Georgetown This Week: March 1 - Continuing the Conversation on Vaccines with Dr. Jesse Goodman

Georgetown This Week: March 1 -  Continuing the Conversation on Vaccines with Dr. Jesse Goodman

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it's good to be back with all of you again this week in each of our weekly videos over the course of this past month i've provided some context on the situation here at georgetown since mid-january we have seen elevated numbers of cases of covet 19 and a higher positivity rate on our main and medical campuses when compared with the fall semester we made the decision in late january when we first saw a spike in cases to pause hybrid learning and to take steps to reduce density on our campuses in mid-february we restarted hybrid courses for our graduate students while continuing to pause on hybrid courses for undergraduates the population in which we are seeing the majority of cases we're continuing to closely monitor this situation as we approach march 8th the date we have tentatively projected for undergraduate hybrid courses to restart our care navigators and public health team on our campuses have been working tirelessly to support those members of our community receiving a positive test or those who are a close contact of someone who has tested positive i wish to offer our deep gratitude to each of our colleagues for their dedication and care for our community during this period of challenge for all of us now at the same time we have seen this increase in the number of cases at georgetown and at different colleges and universities around the country we are seeing an overall drop in the number of cases nationally a promising sign for what is to come we know that there are still significant challenges we marked 500 000 deaths from covid in the united states earlier this past week ringing the bells of healy hall 500 times in honor and memory of each life lost [Music] we are tracking the new variants of the virus more transmissible and perhaps more deadly which are beginning to circulate in the united states and we are watching the distribution of the vaccine around the country and preparing for wider access for additional members of our community our colleague dr angela rasmussen at georgetown's center for global health science and security recently spoke to pbs newshour about the emergence of these new variants and what it means for our current approach to public health and how worried should people be about these new variants especially the ones that we hear the vaccines may not be as effective against so people should be concerned about the variants um but it's really important to tell people not to panic about the variants because these variants while they may be more transmissible while they may be uh less uh protected or the vaccines may be less protective against them we still know that they are transmitted the exact same way as every other variant that's been circulating since the beginning of the pandemic because they're not incredibly prevalent in the u.s yet we have the ability now to really double down on those precautionary measures so masking physical distancing avoiding gatherings outside your household washing your hands increasing ventilation if you can by taking all of these measures as often as we can as frequently as we can in as many situations as we can we can reduce transmission of those variants as well as the variants that are already circulating in our communities overall that means we're going to be able to vaccinate more people and stop the spread of those variants in their tracks so it's really important that we all really double down and remain extra vigilant until we can get vaccines distributed to more people as we discussed last week there is an urgent priority to get vaccines to people across the united states and as you just heard from dr rasmussen vaccines serve as another line of defense against the spread of new strains of the virus but equally important to containing these variants is our continued adherence to our public health measures actions we take in our daily lives that can have a meaningful impact on reducing the transmission of covid19 in today's conversation we'll continue the focus we began last week on vaccines last week i focused on aspects of the vaccine process the status of vaccine development vaccination numbers at the national level and the specific processes put in place by the district of columbia maryland and virginia to administer vaccines to the population in this region in this presentation i'd like to dive more deeply into the issues around vaccines and what we might expect over the coming months as we see increased access to vaccines and as we understand the protection vaccines can offer us against new and emerging variants joining me today in conversation is dr jesse goodman he is professor and attending physician in infectious diseases at our medstar georgetown university hospital and dc veterans administration hospital and is the director of our center on medical product access safety and stewardship working on issues related to antibiotic resistance and global preparedness for infectious disease outbreaks he has previously served as chief scientist of the us food and drug administration and has worked on national and global pandemic responses at the white house the us department of health and human services and has worked closely with colleagues at the centers for disease control and prevention the national institutes of health and the world health organization dr goodman serves as a member of our public health advisory group here at georgetown and has been working closely with a team of colleagues to understand anticipate and respond to the pandemic jesse thank you so much for joining us today and i want to begin with a place you know well the food and drug administration can you describe for us what happens once a manufacturer develops a vaccine what is the role of the food and drug administration in this process how do they work to ensure that vaccines are safe and effective well i think one thing some of our viewers may not realize is that particularly in a public health emergency like this that role in fda's contributions start way before the vaccine is even developed in anybody's arms so typically the manufacturer is sitting down with fda and talking about what studies will need to be done to lead to a specific use and indication uh the size of the studies issues like that and also what would need to be done around issues like the quality and the manufacturing of the product what kind of testing what kind of assays what the manufacturing process will be and in emergency fda works on those issues and takes data in from the manufacturer on all those issues throughout a many month process as the vaccine goes from development in the lab to studies in humans so that's