CNN Sanjay Gupta Discussion with FDA Chief on Pfizer Vaccine Authorization Transcript December 8

Dr. Sanjay Gupta: (00:09)
Welcome everybody and thanks for joining us on this Facebook Live. Delighted, honored really to have the commissioner of the FDA Dr. Stephen Hahn joining us. Thank you sir for being with us today.

Dr. Stephen Hahn: (00:22)
Thank you Sanjay. Really great to be here. Appreciate the opportunity to speak to the American people.

Well sir, it’s been a busy year obviously and a busy couple of days even. A lot of people have heard the news about these vaccines, Pfizer’s and Moderna’s specifically. Is it pretty much a forgone conclusion at this point that they will be authorized at least under emergency use?

Well I’m not going to pre-judge the decision making of our career scientists nor of the vaccine [inaudible 00:00:52] advisory committee. As you know we have a process and this is a very rigorous process to establish the safety and efficacy of a vaccine. Our team has done their initial analysis and we do feel that preliminarily that the success criteria have been met, that’s been reported in the press today. We have public documents out there but we very much depend upon the outside experts from the vaccine advisory committee. That will happen on Thursday and then we expect we shortly thereafter to make a decision.

I want to get to some of the specifics because again we have you for a short time but one of the things I read in the documents was that people under the age of 16, pregnant women, and people with some sort of immune compromising situation, either disease or because of chemotherapy, may not be eligible for this vaccine. Is that what you took away from the data as well?

Yeah, it’s one of the factors that we did take away from the data. Here is what I think is really important and something that uniquely FDA does compared to most other regulatory bodies around the world is that we look at those issues. We’re going to look at underrepresented minorities, we’re going to look at the elderly, we’re going to look at young folks, pregnant women, folks with underlying immunodeficiencies, immune problems. Because these questions are very important. Providers and patients want to know them so it takes us a lot of time to analyze those data and come to our conclusions so yes, that’s part of the entire package that we’ll present to the vaccine advisory committee.

What is the biggest problem you foresee now going forward? Let’s just say that we hear on December 10 and then on December 17 at that point that two vaccines have been authorized. I know you can’t say that is a foregone conclusion which I understand but let’s just say it happens which looks promising. What is the biggest problem do you see then over the next weeks and months?

So if it were to happen, so using that hypothetical situation, I don’t see any obstacles from an FDA perspective. One of the things we have to be really careful about Sanjay and we’ve seen this with therapeutics is that we have to be very clear and transparent about why we made the decision, the data behind it, but also provide clear instructions to providers and patients so that they understand exactly the just sort of if you will use case for any medical product, in this case vaccines.

So that’s one of the issues that will come up. The other issue is can we overcome what is clearly vaccine mistrust in this country, a lack of confidence and one of the reasons we’ve been very transparent about our process and putting public documents out and having the vaccine advisory committee is in fact to try to overcome as much as possible any mistrust there might be. Because at the end of the day Sanjay you and I’ve spoken about this before, it’s the science and the data from the clinical trials that drive this decision, nothing else.

One of the things that people have followed is the fact that there’s two months worth of safety data and there was a lot of back and forth that was widely documented signed between yourself and the White House and OMB but regardless of all of that, two months of safety data will have been presented as part of this. Two months because my understanding is that’s when most side effects or adverse effects are going to occur if they do occur, but what about the longterm data? Getting to this trust thing again, we’re talking about a genetic, mRNA vaccine. It’s not been used before outside of a clinical trial. How do you instill trust when people say a genetic vaccine … Is it going to cause a longterm problem?

So any medical product we approve Sanjay, and you know this. It’s like being a doctor who describes a medical procedure and gets consent from a patient. You don’t have a crystal ball, I don’t have a crystal ball. We can’t predict everything. We can use existing knowledge so we do know that mRNA vaccines have been used in a clinical trial. We do know that the technology is very solid and we do have the current clinical data including clinical data back to March and April and May when the Phase I and Phase II trials were performed. So we do have some data to go on, but you’re right. The two months were chosen because that’s where the majority for most vaccines we’ve seen side effects, but given the fact that for any medical product we authorize or approve, we want to see post-marketing data around safety as well as effectiveness. As you know that’s an outstanding question as well. We’re going to put in place a very vigorous surveillance program. We call it pharmacovigilance meaning let’s keep track for the next two years at a minimum both effectiveness as well as safety associated with the vaccine.

