Topic: Experts will discuss and take questions on COVID-19 vaccine distribution under the new Biden Administration.
Journalists and editors are invited to attend this live virtual event and ask questions either on camera or we can relay your questions to the panelists. Register to attend and receive the on-demand recording after the session is concluded.
Who:
Dr. Kelvin Lee - Director of USA Manufacturing’s National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) and Gore Professor of Chemical Biomolecular Engineering at University of Delaware.
Dr. Angela K. Shen, ScD, MPH - Visiting Research Scientist at the Vaccine Education Center at Children’s Hospital of Philadelphia, retired Captain in the US Public Health Services, and a public health consultant.
Dr. William P McKinney, MD - Professor and Associate Dean. Acting Chair, Dept. of Environmental and Occupational Health Sciences at University of Louisville & and member of the Louisville Metro Vaccination Task Force assembled by Mayor Greg Fischer.
When: February 4, 2PM-3PM ET
Where: Newswise Live Zoom Room
PLEASE REGISTER HERE TO ATTEND
This live event will also be recorded and transcribed for use by media and communicators after it is concluded. All registered participants will receive a copy of the transcript, so even if you can't make this event, we recommend you register.
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TRANSCRIPT:
Thom: Welcome to this Newswise live expert panel, we have with us three panellists today to talk about the current state of the Covid pandemic as well as vaccine distribution and the changes in store under the new Biden administration.
First I want to put things into a little bit of context with the pandemic statistics at the moment. We are four weeks out from the peak of new daily infections, that was 300,000 new infections on January 8th, that’s gradually dropped down to a seven-day average of about 135,000 new cases a day. We also have been having consistently more than 3000 deaths a day, I think the number was about 3,800 yesterday, which correlates to that peak of about a month ago. Things are obviously moving in the right direction, is there light at the end of the tunnel or is it a train that might run is over – so Dr. Shen I want to ask you a little bit about your background working in the federal government and how you envisioned what changes will be implemented with the Biden administration coming in and stepping in – what are your thoughts about that and what could change for the better about vaccine distribution and the general pandemic response?
Dr. Shen: Great, thanks so much. I am a retired captain in the US public health service, I worked in the federal government for over two decades at a number of agencies that you're probably much more familiar with now under the infrastructure of the department of health and human services. Agencies like CDC, FDA, office of the assistant secretary of health as well as the USAID department. So thank you for inviting me today with our esteemed panellists. You ask about this current state of response and distribution – I think we certainly have a lot of good news and good news comes in many different forms every day, I think the thing that’s driving how things will shift and change is that we had two vaccines under emergency use authorisation, we have a third vaccine J&J filing for emergency use, as well as two on the heels of that, and so in the forthcoming months or season if you will, supply won't be so much of a problem.
Clinic locations are kind of working out the kinks of registration and distribution and how to manage, everyday we’re vaccinating more people, so we’ve had the kind of go from 0 to 60 in a really short period of time and we’re expanding strategies in terms of fight for service, so where people can go, as we are waiting in the upcoming months to have more supply than demand which is an inverse of the problem we’ve had before. So in terms of big picture, things should be looking much different as we approach spring and summer. So those are kind of general thoughts to set the landscape.
Thom: Thank you very much Dr. Shen and by way of introduction of Dr. Shen – just to tell everyone how she's joined us for this panel – she's currently visiting research scientist at the vaccine education centre at the children’s hospital of Philadelphia, as well as her status as a retired captain in US public health services. Thank you Dr. Shen – we’ll come back to you with some additional questions shortly, I want to next introduce Dr. McKinney – he is professor and Associate Dean at University of Louisville and he’s also the acting chair in the department of environmental and occupational health sciences, and he's a member of the Louisville Metro Vaccination Task Force assembled by the mayor there, MR. Greg Fischer – Dr. McKinney – thanks so much for joining us. With your experience of getting things up and running and consulting on vaccination drives in a major metropolitan area such as yours, what are your thoughts about the progress and what are your thoughts about the goal of administering as many as two million vaccines in a single day and that being a good target for the right trajectory of getting the vaccine out there?
