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The World & COVID-19

Is the End in Sight? An Inside Look at the COVID-19 Vaccine and Approval Process

Join infectious disease expert Dr. Arnold Monto in a virtual discussion about the COVID-19 vaccine development and approval process. Dr. Monto, a professor of epidemiology and global public health at the University of Michigan School of Public Health, serves as acting chair of the Vaccines and Related Biological Products Advisory Committee, which provides advice to the Food and Drug Administration on the authorization and licensure of vaccines to prevent COVID-19. Throughout his career spanning seven decades, Dr. Monto has been involved in pandemic planning and emergency response to influenza and other respiratory virus outbreaks, including the 1968 Hong Kong influenza pandemic, avian influenza, SARS, MERS and the COVID-19 pandemic. Following his presentation, Dr. Emily Martin, an associate professor of epidemiology at Michigan Public Health, joins Dr. Monto for a Q&A session. Dr. Monto and Dr. Martin co-lead the Michigan Influenza Center, one of five centers across the country that collects data for the Centers for Disease Control and Prevention.


0:04 hello and thank you for joining us for this presentation and discussion on the covet 19 vaccine my name is 0:11 dubois bowman and i'm privileged to serve as dean of the university of michigan school of public health 0:16 the devastating impacts of the covet 19 pandemic have been felt around the globe 0:22 as the world turns its attention to the landscape of covet 19 vaccines and we're all collectively wondering is 0:29 the end of this pandemic finally in sight many open questions remain i'm honored 0:35 to introduce my colleague the world renowned epidemiologist dr arnold monto to help shed some light on what we know 0:42 about the vaccines joining dr monto today is dr emily martin an associate professor of 0:48 epidemiology at michigan public health and another colleague who's been working tirelessly to use her 0:54 expertise to protect the public's health throughout this pandemic in a year that has challenged all of us 1:01 in countless ways i've repeatedly said that the community of faculty staff and students 1:06 at the university of michigan school of public health gives me hope dr monto and dr martin are no exception 1:13 with that i'll turn it over to dr emily martin good afternoon and thank you for joining 1:20 us today for this important and timely webinar we are grateful for your participation today 1:26 and i'm sure you're all looking forward to hearing from our colleague the world-renowned epidemiologist dr arnold monto 1:32 so i'm going to keep my uh my early comments here brief through the event today you'll have the 1:37 opportunity to ask questions in the q a function the presentation will also be available for viewing on youtube after the session 1:44 my name is emily martin and i'm an associate professor of epidemiology at the university of michigan school of public health 1:50 today i'm honored to introduce dr monto the thomas francis collegiate professor of public health at the university of 1:57 michigan school of public health dr monto is the chair of the fda's vaccines and related biological products 2:04 advisory committee that handles covid19 vaccine reviews throughout his distinguished career 2:09 spanning seven decades dr manto has been involved in pandemic planning and emergency response to influenza and 2:16 other respiratory virus outbreaks including the 1968 hong kong influenza pandemic 2:21 avian influenza sars mirrors and of course the coronavirus pandemic 2:26 dr mundo was recruited to michigan public health in 1965 where he was he has worked closely with thomas 2:33 francis jr on the landmark tecumseh community health study dr manto expanded 2:39 the study scope to look at the spread of respiratory infections in the ten thousand residents of tecumseh 2:44 michigan and then during the 1968 influenza pandemic dr armando found that vaccinating 2:50 school-aged children reduced infection in the entire community in early demonstration of how herd 2:55 immunity works since then dr monto has been involved in evaluating a variety of strategies to 3:01 control influenza including vaccines antivirals but also other interventions that have become 3:07 all too familiar for us this year like social distancing and face masks 3:12 in the 2000s he was involved in developing pandemic control strategies leading to work at the world health 3:18 organization and in the us during the 2009 swine flu pandemic he's led clinical trials establishing 3:24 the superiority of inactivated vaccines compared to live attenuated vaccines for influenza 3:30 in 2010 dr monto established the household influenza vaccine evaluation or hive study 3:37 designed to allow the study of many aspects of respiratory virus infections over time 3:43 and this this study has provided the foundation for a continued study of coronaviruses 3:49 over time in 2017 dr monto is the plenary speaker 3:54 of an nih-lead workshop to develop a strategic plan and research agenda aimed at the development of a 4:00 universal influenza vaccine this work has formed the foundation of the now michigan influenza center 4:07 which launched as the pandemic was beginning these are just a few highlights from dr 4:13 mata's impressive and groundbreaking career and it's clear why he was selected to play a critical role in ensuring that we 4:19 have access to a safe and effective covid19 vaccine as soon as possible we at the university of michigan school 4:25 of public health are grateful for dr mata's leadership and expertise in these challenging times so without further ado i will turn it 4:32 over to dr mato for his presentation thank you so much emily and uh 4:38 i want to let everybody know that emily is the co-director of the michigan 4:46 influenza center as we go forward and we have decided not to 4:51 change the name because we