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COVID-19 Vaccine Approval and the FDA

Hydroxychloroquine and convalescent plasma approvals by the FDA under Emergency Use Authorization (EUA) protocols have raised concerns the agency is under withering political pressure to fast-track a COVID-19 vaccine before it is proven safe and effective. Joshua Sharfstein, MD, Johns Hopkins Bloomberg School of Public Health, and JAMA Associate Editor Preeti Malani, MD, University of Michigan, discuss implications for public health and policy responses to ensure vaccine safety. Recorded September 18, 2020.

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This transcript is auto generated and unedited.

>> Howard Bauchner: Hello and welcome to Conversations with Dr. Bauchner. Once again it is Howard Bauchner, Editor In Chief of JAMA. And I'm delighted to be joined by two colleagues and friends today. Preeti Malani is an associate editor. She handles many of our infectious disease papers. She's Chief Health Officer and Advisor to the President at the University of Michigan and a professor of medicine. Welcome Preeti.

>> Preeti Malani: Thank you.

>> Howard Bauchner: And Josh Sharfstein an old friend, a member of our editorial board, a professor of public health and Vice Dean of Public Health Practice and Community Engagement Johns Hopkins. Welcome Josh.

>> Joshua Sharfstein: Good to see you.

>> Howard Bauchner: So we're going to talk about the editorial that three of us wrote last week, it was entitled Reassuring, but Public and Clinical Community about the scientific review and approval of Covid 19 vaccine. What we're not going to talk about is the individual vaccines. But before we get into the editorial I would be remiss if I didn't ask both of you about the events of the last day or so. He notion that there's been interference by health and human services with content that's been put up on the CDC website. Josh you're a former Deputy Commissioner of the FDA, when you read that what was your sense of what that means and its implications?

>> Joshua Sharfstein: There were a couple things that had come out in the last few days. There's the fact that there was a political layer of review over the articles and the morbidity and mortality weekly reports, which is the scientific journal, the CBC and really considered you know the core scientific communication that the agency has with practitioners. And then you have for the public the idea that the CDC could draft something, then it could get totally rewritten with errors and then posted to the CDC website as if it were a CDC document. And it's just a fundamental violation of the integrity of the CDC. Now why do the integrity of the CDC. Now why does the integrity of the CDC matter? We're in a pandemic, the CDC is the lead public health agency in the country and people should - when they see the CDC believe they're getting what the CDC actually thinks. And now what a political area of review has added and not certainly statements by others, but that haven't even been seen by the CDC. It just makes essentially the CDC brand, the CDC mark stand for nothing if it can be violated like that.

>> Howard Bauchner: I mean this is quite germane to what we're going to discuss about kind of reinstilling faith in different federal governmental agencies. Preeti I mean you're an ID person. You know the MMWR is like your Bible.

>> Preeti Malani: That's right.

>> Howard Bauchner: What was your reaction when you saw the story?

>> Preeti Malani: Yeah so Howard much like what - what Josh commented on, for me the CDC holds such a special place as [inaudible] doctor, even - even going to visit the CDC is - is a very special experience. And having handled lots of papers from there over the years and even been involved with a number of different workshops, the - the level of scrutiny that happens any time whether they're submitting a paper or making recommendation is part of - the review process that makes the CDC trustworthy and to - to understand what is being - what's happening now, how there are short cuts being made and over - overridden it sounds like from a political reason is - is heartbreaking and concerning. The lack of trust that is going to emerge from this situation that's already there could have implications well beyond Covid.

