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

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.

The New York Times reported that to determine 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 protocol anticipates that a safety board will perform an early analysis after there have been just 75 cases. If the vaccine is 50 percent effective at that point, it might be possible for the company to stop the trial early and apply for authorisation from the government to release the vaccine for emergency use.

It isn't AstraZeneca alone, Moderna and Pfizer have announced their blueprints for the clinical trials this past week.

Blueprints or protocol for clinical trials are kept secret until studies are complete, but Pfizer and Moderna have made their blueprints public. The blueprint contains information such as clinical trial design, primary and secondary endpoints, patient selection, statistical analysis, measurement of outcomes and adverse events.

Experts say this is an unusual step, given the intense competition between companies who are racing to develop vaccines.

But it helps vaccine and public health experts to get a sense of how the effectiveness and safety of the vaccine. This put pressure on other vaccine makers to do the same.

Pfizer released the 137-page protocol of its mRNA vaccine, which it is developing with Germany-based BioNTech. However US-based Moderna became first to release its protocol for the Phase III trial of its mRNA vaccine.

Both Pfizer and Moderna trials are in phase-3. Moderna is conducting phase-3 and 30,000 subjects and has completed 84 percent of the recruitment. Pfizer is testing the vaccine on 44,000 participants in phase-3.