Webinar: What You Should Know about the COVID-19 Vaccine

0:04 good afternoon my name is du bois bowman and i'm privileged to serve as dean of the university of michigan school of public 0:11 health thank you for joining us for the today's discussion on covet 19 vaccines 0:16 especially at a time when our nation is facing unprecedented challenges 0:22 some of you may have joined our covet 19 vaccine webinar in early december 0:27 even in the month since that time there have been remarkable developments two vaccines 0:33 have been approved here in the united states and millions of doses have been uh dispersed and administered 0:40 it's a remarkable scientific feat and my colleague dr arnold monto has played a key role 0:49 in this for me watching the first round of covet 19 vaccines be administered to 0:54 health care workers brought a sense of optimism and hope and knowing that 1:00 we still had challenges that lie before us uh beginning to see um the light at the end of the tunnel so 1:06 to speak but the vaccine rollout has also brought with it many questions how do we know 1:13 the vaccines are safe and for whom how long will immunity last 1:18 do the approval do the approved vaccines offer the same level of protection 1:25 against some of the new strains that are emerging that we've been hearing about in recent weeks 1:30 and to help answer some of these questions we're joined today by university of michigan school of 1:35 public health professors and infectious disease experts donald dr arnold monto and dr emily martin 1:43 dr monto is a world renowned epidemiologist he serves as acting chair of the fda's 1:50 vaccines and related biological products advisory committee or verb pac which is advising the 1:57 fda on the authorization and licensure of covet 19 vaccines throughout his career dr monto has been 2:04 involved in pandemic planning and emergency response to influenza and other respiratory virus outbreaks 2:10 including the 1968 hong kong influenza pandemic avian influenza sars mirrors and and of 2:17 course the coronavirus pandemic dr martin leads cdc and nih 2:25 funded studies of influenza vaccines and ambulatory care hospital and also community settings and 2:31 during the pandemics she's been using covet 19 public health data to help inform 2:37 mitigation and policy efforts at state and local levels i'm grateful to have the expertise of 2:43 researchers like dr monto and dr martin here within our school of public health community 2:49 especially during this pandemic and i'd like to thank both of you for taking time to share your expertise and with that i'd like to 2:55 turn it over to dr monto thank you dubois i'm going to talk 3:01 for a short time about some of the developments since we last had a webinar 3:09 a little more than a month ago because as the boys said we've had two vaccines approved 3:18 the vaccines have been rolled out and there have been a number of developments 3:24 in the overall epidemiology uh globally of uh 3:31 of this virus especially concern about new variants 3:37 uh i'll try to do uh several things more or less at the same 3:42 time to go over the story and to use 3:47 what we heard at the advisory meetings to give you a little background about 3:55 some of the debates that have arisen globally about 4:00 for example the schedule of vaccination should we 4:08 delay the second vaccine and also something about the dosage 4:14 issues can we spare doses and use less vaccine for more people 4:22 and try to summarize in terms of where we are now i'll also try to talk about 4:29 the future in terms of new vaccines which are being evaluated right now 4:36 so let's get going and look into some of these developments 4:46 let's see 4:51 i don't seem to be able to move my screen let's see what's 5:01 there we go okay now we this is we'll give a little bit 5:07 of a review since last time as i mentioned the reason we've been so successful 5:13 at developing the vaccines so rapidly is that one component of the virus 5:21 the spike protein seems to be related to uh to 5:27 development of protective antibodies so the target of all of vaccine production has been 5:36 the spike protein development of antibodies to the spike 5:42 protein which have uh fortunately been pretty well correlated with 5:50 protection we don't know that for sure once we know that we have a real current 5:56 of protection it might be possible to be able to start approving vaccines 6:02 just on the basis of their producing antibodies to the spike protein but we're not there yet so here are 6:11 the three kinds of approaches that are being used 6:18 the one that's at the bottom the mrna path is the one that is being used now 6:25 in the two approved vaccines the middle one is using an adenoviral vector 6:33 to get the uh rna of the that encodes for the spike 6:40 protein delivered to the body which again produces antibody and the third approach which is number 6:48 one listed here is the one that is uh the uh coming along 6:55 most slowly and that is a more traditional approach to developing the spiked protein 7:01 in a cell culture system and delivering that protein to the body 7:08 for antibodies to be produced and here are again 7:15 as a review the moderna and the pfizer biontec vaccine the mrna vaccines which we now 7:22 already have approved the next ones that are going to come up jansen is probably going to be coming up next 7:30 uh and then the astrazeneca vaccine which has already been approved in the uk which 7:37 are the vectored vaccines that's how the mrna gets into the body through delivery through a vector 7:44 and then the protein vaccines which are going to turn out to be adjuvant in addition 7:51 now this is the agenda the first peso plays a page of the agenda for 7:58 the december 10th vaccine in which the pfizer product was approved 8:06 and uh for those of