30K volunteers, 95 infections, 94.5% efficacy: Moderna vaccine breakthrough
Nov 21 2020
Hepburn's comments followed release of interim results from a late-stage clinical trial that showed the experimental vaccine to be 94.5% effective in preventing COVID-19. The study's primary endpoint is significantly fewer COVID-19 cases confirmed and adjudicated starting two weeks following the second dose of vaccine compared with patients randomized to placebo.
This is a developing story.
The interim analysis included a concurrent review of the available Phase 3 COVE study safety data by the independent, NIH-appointed Data Safety Monitoring Board (DSMB), which did not report any significant safety concerns.
Shares in Moderna rose 9% in pre-market trading on Monday after an independent health board said its COVID-19 vaccine is nearly 95% effective.
Moderna says that within the coming weeks it will be submitting for an Emergency Use Authorization of its vaccine candidate based on the results, looking to get approval from the FDA to use it in emergency circumstances ahead of a full and final approval.
The third phase of Moderna's trial on a coronavirus vaccine candidate involved some 30,000 participants, half of which took a placebo while the other half received the actual vaccine under development.
This news comes after a large test undertaking called the "COVE study" which enrolled more than 30,000 participants in the U.S.
The study will not be finalized until 151 people become infected, Moderna hinted that the efficacy statistics might fluctuate until that point.
Investors appeared to agree with both Yee and Moderna: The company's shares soared 12.88% in premarket trading as of 8:32 a.m., to $101.71 a share from Friday's close of $89.39, before dipping to $95.02 in early trading as of 10:35 a.m., a 6% gain.
By comparison, of the 43,538 participants in Pfizer/BioNTech's Phase III trial, approximately 42% of global participants and 30% of US participants had "racially and ethnically diverse backgrounds", BioNTech and Pfizer said, without furnishing a more precise breakdown.
Phase 3 of the trials will initially involve 6,000 volunteers from 17 sites across the United Kingdom, including Belfast, Bristol, Cardiff, Dundee, Leicester, London, Manchester, Sheffield and Southampton. Finding an effective vaccine with a good safety profile is a top priority in helping to protect us all more quickly against COVID-19.
There were 11 people who fell severely ill, all of whom were in the placebo group.
These adverse events were "short lived", according to a statement.