[Skip to Content]
[Skip to Content Landing]

Coronavirus Vaccine Update From the FDA

Educational Objective
To understand the latest COVID-19 vaccine updates from the FDA
0.5 Credit CME

Peter Marks, MD, PhD, directs the US FDA's Center for Biologics Evaluation and Research (CBER) and will 'call the balls and strikes' on any COVID-19 vaccine, according to FDA Commissioner Stephen Hahn, MD. He joins JAMA Editor Howard Bauchner, MD, for an update on vaccine progress to date and prospects for pre-election political interference in the FDA approval process. Recorded October 5, 2020.

Sign in to take quiz and track your certificates

JN Learning™ is the home for CME and MOC from the JAMA Network. Search by specialty or US state and earn AMA PRA Category 1 Credit(s)™ from articles, audio, Clinical Challenges and more. Learn more about CME/MOC

CME Disclosure Statement: Unless noted, all individuals in control of content reported no relevant financial relationships. If applicable, all relevant financial relationships have been mitigated.


This transcript is auto generated and unedited.

>> Howard Bauchner: Hello and welcome to Conversations with Dr. Bauchner. It is Howard Bauchner, Editor and Chief of JAMA and the JAMA Network. And I - I am - I am joined by someone who is reaching celebrity status. But he may not even know it, Peter Marks. Peter is the director for the Center for Biologicals, Evaluation and Research, CBER at FDA. Welcome Peter.

>> Peter Marks: Hi, nice to be here.

>> Howard Bauchner: So Peter what's it like to wake up every morning - everyone is talking about vaccines. Like how are they going to be approved and know that - that your committee, your group at the FDA is - the people responsible? What's that like?

>> Peter Marks: It's kind of an interesting place to be because usually we're kind of the backwater of FDA. We're actually even located in the back part of the campus at FDA. So it - it is an interesting place. We're used to not being very much in the lime light, despite the fact that we have a lot of very important products, blood products, cell and gene therapies and vaccines. Usually vaccines aren't so much in the news.

>> Howard Bauchner: So - so Peter I just thought for both clinicians many of us who don't know precisely what happens as well as the public, we would quite literally walk through what happens. So when you - firstly how big is your group Peter and what type of people are in it?

>> Peter Marks: So the overall center for biologics is about 1,200 full time equivalents. But the Office of Vaccines about 250 people. Not every one of them is devoted to the review of these vaccines, but that's not the only group actually that will work on reviewing vaccines. We have an Office of Biostatistics and Epidemiology, some individuals from there will work on this. We have an Office of Biologics Quality and those are the folks that make sure that the manufacturing aspects and the inspectional aspects are taken care of. So there are various people from around the center that will come together to help with this.

>> Howard Bauchner: Now when you get an application, I assume it comes in digitally. We're in a modern era; it's kind of like journal reviews. When you used to get packages to review journals; that's not the way we do it anymore. So I assume it comes in electronically. Two questions to begin with. Does the company apply - do they declare that they would request an EUA or full licensure through some pathway or does the FDA make that decision. And how big is an application?

>> Peter Marks: Great question. And that actually is - it's great because it helps us understand the difference between why somebody needs to know what they're doing up front. So the company will determine up front if they're going to be submitting and emergency use authorization request or biologics license application request because the amount of data that will be required just in terms of the formal tables and the analyses is going to be different. It doesn't - the interesting thing for a vaccine is we'll get to a little bit is the substantive amount of information that will need for - for making the decision in terms of a phase III clinical trial results is going to be the same. But it's a lot of the - the other window dressing that's going to be - that you're going to need extra for the BLA that you might not have or an EUA. And so the EUA will be more stripped down in a way, it will still contain I would expect an EUA for a vaccine is going to still be - it will be hundreds of thousands of pages -

>> Howard Bauchner: Okay.

>> Peter Marks: The biologics license application, they can top out at hundreds of thousands of patients - pages. Because we're dealing now with trials that will involve - the trials are - for some of the manufacturers now are above 30,000 for their phase III clinical trial. And so by the time you put all these - the line listings and the tabular listings because we as an agency are one of the last agencies in the world that we still actually get the primary data. We don't get summary data and we - I mean that's - we do get summary data but we don't only get summary data. And so that makes - makes for a big submission.

