Narrator - Dr. Abel  00:00
Welcome to HelixTalk, an educational podcast for healthcare students and providers, covering real life clinical pearls, professional pharmacy topics and drug therapy discussions.

Narrator - ?  00:11
This podcast is provided by pharmacists and faculty members at Rosalind Franklin University, College of Pharmacy.

Narrator - Dr. Abel  00:17
This podcast contains general information for educational purposes only. This is not professional advice, and should not be used in lieu of obtaining advice from a qualified health care provider.

Narrator - ?  00:27
And now on to the show.

Dr. Sean Kane  00:31
Welcome to HelixTalk. Episode 132 I'm your co host, Dr. Kane, and

Dr. Khyati Patel  00:36
I'm Dr. Patel. And in this episode titled the warp speed of covid 19 vaccine authorization. Timeline and discussion with Dr. Archana Chatterjee. We explore the history of the covid 19 vaccine development, and kind of have a heart to heart conversation with our very own Dr. Archana Chatterjee more So diving into her role as the dean of Chicago Medical School, her career path and her positions and functions on the FDA vaccine and related biological Products Advisory Committee. We know that nowadays, as VRBPAC,

Dr. Sean Kane  01:13
Dr. Patel, we haven't really covered a lot of the data specific to covid 19 vaccines, mostly because it's been well covered and a lot of other resources out there. We did talk about EUAs in Episode 124, that would be emergency use authorizations, but we decided that there is a role at this point. You know, we're more than a year out of covid 19 pandemic. It is nice to kind of look back and think about the timeline of where things have gone from, you know, back into December 2019 all the way to today. And really how fast things have really developed. And as we'll talk about with Dr. Chatterjee, the role of that committee in approving these mRNA and other vaccines for covid 19, yeah.

Dr. Khyati Patel  01:56
And so to jump right into it, Dr. Kane, you know, as we mostly, everybody knows, every lay person even knows that there are three covid 19 vaccines that have EUAs stands for authorization by the FDA in the United States. So we got the Pfizer biontech, which is an mRNA based vaccine. Initially, when it was authorized. It was 16 and above, and then a reauthorization for 12 to 15 years old was also authorized.

Dr. Sean Kane  02:28
We also have the moderna vaccine, also mRNA based, and that is for 18 years and above, although there is a likely pending EUA to have the age reduced for that one and

Dr. Khyati Patel  02:39
then last, but not the least the late comer in the company, or the trio, was the J and J vaccine. This is not an mRNA base, but more of the adenovirus vector based vaccine, different than Pfizer and moderna in that manner, but also the fact that it's one dose, and currently it has an EUA for 18 and above.

Dr. Sean Kane  03:01
And what's so fascinating about the whole timeline here Dr. Patel, is that normally, vaccines take about 10 to 15 years, on average, to go from beginning to end. But given the pandemic and given the severity of the virus and how quickly it spread, there was a clear need to not wait 10 to 15 years, and that was one of the reasons that operation warp speed was started on March 30, 2020, do you want to just briefly explain what operation warp speed was and the goals of that project?

Dr. Khyati Patel  03:33
Yeah, you know, a lot of different authoritative bodies, as well as the presidential office at the time, came together to define something called Operation warp speed. And the main purpose of the operation was to fund covid 19 related therapeutic as well as preventative approaches. And if you look at some of the allocations of funding that has occurred in order to produce, manufacture and distribute covid 19 vaccine. It seems almost like that the operation warp speed spent the most energy and money behind covid 19 vaccine research, development, production and distribution, and most of the companies that are traditionally involved in vaccine development and approval, FDA, being one of them worked to support manufacturers who were involved in making covid 19 vaccine. Kind of give them the initial funding, so the risk of the risk they're taking with a novel molecule like this, with the R and D, and the manufacturing and stuff, they didn't have to worry about that risk and the money, because the government was funding that. And then they also decided to reduce the red tape, which comes with lot of the bureaucracies and stuff. So that basically means the documents were reviewed quickly. The committees met really quickly. The decisions were taken really quickly, and all that. Was with the purpose, the sole purpose of, you know, getting these vaccines out and making an impact in the pandemic, and opening up our economy and the nations.

