Duty to Warn
The Suspicious Roster of the FDA’s Advisory Committee that Voted on the Pfizer Vaccine
The Roster of the “Vaccines and Related Biological Products Advisory Committee” that Voted on the Recent FDA/Pfizer Vaccine Decision that was Announced on August 24, 2021
Collated by Gary G. Kohls, MD
Note: I boldened words and phrases in the brief bios below to indicate what to me represented possible Conflicts of Interest that perhaps should have disqualified the member from participating in the Pfizer vote
Also note the following excerpt from the FDA’s 13-page “approval letter” (dated August 23, 2120) says (on page 12)
“This product has not been approved or licensed by FDA, but has been authorized for emergency use by FDA, under an EUA to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 12 years of age and older; and
- The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.
_______________________________________________________________________________________________________________________________
Roster of the Vaccines and Related Biological Products Advisory Committee
Applying for Membership on FDA Advisory Committees
As part of the Food and Drug Administration’s (FDA’s) ongoing efforts to recruit qualified experts with minimal conflicts of interest who are interested in serving on FDA advisory committees, FDA is requesting nominations for members to serve on its advisory committees.
Current Number of Vacancies: 1
Note, one or more vacancies may be in the nomination process or a final appointment may have been made.
Chair
Hana El Sahly, M.D.
Expertise: Vaccines, Infectious Diseases Term: 06/21/2019-01/31/2022
Professor Department of Molecular Virology and Microbiology
Department of Medicine Section of Infectious Diseases Baylor College of Medicine Houston, TX 77030
Paula Annunziato, M.D. ***
Expertise: Industry Representative Term: 02/01/2020-01/31/2024
Vice President and Therapeutic Area Head, Vaccines Clinical Research, MERCK, North Wales, PA 19454
Archana Chatterjee, M.D., Ph.D.
Expertise: Pediatrics, Infectious Diseases Term: 06/21/2019-01/31/2023
Dean Chicago Medical School Vice President for Medical Affairs Rosalind Franklin University of Medicine and Science North Chicago, IL 60064
CAPT Amanda Cohn, M.D.
Expertise: Pediatrics, Vaccines Term: 02/01/2020-01/31/2024
Chief Medical Officer National Center for Immunizations and Respiratory Diseases Centers for Disease Control and Prevention Atlanta, GA 30333
Hayley Gans, M.D.
Expertise: Pediatrics, Infectious Diseases Term: 06/21/2019-01/31/2023
Professor of Pediatrics Department of Pediatrics Stanford University Medical Center Stanford, CA 94305
Holly Janes, Ph.D.
Expertise: Biostatistics Term: 02/01/2020-01/31/2023
Professor Fred Hutchinson Cancer Research Center Vaccine and Infectious Disease Division, Division of Public Health Sciences Seattle, WA 98109
Michael Kurilla, M.D., Ph.D.
Expertise: Infectious Diseases, Pathology Term: 08/06/2018-01/31/2022
Director, Division of Clinical Innovation National Center for Advancing Translation Sciences National Institutes of Health Bethesda, MD 20852
Myron Levine, M.D., D.T.P.H., F.A.A.P
Expertise: Infectious Diseases Term: 05/09/2018-01/31/2022
Simon & Bessie Grollman Distinguished Professor Associate Dean for Global Health Vaccinology and Infectious Diseases Center for Vaccine Development University of Maryland School of Medicine Baltimore, MD 21201
- Cody Meissner, M.D.
Expertise: Infectious Diseases Term: 08/06/2018-01/31/2022
Professor of Pediatrics Tufts University School of Medicine Director, Pediatric Infectious Disease Tufts Medical Center Boston, MA 02111
Paul Offit, M.D.
Expertise: Infectious Diseases Term: 02/01/2018-01/31/2022
Professor of Pediatrics Division of Infectious Diseases The Children’s Hospital of Philadelphia Philadelphia, PA 19104
Steven Pergam, M.D.
Expertise: Infectious Diseases Term: 02/01/2020-01/31/2024
Medical Director Infection Prevention Seattle Cancer Care Alliance Seattle, WA 98109
Andrea Shane, M.D., M.P.H., M.Sc.
Expertise: Pediatric & Infectious Diseases Term: 02/01/2018-01/31/2022
Professor of Pediatrics Director Division of Pediatric Infectious Diseases Emory University School of Medicine Atlanta, GA 30322
Paul Spearman, M.D.
Expertise: Pediatric & Infectious Diseases Term: 05/09/2018-01/31/2022
Director, Division of Infectious Diseases Albert B. Sabin Chair in Pediatric Infectious Diseases Cincinnati Children’s Hospital Medical Center Professor, Department of Pediatrics University of Cincinnati School of Medicine Cincinnati, OH 45229
Geeta K. Swamy, M.D.
Expertise: Infectious Diseases Term: 08/06/2018-01/31/2022
Senior Associate Dean Vice Chair for Research & Faculty Development Associate Professor, ObGyn Department of Obstetrics & Gynecology Division of Maternal-Fetal Medicine Duke University Durham, NC 27710
Gregg Sylvester, M.D., M.P.H. +
Expertise: Alternate Industry Representative Term: 02/01/2020-01/31/2024
Vice President Medical Affairs SEQIRUS INC. Summit, NJ 07901
**Consumer Representative
***Industry Representative
+ Alternate Industry Representative
DIRECTOR
Prabhakara Atreya, Ph.D.
Division of Scientific Advisors & Consultants Center for Biologics Evaluation & Research Food and Drug Administration Silver Spring, MD 20993CBERVRBPAC@fda.hhs.gov
DESIGNATED FEDERAL OFFICER
Kathleen Hayes, M.P.H.