been this very interactive process that's gone on all along what people are then more familiar with is as we get toward the end of that road as the clinical information is submitted to the fda what happens is fda really goes over that data with a fine-tooth comb and unlike most global regulatory agencies fda also performs its own analysis of the actual information so it looks at the data as it comes from patients and will perform its own analyses to check that there are not errors in anything that's presented to it then fda forms an opinion is this product based on that data safe and effective and brings its review along with giving the manufacturer a chance to present its view of the data to a public advisory committee in a very transparent process that in fact is going on today with one of the newer vaccines in last week's presentation we focused on the supply of vaccines in the united states and how distribution has been increasing over these past few months since vaccines were first introduced in december 2020 and i shared a version of an animation of how the supply has accelerated over this period so jesse what are the important aspects that you are focused on when it comes to vaccine supply and distribution what is working well what needs to be improved well i i do think on the very positive news front you know we're seeing both more vaccine being produced and distributed and we're seeing public trust and interest in the vaccines going up as experience develops and over 50 million people have received vaccines so i think that's all on the very positive side what has been you know a challenge is that obviously the early supply is not able to meet the demand i think we're going to very rapidly switch from that kind of situation within the next two or three months to a situation where we have adequate supplies at least in this country for those who want it uh so the time to begin to plan for that is now and to be sure that when it's everybody's turn people have trust in the vaccines uh and uh have all their questions answered and can make informed decisions because as we're starting to see from some of what we call real world data what what happens not just in those well-controlled clinical trials but out in the real world when it's given to a broad group of people you know as we're seeing in israel as we was reported today in nursing home patients in the u.s these vaccines can have a huge impact on helping to bring this pandemic under control so that's an exciting part i expected all these speed bumps along the way i expected supply would not be what people were predicting because having seen what it takes to develop new manufacturing capacity totally new technologies i know and i know and knew that what you predict is not what's always going to happen that there will be bumps along the way so a lot of that is expected um i wish they could have been fixed earlier some of them probably some of the supply chain issues probably could have been handled better but i think we're on the right road now and together it's a remarkable accomplishment so over the coming months as we see greater and greater access to the vaccine what kind of issues should we anticipate and prepare for as more and more of our people are given access to the vaccine well i think you know we are going to see a continued focus on being sure that we monitor in an ongoing way both the effectiveness of the vaccine and the safety of the vaccine and there really need to be clear well conducted national programs that look for rare adverse events that may not have been uncovered in the clinical trials and a lot of those data platforms are still being activated so we're going to need to be sure that's there because things that are rare can occur related to a vaccine and we need to be able to detect those if they do and also coincidences occur unrelated to vaccine i remember when i was at fda every year at some senior center in the u.s a couple of people would have a heart attack after getting a flu vaccine and we had to look and see well was that the normal numbers of heart attacks that might occur in that age group or was this a real concern and we're certainly going to see that with these vaccines so we need that the other thing is that as everybody knows we don't know how long the protection from these vaccines will last we certainly hope it will be many months even years but we don't know that and we also know that new variants are arising all the time so we need to be tracking is the vaccine staying protective are breakthrough cases occurring and if those cases occur are they due to variance are they due to vaccine failure and that will determine do we need to give potential booster shots and if so what kind as we discussed in our presentation last week washington maryland and virginia have all established guidelines for vaccine eligibility so far between 14 to 16 percent of our regional population has been vaccinated for our georgetown community this has meant that our clinical faculty our medical students in clinical settings many above the age of 65 have been vaccinated we're also beginning to see access for those under 65 with certain medical conditions and certain essential roles while georgetown doesn't have authority over vaccine access are there any insights that you can share about how we have been working to prepare for our community to gain access to the vaccine well i can give one personal uh thing you know which is as a health care provider who works in the medstar system for part of my clinical work medstar did a terrific job of offering and getting its healthcare workers from physicians to everybody working in the facilities immunized and that's gone very well and i can say that there is a palpable air of joy and relief among those of us who are in the clinical arena and you know much more comfortable going into the room of patients with covid of patients who might have covid so that's been great so medstar is contributing there and i know we're having discussions at the university level uh including with colleagues in your administration and elsewhere about how can georgetown help as vaccine becomes more broadly available whether through medstar through the university itself through working with the dc department of health how can we help be part of the effort to steer people who are eligible to vaccine and where appropriate you know help get that immunization done and then a big part of this is going to be continuing to communicate with people about when they're eligible and about the benefits of immunization you now i'd like to turn to the specific vaccines for a moment that there are two that are now available and and others likely in the near term but the two that are currently available pfizer bioentech and moderna both of which are approved under an emergency use authorization by the fda