People
Named individuals who appear in the report's narrative — FDA scientists, agency officials, hearing witnesses, and Congressional oversight personnel. Click any name to see the events they appear in and quotes attributed to them.
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Steven Anderson, PhD
Director, Office of Biostatistics and Pharmacovigilance, FDA CBER
Headed CBER's pharmacovigilance office and in September 2021 asked that Dr. Szarfman refrain from using her FDA email to communicate data mining findings using CBER VAERS data.
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Bethany Baer, MD
Official, Division of Pharmacovigilance, FDA CBER OBPV
CBER official who questioned Dr. Szarfman's access to VAERS data and acknowledged in 2024 that the RGPS model yielded significantly higher signals than MGPS.
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Xavier Becerra, JD
U.S. Secretary of Health and Human Services
HHS Secretary from 2021 to 2025; recipient of multiple Sen. Johnson oversight letters on COVID-19 vaccine adverse events and Countermeasures Injury Compensation Program claims.
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Robert Califf, MD
Commissioner, FDA (Feb. 2022 - Jan. 2025)
Received Dr. Szarfman's 2022 paper on unmasking hidden signals and replied only, 'Thanks. These are good.'
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Carole Johnson
Administrator, Health Resources and Services Administration (HRSA)
HRSA Administrator and co-recipient of the April 2023 Sen. Johnson oversight letter regarding Countermeasures Injury Compensation Program claims for COVID-19 vaccine injuries.
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Patrizia Cavazzoni, MD
Director, FDA Center for Drug Evaluation and Research (CDER)
Was warned by Dr. Marks in September 2021 that Dr. Szarfman's data mining could create erroneous conflicts that feed into anti-vaccination rhetoric.
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Mandy Cohen, MD, MPH
Director, Centers for Disease Control and Prevention
CDC Director from July 2023 to January 2025; recipient of multiple Sen. Johnson oversight letters on COVID-19 vaccine safety, EB data mining analyses, and adverse event reports.
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Francis Collins, MD, PhD
Director, National Institutes of Health (NIH)
NIH Director from 2009 to 2021; recipient of multiple Sen. Johnson oversight letters and the April 2021 meeting in which he responded "Senator, people die" when asked about VAERS death reports.
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William DuMouchel, PhD
Then-Chief Statistician at Oracle
Inventor of the data mining algorithms (GPS, MGPS, RGPS) that supported FDA's data mining system. Collaborated with Dr. Szarfman on the analyses underlying this report.
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Anthony Fauci, MD
Director, National Institute of Allergy and Infectious Diseases (NIAID)
NIAID Director and recipient of the March 2022 Sen. Johnson oversight letter highlighting over 1 million VAERS reports of adverse events.
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Richard Forshee, PhD
Associate Director for Research/Acting Deputy Director, FDA CBER OBPV
Reported Dr. Szarfman's mortality-signal findings to Dr. Marks in July 2021 and in 2022 expressed concerns about her published paper on masking.
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Brian Hendrix
Contractor, Commonwealth Informatics (Empirica Signal system)
Commonwealth contractor who in March 2021 received Dr. Menschik's request for a special MGPS run adjusting for masking.
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Karl Jablonowski, PhD
Senior Research Scientist, Children's Health Defense
Pharmacovigilance researcher and co-author of papers on VAERS data quality and COVID-19-era safety surveillance failures. Witness at the April 2026 PSI hearing on COVID-19 vaccine safety signal masking.
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Sen. Ron Johnson
Chairman, U.S. Senate Permanent Subcommittee on Investigations
PSI Chairman who issued the interim report and conducted the underlying oversight of federal health agencies' COVID-19 vaccine safety surveillance.
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Robert F. Kennedy, Jr., JD
U.S. Secretary of Health and Human Services
HHS Secretary and recipient of the December 2025 and March 2026 oversight letters from Chairman Johnson on COVID-19 vaccine adverse events and masking in EB data mining.
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Sen. Mike Lee
U.S. Senator from Utah
Co-signed the June 2021 oversight letter with Sen. Johnson to CDC Director Walensky and FDA Acting Commissioner Woodcock raising concerns about COVID-19 vaccine adverse events.
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Peter Marks, MD, PhD
Director, FDA Center for Biologics Evaluation and Research (CBER)
Led FDA's biologics center during COVID-19 vaccine authorization and surveillance.
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Judy Maro, PhD, MS
Associate Professor, Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute
Harvard researcher working with FDA and CDC who in October 2023 raised concerns about masking in FDA's data mining system.