you who watched uh the procedures the 8:13 of at the meeting uh you need to realize that the agenda and the 8:19 questions that are asked are determined by fda the advisors are more or less a jury 8:28 which are who are brought in to just discuss and vote on 8:34 recommending approval and this is uh the first page of the agenda and you can see 8:40 that what fda was doing was setting the scene for an emergency use authorization to 8:47 establish the fact that there was a need for this authorization showing what was 8:54 being done on epidemiology that the that the uh pandemic was severe 9:01 and required emergency use now from the data that were presented to 9:07 us which you can find this is all publicly available one of the more interesting 9:15 features was the fact that from day zero which is when the first 9:21 dose of the pfizer vaccine was given there wasn't that much difference 9:27 between the red which are infections and the those that received the vaccine 9:36 and the blue those in the i mean in those that did not receive the 9:41 vaccine in the blue which are those who did receive the vaccine but by 9:47 day uh 14 there was already a separation this is 9:53 before the second dose was given second dose for this vaccine is on day 21 10:00 and then if you look at the data here you will see that at the bottom 10:08 there was uh after set seven days after the second dose 10:15 and this is before the antibodies should have been kicked on uh uh kicked in for 10:22 the second dose there was already 90 percent effectiveness or vaccine effects 10:29 efficacy of the vaccine and that's one of the reasons why there has been a suggestion 10:35 to delay the second dose because there is significant efficacy 10:42 uh before that dose really kicks in and but that was never really tested 10:50 and the numbers are relatively small compared to the overall numbers which is why fda 10:57 has said that we're not ready for this kind of an approach which may be used in other countries 11:04 and then we had the vote and the vote here to this question was 17 11:12 yes and no was four and two people said they didn't think we 11:18 were ready yet because they wanted the time from uh the last dose to be 11:26 a bit longer a couple of months but most of the reason that there was a negative vote or 11:33 abstention was because of the issue of vaccinating 16 11:39 and 17 year olds because there wasn't much as much data one of the pediatricians voted in 11:46 favor and the others voted no and in private they mentioned that if the 16 and 17 year olds have 11:56 been removed from the question then they would have voted yes 12:01 so there's no reason to take the no votes here as being any disapproval 12:07 of the process and then we had a week later and i just hope we 12:14 going forward we don't have approvals uh uh that close to one another it takes a 12:19 while to recover from a nine nine hour stint uh working on 12:26 uh on on dealing with uh a large number of people and getting things going in the orderly 12:34 fashion and here we considered another issue in addition and 12:41 that issue was what happens to those who are in the placebo group 12:48 and this is the moderna vaccine who are uh able to get vaccine 12:56 because their priority group has come up this is an unusual situation only is 13:03 in place when we have an emergency use because ordinarily vaccine rollout 13:09 is not so quick and we have no problem in retaining people in the placebo group 13:15 because the placebo group is very valuable for comparisons in terms of side effects with 13:23 the vaccinated group so there was a considerable discussion about this 13:29 the thing that was most impressive about the moderna vaccine was they had a 13:36 number of more severe events occurring in the placebo group than the with the pfizer vaccine this 13:43 was mainly because of timing and where the testing was done and here they had a 13:50 hundred percent prevention of severe disease again the numbers are small 13:56 but certainly this is impressive and they made the point that it was hard to uh ethically say 14:04 that the placebo group shouldn't receive vaccines when they knew they had such high 14:10 efficacy the efficacy against uh just laboratory confirmed 14:16 symptomatic disease was in the same neighborhood in excess of 90 percent 14:22 for the moderna vaccine and for the pfizer vaccine 14:28 the separation you can see it took a little bit longer 14:34 to see the separation uh appear uh from the initial dose 14:39 and here the second dose was given at 28 days why 28 days versus 14:46 21 days there's really no immunologic reason 14:51 for this difference this was just based on what was established in the protocol 14:57 and one of the problems we have with the rapid rollout of these vaccines 15:04 is the fact we spent less time in trying to figure out exactly what the 15:11 appropriate dose would be and the timing if we weren't under the gun in terms of 15:18 rolling out vaccines in the face of a severe pandemic this would have taken a lot more time 15:25 and the positive is we've got the vaccines the negative is we probably 15:32 may want to tinker a little bit with the dose but you can't beat 90 odd percent effectiveness so 15:40 the consensus right now from fda is we go with what we've proven and we continue 15:46 to use what we have approved the other issue is the half 15:54 dose and again they chose 100 micrograms for this vaccine 15:59 because uh 250 micrograms were a bit more reactogenic and we'll talk 16:07 about reactogenicity in terms of sore arms especially afterwards and they picked a hundred 16:14 because it was if you look at the second uh the gmts for 16:22 43 days post-vaccination that's 14 days after the second dose and you 16:29 look at 50 micrograms it was 73 000 uh 16:36 you know seven seven hundred and thirty four