Dr. Sean Kane  05:10
And very briefly, we're going to go through the timeline. And I just want the audience to remember how crazy from beginning to end this is in terms of how quickly things happened in a very good way. And then after we go through that timeline, we're going to jump into the interview with Dr. Chatterjee about, kind of her career path, and then kind of what led her to end up being on the VRBPAC that is one of the committees that made the recommendation for authorization for some of these vaccines. So why don't we go in and kind of appreciate this timeline, because it is a fascinating thing to now look back again from December 2019 and just think about how quickly and how how much has really happened over the last year and a half or so,

Dr. Khyati Patel  05:52
obviously being a pandemic that affects the world and many countries and stuff. You know, there are a lot of intricacies and communications and other regulatory bodies such as the who comes into play too. But things kind of started cooking mid December, and then China finally, in collaboration with who declared that there was this pneumonia happening in cluster of patients in Wuhan. That was end of 2019, and few days later, January 12, China shares the genetic sequence of the covid 19, the novel coronavirus. And this is really important, because some of the mRNA based vaccines, they took information from this genetic sequence in order to develop their technology. So it's important that that was identified as soon as 10, you know, not even 1012, days after it was coined as the novel coronavirus.

Dr. Sean Kane  06:46
And then, you know, later in January, we had our first confirmed case in the United States. And then February, we declared a US public health emergency. And then going into March, the World Health Organization also declared coronavirus to be a pandemic. And as we mentioned earlier, march 30, 2020 that was Operation warp speed, was announced, and focusing on covid 19 vaccine development efforts was the primary goal of that project. Then again, during the summer of 2020 we still had these agreements. So there's no no vaccine yet, no specific data yet, but we're seeing agreements with either, not United States government, with different vaccine manufacturers, kind of guaranteeing the availability of the vaccine and that distribution of the vaccine. It was July 2020 that moderna started their phase three trial that eventually led to that EUA.

Dr. Khyati Patel  07:42
And as we mentioned to the audience, J, and J was a little bit late in the game, but they started their phase three trial in September, so a little bit behind the other two competitors,

Dr. Sean Kane  07:53
and then November 9, 2020, was a very big deal. That was when we really got our first peak at phase three clinical trial data. This was the date that Pfizer published vaccine efficacy data showing 90% efficacy, or even higher. On November 18, they kind of revised it up to 95% vaccine efficacy for the Pfizer version of the mRNA vaccine. And just to put into context, you know, during development, they were hoping for 50 to 60% vaccine efficacy. So to have a 90 to 95% efficacy was beyond everyone's imagination in terms of the effect that we're hoping to see.

Dr. Khyati Patel  08:32
And just to remind the audience, when we say the word efficacy, we're here talking about, you know, risk of covid 19 infection. So getting new covid, 19 infection. It's what they were looking at. But another important update came just a week following. I felt, I feel, Dr. Kane, these two companies were just like neck to neck, just a week apart from each other. Moderna, a week later, published its vaccine results from the trials, and they found close to Pfizer's 94.5% efficacy again.

Dr. Sean Kane  09:03
And then, of course, based on that data, Pfizer submitted their EUA to the FDA, and at the end of November, and then VRBPAC actually endorsed that EUA. That was December 10 and December 11, having the FDA agreed to the EUA and then shipping that first batch of Pfizer vaccines again, December 11, 2020, very big deal.

Dr. Khyati Patel  09:27
And moderna followed soon after. So seven days after VRBPAC heard the data or reviewed the data and voted on Pfizer's, they did the same thing with moderna. And following that, the very next day, FDA said, Okay, you have, we have an agreement on this. EUA and moderna started its shipments as well.

Dr. Sean Kane  09:48
And you know, not available in the US, but it's worth mentioning. AstraZeneca did publish their results in mid to late November, showing 90% efficacy. December, Novavax began their phase three. The trial, right?

Dr. Khyati Patel  10:01
And then the J and J submitted its data, and were part endorsed that EUA in February, and then the very next day, FDA agreed to J and J's EUA. And so we have that one dose vaccine, you know, production and shipment that started, and then kind of backtracking, just so, you know, we got this news a lot that, you know, the EUA is happening, or the data are being reviewed, but the companies have already started the manufacturing, like, Can they even do it? It was a question I got a lot from my friends and family, and the answer was yes. That was all because of the operation warp speeds. Funding massive, I'm talking millions, if not billions, of dollars of funding that was provided that allowed these manufacturer to jump start on the production. So as soon as FDA showed that green light, their first, you know, trucks were out the shipping dock from the manufacturing plants

Dr. Sean Kane  11:02
literally the next day, right? So, yep, that that is amazing, and something that we desperately needed, right? We didn't need to wait weeks and weeks or even longer for the approval to happen and then after that, for distribution to actually occur. You know, kudos to all these companies to getting everything lined up to have as efficient and as quick of a process as we did.