still want to remind people that influenza is 4:57 a critical uh in what we uh what we are going to be looking at in 5:03 the future now emily mentioned the hive study and as we go into the 5:11 winter uh one of the things we saw when we did an analysis of the 5:17 coronaviruses uh back in the about eight months ago 5:23 was that we found that they were very seasonal now there were four seasonal coronaviruses and they uh 5:30 show up every winter and we wondered whether the seasonality of these viruses 5:37 was going to tell us something about the way uh sarsko v2 uh kov2 or the 5:44 kovid 19 was going to spread and uh i think we're beginning to sense 5:50 that what we are seeing now may in fact be a reflection of uh of of uh 5:58 uh of of uh this kind of seasonal spread now having introduced the need 6:06 because we know how badly we need uh vaccines and other pharmaceuticals to control 6:13 uh this infection let's start looking at what we're really supposed to be talking 6:18 about today and that is how we are going to be able to control 6:24 uh this pandemic through vaccines and uh we've all heard about operation 6:31 work speed and uh for those of us who don't have a background having watched star trek uh 6:38 this sounds uh kind of strange and suggests that there's undue speed associated with the 6:45 development and in fact that's not the case what is happening is that we are putting into 6:52 a one-year period what typically takes maybe 15 to 20 years 6:58 in terms of vaccine development and how are we doing that well we're working off platforms that 7:05 have been developed for other regions uh often for the original sars virus or for mers or for 7:12 other viruses to get things going we are also telescoping the studies uh 7:20 where we would have been doing things in in sequence and instead we're doing them in parallel 7:26 for example uh we would never think of manufacturing 7:31 and uh getting vaccines ready to go be before uh they were tested 7:38 and proven the reason this is happening is because 7:44 there's been a lot of attention to this and also a lot of uh funds 7:49 given to this effort so this is one of the major success stories of the response to the 7:56 pandemic so uh what i want to convince you of today 8:01 is that we are doing exactly what we ordinarily do with 8:08 vaccine development but on a shorter timeline now this 8:15 is an example of the kinds of things that are going on at the u.s level 8:22 in terms of trying to get the vaccines out quickly and it's basically a public-private 8:28 partnership and nih in particular and uh 8:33 is taking advantage of a lot of the networks that have been established to test 8:39 vaccines and that's why we've been able to do these very large studies that are currently underway or just 8:46 finishing on evaluating the efficacy of the vaccine this gives you a very broad picture 8:53 of what is going on they're taking networks for example that were testing hiv hiv vaccines 9:00 and other vaccines and in enlisting them to test the vaccines against covet 9:08 this is a much more careful look or uh look in detail at 9:15 the strategies and operational warf speed is uh between departments 9:23 of the federal government is the planning body for getting everything done including 9:30 distribution of vaccines to the states uh the active is the one 9:35 that we are going to be focusing more on today in terms of their activities the results 9:41 of these studies that are being put together mainly by nih and i'll go into this activity 9:49 in uh of active in greater detail and then we have the networks that are doing the studies 9:56 and this is what's going on in active and basically they are 10:01 harmonizing the efficacy trials they're putting together the networks to 10:07 do the studies and most importantly they have a 10:12 unified data and safety monitoring board that is looking at all of the studies 10:19 other than the pfizer study the pfizer study has their own independent data data safety and 10:25 monitoring board so whenever you hear something coming from there from from about about a hold or 10:32 something like that about safety uh or breaking codes or anything like that 10:38 it's coming from a single data safety and monitoring board uh 10:46 now why are we able to move so quickly and you've all read the press 10:52 uh about how successful the vaccine uh has been in early trials or 10:58 prelim in trials that where the code has been broken and it's because immunity 11:06 seems to be related to a specific protein the spike protein 11:12 which allows entry of this virus into the cells and we are indeed fortunate that this 11:20 uh spike protein was identified earlier in work with sars and mers 11:26 related coronavirus as the important component of the vaccine 11:31 so that development could move quickly and all of the vaccines that are being 11:37 developed whatever the platform whatever the way they have been produced are related to the 11:45 spike protein and that is the key to the strategy for vaccine control and 11:54 prevention now there are several different ways i've illustrated three different ways of 12:01 getting the body to produce antibodies and other and to respond in other word ways with 12:08 cellular immunity to this spike protein the moderna and pfizer 12:16 biontech strategy is to use mrna this is a genetic message 12:24 the astrazeneca and later jansen approach is to use a vector 12:31 to attach the genetic material of the spiked protein to an adenovirus 12:38 vector this is a virus which causes common colds 12:43 and other illnesses in humans and to not get antibody developed to that 12:50 they've used the chimpanzee had no virus and then we have another 12:55 system where we use a more traditional approach getting the protein of the 13:02 spike into the body through a new method 13:10 which is to make to get genetic material to make in cell culture the material 13:18 that is going to result in production of antibodies