thousand versus uh eight eleven so you got more 16:45 tighter for the uh for the 100 microgram dose which 16:51 is what has been chosen to be put in the vaccine than with the 50 but it isn't that much 16:58 more and that's one of the reasons why it was suggested maybe we could use half a dose you can see a big drop if we 17:06 we go down further but look at the numbers that were involved these were 15 individuals on which these 17:14 numbers each each of these uh uh stud uh 17:20 distributions occur so it's pretty hard to know what was better and what was not better 17:27 and probably what should be happening and there's a talk about doing this is doing small studies to evaluate 17:35 whether we can fiddle with the dose but we go with what we've got and approved in the phase three studies 17:42 right now we also had this other issue which we were asked to discuss 17:49 and that is the unblinding issue uh and what would happen with the 17:56 placebo groups it's a technical issue but it does affect 18:01 analysis going forward and you may be hearing more about this as months proceed in terms of 18:09 licensure but because one of the requirements for licensure is six months of observation in the 18:18 placebo-controlled trial uh design so we we're going to be hearing more about this going forward 18:25 and then the vote same question and we had nobody voting against 18:32 this time and i made the point closing the meeting that we shouldn't take a difference in 18:39 vote to indicate preference for one vaccine or another it's just that a time had passed we 18:46 didn't have the pediatric question come up in particular and we all felt enthusiastic about the 18:53 efficacy of these vaccines so what's coming in the future jansen is 18:59 probably according to what we read in the press going to come up in february which is a one-dose 19:07 delayed second dose vaccine so there won't be an issue of when to give the second dose because 19:14 it's been delayed it's going to be delayed in their design by several months and the astrazeneca vaccine which has 19:21 already been approved in the uk and then trailing behind the novovax vaccine 19:28 which is going to be a little more traditional in terms of what is delivered to the body and here again 19:34 is just a schematic of the vectored vaccines and the protein-based vaccines which are 19:42 coming along this is all being run through the pfizer 19:47 vaccine was not being run through the nia data safety monitoring 19:54 board the data safety monitoring board is involved in the current the vaccines that are 20:01 currently still in development so they are watching this 20:06 and uh they are the ones that were responsible for the clinical hold 20:12 several months ago so we all things have happened so rapidly we almost forget that the 20:17 astrazeneca vaccine was on clinical hold for several weeks because of 20:24 one side effect that needed further investigation and uh we expect the novavax vaccine to 20:33 be producing about the same level of antibiotic antibodies it's going forward uh and 20:39 they only now started uh the phase three clinical trials so it'll be several months 20:46 before that is ready uh right ready for submission for approval 20:53 safety assessments we've been concerned about safety since the start a major concern with a 21:00 new vaccine and the side effects that we know about 21:05 and there have been most most side effects to vaccines occur within the first six six weeks for 21:12 example the guillain-barre associated with the influenza vaccine 21:17 and basically we have seen very little but the given the known side effects 21:26 associated with administration of the vaccine sore arms 21:31 much more likely to occur than with our flu vaccine at least our current flu vaccine which 21:37 is highly purified much more uh similar to the uh 21:44 herpes zoster uh shingles vaccine where you do get sore arms and you do 21:50 get side effects in terms of uh uh low-grade uh uh feverishness 21:59 and other uh myalgias and the rest in a small proportion of individuals very 22:06 infrequent now what came up be right before licensure 22:11 or approval of the of the pfizer vaccine was this issue of 22:19 anaphylaxis now we know that anaphylaxis does occur very rarely with 22:26 any vaccine and that's why you need to stay at the site of vaccination for several 22:34 minutes 15-20 minutes before cdc just came up with a summary of 22:40 11 cases per million of the pfizer vaccine moderna 22:48 vaccine seems to be less but we're not sure because we the the the number it started out later 22:56 so but one case at least has been reported with the modern vaccine now 23:03 i showed this one before i just wanted to say that the rollout how the vaccine is utilized 23:11 is not a function of fda but more in terms of cdc we may want to talk 23:18 about that but this is a very complicated situation we're only realizing that with our 23:25 health care system in the united states it's not ideal in many respects and it's certainly not 23:32 ideal in terms of the roll out of of of of a vaccine 23:38 which is needs to be given to the entire population there are other models the uk model 23:46 where everybody is part of the health care system and they can recognize those with underlying conditions easily 23:53 the situation in israel which is the most vaccinated country probably in in the world right now where 24:00 they have everybody has to belong to an hmo and they've got all their data 24:06 those are the ideal situations we don't have the ideal situation in the united 24:11 states but we work with what we've got and as more vaccines come online 24:17 we will be able to get them into people's arms and be able to answer a 24:23 lot more of the issues about duration of antibody and things like that 24:30 we now uh will really uh look into some of