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Another Protocol Released

AstraZeneca has now released the protocol for its coronavirus vaccine trial, according to the New York Times.

Moderna and Pfizer, which also have SARS-CoV-2 vaccines in late-stage clinical trials, released their trial protocols last week. The Times notes that these disclosures of trial protocols, which are usually kept secret, aim to boost public confidence in coronavirus vaccines as there have been concerns about political pressure on the development process.

The Times adds that AstraZeneca's candidate vaccine is of especial concern, as there are worries about participants who developed neurological side effects during its clinical trial. Its trial was paused, though it has resumed in the UK and other locales, but not in the US.

According to its newly released trial protocol, AstraZeneca is seeking a vaccine with at least 50 percent efficacy, the lower threshold set by the US Food and Drug Administration for a SARS-CoV-2 vaccine, and will have a safety review board to conduct one interim analysis to determine if the trial should be stopped early, the Times reports. Scripps Research's Eric Topol tells the Times that AstraZeneca's plan for one interim analysis is a better approach than Moderna's and Pfizer's plans which allow two and fours analyses, respectively, as that many analyses could erroneously lead to findings of safety and efficacy.

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