Let’s talk about FDA’s emergency use authorization. Hello, I’m Dr. Jeff Kingsley and welcome to another edition of Riding in Cars with Researchers. The FDA has the ability to get products to market faster in emergency situations. It’s called the emergency use authorization, or EUA.

Emergency Use Authorizations

Normally research takes 7-10 years in human clinical trials before you would ever get FDA approval. In an era of a pandemic, this is being accelerated like I’ve never seen before. Sponsors are conducting what is called adaptive trial designs, where they’re blending different phases of research. They are still following the normal safety protocols that we would – it’s still a gated approach. But it enables faster turnaround times and faster collection of data.

The vaccine trials that we’re doing right now for COVID-19 are two-year-long trials. But what’s going to happen is we will have enough safety and efficacy data (enough information about how safe is the product and how well it works), and how it gives you an effective immune response when coming in contact with the coronavirus. We will have enough data to push that to FDA, and FDA will be able to grant an emergency use authorization. It will be able to say we have enough information to say, that in the era of a pandemic let’s allow this to be used outside of a research protocol.

Conditional Use

The EUA will be conditional upon continuing all the research. So we will continue with all the patients we have in these vaccine trials for the full two years. We will continue to collect all of that safety and efficacy data. But prior to the end of 2020, FDA’s EUA will allow these products to get to the greater community rather than people having to wait two years. So that’s the purpose of this EUA and it’s the reason why we will get solutions to COVID-19 far faster than we would in a normal situation.

Thanks for riding along!

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