and other responses 13:24 and if you see sanity at the bottom this is very similar to what they are 13:31 doing for a licensed flu vaccine called flu block so these are different ways of getting 13:38 the spike in so the body can respond to the spike 13:43 protein and this is just a quick summary of all the ways that vaccines 13:51 can be produced why is rna taking the lead right now because it is 13:57 fast it's much faster than other methods because what you're doing is putting the 14:04 genetic material into the uh into the body and getting the body to respond and 14:12 we have non-replicating vectors which is the adenovirus related uh vectors 14:18 and then we have the protein the protein based which is the third method i was talking about and 14:26 that is slower and we are seeing this playing out in terms of 14:31 uh the timetable for vaccine availability now again this is the nucleic acid 14:41 vaccines and there's the rna at the bottom there and the rna is injected into the 14:49 uh into the muscle and it makes the body produce the viral protein to which the 14:55 body responds so it's all associated with producing 15:01 uh sars cov2 spike and getting the body to respond 15:09 and here's another paper showing the chimpanzee adenovirus if you look at the 15:15 top that's the code for the chimpanzee adenovirus and there is another 15:22 uh example of the method that is being used to get the 15:28 protein in through a spike nanoparticle again the spike keeps coming up that's the critical part 15:38 now why is this going so quickly and efficiently well we've 15:44 talked about the laboratory development of the product that's going to be delivered 15:49 uh there are have been standard assays of purity and lack of toxicity this is 15:55 standard for development of any vaccine but it's being done quickly and efficiently 16:02 because there's been a lot of resources given to it studies in small laboratory animals for 16:08 spike antibody production then in many cases injection 16:14 into non-human primates who were then challenged with the wild virus 16:19 and they've been protected and that gave everybody great confidence at move in moving ahead 16:27 to the large-scale studies that are being carried out phase one and phase two dose finding 16:34 to find the better dose because as i'll point out in just a minute 16:40 there's also been some issue of very ma of mild but uh clear uh side effects in terms of 16:49 aching and in some cases fever associated with these vaccines so you've 16:54 got to get the dose right now this is antibody and i'll go through this very quickly because 17:01 what's been remarkable about these vaccines is they all produce good antibody 17:08 to the sars cov2 spike and this is uh from the the this is from 17:14 the uh the pfizer vaccine mrna vaccine and here is another example and this is 17:22 a little easier to see and this is from the uh 17:27 this is from the the astrazeneca uh adenovirus victor vaccine 17:34 and you can see what's going on here and what you can also see is you don't get as good a response to a 17:41 single dose as you do from two doses so the tudo strategy has been 17:47 just about universally uh used we do think from some of the data 17:53 in the pfizer uh studies that you may get protection earlier before you get 17:59 the second dose but you're not as fully protected until you get the second dose 18:06 side effects there are mild acceptable side effects to these 18:12 vaccines if anybody has got the uh 18:18 [Music] the the the zoster vaccine the shingles vaccine you know that those are 18:25 reasonably reactogenic vaccines and you know that you've gotten them because you may have a little aching and fever 18:32 afterwards especially after the second dose these are adverse reactions to the mrna 18:38 vaccines and you can see the same kind of uh mild and moderate 18:44 reactions to the adenoviral vaccines and this is part of the dose finding so 18:50 you try to figure out what's tolerable in terms of side effects and what gives you the back best vaccine 18:58 response in terms of antibody safety assessments 19:03 we are very concerned about safety of course with anything that's new 19:09 that's anything that is using a novel platform which hasn't been 19:15 licensed before which is the case with the with with two of the three 19:20 approaches we've talked about and the only difference in safety 19:25 between what we're doing now and what is traditionally done is if we go 19:32 with emergency use we're only going to have the time period from the dosage to 19:39 uh the uh availability of the vaccine 19:45 to go on so we're going to have to keep watching there's no reason to think 19:51 that with this kind of efficacy that we're seeing we're going to have any safety problems 19:57 but as you go to larger numbers you have to have that in mind now the 20:04 you the uh collective uh dsmb data safety monitoring board did 20:11 see something with the astrazeneca vaccine and they put a cold on and that just 20:16 shows how well this has been done in terms of trying to 20:22 monitor the vaccine and how well it works now i'm going to use from now on some 20:30 power points that were led to me by the people at fda to tell you 20:37 about the licensure process at fda because i think that's a major 20:43 concern and i'll go through them rather rapidly to allow more time for discussion afterwards and this 20:51 powerpoint just says why we have to do clinical trials to be sure that we are 20:57 not deploying a weekly effective vaccine we want to do the best we want to have a 21:03 standard approach used now the efficacy endpoints that are being used and this 21:10 is from the guidance that fda issued what was being looked at is covid19 21:16 disease of any severity they could have used preventing severe disease they could 21:22 have used preventing asymptomatic infection but most have decided to use 21:27 covid disease of any severity and what they established as the