That includes continuing following people in the clinical trials. That includes looking at claims data from insurances. That means looking at electronic health records. Now de-identified to protect privacy, but we have to have a very vigorous approach in partnership with the CDC who has done a terrific job here to gather those data, but I don’t want anyone to think that this isn’t something we always see with medical products. It’s just heightened here because obviously this has moved through the development process very quickly.

You would have again, pending an authorization … You, yourself or for your family would have no problem getting this vaccine at that point if it is offered to you, when it is offered to you?

Sanjay, thank you for the question. If our career scientists review this application and we issue an authorization and we will based upon … Not we will authorize but if we were to do we’ll do it based upon the science and the data. If that were to occur, I have 100% confidence I will be the first one in line when it’s appropriate for me to get that vaccine and I’ll ask my family to do the same.

Just quickly commissioner, the difference between authorization and approval. We’re not used to hearing about authorizations when it comes to vaccines. I typically think of an emergency situation, someone’s in the hospital, they don’t have a lot of options and you authorize something under emergency use to help them or a population of patients like this. But the vaccine, it is a preventative. It’s given to healthy people. What is the difference between authorization and approval and how does this meet those criteria?

So we’ve been … You’re right, you hit the essential point, Sanjay which is that for emergency use authorization and what we describe as EUA, the statutory … What’s required by law is that it may be effective and that there is a risk-benefit assessment. So with respect to a vaccine, we wanted criteria for authorization to be very similar to what we would do for an approval because as you mentioned it’s going into healthy people. They’re not sick in the hospital or on a ventilator with COVID-19. This is a preventative agent for folks who are outpatients and who are otherwise well.

So we require clear and compelling evidence from a large randomized clinical trial in order to meet the criteria for safety and effectiveness. That’s what we believe we’ve seen so far although we have … I can’t prejudge the situation but that is different than what we might otherwise use for an emergency use authorization in the therapeutic or treatment setting.

So it’s a very similar set of criteria. We’ve done very rigorous assessment of it. We have all hands on deck and we’ve really bought many resources to bear on this and just for perspective for people, this is an application, Pfizer for example that is 44,000 participants in the clinical trial. Typically for a clinical trial that large and an application that large, this would take us four to six months, but what we’ve done is put a lot of resources to bear and in a couple weeks we’re doing the same analyses with the same similar criteria and that’s what we’re going to promise the American people that we’ll make our judgment based upon that.

The title of this discussion we’re having is when can Americans get a vaccine. It’s the most common question. I’m curious, how do you answer that? But let me preface by saying that there’s been a lot of news today that 100 million doses of the Pfizer vaccine were purchased by Operation Warp Speed and that other doses are going to other places around the world. When you start to do the math and you look at what is possible and available based on manufacturing, rollouts, all of that, when do you think most Americans will be able to get a vaccine that want one for real? Like taking all that into account and what is the number that is necessary to get to the point where we have enough immunity into the country?

So Sanjay, with the second question, most of the experts that I’ve spoken to have suggested that 70% of the population will have to be immune. Now it could be smaller or it could be larger but that’s the guess right now in order to really shut down the virus and frankly make it go away. That includes people who have had the virus itself and have natural immunity as well as those who receive the immunization. So if you do the math, that’s a little north of 200 million people in the U.S. who would have to receive the vaccine.

In addition to that we’re looking at a number of different factors. We had two applications in front of us and the real question then Sanjay is number one, what’s the ramp-up on those vaccines and we’re working very hard with both manufacturers to try to make sure there is a reasonable supply chain and also a very important part of our responsibility that the quality manufacturing is there. We want every vaccine coming off the lot to be of high quality and the same that was used for the clinical trial.

So we’re working hard to have that ramp-up occur and more to come on that information, but it also depends on what of the other manufacturers and developers, when their clinical trials are done and when they can come to us with an application because that will increase supply as well.

I’ve heard a variety of predictions in the media and again I don’t have a crystal ball but a lot of folks have predicted late spring/summer for that sort of to occur. We’ll see, maybe it will occur sooner because we’ll have more vaccines available from other manufacturers or from the two that we have in right now, but again, I don’t think we can make … I don’t think we can make predictions because we don’t know the answer to those questions.