>> Howard Bauchner: So there's a CDC, FDA and the NIH are the big three. Let's put the NIH aside, you know Francis Collins Director of the NIH always talks about it as being the agency of scientific discovery. There's other governmental agencies obviously involved with health. And then you have CDC and FDA. Josh you were at the FDA. Just some other brief updates to frame the discussion. So about a week ago a group of I think seven, eight or nine companies announced a pledge not to release a vaccine that was not safe and effective. I would expect nothing less. It was nice to see the pledge, but of course I would expect nothing - nothing less. And then yesterday there was another report, one of the kind of major news organizations survey about 50% of Americans are very hesitant about a vaccine. So let's put aside the MRNA vaccine, the adenovirus vaccine, the traditional heat, kill virus vaccine. We've had an emergency youth authorization for both hydroxychloroquine and convalescent plasma, surprisingly the NIH weighed in on the way about convalescent plasma, which is very surprising. Josh before we talk about the process for approving the vaccine. Could you tell our listeners what in an emergency use authorization is, how quickly is it issued and why do we issue it?

>> Joshua Sharfstein: Sure, thanks for those great questions. Emergency use authorizations came about essentially in the wake of the anthrax attacks that happened I guess about 17 years ago now. And Congress felt like they wanted to give FDA the ability to bring things onto the market rapidly in the setting of a declared emergency. Even if those products did not meet the normal standards for safety and effectiveness and the normal process for bringing things onto the market. So the requirement is that it has to be an emergency. And then there's another minimum requirement that the benefits and potential benefits of the device or the product exceed the benefits that the risks are potential risks. Those are the minimum requirements. The entire process though is discretionary. There has to be a really good reason for FDA to make something like this available. Now when I was at the FDA as the acting commissioner in 2009 I signed some of the first emergencies, authorizations for example right when H1N1 hit, an emergency was declared and it was clear that it could affect children, even babies. There was a question about what the right dose of Tamiflu might be for little babies. And you know the agency had the ability to look at the data and change the labeling under an emergency use authorization relatively quickly without the normal process it might take so many months, it wouldn't actually help the doctors who needed to take care of babies who might be sick with H1N1. So basically using the information you have at your disposal if it makes sense to do in that case we said it made sense to do because people needed to treat babies, what was the best dose? The agency has some flexibility in deciding how to use this tool. So that's the background and so the big question is should the FDA use an emergency authorization for products for Covid and then how and what should be communicated about that process?

>> Howard Bauchner: when a company files for one say they file for one in late October, early November, pre-election, post-election. I'd rather stay out of that debate. How - how long does it take the agency to respond to an application from a company?

>> Joshua Sharfstein: Well the emergency authorization is pretty flexible. So you know in theory the agency could just look at an issue one. There are a lot of good reasons not to do that so fast. And I think the FDA Commissioner has written in JAMA that he thinks for example, for a vaccine it should first be reviewed all the data should be reviewed by an advisory committee. And the advisory committee should recommend to the agency what to do. And I think it's also very important for the agency to explain the process, show and share the data with the public so that there's real trust in the entire enterprise. So even though if under the law the agency could take a quick scan through it and sign off on something that would not be a good idea in my opinion. I think that the process and what we talk about in the editorial is very important, both to get the decision right and to really generate a trust in the public.

>> Howard Bauchner: Now Preeti in the editorial, and I just really want to emphasize that this was sculpted by the three of us. I often draft editorials but they're kind of these skeletons and then the people who are writing with it really ad d the important material. So - so Preeti we talk about the FDA advisory panel, the DSMV and the advisory committee on immunization practices. And we think because there's so much uncertainty about trust and the vaccine that we're talking about a somewhat different process. Could you describe for our listeners those different groups and then what we think would work best in these circumstances?

>> Preeti Malani: Sure, in my description is going to be of course not quite as elegant as the good Dr. Sharfstein, but the sort of - there are multiple layers, and again the ESMB is the one that we think of with really all clinical trials but the idea that the investigators, they have a group of people that should be independent, but knowledgeable that are going to look at the data as you move along and then with all these vaccine trials, those groups are in place. And Josh can correct me on this. In terms of who gets to look at that material, whether that's only investigators or does that come to the FDA or not? But I think again, any kind of safety signal that is seen in this - in that setting would be really helpful for people to see and you talk about mistrust and vaccine hesitancy. I think really seeing data and - and what kind of concerns come up. The advisory committee on immunization practices is sort of the far end of this process. It's the one that I think of and actually the CDC is involve. If we talked a little bit about the CDC and this is a group of policymakers, vaccine experts, pediatricians, internists, public health and a big group of people. It's very prestigious group who end up deciding the recommendation and this is really important because this is where payers and schools and others that - whatever is recommended gets put in there. And again recently one of the things that came up was the shingles vaccine, and what - which one you should get and should you get revaccinated. And so again this will be a lot of work for the committee once there are multiple vaccines to sort of figure out are they [inaudible] is there one that's better, are there certain groups? And then the important one, I think the one that sort of comes earlier is the FDA's advisory group. And again this is - I'm interested to hear a little bit from Josh exactly how that is structured, but I assumed that even with the EUA there is some input there from the FDA panel.