endpoint 21:33 for approval would be greater than 50 efficacy not realizing that the efficacy was 21:41 going to be as high as has currently been seen and among the secondary endpoints was 21:49 going to be prevention of serious disease and again they thought that this would be 21:54 uh questionable and they put a lower bound of the confidence confidence interval at zero percent and 22:02 what we're going to see with the pfizer vaccines is that there was near 100 22:09 prevention of serious disease clinical trial populations have to 22:15 include racial and ethnic minorities this has been done and will be part of the reports that 22:23 everybody is going to see when we have our meeting uh next week 22:31 and the safety database needs to be large they say three thousand here well we've 22:37 got thirty thousand or forty thousand within these trials again money talks and the there have been a 22:45 lot of investments put on into vaccine development which has resulted 22:51 in large numbers of people being involved which has had a lot of so we have a lot 22:57 of data and not only do we have a lot of data we also have a great deal of uh 23:05 uh observations on clinical disease and that's one of the reasons we've got to this point 23:12 where we are able to look at emergency use very quickly 23:17 now emergency use originally they the the the the statements were 23:24 vague about when emergency use was going to be issued but what we can say now is 23:32 that they are using the same standards for efficacy 23:37 for emergency use authorization the only difference is that they we 23:44 are only having an average a median of two months 23:49 from the second dose so there's a shorter duration and what we're going to have to do is 23:56 watch what happens going forward there is no indication that we're going to have any surprises 24:03 but obviously you don't know what's going to happen as you go forward and safety monitoring 24:10 is going to continue whatever whether you have full licensure 24:17 emergency use authorization and cdc and fda are responsible for that 24:24 and we here with emily are going to be part of cdc studies following 24:32 the use of the vaccine in emergency use and then later on after full life 24:43 so we're going to be doing all of these things and following up with both licensure and 24:49 emergency use through observational studies now i'll just very quickly 24:57 talk about the vaccines related biological uh committee and i'm going to just uh 25:04 skip a few of these powerpoints just to allow more time for discussion and this 25:10 is the verb pack and the seed of the the uh 25:15 uh fda uses the verve pack in an advisory function they generally agree with the 25:23 recommendations of the rear pack and we held a meeting on october 22nd 25:29 to talk about the general principles of the vaccine approvals to agree that fda is setting these up 25:37 right in terms of emergency use and full licensure 25:42 and uh there was discussion about this and the issue was the two 25:49 months for emergency use and as i mentioned uh the question of 25:54 two months versus a longer period came up it was decided that given the fact 26:00 that we're in the mur at in an emergency that people are developing severe disease that needs to 26:07 be prevented uh that two months was a a reasonable 26:12 time to begin deployment of vaccines and uh there were discussions of the 26:19 primary endpoint should we be using more severe disease should we be using 26:25 asymptomatic infection and it was decided that the issue of asymptomatic infection could best be 26:32 handled in post-licensure studies or post-availability studies 26:38 because vaccines are rarely uh assessed in terms of how they prevent 26:46 asymptomatic infection and we but we need as we all know to get a handle on the role of 26:54 asymptomatic infection in transmission 26:59 pediatrics and this it was a little bit of a more complicated discussion 27:07 because we've seen some complications of infection of sars cov2 infection 27:13 in children so the vaccines may need to be evaluated a little differently as we 27:19 move into children so we do not expect very quick approval for children based on the 27:26 results in adults bridging studies so-called but there may need to be further studies in children 27:33 now we all are concerned about distribution of vaccines and that's not 27:40 what the verb pack does and yesterday the advisory committee on 27:46 immunization practice came up with recommendations for use of 27:52 the vaccine and this is a powerpoint from the verb from from the acip 28:01 at cdc how they make their decisions and this is a again 28:09 from the acip based on limited doses being available 28:16 and now we are told that these will be available to healthcare workers 28:21 who have direct contact with patients and then and also nursing home residents 28:28 and uh people who care for nursing home residents when larger doses are available then the 28:37 availability the the recommended target groups will be increased and then we will have 28:43 continued use so when we talk talk about the end game where we will be it will probably be in 28:52 uh late late uh late winter into the spring when larger 28:59 numbers of doses of vaccine are that are available and are 29:04 and can be administered and we can discuss that uh when we want to think about the end 29:10 game is the end in sight uh now 29:17 just in closing i want to let you know that our next meeting the meeting of the verpack 29:23 is on december 10th this will be specifically to review the 29:29 pfizer vaccine for emergency use authorization this is the 29:35 web page that you can access and as the previous 29:41 meeting was on uh live on youtube this meeting will be on live on youtube and unfortunately 29:50 for me uh sitting his chair it's going to go from 9 00 am to 6 pm i hope we can finish early 29:58 but what you're going to be able to find on december 8th is the report