>> Howard Bauchner: Peter can you just - explain to people who are listening the difference between primary data and summary tables. Journals see summary tables. There's a very substantial difference between what journals evaluate in terms of the peer review process and what the FDA evaluates. Could you really distinguish between the two?

>> Peter Marks: So - so let's just - let's just think about how a clinical trial is done. Right? So there's obviously - there's the source data. There's what's in the medical record and then for the clinical trial, that's put into case report forms and the olden days those were paper, now that those - now that those are electronic, those electronic - that electronic information is translated into line listings for each patient. And we get those line listings. That allows us to actually manipulate the patient data. So the company can do its analysis on the patients. And we have the ability, because we have the data to do our own analyses and make sure they match up. And sometimes that can be important because we can decide that for instance perhaps there is a certain type of patient that the - that the company included in their analysis that we don't believe should be included in the analysis. We will - can leave those out and see if these - if the end result is similar between the companies and our own, or maybe it's different so that - that's the - that's the idea there.

>> Howard Bauchner: So you actually in a - in a trial of 30,000 you'll get 30,000 case reports?

>> Peter Marks: Yeah - essentially yes. That's right.

>> Howard Bauchner: Now we - we've talked about this all the time around data sharing. You know you need a play book to analyze a randomized clinical trial. The SAP and the protocol are nice, statistical analytic plan and protocol. But that's not the play book. The playbook has much - many more details about how - how things were coded. Do you get the playbook from the company?

>> Peter Marks: We get - they - we get the statistics analysis plans. We get pretty detailed plans and what we don't get if we can't understand, we ask for and that's actually what - so that's yet another - you're getting at a great - another great difference between EUA and a biologics license application. And emergency use authorization is going to be something that's going to be submitted to us. We're going to get the data, it will probably be a little bit of back and forth, but there won't be a lot - we'll - we'll take it mostly for face value. The amount of information that's - that's submitted in a biologics license application it's virtually unheard of to have one submitted. There'd be silence and then FDA to go thumbs up, everything's done. There is an interactive process where we're constantly having our statisticians, our pharmacologists - our chemistry manufacture controls experts, those people go back and forth with a dialog because they need to get things like okay, how did you get to this analysis? This - because sometimes even if you do have all the paper of the analysis plan, it's hard to follow and you need to have that interactive review. So that's the difference between what happens with an EUA and a BLA. A BLA will be a much more robust back and forth because there's a lot more to cover.

>> Howard Bauchner: Now the person who opens up the email with whatever - with whatever is attached, how does he or she even start? Like how do you even imagine going through an EU application for vaccine X on January 5?

>> Peter Marks: Right, so these - these applications will - the hopefully the emergency use authorization applications will come in a similar - somewhat similar format to what a BLA application would be, which is - they - there is - for those who aren't familiar thankfully we all agree by consensus that we use something that's - that's essentially similar to a common - what's called a common technical document or a CTD.

>> Howard Bauchner: Okay.

>> Peter Marks: Basically we kind of agree that there are - they kind of start out with overall summaries. They move on to summaries of efficacy and summaries of safety, then below that you have individual studies and manufacturing information, etc. so there's kind of a way that you move through this and so what comes in is this big submission and then it's essentially almost farmed out so that different pieces of the organization get the things that they specialize in. Safety reviewers, efficacy reviewers and obviously there is kind of the - the people who keep tabs on what's going on over all. And all the reviews get written in these different disciplines the chemistry manufacturing controls, pharmacology, toxicology, the pharmacovigilance plans will get reviewed. Clinical will review it; stats will review it, statistical review. They all then get together - there will be essentially a committee meeting to determine then if everything meets what it needs to. Now that will happen both for an emergency use authorization as well as for biologic license application. It just won't happen again in as - it will happen in a much more abbreviated fashion for a - an emergency use authorization, because there the focus will be much more on the result of that phase III clinical trial. Some of the manufacturing information, some of the pharmacovigilance plans as opposed to the larger analysis that can go on in a biologics license application where you have early phase, late phase data, the manufacturing information and a lot more analyses on sub groups.