>> Howard Bauchner: Josh just before you answer I just want people to - to understand that in the editorial we are recommending some changes to the traditional process. And I think people really need to understand that traditionally data from an EUA or from a full application may not be filled - may not be shared with the advisory committee on - on immunization practices, but we think in this case those data should be shared. And that is very different than what traditionally happens. Josh if you want to respond to Preeti's query conversation?

>> Joshua Sharfstein: Sure so you know there's really not, the only thing I'd say Howard is that there really isn't a big tradition of this. Emergency, authorizations haven't been used that often. Never for a vaccine that would be widely used in the US population. So I think what we're suggesting is that these are steps that are important to really put the FDA not just on [inaudible] decision making putting, but also really generating a lot of understanding and trust in the process of bringing a vaccine on Covid to the American people. And so we're suggesting that what that DSMB that committee that advises the companies says and does should be made public.

>> Howard Bauchner: Right.

>> Joshua Sharfstein: That's not you know, always done let's say. We're also saying that it definitely should go to the advisory committee at FDA with data for them. So that they can recommend to the agency what to do. There's no legal requirement for that, it's generally the practice to do that for any new vaccine. Certainly the first in class coming to the market, but that should definitely be followed here. And then rather than waiting for the advisory committee on immunization practices after you know the decision to bring it to the market. We're suggesting that that committee be involved earlier, take a look at the data earlier and basically signal that it is also in agreement with bringing this to market. Even if some of the finer points are worked out later. So the advantage of doing this is you've got the same committees that are always going to be involved, so we're not recommending new structures be created. But that the authority and the review and the science that they all bring are brought to bear before the FDA really makes its announcement; so that it has a very clear signal that this is the right thing to do based in science. And you know going back to your initial question about CDC how like we can't have a shadow over and FDA decision like there's been now a shadow over the CDC. And I think this is one way to prevent that from happening

>> Howard Bauchner: Right I think what we really want to make sure doesn't happen is what happened with convalescent plasma. Where an EUA was issued by the FDA and then leadership at the NIH called into question that EUA. If the advisory committee, ASIB or the FDA advisory panel at some point have misgivings about an EUA for vaccine, it's just going to create more and more uncertainty in the minds of many people, including many of my friends and colleagues who - who are nervous about accepting a new vaccine. Do you think it's worth an extra week or two for ASIB or the FDA advisory panel to take to look at the data even if it holds up in EUA by a week or two?

>> Joshua Sharfstein: I mean personally I think that it would be a very small delay because we know that the vaccine is not just all sitting there. I mean it's going to have to rev up to get out there. So I don't think that would be a consequential few days to do that. But I would just make one you know, additional point which is that I don't think what we're saying is that everyone has to agree on every detail. But we should surface these issues; we should have this consultation before the FDA makes a decision. If the FDA is going to make a decision that in some respects isn't exactly the same as what one of those groups might say, they should explain that. They should be transparent. They should say what is going on. So it's not something that's sort of you know, unfolding behind closed doors and confusing everyone, but something that's up front and there are plenty of examples of decisions that the FDA has made where there's been some debate about that. Then the FDA goes forward explains the debate and explains why it's making a certain decision. So you know getting everyone's input in advance, having it be a public process, all that lends credibility to the process even if in the end, you know not every single person is - is in agreement.

