In a rare move, drugmakers release vaccine trial blueprints

Sept. 18, 2020

Amid growing vaccine skepticism and calls for transparency, Moderna, followed by Pfizer, released their COVID-19 vaccine trial blueprints, with AstraZeneca promising its protocols are forthcoming.

Typically not shared with the public, Moderna's 135-page Phase III clinical study protocol and Pfizer's 137-page Phase 1/2/3 study protocol reveal details about trial participant selection and monitoring, the conditions under which the trials could be halted early, and the evidence researchers will use to determine efficacy.

Dr. Tal Zaks, chief medical officer for Moderna, told the NY Times that Moderna had consulted an outside ethics expert who advised the company that the only way to win trust was to be “transparent to the point of discomfort,” prompting the company to be the first to release the trial protocols. 

A spokeswoman for AstraZeneca told the NY Times that the drugmaker intends to publish its protocol shortly.