For more information: www.cdc.gov/COVID19

ACIP COVID-19 Vaccines Work Group

Dr. Beth Bell, Work Group Chair

November 23, 2020
 ACIP responding to ongoing pandemic and accelerated vaccine development through 

scheduling of additional ACIP meetings

 At the October 30th meeting, ACIP reviewed:

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Updates from VRBPAC meeting 

Development program from 2 COVID-19 vaccine manufacturers

Updates on vaccine implementation and communication plans

Post-authorization safety monitoring 

Ethical principles and modeling strategies for initial allocation of COVID-19 vaccines 

Updates to immunity and epidemiology 

Work Group interpretation of data

Policy questions, Evidence to Recommendation Framework and Outcomes 

Background

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 COVID-19 Vaccine Work Group meets weekly 

 Topics covered in November:

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Ethical principles for allocating initial supplies of COVID-19 vaccine 

Current evidence for each domain in Evidence to Recommendation Framework 

Further discussions around initial allocation recommendations

COVID-19 Work Group activities – October 2020

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Today’s agenda

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 EtR Framework: Public Health Problem, Resource Use and Equity Domains: 

Dr. Sara Oliver (CDC) 

 EtR Framework: Values, Acceptability and Feasibility Domains: 

Dr. Sara Oliver (CDC) 

 Phased Allocation of COVID-19 Vaccines: 

Dr. Kathleen Dooling (CDC) 
 Over 200 COVID-19 vaccines currently under development

 Within the United States: 

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Four vaccines in Phase III clinical trials 

Six vaccines in Phase I/II clinical trials

Vaccine Update

Sources: https://www.modernatx.com/cove -study; https://www.pfizer.com/science/coronavirus/vaccine, https://connect.trialscope.com/studies/34986a8a-b779-4169-a35c- 5

5d929149d426; https://www.reuters.com/article/us-health-coronavirus-pfizer/pfizer-says-coronavirus-vaccine-study-shows-mostly-mild-to-moderate-side-effects-idUSKBN26631T 
Phase III Results from Two mRNA Vaccines

6 Sources: https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-conclude-phase-3-study-covid-19-vaccine

https://investors.modernatx.com/news-releases/news-release-details/modernas-covid-19-vaccine-candidate-meets-its-primary-efficacy

 BNT162b2 vaccine 

(Pfizer/BioNtech)

– Final analysis of 170 cases

• 162 cases in placebo group

8 cases in vaccine group

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95% effective 7 days post dose 2

94% effective in adults ≥65 years of age

10 severe cases, 9 in placebo group

DSMB: no serious safety concerns

EUA submission Friday Nov 20, 2020

 mRNA-1273 vaccine 

(Moderna)

Interim analysis of 95 cases

• 90 cases in placebo group

5 cases in vaccine group

94.5% effective 2 weeks post dose 2 

11 severe cases, all in placebo group

DSMB: no serious safety concerns

EUA submission soon

*Information from manufacturer press releases
COVID-19 vaccines in human clinical trials – United States*

*As of Nov 21, 2020

Sources: https://milkeninstitute.org/covid-19-tracker; https://www.who.int/who-documents-detail/draft-landscape-of-covid-19-candidate-vaccines; https://vaclshtm.shinyapps.io/ncov_vaccine_landscape/ ; https://clinicaltrials.gov/; https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html

Candidate Manufacturer Type Phase Schedule Age Size Trial # Recruiting

mRNA-1273 Moderna mRNA III 2 doses (0, 28d) ≥18 years 30,000 

participants NCT04470427 Enrollment 

complete

mRNABNT162Pfizer, Inc./

BioNTech mRNA III 2 doses (0, 21d) 12-85 years 44,000 participants NCT04368728 

AZD1222 U of Oxford/ 

AstraZeneca

Viral vector 

(Non-replicating) III 2 doses (0, 28d) ≥18 years 40,000 participants

NCT04516746 

Ad26COVS1 Janssen Viral vector

(Non-replicating) III 1 dose ≥18 years 30,000 participants NCT04614948 

NVXCoV2373 Novavax Protein Subunit I/II 2 doses (0, 21d) 18-84 years 1400 

participants NCT04368988 Enrollment 

complete

-- Sanofi/GSK Protein Subunit I/II 1 dose or 

2 doses (0, 21d) ≥18 years 440 participants NCT04537208 
COVID-19 vaccines in human clinical trials – United States*

*As of Nov 21, 2020

Sources: https://milkeninstitute.org/covid-19-tracker; https://www.who.int/who-documents-detail/draft-landscape-of-covid-19-candidate-vaccines; https://vaclshtm.shinyapps.io/ncov_vaccine_landscape/ ; https://clinicaltrials.gov/; https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html

Candidate Manufacturer Type Phase Schedule Age Size Trial # Recruiting

V591 Merck Viral Vector 

(Replicating) I/II 2 doses (1, 57d) ≥18 years 260 participants NCT04498247 

VXA-CoV2-1 Vaxart Viral vector 

(Non-replicating) I 2 doses (1, 29d)*Oral 18-54 years 48 participants NCT04563702 

INO-4800 Inovio DNA plasmid I 2 doses (0, 4w)

*Electroporation ≥18 years 120 participants NCT04336410 Active, not recruiting 

AV-COVID-19 Aivita AuDendritic cell I/II 1 dose ≥18 years 180 

participants NCT04386252 Not yet recruiting
COVID-19 vaccines in human clinical trials outside United States – Phase III actively 

recruiting*

*As of Nov 21, 2020

Sources: https://milkeninstitute.org/covid-19-tracker; https://www.who.int/publications/m/item/draft-landscape-of-covid-19-candidate-vaccines; https://vaclshtm.shinyapps.io/ncov_vaccine_landscape/ ; https://clinicaltrials.gov/; https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html

