Case 1:25-cv-11916-BEM Doc 291 Filed 03/16/26
Web page 30 of 45
51
Milhoan, 50 Dr. James Pagano, Dr. Raymond Pollak, 52 -appear to lack any experience or skilled {qualifications} associated to vaccines or immunization as required by ACIP’s Constitution. See ACIP Membership Roster, supra observe 16. An extra three of the present ACIP members Dr. Retsef Levi, 53 Dr. Robert Malone, 54 and Dr. Catherine Stein 55_though they’ve
50 Dr. Milhoan “is a pediatric heart specialist and former U.S. Air Drive flight surgeon,” who “holds a Ph.D. within the mechanisms of myocardial irritation.” ACIP Membership Roster, supra observe 16. There isn’t a proof within the file that Dr. Milhoan has any related vaccine-related expertise or experience.
51 Dr. Pagano “is a board-certified emergency medication doctor with greater than 40 years of medical expertise.” ACIP Membership Roster, supra observe 16. There isn’t a proof within the file that Dr. Pagano has any related vaccine-related expertise or experience.
52 Dr. Pollak “is a surgeon, transplant immunobiologist, and transplant specialist who has printed greater than 120 peer-reviewed works and served as principal investigator on NIH transplant biology grants and quite a few drug trials.” ACIP Membership Roster, supra observe 16. There isn’t a proof within the file that Dr. Pollak has any related vaccine-related expertise or experience.
53 Defendants describe Dr. Levi, Professor of Operations Administration on the MIT Sloan College of Administration, as “a number one professional in healthcare analytics, provide chain and manufacturing analytics, threat administration, and biologics and vaccine security” and observe that he has “collaborated with trade stakeholders and public well being companies to develop decision-support fashions to guage biologics and vaccine security” and co-authored research analyzing the affiliation between mRNA COVID-19 vaccines and dangers of heart problems, mortality, and hostile being pregnant outcomes.” ACIP Membership Roster, supra observe 16. Nevertheless, primarily based on the present file, he has printed solely two papers discussing vaccines, and each of these had been printed mere months earlier than his appointment. Retsef Levi, et al., Twelve-Month All-Trigger Mortality after Preliminary COVID-19 Vaccination with Pfizer- BioNTech or mRNA-1273 amongst Adults Residing in Florida, MedRxiv (Apr. 29, 2025), [ (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), text [ (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 information in a specific topic; specialised expertise that provides rise to a facility that comparatively few individuals possess”).
54 Defendants describe Dr. Malone, an adjunct professor at Pennington Biomedical Analysis Heart, Louisiana State College, as “a vaccinologist, scientist, and biochemist identified for his early contributions to mRNA vaccine expertise” whose “experience spans molecular biology, immunology, and vaccine growth.” ACIP Membership Roster, supra observe 16. The one proof within the file of his expertise associated to vaccines is that he was concerned in early analysis on mRNA expertise within the Nineteen Eighties and Nineties. See id. Even crediting that have, the Courtroom can not conclude that this expertise, thirty plus years in the past, constitutes the requisite experience mandatory for ACIP immediately. Additional, the scope of his function in that analysis is disputed, see Davey Alba, The Newest Covid Misinformation Star Says Не Invented the Vaccines, N.Y. Instances (Apr. 3, 2022), (cited at Compl. ¶ 77(h) n.59), which the Courtroom needn’t resolve at this juncture.
55 Dr. Stein is a professor at Case Western Reserve College and “an epidemiologist with greater than 20 years of analysis expertise on tuberculosis and infectious illnesses and 115 peer reviewed publications.” ACIP Membership Roster, supra observe 16. Nevertheless, there isn’t any proof within the file that her expertise and experience relate to vaccines, vaccination, vaccine security, or vaccine coverage as to be related to ACIP’s perform.
30
30