these other 24:37 issues and i'd like to turn over to my colleague emily martin who we 24:43 who who will lead us through through these questions and thank you for listening to me ramble 24:50 on about all these issues i hope uh i've been able to help 24:56 in trying to deal with these rapidly moving events excellent well yes let's go ahead and um 25:04 kick off the q and a portion um and arnold if you can there you go um 25:09 perfect so um i'm slow but i figure it out 25:15 so um thank you for those who submitted questions in advance in the registration we saw a few common themes and the 25:22 questions we're going to start with addressing some of those first but in the meantime at the bottom of your 25:28 screen there's a q a button on zoom where you can submit additional questions there are people that are 25:33 going to be watching for those questions and we'll get to many as many of those as we can as time permits 25:39 as well so to kick it off on i'm going to start with a hot topic 25:45 um you see you mentioned the debate on the 16 and 17 year olds that came up during the burp pack meeting 25:50 from my mind um the 16 and 7 year olds um you know they're not a high risk of 25:56 severe disease population but they're an important population if you think about transmission they're very mobile they interact a lot they 26:02 they um jobs where they may be interacting with the general public what is what is your view on vaccine 26:09 safety with the two products that are on the table right now and using them in 16 to 17 year olds 26:16 well the interesting thing about the 16 and 17 year olds is that we had two things going on 26:25 at the meeting one was the standard uh need 26:32 especially among pediatricians to demonstrate that vaccines which are given for adults 26:39 work the same in children uh there the other thing was just 26:47 uh not paying attention to some of the data that was presented to us because pfizer had already 26:55 done some studies in 12 to 15 year olds where the vaccine had performed just as 27:03 well as in the uh in adults 27:08 so uh i think we will see bridging studies which will 27:16 allow the vaccine to be given to younger individuals and the question 27:22 will come up about prioritization i recall that uh in the past flu pandemics we've 27:30 had discussions about who should be vaccinated first with flu 27:35 as you know emily school-aged children are the vectors in the population they spread it in the 27:42 population should we prioritize them because then we can really bring an epidemic under control more rapidly 27:50 that's a discussion we haven't had here because we haven't seen that much symptomatic 27:57 infection in young individuals but boy that asymptomatic infection is playing a much bigger role than we ever 28:04 thought with this virus this weird virus right and actually that brings up 28:11 another it's kind of alludes to another question that we've gotten a lot of comments about is learning more about how 28:18 how the acip process work the the committee at the cdc that decides how vaccine priorities like how did we 28:24 get to where we are with prioritization you know because there are a couple different ways to approach it right you 28:29 can as you mentioned with the you know efforts to vaccinate school-age children against influenza you can approach it by vaccinating 28:35 the people spreading the disease but may not be that impacted themselves as severely 28:41 you can vaccinate your um people that are most likely to get severely ill first or um you can as they 28:49 they did to some degree in acip focus on your critical infrastructure so vaccinating the people that you need to 28:55 keep your hospital you don't want you don't want massive amounts of your health care workers calling in sick in the middle of 29:01 a pandemic right or the nursing home issue which uh one of our colleagues uh uh got very much 29:09 uh involved with discussing in discussing the nursing home yeah and so and so it's 29:14 kind of a mix of both uh if i kind of listed out three options and it's a mix of number two and three 29:19 it's you're getting your infrastructure and then in your front line workers and then you're getting 29:26 nursing home residents um you have an age some bite bit some age based strata to try to do it by 29:32 risk as well and so it's sort of a hybrid of two different strategies which is complex operationally but it does kind 29:39 of meet two needs at once which there are benefits to doing that as well well the 29:46 i think now we've really had a demonstration of the different roles and it's unique 29:51 to the united states of the fda which approves basically it says who can get the 30:00 vaccine and doesn't go into any detail 30:05 fda has approved vaccines that have been rarely used but it's a 30:12 it's acip that really says how the vaccine should be used 30:17 and makes recommendations based on evidence and then goes into details and 30:24 the question in my mind is whether there is not too much detail in terms of 30:33 who should get the vaccine here in terms of our health care system and their ability to 30:39 deal with the rollout because i'm concerned about 30:45 in in one see people who have underlying conditions i think i've alluded to that how do people 30:52 recognize who has underlying conditions checkman who has an underlying condition 30:59 with the flu uh recommendations they used to have a recommendation for 31:05 people with underlying conditions they found it was unworkable and they basically went by age 31:12 so you've got all those logistic problems in addition to trying to 31:18 get things moving and our health care system is fragmented as we 31:24 know and under our state health departments and especially our local 31:30 health departments are under resourced to do what it needs to be done here which 