20-0-1：mRNA-1273

CAMBRIDGE, Mass.--(BUSINESS WIRE)--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 confirmed that the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) recommended that the FDA grant an Emergency Use Authorization (EUA) for the Company’s COVID-19 vaccine candidate, mRNA-1273. 20 VRBPAC members recommended for EUA, 0 members voted against, and 1 abstained.

在线视频

https://www.youtube.com/watch?v=I4psAfbUtC0&feature=youtu.be

9:00 a.m. 

Opening Remarks: Call to Order and Welcome (10 min)

Arnold Monto, M.D. Acting Chair, VRBPAC

Professor of Public Health and Epidemiology, University of Michigan

Administrative Announcements, Roll Call, Introduction of Committee, Conflict of Interest Statement (20 min)

Prabhakara Atreya, Ph.D. Acting Designated Federal Officer, VRBPAC

Director, Division Scientific Advisors and Consultants, CBER, FDA

9:30 a.m. 

FDA Presentation on Emergency Use Authorization (15 min)

Doran L. Fink, MD, PhD

Deputy Director – Clinical

Division of Vaccines and Related Products Applications (DVRPA)

Office of Vaccines Research and Review (OVRR)

Center for Biologics Evaluation and Research (CBER), FDA

https://www.fda.gov/media/144584/download

10:05 am 

Considerations for placebo-controlled trial design if an unlicensed vaccine becomes available (15 min)

Steven Goodman, MD, MHS, PhD

Associate Dean of Clinical and Translational Research

Professor of Epidemiology and Population Health and of Medicine

Stanford University School of Medicine

https://www.fda.gov/media/144582/download

10:45 am

Sponsor Presentation: Emergency Use Authorization (EUA) Application for mRNA-1273 (50 min)

Tal Zaks, M.D. Chief Medical Officer and Head of Clinical Development

Jacqueline Miller, M.D. FAAP, Senior Vice President, Infectious Diseases

Development, Therapeutic Area Head

https://www.fda.gov/media/144583/download

2:00 p.m. 

FDA Presentation and Voting Questions (50 min)

Rachel Zhang, MD

Medical Officer

DVRPA, OVRR, CBER, FDA

https://www.fda.gov/media/144585/download