FOOD AND DRUG ADMINISTRATION (FDA) Center for Biologics Evaluation and Research (CBER) 164th Vaccines and Related Biological Products Advisory Committee (VRBPAC) Meeting OPEN PUBLIC MEETING Web-Conference Silver Spring, Maryland 20993 February 26, 2021 This transcript appears as received from the commercial transcribing service after inclusion of minor corrections to typographical and factual errors recommended by the DFO. 2 ATTENDEES COMMITTEE MEMBERS Paula Annunziato, M.D. Merck Archana Chatterjee, M.D., Ph.D. Rosalind Franklin University National Center for Immunizations and CAPT Amanda Cohn, M.D. Respiratory Diseases Centers for Disease Control and Prevention Hayley Gans, M.D. Stanford University Medical Center Michael Kurilla, M.D., Ph.D. National Institutes of Health H. Cody Meissner, M.D. Tufts University School of Medicine Paul Offit, M.D. The Children’s Hospital of Philadelphia Steven A. Pergam, M.D., M.P.H., FIDSA Seattle Cancer Care Alliance TEMPORARY VOTING MEMBERS Arnold Monto, M.D. (Acting Chair) University of Michigan A. Oveta Fuller, Ph.D. University of Michigan James Hildreth, Sr., Ph.D., M.D. Meharry Medical College U.S. Department of Health and Human David Kim, M.D., M.A. Services Jeannette Lee, Ph.D. University of Arkansas for Medical Sciences Ofer Levy, M.D., Ph.D. Massachusetts Institute of Technology Wayne A. Marasco, M.D., Ph.D. Harvard Medical School Pamela McInnes, D.D.S., M.Sc. National Institutes of Health Patrick Moore, M.D., M.P.H. University of Pittsburgh Cancer Institute Stanley Perlman, M.D., Ph.D. University of Iowa Jay Portnoy, M.D. Children's Mercy Hospital www.transcriptionetc.com 3 Eric Rubin, M.D., Ph.D. Brigham and Women’s Hospital Mark Sawyer, M.D., F.A.A.P. Rady Children’s Hospital San Diego Melinda Wharton, M.D, M.P.H. Centers for Disease Control and Prevention GUEST SPEAKERS Adam MacNeil, Ph.D., M.P.H. Centers for Disease Control and Prevention Tom Shimabukuro, M.D., M.P.H., M.B.A. Centers for Disease Control and Prevention SPONSOR Janssen Pharmaceuticals Companies of Macaya Douoguih, M.D., M.P.H. Johnson & Johnson Gregory A. Poland, M.D., F.R.C.P. Mayo Clinic Janssen Pharmaceuticals Companies of Hanneke Schuitemaker, Ph.D. Johnson & Johnson Janssen Pharmaceuticals Companies of Johan Van Hoof, M.D. Johnson & Johnson FDA SPEAKERS/PARTICIPANTS Maria Allende, M.D. Center for Biologics Evaluation and Research Steven Anderson, Ph.D., M.P.P. Center for Biologics Evaluation and Research Doran Fink, Ph.D. Food and Drug Administration Marion Gruber, Ph.D. Food and Drug Administration Yosefa Hefter, M.D. Center for Biologics Evaluation and Research Philip Krause, M.D. Food and Drug Administration Peter W. Marks, M.D., Ph.D. Food and Drug Administration CDR Valerie Marshall, M.P.H., P.M.P. Food and Drug Administration Jerry Weir, Ph.D. Food and Drug Administration Celia M. Witten, Ph.D., M.D. Food and Drug Administration www.transcriptionetc.com 4 Rachel Zang, M.D. Center for Biologics Evaluation and Research FDA ADMINISTRATIVE STAFF Prabhakara Atreya, Ph.D. Food and Drug Administration Kathleen Hayes, M.P.H. Food and Drug Administration Monique Hill, M.H.A. Food and Drug Administration Michael Kawczynski Food and Drug Administration www.transcriptionetc.com 5 TABLE OF CONTENTS OPENING REMARKS: CALL TO ORDER AND WELCOME................ 6 ADMINISTRATIVE ANNOUNCEMENTS, ROLL CALL, INTRODUCTION OF COMMITTEE, CONFLICT OF INTEREST STATEMENT .................................................................................... 8 FDA PRESENTATION ON EMERGENCY USE AUTHORIZATION ... 26 EPIDEMIOLOGY OF COVID-19 VARIANTS .................................... 39 POSTMARKETING SURVEILLANCE FROM CURRENTLY AUTHORIZED COVID-19 VACCINES ............................................. 70 SPONSOR PRESENTATION: EMERGENCY USE AUTHORIZATION APPLICATION FOR COVID-19 VACCINE ....................................... 95 ADDITIONAL Q & A FOR SPONSOR PRESENTERS .......................143 OPEN PUBLIC HEARING ...............................................................163 FDA PRESENTATION AND VOTING QUESTIONS .........................217 COMMITTEE DISCUSSION AND VOTING .....................................266 www.transcriptionetc.com 6 1 OPENING REMARKS: CALL TO ORDER AND WELCOME 2 3 MR. MICHAEL KAWCZYNSKI: Good morning and 4 welcome to the 164th meeting of Vaccines and Related 5 Biological Products Advisory Committee meeting. I'm 6 Mike Kawczynski, project manager with FDA, and I'll be 7 today's meeting facilitator. This is a live virtual 8 public meeting that is being broadcast in its entirety 9 though C-SPAN, YorkCast, Facebook Live, YouTube, 10 Twitter, and various other methods. 11 Today’s event is also being recorded and will 12 be posted on the FDA’s VRBPAC webpage along with all 13 relevant meeting materials. Throughout today’s meeting, 14 I will be reminding our speakers and presenters 15 committee members and sponsors as to when it's closer 16 to their allotted time and assisting them when needed. 