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We need the raw data

Addressing the many open questions about these trials requires access to the raw trial data. But no company seems to have shared data with any third party at this point.

Pfizer says it is making data available “upon request, and subject to review.” This stops far short of making data publicly available, but at least leaves the door open. How open is unclear, since the study protocol says Pfizer will only start making data available 24 months after study completion.

Moderna’s data sharing statement states data “may be available upon request once the trial is complete.” This translates to sometime in mid-to-late 2022, as follow-up is planned for 2 years.

Things may be no different for the Oxford/AstraZeneca vaccine which has pledged patient-level data “when the trial is complete.” And the ClinicalTrials.gov entry for the Russian Sputnik V vaccine says there are no plans to share individual participant data.

The European Medicines Agency and Health Canada, however, may share data for any authorized vaccines much earlier. EMA has already pledged to publish the data submitted by Pfizer on its website “in due course,” as has Health Canada.

Peter Doshi, associate editor, The BMJ