>> Howard Bauchner: Now one of the critical issues with the vaccine that you hear all the time when I speak to people in conversations or friends, people are worried about safety. A couple of the products that are coming down are - are relatively new, new approaches. How is the FDA going to specifically look at safety?

>> Peter Marks: So the safety is clearly going to be something that we have to keep first and foremost and we will look at the data that comes in through the safety dataset, we've made it clear that we want to see a meeting of about two months of follow up for any of the vaccines that comes in and while it would be nice to have much more, we have to balance the safety we get up front with a need to try to save lives with the vaccine that's helping to prevent a - a virus that's killing you know, 1,000 or more people a day in the United States. So there's a balance there. So what we'll do is we'll look at the safety information, make sure that as we approve it or authorize it that we feel comfortable with what we're seeing right up front. And then we're going to have a very robust pharmacovigilance plan. Now one of the things we have now that we didn't have 20 years ago was the ability to use large claims databases and claims databases that can be linked to the electronic medical records, so that we can look to see if there are issues that are arising in real time as these vaccines are deployed. So we'll be looking - we'll make sure that we have a clear plan to look at any areas of concern as well as to capture areas that might be you know, things that might show up that we weren't expecting and we'll do that in collaboration. FDA will work on that. We'll do that in collaboration with the Center for Disease Control and prevention as well with complementary methods. Some of this will be passive reporting, people reporting from apps, you know this happened to be after I got the vaccine. And some of this will be active safety surveillance where we will comb these claims based databases to make sure that during a window of time after people get the vaccine, we don't see certain events occurring compared to a window of time before they get the vaccine. That's one of the ways you can use these, you can say okay for the - for the 42 days prior to the vaccine did something happen to the 42 days after they got the vaccine. Oops is something happening more commonly? It's more complicated than that, but that's kind of a simplification that I can understand told to me by our statisticians.

>> Howard Bauchner: Peter can you - can you mandate additional post EUA approval for pharmacovigilance? This has come up all the time. More recently because you're fast tracking so many drugs that people have said well we still need more safety data. So can you mandate additional safety collection - collection of safety data?

>> Peter Marks: Indeed that can happen for either an EUA or biologics license application. And we will do what we need to, to get the appropriate safety data to make sure that the deployment of any vaccine is sacred. That is clearly - look if we don't really - this is - if there's anything I'd like to say today it's that safety is what keeps me up at night because all we need is - is something happening with vaccine safety to create a real problem here. Because the way we're going to get over Covid 19 is if we get a vaccine that has 70-80% efficacy and we can deploy that to 70 or 80% of the population we actually have a chance of having heard immunity and we'll be back in restaurants and in banks and in buying - doing what we do normally.

>> Howard Bauchner: School, college we talked about -

>> Peter Marks: Schools, colleges. I'll get my living room back from where my kids are going to college right now. You know so all of that will be - be needed. But it's only going to happen if people have confidence enough to go get vaccinated and we do have a crisis in vaccine confidence now. There are lots of factors that may have led to that. But our job in FDA is to do whatever we can through transparency - through making it clear that we're focusing - we're here for one purpose only which is to make sure we get a quality, safe, effective vaccine and that people can see transparently that that's what's happening here.

>> Howard Bauchner: Now there's a few other groups that are involved. So I'd like to talk about them and then come back specifically to your - to your group. So the people who see the data first, besides the investigators are the Data Monitoring Safety Board, DSMB. Do you see the correspondence between the investigators and the DSMB or the DSMB and the company? Or is that held separate from the application?

>> Peter Marks: So usually that's something that's between the company and the DSMB. We may see sometimes - see correspondence may be handed to us, but we're not part of that correspondence up front. That - that is sometimes we'll get the results, companies will show us the correspondence that occurred. But the correspondence that will occur typically will - will occur with [inaudible], so probably what will happen hopefully at some point in the next couple months is that one of the trials will meet the specified number of end points that trigger an analysis. The company will perform that analysis; they'll show it to the DSMB. The DSMB will declare either - declare a victory. They'll declare that the trial should continue or they could if it's something in the wrong direction, declare futility. But they'll make that decision and then based on that the company will then start to decide what they're going to do in terms of transmitting the results to us in the form of either emergency use authorization or biologics license application.

