Have Pfizer and Moderna published their clinical trial protocols and full datasets for Covid vaccines?
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Executive summary
Pfizer and Moderna made their phase‑3 trial protocols publicly available early in the pandemic, enabling external scrutiny; however, access to the full, patient‑level trial datasets has been limited and contested, with partial releases and legal pressure producing incremental disclosures rather than an open‑access, complete individual participant dataset from both sponsors [1] [2] [3] [4] [5].
1. Protocols: opened early for public review
Both companies published full trial protocols in 2020, a move highlighted by The BMJ as a rare opportunity for “real time transparency” when four manufacturers made their full study protocols publicly available; Pfizer’s C4591001 protocol and Moderna’s mRNA‑1273 P301 protocol were among those released and have been cited in regulatory and academic analyses [1] [2] [3].
2. What “full dataset” means — and why that matters
Clinically useful transparency typically means access not only to protocols and summary results but to the underlying individual participant data and case narratives so independent researchers can re‑analyse safety signals and subgroup effects; regulators like the FDA receive and review these detailed datasets, but sponsors and agencies have different policies and timelines for external release, complicating expectations about what “published” means in practice [4] [3].
3. The reality: protocols published, participant‑level data mostly withheld initially
By mid‑2022 independent researchers were still waiting for patient‑level data from Pfizer and Moderna, with both companies extending trial completion dates and Pfizer’s protocol stating individual participant data would be made available two years after study completion — a timeline and process that left researchers without the raw datasets used for EUA and licensure analyses at that moment [4].
4. Partial releases and legal pressure changed the landscape incrementally
Legal challenges and FOIA litigation produced concrete outcomes: a key Pfizer trial dataset was released in March 2023 according to reporting cited by The BMJ, and a U.S. district judge later ordered the FDA to produce documents it relied upon to license vaccines for younger age groups — an order that compelled more public disclosure on a defined schedule [5]. These developments show that while sponsors did not immediately open full datasets for unrestricted public download, litigation and public pressure pushed additional transparency.
5. Sponsors’ stated reasons and independent critiques
Pfizer’s public materials emphasize patient privacy and protecting trial integrity when describing how and when data will be shared, framing staged access within a governance model for data requests [6] [2], but independent scientists and commentators — including voices collected by The BMJ — argued for faster release of participant‑level data to allow independent safety analyses and verification of reported adverse events, highlighting a persistent tension between corporate/regulatory process and calls for open science [4] [1].
6. Bottom line: protocols yes; full open datasets, not uniformly
The core fact is straightforward: Pfizer and Moderna published their trial protocols publicly in 2020, facilitating methodological critique [1] [2] [3], but comprehensive public release of the full, de‑identified individual participant datasets was not universal or immediate — disclosures have been piecemeal and sometimes court‑driven, with at least one major Pfizer dataset disclosed in 2023 while broader availability depends on company policies, regulatory holdings, and legal processes [4] [5].