31:36 means we really have to fall back on what we have yeah and i wanted to um mention to that 31:43 end there's a lot of people that have asked um related questions about how 31:48 how to find out where we are in the vaccine distribution process how to get instructions on where to get a vaccine who to call 31:54 and um you know it it the way the us healthcare system works it either lives with you or primary care provider or it 32:01 lives with your county health department now the the health care systems the primary care providers 32:07 are still getting up to speed on how to mobilize at that level and so for the best source of 32:13 information to go to is going to be the website for your county health department to figure out where they are 32:18 various health departments are in the process and how it's going and then you know it's going to be uh it's going 32:24 to be uh the work of kind of um announcing as they move through the phases the 32:30 priorities i think michigan's uh decisions to start changing their prioritization 32:36 structure to expand things is going to move things faster here too and we have a lot of people who now are 32:44 authorized to get the vaccine going down to age 65 rather than age 75. yeah and then one of 32:50 the tricky things will be to balance the needs of communities that are more integrated 32:56 in into communities they've got big health systems or sort of big infrastructures and then the needs of communities that 33:02 are further out that have more distribution challenges and um 33:07 infrastructure challenges for sure i'm gonna um take us back to safe because i feel like 33:12 there's a lot more safety questions that we sort of started out talking about safety and then um i veered into uh operations a little 33:20 bit more because i like wow yeah so aside from the anaphylaxis 33:26 safety has really not come up we've heard much less uh much fewer reports about side effects 33:34 which yes and the um the allergic side effects that have been 33:41 um talked of that have been discussed are right now it's point zero zero one percent of the time 33:49 per million yeah and so uh interesting to see that um so a lot of 33:55 this i think discussion around safety comes from the fact that there's so much talk about how fast the whole process 34:01 um the whole process happened because when warp speed makes it sound like you're just like hurtling through space 34:06 developing vaccines at the same time who were star trek uh aficionados 34:14 recognize the term immediately exactly and so but you know it the the terminology in 34:20 the way of it kind of leaves behind in my mind the fact that these are based on technologies that 34:27 have been in development for and honestly the flu vaccine field has kind of propped up some of these things but 34:33 these are vaccinology strategies that have been around for a while and have been in development for a 34:38 while um and so it's you know what do you think about speed 34:44 whether there's been a kind of a speed versus safety trade-off well i don't i don't think there's 34:50 safety concerns that we really have to be worried about when we know we have a 95 percent 34:58 of vaccine efficacy there is always a possibility 35:06 of infrequent uh side effects we typically don't figure them 35:14 out until we have the rollout of the vaccine and the vaccine 35:19 being used in millions and millions of people as long as those side effects are 35:27 not severe this is not really a concern because we need to deal with risk 35:35 benefit and if there were much of a risk we know it as the vaccine gets rolled 35:42 out we usually don't see those because of numbers in the clinical trials but only 35:50 after the fact the one thing that there was a slight signal about was 35:57 bell's palsy in both of the trials maybe one more in the placebo group in in the 36:04 vaccinated group than the placebo group the problem there is this is something which occurs 36:10 naturally in the population in the unvaccinated so there may be a slight 36:17 excess but again it's so rare that you need to get 36:24 millions of people vaccinated in order to be able to show there is a slight excess which means 36:32 that really the benefit so far far outweighs the risk that in the face 36:39 of what we've got going on people should get vaccinated without concern 36:44 yeah you know it also um i'm impressed by the fact that i think modern technology and mobile technology 36:52 and the fact that everybody can do that the v there's the v safe program now where 36:57 all of the uh every buddies gets facing is doing regular reporting on their side effects and any effect 37:04 they've had from the vaccine for weeks after they get it and we're getting that data in real time now 37:10 instead of a passive system for every other vaccine we've rolled out we wait to find out if we're hearing 37:15 reports from doctors or hospitals about there being a problem i think doing it at this granular level 37:21 with this amount of data collection um we're going to find out about if if there are any 37:27 safety issues we're going to see them really really fast compared to where we would have been years ago if we had done a similar kind 37:33 of mass but i alluded to some of the issues about the fast rollout and that is they had to choose 37:40 the right interval between the two doses and how much to put in the vaccine uh 37:47 uh quickly they usually would take quite some time with dose 37:52 finding and looking at different intervals they just picked intervals and we're we're 37:59 really locked in and appropriately so with the dose and the d and the interval 38:05 that we've got right now because that's all we've got data on in parallel there probably will be 38:12 studies to see whether we can uh opt not even not optimized because i 38:18 don't think we