What are the FDA and EMA data‑sharing policies and processes for accessing clinical study reports and raw datasets for licensed vaccines?
Executive summary
Regulatory frameworks in the United States and European Union provide detailed technical standards for the submission of clinical datasets to regulators but stop short of guaranteeing broad public access to participant‑level data; the FDA prescribes dataset formats and submission pathways for vaccines while the EMA has had formal transparency policies but also placed limits and temporary suspensions on proactive releases during high‑profile reviews [1] [2] [3]. Clinical study reports (CSRs) and summary results are more routinely subject to disclosure obligations or requests, whereas individual participant‑level data (IPD) often remain subject to eligibility rules, embargos, consent constraints, and sponsor processes that leave much pivotal vaccine data effectively out of public scope [4] [5].
1. FDA: rules for what sponsors must submit and how datasets must be formatted
The FDA requires vaccine applicants to submit comprehensive clinical and manufacturing information and has detailed technical guidance for submitting study datasets to the Center for Biologics Evaluation and Research (CBER), including recommended data standards, study data standardization plans and domain specifications for adverse events, vital signs, microbiology and other clinical domains [1] [2] [6]. Those submission requirements are geared to regulatory review and post‑marketing safety surveillance rather than public release: the guidance specifies formats and standards (for example CDISC conventions and the FDA Data Standards Catalog) that sponsors must use when filing but does not itself create a public IPD release mechanism [1] [2].
2. EMA: Policy 0070, exceptional transparency and its limits
The EMA developed a formal transparency policy (Policy 0070) and during the COVID‑19 crisis adopted exceptional measures to publish more regulatory materials, but the agency’s proactive publication has been uneven and at times temporarily suspended, and critics note that key clinical datasets—particularly IPD underpinning COVID‑19 vaccine approvals—remain out of scope for public request in many cases [3] [4]. The EMA has engaged public consultation and revised its approaches over time, yet legal, privacy and commercial redaction concerns have constrained routine, immediate public disclosure of participant‑level datasets [3] [5].
3. What is actually accessible: CSRs and summary results versus IPD
Across regulators and industry, clinical study reports and summary‑level results are the data elements most commonly made available or required to be registered and reported (for example under FDAAA and related recommendations), whereas participant‑level data are treated as sensitive and subject to controlled access or deemed ineligible for sharing for reasons such as ongoing follow‑up, extended embargos, or consent limitations [5] [4]. Multiple reviews and policy updates over the last decade have argued that participant‑level data underpinning product labels should be eligible for sharing, but empirical analyses find that roughly half of participant‑level datasets supporting new medicines are presently out of scope for requests [4].
4. How researchers typically try to gain access in practice
When IPD is made available, it usually happens through sponsor‑managed controlled‑access platforms or via negotiated data‑sharing agreements that impose safeguards, permitted uses and sometimes fees; regulators themselves focus on accepting standardized submissions for review [1] [2]. The FDA’s technical documents instruct sponsors how to prepare machine‑readable datasets for agency review and for post‑marketing pharmacovigilance reporting, and the EMA’s published CSRs or regulatory assessment reports are the main public regulatory outputs researchers consult when full IPD is not released [1] [2] [3].
5. Gaps, controversies and competing agendas
Tensions between transparency advocates, commercial interests, participant privacy and regulators’ duties to protect confidential information create messy incentives: independent scholars urge immediate eligibility of IPD for trials underpinning approvals, industry and some regulators point to the need for embargos, consent and redactions, and pandemic‑era emergency pathways (e.g., EU and FDA accelerated reviews) intensified pressure on both disclosure and speed of review, with follow‑up monitoring requirements added as a counterbalance [4] [7] [8]. Analyses of COVID‑19 vaccine regulatory handling show that public pressure sometimes forced later disclosure of protocol details and other materials, highlighting that transparency often advances through political and scientific advocacy as much as through existing policy [9] [8].
6. Bottom line: predictable process, limited public reach
For licensed vaccines the FDA provides prescriptive technical requirements for dataset submission to support regulatory review and safety monitoring, and the EMA has mechanisms to publish regulatory documents and CSRs, but neither regime guarantees routine public release of raw IPD; access to participant‑level datasets typically depends on sponsor policies, controlled access agreements, and legal/privacy constraints, leaving notable gaps—especially for some COVID‑19 vaccine datasets—that experts and policy reviews have repeatedly called on regulators and sponsors to close [1] [2] [3] [4].