>> Howard Bauchner: No Preeti you're an ID doc. You get calls well like from me, "What should we do?" And you've written extensively for us. What's your sense about trying to overcome some of this notion of vaccine hesitancy in US, which I think has become even greater than perhaps even three, four, five months ago because I think there's a lot of people who are just now mistrusting that EUA may be issued based upon direction from the executive branch?

>> Preeti Malani: Yeah and I'm happy to talk to the - to pediatricians about this issue and for so long the issues around vaccine hesitancy kind of lived in that space because of course children get a lot of vaccines. And adults don't get quite as many and that's sort of a separate issue. But here we have a situation where - and I'm just reflecting on - on Josh's comments around the idea that not everyone has to agree, but we need to understand where they're coming from scientifically. I would say sort of the same thing here around when the vaccine is eventually - the vaccine, meaning like multiple likely are available. And you know when you think about how to - how to sort of counter vaccine hesitancy or vaccine refusal it's really with good information and something that can sort of get above the noise. And the amount of noise out there around Covid and again think about masks and we don't have a vaccine right now but we have something that looks pretty darn good in terms of prevention. And all the noise around masks and imagine if the same thing happened around a safe and effective vaccine. What a tragedy that would be. And so I worried. I actually am - I think in this case having messengers that really can get above the noise that are credible and I'm - I'm not sure that that's the same person for everyone. Many people do still trust their own doctor even if they don't trust medicine broadly and Howard I'm reflecting back to Art Kaplan's piece earlier around the idea of rushing a vaccine and what that might do around mistrust of medicine and mistrust of vaccine, so one way to get at it here is to really do due diligence and in a coordinated fashion and sort of lay out the risks, because getting Corona virus is not risk free either. And there may be some residual risk related to the vaccine and we talk about vaccine - it occurs to me that we always talk about safe and effective safety and efficacy, always in that order. And so the idea that there could be a vaccine pushed out there that would be completely unsafe. But it's just pushed out there for political reasons. That to me sounds horrible, but I can see where people might believe that.

>> Howard Bauchner: Well what's so striking to me is it's absolutely opposite of masking. So in general we've had a president who has been resistant to masking. He has not personally masked very much and he's generally been resistant. I'm pleased that Bob Redfield and others really said almost six weeks or eight weeks ago one on this - on this show saying we need to mask. And I think there was a general trend. But he, the President is still generally been resistant. Meanwhile now he's touting a vaccine, so it's exactly the opposite in some regards and so I could imagine that people who are masking but are uncertain of the direction from the President would refuse the vaccine, so it could be an entirely flipped dynamic at whatever time a new vaccine emerges. Josh, what's your sense of that? It could be exactly the opposite of what's occurred with masking.

>> Joshua Sharfstein: It is a very tumultuous atmosphere right now for all of these different interventions, the scenario you lay out could well be the case. It certainly if there is a violation of the integrity of FDA, I think it will be the case that you would see resistance to a vaccine because scientists at FDA would be saying that it's not safe in that scenario. You know I think we have to think about this process as almost like a cascade where everything has to go well, to have a trusted and accepted vaccine. The first step is that the approval really needs to have credibility and that's what we're writing about in this editorial. The steps that would help foster that credibility. Let's say we get to that point. We get the different input - the input is positive, the data looks good. It's made public. The FDA explains itself well. The vaccine is brought into the market. That is just gets you to the next step and that next step has to - really some of that prep work needs to be done now. But people need to have their questions answers. Misinformation needs to be countered, local groups, local leaders particularly from hard hit communities need to be brought in and engage for how to explain and have dialog with people about the vaccine. There's an awful lot that has to be done once we get that first step. But if you don't do that first step well, all those other things are extremely difficult to accomplish and it will really hold up the ability to - to deliver.

