International

Pharma wrap: Three coronavirus vaccine makers release clinical trial blueprint as part of transparency push Coronavirus vaccine makers

September 20, 2020 04:59 PM

AstraZeneca, Pfizer and Moderna have released the blueprint that contains information such as clinical trial design, primary and secondary endpoints, patient selection, statistical analysis, measurement of outcomes and adverse events.

AstraZeneca has released its 111-page clinical trial blueprint for its Covid-19 vaccine, following concerns raised about transparency as the company’s refusal to provide details about neurological illness in two trial participants in the UK.

The phase-3 trial had to be put on hold temporarily for a review of the adverse events, before resuming the trial earlier this month. The studies have resumed in the UK, India, Brazil and South Africa. The trial is still on pause in the US.

AstraZeneca's clinical trial blueprint or protocol says its goal is a vaccine with 50 percent effectiveness. The USFDA in its coronavirus vaccine guidance has stated its bar for approval is a vaccine that reduces the risk of falling sick with Covid-19 by 50 percent.

AstraZeneca's clinical trial blueprint or protocol says its goal is a vaccine with 50 percent effectiveness. The USFDA in its coronavirus vaccine guidance has stated its bar for approval is a vaccine that reduces the risk of falling sick with Covid-19 by 50 percent. the statistical confidence whether the company has met that target, there will have to be 150 people ill with confirmed coronavirus among participants who were vaccinated or received placebo shots.

The statistical confidence whether the company has met that target, there will have to be 150 people ill with confirmed coronavirus among participants who were vaccinated or received placebo shots.

Have something to say? Post your comment