Anthony S. Fauci, MD, returns to JAMA's Q&A series to discuss the Pfizer/BioNTech and Moderna vaccines: the public data, deliberations at Thursday's FDA Advisory Committee meeting, and prospects for an agency Emergency Use Authorization designation, licensure, and rollout. Recorded December 11, 2020.
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>> Howard Bauchner: Hello, and welcome to Conversations with Dr. Bauchner. Once again, it is Howard Bauchner, Editor in Chief of JAMA. And I'm here with Anthony Fauci, Tony Fauci. I think at this point, Tony needs no introduction, so welcome, Tony.
>> Anthony Fauci: Good to be with you, Howard. Thank you for having me.
>> Howard Bauchner: Why don't we get to the questions? I thought we'd bucket them. And I'd to begin with the vaccines. It's an extraordinary story, a positive story. But Tony, let's start with the struggle, the troubling numbers. When I interviewed you about a month before Thanksgiving and I asked you, could you talk a little bit about Thanksgiving and Christmas, you said, I'd prefer not to even touch Christmas or the holidays, because let's get through Thanksgiving. The numbers are frightening, Tony, 100,000 people hospitalized, more than 3,000 people in the last few days have died each day. How is this going to play out over the next two or three months, Tony?
>> Anthony Fauci: Howard, I'm really concerned. I'm concerned because the numbers that we're looking at as of yesterday and today, as you mentioned correctly, are record breaking. I mean, we have over 2,000 people who die each day. Yesterday, it was 3,000 people. We have, as you said, over 200, yesterday was 241,000 new cases. We have over 100,000 hospitalizations. And we're approaching a totality of 300,000 deaths. It's 289 as of last night, 289,000. We have not yet seen the full brunt of the travel and the family get togethers socially with dinner and friends over Thanksgiving. Likely that will peak in the beginning of next week, because it's usually about 2 to 2 1/2 weeks following a particular event when people congregate or when you have people getting involved in situations that are high probability of transmission. That would mean that given that today is the 11th of December, next week you're halfway through, you're going to go right up until the beginning of the travel period of Christmas. And we're going to do the whole thing over again. We're going to have more people traveling. And instead of just having a weekend of the holiday, it's well over a week. It's Christmas, the week between Christmas and New Year's, and then New Year's. I'm really concerned that if we don't have the population as a whole, Howard, seriously realize that this type of a situation is high risk. That means that the recommendation, as stern as this sounds, it's not insensitive, it's just good public help. Limit as much as you possibly can your travel. You must say that this may be the time that we're not going to gather with 15, 20, 25 people at a big dinner with family and friends as much as the season essentially that's part of the season that we've traditionally experienced and love. This may be the time to say, you know, we're entering into a very, very difficult time of December, January, and into the heart of the winter. Although we're getting some relief, and we will very soon, as we'll discuss I'm sure in a moment with vaccines, the fact is vaccines are not going to have a public health impact for at least several months. It may have an impact of protecting individual people. But from a public health impact, it will likely be several months before we get the full positive impact of a vaccine. So, it's in our hands now by mitigating with public health measures. And it's particularly challenging giving the terribly historic numbers that we're seeing.
>> Howard Bauchner: Tony, do you think I've been trying to figure out how to convince people to mask, social distance, not travel, keep gatherings to very personal family members. Do you think religious leaders have a greater role? We're coming up to the season when we talk about your family, your friends, loving and caring for your neighbors. And for me, that starts with healthcare workers. You know? We're just challenging them with more and more cases. I go into a store and sometimes see someone without a mask, and I think, you know, do they recognize that they're really unfair to the people in that store? Do you think it's time for religious leaders to step up and really say this is what you must do? This is actually a part of what our code of our religion is.
>> Anthony Fauci: Yes, I think it's time for any group, any group that has influence by nature of their position in the community should step up and try and help out to get people to appreciate the importance of the public health message. That could be religious leaders. That could be celebrity figures and entertainment. That could be sports figures. People who the community respects who might say, well, if this person is doing it, well then maybe I can do it. I mean, if you see a sports hero, or as you said correctly, Howard, you know, faith based people, religious leaders who do that, the thing that impressed me the most the other think when I was, you know, catching a five minute flash on the TV, was an ad showing a nurse coming out of an ICU completely exhausted, you know, with a mask on, saying please, you know, do something, wear a mask, don't crowd. I just came out of an ICU where there were 25 patients in there that are dying. It was really a very powerful ad.