Division of Scientific Advisors & Consultants Center for Biologics Evaluation & Research Food and Drug Administration Silver Spring, MD 20993 CBERVRBPAC@fda.hhs.gov
COMMITTEE MANAGEMENT SPECIALIST
Monique Hill, M.H.A.
Division of Scientific Advisors & Consultants Center for Biologics Evaluation & Research Food and Drug Administration Silver Spring, MD 20993 CBERVRBPAC@fda.hhs.gov
As part of the Food and Drug Administration’s (FDA’s) ongoing efforts to recruit qualified experts with minimal conflicts of interest, who are interested in serving on FDA advisory committees, FDA is requesting nominations for members to serve on its advisory committees.
Chair
Hana El Sahly, M.D.
Expertise: Vaccines, Infectious Diseases Term: 06/21/2019-01/31/2022
Professor Department of Molecular Virology and Microbiology
Department of Medicine Section of Infectious Diseases Baylor College of Medicine Houston, TX 77030
Paula Annunziato, M.D. ***
Expertise: Industry Representative Term: 02/01/2020-01/31/2024
Vice President and Therapeutic Area Head, Vaccines Clinical Research, MERCK, North Wales, PA 19454
Archana Chatterjee, M.D., Ph.D.
Expertise: Pediatrics, Infectious Diseases Term: 06/21/2019-01/31/2023
Dean Chicago Medical School Vice President for Medical Affairs Rosalind Franklin University of Medicine and Science North Chicago, IL 60064
CAPT Amanda Cohn, M.D.
Expertise: Pediatrics, Vaccines Term: 02/01/2020-01/31/2024
Chief Medical Officer National Center for Immunizations and Respiratory Diseases Centers for Disease Control and Prevention Atlanta, GA 30333
Hayley Gans, M.D.
Expertise: Pediatrics, Infectious Diseases Term: 06/21/2019-01/31/2023
Professor of Pediatrics Department of Pediatrics Stanford University Medical Center Stanford, CA 94305
Holly Janes, Ph.D.
Expertise: Biostatistics Term: 02/01/2020-01/31/2023
Professor Fred Hutchinson Cancer Research Center Vaccine and Infectious Disease Division, Division of Public Health Sciences Seattle, WA 98109
Michael Kurilla, M.D., Ph.D.
Expertise: Infectious Diseases, Pathology Term: 08/06/2018-01/31/2022
Director, Division of Clinical Innovation National Center for Advancing Translation Sciences National Institutes of Health Bethesda, MD 20852
Myron Levine, M.D., D.T.P.H., F.A.A.P
Expertise: Infectious Diseases Term: 05/09/2018-01/31/2022
Simon & Bessie Grollman Distinguished Professor Associate Dean for Global Health Vaccinology and Infectious Diseases Center for Vaccine Development University of Maryland School of Medicine Baltimore, MD 21201
- Cody Meissner, M.D.
Expertise: Infectious Diseases Term: 08/06/2018-01/31/2022
Professor of Pediatrics Tufts University School of Medicine Director, Pediatric Infectious Disease Tufts Medical Center Boston, MA 02111
Paul Offit, M.D.
Expertise: Infectious Diseases Term: 02/01/2018-01/31/2022
Professor of Pediatrics Division of Infectious Diseases The Children’s Hospital of Philadelphia Philadelphia, PA 19104
Steven Pergam, M.D.
Expertise: Infectious Diseases Term: 02/01/2020-01/31/2024
Medical Director Infection Prevention Seattle Cancer Care Alliance Seattle, WA 98109
Andrea Shane, M.D., M.P.H., M.Sc.
Expertise: Pediatric & Infectious Diseases Term: 02/01/2018-01/31/2022
Professor of Pediatrics Director Division of Pediatric Infectious Diseases Emory University School of Medicine Atlanta, GA 30322
Paul Spearman, M.D.
Expertise: Pediatric & Infectious Diseases Term: 05/09/2018-01/31/2022
Director, Division of Infectious Diseases Albert B. Sabin Chair in Pediatric Infectious Diseases Cincinnati Children’s Hospital Medical Center Professor, Department of Pediatrics University of Cincinnati School of Medicine Cincinnati, OH 45229
Geeta K. Swamy, M.D.
Expertise: Infectious Diseases Term: 08/06/2018-01/31/2022
Senior Associate Dean Vice Chair for Research & Faculty Development Associate Professor, ObGyn Department of Obstetrics & Gynecology Division of Maternal-Fetal Medicine Duke University Durham, NC 27710
Gregg Sylvester, M.D., M.P.H. +
Expertise: Alternate Industry Representative Term: 02/01/2020-01/31/2024
Vice President Medical Affairs SEQIRUS INC. Summit, NJ 07901
**Consumer Representative
***Industry Representative
+ Alternate Industry Representative
DIRECTOR
Prabhakara Atreya, Ph.D.
Division of Scientific Advisors & Consultants Center for Biologics Evaluation & Research Food and Drug Administration Silver Spring, MD 20993CBERVRBPAC@fda.hhs.gov
DESIGNATED FEDERAL OFFICER
Kathleen Hayes, M.P.H.
Division of Scientific Advisors & Consultants Center for Biologics Evaluation & Research Food and Drug Administration Silver Spring, MD 20993 CBERVRBPAC@fda.hhs.gov
COMMITTEE MANAGEMENT SPECIALIST
Monique Hill, M.H.A.
Division of Scientific Advisors & Consultants Center for Biologics Evaluation & Research Food and Drug Administration Silver Spring, MD 20993 CBERVRBPAC@fda.hhs.gov