What’s Taking the FDA So Long?

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S1: Lately, I’ve been thinking about how certain terms from the pandemic are just part of our vocabulary now, words and phrases that we’re utterly unfamiliar to us. Twenty nineteen, super spreader, social distancing PPE. And one of those for me is emergency use authorization or U.A.. You know, I realized that that I as a reporter have been using the term emergency use authorization and EOA a lot since December, and yet at the same time, I’m not sure I could actually define what it means. Can you define it?

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S2: So emergency use authorization is something that came about in 2005. So it’s relatively recent to the history of drugs and regulation.

S1: Sarah Owermohle is not new to the term. She covers health care for Politico. Right now she’s mostly focused on covid and vaccines.

S2: It came about for an anthrax vaccine that the armed services needed because of biological threats and has been used since then for desperately needed vaccines or treatments for things like Ebola, for other viruses, and most recently, the coronavirus,

S1: the three coronavirus vaccines that are on the market in the U.S. now, Pfizer, Moderna and Jannsen, also known as J. And Jay, all got emergency use authorization from the Food and Drug Administration.

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S2: The whole point of an emergency use authorization is that you can get something to market fast, even if there are some lingering questions about who it is best for

S1: as long as the benefits outweigh the risks.

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S2: So they still are asking for a certain bar of information about whether it’s safe and and how effective it might be. But for the vaccines, for instance, they only had a few months data when they made those authorizations.

S1: But now there have been almost nine more months of data. The Delta variant is spreading quickly. Case counts are climbing. Some employers want full FDA approval before they can mandate the shots for employees. And there’s some evidence that a portion of people who haven’t gotten their shots are waiting for the FDA to make them official.

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S3: And I believe that some people on their own, once it gets approved as a full approval, will go ahead and get vaccinated. But for

S1: those. So why hasn’t the FDA fully approved these vaccines today on the show? What will it take for covid vaccines to be fully FDA approved? And will that move the needle on U.S. vaccination rates? I’m Lizzie O’Leary and you’re listening to what next? TBD, a show about technology, power and how the future will be determined. Stick with us. Toward the end of last year, an important group of doctors started meeting online. The Vaccines and Related Biological Products Advisory Committee is a mouthful. The group evaluates vaccines and advises the FDA. And the agency doesn’t have to do what these doctors recommend, but it often does.

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S4: I’d like to add my welcome to this one hundred and sixty second meeting of the vaccines and related biological advisory committee of the FDA

S1: last year, the committee started looking at the covid vaccines, beginning with Pfizer.

S4: We have one task ahead of us today, and that is to discuss and vote on the emergency use authorization of the Pfizer byan check covid-19 vaccine

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S1: for the the whole thing is in the public record. And if you listen to their meetings, you can hear the doctors ask the company representatives all sorts of questions about the vaccines mechanisms, reactions and who was included in clinical trials.

S4: Thank you, Doctor. My question is for Pfizer, and it relates to the recruitment of minorities into the study. My understanding is that the minorities were recruited fairly late in the process. Do we have an adequate follow up to that group compared to the majority of participants?

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S1: At the end of the big meetings, there were three one for each vaccine. The panel voted in favor of emergency use authorizations. They said the benefits of these vaccines outweigh the risks. Shortly thereafter, the FDA granted the US. Sara Owermohle, watch this all play out. Could you lay out kind of the relationship between that advisory committee, the FDA and the various authorizations? How does that picture fit together?

S2: The advisory committees have played an important role for the FDA for years. They’re a group of outside experts in the case of this vaccine committee, a lot of virologists and vaccine experts and pediatricians and also people from different agencies. They’ll have representatives from FDA, from CDC, from the NIH. What they did was kind of lay out the concerns that could be had about vaccines in a way where they ask questions about, you know, have you had enough data from pregnant woman? Have you had enough data from ultra elderly people, people who are above the age of 80 or 90? Why are there not enough non-white people in this child

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S1: when this panel is asking its questions? Do you ever get hints about things they or the agency might want to see as a vaccine moves toward full approval after that emergency use authorization?