from pfizer the complete 30:05 report from pfizer on the attached to the web page so you can see 30:10 how the vaccine has done and how well it has prevented and the safety 30:16 data so nothing is being hidden this is all an open transparent process 30:25 and uh thank you all for listening and uh i look forward to a robust 30:31 discussion thank you arnold um wonderful presentation so uh before we get into a discussion now 30:37 arnold and i can debate vaccines and cove everything covet and restore viruses 30:42 um from now until two o'clock but we want to see everybody else's questions so at the bottom of your screen there is an 30:49 option to choose the q and a function and there is where you can put questions in there people will be 30:55 watching and we'll i'll i'll be watching for questions that we can add 31:00 um to to primary discussions so 31:05 arnold are you ready for i am ready all right first question so you know there's been 31:11 a lot of discussion especially following the acip um meeting yesterday 31:17 about prioritized groups for vaccination who's going to get the vaccination when but there's a lot of people that 31:23 aren't um seeing themselves discussed in those conversations right because we're talking about who the first 31:29 batch of vaccines are going to come on but what would be your best guess for people that aren't in the priority 31:34 groups the first priority groups in terms of when they could see a vaccination so people like a healthy 65 year old 31:43 a healthy 30 year old where where's your guess in terms of when that's actually going to be available well 31:49 i think we all are working from the same uh information 31:57 availability on in which is basically in the media what whereas there's a great deal of 32:06 transparency about the fda process there's been less transparency because there are 32:12 commercial considerations about the availability of doses 32:18 and one of the things that people don't realize is that this is a public private 32:24 partnership and when fda looks at this they look at this as pfizer making an 32:31 application for a vaccine for the same reason 32:37 there are issues about figuring out how many doses are going to be available 32:42 and how many vaccines are going to be approved by that time because we know that modern is coming 32:49 along they're going to be discussed on december 17th and then the next one's probably going 32:56 to be astrazeneca uh but there have been some issues that have been in the media 33:02 it's hard to judge that my best guess is that it's going to be into the 33:10 late winter early spring be before we're going to have enough doses available because this is going to be driven by 33:16 the number of doses available along those lines with um in terms of 33:22 um the way the trials have gone um and in the speed with which the the fact that we're kind of 33:28 compiling all the questions for vaccine trial into one big trial for every product um what kind of safety what does this 33:35 mean for safety and efficacy data for populations where there would typically be a special trial 33:41 just for this population so one big example is pregnant people we typically would have a trial just for pregnant people um what is what 33:47 does this strategy mean for safety and efficacy data well i'm not sure that there's really 33:54 typically a trial in pregnant women for most vaccines in fact most vaccines 34:02 are are used in pregnant women on the basis of observational studies 34:10 and part of that is because the companies typically do these trials and they're terribly concerned about 34:17 liability as they do studies in pregnant women the most recent studies that we've seen in 34:23 pregnant women and this is relatively unique are rsv and influenza trials as you well know 34:29 being directed to pregnant women often to see if it protects their 34:34 offspring against the particular uh illness 34:40 we are recommending vaccine for pregnant women for flu a high priority at wbho 34:48 on the basis of mainly observational studies and you and i do observational studies 34:54 together so we are convinced that we can learn a lot from observational studies 35:00 and i think as we go forward with these covet vaccines given the fact that nobody wants to will 35:08 want to be in a placebo group anymore we're going to have to rely on observational studies and good 35:14 observational studies to give us the information we need yeah and i wonder i wonder how much the 35:20 world is expecting how important observational studies are about to become 35:26 better because nobody we can't export our studies yeah 35:32 yeah once once we've got what once we we we uh what and and this will apply to 35:38 any improved vaccines these this this is the first generation 35:43 of covet vaccines we may have improved vaccines come up later on and how do you study those yeah you're 35:50 going to have to study them in comparative trials and observationally and how are you 35:57 going to be able to say which vaccine gives you longer protection that's going to be again observational 36:04 data it's going to look like the last couple of years of flu vaccine where you have all these different products on the 36:09 market and you're trying to figure out which one you know everybody's trying to figure out which one should they drive 36:14 to to this can get that vaccine or that pharmacy and get that there's no incentive for companies to 36:20 to do this unless they've they're really convinced that they can make money and that their 36:25 vaccine will prove superior yeah i'm gonna um i'm gonna bring up a 36:32 question that's a little bit um on a little bit of a different topic now as you know so there's been a lot of 36:38 a lot of papers particularly recently on changes in the virus and genetics 36:44 genetic changes in the virus um and so question freeze what do you think is that going to have any impact 36:50 on vaccine effectiveness like we're so