>> Howard Bauchner: So, Tony, I want to turn to the good news, and there's quite a few questions already. On April 10th, 2018, you wrote in JAMA with Barney Graham and John Mascola, two of your co authors, novel vaccine technologies. There's a quote, in summary, emerging viral diseases with pandemic potential are perpetual challenge to global health. That was obviously the case. And you talked about novel platforms, one of which were DNA or MRA nucleic acid vaccines. That was two years ago. In January, late December, January, we get to genetic code. And yesterday, there's a public hearing about an FDA potential EUA approval of a Pfizer BioNTech COVID 19 vaccine. Had you ever imagined in your life the capacity of scientists to produce a vaccine in 10 months?
>> Anthony Fauci: Well, the answer to that, Howard, is an absolute no. I mean, in my wildest dreams, I thought it would be fast. But fast means if it takes seven years, maybe you can get it down to a couple of years. When we wrote that article in JAMA and talking about the vaccine platform technologies, even then when I projected what would happen with an emerging infection, even then two years ago, I didn't imagine that we would go from sequence identification to actually having a vaccine in somebody's arm, not a vaccine trial, not, you know, halfway through phase three, but actually having the vaccine in somebody's arm in less than a year. Eleven months, to be exact, from January to the beginning of December. It would have been inconceivable to me a year or two or three ago to think that we were going to be successful in that. There's great news about that. Now it's our challenge to convince people that that wasn't rushed in a reckless way, that it was an expression of the extraordinary scientific advances made with vaccine platform technology and the investment that was made that we discussed on a previous podcast of the hundreds of millions if not billions of dollars putting upfront to get vaccine doses made so that when the EUA is issued, you have vaccines that are ready the next day to go into somebody's arm. And that's where we are today.
>> Howard Bauchner: Tony, I do want to congratulate the scientists at Pfizer, and, and likely next week Moderna. But I want to go through some of the data that's been released publicly. And I really want to comment that I think the FDA really was incredibly, acted incredibly appropriately in taking its time doing the analysis. For me, the goal wasn't for the FDA to approve the EUA first. It was to approve it appropriately. And I think they've taken that, that to heart. So, for all participants, the vaccine efficacy was reported as 95%. And, you know, we have a sophisticated listening group, so I really want to talk a bit about the confidence intervals, because they change with certain groups. So, it's 90.3 to 97.6%. So, efficacy is 95%. Firstly, can you remind people the difference between protecting from disease and protecting from transmitting disease? It remains a source of confusion for many people.
>> Anthony Fauci: Okay, so, it really is simple. The primary endpoint upon which the 95% efficacy was determined was based on the prevention of clinically recognizable disease. Not asymptomatic, not infection, symptomatic disease. The secondary endpoint was protection against severe disease, requiring hospital intervention. It was also a secondary endpoint, though it wasn't clearly whether we could reach it, but we're still looking at that. Does it protect against infection? So, a typical scenario could be a, that someone is protected against infection, and certainly against infection, against clinically recognizable disease. But there's also a likely scenario where someone was protected against clinically recognizable disease, but they still have replication competent virus in their nasopharynx. Hence, by definition, they are infected. The question is A, we don't know yet. Hopefully data in a longer term follow up, more subsequent trials, will determine whether or not you have a significant inhibition of actual infection. The other thing that's even a little bit more complicated is that it is conceivable that you could be protected against clinically recognizable disease. You could, however, get infected. But the level of immune response that protected you from clinically recognizable disease would be enough to lower the tighter of the virus in your nasopharynx such that you would not be infective. So, you could be infected, but not have enough virus in your nasopharynx to transmit it. So, we don't know the answer to those last two questions. A, does it protect against infection? And if you are infected, does it render the viral load so low that you're not transmitting it to anyone?
>> Howard Bauchner: Tony, is there enough data from other vaccines over the course of many, many years to know if there often is a substantial difference between those percent of individuals who are protected versus disease versus those protected versus from infection? Because this goes to what would be the number needed to vaccinate in the U.S. to get to herd immunity. Do we know enough from other vaccines to make some projections?
