Last time a vaccine manufacturer released full raw patient data regarding vaccine

Checked on January 8, 2026
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Executive summary

The most recent documented release of a key, participant‑level clinical trial dataset from a vaccine manufacturer occurred when the FDA included the Pfizer pivotal trial ADSL (subject‑level analysis) dataset in a March 2023 tranche of documents made public under court order [1]. That disclosure followed a separate 2022 federal ruling that forced the FDA to accelerate publication of the documents it relied on to license Pfizer’s COVID‑19 vaccine after the agency had proposed an extremely slow release schedule [2] [3].

1. What the question is asking — and the short answer

The query seeks the last instance when a vaccine maker publicly released full, raw patient‑level trial data; the clearest, source‑documented example in the reporting provided is Pfizer’s ADSL dataset, which the FDA released as part of its March 2023 document tranche after litigation compelled expedited disclosure [1].

2. How that release came about — the legal and administrative timeline

A coalition of scientists sued the FDA under FOIA to force release of the agency’s review documents for Pfizer’s COVID vaccine; the FDA initially proposed producing at most 500 pages a month — a schedule that would have taken decades — and a judge rejected that timetable, ordering faster disclosure and triggering monthly tranches of tens of thousands of pages beginning in early 2022 [3] [2]. The agency began releasing 55,000 pages in March 2022 and continued tranches thereafter; the ADSL subject‑level dataset was later identified in the March 2023 tranche [4] [1].

3. What “full raw patient data” meant in this case — and the limits

The documents FDA released included de‑identified, subject‑level analysis files and other trial materials, but the agency and courts required redaction of confidential business information and private patient identifiers before public posting, meaning the publicly available files were anonymized and accompanied by redactions to protect trade secrets and privacy [2] [4]. Reporting and expert comment warned that tens of thousands of pages of regulatory filings can be difficult to interpret and may be prone to cherry‑picking without careful statistical re‑analysis [2] [4].

4. Other manufacturers and surveillance datasets — what was and wasn’t released

Advocates and journals noted that among regulators the FDA holds large amounts of underlying data but does not proactively release participant‑level datasets for all manufacturers, and at the time it was producing data mainly for Pfizer while datasets for Moderna and others were not publicly available until or unless required by regulation or litigation [5] [6]. Separate vaccine‑safety surveillance systems such as VAERS and v‑safe make raw surveillance files available to the public in downloadable formats, and CDC/FDA expanded VAERS access in May 2025 to include more reporting details, but those are post‑market surveillance data rather than sponsor‑held trial databases [7] [8].

5. The transparency debate and why the March 2023 dataset matters

Major medical journals and independent scientists pressed for immediate access to anonymized participant‑level trial data to enable independent verification and analysis, arguing that aggregate summaries and press releases are insufficient; that campaign of pressure helped underpin the FOIA litigation and public interest in the FDA’s document releases [5] [9]. Plaintiffs and some editors framed delayed or partial disclosure as unacceptable for an intervention given to millions, while industry and regulators cited privacy, trade secrets, and redaction workload as constraints — a tension reflected across the reporting [3] [2] [4].

6. Bottom line — what can be stated with confidence and what the record leaves open

Based on the reporting provided, the most recent concrete instance of a manufacturer’s subject‑level trial dataset entering the public domain was Pfizer’s ADSL file included in the FDA’s March 2023 tranche after court‑ordered disclosure [1]; however, that file arrived as an anonymized, redacted dataset released by a regulator rather than an unredacted dump voluntarily posted by the manufacturer, and other manufacturers’ trial‑level datasets remained unreleased absent regulatory action or litigation [1] [5]. Reporting beyond these sources would be needed to confirm whether any later voluntary, full, unredacted patient‑level release by a vaccine maker occurred after March 2023.

Want to dive deeper?
What is the ADSL dataset and how do researchers use it to reproduce vaccine trial results?
What legal rulings and FOIA actions compelled the FDA to release Pfizer’s COVID‑19 vaccine trial documents?
How do de‑identification and redaction practices affect independent reanalysis of clinical trial participant‑level data?