Small Window - sneak preview: Comirnaty (BNT162b2): What Went Wrong in Germany and Europe, and How It Reached the United States Bottom line. The internal minutes of Germany's federal vaccine authority, the Paul-Ehrlich-Institut (PEI), and the EU authorization record show three things. Europe authorized Comirnaty while still requiring further data on characterization, control strategy, process validation and both novel lipids. It worked under political pressure tied to the FDA calendar. And the record shows no on-site European inspection of the U.S. trial sites or of the U.S. manufacturing and testing sites. These failures reached the United States in three ways: directly, through the product both markets share, and through reliance on a European check that was not independent. One allegation, a PEI request to CDC to delete German VAERS records, acted on a U.S. system and can be verified within HHS. Status: Documented, in a record reviewed (PEI minutes, EU decisions, EMA assessment report, FDA Summary Basis for Regulatory Action, published study); As cited, an official record quoted in counsel's complaints; Alleged, counsel's assertion; Open, not established. I. Direct effect 1. Request to CDC to delete VAERS records (Alleged). Counsel's complaints state that the PEI applied to CDC for the deletion of approximately 56,000 German data records from VAERS (Darmstadt complaint p. 19; Mainz complaint p. 22). U.S. effect: VAERS is co-managed by CDC and FDA. Any such request, and what became of it, bears on the completeness of the U.S. safety database and can be checked in CDC and FDA records. II. Effect through the shared product The active substance for the U.S. product is made in Andover, Massachusetts, a site also authorized for the EU product. U.S. drug product comes from Puurs, Belgium, or Kalamazoo, Michigan, and the lipids ALC-0315 and ALC-0159 are the same (FDA SBRA; EU Annex II.A). 2. SV40 element not identified (As cited). The SV40 promoter/enhancer in the expression plasmid was not identified in the plasmid map submitted for authorization. It first appears in an EMA assessment report in February 2024 (EMA/CHMP/21199/2024; Marburg complaint p. 21). U.S. effect: the DNA template draws on Pfizer plasmid technology, the plasmid is reportedly made in Chesterfield, Missouri (unverified), and Andover lots are among the 236 lots reported in 2024. If the U.S. file holds the same map, the element is unidentified there too. 3. Political deadline; open quality objections (Documented). German politicians wanted the inspection results for the U.S. sites by December 10, 2020, the day of the VRBPAC meeting: "It would be difficult to communicate if a vaccine developed in Germany were available first to U.S. citizens and only later to Europeans" (PEI p. 130). A participant whose name is redacted: "The major objections concern essential points, and an authorization without complete assessment would be unprofessional" (p. 133). PEI Vice-President Vieths called the RNA purity "suboptimal" (p. 134). EMA found the characterisation of truncated mRNA species "still limited" (EPAR § 2.2.4). U.S. effect: these concerns relate to the product FDA authorized for emergency use on December 11, 2020. The files do not show whether FDA addressed them. 4. Quality data still owed after authorization (Documented; lateness of the lipid data per counsel). The EU required additional data on characterization, control strategy, process validation and the two lipids, due March or July 2021 (EPAR § 2.2.5). According to counsel, the lipid data came late while the PEI kept releasing batches. The Commission declared the obligations fulfilled on the basis of data submitted on June 17, 2022 (C(2022) 7342 final, recital 2). U.S. effect: FDA approved the BLA on August 23, 2021, after the EU deadlines. Whether FDA held at approval the data the EU had required by July 2021 is open. 5. Residual DNA (Documented as to EMA; study findings published; biological effect open). EMA: "The robustness of the DNase digestion step is not considered comprehensively demonstrated" (EPAR § 2.2.2, recommendation REC7). A published study of four German lots measured 32.7 to 43.4 ng of residual DNA per dose after RNase digestion, against a limit of 10 ng that the authors attribute to WHO. It found the DNA "in amounts similar to that reported ... for US-Pfizer lots" (Kämmerer et al. 2024, pp. 11–14). Counsel notes that the manufacturer's qPCR method and the study's fluorometric method differ, which needs expert clarification (Marburg p. 24). U.S. effect: the finding concerns the authorized active-substance process, including the Andover site that supplies the U.S. product. III. Effect through reliance 6. No European GCP inspection of the pivotal trial on record (Documented as of October 22, 2020; later inspections open). Of 33,811 subjects, 26,817 (about 79 percent) were enrolled in the USA. The only Phase II/III inspection recorded is one by Argentina's regulator ANMAT, at one site holding 15 percent of subjects. EMA weighed a "remote sponsor inspection" or a "document desk review" (PEI pp. 127–128). A PEI official reported to PEI President Cichutek on the "business as usual" faction: "I believe that this argument is ultimately used to carry out no inspections at all." The official also reported the argument "that increased attention to vaccine studies could give ammunition to vaccine opponents," and that the decision had been postponed (p. 112). U.S. effect: unless Europe inspected later, which the record does not show, the EU authorization does not independently confirm trial conduct at the U.S. sites. FDA reports inspection assignments for nine trial sites; "The inspections did not reveal findings that impact the BLA" (FDA SBRA § 6.b). 7. U.S. manufacturing and testing sites assessed remotely (Documented; extent of the PEI's own testing alleged). The EU's GMP inspections of Andover and Chesterfield were "distant assessments," carried out from November 20 to December 2, 2020 (EPAR § 1.2), while politicians pressed for results by December 10 (PEI p. 130). Until August 31, 2021 the EU was allowed to rely on batch control tests performed in the third country (Annex II.A). The minutes record that the usual testing on importation might not be performed: "it is unclear whether this is fixed in writing" (PEI p. 131). On the PEI's own batch tests: "A validation and certification can be done subsequently" (p. 134). U.S. effect: both are U.S. supply sites. FDA's pre-license inspection of Andover took place on July 19–23, 2021. For Chesterfield FDA recorded a waiver; its last surveillance inspection there was in August 2019 (FDA SBRA). Neither record shows an on-site inspection of the Chesterfield testing site for this vaccine before licensure.