Have independent researchers been granted access to raw trial data for Pfizer or Moderna vaccines, and what were their findings?
Executive summary
Independent access to raw, participant-level trial data from Pfizer’s pivotal COVID-19 vaccine trial has been limited but has progressed through court orders and company data‑access programs; Pfizer states it will provide de‑identified patient‑level data on request [1] and key FDA datasets were ordered released by a judge beginning in 2023–2025 [2] [3]. Moderna’s public commitments on sharing comparable raw datasets are less clearly documented in these sources; reporting shows Moderna had not committed to the same data‑sharing timetable as Pfizer as of early 2025 [3].
1. What “raw data” means and who controls it
Regulatory and academic scrutiny has focused on de‑identified, subject‑level analysis datasets (the ADSL and similar files) that allow independent reproduction of analyses; manufacturers and contract research organizations hold those datasets and control access while regulators hold copies used for approvals [2]. Pfizer explicitly says it will provide de‑identified patient‑level data in response to scientifically valid proposals — i.e., the company controls when and how external researchers can obtain subject‑level files [1].
2. Court orders and FDA releases: forced transparency, piece by piece
Litigation accelerated public access: a U.S. judge ordered the FDA to release the documents underpinning the Pfizer EUA and later to produce large volumes of Pfizer‑submitted material at a much faster pace than the agency proposed [2]. Follow‑up reporting documents a staggered, court‑driven schedule in which the FDA was ordered to release Pfizer’s EUA file by mid‑2025 and to produce datasets beginning in 2023 with major productions through 2025 [3] [4].
3. Pfizer’s formal data‑access pathway and timeline
Pfizer’s public policy states it will grant access to de‑identified, patient‑level data for trials supporting approved indications, in response to scientifically valid proposals, and with safeguards for privacy and regulatory interests [1]. Independent critics and journals pressed for faster, broader access early in the pandemic; The BMJ reported Pfizer would not entertain requests until a 24‑month post‑completion window for certain trials, a timeline that spurred litigation and judicial orders [2].
4. What independent researchers actually found — evidence so far
Available sources do not detail independent researchers’ complete reanalyses of Pfizer or Moderna raw trial files in this dataset set. The BMJ and court records document the release and availability of key datasets such as subject‑level analysis files (ADSL) and that researchers had obtained millions of pages of documents via FOIA and litigation [2] [3]. Specific independent analytical findings drawn directly from those raw FDA/manufacturer datasets are not described in these sources; therefore, independent reanalyses and their conclusions are not detailed in current reporting [2] [3].
5. Competing narratives: transparency defenders vs. company/regulatory concerns
Advocates — including some journals and academic groups — demanded immediate, full access to participant‑level data to allow independent reproduction and scrutiny [2]. Pfizer and regulators counter that data access must protect patient privacy, preserve regulatory processes, and maintain incentives for sponsors to conduct trials; Pfizer’s site reiterates those privacy and regulatory caveats tied to its data‑request process [5] [1]. The sources present both perspectives: public‑interest calls for prompt release [2] and Pfizer’s controlled, conditional sharing policy [1].
6. Moderna: less clarity and fewer commitments in these records
Reporting compiled here notes that Pfizer had a stated timetable to begin entertaining data requests by early 2025 while Moderna had not committed to the same schedule as of January 2024, according to coverage referenced by The BMJ [3]. These sources do not contain a clear, Moderna‑published data‑access policy comparable to Pfizer’s within the provided results; therefore, specifics about independent access to Moderna raw trial files and resulting independent findings are not found in current reporting [3].
7. What readers should watch next
Follow court dockets and the FDA’s FOIA productions for tranche releases of underlying trial datasets [2] [3]. When access is granted through Pfizer’s formal portal, independent researchers typically publish reproducibility studies and post‑analysis code; monitoring peer‑review outlets and preprint servers will show whether independent analyses using the released ADSL and other files produce substantive challenges or confirmations of original trial conclusions [1] [2].
Limitations: my account is constrained to the documents and news items you provided. Those sources document release orders, Pfizer’s access policy, and reporting on litigation timelines [1] [2] [3] but do not contain published, peer‑reviewed independent reanalyses of the full raw trial datasets extracted from FDA or company files — such findings are therefore not described here [2] [3].