>> Howard Bauchner: Now there's - there's' two other committees that people have becoming increasingly familiar with if they just read the popular press every day or all our journals since we're all publishing on it. One is the FDA - you have an FDA advisory board on vaccines and then you have the advisory committee on immunization practices. So could you tell - tell our listeners how does you group CEBR interact both with the FDA advisory committee as well as ACIP?

>> Peter Marks: Right so they - the vaccine and related biologic products advisory committee is a - is it's a federal advisory committee that's comprised mostly of academics with - with a non-voting industry representative and a consumer representative. It's mostly experts and vaccine development in this case the committee, which is a standing committee has been augmented with some experts in Corona virus.

>> Howard Bauchner: Okay.

>> Peter Marks: Experts in statistical analysis. And those individuals they're special government employees. They have been very thoroughly vetted for conflict of interest. I mean they can't have - basically they can't - we really try to make sure that they don't have anything that someone could point back and say oh they did this because they had some interest in seeing this vaccine approved. They're vetted for conflict of interest. They are provided with a briefing packet that comes from the company about what is submitted and the FDA provides its own briefing packet to the experts. They read those over. There will then be a meeting in which they'll discuss the application in the case of - of an - it was an application that came in. And we will often then have voting questions where we might ask about the quality of the safety data, the quality of the efficacy data. Which essentially translates then into whether the committee feels that the vaccine should be approved or not. Now it's an advisory committee. We don't have to take their advice, although by and large we generally do. Just to give you an example of an upcoming one, on October 22 that committee, that vaccine and biologics - related biologics advisory committee will meet just to discuss the development of Covid 19 vaccines in general. And so that action - that meeting will be televised and we've committed to televising these meetings. What I mean by televising here, I should say this is we will be - we have a web based broadcast, but we'll also be sending out the live feed so that a television networks want to pick it up, they'll be able to pick it up. Whether they will or not, doesn't matter exactly. But we also have a sufficient number of - of web portals so that people can get on that way as well; so hopefully people who want to see this will be able to see this.

>> Howard Bauchner: Before -

>> Peter Marks: Let me just take the next part of your question, which is the advisory committee on immunization practices.

>> Howard Bauchner: I just wanted to clarify one point with what you just said. So is the FDA reviewing an application for EUA or licensure. Simultaneously this advisory panel is seeing data, or they're getting the briefing package that the company prepared, and a briefing package that - that the FDA prepares. Before the FDA will make a final decision, the FDA advisory panel will - will give you their opinion about what they think?

>> Peter Marks: Yeah so that will happen on the day of that advisory committee meeting. And kind of the way it works is usually the way it works, just so we're really transparent here is that usually the FDA has done a lot of work on the review. We put together a package. The companies put together their package. It's handed over to the advisory committee. After, there's a fair amount of work that's been done. They then go through this, discuss it in this public venue and the day of that public venue they'll make some - they'll make - they'll vote and discuss it at that and then we will take back those recommendations usually do some additional work and then make a decision.

>> Howard Bauchner: Great, okay. Now ACIP. Thanks Peter. Sorry.

>> Peter Marks: Okay so the Advisory Committee on Immunization Practices is almost like they're the next - their next stop after - after an FDA authorization or approval. They're the ones who look at what FDA has approved. Now we might give something a broad approval or we might give a narrow approval, but they'll look at the data and then try to see in practice how do you go about most effectively applying that? They're not limited in the way we are to the data that the companies submits. They are - they - and although we're not entirely limited to what the company submits, they will take sometimes a broader view to try to decide what population will be most benefitted and there also it's a - it's a committee of people with academic expertise in the area of vaccines as well as some government employees as well.

>> Howard Bauchner: But just to be clear, ACIP weighs in with their opinion after the FDA has made a decision about an EUA or licensure not before?