>> Howard Bauchner: Preeti I want to read Mike Berkowicz's Sunday Me comments so I want to read one to you. Because it's - it's striking and then respond to it. I think that a fundamental error is being made when we discuss providing the public with data so that trust can be restored. I live in a town in Texas where data is viewed much in the same vein as witchcraft. The only thing that would change their minds is a strong political leader setting an example and creating a more conformist environment. Much of the US are not only opposed to data but blind to even if spoon fed. How do you respond to that?

>> Preeti Malani: Well it makes me sad to hear it, but it is likely reflective of at least some portion of - of our population certainly in and around the world. And you know how do you counter this - this situation and again we can though however focus on trusting the trusted - getting trust in the trusted messengers. The act that politics has entered in this at all is tragic. There are a lot of tragedies around Corona virus, but this is one of them. The fact that science could be viewed through a political lens when it is science. You could have an opinion but you can't have your own science. My hope is that we can also gain trust from the healthcare community. I know we talked about this too that if a vaccine were pushed through and without data, maybe positions and other healthcare providers would refuse to give it which could create another problem. But that is maybe less focused on data, but at least messaging it - really the things Josh talked about is making sure that we're touching all the different communities and the culturally sensitive way, in a way that makes sense to know that is appropriate for people's level of health literacy. Because this could just - you could have a safe effective vaccine that no one wants to take.

>> Howard Bauchner: You know I did appreciate the pledge of the companies. I did really appreciate Maderna's release of 160 page document, which people have already send me notes about. I do think that's a movement towards - towards transparency. But we have an FDA for good reasons and - and in the editorial and Josh you really wanted us to emphasize the expertise in this country to understand whether or not a vaccine is effective and safe resides in the FDA. Could you just comment on that?

>> Joshua Sharfstein: Absolutely. You know there is - everybody gets up and goes to work with a particular job in mind. And some people are trying to figure out new vaccines, some people are experts in communications about vaccines and reaching skeptical populations and some people get up and they go to work and their job is to figure out whether vaccines are safe and effective. And they've been doing that for 20 years. They know how to interpret the results of these studies. They actually at FDA reanalyze to a lot of data themselves to make sure that they - they are doing it in the way that they're most comfortable to see the evidence of safety and effectiveness and beyond just the general evidence what is happening in different subpopulations? What can we learn about older adults for example where people with certain chronic illnesses. And so you know those are the people whose analyses really need to drive the decisions, these are people with great judgment over whether they would take a vaccine or they would give one to their families and communities. And it's their job. And so people who have a lot of expertise in science, it's really important to get their input on specific questions to get their thinking around these things. But ultimately we want to continue to realize we have an FDA for a reason. The FDA can make difficult decisions, does have integrity if it's respected and can really be the - the kind of the pillar that we're leaning on for the scientific review here. And I do appreciate the point that not everybody is going to be looking at the data that is you know, released by the FDA. Not everyone will read the FDA's technical documents. They're not - it doesn't have to be that everybody can read the FDA's technical documents, but those opinions and the reasoning that FDA can bring to that is that first step in the cascade that really can create a compelling sense in the scientific community that this is a vaccine, can convince many doctors, many trusted people in every community in this country and that's why the agency is just so important. Josh can an EUA be issued with - against the advice of the FDA scientists?

>> Joshua Sharfstein: Legally it can be and so I have now some conspiracy minded people calling me saying like what if the company doesn't want to do it, and the FDA doesn't want to do it, could you know somehow [inaudible] on orders from the White House. And you know the answer to that is legally, yes. But you know that's like a dystopian science fiction, you know kind of novel that we would all be trapped in. who would want to take a vaccine that the scientist of the FDA are not ready to recommend or that the company doesn't think is a good one? I mean it just seems like utterly self-defeating to try to do that. And I just - it's not within my capacity to imagine that anyone would think that's a good idea.

>> Howard Bauchner: Would it be made public if that were the case?

