The FDA’s power of emergency use authorization, or EUA, was introduced in 2005 as a way to get the anthrax vaccine out to the armed services. Since then, it has been used to bring desperately needed vaccines to market quickly—most recently, the three COVID vaccines currently in use in the U.S.: Pfizer, Moderna, and J&J all received emergency use authorization from the FDA.
These vaccines were all authorized for emergency use based on only a few months’ worth of data. Now, with almost nine more months of data and cases surging thanks to Delta, employers, public health officials, and individuals are wondering: When will the COVID vaccines receive full FDA approval?
On Friday’s episode of What Next: TBD, I spoke with Sarah Owermohle, a health care reporter for Politico, about the painstaking FDA approval process and what’s really at stake when it comes to approving the COVID vaccines.
Lizzie O’Leary: Toward the end of last year, an important group of doctors—the Vaccines and Related Biological Products Advisory Committee—began meeting to evaluate the COVID vaccines. They voted in favor of emergency use authorizations for all three vaccines currently used in the U.S., and shortly afterwards the FDA granted the EUAs. Could you lay out the relationship between that advisory committee, the FDA, and the various authorizations?
Sarah Owermohle: The advisory committees have played an important role for the FDA for years. In the case of this vaccine committee, there were a lot of virologists and vaccine experts and pediatricians, and they had representatives from FDA, from CDC, from the NIH, who laid out the concerns that could be had about vaccines by asking questions: Have you had enough data from pregnant women? Have you had enough data from people who are above the age of 80 or 90? Why are there not enough nonwhite people in this trial?
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?
That’s one valuable thing about these panels. Outside experts don’t have to be as diplomatic as government officials do. They will very explicitly say, “You are missing information about this, and I want to see this.” And those companies have been working on answers for those questions and a more complete picture of what their vaccine does, who it does it for, and how well it does it for different populations.
When FDA approves something, they’re putting their stamp on it, saying “This is safe and effective.” Its benefits absolutely do outweigh its risks, and also, we know what those risks are. 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. For every person.
Because they have more data?
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 hitting a higher bar than they did for the authorization. And ideally all those questions are answered.
I think a lot of people are wondering, what’s taking the FDA so long? Is that a fair question to ask?
It is! Especially when people have only just recently gotten familiar with how the vaccine development process works. The answer is that it generally does take them months to approve something. There is a lot of urgency with the COVID vaccine, but what they’re doing in those months between authorization and eventual approval is going through raw data for tens of thousands of people. So where the emergency use authorization depended on 15,000 people, overall trials had to be 30,000 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. The FDA has to go through all of that information, all those thousands of pages about those thousands of people. That’s ultimately why it’s taking this long.
What else goes into the process that we might not think about? I didn’t know, for example, that there are inspectors looking at facilities.
That is vital because the consistency of vaccines is crucial, obviously. Just as they are asking all the companies about the data in different populations and who was enrolled in clinical trials, they are doing onsite visits to factories, batch-testing different batches that come off the production line to make sure they’re exactly like each other. They’re looking at the hygiene, the safety. That’s one of the major reasons that another vaccine, AstraZeneca, hasn’t even bothered filing for authorization yet, and might not even file for approval. They haven’t gotten those production questions sorted out.
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. I have to admit, I read it and thought, wait a minute, weren’t they already working around the clock?
Fair. Hey, I even thought that. It is typical that it takes this amount of time for a vaccine or new medicine to be approved. The FDA actually by law 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.
A lot of parents are waiting on what the FDA has to say about vaccines for kids, and what the clinical trials for those pediatric vaccines show. What do we know about the trials for kids?
What we know about them is that they’re a lot smaller than the adult trials. Where the adults, for each manufacturer, had to enroll at least 30,000 adults, these trials actually are only a few thousand kids. It’s hard to enroll kids, especially very, very young children. 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 their trials earliest.
Does approving the vaccines for adult use—full approval—delay the emergency use authorization for kids, or are they totally separate tracks?
It does not delay at all, but the tracks could merge. There are real questions right now within FDA and even within the vaccine manufacturers about whether they would apply for emergency use in children. Emergency use has to be something done because the benefits far outweigh any sort of risk. And it’s not that they think that the vaccines are 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.
There have been some large employers mandating vaccines. The military is doing it. How much does full approval matter in making employers comfortable with mandates, and making employees comfortable with those mandates?
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. They have to A, have vaccines actually be approved or else they’re definitely going to face legal battles 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 one’s an easier argument to make.
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 an emergency use authorization. Do you think full approval might really sway people, or is it more of a proxy for discomfort with the whole process?
Kaiser actually touched on this in that poll because when they asked respondents, “Is it approved? Is it authorized?” two-thirds thought it already was approved. 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. There’s going to have to be much more dialogue to get people on board with this.
On Aug. 12, the FDA gave emergency authorization for booster shots for immunocompromised people. But you’ve reported that some folks in the Biden administration worry that the need for boosters might feed fears that the vaccines are ineffective and slow down vaccination rates. You also note that right now, the FDA has only an acting commissioner—President Biden hasn’t named a permanent person to the post. How does the lack of a permanent head of the FDA play into all of this?
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 mascot, be the person on the airwaves and on the television who can say here is what to expect about an FDA vaccine approval, to have that public face. That right now is basically falling on Fauci, who people do broadly trust, but he’s not the head of the FDA.
Internally, FDA is a massive place and a really well-oiled machine. The vaccine department is headed up by a man called Peter Marks who is well-trusted, well-respected, 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 the public facing aspects of this.