Dr McKinney: I think we’re moving in the right direction; I think the Presidents team has stated clearly that the initially announced goal of 1 million doses per day administered was really a floor, not a ceiling and the goal was to get as high as they possibly can and I think the goal of 2 million per day would be a reasonable next target. It’s a doubling of what was previously announced, but we need to get up there pretty quickly because of the rate of mutation of the virus and the mutants that we currently see appear to be - still individuals who have been vaccinated will probably be protected from those strains as far as we know, but the margin, the buffer protection is diminishing and at some point there is going to be strains that will be resistant entirely to what we have to offer and that will not – the vaccines available will not be protective against them. So we need to stop the circulation of the current strains as quickly as possible and the way to do that is to really roll out in a major way, as being said by many in a wartime type footing, the largest vaccination effort that we possibly can, so in the range of 2 million or a little bit over a day would be something that would definitely change the trajectory of viral transmission over the next several months. I think its global, I think its especially achievable if larger cities that can do this – develop mass vaccination sites that can handle many thousands of individuals per day, either as drive through events or walk-through events that are attended by large numbers. We have established capability to do many thousand per day, we have in the past and did for the H1N1 swine flu event, we did 10,000 doses of vaccination at an outdoor drive thru event, I think that could easily be done here if we had sufficient vaccine, and so if you have 10,000 doses per day at 200 sites around the country, that’s 2 million doses right there. I think that’s achievable, its going to require effort, its going to require coordination at the highest levels and one thing that I have been trying to push for in every conference I've attended is the notion that there should be coordination among the academic schools of health sciences training, schools of medicine, nursing, pharmacy, dentistry, public health etc – can get together to help coordinate an approach that can be used to train student rapidly, to fill in some roles in mass vaccination sites. They are under supervision of faculty and provide an enormous reserve of personnel power for these kind of major efforts.
Thom: Thank you Dr. McKinney – to talk a little bit more about the vaccines and the development and manufacturing behind that supply that’s hopefully getting out there at the volume needed to do 2 million a day, I want to introduce Dr. Kelvin Lee, he’s director of the Manufacturing USA National Institute for Innovation and Manufacturing Biopharmaceuticals. He also comes to us by way of being the Gore Professor of Chemical and Biomolecular engineering at the University of Delaware.
Dr. Lee, tell us about what’s so remarkable in launching these two vaccines that have approval, that are the first ever MRNA based vaccines, and what does that set us up for in terms of revolutionising that as a platform for vaccines in general?
Dr. Lee: Thanks for that question and thanks for having me with you today. The space that I work in alongside scientific colleagues across academia and across industry is one where we think a lot about biotechnology-based medicines, whether they be monoclonal antibodies of vaccines and so on, and one of the really remarkable things about the MRNA based vaccines driven by this global pandemic is the speed with which these products could be brought to market. The real primary driver I would argue for developing vaccines using the MRNA approach is really based on the ability to respond rapidly. Now, a year may sound like a long time, but as I think we’ve heard about, one year is far shorter than development of most vaccines historically. So I think the things we’ve learnt about MRNA platform is that it has been successful in generating vaccines that at least today have been shown to be very efficacious and safe and allow us to respond relatively quickly and if I take that one step further and we think about MRNA as a platform, a manufacturing platform for bringing vaccines to market, we start to hear about these variants and we worry broadly about the ability to escape immunity if the sequence variant changes enough so that we’re not immunised against it. One of the really nice things about the manufacturing platforms used to make vaccines including MRNA, is that once you’ve established that platform for manufacturing, it becomes relatively simple and straightforward to swap out and adapt that vaccine to be prepared for the next variant or the next pathogen. I actually think about it a little bit like baking chocolate chip cookies – now it’s a lot more complicated than baking chocolate chip cookies, but once you know how to make those cookies and once you're figured out based on your oven and your elevation and you’ve got the recipe you like, whether you use milk chocolate chips or semi-sweet chocolate chips, its relatively simple to swap those out, you don’t have to relearn the whole manufacturing process. So, I think the other thing about these platforms is not only the speed, but it also provides the framework for responding faster in the future.
Thom: Thank you Dr. Lee, I want to open up the floor for questions, we have a question from freelancer Dan Keller, I want to invite him to ask the question himself.
Dan Keller: Looking ahead will future immunisations require a polyvalent vaccine incorporating various SARS-COV-2 strains and along that lines, is the spike protein really the best target? Is there something more conserved protein or even an epitope on the virus – something that’s more essential that would make for a more universal vaccine.
Thom: Thank you for the question Dan, any of our panellists want to start off on that question? Dr. Lee?