and johnson johnson whose request for an eua is being reviewed by the fda as we speak can you talk a little bit about the emergency use authorization process and can you talk about what is important when a vaccine seeks eua approval what what are the safety and efficacy considerations that the fda looks at yes it's it's a really good question because the emergency use authorization for short the eua is a regulatory mechanism designed to be used in public health emergencies only when there is a crisis going on in the health of the community and individuals are threatened and we don't have approved medical products to adequately address that threat so this is unique it allows fda to make risk benefit decisions on a data set that may not have the duration of follow-up or the degree a number of data points that would normally be required for a full approval or licensure so it is allows the agency to make a risk benefit assessment in an emergency now one of the things fda did in the case of vaccines which i think was very important and has helped people to feel they can trust the vaccines is they set quite a high standard for the issuance of euas for covet vaccines they recognize that this isn't like a treatment you're in the icu you're desperate you're getting worse you have a high likelihood of a terrible outcome and you're willing to accept a fair amount of risk from a product this is a vaccine being given to healthy people who may become exposed to covet and if they did may get the disease and if they did then may have a bad out outcome so you're giving it to basically healthy people it is in a crisis that's killing you know one in a thousand americans or whatever so we can't understate the impact of this pandemic but for giving something to healthy people you want it to be very safe and have a high likelihood of helping them so fda put guidance out that was very clear to manufacturers that said you basically are going to need to perform studies similar into size tens of thousands of people and with results similar in terms of high level of safety high level effectiveness to what we would expect for issuing a vaccine approval so they required these large what we call phase free studies that are very similar data to what would be required for approval and that's what those two were authorized on and that's what the third one which johnson and johnson has brought to fda today is being is uh also being evaluated based on so there's quite a bit of data what differs is that the follow-up is fairly short for many of the patients it's only a couple of months after they completed the series of of vaccination so we don't have the sort of long-term follow-up as i said earlier to say how long does that protection last and are there any rare side effects that we might not have detected in the couple of months after receiving the vaccines in addition fda may not have reviewed in the same depth all of the issues around the manufacturing process hundreds of thousands of pages of documents looking through facilities in great detail things that might take several months more so rather than delaying vaccine for things that don't have major effects on safety and effectiveness fda performs a risk benefit and says the data are strong we see this as self safe and effective and we're comfortable going ahead in an emergency from an emergency use authorization the next step is full licensure of a vaccine if we focus on pfizer bioentech the vaccine that that they've developed as a way of talking about this next stage of vaccine development they've indicated that they will seek a full licensure of their vaccine this april can you describe what this step is like how does a full licensure differ from an eua and how might we expect the landscape to change once pfizer and other manufacturers receive this full authorization so the if they are ready in april or when or when they're ready they will presumably have you know several months of additional follow-up they will have worked out and provided to fda all this additional information on manufacturing and there may be other areas where there were additional studies that were needed for an approval but weren't performed prior to when the eua was submitted so these are typically applications of hundreds of thousands of pages of data um that you know are then reviewed in exquisite detail to meet that high standard the gold standard of full licensure um and fda typically as opposed to emergency use authorization where they've done these reviews in days to weeks this is would be a much more in-depth review of the data and probably take considerably longer weeks to maybe a couple months typically even for a high priority product at six months i think in this case because fda has been reviewing a lot of the data all along the way uh it will probably be fast but they may find issues that there will be back and forth with the manufacturers on so if they have uh you know there are very a lot of things that are arcane to us but are really important in ensuring that the vaccine in february 2021 is exactly the same as in february 2020 and we can count on it things in the quality and testing that can be quite complex those kinds of things will need to be assessed and worked out now what difference will that then make well if they submit that and fda approves it it becomes a product that can be commercially marketed for those indications uh it's no longer handled as investigational uh which has certain kinds of reporting requirements on and in theory if they could meet the whole supply the demand for the for supply for vaccine there might it might prevent other euas from happening because a condition is that you have an unmet medical need but i think the u.s and global supply is so far from being met that it's not going to impact other euas for some time but but those are the main things i think also people will obviously reach another level of reassurance about the vaccine safety and performance because there will be this considerable amount of additional data and follow-up that's brought to fda that will again be brought to an advisory committee so there'll be a chance for the public to see several months more and a great deal more detail of data on these vaccines okay now moderna and pfizer are mrna vaccines mrna for messenger rna these vaccines use a technique that teaches our cells to make a protein that triggers an immune response there is no live virus the johnson johnson vaccine uses a similar approach but rather than using messenger rna it uses double-stranded dna to teach the cells how to build an immune response unlike the moderna and pfizer vaccines however the johnson johnson vaccine can be delivered in one dose given that we are seeing the development of multiple vaccines should people be worried if they receive one vaccine rather than the other what's important