used to hearing with influenza vaccine effectiveness being impacted by 36:55 changing the virus so one is that going to matter and two to what degree are we paying attention to 37:02 other elements of that of the virus besides that one kind of spike 37:09 site that we're mostly paying attention to well the first one's relatively easy and 37:15 as you well know because we have our colleague adam laurin who's doing the sequencing with us uh 37:22 and uh while the virus is changing somewhat it's not changing enough to 37:30 escape from antibody produced to the uh the to the the virus that's uh 37:38 messaged in the vaccine uh whether that's gonna last who knows the positive 37:47 is that we have been living with four seasonal coronaviruses which cause common colds 37:55 and those viruses have been just about the same for the 50 years i've been involved in 38:01 studying them so we can still see the same genes associated with those 38:09 viruses that produce antibodies that's the good news the bad news is that we do see 38:16 reinfection with these viruses and uh we need to figure out what the 38:22 correlates of protection are because people have a lot of antibody 38:27 to the spike of these viruses so first things first we can 38:35 stop the pandemic through use of the current vaccines and through unfortunately the herd 38:42 immunity that's building up because of bad behavior bad behavior may 38:48 be having good results in terms of getting natural infections producing antibody in 38:54 the population which didn't happen last spring and that combined 39:00 with a vaccine is going to result i would predict in a decrease in transmission in our 39:06 populations and then we have to worry about improved vaccines 39:12 drift all sorts of things but we are indeed fortunate that the path to 39:18 these vaccines was easy from a scientific standpoint 39:26 much easier than an hiv vaccine remember they've been working on that for how many years it's been 10 years away 39:33 for a very long time exactly and uh and and and 39:39 and also because of the resources that have been given to make people to to to 39:46 uh de-risk the the whole operation you they've de-risked 39:52 companies and taken away any kind of liability 39:57 and that that's in our society that's what you need to get 40:02 to get them to uh to really move ahead quickly and it's um you know i've seen some 40:09 questions come through about um how how can we assess duration of protection especially given 40:15 that um and that's going to be i mean i think you've it's sort of where the observational studies come in that we're going to have to be 40:21 watching carefully um how long infection or how long protection continues 40:27 after all of these vaccines are administered even outside of clinical trials right and that and and that will be 40:34 relatively easy as long as we can get as we as you and i both know the data on 40:40 who got what vaccines and things like that that's going to be the hardest thing my 40:46 concern is that a lot of effort we've warped speed speeded vaccine development 40:54 we haven't put the same kind of resources into deployment and follow-up and we're going to need a 41:01 lot of a lot of attention given to this to answer the critical questions that 41:07 everybody wants to know that you can't learn uh from the clinical trials even if they 41:13 involve 50 to 60 000 people you're not going to learn everything in that kind of 41:20 population when you're giving the vaccine to millions yeah and i think one of the big 41:26 questions that's going to come up as this gets deployed is you know now that we're starting to see reports 41:31 um about reinfection which we know happens with the seasonal coronaviruses and we've seen reinfection with the 41:37 other coronaviruses as we're starting to see cases of reinfection with this how does that interplay with vaccination 41:44 and um particularly how does that help us answer people who are you so we usually tell people that had 41:51 coveted already if you've had it in the last 90 days you don't need to get tested you're probably protected for a little while 41:57 but should we be also vaccinating those people because of that 42:02 potential for reinfection what do you what's your opinion on that my answer would be yes but lower in the priority 42:08 scheme and the reason i say that is paradoxically the antibody being produced by these 42:15 vaccines is better than what's been seen in 42:20 people who have recovered from covet whether that and also as you and i 42:26 both know that there are some weird things about asymptomatic infection mild infection 42:33 not producing the kind of antibody titer that you see in severe infection which 42:39 is something we usually don't think of so my answer to that is yes they should be vaccinated 42:46 but since they certainly have partial protection they are lower down on the priority list 42:52 than uh than others who have not been previously infected yeah this reminds me 42:59 of when we did um a seminar in january and we got asked about vaccination we said a vaccination 43:05 was going to have to beat nature because the vaccination would have to be better than natural immunity to a coronavirus in and 43:13 we're not used to seeing that not used to that this is a 43:18 i keep coming back to calling this a weird virus it's weird in so many ways the disease that causes 43:25 the kind of transmission we saw in the spring and even now the transmission when 43:31 you're exposed some peop some households will transmit to everybody and some households will be 43:37 practically no transmission and we have super spreaders and non-spreaders and with flu we're much more 43:45 we can always predict it'll spread with this who knows yeah absolutely 43:51 can we talk a bit more about side effects and particularly side effects as they pertain to the fact 43:58 that we've got all these different types of platforms i mean are these are the side effects 44:03 