Have Pfizer and Moderna released all raw study data for Covid vaccines
Executive summary
Pfizer has been subject to court orders and Freedom of Information battles over release of its trial documents; a judge ordered the FDA to release Pfizer data at 55,000 pages a month after the agency’s slow-provision offer [1]. Moderna has said patient-level datasets would be available “upon request” after trial completion and indicated final results publication timing would govern access [1]. Available sources do not state that either company has fully released all raw, participant‑level clinical trial data to the public [1].
1. Why “raw data” matters — and who controls it
Researchers, clinicians and journalists demand participant‑level datasets because they allow independent reanalysis of efficacy, safety signals and trial conduct; but the companies and contract research organisations hold those datasets, not regulators, which limits third‑party access [1]. The BMJ commentary and reporting cited in these sources underline that regulators such as Health Canada and the EMA do not necessarily receive or analyse participant‑level raw datasets, intensifying calls for direct release from sponsors [1].
2. Pfizer: court fights, slow releases, and a judge’s order
Public reporting notes that after litigation and FOIA requests the FDA initially offered to release Pfizer vaccine documents at a rate of 500 pages per month — a pace critics said would take decades — and a judge later ordered a much faster pace of 55,000 pages per month [1]. That litigation demonstrates the contested nature of what, when and how much Pfizer‑held material is made public; the source does not claim every piece of participant‑level data has been released [1].
3. Moderna: conditional access tied to trial completion
Moderna’s stated position in reporting is that key datasets “will be available upon request and subject to review once the trial is complete,” and Moderna indicated data availability would follow publication of final study results [1]. That language signals controlled, case‑by‑case sharing rather than an automatic public dump of raw trial files [1].
4. Regulators’ role — what they receive and what they publish
The BMJ coverage emphasizes that some regulators do not receive participant‑level datasets and that the FDA in the Pfizer case was the focus of legal action to disclose its review materials [1]. Available sources do not provide a complete inventory of what the FDA, EMA or Health Canada have released in full for Pfizer or Moderna; they instead highlight gaps and disputes over access [1].
5. Data release timelines and the “two‑year” reference
Reporting notes that Pfizer indicated it would not begin entertaining requests for trial data until May 2025 — described as 24 months after a listed primary study completion date — and that Moderna tied release to the estimated primary completion or publication milestones [1]. These scheduling details matter: they mean requests for detailed datasets could face long waits and are subject to sponsor policy [1].
6. Independent transparency efforts and advocacy pressure
The sources document advocacy groups and lawyers suing or petitioning regulators to force faster disclosure — for example, groups like Public Health and Medical Professionals for Transparency pressing the FDA over Pfizer materials — showing pressure comes both from inside and outside academia [1]. That pressure produced court rulings compelling faster agency releases in at least one high‑profile instance [1].
7. What these sources do not say (important limits)
Available sources do not state — and therefore do not confirm — that Pfizer or Moderna have completely and publicly released every raw, participant‑level dataset from their COVID vaccine trials [1]. They also do not provide a full, up‑to‑date catalog of which specific files have been made public by sponsors or regulators after these reports [1].
8. Takeaway for readers: transparency is partial and contested
The record in these sources shows the companies control raw trial data, that Moderna has conditioned sharing on trial completion/publication, and that Pfizer faced court‑ordered unblocking of large document volumes after regulatory resistance [1]. Those facts mean transparency has improved under legal pressure but, per the cited reporting, full public access to all raw, participant‑level data is not documented in current reporting [1].