Dr. Khyati Patel  11:25
We're going to do a vaccine hesitancy episode, but a lot of people were hesitant to get the vaccine. The fact that how fast they're approved, because it takes, normally, 10 to 15 years on average, to get a vaccine approved. How can they do it so quickly? And you can kind of understand that some of this funding that came in that kind of put the manufacturers brewery away for the huge financial risk that they could be taking, and also removing some of these red tape and bureaucracies that expedited the manufacturing production as well as delivery of these vaccine

Dr. Sean Kane  12:02
and, you know, probably beyond the scope of today's podcast, but in a kind of silver lining problem. One of the reasons that we were able to get the data that we did so quickly is that we had literally a pandemic. You know, it's not like we're studying something that happens in one out of every 100,000 cases, or something like that. We had millions of people getting covid 19, and it was, you know, ravaging the country. So it was easy to find people who did not and did get covid, who were, were not protected from the vaccine, or not having the vaccine. And that expedited the entire process. You know, the moderna and Pfizer trials both finished quicker than they anticipated, because we literally had an outbreak of covid 19, and we had a vaccine to prove that it was effective during

Dr. Khyati Patel  12:47
that time. Yeah, you make a really good point. And that brings me to talk about the EUA, which is an authorization versus full approval, which is how most vaccines are approved. That's a full review. So so far, what we discussed was all this emergency use authorization, but now that there is more phase three data, more widespread phase three data, the Pfizer and moderna has applied for FDA full approval. So Pfizer did it in May, and moderna actually just did eight days ago. So we'll see what kind of decision FDA takes after reviewing more in depth data than what it was available earlier with just authorizations.

Dr. Sean Kane  13:31
Then we should also mention that, you know, the Pfizer EUA was also extended to those 12 to 15 years of age. That was May 10. And as we'll talk about with Dr. Chatterjee, many people are expecting both this full approval for adults and then later on, either more EUAs for younger age groups, or even full approval for younger age groups as we move into the fall of 2021, and maybe into the winter. Nobody knows the exact timeline, but it's certainly something that people are expecting.

Dr. Khyati Patel  13:59
Yeah, and you may wonder, you know, what happened to AstraZeneca? What happened to novax, with the having three vaccines and good deals on the number of doses that should be available and the goals we have to, you know, mass immunize patrons of this country. FDA says that if we didn't, you know, start the discussion of EUA before this date, and I think that day was declared just recently, we are no longer accepting additional EUAs. So AstraZeneca has kind of different focus now that they don't want to concentrate on the US market. They want to concentrate on non US market worldwide. And Novavax is hoping to get authorization in the US market soon.

Dr. Sean Kane  14:45
And if you think about it, you know a pandemic is literally a worldwide problem. So even if everyone in the US got vaccinated, everybody else in the world really needs to have this kind of herd immunity for this thing to eventually go away. It's not. Just a per country approach.

Dr. Khyati Patel  15:03
You bring up a really good point, as we have these pockets of outbreaks happening, India is a good example. And I've gone, you know, and read forums and discussions and stuff, and they're all saying that if one of us is unsafe, then all of us are unsafe. So to your point, yes, vaccines need to reach to all countries, and it's just not about United States getting vaccinated. So Dr. Kane, I enjoyed looking into this timeline and having this, you know, brief overview for our audience too, but I'm actually even more eager to discuss how this process of endorsing the EUA is happen on the VRBPAC, and we're going to have a conversation with our very own Chicago Medical school dean, Dr. Arthur Chatterjee to provide those insights. Well, alongside the discussion we are having about the unprecedented progress of covid vaccine development, we are very excited to bring aboard an expert in the field, Dr. Archana Chatterjee. Most of you know her because she has done various interviews with mainstream media. However, she's close to heart and home. She's also the CMS Dean at the Rosalind Franklin University. So in a true sense of interprofessionalism, we are very excited to have this conversation with Dr. Chatterjee. Dr. Chatterjee, welcome.

Speaker 1  16:28
Thank you. Thank you. Dr. Patel. DAVID KING, it is my distinct honor and pleasure to join you today in this conversation. But before we start talking about covid and the covid vaccines, there is something that I need to let the audience know. Any information I provide and my opinions on requested questions are completely based on my own personal and professional knowledge, understanding and expertise, only. My expressed opinions on the vaccines approval process do not necessarily reflect the opinion of either the vaccines and related biological Products Advisory Committee, or VRBPAC, as it's called, or the FDA, to which the committee provides only advisory services, and they should not be misconstrued or misrepresented. Also, this information does not directly or indirectly bind either the committee or the agency that is served by the committee. Lastly, I am required to complete the FDA conflict of interest screening forms provided before each meeting of the work. Thank you.