Dr. Lee: Sure I’ll take an attempt to try to answer some of that question – I think it’s a really great question, it’s a really important question – I think as you look at the first generations of vaccines that have been brought to society, they certainly were designed to attack the virus and particularly you mentioned the spike protein, they're designed to help our bodies recognise that molecule and that’s because based on the information we had in the early days, that’s what we could build vaccines against. I think as we are learning more and more about Sars-Cov-2 and as we’re seeing this variety of strains emerging, certainly people are thinking about whether you would have the ability to vaccinate against multiple strains in a single dose or whether you would think about other kinds of epitopes. Those are activities that I think are ongoing, people are exploring and I think there's a lot of promise and hope in being able to deploy a vaccine that would address multiple strains, it could be more universal in the future.
Its not necessarily easy to do, but it certainly would be a tremendous advance, so in the community that I work in, people talk about getting that 1st generation vaccine out into society and that’s already happening now, and I know people are working on what would that second generation vaccine look like? What would that third generation vaccine look like? And that’s where people start to address the questions that you're raising.
Thom: Dr. Shen, would you like to add to that?
Dr. Shen: Its tough to add on to an already great answer. I think that to build on to this concept of first generation and second, as you hear about other clinical trials staging down to earlier ages for paediatrics and adolescent indications, but still I would clarify a point to kind of building on to the first generation vaccine and then exactly on to what Dr. Lee had said – the second generation asks a lot of those questions that you pointed out in terms of whether or not this is the right target and whether or not as we learn more about the three new variants that are causing some concerns, as we know two of the companies that have existing EUA’s in play, the Pfizer as well as the Moderna, has already announced some engagement about what a booster would look like, and then there's some data that has recently been released around J&J and so I think that, as you noted as well as Dr. Lee commented, it stands to reason that we need to wait to see what we learn from there and what we understand from some of the preliminary data and that some of the studies around neutralising antibodies aren’t necessarily the totality of what we want to understand in the immune system.
Thom: Thank you Dr. Shen and thank you for your question Dan. I want to go to Dr. McKinney – we’ve heard reports that some patients are experiencing some more severe side effects after getting the second dose of the vaccine, that’s been something circulating in social media – what can you say to reassure people about that – is that normal? What are those kinds of expected normal symptoms? What are adverse things to look out for and what precautions are taking place to make sure that someone doesn’t have a more severe reaction?
Dr. McKinney: Well I think its very fair to say that the types of reactions that have been mentioned pretty widely in the press, especially from the second dose of vaccine are entirely expected, that’s what has been seen in the clinical trials – that’s what I've heard anecdotally from people who have gotten the vaccine anti-doses. I have heard a second dose myself as I'm a practitioner, I see patients still and I can tell you that doze two was very noticeably different than dose one, I did get some fever, I did get some chills – short lived and kind of a bad headache for a while but you can tolerate that for a few hours or a day, it goes away and you're done with it and it’s a whole lot better than having gotten Covid, that’s for sure. But, people need to be aware that there are going to be some of these symptoms that may be mildly uncomfortable for a couple of days at most probably, and less than a day for majority of people that no one should be pre-treating with Tylenol in expectation that they're going to get them. But if they did get something that’s quite significant and they're not feeling well at all and they can't function normally then they can take Tylenol as they need to for symptoms, but if it’s a very mild fever that you're talking about – temperatures of a 100.1 – 100.5 – low grade temperatures, things like that, its not any urgency about treatment, you just manage symptomatically drinking lots of liquids, taking a cool shower or something like that, no big deal – tis not harmful to tolerate a low level temperature elevation, mild fever, but this is evidence that the immune system is functioning and the people who have zero symptoms, you may question whether they're getting appropriate immune response or not. The other thing is a sore arm and people get sore arms with pretty much any kind of injections – certainly with influenza its very typical for the arm to hurt for a day or two mildly and if you're a right-handed person who is a professional tennis player, that might be a big impediment – the day after the shot and you’ve got your shot in your dominant arm, but for an average person you can work around and get it in the non-dominant arm, no big deal.
The severe side-effects are extremely rare, we are seeing some degree of severe allergic reaction or anaphylaxis, but it’s in the level of two episodes per million doses or 5 episodes per million doses depending on vaccine. Pretty uncommon and all the sites that are administering vaccine out there, all sites – certainly ones of major size do have emergency personnel on hand, they can administer epinephrine and they can intubate somebody if required but no one has to my knowledge ever died as a result of one of these types of reactions. They're readily treatable, they do respond quite well to standard therapy and so long as we’re forewarned and alert of what can happen I think that’s the best information we can provide.