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David Menschik, MD, MPH
Associate Director for Surveillance Informatics, Division of Pharmacovigilance, FDA CBER OBPV
Distributed FDA's weekly COVID-19 vaccine data mining reports and helped draft the May 2021 email directing Dr. Szarfman to hold off on her analyses.
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Narayan Nair, MD
Division Director, Division of Pharmacovigilance, FDA CBER OBPV
Suggested in 2022 that FDA discontinue routine distribution of weekly COVID-19 data mining reports to CDC and acknowledged in 2023 that FDA was aware of the masking limitation during the pandemic.
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Manette Niu, MD
Acting Branch Chief, Division of Pharmacovigilance, FDA CBER OBPV
CBER official who received Dr. Szarfman's RGPS analyses in 2021 and told her CBER could not collaborate with her on the project.
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Vinay Prasad, MD, MPH
Director, FDA Center for Biologics Evaluation and Research (CBER)
CBER Director whose memorandum on deaths of children following a COVID-19 vaccine was the subject of Sen. Johnson's December 2025 letter to HHS Secretary Kennedy.
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Jeff Reczek, MPA
Official, Centers for Disease Control and Prevention
Authored the March 2023 CDC letter to Sen. Johnson on EB data mining cited throughout the report.
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Tom Shimabukuro, MD, MPH, MBA
Deputy Director and later Director, Immunization Safety Office, CDC
Senior CDC vaccine safety official who in June 2022 lauded FDA's EB data mining as the 'gold standard' for disproportionality analysis.
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Peter Stein, MD
Director, Office of New Drugs, FDA CDER
Reported to Dr. Marks in September 2021 that his office had made clear to Dr. Szarfman that she should not be discussing or providing internal analyses externally.
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Norman Stockbridge, MD, PhD
Division Director, Division of Cardiology and Nephrology, FDA CDER
CDER division director who attended Dr. Szarfman's December 2020 meeting on new safety methodology and received her May 2021 analysis on undervalued myocardial infarction signals.
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John Su, MD, PhD, MPH
Immunization Safety Office, CDC; later Deputy Director and Acting Director
CDC vaccine safety official with whom Dr. Menschik discussed the masking limitation in September 2021 in connection with a draft article on COVID-19 vaccine safety.
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James Sydnor
Contractor, Commonwealth Informatics (Empirica Signal system)
Commonwealth contractor who in September 2021 followed up with Dr. Szarfman about her data mining questions and directed her to speak with Drs. Menschik or Baer.
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Ana Szarfman, MD, PhD
Senior Medical Officer & Safety Data Mining Developer, FDA CDER
Co-developer of FDA's data mining system; advocated for the RGPS method during COVID-19 vaccine safety surveillance.
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Lawrence Tabak, DDS, PhD
Acting Director, National Institutes of Health (NIH)
NIH Acting Director and co-recipient of the October 2023 Sen. Johnson oversight letter reiterating earlier requests for vaccine safety information.
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Rochelle Walensky, MD, MPH
Director, Centers for Disease Control and Prevention
CDC Director who in 2022 wrote to Sen. Johnson defending EB data mining as 'a more robust technique' for analyzing VAERS reports.
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Sarah Walinsky, JD
Acting Chief of Staff, FDA CBER
In February 2022 circulated Dr. Szarfman's preprint on masking to FDA officials weighing Moderna's pediatric COVID-19 vaccine appeal.
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David Wiseman, PhD, MRPharmS
Independent medical researcher
Authored a September 2025 preprint identifying masking and other limitations in EB data mining that resulted in underestimation of COVID-19 vaccine adverse events. Witness at the April 29, 2026 PSI hearing on COVID-19 vaccine safety signal masking.
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Janet Woodcock, MD
Acting Commissioner, U.S. Food and Drug Administration
FDA Acting Commissioner during 2021; recipient of Sen. Johnson oversight letters on COVID-19 vaccine safety surveillance, hot lots, and adverse event reports.
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Maria Young
Patient advocate; COVID-19 ARDS / ECMO survivor
Survived severe COVID-19 in 2020 after 69 days on ECMO and 70 on a ventilator; now advocates with Vaccinate Your Family for COVID-19 vaccination and post-ICU survivor support. Witness at the April 2026 PSI hearing.
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Craig Zinderman, MD, MPH
Associate Director for Medical Policy, FDA CBER OBPV
Transmitted the May 7, 2021 email directing Dr. Szarfman to hold off on creating and sending COVID-19 vaccine data mining reports and analyses.