for people to think about when they see these different vaccines becoming available i think there is the potential for you know kind of a confusion like you walk into the supermarket and there's 12 different kinds of something and you know you want to be sure to get the best thing um i you know what i would say is right now we have such a need for everybody to get immunized that if a vaccine has met fda's criteria for safety and effectiveness under an eua and you are offered it take it and get protected there are some differences between these vaccines which may favor one or another for one circumstance or another but we're still early in our understanding but i'll mention a couple of them one big advantage of the non-mrna technologies right now and particularly the j being reviewed today is it can be stored in a simple freezer for two years okay it doesn't require this complex storage that's usually only available in hospitals or with special especially purchased equipment also once it's thought out it can be stored at room temperature i think for three months not room temperature at refrigerator temperature for like three months and it's be been studied in a single dose regimen so when you put those things together it becomes extraordinarily more convenient particularly for rural areas uh global use where some of these special capabilities might not be possible so that's a real plus on the open question side still is it looks like the efficacy in preventing infection may be somewhat slower for the j j vaccine estimated at 72 in the u.s than for these rna vaccines which were over 90 however important for people to realize that the j j vaccine had one of the best studies and it had a lot of sicker individuals and in their study it was extremely effective at preventing hospitalization death severe disease the things that really matter so i think people can be assured that any of those three products if the j j is authorized by the fda uh would be good for them and we're going to have to monitor these going forward in terms of whether some differences may end up being significant in the long term and how they get recommended one other good piece of data about the jnj vaccine which we don't yet have for the other vaccines is that not just in the test tube but in the patient it was effective in preventing against severe complications from south african and brazilian variants that right now we're most worried about so there's strong evidence there and that's what to me been one of the most encouraging things i've seen in the last several weeks we believe these vaccines including the rna vaccines will help protect against those diseases those variants although not as well but this is the first data that really shows that i'd like to go a little bit deeper in into the emergence of the new variants the new strains of of coven 19.

three new strains were discovered the united kingdom brazil and south africa and all have been detected here in the united states and we've seen the recent news that moderna is going to be starting a new clinical trial for a new vaccine specifically focused on the strain first identified in south africa what do these new variants mean for the current vaccines that we have available to us and the development of other vaccines what kinds of responses can we expect from vaccine manufacturers to deal with these emerging strains well you know some good news is that particularly the rna technologies really lend themselves to like quick switches to uh deal with things like variants that's partly what helped them get out so quickly you know for covid and ahead of some of the other technologies to begin with so both modern and pfizer are already making lots of vaccine that are targeted specifically to these changes in this specific protein the s protein of stars coronavirus so pretty soon those studies will be underway um today at the advisory committee meeting uh j and j said they too are preparing vaccines based on some of these emerging strains it's very important that we do that now even if we don't end up needing them to learn if we need it for this strain or if we need it for future variants that maybe are even more effective at escaping the vaccine how do we use it you know what's the dose is giving one dose of one and one dose of another okay could you give two together sort of laying the groundwork for what we will probably have to do in the future if new strains that can escape the vaccine emerge so i think we're on the right track there where we have a lot of work to do cdc has recently announced some progress in this but we still don't have good us or global surveillance for these strains you know we need to be sequencing many more strains i think i mentioned before we especially need to look at viruses from people who broke through on vaccination there needs to be a global coordinated effort and information sharing on that and and we're just not there yet thank you now as we close are there other issues that you think it's important for us to be focused on when it comes to vaccines what issues are at the forefront of your mind well you know i think a big one and i'm sort of repeating myself is you know get ready to be vaccinated i know people who want to be vaccinated right now and haven't been yet are really frustrated but you know be a little patient and you will be vaccinated and for those of people who are sitting on the fence or maybe don't see themselves as at risk or don't even today i had somebody say to me um one of my patients uh well i i just you know haven't seen anybody with this disease and you know it's hard for me to believe it's real and i've been safe and just realize this is a terrible disease that has killed many many people so get vaccinated when you can take it seriously um don't let down your guard yet on social distancing you know there's hope ahead and cdc is starting to look at how people who are vaccinated may be able to modify some of these behaviors but for now you know we've got a chance to get back to normal like you know i wanted all of us to go back to school and work by the fall and you know if we all work together uh we can do that thank you very much jesse for for everything you are doing for our community i can't tell you how grateful we are well thank you very much and thanks for the home georgetown has provided jesse thank you your insights and your expertise have been invaluable to our community and we're so grateful for the work you are doing every day as a physician and in guiding and advising our public health response here at georgetown thank you so much for joining me and sharing your perspectives with us and i look forward to being with all of you again next week take care of yourselves and everyone around you for every hoya everywhere

2021-03-06 03:25

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