>> Joshua Sharfstein: Well I'll tell you my experience at FDA. Certainly with the - whether the company is applying or behind it, I think would be pretty obvious by the nature of the application. It would be public who is granting the EUA, so it would be the secretary rather than the FDA commissioner. And I would also say based on my experience with FDA that in general FDA scientists are not afraid to speak out when there is political interference, and I would expect that that would be pretty widely known pretty quickly. And that comes from being an observer the FDA for a long time. I think you may have noticed that some of the [inaudible] officials of the FDA have already stood up themselves and written saying that they won't be pushed around and I think that is a bit of a distinction from the CDC at this point. The FDA is you know, constantly under siege by vested interest or just interest that have huge amounts of money at stake by FDA decision making, so the concept of integrity at the FDA is existed for a long time. And people who work at the FDA really know how important that is to what the agencies work is and I would expect - I would expect that violations of that integrity would be pretty loudly reported pretty quickly.

>> Howard Bauchner: Preeti, I want to finish with two questions to you. I - I promise we wouldn't discuss it but it's on vaccines, so I have to ask the question. What's your sense of where we are with the vaccines? I mean you and I talk about it by email and on the phone, but what's your sense of where we are with vaccines, the MRNA and no virus. We - we - I know the phase III study that we published a phase I, phase II trial from China they're well into the phase III trial. I spoke to them yesterday. What - what's your sense of where we are with vaccines?

>> Preeti Malani: I think we're in a great place as far as everything I know. And I'm kind of a casual observer of this waiting and - and hoping that - that something does move forward with all the caveats that Josh so elegantly laid out. The - the interest that I've seen in terms of people signing up for the phase III trials has been really encouraging too. We have a couple that are supposed to start at the University of Michigan and you know I was one of the people that said you know what, I think it would be interesting to be in this trial. I didn't get a call yet, so I'm not sure if I'll ultimately be part of it, but you know this is - this is sort of just from a scientific standpoint. When you look at it, it's really remarkable as things move forward since January and then with the first in human phase I shortly thereafter. And here we are, my sense is enrollment is good and that the results will be looked at very soon. But you know October, November we're already there, so I don't think - I'm certainly not hopeful for the fall. But it would be nice to have something available in early 2021 and it feels to me like everything I've seen and read and again I sort of read the same things you do Howard. It feels to me like that's realistic and that we will have a vaccine that helps us move to the next phase of this awful situation.

>> Howard Bauchner: So let me go into the last question and it's for both of you. The - the number of people who are "high risk" varies from study to study, but it's certainly north of 50 million just based upon age alone or healthcare workers or essential workers, people who stock my grocery store as far as I'm concerned they should be first or second online. You know I've jokingly said Preeti, both of you have heard me say maybe we need Good Humor trucks to go down the street, but now we don't have information technology to give me the shot and tell my healthcare provider to do it. I'm not sure we're going to be able to do it at CVS or Walmart or Walgreen's whatever the stores are. You know I know McKesson been charged with distributing 100 million doses. I don't - and let's take out the debate about who qualifies, who makes the decision about who qualifies, do you see the emergence of infrastructure to deliver 100 million doses, to 50 million twice? Do you see an emergence of an infrastructure Preeti?

>> Preeti Malani: I - I do. I am hopeful on this and I - what I don't think is going to happen is people making appointments at their regular primary care office and - and going in to get a vaccine, because that will be very quickly overwhelming. But we've had in recent history and Josh will know more about this you know, I'm thinking of the Mening B outbreak on college campuses where they'll put up a tent, vaccinate 15,000 people quickly. And I think it's going to take that type of ingenuity and I think this is a place where our industrial engineers, people like my son who think about this stuff are going to have to really step up and tell us how to do this efficiently in a way that's safe in terms of social distancing and things. But I sort of envision tents and maybe Good Humor trucks and things. I think that we can do it. But it will take planning now.

>> Howard Bauchner: Josh do you have - as I said I haven't - I mean there's been a debate about who should get it and then who makes decisions you know if the other 65 year old and are they frail enough to qualify or not. Or who is an essential worker is every person who works at a - a nursing home essential? I mean this becomes an ethical debate and who makes the decision in the gray zone? But I'm still worried about just physical infrastructure to deliver 100 million doses.

