How the FDA’s Expedited EUA Process for COVID-19 Vaccines Works

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: So, Chad, how does the EUA process expedite the FDA’s normal approval procedures?

Chad Landmon: Sure, thanks for having me today. So, the EUA process at a basic level is expedited, and basically the way this works is it starts with an emergency declaration by the HHS secretary.

The EUA process was put in place actually by various legislation over the years. A lot of it was actually focused early on terrorism aspects and worries of some sort of biological or radiation weapon being used. So over time, the various legislation has addressed how the EUA process works, but at its core it starts with an emergency declaration from the secretary of HHS finding that there's an emergency—some sort of public health emergency, some sort of threat or actual terrorist attack—and then that pretty much puts FDA into motion on how they handle these.

Very generally, it's an expedited process where the agency works very closely with the applicant—often actually the request is made from somebody within the government, so from NIH, from CDC, from FDA to the applicant—and then they work pretty much to expedite all stages of the development.

So, a lot of times, instead of doing things in steps where you complete phase 1, and then you do phase 2, then you do phase 3, a lot of things are kind of done all at the same time to get the review done quicker. There's a lot more interaction between the agency and the companies in terms of what needs to be done, what studies need to be done, how the review process works, and it's really put not only at the top of the queue, but all of FDA's resources are kind of thrown at it in order to get the review done quickly.

Alana Hippensteele: Right. How does the speed of the EUA process for COVID-19 vaccines and tests over the past year compare to the normal expected timeline for an EUA or an approval by the FDA?

Chad Landmon: Yeah. So as far as EUAs, it's kind of hard to do a comparison. I mean, they all move very quickly, so there's been EUAs in the past for the Zika virus, kind of one of the more recent times where we've had a series of EUAs. But for testing and other things within FDA, they all move very quickly.

I think during COVID-19, we saw some incredibly quick movements on EUAs, particularly as has had to do with PPE and other testing items early on, and then with the vaccines as well. It's hard to say whether it's quicker or slower.

As compared to the normal approval process, I mean it really shaves years off of the approval process and development process. Normally vaccines probably would have gone through a 3 to 5 year development cycle in review by FDA, and as we saw less than a year, if not significantly less than a year, for the review by FDA.

Alana Hippensteele: Right. What is the process the agency goes through as it considers whether or not to grant EUAs?

Chad Landmon: Yeah. So, it starts by the agency determining first that there's some sort of serious condition or disease that's being treated. It has to also look to see that there are no alternatives out there on the market that can be used that are already approved, and then the standard is very different.

So, a normal approval standard is the agency determining that a vaccine, a treatment, whatever is both safe and effective. The EUA threshold determination is just that the vaccine, the therapy, or whatever it is may be effective, and that's a significant difference.

Basically, FDA looks at whatever information it has, whatever information through abbreviated clinical studies, or whatever has been done, and it makes a determination that the vaccines, as we've been talking about, that they may be effective in doing what they need to do. So, obviously it's a shorter analysis, it's looking at less information than would go into a full approval or a full review, and FDA then finally kind of does a risk benefit analysis. So, it looks at okay now that we know that it may be effective, then how risky is it.

So, through the safety studies that have been done, through whatever other information is out there how risky is it, and how beneficial will it be. I mean, obviously with COVID-19 worldwide pandemic, I mean we don't need to get into the extent of the death and loss and everything that's going on, but the risks were obviously very big, so if you look at something that may be effective, you need to do that balancing act, and FDA came out in favor, at least with these vaccines, that the risk benefit analysis was in favor of authorizing these vaccines.