>> Anthony Fauci: Well, we know from influenza that the efficacy point in influenza is not measured by whether you get infected with influenza. It's measured by whether you sought medical care. So, when you see an influenza vaccine that among people between the ages of 30 and 59, how effective it is, the number that you see is the number that protects them against getting infected to the point of requiring some medical attention, like going to the pharmacy and getting an anti-inflammatory, antipyretic. So, many people who get protected from influenza don't necessarily get protected against infection.
>> Howard Bauchner: Tony, there's many questions, but I wanted to ask specifically about two, two groups. The vote yesterday, I believe, for recommendation for approval to move ahead with the EUA was 17th four, and I think one abstained, and there were a couple questions about teenagers who are in the group of vaccinated individuals. The data for those who are 65 and older not at risk, now the numbers get small. And the efficacy, the point efficacy is above 90% for every group. But for those at greater than 65 and at risk, it was 91.7. But the confidence intervals were as low as 44%, as high as 99%. And if you look at teenagers, the numbers are small, so, again, you have the same issue. Are you concerned about the elderly? And they make up 80 or 85% of the deaths. And are you worried about teenagers? The two ends of the age spectrum.
>> Anthony Fauci: I wouldn't say I'm worried about them, but obviously when you get that demographic group with a much wider confidence interval, you're less confident, that's why they call them confidence intervals, you're less confident that that point efficacy is there, or maybe a little bit less. But I wouldn't say I worry about it. I say I am always more concerned about responses in the elderly than I am in the young. So, if the difference between, you know, a lot of discussion yesterday by the VRBPAC was 18 years old versus 16 years old.
>> Howard Bauchner: Right, I know.
>> Anthony Fauci: I don't really worry about the difference between a 17 year old and an 18 year old, or between a 16 year old and an 18 year old. To me, you know, and there may be some significant physiological difference there, but it escapes me. I am, I wouldn't say concerned, but I always worry about whenever we do a vaccine trial, about getting a good degree of efficacy among the elderly. But the thing that was really, I wouldn't say surprising, Howard, but it was gratifying, that when we looked at the data in the phase one study, we surprisingly found that the neutralizing antibody levels in the elderly was as good as it was in the younger group. We don't usually see that. So, to see at 91% point efficacy in the elderly right now is not surprising. It would have been surprising, you know, a year ago before I saw the original phase one data. But now, you know, it makes perfect sense to me, so I feel good about it.
>> Howard Bauchner: Yeah, the issue about, you know, the younger cohort is always interesting to me as a pediatrician. I always think, we always say children, but we should really say prepubertal and postpubertal. The 16, 17 year old is much more like a 25 year old and much less like a 5 year old. Let's just continue with some of the vaccine questions that have already come in, Tony. So, obviously the reports out of the UK around allergy, you know, that wasn't discussed very much in the document, or even yesterday, it has not shown up in the United States in the, in the Pfizer trial. And I didn't know if you have any sense about that, because I'm concerned that it can be, it uses a way to alarm people so that they will not get vaccinated. Do you have any sense about that?
>> Anthony Fauci: Yeah. As you know, there were two cases in the, in the implementation of virus, of the vaccine study. I think people need to realize, and this is, in some respects, a good lesson for people to understand, that safety considerations go well beyond the clinical trial. There's observation of potential adverse events, you know, well into the implementation of the vaccine distribution. So, if you look at the numbers of people in the clinical trial, there were 44,000 in the Pfizer trial. Once you push the button and start distributing vaccines, you are going to be giving it to millions of people. So, there were two things that mitigated against knowing that maybe when people have a very strong diathesis towards allergic reactions that you need to have a bit more precaution. You might want to make sure that those people get vaccinated in a facility that has the capability of quickly giving them some epinephrine or giving them whatever it requires to block an anaphylactic reaction. But the fact is the clinical trial excluded people with severe allergic reactions. So, there was no way in the clinical trial to know what the vaccine would do to people with that sort of diathesis. Now that we got this heads up, what you do is what you do with everything in clinical medicine. You stay alert for it, and you keep a situation so that if it happens again, that people are in a facility that can take care of them. I don't think it should mitigate against people getting vaccinated, because we don't know the extent. Is it people who only have allergic diathesis that requires them to walk around with an EpiPen? Maybe. I mean, if somebody has a very mild allergic diathesis with, you know, contact dermatitis, I don't think that's going to be a situation. I think it's going to be people who have had systemic reactions to allergic stimuli.