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S2: Totally. Yeah, yeah. That’s one really valuable thing about these panels. Outside experts don’t have to, you know, be as diplomatic maybe as government officials do. So they will very explicitly say, you know, you are missing information about this and I want to see this. So in the months between those committee meetings ahead of the authorization and the approvals that we could have within the next few weeks or months, those companies have been working on answers for those questions and a more complete picture of what the vaccine does and who it does it for and how well it does it for different populations.

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S1: Nine months after those first few days, the data overwhelmingly suggest the vaccines are safe and effective. And recent data published in the New England Journal of Medicine says full Amarone vaccination is about 88 percent effective at preventing symptomatic covid with a Delta variant. But those questions that the advisory committee asked about pregnant women, minority populations and various rare side effects, the answers to those questions will dictate how soon the vaccine’s clear. The next big regulatory hurdle, full approval.

S2: The whole idea here is that when FDA approved something, they’re putting their stamp on it, saying this is safe and effective. It’s benefits absolutely do outweigh its risks. And also we know what those risks are. So if you recall, this feels like a century ago, but when the Pfizer vaccine rolled out, there were reports of serious allergic reactions that were not seen in the early data that was submitted for the authorization. Once you roll something out to the broader population, you are going to get a bigger picture of how a vaccine works or doesn’t work or what risks happen. The idea is that with approval, they know what those risks are for a wide range of people because

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S1: for more data.

S2: Exactly, they have more data. They have tens of thousands of people that they’ve been tracking for months and months. And so they’re heading a higher bar than they did for the authorization. And ideally, all those questions are answered.

S1: You know, I think a lot of people are maybe bluntly wondering what’s taking the FDA so long, is is that a fair question to ask?

S2: It is especially when people have only just recently gotten familiar with how the vaccine development process works, like, yeah, what is taking FDA so long? And the answer is that it generally does take them months to approve something. Of course, you would expect that with covid vaccine, there’d be a lot of urgency. And I think that there is. But what they’re doing in those months between authorization and eventual approval is going through all this raw data for tens of thousands of people. So where the emergency use authorization depended on fifteen thousand people over all trials had to be thirty thousand people. And you’ll get people enrolled with any range of medical issues, people across the board on age, people with any other socioeconomic factors that can play into this, people with different jobs where they could be highly exposed. It’s about enrolling all those people, then handing all that information to Eva. And they have to go through all of that, all those thousands of pages about those thousands of people. And so that’s ultimately why it’s taking this long.

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S1: What else goes into the process that we might not think about? I didn’t know, for example, that, you know, there are inspectors looking at facilities

S2: that is vital because the consistency of vaccines is is crucial, obviously. And you don’t want your vaccine to be slightly different than the one that your brother or sister or a friend got. And so just as they are asking all the companies about, you know, the data in different populations, who is enrolled in clinical trials, they are doing on site visits to factories, batch testing, different batches that come off the production line to make sure they’re exactly like each other and looking at the hygiene, the safety, et cetera. That’s one of the reasons, actually, one of the major reasons that another vaccine, AstraZeneca, hasn’t even bothered filing for authorization yet and it might not even file for approval. They haven’t gotten those production questions sorted out. And so that is just as important to the FDA as analyzing the clinical trial data.

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S1: I feel like in the past few weeks, the demands for the FDA to grant full approval to these covid vaccines have gotten a lot louder. I guess I kind of want to explore the reasons why with you and why it matters. You wrote a story saying the FDA is expected to approve the Pfizer vaccine by early September and that people within the FDA were working around the clock. And I have to admit, I read it and thought, wait a minute, were they already working around the clock there?

S2: Hey, I even thought that. I mean, it is it is typical that it takes this amount of time for a vaccine or new medicine to be approved. FDA actually byelaws is required to review new drugs and vaccines in a certain amount of time. And they have not reached that time limit with these vaccines. But you’re right in questioning why there wouldn’t be a 24/7 top priority effort on coronavirus vaccines. There’s a lot of pressure riding on this.