can go higher than 95 but to spare doses and 38:26 allow more people to be vaccinated but that has to be done in parallel and in small groups where 38:32 you have an efficacy endpoint because one we really don't have a correlated protection we can't just 38:41 use antibody as a surrogate for protection and then 38:46 we have the duration issue and that's gonna take a while to figure 38:51 out yeah and it's you know it's interesting that a lot of um the dosing schedules for other vaccines 38:57 have evolved over time as we've seen them be used and see what works in the population 39:02 and we're not used to tackling that question we're used to taking that question after our vaccine's been out for two or three years now 39:08 you're changing the dose or changing the schedule um our last safety question um before we 39:15 tackle some other i want to get into the variant the variance strain um questions but is um 39:22 so let's talk more about pregnant women so there has not been a specific study of pregnant women but pregnant women 39:27 were including specific studies because 39:33 especially the pharmaceutical companies don't want to tackle it because of liability issues and all sorts of things 39:40 yeah but the um it's always it's all time to figure out except when we get 39:46 into a recommendation for pregnant women as with influenza for many years we 39:52 didn't use influenza vaccines hardly at all in pregnant women until until well really the 2009 pandemic 40:00 where we saw that pregnant women were at particular risk for if they got 40:06 influenza and now we recommend vaccinating pregnant women we know it's perfectly safe 40:14 yeah and i think them similar you know looks similar for the the cova 19 vaccine as well of pregnant women 40:20 we pregnant women pregnant people react similarly to the rest of the population 40:26 um that has been looked at and and no long-term effects are expected with that just like the rest of 40:31 expected to work just like the rest of vaccines and cdc's got permissive recommendations 40:39 yeah in other words if you're in a risk group and you're pregnant you can get the 40:45 vaccine so um all right switching topics let's 40:51 talk a little bit about the new the new variants of the virus so there's the b117 40:57 variant in the uk there's um a similar kind of a similarly structured 41:02 variant reported in south africa um and got a lot of questions about about 41:09 that i can tackle that one or you can you can do you have a rap one because 41:15 you're much more molecularly inclined than i am yeah to the uk one was 41:22 oh we've had variants come up every from the start and it it came up just when they were 41:27 having some political problems with shutdowns in the uk and i wondered whether the news was 41:33 overblown but it seems not that this is really different it does seem to be different one thing i want to 41:39 make sure everybody understands is that viruses especially these kinds of viruses are always mutating and changing 41:44 and so it's not like a um oh something is it this is sort of a natural process this is kind of 41:50 evolution a natural evolution at play in these viruses the changes for through um these particular variants 41:58 they seem to be operating in a way where they they do seem to make it more transmissible you can see it in the 42:04 epidemiology data and you can see it in the molecular data now it makes it so that the virus is 42:09 particularly good at sticking to the cells that it needs to replicate and produce and go on to 42:15 replicate and infect other people and so it probably makes it spread faster because it makes infection more 42:21 efficient but it doesn't change the way that at least so far these two 42:27 doesn't change the proteins of the virus in a way that makes our body react differently to them 42:33 to our body they look similar to the back the vaccine the the proteins that come out 42:38 of the vaccine process they look similar to other versions of stars cov2 42:44 and so at this point there's not any concern on the table about the vaccine not 42:50 working or various treatments not working it it also doesn't look like they're more 42:57 severe they're causing deaths at a higher rate i think they are just spreading faster so i think it's going 43:03 to um mean we've got to be more careful with our public health mitigation 43:08 um but uh the vaccine's going to just the vaccine becomes even more important because it 43:14 the vaccine is still going to work just as well against the variants and if there is any issue in terms of 43:20 vaccine efficacy we'll probably hear about it first from the uk they're rolling out the 43:25 astrazeneca vaccine along with the pfizer vaccine and they've got 43:31 uh really uh domination of the new variant which actually 43:37 emerged there in september it's not really anything that uh just recently 43:42 came up yeah it really it really seems to have taken hold right as they were coming out 43:47 of their restrictions period right difficult timing and and 43:53 and basically this is not something which emerged because of antibody pressure 44:00 that uh it's something that probably was a random event and because it had an advantage took 44:07 over yeah and um and i don't think you know a lot of people don't realize we already 44:12 have a huge kind of plan and infrastructure an existing way to look at this because we're so used to watching this for flu 44:20 we're used to watching changes for flu throughout the year and looking to see if um if it changes who's getting 44:28 infected depending on who's getting vaccinated and so we're kind of i mean there's a system 44:33 already set up to watch this going forward and it'll tell us i'm sorry especially in michigan right 44:40 yeah yeah especially in michigan um and so uh six percent of all the 44:46 sequences