How to Discuss the FDA’s Expedited EUA Process With Vaccine Hesitant Patients

Pharmacy Times® interviewed Chad Landmon, JD, chair of intellectual property and FDA practice groups at Axinn, Veltrop & Harkrider, on the FDA’s emergency use authorization (EUA) process for COVID-19 vaccines, such as the expedited process for the recently authorized Johnson & Johnson COVID-19 vaccine.

Alana Hippensteele: How would you recommend pharmacists approach discussing the approval process of the COVID-19 vaccines with patients who are concerned about the expedited nature of the authorization process?

Chad Landmon: Yeah, so that's obviously a very touchy and difficult subject. There's not only been a lot of misinformation that's out there about COVID-19 treatments, there's a lot of distrust in terms of the process, and there's a lot of distrust just out there in society these days, and obviously a lot of divisiveness.

My kind of frank advice is to be very truthful about it and don't sugarcoat things to let people know that: Yes it was an abbreviated process, yes it did not go through the full approval and review that happens, the clinical studies had less participants in it than you would see of a study that takes years of time, and obviously the safety data is a much shorter period of time than you would normally see for a drug or vaccine to get approval.

All of that being said, I think you can also tell people that there were significant clinical studies that were done with tens of thousands of patients who were given these vaccines. I think depending on what the vaccine is, you can talk about the efficacy data that's out there, that Pfizer and Moderna have similar efficacy data, the J&J has somewhat slightly different efficacy data, and I think you can talk to people about that to the extent that they're concerned.

On the safety side, I think there are a couple things. One not only was safety considered throughout the phase 1, 2, and 3 clinical studies that were done, but also we have a fair amount, especially for the Pfizer and Moderna vaccines, of real world experience. It's been dosed into hundreds of millions of people across the world already, so we do have some experience on that front as well.

But my kind of general advice is really to be upfront with people about the expedited nature of the authorization, but I think there's a lot of positive things that can be said about the data that is available.