S1: When we come back with full approval is so crucial right now. This is what next TBD, I’m Lizzie O’Leary and I’m talking with Politico reporter Sara Owermohle. Right now, the FDA feels a little bit like a watched pot. Public health officials are anxiously hoping for full approval of the three covid vaccines. And at the same time, they and a lot of parents are waiting on what the agency has to say about vaccines for kids and what the clinical trials for those pediatric vaccine show. What do we know about the the trials for kids? I mean, I’m I’m the mother of a one year old. I want him vaccinated yesterday. But, you know, like any person who I think trust an independent agency or believes in the independence of agencies, I want them to have looked at all of of the data. And I do feel like that kind of encapsulates where they are, where a lot of a lot of people are. So where are we in those trials?

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S2: What we know about them is that they’re a lot smaller than the adult trials where the adults for each manufacturer, they had to enroll at least thirty thousand adults. These trials actually are only a few thousand kids. And the reason for that is it’s it’s hard to enroll kids in especially very, very young children. I mean, they are going down to as young as six months old. We know that data are expected in the fall, probably Pfizer and Moderna first because they started the trials earliest and that also those trials are ongoing and in several countries does.

S1: Approving the vaccines for adult use, full approval delay at all, the emergency use authorization for kids, or are they totally separate tracks?

S2: It does not delay it all, but the tracks could merge, there are real questions right now within FDA and even within the the vaccine manufacturers about whether they would apply for emergency use in children. The reason for that being an emergency use has to be something done because the benefits far outweigh any sort of risk. And not that they think that it’s risky to children, but severe covid-19 is less risky to children than it is to adults. And so it is possible, especially if they’ve already got the foundation of adults and teenagers being approved for this, that they might wait out emergency use authorization for children. It’s a really hard sell to tell parents of a six year old, hey, this is emergency use to authorize. Your child needs to get it. There’s this policy discussion about whether it’s better to just go to approval with those. And that is not a definitive that is ongoing. They are still talking about what what that will look like.

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S1: So we don’t know yet whether someone like my child, who’s the youngest batch out there, would maybe get an emergency use authorization or whether we’ll just skip straight to full approval for him.

S2: Yeah, we don’t know.

S1: There’s also the idea that you have some large employers mandating vaccines, the idea of the military doing it. You know, how how much does full approval matter in making employers comfortable with mandates and maybe making employees comfortable with those mandates?

S2: I think it’s essential, and that’s one of the reasons why Biden officials have been so keen for FDA to approve as fast as possible, President Biden did say that he wants every federal worker to be vaccinated or to undergo routine testing, but that doesn’t apply to the Department of Defense. They have to have it actually be approved or else they’re definitely going to face legal battles from from armed service members who say, why am I required to get something that’s not approved? And, B, there has to be a safety argument for it that we need you to have this for your own safety, that that one’s an easier argument to make.

S1: Then there are the other people who aren’t vaccinated yet, those who are 12 and older just chosen not to get their shots. And there’s some evidence that full FDA approval might nudge some of them toward the shot. In a poll from the Kaiser Family Foundation, roughly 30 percent of unvaccinated people said they’d be more likely to get a fully approved vaccine rather than one with no emergency use authorization. I wonder if you think full approval might really sway people or if it’s a sort of a proxy for. Discomfort with the whole process.

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S2: Kaiser actually touched on this in that poll because they said that while 30 percent of people said that when they asked respondents, is it approved, is it authorized? Two thirds thought it already was approved. And so there’s a general public lack of understanding about this process. And I don’t blame people. It’s a regulatory process that few people have had to understand before this pandemic. But I think you’re totally right that this could be just kind of a proxy for general safety concerns or general hesitations and that there’s going to have to be much more dialogue to get people on board with this.

S1: Yeah, I, I, you know, I hear you describe this regulatory process that does sound quite thorough because the FDA was specific and making it thorough. And yet I think the word emergency still trips people up.

S2: Yeah, it’s not a it’s not a particularly nice phrase, emergency authorization. And it does imply the urgency that we have had around this. And now we’ve all been living with these vaccinations and we know that largely, you know, bad things have not happened. Or when they have the blood clots, you know, the allergic reactions, we we now have a better understanding of them. I think another part of the challenge there, though, is it’s not just that all of us who got vaccinated are fine, but this idea of whether these vaccines are going to be around for years and years, the specter of of boosters and how that could also play into confidence. Questions for people are we’re still holding out on vaccines.