in the united states are from michigan for michigan and so you know we're used to watching it and 44:52 figuring out what it means for the vaccine but then that also tells us you know we're also used to doing 44:57 um the us does such a good job of all the monitoring of vaccines that are already 45:02 already around so um how long does protection last 45:07 uh are we going to need booster doses after a year or something like that or is the virus changing enough that we're 45:13 going to need to update it we can use the same methods that we use for the flu vaccine to to figure that out 45:20 um what do you based on the um what you saw in the fda meetings 45:25 um what do you think about waning and how long immunity is going to last from from 45:32 you know we in our household uh study 45:39 we've got data on eight well really 10 years of since 45:45 since 2010 uh uh data on the seasonal coronaviruses these are 45:51 four viruses common coronavirus seasonal coronaviruses four viruses that cause 45:58 uh in most people common colds occasionally more severe disease and we know there are re-infections 46:06 we even have as you are well aware emily one individual who had three infections 46:12 with that virus and was one of the first people in the group of households that got sars 46:20 cov2 this would suggest that antibody is not 46:25 going to be long term that we are going to need booster inoculations 46:31 but also what we know from other viruses such as flu is an rsv in particular 46:39 that a reinfection once you've got antibodies is not as severe 46:44 so there's again no downside to be vaccinated as a matter of fact 46:51 there's an upside because if there is waning of immunity you're likely to have a more 46:59 mild disease if you do get infected so let's talk a little bit about um so 47:06 we talked about a lot about effectiveness in um preventing disease in the person that's vaccinated 47:12 let's talk about effectiveness against transmission which field of infectious diseases has been 47:18 like uh the the tricky question for a long time is um if the vaccine is preventing disease 47:24 in person is it also preventing them from transmitting and just to kind of clarify where this question comes from 47:30 from people before i i bump into arnold is is um you know you might be able to have 47:36 an infection that's very mild and asymptomatic that you're able to spread and that wouldn't necessarily show up in 47:43 the initial trials of the vaccines because those were measuring to see who got sick and so you could 47:49 end up having being vaccinated by getting an asymptomatic infection that could still be transmitted 47:55 and i think data is still coming to show that how likely i i mean i you know with 95 48:01 i'm having trouble believing that but but they're still waiting mr first give 48:06 give us your opinion because i'm on the fence so for what this is an incredibly 48:12 effective vaccine it is way more effective than i expected to see coming out of the trials 48:17 and so i'm very hopeful that it can prevent transmission at the same time we've already seen how 48:24 well this virus works asymptomatically um and so i think we have 48:31 i do want to wait for the data to see whether transmission is possible uh you know 48:38 post vaccination we've had to change our thinking totally about asymptomatic 48:44 transmission since this virus emerged there was little evidence with the original 48:50 sars virus that there was asymptomatic transmission this virus is much more 48:56 efficient at well less efficient in 49:01 causing severe disease so there are more asymptomatic cases and those cases seem to transmit 49:10 but not regularly and we still don't know why some people transmit more than 49:16 others and i think we're not going to be able to figure this out until we get more data and again 49:24 it's certainly not a reason to get the vaccine it's a reason to get the vaccine so we 49:30 can figure it out better once we've got a more vaccinated population 49:35 because uh we'll never be able to say how to do how to prevent transmission but even 49:42 if there is asymptomatic transmission and you have a vaccinated person 49:49 who gets infected asymptomatically you're preventing symptoms so it 49:55 certainly should not be a reason not to get vaccinated yeah but that is but that's also why 50:01 people can expect to still see things like mask recommendations social distancing all of the tool the 50:07 non-pharmaceutical tools that we've been using to date are still going to be in place until both until a critical number of people 50:13 start getting vaccinated and until we know more about how transmission works 50:20 um so i'm gonna hop topics again so now there's two vaccines um 50:29 are there well i think um talk about the different types of products so pfizer versus moderna there's two 50:37 different vaccines it's very similar technology do you think that there is a difference between the two 50:44 well there is clearly a difference between the two in the way they've stabilized the rna 50:52 in terms well i don't know that there's any real 51:01 difference except maybe because of packaging of the rna and there are proprietary 51:10 elements here in terms of the anaphylaxis uh i don't think we know because modern 51:17 have followed the pfizer not quite as much has been used whether we're going to see the 51:23 anaphylaxis with the moderna product as commonly as we do 51:28 it's not common but with 11 per million uh we're using so much vaccine we'll probably have not 51:36 statistically significant differences but a bit of a trend there uh that and the way 51:42 the vaccine has to be handled i i think are the only differences that 51:47 i can see so far duration we'll know that 51:53 long term there may be some tighter differences all of these vaccines are 52:00 being