https://investors.modernatx.com/news-releases/news-release-details/modernas-covid-19-vaccine-candidate-meets-its-primary-efficacyModerna’s COVID-19 Vaccine Candidate Meets its Primary Efficacy Endpoint in the First Interim Analysis of the Phase 3 COVE StudyCAMBRIDGE, Mass.--(BUSINESS WIRE)--Nov. 16, 2020-- Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced that the independent, NIH-appointed Data Safety Monitoring Board (DSMB) for the Phase 3 study of mRNA-1273, its vaccine candidate against COVID-19, has informed Moderna that the trial has met the statistical criteria pre-specified in the study protocol for efficacy, with a vaccine efficacy of 94.5%. This study, known as the COVE study, enrolled more than 30,000 participants in the U.S. and is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services.
The primary endpoint of the Phase 3 COVE study is based on the analysis of COVID-19 cases confirmed and adjudicated starting two weeks following the second dose of vaccine. This first interim analysis was based on 95 cases, of which 90 cases of COVID-19 were observed in the placebo group versus 5 cases observed in the mRNA-1273 group, resulting in a point estimate of vaccine efficacy of 94.5% (p <0.0001).
A secondary endpoint analyzed severe cases of COVID-19 and included 11 severe cases (as defined in the study protocol) in this first interim analysis. All 11 cases occurred in the placebo group and none in the mRNA-1273 vaccinated group.
NIH started working with Moderna in late January, one of the months
Biden & the Dems claim Trump wasted.
So here are the major milestones, past and soon coming in vaccines and treatments:
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Pfizer is likely to receive Emergency Use Authorization (EUA) for its vaccine within weeks;
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Moderna is likely to receive EUA for its vaccine within weeks;
* Depending on how much credit the FDA gives testing done in the UK, South Africa, and Brazil,
AstraZeneca could receive EUA for its vaccine within weeks;
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Eli Lilly last week received EUA for the monoclonal antibody (mab) treatment developed with
AbCellera (begun in January 2020 as part of AbCellera's participation in a 2018 DARPA project to develop fast response processes to disease outbreaks);
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Regeneron is likely to receive EUA for its mab treatment within a few weeks or even days;
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GlaxoSmithKline could receive EUA for its mab treatment within a month or two;
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Gilead received authorization about 4 weeks ago (not just EUA) for the use of Veklury (remdesivir) in treating Covid-19.