which include the incredibly quick process of dosing the first human patient just 63 days after the coronavirus sequence was released.
Moderna stock has soared in recent months and was trading at $66 a share on Friday before jumping to $80 at close on Monday.
Worldwide, about a dozen vaccine candidates are in the first stages of testing or nearing it. Health officials have said that if all goes well, studies of a potential vaccine might wrap up by very late this year or early next year.