Communication and education are critical to patient confidence in emergency use authorization vaccines.
Mitchel Rothholz, RPh, MBA: With regard to the difference between the process that the FDA uses in designating something as an EUA [emergency use authorization]–approved product or authorized product vs an approved or licensed product, is there a difference between the vaccines?
Jeff Goad, PharmD, MPH: For the general population, there isn’t. In other words, the FDA still looks at safety No. 1, the efficacy, and the studies. In terms of the completion of the studies, the FDA often wants to see long-term studies that may not be available when there’s an evolving pandemic. This thing is moving right now. The EUA process allows the FDA to take the data it has and apply the same rigor it uses to the approval process but to get a very limited, focused approval in place to allow the population to take advantage of this new technology rather than waiting for years.
Of course, the CDC [Centers for Disease Control and Prevention] is a little different. They aren’t in the approval process. They’re in the recommendation business. Their job is to take the data that the FDA has and other data that comes in post-FDA submission, and combine it with social, operational, and public health good to come up with recommendations that are operationalizable and maximize that EUA process. If you’re going to get a vaccine on the market through the EUA, you’re going to need the CDC to give you a lot more robust guidance to use it.
Mitchel Rothholz, RPh, MBA: The bottom-line message from a practitioner perspective is that an EUA vaccine isn’t different from a license or authorized to be an approved product from the FDA. As providers, that’s the message we need to take with us as patients ask that question. I’ve had situations in clinics in which somebody wanted to look at the vial I was drawing the vaccine out of to see if it was the EUA product or the licensed products. There’s no difference. This is the one we’ve got. It’s important from the public’s perspective of being comfortable with what they’re getting. Be confident, give the facts, and move forward.
Transcript edited for clarity.