Dr. Khyati Patel  17:28
Thank you so much. Dr. Chatterjee, you know we cannot ignore but you know your decorated portfolio and a career path has been really interested. You're the expert in pediatric infectious disease. Can we kind of discuss, because you have lot of decorations and lot of achievement, can we discuss some of the important milestone of your career, and what's kind of like, your secret recipe for achieving them so seamlessly?

Speaker 1  17:58
Well, there's no secret recipe. You know, each of us has our own career path, so there's a lot of people who've asked me about mine, and I'm happy to share what I think might be of interest and value to people. So I think, you know, my early education was in India. I was born there. My father was in the Navy. So I have a strong connection to the military. I went to my military medical school. I served for five years in the Army in India as a general duty medical officer. And some of those early experiences, I think, have informed who I am today and how I deal with some of the obstacles and adversity that we all face in our careers. I had the good fortune to be accepted into a graduate program at the University of Nebraska Medical Center where I completed my PhD. And I've had some excellent mentors, including my PhD mentor, Dr. Patricia Lucian, along the way, who really guided my career path and helped me choose between options that were available to me at various turning points in my career, I went on to complete a residency in pediatrics and a fellowship in pediatric infectious diseases, both joint programs between the University of Nebraska Medical Center and Creighton University School of Medicine. And that really laid the foundation for my specialty area, which is in pediatric infectious diseases, and which I've been practicing for over 20 years now. And there again, I had a couple of excellent mentors, Dr. Chris Harrison, the late, Dr. Steve shotran, he passed away a few years ago, who were very significant in forming the early part of my career in my specialty, I went on to have a first faculty experience in South Dakota. There, again, is someone who took a chance on me, Dr. Larry Fenton, who was chair of the department of pediatrics, recruited me right out of fellowship. A greenhorn to be the only pediatric infectious disease specialist in the state of South Dakota. It was a challenging position to have, and it was a great deal of fun. I not only got to take care of patients, teach medical students, but also to do some work in the community, working with the state health department to promote immunizations. Actually started my work with media at that time because, you know, I was sort of an anomaly there, you know, the only pediatric infectious disease specialist in the state. So everybody wanted to talk to me. And these were not things that I had been trained for, but I sort of learned on the job, if you will. I didn't stay there very long. I went back to Creighton because my husband, who's an engineer, was not happy with the work that he could find in South Dakota, and so we ended up going back to Nebraska. I was back at Creighton now for a total period of 13 years, where I went through the faculty ranks and again, had many, many opportunities that came my way, particularly going down the path of leadership. This time my mentor and she remains my mentor to date, Dr. Roberta sonnino appeared on the scene and really guided me towards completing a fellowship. This is in leadership for women leaders. It's run by Drexel University. It's in its 26th year now, and has trained many of the women leaders in the country in medical schools around the country. And so I entered into the administrative side of the medical school and was there in the role of initially assistant and then Associate Dean for Faculty Affairs, faculty and academic affairs at Creighton. And then South Dakota came calling again, this time to recruit me as the Chair of Pediatrics, which I was for seven years before RFU came calling and recruited me into my current position in South Dakota. I had the support of many, many people, including my former dean, Dr. Mary nettleman, who actually supported me in completing a second fellowship in leadership, this time the Council of Deans fellowship that is sponsored by the Association of American Medical Colleges. So I was able to complete that. It's a very prestigious, very select fellowship. Only five people are selected from around the country every year, and so I was fortunate enough to be one of those five in 2016 and here I am today talking to you all about my career path. That's a thumbnail sketch of a 30 plus year career, but hopefully it's helpful to the audience to hear a little bit about the things that were helpful to me as I progressed on this career path.

Dr. Sean Kane  22:46
So Dr. Chatterjee, one thing I took away from that is the importance of mentorship and probably networking along the way as well, which is something that Dr. Patel and I have talked about, you know, in other podcast episodes related to the field of pharmacy. But it's really global, regardless of what profession you're in. I did want to touch a little bit on your career path. So according to our website and your CV, you have conducted more than 120 clinical trials. You've published extensively, more than 90 peer reviewed publications, 24 book chapters, one book lectured hundreds of hours, many, many scientific presentations. You have done a lot in your career in terms of time management. You've juggled a lot in your career, both from a leadership perspective, research perspective, teaching perspective. What tips do you have in terms of maintaining a good work life balance, or just being more efficient with your time, to be able to output such large amounts over a career, which is something that many people can't do despite having decades long careers. You know, you're you're notable in that.