S1: As we’re taping this episode, the FDA is expected to give emergency authorization for booster shots for immunocompromised people at any moment. But Sarah has reported that some folks in the Biden administration worry that the need for boosters might feed fears of the vaccines are ineffective and slow down vaccination rates. The administration is left walking a tightrope, eagerly awaiting approval while being very careful not to appear to be pressuring the FDA. And right now, the agency doesn’t even have a permanent boss, someone to fight its public battles in Washington.

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S2: One thing that definitely people inside the FDA and former FDA officials want to see is a permanent commissioner. So right now there is an acting commissioner. President Biden has not named a permanent person to the post. And while the acting commissioner, Janet Woodcock, has been there for decades and is very experienced, I think that there is this general desire that someone on top of the agency can really be its best mascot. The person on the on the airwaves, on the television who can say here is what to expect about an FDA vaccine approval. Here’s how we did it. To have that public face that right now is basically falling on on Foushee, who people do probably trust, but he’s not the head of the FDA.

S1: No. And indeed, Falta has been out there saying, gee, I hope they do this soon.

S3: I hope I don’t predict, but I hope that it will be within the next few weeks. I hope it’s within the month of August, if that’s the case.

S1: Yeah, I guess I wonder how the lack of a permanent head kind of plays into all of this. Is it, as you’re saying, that there’s no one out there to be a cheerleader and explain what the agency does? Or does that have organizational ramifications

S2: internally is a massive place and it really sort of well oiled machine. So the vaccine department is headed up by a man called Peter Marks, who is well trusted, well respected, even among or I should say, regardless of political party. He worked closely with the Trump administration and now with the Biden administration. So in terms of the vaccine decisions, it doesn’t actually matter who’s on top of the agency. And I know that sounds weird, but I think it’s more about these lingering confidence questions and kind of the public facing aspects of this.

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S1: In that story that you wrote, you had sources telling you that, you know, people in the administration were frustrated by how slow this process was. But, of course, if you as an administration, as the Biden administration has done, come out and say, we believe in science and we want science to lead the way, you you have to let the science have the time to to breathe how. How do the various players involved strike a balance here?

S2: It’s hard. I mean, you talk to Fouchier, well, he’ll talk on television, but he also he’ll tell reporters individually that he’s not saying he wants them to approve, but soon he’s saying he hopes they’ll soon. But he’s still saying it. And, you know, it is it is a very delicate play that they have here. The events of last year still hang heavy over FDA, the idea that President Trump was openly pressuring the agency and that the Biden administration feels in the way that it’s been described to me that they want to make sure that they are showing people that they’re leading with science and not trying to lead the scientists. And so while they want this, they are also conditioning it on when FDA is ready.

S1: Yeah, there’s a sentence from The New York Times columnist Michelle Goldberg that that really stuck with me. She wrote about kids and and getting emergency use authorization for kids. And she’s writing about the FDA. And she wrote, at some point, too much institutional risk aversion is a risk itself. And it like it somehow nailed how complicated all of this is because, yes, it’s science. But that sentence is like, oh, wait, maybe this is politics.

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S2: I see exactly where she is coming from there. I think the opposite is equally damaging, though, that if you move too quickly on something, you could be paying for that for years. And so what is so interesting, though, about that sentiment is it’s kind of already in motion. The FDA has learned a lot in this past year about what it can do and how quickly it can work.

S1: Sarah Owermohle, thank you so much for talking to me.

S4: Thank you for having me.

S1: Sarah Owermohle is a health care reporter for Politico. And that is our show for today, TBD is produced by Ethan Brooks and were edited by Torie Bosch and Allison Benedict. Alicia Montgomery is the executive producer for Slate podcasts. TBD is part of the larger What Next family. And it’s also part of Future Tense, a partnership of Slate, Arizona State University and New America. And I want to recommend that you take some time to listen to Thursday’s episode of What Next? It’s a portrait of one California town devastated by fire and a catalogue of all the things that were lost when it burned. Mary Harris will be back in your feed next week. I’m Lizzie O’Leary. Thanks for listening. Have a great weekend.