standardized in one nih lab that we know well so uh we will be able to see 52:09 things long term what i think is going to be very interesting is what happens 52:15 with the other products what we've heard from astrazeneca is a 52:21 bit confusing because uh we've heard estimates of 52:26 efficacy anywhere from 60 odd percent with the standard dose to 90 odd percent 52:33 with half dose which is not what's in their protocol and that's one of the reasons why the 52:38 astrazeneca vaccine which was supposed to come up for review 52:43 in february is probably going to be delayed to april because things are a bit confused in terms of 52:50 some of the results of the trials i think the the yanson or jnj vaccine is going to be 52:57 very interesting with the one dose because uh and and they do have in their 53:03 protocol that's in [Music] clinicaltrials.gov so it's it's 53:08 it's publicly available that a second dose will be given three or four months later 53:13 but there's an interval there and we'll be able to see what happens and it's almost like a booster dose 53:19 yeah and um so you know i think the the us is notable from the fact that we 53:25 are we are solidly on these two mrna vaccines for now and we're starting to see a broader 53:31 range of other other vaccine technologies being used in other countries but the the data on these i 53:36 mean these two vaccines are both coming out with these efficacy numbers that are definitely in the higher 53:41 echelons that we see with vaccines well it's going to be interesting to see how the traditional 53:47 vaccines fa fair the the novavex 53:52 and one of the problems they're going to have in the u.s is to run the trials because by the time 54:00 they get going i alluded to the placebo group and people in the placebo group wanting to get vaccine wanted to get be 54:07 unblinded and get the vaccine they're not going to be able 54:13 to run the nova x trial in the u.s for older individuals 54:21 and that was a requirement for the two vaccines that are currently like uh under emergency use 54:27 authorization they're going to have to go outside the u.s because would you 54:32 if you're over age 65 want to be in a placebo group 54:38 when you can get one of the vaccines that's already licensed so they're going to be going and as you know they've done rsv vaccines in 54:46 various countries in the world they're going to go back to those countries in order to test in older individuals 54:53 so they can maintain the placebo group and we're going to have even more problems going forward we're going to have as we improve the 55:01 if we if we start changing dosage and things like that it's going to have to be it's going to 55:06 have to be against a an active comparative vaccine against vaccine 55:12 because we're not going to be able to do a placebo trial in the u.s ethically absolutely 55:19 um and you know i think was one of the things about um kind of in the theme of safety and 55:25 administration we haven't covered is vaccine vaccine hesitancy and um and 55:31 how how you know in this age of social media and internet how widespread vaccine hesitancy is uh and how well 55:39 polarized we're a polarized country in so many ways one of the things that 55:44 we're polarized about is getting this vaccine because there are the some of us including me who are eager to get the 55:51 vaccine and there are a lot of people who really want to get the vaccine and then there's 55:57 some people who don't want to get the vaccine and it's it's it's really a paradox 56:03 because those that wanted want it bad yeah it's interesting i mean i do i i do 56:10 um having talked to some of my my contacts that are more vaccine hesitant i mean it the results 56:18 from the trials about how striking the effect was and how fast it was i think we're going to see it working 56:24 we're going to start seeing the vaccine working and i think that's going to mean a lot to people once they start to see that it really 56:29 does prevent death and because we're rolling out so much vaccine they'll see 56:34 that there is no safety signal yeah most most definitely um 56:42 you know so you we talked a little bit about uh you know one of the the the questions 56:48 i often hear come up and i've seen come up in the in the q a was about um people that have been infected 56:54 previously and i know you touched on reinfection and this idea of why are we vaccinating 57:00 everybody um even if you've been infected before and this this you know even you know we 57:07 know that um that covet 19 can cause long-term long-term chronic chronic disease 57:14 chronic issues that go for much longer than just the acute phase of the disease 57:19 um i think that uh you know you talked about the importance of reinfection kind of it speaks to the importance to 57:25 vaccinate uh everyone not just those people who have not gotten infected already yeah and 57:32 some of the people in the clinical trials were known because they because of the antibody survey they did 57:40 at the uh original vaccination were va were infected before so there's no 57:45 safety concern yeah so they've previously checked that yeah excellent well um i see that we are at 57:53 um two o'clock and so i want to thank everybody for joining us today 57:59 um unfortunately i wasn't able to get all of the questions on the list but we will continue hosting these rights 58:06 and weaving them in i try i try um and my students have taught me well 58:12 so um so uh yes so we're gonna continue hosting the webinars regularly watch for more information from michigan 58:19 public health on vaccines on all sorts of public health issues and 58:24 we'll be sending out a recording of the webinar over email to all registrants and so um feel free to share to to share 58:31 around and we look forward to seeing you again bye-bye thank you