>> Howard Bauchner: So, Tony, the EUA is likely to be approved over the weekend for the Pfizer product. Moderna's next up. And then there's a number of other vaccines coming. And we'll talk about them in a second. The numbers, number of doses that are available, both these vaccines require two doses, keeps changing. I think there's broad agreement that healthcare workers and nursing home individuals who reside in nursing homes and individuals who take care of those individuals will be first up. That's 20, 25 million. But vaccine production is fragile from supply to manufacturing to distribution. What do you think the numbers will look like in terms of the capacity to vaccinate based upon Pfizer and Moderna only? And we'll get to the other vaccines. For the rest of this year, perhaps January and February, I think going beyond February gets a little fragile. Do you have a sense of what you think will be available for December, January, February?
>> Anthony Fauci: Well, Howard, as you said, the numbers do seem to change a bit. Not dramatically, but enough that whenever you hear two health officials give numbers, they're not always exactly the same numbers. But from the many meetings that I've been on, and I've been on almost all of them, we were talking about a total of about 100 million each from Pfizer and Moderna where they would have 40 million between the both of them in December, and then again 50 million between the both of them in January. And then maybe 50 to 60 between the both of them in February, which should bring you up to about 100 each. What we hope, what we hope, is that A, that does occur, and the supply chain continues. Number two, we hope that by the time we get to February, March, we will start to see J&J or Janssen kick in, because they're well into their trial now. Hopefully they'll get similar types of results that Moderna and Pfizer did. So, what I was hoping that you would have almost a transition of Pfizer Moderna into December, January, February, early March, and then J&J coming in in March, April, May, and then ultimately Novavax after that. And AstraZeneca. Don't forget they're in the mix too. So, we have a lot of companies that are in the mix. I hope that there will be continuity of seeing the numbers of doses going up as opposed to a plateau and then coming back down and then going back up.
>> Howard Bauchner: Right. I hope the websites that count all of the cases and hospitalizations and death begin to count the number of people who have been vaccinated. That would be, that'd be the nicest graph for me to look at if it keeps going up.
>> Anthony Fauci: That's an inflection curve we like to see.
>> Howard Bauchner: Tony, a lot of questions. About 500,000 patients are diagnosed with cancer each year. And quite a few patients are diagnosed with diseases that require immunosuppression or are on immunosuppressant drugs. Vaccinations for those individuals.
>> Anthony Fauci: It's going to be very important to vaccinate them. What we don't know, since they were not in the clinical trial, as to what the level of protection is in those individuals. Historically, Howard, as you well know, if you have a person who's on chemotherapy for a cancer or for an autoimmune disease, the likelihood, from experience, that their level of response to any vaccine will not be as robust as someone who doesn't have an underlying condition. So, I think we need to be prepared. That doesn't mean you don't want to vaccinate them. That means you have to vaccinate them. But you've got to be prepared that you're not going to have necessarily a 95% protection in those individuals, given the underlying conditions.
>> Howard Bauchner: Tony, given the number of vaccines, and we know that they're going to go to healthcare workers first. Actually, one of my sons is working in a healthcare facility, and he was already told he could get vaccinated next week or the following week. When do people outside of healthcare workers and the elderly, when do you think they'll begin to have options around being vaccinated?
>> Anthony Fauci: End of March, beginning of April.
>> Howard Bauchner: Okay. So, again, I want to change the conversation a bit. I believe president elect Biden will be the seventh president, the seventh president that you will advise. What's that been like, Tony?