coming out of the trials primarily like injection site a couple of days or are they long-term side 44:10 effects that are being seen well they're not not long-term side effects i i think and interestingly 44:17 they seem to be associated more at least with some of the vaccines with the second shot than the first shot i 44:25 think the interesting thing will be to see if when people give the baculovirus express 44:32 vaccine the protein vaccines which are a lot more traditional in 44:37 terms of not including genetic messages and and and different platforms adenovirus 44:45 is getting in there it's even though it's not replicating it's still doing things to t cells 44:53 what happens when we start going with those other vaccines is it a function in other words of the 45:00 of of the spike protein that's attached or is it a function of the platform 45:06 that's being used we really don't know that yet yeah and i think you know as we think 45:11 about different platforms there's a question about and i've seen a couple of questions with this theme of 45:17 when do you choose one versus if you have a choice between multiple vaccines which product should you choose 45:22 are we going to know and i mean my viewpoint on this is that you know we see this with influenza vaccines you 45:28 you choose the one that's right there and i think with the distribution and the production challenges i i wonder 45:34 if what we're going to see is different products being deployed to different populations different places but me as an individual i'm not going to say 45:41 i have my choices between a b and c at least in the early days and then you have the minus 45:47 the minus 70 centigrade issue yeah which is going to limit distribution of 45:52 the pfizer vaccine and i wonder what kind of future that vaccine is going to have 45:58 as other vaccines emerge and are easily more easily administered yeah yearly will have an effect in 46:06 much of the rest of the world we we look at some of our rural areas 46:11 but you have most where most of the population of the world lives there's no way 46:17 a vaccine like the pfizer vaccine can be administered there yeah absolutely and then you know it's 46:22 nice to see that the pfizer and the modern vaccines both have similar i mean their their efficacy is 46:28 around the same range but if these other products come up with a different range of their efficacy then 46:34 we're gonna have to figure out where we prioritize the more potent vaccines versus not and it's kind of what we do with flu vaccine 46:40 right we prioritize accidents for certain arguments okay and but but 46:45 but the other thing is let's hope enough people are given these other platform 46:51 vaccines because they may last longer you may get a longer duration of immunity 46:58 that's a good point it may be up and back and that's why this is also important 47:04 because under emergency use authorization it's a median of two months in terms of safety it's also a 47:12 median of two months in terms of efficacy so this is they're very efficacious 47:18 right after they're administered yeah knows what happens long term it 47:23 means you can't wait too long to get through a group of people too you got to really get vaccine out there but the need is there 47:31 so then that's the rationale for the emergency use yeah um all right changing topics again 47:38 slightly what are we gonna do about the kids and the teens having uh having an almost team in the 47:44 off in the office next to me that would really like to go back to well i'm not sure where this emergency use will end 47:52 in terms of age some of the studies have been done down 47:58 to 12 years of age they have not been done in younger children and 48:06 as you well know it's the teens that have been getting infected and some 48:11 of them have been getting sick so i would predict that as we go forward 48:18 we may well slowly use the vaccines in older children and 48:26 then before we go to younger children because it's the younger children mainly 48:31 that have we've seen this misc the multi-system 48:36 inflammatory syndrome occurring with infection and that's with infection so who knows 48:43 what happens if you give a vaccine and there it may make a difference if you give a 48:49 genetic genetic material versus protein yeah to what i mean i think there are some 48:56 pediatric there are some pediatric trials going on now i think the 49:02 pediatric trials really have taken uh have been put on the back burner in 49:08 terms of of prioritization they're not they they don't have nih 49:15 pushing them the way and using all the networks yeah do you think that was because 49:21 i think this is that this is in part of the concern about moving too fast and 49:26 short do you think that maybe the early the kind of the early viewpoints that children 49:31 weren't getting infected when it might have just been an epidemiologic phenomenon um but i think that may have also maybe 49:38 set the stage for moving slower in children it it did but at the advisory if there was 49:45 any pushback about anything it was about children's studies from the 49:50 pediatricians in the group they felt that through the traditional 49:56 approach of just using bridging studies relatively small numbers of studies in 50:01 children using production of antibody as the outcome rather than looking at 50:10 clinical protection of the rest which you can't get in relatively small studies 50:16 should not be used that larger studies should be carried out and of course as 50:22 pediatricians they said we should be doing and i'm sure we will 50:27 yeah but the question is when right so um i think we have just a couple of 50:34 minutes left i'm gonna ask you one more question and then um let's see if there's anything else that we want to 50:40 say before we close up but um so one of the things that i think you 50:45 know we're so i think the american public is so used to flu vaccine campaigns and