>> Joshua Sharfstein: Right and the decision is about who would get the vaccine and what order. That process has started, you have some recommendations. Eventually that will be that advisory committee.

>> Howard Bauchner: right.

>> Joshua Sharfstein: So I think yesterday or the day before the CDC put out a 50 plus page guide to states to get them ready for distributing of vaccine. And I read it and I took a big gulp afterwards. I imagine back being the health secretary in Maryland and this is a big job to do. I think they have some important structures in place. The role of the state is not to move the vaccine around but to pretty much authorize a particular order and to make sure that key data gets into the system. But those - that's a lot - that's actually a lot of work in both of those. Because you're authorizing orders to those tents that will get set up, to I think it probably will be pharmacies you know under certain conditions at some places and then you're going to have to try to get IT infrastructure set up that can work so that people can be tracked and ideally reminded to get their second dose. It's an enormous amount of work in short order if we're going to have a vaccination program roll out in 2021. So you know unfortunately a lot of this will be built on our public health infrastructure which is as we've seen very variable across the country. It's going to be an extraordinary test for health departments.

>> Howard Bauchner: I mean what gives me pause about it is that we did not do very well on initial distribution of Rendisivir and who got it and who didn't get it. I mean there was a lot of discussion. So I mean you have 100 million doses sitting in some warehouse, how many doses go to the individual states? And I just want to follow up on something you said; it is likely that people will need second doses. And if you want to know about side effects, you need to know who was vaccinated and that needs to go into a healthcare repository. That - that is a very different system than we generally have in the US. The same countries that have been able to track and trace and quarantine probably have a more integrated health information technology system to do it. You know that - that's my hesitancy. I just got my flu vaccine at CVS and maybe they would have the capacity to remind me and to give that information to my provider at - at Northwestern. But it's not what we do very well in the US. Do you think there needs to be more direction provided to the states? You know oftentimes there's this federal versus state back and forth. Do we need the federal government to be more directive? Or is it better left to the 50 states, Preeti I'll let you go first and then Josh.

>> Preeti Malani: Well when you look at the pandemic response it's been 50 different states, 50 different responses and so I - I suspect it will be the same way around vaccine. And I think Josh's point is spot on that we already have an - even after all this the public health infrastructure is just - it's in shambles in some places and again those are the places that probably don't have a great health infrastructure in general. But yeah this is - I think the states do need to have the final say, but there needs to be some push and some resources given to them from the federal government.

>> Howard Bauchner: Josh is federal and state struggle where do you think the - the ultimate decisions need to reside?

>> Joshua Sharfstein: I think the best case scenario is that the state can put together a great plan with its local health departments, that really you know reflects their understanding of where high risk communities are. But I hope that if states and localities can't do that or they're not doing it, that there is another gear that the federal government can get into. And even if it's not as good a job as a great state and local health department could do, they could at least get a lot of vaccine out to a lot of people who need it, and not just leave it state to kind of fail.

>> Howard Bauchner: This is Howard Bauchner Editor in Chief of JAMA. I've been here with two of my favorite individuals Joshua Sharfstein is on our editorial board and he's a professor of public health at Johns Hopkins. Preeti Malani is an associate editor handles many of our infectious disease papers. She's chief health officer at the University of Michigan where she's a professor of medicine. The three of us have written an editorial entitled Reassuring the Public and Clinical Community about the Scientific Review, and approval of a Covid 19 vaccine. We're calling on a somewhat different process than in the past where there's greater transparency with respect to the recommendations of the DSMV. That data is shared in a way that's - would be unusual with the FDA vaccine and advisor committee as well as the advisory committee on infectious disease practices. And even that takes an additional week or two we'd like to see all three of those groups comment on whatever decision the FDA makes regarding an EUA and a vaccine. Josh and Preeti thanks so much for joining me today.

>> Preeti Malani: Thank you.

>> Joshua Sharfstein: Thanks Howard.

>> Howard Bauchner: Stay healthy as always.

>> Preeti Malani: Yep.


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