>> Peter Marks: That's exactly correct, that's exactly correct in the order. But now in this particular case we're going to have things probably cued up so there's not a long time between those two events because we realize the time can be lives here. So it will probably be a rapid fire of - of getting through the - an approval from FDA or an authorization from FDA and then getting to ACIP.

>> Howard Bauchner: How long does an EUA take you Peter?

>> Peter Marks: You know it's a great question. It's a question in which the answer is it depends.

>> Howard Bauchner: Okay.

>> Peter Marks: We've told manufacturers what we need to know up front in terms of manufacturing information. Depending on how much we have up front in terms of information that's come up - come to us before the actual arrival of the EUA and depending on the complexity of the EUA. It's probably going to take a matter of weeks. Fewer weeks if we've had more information up front. More weeks, but we're talking about weeks as opposed to months. A biologics license application even a very well put together one will take us a few months at least to get to - to get through because it's just so - such a massive information. It's - its thousands and thousands of pages. We have to make sure the manufacturing is in conformance with all of our standards. And - and it's a much heavier lift. So an EUA is weeks, biologics license application, months.

>> Howard Bauchner: There's a couple questions. Is there any - any way to keep the DSMB's from prematurely terminating studies and limiting data sets?

>> Peter Marks: I guess that's a - a question - that's a great question. I think it's one that - that's been something more for the discussions that have occurred actually through NIH and Francis Collins, through his active collaborative has tried to keep a good dialog going on there. Because we don't directly have interaction with DSMB's. This would be more of the company's having that interaction and the academics that are part of those thinking about this. It is a really important thing though just to use that as a springboard. As we have our conversations at - for instance at the upcoming advisory committee meeting, some of the things that we're - that go through our head is how do we make sure that after a first emergency use authorization we continue the studies that are really needed to see additional vaccines. And I don't have all the answers there and that's the type of question that's really helpful for us to hear from our advisors about.

>> Howard Bauchner: Peter what's the meeting like when you - you know when the statisticians and the pharmacovigilance, the efficacy people. I assume it's a big - a big round table and you know everyone knows who is representing which group. Is that an hour meeting - a day meeting? Does everyone report? I'm assuming you're listening - I'm assuming Steve will - Steve Hahn the Commissioner of the FDA may participate in this. What's that meeting like? You've gone through a number of these.

>> Peter Marks: So Dr. Hahn, although he'll be brief, he probably won't participate because he's at a political level and they've been very, very careful to try to make sure that they really want to assure that there's not political pressure here - that this is really driven from the career staff at the agency. And that's been a real commitment of mine, others that we're going to make sure that as career staff we want to make sure that the American public knows that what they're getting is not pressure to do something but it's - it's what comes from actually looking at the data and making sure it's the case. What will happen is that they'll be - each discipline will write a review memo up, people will read each other's review memos at - at least at the supervisory level. We'll get together and could it take hours? It may take hours? Could it take days? It will take - we will get together and it's - it's - it varies depending on the nature of the submission. For some of these submissions you know we were through Ebola, we've been through - it can take hours and hours. And it's an aggregate many, many hours because different disciplines meet to get together their recommendations and then the whole groups meet. So it's a lot of - it will entail a lot of work and there incredible number - I mean the people are so committed to this that it's - it's quite amazing.

>> Howard Bauchner: If you - if you need more information from the company, will that occur before this meeting? Before the kind of meeting when each group is presenting?

>> Peter Marks: So that - that will certainly occur. I mean I think we will - the hope is that with the emergency use authorization we're going to be clear enough with the companies that they'll know what they need for that. But if we need more information, we will try to get that before - we try to get that before the - the advisory committee meeting and it certainly will occur before we make some regulatory decision. For the biologics license application there's a whole scripted process of how we go back and forth with the company and we actually have meetings interspersed so that we actually can touch bases with the company to make sure they understand what we need from them at various points in the process.

>> Howard Bauchner: So it's an iterative process before you get the applications. It's not like it's been a wall, don't talk to us. It's back and forth before.

>> Peter Marks: That's right. And that - that back and forth process is really important.

