Pfizer releases COVID-19 vaccine trial protocol

Pfizer released the protocol for its phase 3 COVID-19 vaccine trial Sept. 17, shortly after Moderna did the same, The New York Times reported. 

The protocol details how participants are being selected for the trial, the conditions under which the trials could be stopped early and the evidence researchers will use to determine whether the vaccine is safe and effective. Companies typically only share this information after trials are complete, but in this case, Pfizer said “the need for transparency is clear,” according to the Times

Both Pfizer and Moderna are trying to address growing concern that President Donald Trump’s push to deliver a COVID-19 vaccine before Election Day could result in an unsafe vaccine being distributed, the Times reported. 

Pfizer, Moderna and AstraZeneca are the furthest along in clinical trials for their experimental vaccines. A spokesperson for AstraZeneca said the drugmaker would also publish its protocols shortly, according to the Times

Pfizer’s protocol doesn’t appear to estimate when results could be available, but CEO Albert Bourla, PhD, has said that the drugmaker could have an answer as early as October. 

Eric Topol, MD, a clinical trial expert at Scripps Research in San Diego, told the Times that he is concerned about some aspects of Pfizer’s protocol, including that it allows mild cases to be counted and provides too many opportunities to stop the trial early based on a few cases. 

Read the full article here

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