Do we have enough of the basic sort of stuff Commissioner, the syringes and the needles. We have problems with things like nasal swabs with regard to testing earlier on in this pandemic. Obviously as you mentioned there’s all sorts of different things that come into play when trying to manufacture at this huge industrial scale, not to mention there are quality control checks, 20 to 25 my understanding is for these particular mRNA vaccines, but just the basics. Do we for certain have the basics covered? We’re not going to run out of syringes or needles or things like that, are we?

So I do not believe so Sanjay. We have provided technical assistance to Operation Warp Speed and this has been a core responsibility for them in talking to General Perna and others. Since the summer, they’ve been actively procuring the supplies that you’re talking about which are absolutely critical looking at from A to Z what would be involved in the process of actually delivering a vaccine. FDA’s responsibility is to identify the supply chain as well as available supplies, and so we’ve been doing that. I’m confident talking to Dr. Perna that this has certainly been on their radar and they’ve been working on this for some time. So I believe so.

We had some viewer questions and I want to take one. You’ve sort of talked about this earlier but this is from Leslie Johnson who asks, “How is it that that U.K. was able to roll out a vaccine so quickly and we haven’t? Are we set up differently?” Commissioner, this is one of those things where obviously we talk about the regulatory process and you mention that you want to look at the specific demographics and how the vaccine may behave differently in demographics, you want to reproduce the methods that the companies use to make sure that it matches what the FDA scientists, but I think what I’ve heard … What I’m hearing from this question other people have asked is we’re in the middle of a pandemic, the data was submitted three days earlier to the FDA versus to the U.K. regulatory authorities. Why is it, why is it taking longer here? Weeks, days even matter now.

Oh certainly weeks and days matter and the agency is very aware, Sanjay, of the urgency of the situation and we certainly cannot and will not disregard that. We do however have a different regulatory framework and a different legal framework with respect to our reviews. We have what is considered around the world the gold standard for assessing the safety and efficacy of medical products. That’s something FDA has been known for and will continue to be known for. As I mentioned we’re really expediting this process from four to six months to basically a matter of weeks and as you can see from the other major regulatory agencies around the world, the European Union for example, they also are following a process that really allows for a thorough assessment of this.

Think about where we are Sanjay. We have significant vaccine hesitancy in the country. If we don’t do our job to reassure and ensure the safety and efficacy of the vaccine to the American people, then we’re going to contribute to vaccine hesitancy so there’s a scientific issue to make sure that the conclusions are correct and I have to tell you that we take as a solemn obligation to the American people but there is also an issue around making sure that people feel reassured that the appropriate vetting of the information was done, our scientists have been working around the clock, they will continue to do that. Understanding of course the urgency of the situation.

I have complete confidence in this process. I have gone through this process with them and I think the right thing is being done on behalf of the American people.

Another question that comes up a lot Commissioner. Right now the projections are that maybe 15 to 20% of the country has already had an exposure to the coronavirus and maybe generated antibodies. We don’t know for sure, those are estimates and models, but should someone who has been infected and may still have antibodies, should they still go ahead and get the vaccine? If so why? Is there something better about the vaccine in terms of how long it lasts or how strong the immune response is? Why would they need the vaccine on top of having already been infected?

So we actually I think as a medical community don’t know the complete answer to the question that you’re asking and it is something that we’re going to have to delve into the data so for example we did not require as part of the clinical trials that someone have prior knowledge for example of the infection so it wasn’t an exclusion criteria if you will. We do know that it is likely that some people who are asymptomatic and had the disease will have been entered into the trial and so we know that there will be some in the placebo group versus some in the active group and when we look at the correlative data that might be generated from these trials that is antibody levels et cetera before and after, we’ll be able to parse those issues out and actually ask the question. It is certainly possible Sanjay that when those data are fully analyzed that we’ll have an answer to say that for example a vaccine wouldn’t be necessary in those people or it might be needed as a booster to natural immunity. At this point it is an unanswered question. We’ll need more data to actually figure that one out.

We have a few minutes remaining. I do want to ask about these … In the news, you went to the White House a couple of times in the midst of this review process. Chief of Staff Mark Meadows I guess you and he had a conversation. What happened? What happened in the room there? What was the conversation all about?

