Case 1:25-cv-11916-BEM Document 291 Filed 03/16/26

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Milhoan, 50 Dr. James Pagano, Dr. Raymond Pollak, 52 -appear to lack any expertise or professional qualifications related to vaccines or immunization as required by ACIP’s Charter. See ACIP Membership Roster, supra note 16. An additional three of the current ACIP members Dr. Retsef Levi, 53 Dr. Robert Malone, 54 and Dr. Catherine Stein 55_though they have

50 Dr. Milhoan “is a pediatric cardiologist and former U.S. Air Force flight surgeon,” who “holds a Ph.D. in the mechanisms of myocardial inflammation.” ACIP Membership Roster, supra note 16. There is no evidence in the record that Dr. Milhoan has any relevant vaccine-related experience or expertise.
51 Dr. Pagano “is a board-certified emergency medicine physician with more than 40 years of clinical experience.” ACIP Membership Roster, supra note 16. There is no evidence in the record that Dr. Pagano has any relevant vaccine-related experience or expertise.
52 Dr. Pollak “is a surgeon, transplant immunobiologist, and transplant specialist who has published more than 120 peer-reviewed works and served as principal investigator on NIH transplant biology grants and numerous drug trials.” ACIP Membership Roster, supra note 16. There is no evidence in the record that Dr. Pollak has any relevant vaccine-related experience or expertise.

53 Defendants describe Dr. Levi, Professor of Operations Management at the MIT Sloan School of Management, as “a leading expert in healthcare analytics, supply chain and manufacturing analytics, risk management, and biologics and vaccine safety” and note that he has “collaborated with industry stakeholders and public health agencies to develop decision-support models to evaluate biologics and vaccine safety” and co-authored studies examining the association between mRNA COVID-19 vaccines and risks of cardiovascular disease, mortality, and adverse pregnancy outcomes.” ACIP Membership Roster, supra note 16. However, based on the current record, he has published only two papers discussing vaccines, and both of those were published mere months before his appointment. Retsef Levi, et al., Twelve-Month All-Cause Mortality after Initial COVID-19 Vaccination with Pfizer- BioNTech or mRNA-1273 among Adults Living in Florida, MedRxiv (Apr. 29, 2025), https://www.medrxiv.org/content/10.1101/2025.04.25.25326460v1 [https://perma.cc/NGN8-SARX] (cited at Compl. ¶77(g) n.53); Josh Guetzkow, et al., Observed-to-Expected Fetal Losses Following mRNA COVID-19 Vaccination in Early Pregnancy, MedRxiv (June 20, 2025), https://www.medrxiv.org/content/10.1101/2025.06.18.25329352v1.full- text [https://perma.cc/EKL3-ELMS] (cited at Compl. ¶ 77(g) n.53). Publishing two papers on a topic, while no doubt relevant to ACIP, likely does not rise to the level of “expertise” called for under ACIP governing documents. See Expertise, Black’s Law Dictionary (12th ed. 2024) (defining “expertise” as “[s]kill or knowledge in a particular subject; specialized experience that gives rise to a facility that comparatively few people possess”).
54 Defendants describe Dr. Malone, an adjunct professor at Pennington Biomedical Research Center, Louisiana State University, as “a vaccinologist, scientist, and biochemist known for his early contributions to mRNA vaccine technology” whose “expertise spans molecular biology, immunology, and vaccine development.” ACIP Membership Roster, supra note 16. The only evidence in the record of his experience related to vaccines is that he was involved in early research on mRNA technology in the 1980s and 1990s. See id. Even crediting that experience, the Court cannot conclude that this experience, thirty plus years ago, constitutes the requisite expertise necessary for ACIP today. Further, the scope of his role in that research is disputed, see Davey Alba, The Latest Covid Misinformation Star Says Не Invented the Vaccines, N.Y. Times (Apr. 3, 2022), https://www.nytimes.com/2022/04/03/technology/robert-malone-covid.html (cited at Compl. ¶ 77(h) n.59), which the Court need not resolve at this juncture.

55 Dr. Stein is a professor at Case Western Reserve University and “an epidemiologist with more than two decades of research experience on tuberculosis and infectious diseases and 115 peer reviewed publications.” ACIP Membership Roster, supra note 16. However, there is no evidence in the record that her experience and expertise relate to vaccines, vaccination, vaccine safety, or vaccine policy as to be relevant to ACIP’s function.

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