Speaker 1  23:52
I'll first start by saying that I think what you call work life balance. I call life work integration. It's the same thing, but you put life before work, because I think life comes first, and because our work lives and the rest of our lives, our personal lives, are actually quite intermingled. And this is not just in covid time, even before that. You know, this is something that has been growing, and there are people who who want to push back against it and say, no, no, I want to keep my personal life separate from my work life. And I think that boat has sailed. You know, that's really, virtually impossible to do in the modern world. The second thing that I will say is that this is attributed to Mark Twain. The quote goes something like this, that opportunity comes dressed in overalls and looks like work, and so, you know, when opportunity is offered to us, I think we have to make a decision of whether to take it or not. I was fortunate enough to have many of these opportunities come my way and have the guidance from my mentors to decide. Which ones I should and should not accept. Third thing that I will say that is critically important is the role of our friends and families. I'm very, very fortunate to have an absolutely amazing husband who is my biggest supporter. Has been since we were married 28 years ago, and always been the person to encourage me to go for the next step, to try for something, whether I'm successful or not. I also have a daughter who is a second year medical student, Maya, and she's a medical student in South Dakota, and, you know, I draw a great deal of inspiration from her and seeing her address the obstacles and the issues that she has. So I think we can learn from our friends and our families as well, and need their support. You know, careers in academia are not easy, and so I think it's very important to have that support from our co workers, from our family and friends as well as our mentors and sponsors.

Dr. Khyati Patel  26:00
Dr. Chatterjee, talking about not so easy path taking and being in academia. You joined the Chicago Medical School as a dean in April 2020, and let alone pandemic, that was a very difficult time and to lead the college. And so we want to know how your journey has been thus far at CMS, as well as at RFU as a Dean,

Speaker 1  26:26
thank you for that question. Dr. Patel, it has been an interesting and challenging journey this past year. I think this is true for probably everybody on the planet. I'm not alone in this. However, there were some additional challenges that I took on coming into this new position at a time when, you know, the state was in lockdown. I started April 6 of 2020 I had met a handful of people that I was to work with over this past year, both at the university and at the medical school, and coming in from the outside, this was a big drawback, because I didn't know them, they didn't know me, and we were in the midst of this pandemic. So I think a great deal of trust had to be developed very quickly between myself and the administrators at the university, as well as the medical school, with the staff, with our students, there were some hurdles along the way, particularly around the racial justice issues that came up over last summer. I think that's an area that everyone struggled with. It wasn't just us, but I think the particular difficulty I had was because people didn't know me. They had no idea of who I was and what I was about. And earning that trust during this past year, I would say, has been one of the biggest challenges, but I was also very fortunate to have very experienced people who were willing to give that trust, who were willing to provide that support to me as I walked through the challenges that we had. And then, of course, I joke about it now and say I hit the trifecta, because the third challenge we had was our LCME accreditation visit, which was looming at the time that I arrived. They were supposed to come at the end of April 2020, well, fortunately, they put that off for a few weeks, and so that gave us a little more time to prepare, but it was still very challenging, because no one had done these virtually before. So we were doing a virtual visit, but I'm very happy to share with your audience that fortunately, the visit went very well. We have received a full eight year accreditation from the LCME, and that has really freed us up to do some of the things that I think we need to do to take the medical school and the university to the next level.

Dr. Sean Kane  28:53
What I love about that story Dr. Chatterjee, is that adversity comes in many different forms throughout life, and you can't predict it, and it's something that can't avoid, and you just have to kind of roll with the punches and take it and move forward. And I think that that's always neat to see that happen. And I think everyone listening can take that and apply it to their own lives in terms of other hardships that they've had, or adversities that have come up, and kind of that grit to accept it for what it is and move forward and make the best of it. I love it. I did want to switch gears a little bit. We are talking about covid, and you know, you have been interviewed quite a bit for your involvement on this committee through the FDA, called the vaccine and related biological Products Advisory Committee. Could you just a, tell us a little bit more about the committee, what it is, and then B, more importantly, can you tell us how you get involved in it? Was it something you're interested in that you kind of decided that you wanted to go get involved in it, or was it more that you were asked to be part of it?

