List drugs and vaccines for which raw patient datasets have not been released
Executive summary
Independent researchers and public-health advocates have repeatedly flagged that raw, participant‑level datasets from several high‑profile COVID‑19 vaccine trials have not been made publicly available: notably Pfizer’s and Moderna’s pivotal trials, while Oxford/AstraZeneca has promised sharing only “when the trial is complete” and Russia’s Sputnik V registered “no plans” to share individual participant data [1] [2]. Regulators such as the US FDA are known to hold much of the underlying data but have resisted proactive public release, offering extremely slow disclosure timetables until a court forced faster production in one high‑profile case [3].
1. Pfizer and Moderna: large trials, withheld participant‑level data
Reporting in The BMJ documents that independent researchers seeking patient‑level data from Pfizer and Moderna vaccine trials have faced delays and deferred completion dates, and that participant‑level datasets for these sponsors are held by the sponsors and the FDA rather than public repositories — meaning raw trial data were not broadly released to independent scientists at the time of reporting [1]. Pfizer’s public statements indicate it will provide de‑identified patient‑level data in response to “scientifically valid research proposals,” a conditional access model rather than blanket public posting [4] [5].
2. Oxford/AstraZeneca and Sputnik V: promises, pledges, and explicit refusals
Peter Doshi and colleagues noted that Oxford/AstraZeneca pledged to share patient‑level data “when the trial is complete,” signaling a future‑oriented commitment rather than present open access [2]. By contrast, the ClinicalTrials.gov entry for Russia’s Sputnik V vaccine explicitly stated there were no plans to share individual participant data, an explicit declaration of non‑release [2]. The sources do not report that those datasets were publicly available at the cited times.
3. Regulators, legal fights, and the slow release problem
The BMJ traced a pattern in which regulators receive raw data but do not proactively publish it; a high‑profile freedom‑of‑information case over Pfizer’s dossier exposed an FDA offer to release only 500 pages per month — a timetable a court characterized as unacceptably slow and later increased to 55,000 pages per month by judicial order [3]. This episode illustrates that even when regulators possess the data, release is controlled by legal, logistical and privacy arguments rather than immediate public access [3].
4. Sponsors’ conditional access policies and privacy arguments
Pharmaceutical sponsors publicly frame access as compatible with patient privacy and regulatory prerogatives: Pfizer’s access portal states de‑identified participant‑level data can be provided to researchers who submit scientifically valid proposals, and notes limits where de‑identification is difficult or re‑identification risk persists [4]. These conditional access regimes are an explicit alternative to open public dumping of raw datasets and are cited by sponsors and some regulators as necessary safeguards [4] [5].
5. What is known, what remains unknown, and why the list is partial
Source reporting allows a clear list limited to the vaccines discussed: Pfizer and Moderna trials’ participant‑level datasets were not publicly released to independent researchers at the times reported, Oxford/AstraZeneca had only pledged future sharing, and Sputnik V declared no plans to share individual data [1] [2] [4]. The sources do not provide a comprehensive catalogue for all drugs and vaccines worldwide, so this compilation reflects the published cases in the reporting provided rather than an exhaustive inventory of every product for which raw patient data remain unreleased [3] [1].
6. Alternatives and implicit agendas in the debate over raw data
Pro‑transparency advocates argue that public release enables independent verification and better informed consent, while sponsors and some regulators emphasize privacy protection, regulatory integrity, and commercial incentives as reasons for conditional or delayed access — positions visible in Pfizer’s access policy and regulators’ redaction arguments in court [4] [3]. The BMJ coverage and commentators like Peter Doshi foreground an agenda for maximal openness in the public interest, whereas industry statements emphasize managed access and legal constraints; both positions appear in the record and explain why raw datasets remain largely guarded [2] [5].