So Mr. Meadows was certainly aware as you’ve brought up of comments that have been made in the press about the amount of time it’s taking us to do the review and he wanted a full briefing and I provided that to him. I felt very comfortable with that briefing, we explained the situation and talked about what the steps were that we were doing and why the scientific review and the connection to vaccine confidence but also the parsing of the data that I just described, the sort of … The detailed assessment of patient groups et cetera that needed to be done. So it was an issue of communicating what was our underlying process and why that was so important. I felt very comfortable with the briefing, it was a vigorous discussion and we’ve continued with that process and I’m comfortable where we are.

I bring it up not to put you on the spot but because look, that’s been one of those things where we feel there’s been a political entanglement into the scientific process and you say it was a vigorous discussion. Were you pressured?

To the same I think as being sort of pressured by you although you’re not really pressuring me Sanjay with asking questions about why it takes us so long. I think it’s a natural question. I don’t mind being asked that so no I don’t think it’s any different than this. Your viewer asked a really good question and people may see, “Hey, it’s an emergency. Why would you worry about the process? Why would you worry about the scientific review that you’re doing?” It’s my job, it’s our job to explain that and that’s what happened. So it was nothing more than that.

In the news today you’ve heard that 100 million doses of Pfizer’s vaccine were purchased I guess by Operation Warp Speed. They I understand had an option to buy more but did not exercise that option to buy more. They have other vaccines that they’re buying as well, another 100 million of Moderna, I believe 300 million of Astrazeneca, 100 million of Johnson & Johnson. Was it a mistake? I mean again, you can obviously look with hindsight on anything but in the middle of a pandemic, more than a quarter million people have died, we knew how bad this was going to get. Was it a mistake for the United States government not to buy more of these vaccines?

You know as you know Sanjay, we have drawn a very bright line between the decision making at OWS and FDA. I don’t have any insight into that because we provide technical assistance. We’re not involved in those contractual discussions and frankly I’d never been at a meeting where that was discussed so I really can’t answer your question one way or the other. I do know that OWS does have a line of sight into all the development processes of the companies they’ve contracted with and it may very well be that those discussions have given them insight and allowed them to make the decisions they made. I’m sure there’s more to come on this and those questions really will have to be referred to OWS and the department.

I want to take another viewer question, we have a minute, commissioner. You’ve sort of talked about this already. This is from Lydia Marquez. “I am three months pregnant and worried about COVID. Can I take the vaccine? What are the risks?” We’ve actually gotten lots of questions from pregnancy women or about pregnancy in general. I know you got to learn more but right now your friend is asking you this question, what do you tell them?

What I’m going to tell them is that we may not have enough data from the clinical trials. Pregnant women weren’t specifically enrolled in the clinical trials and it may require additional studies. What we do know is that we did not require a pregnancy test for women of childbearing potential so it could very well be that we have data associated in both the placebo group and the active group around safety and efficacy in pregnant women. I’m only speculating and I don’t have the answer but when the authorization or if the authorization occurs and there’s information in our data packet, that will address this specific question. That’s when we’ll have a more definitive answer, but at this point I would say we may not have the data we need to actually be able to advise pregnant women and we may need additional study.

That’s the nature of a public health emergency is that we ask questions, we answer, we find data, and if we need additional study we need to do it.

Later on today, Commissioner as you know, President-Elect Biden’s going to be having a briefing about his new health term. Have you had contact with them or … What are your plans, Sir, going forward now over the next couple of months?

So I haven’t had any contact. Our contact is shepherded through the Department of Health and Human Services, that has not occurred with anyone on the Biden team. So right now Sanjay, I’m focused on therapeutics and I’m focused on vaccines in particular and making sure the agency keeps focused and puts resources possible toward that end to help us fight this pandemic.

We’re also going to be public in the near future about our assessment of our performance, what lessons have been learned, and what we need to do moving forward as an agency to learn those lessons. What should we keep, what can we do differently and you may have seen my announcement from a couple weeks ago around transparency. It’s something that I feel very strongly about. That will really help the American people understand what FDA does and I think build trust in the agency’s actions. Who would have thought a year ago that we’d be talking about EUA Sanjay, or clinical trial methodology to the extent that we are or Phase III trials and data safety monitoring boards? We never thought that this would be in our national lexicon, it is. Part of this and part of my job and I think part of FDA’s job is to have as much transparency as the law allows us.

So there are lots of things, lessons learned. We’re going to be very forward about that. That’s what I’m focused on and we’ll see what happens in the future.

