Coronavirus / Biotech Stock News Bites: Moderna (Nasdaq: $MRNA) Announces Phase 3 COVE Study of mRNA Vaccine Against COVID-19 (mRNA-1273) Begins
Phase 3 study being conducted in collaboration with NIH and BARDA
Expected to enroll 30,000 participants in the U.S.
CAMBRIDGE, Mass - July 27, 2020 (Investorideas.com Newswire) Coronavirus / Biotechnology (COVID-19) Stock News Bites - Moderna, Inc., (Nasdaq: MRNA) a clinical stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced that the Phase 3 study of its mRNA vaccine candidate (mRNA-1273) against COVID-19 has begun dosing participants. The Phase 3 study, called the COVE (Coronavirus Efficacy) study, 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.
"We are pleased to have started the Phase 3 COVE study," said Stephane Bancel, CEO at Moderna. "We are grateful to the efforts of so many inside and outside the company to get us to this important milestone. We are indebted to the participants and investigators who now begin the work of the COVE study itself. We look forward to this trial demonstrating the potential of our vaccine to prevent COVID-19, so that we can defeat this pandemic."
The Phase 3 study protocol follows the U.S. Food and Drug Administration (FDA) guidance on clinical trial design for COVID-19 vaccine studies. The randomized, placebo-controlled trial is expected to include approximately 30,000 participants in the United States, testing an mRNA-1273 dosage of 100 µg. The primary endpoint will be the prevention of symptomatic COVID-19 disease. Key secondary endpoints include prevention of severe COVID-19 disease (as defined by the need for hospitalization) and prevention of infection by SARS-CoV-2 regardless of symptomology. SARS-CoV-2 is the virus that causes COVID-19.
The primary efficacy analysis of the Phase 3 study will be an event-driven analysis based on the number of participants with symptomatic COVID-19 disease. To ensure the ongoing safety monitoring of the participants in the trial, data will be reviewed by an independent Data and Safety Monitoring Board organized by NIAID throughout the study. The clinicaltrials.gov identifier is NCT04470427.
Moderna also is collaborating with long-standing partner PPD (Nasdaq: PPD), a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. PPD supported the Phase 2 study for Moderna's COVID-19 vaccine program, which completed the enrollment of 600 subjects at eight research sites within a month. PPD has contributed an array of clinical development and laboratory services, including strategic expertise to the study design, patient-enrollment epidemiology modeling and biostatistics.
With its collaborators, Moderna has selected nearly 100 clinical research sites with representative demography and is partnering closely with those sites to ensure that volunteers at increased risk for COVID-19 disease are enrolled in the study. The clinical research sites, with the support of the Company, are working within their local communities to reach a diverse population. Working together with collaborators, the Company hopes to achieve a shared goal that the participants in the COVE study are representative of the communities at highest risk for COVID-19 and of our diverse society.
The Company remains on track to be able to deliver approximately 500 million doses per year, and possibly up to 1 billion doses per year, beginning in 2021 because of the Company's internal U.S. manufacturing capabilities and strategic collaboration with Lonza, Ltd. In addition, Moderna recently announced a collaboration with Catalent, Inc. for large-scale, commercial fill-finish manufacturing of mRNA-1273 at Catalent's biologics facility for the U.S., and with ROVI of Spain for fill-finish manufacturing outside the U.S.
Read the company's full news and disclaimer here:
Visit Investorideas.com biotech and coronavirus stocks directory https://www.investorideas.com/BIS/stock_list.asp
About Investorideas.com - News that Inspires Big Investing Ideas Investorideas.com is a recognized news source publishing third party news, research and original financial content. Learn about investing in stocks and sector trends with our news alerts, articles, podcasts and videos, looking at cannabis, crypto, AI and IoT, mining, sports biotech, water, renewable energy and more. Investor Idea's original branded content includes the following podcasts and columns: Crypto Corner, Play by Play sports and stock news column, Investor Ideas Potcasts Cannabis News and Stocks on the Move podcast and column, Cleantech and Climate Change, Exploring Mining the AI Eye.
Stock Bites is a branded product of Investorideas.com Disclaimer/Disclosure: Investorideas.com is a digital publisher of third party sourced news, articles and equity research as well as creates original content, including video, interviews and articles. Original content created by investorideas is protected by copyright laws other than syndication rights. Our site does not make recommendations for purchases or sale of stocks, services or products. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. All investing involves risk and possible losses. This site is currently compensated for news publication and distribution, social media and marketing, content creation and more. Disclosure is posted for each compensated news release, content published /created if required but otherwise the news was not compensated for and was published for the sole interest of our readers and followers. Contact management and IR of each company directly regarding specific questions. This stock bites news release publication is available as a paid for service on Investorideas.com https://www.investorideas.com/News-Upload/
More disclaimer info: https://www.investorideas.com/About/Disclaimer.asp Learn more about publishing your news release and our other news services on the Investorideas.com newswire https://www.investorideas.com/News-Upload/ and tickertagstocknews.com
Follow us on Twitter https://twitter.com/Investorideas
Follow us on Facebook https://www.facebook.com/Investorideas
Follow us on YouTube https://www.youtube.com/c/Investorideas
Download our Mobile App for iPhone and Android
Get free investor news alerts
Join our Investor Club https://www.investorideas.com/membership/
800 665 0411