List vaccines for which manufacturers have released full raw patient datasets for independent analysis
Executive summary
Only one COVID-19 vaccine manufacturer—Pfizer/BioNTech—has been documented in these sources as having released key subject‑level trial data and broader review documents to regulators and, under court pressure and company programs, to the public or qualified researchers for independent analysis [1] [2] [3], while other major manufacturers have not provided fully public raw patient‑level trial datasets and in some cases still restrict access behind requests or regulatory approval processes [4] [5].
1. Pfizer: partial public release and controlled access to patient‑level trial data
Pfizer’s COVID‑19 vaccine files were the focus of a court‑ordered document release that forced the FDA to publish large batches of review documents and resulted in the release of a key subject‑level analysis dataset (ADSL) in March 2023, and Pfizer states it will provide de‑identified patient‑level data to qualified researchers via controlled platforms such as Vivli under data use agreements and scientific review [1] [3] [2].
2. Moderna, Johnson & Johnson and other manufacturers: no full public raw patient datasets documented
Reporting in The BMJ and related coverage makes clear that regulators and manufacturers other than Pfizer had not publicly released participant‑level trial datasets; the BMJ noted that the FDA was producing data only for Pfizer and that raw datasets from Moderna and Johnson & Johnson were not available for request at the time of that reporting [4], and independent researchers continued to face waits for patient‑level data from both Pfizer and Moderna trials according to follow‑up BMJ reporting [5].
3. Surveillance systems and adverse‑event databases are public but are not the same as trial raw data
Public, downloadable datasets such as VAERS provide open access to adverse‑event reports submitted by providers, manufacturers, and the public and are useful for surveillance; however, VAERS is not a replacement for anonymized participant‑level randomized‑trial datasets and explicitly excludes identifiable patient information from public files [6] [7], and FDA/CDC raw data mining outputs used for surveillance are distinct from raw clinical trial participant‑level datasets [8].
4. Why manufacturers and regulators have limited or staged releases
Multiple sources document legal, commercial‑confidential and privacy constraints that slow or limit public release: industry is not legally required to honor independent‑researcher requests for raw trial data [4], FDA releases have been subject to court orders and redaction requirements to remove trade secrets and identifiable patient information [1], and companies commonly channel data access through controlled request systems that require proposals, independent review and data use agreements [2].
5. Alternative viewpoints and what the sources do not settle
Advocates like The BMJ demand immediate public release of participant‑level datasets to enable independent verification and to restore public trust [4] [9], while regulatory and industry statements cited here emphasize staged, redacted or request‑based access to protect privacy and proprietary information [1] [2]; the assembled sources document Pfizer’s exceptional visibility on this front but do not support a claim that multiple manufacturers have released fully open raw patient datasets for unrestricted independent analysis [4] [5] [2].
6. Bottom line and limitations of this account
Based on the reporting and documents compiled here, Pfizer is the only manufacturer explicitly connected to public releases of pivotal trial review documents and at least one subject‑level dataset, with controlled access pathways for additional de‑identified participant data [1] [3] [2]; other manufacturers have either not released full participant‑level trial datasets publicly or remain accessible only via delayed or conditional requests, and the sources available do not provide evidence that those raw trial datasets have been made openly downloadable for unrestricted independent analysis [4] [5]. The sources used do not definitively catalog every dataset release globally or after their publication dates, so this assessment reflects the documented state in these reports rather than a claim of absolute completeness.