>> Anthony Fauci: Well, it's been a very interesting journey. I've been very privileged to have had the opportunity, because of the nature of the diseases that have emerged, they've been of national and global significance, that happens to be the discipline I'm in, I also happen to be in a position as director of this institute that we play a major role in the government's response. So, I've had the opportunity that very few people have of actually working closely with six and soon to be seven presidents. It's an interesting experience because you see differences of style, you know, differences of interest in scientific and public health issues. But more important, Howard, that I say very often, and I will emphasize this when I get the time to sit down and write about it, that a presidency, when it comes to health and medical issues, is very often dictated by events and happenings outside of the power of the president him or herself. In other words, Ronald Reagan had no idea that HIV would have an impact on his legacy, on his presidency. George H. W. Bush did, and that's why he tried, was one of the first to try and say, you know, we really need to do something about this. You know, Clinton continued it. George W. Bush had no idea that in the first year of his presidency, we would have 9/11 followed by the anthrax attacks, which would trigger us to develop a major medical effort against bioterrorism, which really transformed into an effort against all emerging diseases. So, our really core effort of how we respond in pandemic preparedness, that started off in George W. Bush's presidency. I mean, in my conversations with him early on, he never in his wildest dreams would have thought that that was going to be dominating in his presidency, nor would one have predicted, I did because I think he's an amazingly good human being, would have thought that George W. Bush would have developed the PEPFAR Program, which, in the history of all presidents, probably has saved more lives than anything in the field of health that any president has done. And then President Obama, he comes in and you have Zika, Ebola, and pandemic flu. One, two, three. So, that's what I mean by an interesting journey. You know, I had written about the, my experience with five presidents. And when I got to Trump, I had a slide that said what next. You know, in the lecture that I think you know, it says what's next, we don't know. I mean, who would have predicted that a pandemic of historic proportions like we haven't seen in 102 years would totally dominate the last year of a presidential administration? So, the answer to your question is it's been really quite a journey going through these six and soon to be seven presidents.
>> Howard Bauchner: Tony, so that brings us to January, February, March. You'll have two co leaders around COVID 19 Biden administration response. Vivek Murthy has been appointed surgeon general. Rochelle Walensky, who I've actually had on the show numerous times, has been appointed to lead the Centers for Disease Control and Prevention. I think the three of you have been asked to lead the Biden response. How do you see that playing outcome January 21st or 22nd onto February, March? I'm assuming the three of you are being to strategize about that.
>> Anthony Fauci: Well, the actually leader, Howard, is Jeff Zients.
>> Howard Bauchner: Correct.
>> Anthony Fauci: Jeff is the one who is really the overall coordinator of the response. So, my role as the chief medical advisor and Vivek's role as surgeon general and Rochelle's role as CDC director will be coordinated under Jeff. And I think this is going to be a really good partnership, because fortunately I've had the opportunity to work for, with, as a colleague Vivek when he was the surgeon general under Obama. So, we've worked together a lot already. We know each other well. Rochelle is a very close colleague and friend who we've had the opportunity of collaborating with from the standpoint of policy within IAID. She's called upon very often in advisory committees. So, I'm looking forward to this. This, I think, could turn out to be, you know, an important partnership, but also a very productive partnership.
>> Howard Bauchner: Tony, last, last question. There are many more, but I feel like I know you have other things to do. You know, I was listening to a few physicians being interviewed. And, you know, they were talking about their own family members or their own vaccine hesitancy, and they said, well, I want to hear what Dr. Fauci will say. Will he be vaccinated? Will he recommend the vaccine for himself? Would he be vaccinated? And would he recommend the vaccination, the vaccine immunization for himself, his wife, his children? And I asked you before we came on if you minded that personal question, and you indicated you would be comfortable with it. Could you respond to the medical community and the public at large about how you yourself will consider the vaccine?
>> Anthony Fauci: Yeah. Well, I'd be happy to do that, Howard. Having looked at the process by way of this vaccine and how this vaccine was tested, the evaluation of the data by the Data and Safety Monitoring Board, the intense scrutiny given to the data by both the career FDA scientists and the VRBPAC advisory committee, and knowing what I know personally having gone over the data, definitely I will get vaccinated, and I will get vaccinated publicly in order to show that, in fact, I am willing to get vaccinated. And I would recommend it to my wife and my three daughters that they get vaccinated when their time comes.
>> Howard Bauchner: Thank you. I don't think there could be a stronger endorsement by a single individual in this country than hearing you be so clear in stating that. Tony, you know, I always try to finish with something personal. It's your birthday in a few weeks. I will not reveal your age. People are welcome to look it up themselves. It's in the public domain. When I was bar mitzvahed, the one thing the rabbi said is, well, you may be pretty smart, but you can't sing. So, I will not sing happy birthday to you. But from everyone at JAMA, and the entire medical community and the public, I wish you a happy birthday, Tony. And nothing but good health for many, many, many more years to come. Happy birthday, Tony, and stay healthy, and happy new year.
>> Anthony Fauci: Thank you very much, Howard. Thank you for that very thoughtful action on your part. I really, really appreciate it. Thank you. Happy holidays to you, and happy new year. I look forward to getting together with you again soon.
>> Howard Bauchner: Other side of the year. Bye bye, Tony.
>> Anthony Fauci: Bye bye.
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