How will a vaccine be proven safe?

If and when a vaccine is made available may not be up to the President alone – or the US Food and Drug Administration. There's a small, secretive group that sees the data before anyone else, and right now they have one of the most monumental tasks in the world: to ensure a vaccine would be safe for distribution.

The Data and Safety Monitoring Board, or DSMB as it's known, is a group of experts in areas such as statistics, ethics and vaccine development. They are the only ones to get a few "unblinded" looks at the data as it starts to come in.

With vaccine hesitancy and confusion about timelines at the top of many Americans' minds, we spoke to experts about what this group is tasked with doing and who is behind these decisions.

Interest in the groups has increased as debates about the timeline of a vaccine have played out on a national scale with the president declaring that he thought a vaccine could be available before Election Day. That’s a decision that the DSMB would help make.

 

We’ve also seen updates from some of the key companies saying that they don’t expect a vaccine by Election Day. Moderna’s chief said a Covid-19 vaccine Emergency Use Authorization would probably not happen until November 25, at the earliest and a vaccine won't be widely available before late March.

And there are still questions about when AstraZeneca's vaccine trial will resume. It is still on pause in the US, as questions continue about a trial participants' mysterious illnesses. That trial was halted by a DSMB.