BNT162b2 Vaccine 过堂记

今晚10点开始视频链接，现在才结束2个

9:30 a.m. FDA Presentation on Emergency Use Authorization

10:00 a.m. Update on Epidemiology

<现在>

10:30 a.m. Vaccine Safety and Effectiveness Monitoring 

10:50 a.m. Considerations for placebo-controlled trial design if an unlicensed

vaccine becomes available

1:00 p.m. Sponsor Presentation

2:00 p.m. FDA Presentation and Voting Questions

后面有各个session的slides下载

https://www.youtube.com/watch?v=owveMJBTc2I&feature=youtu.be

https://fda.yorkcast.com/webcast/Play/d75d80a3eb6e419986181c1a881fe2671d

9:30 a.m. FDA Presentation on Emergency Use Authorization

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

FDA Review of Efficacy and Safety of Pfizer-BioNTech COVID-19 Vaccine Emergency Use Authorization Request

https://www.fda.gov/media/144337/download

10:00 a.m. Update on Epidemiology 

Aron J. Hall, DVM, MSPH, Dipl. ACVPM

Co-Lead, Epidemiology Task Force, COVID-19 Response

Chief, Respiratory Viruses Branch, Division of Viral Diseases

National Center for Immunization and Respiratory Diseases

Centers for Disease Control and Prevention

Epidemiology of COVID-19 in the United States

https://www.fda.gov/media/144330/download

10:30 a.m. Vaccine Safety and Effectiveness Monitoring

Nancy Messonnier, MD

Director, National Center for Immunization and Respiratory Diseases

(NCIRD), Senior Official, Vaccine Task Force, CDC

COVID-19 Vaccine Post-authorization Safety and Effectiveness Monitoring

https://www.fda.gov/media/144327/download

Operational Distribution Plans

Anita Patel, PharmD, MS

Deputy, Vaccine Task Force, CDC

Distribution Overview

https://www.fda.gov/media/144328/download

1:00 p.m. Sponsor Presentation

Moderator: Kathrin U. Jansen, PhD Senior Vice President and Head,

Vaccine Research and Development, Pfizer Inc.

Presenter: William C. Gruber, MD Senior Vice President, Vaccine Clinical

Research and Development, Pfizer Inc.

BNT162b2 Vaccine Candidate Against COVID-19

https://www.fda.gov/media/144325/download

2:00 p.m. FDA Presentation and Voting Questions

Susan Wollersheim, MD

Medical Officer

DVRPA, OVRR, CBER, FDA

Emergency Use Authorization Overview and Considerations for COVID-19 Vaccines

https://www.fda.gov/media/144329/download

3:10 p.m. Committee Discussion and Voting

团结的大会，胜利的大会。。。

终