>> Howard Bauchner: Does the FDA advisory committee - I believe they do take a formal vote about recommendations?

>> Peter Marks: Right they can be asked - so advisory committee meetings, we can ask them to do several different things. We can ask them to discuss things. We can ask them to vote various aspects of the application and we can ask them about whether certain things support approval or not. And so we can ask them any one of those types of questions.

>> Howard Bauchner: How are the career scientists doing Peter? I mean on a very personal basis? I mean you know you just have to get up and read the newspaper every day and worry that they're being battered. I worry that they're being battered around and they've committed their work life to - to producing high quality biologics and vaccines. How are the staff feeling Peter?

>> Peter Marks: You know we have an incredibly resilient staff. And it's driven by the knowledge that we have to do this job. We - we - the American public has put their trust in us that we're going to make sure that this vaccine, whatever comes through us is going to be a quality vaccine that's safe and effective. And the devotion I've seen to making sure that's what happens, I think has helped us all kind of keep our hands over our ears to the noise that's coming in from all sides. And keep our eyes on the prize, which is that we need to make sure that we do our job really well here. We can't be perfect. We could mess up, it's true. But we're going to make sure we've done our darndest to - to make sure that the American public has a vaccine that is the best possible vaccine that can come through this process and hopefully you're going to have multiple ones. And so people it's been stressful. I think the issue is we have people who are very concentrated on this. At the same time they're dealing with their own personal lives. I mean especially many of our [inaudible] are a little bit on the younger side. I'm lucky enough to have older children who can basically take care of their school work on their own, although sometimes I - I wonder with college aged kids. But for the - for young children at - at home. I'm sorry to make light of it but when you have young children at home so we have reviewers that are - that are having to deal with that. Plus get their work done and they do it just amazingly well such that people are working more - it's an incredible group. It's working more hours now than we were ever before, despite the fact that we're working remotely much of the time.

>> Howard Bauchner: What's it been like for you personally?

>> Peter Marks: This has been probably one of the most interesting times in my career and I have - it's gone from - I love what I do in biologics. The vaccines are wonderful, blood products - I'm a hematologist, oncologist by training. So blood products have always been exciting. And gene therapies have become a passion. So these were all great things and it was kind of a relatively quiet life in many ways. And now we're kind of thrust into this kind of lime light. It's been - it's been a long - a long road. But what I - what keeps me going is the fact that so many colleagues have been supportive. Have - have really been very understanding and - and that's kept me going with some very, very long days and nights. We - we have a group now that's almost - it's actually a little scary. When I look at my email we're almost - it's not quite 24 hour a day operation but we have an early shift and a late shift. I'm kind of the early shift, the 4:00 a.m. to the 8:00 p.m. shift and then we kind of have a shift that comes on about 4:00 p.m. and goes on until about 2:00 in the morning; so there may be about two hours that it kind of quiet -

>> Howard Bauchner: Quiet time, right.

>> Peter Marks: I'm sure others are experienced the same thing.

>> Howard Bauchner: So every time I do a conversation I end with the crystal ball. Now in this case I know what I'm going to ask. The FDA just - and you mentioned it earlier, wants two months of follow-up. I believe in the trials that are two vaccines that's two months after the second immunizations.

>> Peter Marks: Exactly correct.

>> Howard Bauchner: There's - there's one major study that's a single - single injection. Do you have a sense Peter; I mean you've been talking to the companies. Do you have a sense of when you'll see an application? You don't have to tell me which company. I don't really care.

>> Peter Marks: Okay - I think - I think it's possible we'll see something before the end of the year in terms of an emergence use authorization application from some company. I think they are - it's unfortunate that we're having so many cases but with some of the trials now fully enrolled the - they're just accruing cases. So hopefully we'll see something by then. That's - that's my - that would be a prediction -

>> Howard Bauchner: Just one - just one other -

>> Peter Marks: I don't know for sure -

>> Howard Bauchner: Right. If you have a trial of 30,000 and they just finished enrolling let's say the last hundred or two hundred people. But they have enough cases from before the two month follow-up of the last case. Would you be willing to look at an EU application then? So was I clear in that? Because the two months is a huge issue. They may have accrued enough cases - 150 or 200 cases to know something about efficacy but they will not have accumulated two months of follow up of the last person who was vaccinated. Would you look at an EUA then?