flu vaccine campaigns are so centered 50:51 around the one dose strategy where you just find people wherever you can find them and you give them a dose and 50:57 they're good for the season well depending on how effective the flu vaccine is that year well we hope it works 51:03 this is a two dose strategy which is operationally fundamentally different in how we think about things especially when you have 51:10 multiple products and i we want to get product a and then get product a again 51:16 um so can you kind of explain for the audience why why there's why are we even going 51:22 down this road why is there a two district i know you touched on it in your presentation but why are two doses important 51:28 well two doses seem to be much more protective than one dose some of the studies 51:35 may show and they are looking at people who were infected during the clinical 51:43 trials after the first dose and we may see whether prote there is some level of 51:50 protection uh right now all of the data 51:55 are for the two dose strategy so it is important for people 52:01 to get the second dose and for health care providers to know what the first dose was so that they 52:08 could give the right second dose unless we have regional 52:14 differences so everybody in one region because of availability it's getting one vaccine 52:20 in some other areas they're getting another vaccine uh but that that's where we are now 52:27 we just have to remember we didn't even have the sequence of this virus 52:33 until january 2020 when the chinese let us have it 52:40 after not half and i won't go any further than that but that was one of the first 52:47 things we got around the 20th uh or so of january last uh in 2020. look how far we've gone 52:56 since we've got that sequence it's incredible all right so given so given that um 53:04 that if a vaccine when a vaccine is available for you are you going to get it and does that 53:10 answer depend on which vaccine it won't depend on which vaccine 53:17 i will get it but since i've been happily living not going outside i want to be sure that 53:25 those people who are more at risk get it first 53:32 and then i will happily get the vaccine i think what we've seen is 53:39 much more encouraging and you can tell how encouraging this is because of the 53:45 50 percent positivity that was set in the cdc in 53:50 the fda guidance and having this as at greater than 90 53:57 percent at least from the preliminary reports really changes everything and it should 54:04 change people's attitudes and it certainly should make p 54:10 and and and they really haven't seen severe disease in anybody who has been vaccinated now 54:18 that may not continue because the most vulnerable they've gone to older people but they 54:24 haven't gone to the most vulnerable and some of these people may actually because of co-morbid conditions than the 54:31 rest have severe disease but that sure is encouraging and i think that we should 54:39 move ahead and get vaccinated when it's our our turn to get vaccinated 54:47 because because i think this is being looked at very carefully 54:52 and let's help let's hope our our local authorities who are going to 54:58 be under tremendous strain when they're into handling the pandemic 55:04 and now also trying to organize the distribution of vaccine 55:09 support them as best we can well it's definitely i agree it might my turn is going to come later than your turn but i'll 55:16 definitely give it as my turn but i will um i think i might still use grocery delivery even 55:22 after i get it because i'm i'm becoming used to not going to the grocery store and i enjoy it well my dear wife is in the other cafe 55:31 she does not enjoy not being able to go into the grocery and and pick out exactly what she wants so 55:38 we have a we have one of our few diversions in opinion on that one yeah so when 55:45 when are given all of this with the vaccine landscape and all the distribution things um when do you you know this is a 55:51 combination of both vaccine and this idea of vaccine driven hurt immunity when do you 55:56 think life is going to feel normal again or are we sort of forever changed as a society and how we interact with people 56:02 well i'm not going to go into the socioeconomic considerations whether 56:09 big office buildings will ever be filled the way they have been in the past whether some of the things that we've 56:15 done have changed i'll just tell you my own view 56:21 that it's so much more efficient when you and i are down the hall from each 56:26 other and getting things done that having to communicate the way we're communicating now 56:32 and i think i think we'll be back to that level probably if not in the middle of the 56:39 spring probably by early summer because i think we're going to see seasonality i think we're good 56:44 it's going to be much more like a behaved like like flu outbreaks which behave 56:51 themselves this one has not behaved itself i was surprised we had as much 56:57 transmission over the summer as we did and it's probably because we had nobody immune 57:02 so we're going to have a lot of people immune we may not ever see stopping of transmission 57:10 at least uh in the middle of the winter but things are going to go be a lot more 57:16 like normal uh by the time we get into warm weather i hope so 57:21 all right well with that um i am going to close today's session on that note um 57:28 thank you again arnold for the presentation and the conversation uh a link to this recording is going to 57:34 be shared with all registrants and it's also going to be posted on the school of public health website it's 57:40 going to be posted on youtube for viewing and sharing later and it's going to be available on the school of public 57:45 health social media platforms so please share widely and get this information out there 57:52 thanks everybody for submitting your great questions and engaging and thanks for coming to the talk today