Speaker 1  29:51
So you know, as far as the committee itself goes, it has become sort of a household name in recent months. Because of covid. But the committee has actually existed for many decades before it is an advisory committee. You know, many governmental agencies have these advisory committees. The CDC, for example, has an advisory committee called the Advisory Committee on Immunization Practices, or the ACIP. So there are these advisory committees that are generally composed of experts in whatever field that particular agency is overseeing. So in the case of vaccines, these are infectious disease experts in both pediatrics and adults. They are immunologists, statisticians. There's actually a community member. There is a non voting industry member who is a member of the committee. Usually there's about 15 people or so who comprise this committee. And our regular job, Before covid came along, was to evaluate information that was provided to the FDA by vaccine manufacturers for either new or existing vaccines for which there might be a new application. We would meet twice a year to select the vaccine candidates that would be included in the influenza vaccines in the northern and southern hemisphere. So this was our routine, regular work. One of my colleagues on the committee, Dr. Paul Offit, he calls us a committee of nerds, which is basically where we are. And, you know, we went about our work, and nobody really bothered much about us. And it wasn't something that, you know, was of much prominence. Now, with covid, of course, there was a great deal of interest in the vaccine development and in the process by which the vaccines actually were authorized, you know, there's a difference between authorization and approval, as you know, and because of this deadly pandemic, the FDA chose to go the route of authorization, which is normally not used for vaccines. It's usually used for medications and treatments. But in this instance, it was used for some of the tests, if you recall, early on, were also authorized for use under the EUA, and then they decided to do it for the vaccines as well. In terms of how I got on the committee, I had actually served on a previous FDA committee. At that time, it was called amdac. It's now called ADAC, but it is the antimicrobial agents advisory committee where new medications for treatment of bacterial, viral, parasitic, fungal infections would come before that committee. And so I'd had a stint on that committee, and the FDA people knew about me. I think the second thing is that in the field of pediatric infectious diseases, my specific area of focus has actually been vaccines. So I'm basically a vaccinologist. You mentioned some of the work I've done, the clinical trials I've conducted, about half of them have been on vaccines, particularly for children, most of the teaching I've done, the publications, the book you mentioned, it's, it's all in the field of vaccines. So I think they asked me to participate because of my background. And yes, you do have to be invited to be on the committee. Sometimes these recommendations are made by existing members of the committee who will say, you know, you should ask so and so, that kind of a thing. And so that's how you get on the committee. It's a three year term, and sometimes the term is extended. So my term on amdac, for example, was extended by a year. So I ended up serving four years on amdac. But this is how you become a member of the committee. And in terms of the amount of work, typically, you know, it's a few meetings a year, and you would go to go to Washington, DC, and there would be a meeting at usually one of the hotels, you know, there was a conference room or something like that. The meetings are open to the public. And so in the covid year, of course, we went virtual, but the meetings are still open to the public, and there is actually a period of public comment that can be offered during the meetings. So that's a little bit about the committee, and about how I got on it and what we do.

Dr. Khyati Patel  34:15
And so with your extensive role on on the committee itself, I believe much of the media highlights were back in December 2020, when you had voted no, especially for the Pfizer's initial authorization for the pediatric youth, 16 to 17 years old. Because there was lack of data in this age group, I believe the final vote was 17 in favor, and four opposed. You were one of the opposed member on this vote, and Sean and I were wondering, you know, on such an important committee, what was it like to stand up to the data and vote no, even though it was more of an unpopular opinion. Per se. So what kind of courage or confidence does it take for you to vote no on an important vote like that?

Speaker 1  35:10
So, you know, I think it's there's more being made of it than I think really deserves. You know, as a member of the committee, I looked at the data, just like all of my fellow committee members did, and it's weighing the data and deciding whether we think that's sufficient or not. It's really a scientific decision. It's been made out to be more of a, you know, political or a public stance kind of thing, but that's really not what we do on the committee, and so I think that a number of the committee members, even those who voted yes, actually had concerns of the limited amount of data that we had for 16 and 17 year olds. When I got asked afterwards in many of those media interviews about why I had voted no, that was the only reason I had no concerns about the use of these vaccines in adults, because we had already determined what the criteria would be. We had seen the efficacy and safety data at two months, which is what we had asked to see. And I thought that was sufficient, actually. And if it had been a vote for adults only, I would have voted yes. So it was really not as courageous a decision as some people might think it to be. But I will also say this, that having done this work in the field of vaccines for so many years, I've learned to expect some blowback and pushback, and that happened after that vote. I got hate mail, you know, people questioning my intentions, my background. How did I get on this committee? I didn't deserve to be on it. You know, all of this, this kind of stuff, and you just, you just sort of expect those kind of things to come your way and learn to deal with with those things. Ultimately, what we're there to do is to do our best, apply our knowledge and expertise so that the vaccines that are authorized or licensed for use are safe and effective. So we represent the public in that sense, and that's really what we do.