Just in our couple minutes remaining, a lot of attention on the vaccine obviously but as you mentioned therapeutics and other things obviously come under your domain as well. Monoclonal antibodies, it’s very interesting, the president says he received monoclonal antibody therapy when he was diagnosed with COVID. We had heard that Ben Carson also received it. From their accounts at least it sounds like it had a significant impact on them. It’s hard to know obviously from just these stories but what about other people right now who hear those stories and say, “Okay, I’m in my seventies or sixties, I’ve got this, I’m pretty sick.” What are the chances, the likelihood I could also get monoclonal antibody therapy as things stand now?

Sanjay, really important question. I’m so glad of the opportunity to talk about this. As you know we’ve issued two emergency use authorizations or EUAs for monoclonal antibodies and what we learned in review of the data and this is why FDA’s review of the data is so important. What we’ve learned is the following. Monoclonal antibodies, as we know them now, and clinical trials are still ongoing so we may have … We’ll likely have more information in the future. The monoclonal antibodies we’ve authorized seem to work best for preventing hospitalization in outpatients early in their disease, typically within 10 days of the onset of symptoms, if you are a high risk individual. So over the age of 65 or over the age of 55 with a comorbidity or some pre-existing illness that puts you at risk. We also specifically state that they shouldn’t be given to people who are inpatients because there’s a suggestion that they may not actually help but might be harmful for folks who are sicker with COVID-19. So these antibodies for the last month since authorization have been distributed around the country so they should be available locally and it’s under state jurisdiction so I would encourage anyone who might be in the categories I described to talk to their provider about this because as an outpatient these can be infused to those folks who are in high risk populations.

Very, very important. We know that the clinical endpoint is prevention of hospitalization. We know that the effect was there so God knows the health care systems are significantly overstressed at this point so I would encourage your viewers to ask the providers about this.

Do we have enough? Because we have 200,000 people becoming newly diagnosed every day. Not all of them are going to fit into this high risk category but even if you say 20% of them are that’s 40,000 people a day, Commissioner. Do we have enough of the types of therapies that we’re giving to the president and the cabinet secretary?

Well we’re working hard with the manufacturers to ramp up as much as possible. It’s another one of our core responsibilities. With respect to supply I think that’s a good question for the folks at Operation Warp Speed. We will push really hard to make sure that we have as much supply as we possibly can because you’re right, we would want to make sure that we had it to all the most vulnerable as much as we could, particularly in this period while we’re waiting to hear the decisions around the vaccines.

Commissioner, I know we’re basically out of time. You are focused on therapeutics and vaccines and testing and we really appreciate it. Again it is worth really reflecting on the fact that between the time the genetic sequence for the virus was sort of shared and an emergency use authorization was applied for, it was 243 days, just about eight months. I feel like the pace of medical innovation has been forever changed in a positive way as a result of what has happened this year, so there are some things worth celebrating and still there’s this cognitive dissonance because we’re still very much in the middle of this and the vaccine is coming but it won’t come soon enough for a lot of people. For you, again I know you’re focused on that. Would you like to stay on as FDA commissioner?

So … I mean that’s not even on my radar right now and I’m not expecting that. I just want to do my absolute best for the agency and most importantly the American people and that is what I’m going to be focused on. I’m committed to doing the right thing for public health and the American people and Sanjay, just to emphasize your point, we must stay focused on the mitigation factors. We must be concerned about community spread. We must do everything we can to protect the vulnerable as we wait for more of these therapeutics and the vaccines to potentially come out. So critically important Sanjay and just anything you can do and all of us can do to amplify that message to our fellow Americans I think would be really important.

We will continue trying to do our part, Commissioner. There are a lot of people who are doing the right thing and you’ve got to give them credit but it is amazing to me, as scientifically sophisticated as we are, if we don’t pay attention to the basics, science can’t rescue us from our own behavior sometimes. I think that’s one thing I’ve certainly learned throughout this Commissioner. I’ve already taken more of your time than you promised and I know you’re very busy so we’ll let you get back to that important work but thank you. Always a pleasure to speak with you sir.

Sanjay, you as well and my best to your viewers and we’ll be moving forward at FDA. Thank you.

Yeah, thank you.

CNN Sanjay Gupta Discussion with FDA Chief on Pfizer Vaccine Authorization Transcript December 8

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