>> Peter Marks: You know we're going to look at what - we'll look at things the totality of what's submitted to us. I have to say that if you look it's a median of two months. Unlike there are some other places in the world in Europe where they'd like a set number - an absolute number of months, we're saying in median and actually these trials open in late July some of them.

>> Howard Bauchner: Correct.

>> Peter Marks: so the median may turn out to be - I think one of the things we are at FDA - we're flexible. We're not going to be completely flexible. It's not like we're going to do take anything, that would be dangerous. On the other hand you know if it turns out the median is seven weeks and not - and not two months, that's not going to be an issue. And I think even - even because you know that I've told you it's going to take weeks for this process -

>> Howard Bauchner: Accumulate more data.

>> Peter Marks: While things are going on we'll get there. So we're going to be - we're going to obviously - I think the spirit of the emergence use authorization was to be able to allow FDA to take into account this complex benefit risk calculations and that's what we do. And that's - if I had to say what we - what we really specialize in at FDA it's not so much just the product approval and safety and efficacy; it's actually this - it's - it's understanding how that fits into benefit risk, which takes into account the situation that we find ourselves in. so that means - but still for vaccines just to be reassuring here. That still means that the safety profile of a vaccine that's going to be deployed in millions of people has to be incredibly clean.

>> Howard Bauchner: Right.

>> Peter Marks: I mean that's -

>> Howard Bauchner: People have talked about you know when you're hospitalized in the ICU with mortality risk of 20 - 205 that's a very different population and giving it to 330 million Americans, none of whom are ill when they receive the vaccine. So that balance is more complicated for you.

>> Peter Marks: And that's why I said this before and I'll say it again the - what will come through in support of an emergence use authorization for a vaccine, the data will look more like a - what we would need for biologics license application than it would for perhaps a therapeutic emergence use authorization for something for use in critically ill patients. And that's because when you're going to deploy something in millions of individuals. We need that kind of robust safety data. We need to have a strong efficacy signal because we know that when people get vaccinated if we tell them it's got 705 efficacies, they may change their behavior. And if they're going to reduce their - take their guard down a notch, we better make sure that it does what it says it's supposed to do.

>> Howard Bauchner: This Howard Bauchner, Editor in Chief of JAMA. This has been Conversations with Dr. Bauchner and this case I've been talking with Peter Marks, who's CIPR. He joined the FDA in 2012. Became Director in 2016. You still seem to be good humored, which I really appreciate because it has to be a difficult time for you Peter. And it - I was really reassured when I spoke to Steve a few weeks ago and I'm even more reassured after talking with you. I thank you and your staff for the remarkable service, career scientist at the FDA - FDA are just remarkably important and valued people. So thank you - thank you very much Peter for joining me today.

>> Peter Marks: Thanks so much for having me.

AMA CME Accreditation Information

Credit Designation Statement: The American Medical Association designates this Enduring Material activity for a maximum of 0.50  AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Successful completion of this CME activity, which includes participation in the evaluation component, enables the participant to earn up to:

  • 0.50 Medical Knowledge MOC points in the American Board of Internal Medicine's (ABIM) Maintenance of Certification (MOC) program;;
  • 0.50 Self-Assessment points in the American Board of Otolaryngology – Head and Neck Surgery’s (ABOHNS) Continuing Certification program;
  • 0.50 MOC points in the American Board of Pediatrics’ (ABP) Maintenance of Certification (MOC) program;
  • 0.50 Lifelong Learning points in the American Board of Pathology’s (ABPath) Continuing Certification program; and
  • 0.50 credit toward the CME [and Self-Assessment requirements] of the American Board of Surgery’s Continuous Certification program

It is the CME activity provider's responsibility to submit participant completion information to ACCME for the purpose of granting MOC credit.


Name Your Search

Save Search

Lookup An Activity


My Saved Searches

You currently have no searches saved.


My Saved Courses

You currently have no courses saved.