Me vaccine trial raw patient data
Executive summary
Requests for "raw patient data" from COVID‑19 vaccine trials have driven years of legal and scholarly pressure: portions of Pfizer’s phase 3 subject‑level datasets and other documents were released in tranches and via FOIA, and a key ADSL dataset was reported released by FDA in March 2023, but full, timely access to harmonised individual participant data across manufacturers was incomplete and contested [1] [2] [3]. Independent researchers, journals and watchdogs continue to press for earlier, routine release while regulators and industry cite privacy, resource and legal constraints for staged disclosure [4] [5].
1. What exists now: partial releases, court orders, and public repositories
Hundreds of thousands of pages including 37 patient‑level datasets for Pfizer’s phase III trial (C4591001) have been posted for public download via the PHMPT repository, and the FDA reportedly included the ADSL (Subject‑Level Analysis Data) in a March 2023 tranche of documents it produced, addressing a central gap for reproducing Pfizer’s analyses [1] [2]. In related litigation a U.S. district judge ordered the FDA to produce all documents FDA relied upon for certain authorisations, criticizing the agency’s proposed multi‑decade production schedule and setting an accelerated timetable [2]. ClinicalTrials.gov retains the trial registry entries that underpin these datasets even where raw files have been delayed [6].
2. What’s still missing or fragmented: manufacturer gaps and timing problems
Independent reviews warned early that individual participant data for most COVID‑19 vaccines would not be available for months or years, and that only Pfizer’s data were initially being produced by the FDA while other manufacturers’ datasets remained inaccessible until approvals or other triggers occurred [3] [4]. Companies updated trial completion timelines—Pfizer extended completion dates during 2022—complicating expectations about when locked datasets would be finalised for sharing [7]. Academic critiques noted inconsistencies and reporting gaps in journal publications that make reconstruction difficult even when some raw files exist [8].
3. Why activists, researchers and some clinicians demand raw data
Advocates and methodologists argue that access to deidentified participant‑level data, analysis code and protocols is necessary to independently verify efficacy and safety claims, explore subgroup effects, and audit trial conduct—especially given past instances of problematic site practices flagged in reporting during the pandemic [4] [7]. Cross‑disciplinary calls for a real‑time data‑sharing infrastructure for vaccine trials have been published in peer‑reviewed forums urging investigators to release protocols, raw data and analytic code upon trial completion [9].
4. Industry and regulators’ stated constraints and protections
Pharmaceutical companies and some regulators defend staged or controlled access on grounds of protecting patient privacy, ensuring data are interpretable and preventing misuse, and regulatory workflows can slow proactive publication; Pfizer publicly states a commitment to sharing clinical trial information while also noting the need to protect patient confidentiality [5]. The FDA’s resource limitations and legal procedures for FOIA production were explicitly referenced in court, with the judge rejecting a multi‑decade timetable as incompatible with FOIA rights [2].
5. How to access what’s available and what that means for independent analysis
Researchers seeking raw files can start with the PHMPT downloads for Pfizer’s pivotal trial and the FDA production tranches that reportedly included ADSL in March 2023; vaccine safety surveillance datasets such as VAERS are also publicly downloadable as CSV files and were expanded in 2025 to include more reports and a CDC/FDA WONDER interface for queries [1] [2] [10]. However, replication is not always straightforward: corporate press releases and NEJM publications summarise efficacy and safety—Pfizer’s phase 3 paper reported 95% efficacy based on 43,448 participants—which do not substitute for harmonised, fully documented participant‑level data and analytic code that many epidemiologists call for [11].
6. Bottom line: progress made, but transparency goals not yet met
Significant material has reached the public sphere and court orders have accelerated disclosure, but the landscape remains patchy—some crucial datasets were delayed, other manufacturers’ participant‑level data lagged, and advocates continue to press for routine, timely release of deidentified individual participant data with analysis code to enable independent verification and public trust [2] [3] [9]. Where claims fall outside the scope of available reporting—such as precise current inventory of every manufacturer’s raw files—this account reports only what the cited sources document [2] [1].