Candidate Manufacturer/Institute Type Location Phase Trial number

BIBP/Sinopharm BBIBPCorVBeijing Institute of Biological 

Products/Sinopharm Inactivated Argentina Phase III NCT04560881

Sinovac CoronaVac Sinovac/Instituto Butantan Inactivated

Turkey, Brazil, 

Indonesia Phase III

NCT04582344; 

NCT04456595; 

NCT04508075

WIBP vaccine

Wuhan Institute of Biological 

Products/Sinopharm Inactivated Morocco Phase III ChiCTR2000039000

WIBP/BIBP/Sinopharm

vaccines

Beijing Institute of Biological 

Products/Wuhan Institute of 

Biological Products/Sinopharm Inactivated

UAE, Bahrain, Jordan, 

Egypt Phase III NCT04510207

4 inactivated vaccines candidates are in Phase I/II

Protein Subunit Vaccines

Inactivated Vaccines

Candidate Manufacturer/Institute Type Location Phase Trial number

Novavax NVX-CoV2373 Novavax Protein subunit UK Phase III NCT04583995

11 protein subunit vaccines candidates are in Phase I/II
COVID-19 vaccines in human clinical trials outside United States – Phase III actively 

recruiting*

*As of Nov 21, 2020

Sources: https://milkeninstitute.org/covid-19-tracker; https://www.who.int/who-documents-detail/draft-landscape-of-covid-19-candidate-vaccines; https://vaclshtm.shinyapps.io/ncov_vaccine_landscape/ ; https://clinicaltrials.gov/; https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html

Candidate Manufacturer/Institute Type Location Phase Trial number

Cansino Ad5-nCoV

CanSino Biological Inc/ 

Beijing Institute of 

Biotechnology Non-replicating viral vector Pakistan, Russia Phase III

NCT04526990; 

NCT04540419 

Gamaleya Gam-COVIDVacGamaleya Research 

Institute Non-replicating viral vector Belarus, Russia Phase III

NCT04530396; 

NCT04564716

Janssen Ad26.COV2.S

Janssen Pharmaceutical 

Companies Non-replicating viral vector

USA, Argentina, Brazil, 

others Phase III NCT04505722

Oxford ChAdOx1-S

University of 

Oxford/AstraZeneca Non-replicating viral vector

UK, Brazil, India, 

South Africa Phase II/III

NCT04400838; 

NCT04536051; 

CTRI/2020/08/027170

7 non-replicating viral vector vaccines candidates are in Phase I/II

7 RNA vaccines candidates are in Phase I/II

Viral Vector Vaccines (non-replicating)

RNA Vaccines

Candidate Manufacturer/Institute Type Location Phase Trial number

BioNTech BNT162 

(b1/b2)

BioNTech/Fosun

Pharma/Pfizer RNA

USA, Argentina, Brazil, 

others Phase II/III NCT04368728
ACIP members

 Beth Bell (chair)

 Grace Lee

 Jose Romero

 Keipp Talbot

Ex-officio/government members

 FDA: Doran Fink, Rachel Zhang

 NIH: Chris Roberts

 IHS: Thomas Weiser, Jillian Doss-Walker

 DOD: Bryan Schumacher

 CMS: Jeff Kelman

 BARDA: Christine Oshansky

 HHS: David Kim

CDC Co-leads

 Kathleen Dooling

 Sara Oliver

Work group members

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Liaisons

 AAFP: Jonathan Temte

 AAP: Sean O’Leary

 ACOG: Denise Jamieson (primary), 

Laura Riley (alternate)

 ACP: Jason Goldman

 AGS: Ken Schmader

 AIM: Rob Shechter (primary), Jane 

Zucker (alternate)

 AMA: Sandra Fryhofer

 ANA: Kendra McMillan (primary), 

Ruth Francis (alternate)

 APhA: Michael Hogue

 ASTHO: Marcus Plescia

 CSTE: Susan Lett

 IDSA: Jeff Duchin (primary), 

Carol Baker (alternate)

Liaisons, cont’d

 NACCHO: Matt Zahn (primary), 

Jeff Duchin (alternate)

 NACI: Matthew Tunis (primary), 

Linlu Zhao(alternate)

 NFID: Bill Schaffner (primary), 

Marla Dalton (alternate)

 NMA: Oliver Brooks

 SHEA: Marci Drees

Consultants

 Ed Belongia (safety)

 Matthew Daley (safety)

 Kathy Kinlaw (ethics)

 Dayna Matthew (health equity)

 Kathleen Neuzil (vaccinology)

 Stanley Perlman 

(microbiology/immunology)
 Doug Campos-Outcalt

 Mary Chamberland

 Thomas Clark

 Amanda Cohn

 Jean Cox-Ganser

 Katie Curran

 Jonathan Duffy

 Anthony Fiore

 Mark Freedman

 Sue Gerber

 Jack Gersten

 Susan Goldstein

 Sam Graitcer

 Lisa Grohskopf

 Rita Helfand

CDC participants

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 Terri Hyde

 Tara Jatlaoui

 Cynthia Jorgensen

 Erin Kennedy

 Ram Koppaka

 Jessica MacNeil

 Sarah Mbaeyi

 Nancy McClung

 Lucy McNamara

 Rebecca Morgan

 Titilope Oduyebo

 Christina Ottis

 Anita Patel

 Janell Routh

 Stephanie Schrag

 Tom Shimabukuro

 Natalie Thornburg

 Jennifer Verani

 Megan Wallace

 Cindy Weinbaum

 Yon Yu

 Jane Zucker
For more information, contact CDC

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.

Thank you!