17 Just a reminder to everyone that once called 18 upon, please manage your mute and activate your 19 webcams. Note to all members and participants, we are 20 aware of the adverse weather conditions some of you -- 21 and are having to take precautions, and, if we www.transcriptionetc.com 7 1 encounter any issues, we will take it on a scheduled 2 break. At this time, I’d like to now introduce Dr. 3 Arnold Monto, the acting chair, who will now provide 4 opening remarks. 5 Dr. Monto, please, activate your webcam and 6 take it away. 7 DR. ARNOLD MONTO: Good morning. I'd like to 8 open this meeting, the 164th meeting of the Vaccines 9 and Related Biological Products Advisory Committee and 10 to specifically tell us -- state the reason for our 11 meeting, and this is to provide and discuss Emergency 12 Use Authorization of the Janssen Biotech COVID-19 13 vaccine for active immunization to prevent COVID-19 14 caused by SARS-CoV-2 in individuals 18 years of age and 15 older. 16 I would also like to welcome to the meeting 17 our voting members, our standing members, the other 18 speakers, those representing the sponsor Janssen as 19 well as the public. Your participation is very 20 important because you will see an open meeting 21 discussing scientific findings in action. www.transcriptionetc.com 8 1 And now I'd like to turn over to the 2 designated federal officer for this meeting, Prabha 3 Atreya. Prabha. 4 5 ADMINISTRATIVE ANNOUNCEMENTS, ROLL CALL, INTRODUCTION 6 OF COMMITTEE, CONFLICT OF INTEREST STATEMENT 7 8 DR. PRABHAKARA ATRAYA: Thank you, Dr. Monto. 9 Good morning, everyone. This is Prabha Atraya, and it 10 is my great honor to serve as the designated federal 11 officer for today's 164th Vaccines and Related 12 Biological Products Advisory Committee meeting. 13 On behalf of the FDA, the Center for Biologics 14 Evaluation and Research, and the Committee, I would 15 like to welcome everyone to this virtual meeting. The 16 topic of the meeting, as Dr. Monto mentioned, is the 17 Emergency Use Authorization of Janssen Biotech's COVID- 18 19 vaccine for the active immunization to prevent 19 COVID-19 caused by SARS-CoV-2 in individuals 18 years 20 and older. Today’s meeting and the topic were 21 announced in the federal register notice that was www.transcriptionetc.com 9 1 published on February 11, 2021. 2 I would like to introduce and acknowledge the 3 excellent contributions of the staff in my division and 4 the great support team we have in preparing for this 5 meeting. 6 Ms. Kathleen Hayes is my backup and co-DFO 7 providing excellent support in all aspects of preparing 8 for and conducting this meeting. The other staff are 9 Ms. Monique Hill, Dr. Jeannette Devine, and Christina 10 Vert, who provided excellent administrative support. 11 Thank you, DSAC team, for your support. 12 I would like to express CBER's sincere 13 appreciation to Mike Kawczynski for facilitating the 14 meeting for today and also a big shout out to many FDA 15 staff working hard behind the scenes trying to ensure 16 that today's virtual meeting will also be a successful 17 one like the previous three VRBPAC meetings on the 18 COVID topic. 19 Please direct any press or media questions for 20 today’s meeting to the FDA’s Office of Media Affairs or 21 FDAOMA -- one word -- @fda.hhs.gov. The www.transcriptionetc.com 10 1 transcriptionist for today’s meeting is Ms. Linda 2 Giles. 3 We will begin today’s meeting by taking a 4 formal role call for the Committee members and 5 temporary members. When it is your turn, please turn 6 on your camera, unmute your phone, and then state your 7 first and last name, and, when finished, you can turn 8 your camera off so we can proceed to the next person. 9 Please see the member roster slide in which we will 10 begin with the chair. Dr. Arnold Monto, can we start 11 with you, please? 12 DR. ARNOLD MONTO: Good morning, again, and 13 welcome to all. 14 DR. PRABHAKARA ATRAYA: I think, Dr. Monto, 15 your volume is a little bit low. If you can improve 16 it, that would be great. Thank you. Dr. Amanda Cohn. 17 DR. AMANDA COHN: Good morning. Dr. Amanda 18 Cohn, Chief Medical Officer at the National Center for 19 Immunization and Respiratory Diseases. 20 DR. PRABHAKARA ATRAYA: Thank you. Dr. 21 Chatterjee. www.transcriptionetc.com 11 1 DR. ARCHANA CHATTERJEE: Good morning. My 2 name is Archana Chatterjee. I am the dean of Chicago 3 Medical School and Vice President for Medical Affairs 4 as Rosalind Franklin University of Medicine and 5 Science. I'm a pediatric infectious diseases 6 specialist with a background in research in vaccines. 7 Thank you. 8 DR. PRABHAKARA ATRAYA: Great. Dr. Cody 9 Meissner. 10 DR. CODY MEISSNER: Good morning.