Dr. Sean Kane  37:14
First of all, I want to say that saddens me to hear that you would receive mail like that, you know, given the importance of the decision and the rationale for your decision, but I did want to follow up with that and ask, in your career, have you had any milestones that helped you prepare for that moment better, in terms of dealing with feedback that felt unfair, or being the dissenting opinion, anything like that, that has kind of helped you now. I mean, you seem like you take it in stride, but I can imagine a younger you, 2030, years ago, maybe not, or anyone listening to the same effect, where that would maybe be more difficult to deal with that kind of a scenario.

Speaker 1  37:57
Very true, very true. You know, all of us can look back on our younger selves and see how we have grown, hopefully over the years, and learn to deal with adversity and negative things. And I should start out by saying that I didn't just get those negative things. I got a lot of positive support as well. And actually a number of people who wrote to me and said to me that they felt that I had voted my conscience, basically, and that that was was the right thing to do. So it comes, you know, in both kinds of flavors, both the negative and the positive, in terms of how I deal with negative things that happen, and then you're absolutely right that they will happen in our personal lives and our professional lives. I think some of it is internal. You know, it's just your personality and who you are. A lot of it is your upbringing. You know, I grew up at a time in India where it was fairly uncommon for women to be supported in their education. I'm the third girl in my family. My two older sisters are physicians as well, and my parents dealt with a lot of pushback from family members, from friends, who said they were wasting their money educating these girls. And so, you know, they stuck to their guns, and I'm very, very happy that they did, because all three of us became physicians and have have had amazing careers in taking care of people. My oldest sister is a neurologist. My second sister is a family physician, and of course, I went into pediatrics and infectious diseases. So that came early in my life. And then, you know, I mentioned earlier my own experience as a physician in the military in India. I was posted to a station for four out of those five years where I was the only woman in uniform other than. Couple of nurses who were there, and it was almost like I was an alien creature there, because they'd never seen a woman in uniform before. There are some funny stories I have to tell about that time because, you know, I was in uniform. I was in charge of the women and children. That was my responsibility. So I did women's health and delivered babies and took care of the women as well as the kids. And one of the issues in India, you know, the troops, they're fairly healthy, but they come from different parts of the country. Often they speak different languages, and I didn't know all of the languages. So to communicate with a woman who was about to give birth. You know, sometimes you'd have the the husband there to translate, because we didn't have translators. We didn't have interpreters. And so one time, you know, this woman was wasn't following what I was saying, was very agitated, and I kept asking, What's wrong with her? Why doesn't she listen to what what I'm saying? And finally, the gentleman said to me, you know, he was very embarrassed, and he said, It's because she thinks you're a man. And, you know, she doesn't want her baby delivered by a man. And so I said, have her take a good look at me and see if she still thinks I'm a man. You know, just because I'm wearing a uniform, I'm not a man, but it was, it was experiences like that, which, you know, taught me that you have to meet your patients where they are. You have to be willing to understand what the situation calls for at the time. And so at the time, I didn't think it was funny. Now, when I think back on and I think it's hilarious, but you know, there were those experiences I had very early in my career that really prepared me to sort of deal with anything that might come my way.

Dr. Khyati Patel  41:48
Dr. Chatterjee, this is definitely inspiring to hear. And being from India. I was born and brought up in India. I can, I can relate to some of the stories about education for girl child, as well as you know the military experiences that you mentioned. So thank you for sharing those kind of going back to the functions of the FDA committee that you're serving on currently, and you, you did a really good job describing how difficult it is sometimes to consider this because you're putting patients first. You're really making this decisions in the best favor of the patients. Can you kind of high level overview? Provide us an idea of as a committee in general, which is very large. How do they review the data presented? And I know you kind of provided information about how these are open committees and public hearings are possible as well, but kind of any kind of examples you can share about how the review of data occurs and some of the complexities and intricacies are considered when making a decision. Sure.

