ACIP COVID-19 Vaccines Work Group Dr. Beth Bell, Work Group Chair - PowerPoint PPT Presentation

ACIP COVID-19 Vaccines Work Group Dr. Beth Bell, Work Group Chair December 1, 2020 For more information: www.cdc.gov/COVID19

Background  ACIP responding to ongoing pandemic and accelerated vaccine development through scheduling of additional ACIP meetings  At the November 23 rd meeting, ACIP reviewed: – Evidence to Recommendation Framework: Public Health Problem, Resource Use and Equity Domains – Evidence to Recommendation Framework: Values, Acceptability and Feasibility Domains – Phased Allocation of COVID-19 Vaccines 2

COVID-19 Work Group activities – November 2020  COVID-19 Vaccine Work Group meets weekly  Topics covered since last ACIP meeting: – Additional discussions around Phase 1a populations – Clinical considerations for populations included in Phase 1a 3

Today’s agenda  Allocation of initial supplies of COVID-19 vaccine: Phase 1a Dr. Kathleen Dooling (CDC)  Clinical considerations for populations included in Phase 1a Dr. Sara Oliver (CDC)  Post-authorization safety monitoring update Dr. Tom Shimabukuro (CDC)  Public Comment  Vote: Allocation of initial supplies of COVID-19 vaccine: Phase 1a 4

Vaccine Update  Two COVID-19 vaccine manufacturers announced filing with U.S. FDA for Emergency Use Authorization – Pfizer/BioNTech announced submission on November 20, 2020 1 – Moderna announced submission on November 30, 2020 2 1 Pfizer and BioNTechto Submit Emergency Use Authorization Request Today to the U.S. FDA for COVID -19 Vaccine | Pfizer 2 Moderna Announces Primary Efficacy Analysis in Phase 3 COVE Study for Its COVID -19 Vaccine Candidate and Filing Today with U.S. FDA for Emergency Use Authorization | Moderna, Inc. (modernatx.com) 5

Work group members ACIP members Liaisons Liaisons, cont’d  Beth Bell (chair)  AAFP: Jonathan Temte  NACCHO: Matt Zahn (primary), Jeff Duchin (alternate)  Grace Lee  AAP: Sean O’Leary  NACI: Matthew Tunis (primary),  Jose Romero  ACOG: Denise Jamieson (primary), Linlu Zhao(alternate) Laura Riley (alternate)  Keipp Talbot  NFID: Bill Schaffner (primary),  ACP: Jason Goldman Marla Dalton (alternate) Ex-officio/government members  AGS: Ken Schmader  NMA: Oliver Brooks  FDA: Doran Fink, Rachel Zhang  AIM: Rob Shechter (primary), Jane  SHEA: Marci Drees  NIH: Chris Roberts Zucker (alternate)  IHS: Thomas Weiser, Jillian Doss-Walker  AMA: Sandra Fryhofer Consultants  DOD: Bryan Schumacher  ANA: Kendra McMillan (primary),  Ed Belongia (safety)  CMS: Jeff Kelman Ruth Francis (alternate)  Matthew Daley (safety)  APhA: Michael Hogue  BARDA: Christine Oshansky  Kathy Kinlaw (ethics)  ASTHO: Marcus Plescia  HHS: David Kim  Dayna Matthew (health equity)  CSTE: Susan Lett CDC Co-leads  Kathleen Neuzil (vaccinology)  IDSA: Jeff Duchin (primary),  Kathleen Dooling Carol Baker (alternate)  Stanley Perlman  Sara Oliver 6 (microbiology/immunology)

CDC participants  Doug Campos-Outcalt  Rita Helfand  Janell Routh  Mary Chamberland  Terri Hyde  Stephanie Schrag  Thomas Clark  Tara Jatlaoui  Tom Shimabukuro  Amanda Cohn  Cynthia Jorgensen  Natalie Thornburg  Jean Cox-Ganser  Erin Kennedy  Jennifer Verani  Katie Curran  Ram Koppaka  Megan Wallace  Jonathan Duffy  Jessica MacNeil  Cindy Weinbaum  Anthony Fiore  Mona Marin  Yon Yu  Mark Freedman  Sarah Mbaeyi  Jane Zucker  Sue Gerber  Nancy McClung  Jack Gersten  Lucy McNamara  Susan Goldstein  Rebecca Morgan  Sam Graitcer  Titilope Oduyebo  Lisa Grohskopf  Christina Ottis  Julia Gargano  Anita Patel 7

For more information, contact CDC Thank you! 1-800-CDC-INFO (232-4636) TTY: 1-888-232-6348 www.cdc.gov The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention.