harmaceutical giant AstraZeneca has been forced to put its COVID-19 vaccine trial on hold after a participant suffered an unknown illness.

The company says more tests are required to determine the diagnosis, which will be reviewed and established by an independent safety committee.

While they’re waiting, the trial is on pause in case the illness is deemed to be a side effect of the vaccine.

So how does reviewing an incident like this work and what happens next?

If safety issues arise, that’s when a clinical hold or a pause on the trial can be imposed.

“Vaccine safety is a scientific and medical question, so the Drug Safety Monitoring Board is typically made up of doctors, a biostatistician, and a medical representative of the sponsor company running the trial,” he says.

“The DSMB is different to the ethics committees that initially approve the trial, which typically have a broad range of people including consumers, lawyers, priests and clinicians represented.”

Biostatisticians are crucial components of DSMBs, as they determine whether any adverse effects are likely to be related to the vaccine trial or not.

Full article published by ABC News on the 12th September 2020 to read the full article click here.