Speaker 1  42:54
So the way it works is that, typically, the vaccine manufacturer will submit their data to the FDA. It is then reviewed. The data reviewed by the FDA is own scientists, and what is provided to the committee members is a briefing book that comes from the FDA. So the FDA has its own Briefing Book, and then we also get a briefing book from the manufacturer. So you get two interpretations of the same data set, essentially, and then we are given a period of time to review those data. And at the meeting itself, the manufacturers, the sponsors, as they call, they come, they give a presentation. You're allowed to ask questions of the the sponsors. The FDA has a presentation that they do as well, and they kind of give us, you know, what their take on on the data are, and then the FDA poses a question, and typically or or more questions. Sometimes it's more than one question, but typically the question is, do you approve? Do you recommend approval? Do you recommend authorization of this product? So that's how the process works. The involvement of the community at the open hearings is that the community members can actually come and speak. They there are sometimes patients who come, family members of patients who come and talk. Sometimes there are other experts who come and offer their opinions, and that has been retained by the FDA during this virtual process. So in fact, for each of the meetings at which a particular product was being discussed, there was an open hearing session of an hour where various people were able to come and speak, sometimes they present data, but they're allowed to give their opinions to the committee, and we consider everything and then make up our minds based on all of the totality of the evidence that is provided, the opinions that are shared, et cetera.

Dr. Sean Kane  44:58
I want to kind. Wrap up with one kind of future looking question. Dr. Chatterjee, so we are recording this at the beginning of June 2021 this point, we have an EUA approval for the Pfizer vaccine and 12 to 15 year olds. In addition to the EUA for 16 and up, moderna has announced that they plan to submit an EUA for those age 12 to 17, if you had a crystal ball, and I know you don't, but if you did, what would you say the next year is going to look like from a covid vaccine standpoint, in terms of full approvals of anything younger age groups that are being tested and then an EUA, I know you don't know for sure, but can you give us a sense of what are likely scenarios moving forward?

Speaker 1  45:42
Yes, absolutely again. This is complete speculation on my part, but I do think that those trials are ongoing in younger children, you know, or six to 11 year olds, for two to five year olds, and then for six months to two year olds. And so those have been announced by both moderna and Pfizer. I expect that sort of going working backwards, you know, so the six to 11 year olds, first, then the two to five year olds and then the six months to two year olds, we will start to see those data come in, and hopefully they will be made available either through an authorization process in EUA or actually a licensure process. So I do think that we will have vaccines available for younger children in the coming months. When exactly that's going to happen is very difficult to say, because it depends how the trials go and when the when the sponsors submit the data to the FDA, etc. But I do think that's going to happen. The second thing with regard to licensure, full licensure, I do believe that that is also going to happen. As these trials progress and the manufacturers acquire more data, it's really a matter of how much more data do they need to submit to the FDA for the actual licensure. And that's a question that's very difficult to answer. It really depends, again, on how the data look, and how much more do we need to evaluate those. But I do expect, and there's been media reports, as you know, of some of these companies putting forward licensure applications so that, I think, is probably also going to happen. And then there are, you know, some other exciting things that I think are happening in terms of other manufacturers and the three that are currently authorized, the three vaccines that are currently authorized in the US that there are more vaccine manufacturers that are conducting trials, and maybe we will see those. There's also newer versions of the vaccines that we might see. There are combinations that are being worked on for a combination SARS, cov two flu vaccine, for example. So there's a lot of exciting stuff coming down the pike over the next few months and even perhaps years, with regard to these vaccines.

Dr. Khyati Patel  47:57
Well, one thing for sure, Dr. Chatterjee and Dr. Kane and I can be at rest that your expertise on this committee and the way you vote with your knowledge and experiences, that the committee, as well as FDA, will make the right decision for the patients around the country. So thank you so much for being here for your time and sharing some of your personal ups and downs in the careers and the word of wisdom with our audience. It's really appreciated Absolutely.

Speaker 1  48:27
Thank you both very much. I've really enjoyed this conversation and this opportunity to speak with you and hopefully share a little bit of my knowledge and expertise with your audience. Thank you very

Dr. Sean Kane  48:38
much. So with that, I'm Dr. Kane and I'm

Speaker 2  48:40
Dr. Patel, and as always, study hard.

Narrator - Dr. Abel  48:44
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Narrator - ?  48:55
to suggest an episode or contact us. We're online at HelixTalk.com thank you for listening to this episode of HelixTalk. This is an educational production copyright Rosalind Franklin University of Medicine and Science.