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ACIP Meeting, Atlanta
September 19, 2025ACIP COVID -19 IMMUNIZATION WG:
INTRODUCTION
Professor Retsef Levi, PhD, MIT
ACIP Meeting, Atlanta
September 19, 2025Immediate Goals
1)Formulate possible recommendations regarding the recent FDA authorized
products with respect to sub- populations for discussion and vote during the ACIP
meeting on Sep 18- 19 (with supporting data/analyses):
-What are the appropriate subgroups (age, risk factors, prior infection, others)?
-Options: Recommend, not recommend, Individual -based decision
2)Formulate a list of risks and uncertainties the WG suggests should be communicated to patients and medical providers as part of inform consent (changes to the Vaccine Information Statement)
ACIP Meeting, Atlanta
September 19, 2025Medium -Term Goals
1)Expansive Terms of Reference
2)Three focus clusters assigned to WG members based on expertise
3)The goal for each cluster is to summarize ALL available knowledge for
discussion in the WG and highlight important issues and knowledge gaps
4)Formulate policy options on broad vaccination- related issues for consideration
by ACIP
ACIP Meeting, Atlanta
September 19, 2025Values & Conduct
1)Leverage all relevant published and unpublished scientific, clinical and public
health data, information and knowledge, including experiences from the field
2)Personalized risk -benefit analyses vs. ‘safe & effective’ (broad set of questions)
3)Debate with respect
4)Communicate the WG members’ diverse positions and opinions with maximum
transparency
ACIP Meeting, Atlanta
September 19, 2025Today’s WG Member Presentations
1)Professors Wafik El-Deiry (Brown University) and Charlote Kuperwasser (Tuffs
University):
Safety Uncertainties of COVID -19 Vaccines
2)Professor Bruce Carleton (University of British Columbia):Genomics of Vaccine-Induced Myocarditis
3)Professors Hennery Bernstein (Hofstra/Northwell in New York), Mitchell Miglis (Stanford)
and Stanely Perlman (University of Iowa)WG Minority Opinion
ACIP Meeting, Atlanta
September 19, 2025Other ACIP Members on WG
1.James Pagano, MD, FACEP, Emergency Medicine Physician
with More than 40 Years Clinical Experience, ACIP Committee
Member
2.Robert Malone, MD, MS, Vaccinologist, Scientist, Biochemist, Contributor to mRNA Vaccine Technology, ACIP Committee
Member
ACIP Meeting, Atlanta
September 19, 2025WG External Subject Matter Experts
1. Henry H. Bernstein, DO, MHCM, FAAP , Professor of
Pediatrics, Zucker School of Medicine at Hofstra/Northwell
2. Christine Stabell Benn, PhD, DMSc , Bandim Health
Project, OPEN, Department of Clinical Research, University of Southern Denmark
3. Bruce Carleton, Pharm.D , Professor, University of
British Columbia
4. Wafik El-Deiry , MD, PhD, FACP , Director, Legorreta
Cancer Center at Brown University
5. Joseph Fraiman, MD, Emergency Medicine Physician, Baton Rouge, LA
6. Suzanne Gazda, MD, Medical Director, Neurology institute of San Antonia (NISA)
7. Douglas H. Jones, MD, FAAAAI, FACAAI, Board certified American Board of Allergy and Immunology; CEO Global Allergy Immune Network7. Charlotte Kuperwasser, PhD, Professor,
Developmental, Molecular & Chemical Biology,
Director, Tufts Convergence Laboratory of Biomedical, Physical, and Engineering Sciences, Tufts University
8. Mitchell Miglis , MD, Clinical Associate Professor,
Department of Neurology and Neurological Sciences, Secondary in Department of Psychiatry and Behavioral Sciences, Stanford University
9. Stanley Perlman, MD, PhD, Professor, Department of
Microbiology and Immunology, University of Iowa
10. Erle Robertson, PhD., Harry P . Schenk Endowed Chair
Professor, Vice -Chair, Department of
Otorhinolaryngology, Head and Neck Surgery
11. Jordan Vaughn, MD, CEO of MedHelp Clinics
ACIP Meeting, Atlanta
September 19, 2025ACIP Ex Officio
1.Tracy Beth Hoeg, MD, PHD, Senior Advisor for Clinical
Sciences, Food and Drug Administration Ex Officio
2.Andrew Johnson, Centers for Medicare & Medicaid Services
Ex Officio