Thom: Thank you Dr. McKinney – further on the topic of communicating with the public, I want to ask Dr. Shen – convincing people who’ve been averse to wearing masks and social distancing, we know that this still needs to happen even though the vaccines are out, we’re not across the finish line yet – what would you say to try to convince those folks in that camp to start wearing mask and keep wearing masks and doing these other measures even while they themselves may be vaccinated.
Dr. Shen: It’s a very tricky question – I think that I would talk about how individual behaviours matter, so even after vaccination while you may be protected, as you rightly noted – you may still be able to transmit to others. The big take away is that if you want to end this pandemic or get it under control, if you want to get back to life as close to as possible as it was before, then this really requires the collective effort. It’s not just about you, its really about also those around you. Its very analogous to have vaccines themselves work - vaccines are very unique and different than other drugs or medical products, because by taking a vaccination you protect yourself, but by taking a vaccination with a large proportion of your community taking the vaccination, it protects the community at large which is how they’ve claimed the term herd immunity or community immunity. In the same way as to how the function of a vaccination occurs and works, in the same way that infectious diseases, township or county or state or geopolitical reliance and jurisdiction, as folks want to get back to some sense of normalcy – not the new normalcy but closer to the normalcy that they remember one year ago, that this requires not just thinking about you and the fact that you’ve got a vaccination but also about those around them. Its also noteworthy to point out that, that while highly efficacious these vaccines are, there is still a small chance that folks may also contract Covid as well, and so you're not necessarily out of the woods, but we’re all progressing in this forward direction in a positive way moving forward, towards I guess across the finish line.
Thom: I want to dig into that just a tiny bit, one of the last things you said because there was a very controversial video going viral on social media that purported to say that if you might still get the infection of the corona virus itself, but it’s not bad because you’ve got the vaccine, you'll be able to fight it off, that that was somehow controversial. This is completely ordinary route of how vaccines work right Dr. Shen? That you may still get the virus infecting yourself but then your body is able to mount the immune response.
Dr. Shen: Yeah I think that the comment that I would typically say is to understand in that particular case – whether or not it was a failure to vaccinate or a vaccine failure. Whether or not in the case in which there is a break through case its because of the vaccine itself or conditions around that or it had to do with sub optimate vaccination, it had to do with perhaps they got only 1 out of 2 doses, it had to do with an administration issue and so this concept around whether or not it was a vaccine failure or this failure to vaccinate within that community or that household or what have you –
Thom: Thank you Dr. Shen – I want to go to Debb Wood from Nurse Zone with a question –
Debb Wood: I actually have two questions; how will we know if the vaccines have provided people with the expected immunities and how the immunity may fade over time – will we be doing titers or antibody tests or how will we know a year from now if somebody needs to get a booster.
Thom: Thanks Debb – who would like to respond to Debb’s question about tracking whether or not the vaccine effectiveness fades over time?
Dr. Shen: I think the short answer to that is the VE studies are going on, the duration of immunity we don’t know yet. What we have authorized for use broadly is under emergency use with a minimum threshold of 8 weeks safety data so on so forth – a minimum trial size of 30,000 and so on, and so those studies are ongoing in addition to corelating studies for example collecting on stability as well on the product – so those VE studies are going on as well as understanding what the duration of protection is for these vaccines. I'm sure others have a more thorough answer.
Thom: Thank you Dr. Shen – Dr. McKinney, Dr. Lee would you like to chime in on this too?
Dr. McKinney: I guess I would just second that statement by saying that all the companies that have been involved in vaccine development have committed to long term studies. Individuals are immunized and they’d like to compare recipients and control groups for as long as possible, they do plan to look at incidents of symptomatic disease from Covid in the future and I know that there are plans to do at least some periodic monitoring of antibodies of recipients in the trials to see how long the protection might persist based on antibody titer is. the other thing we don’t know about immunization is, exactly how important relatively T-cell immunity is – T-Cell immunity is harder to measure, it’s not like just doing an antibody titer which is a very simple procedure but one that requires several more complicated steps and different procedures entirely, but it may be that even if the antibody levels decline that the Tcell immunity will persist and that will be important in protecting individuals who are immunized. So, we’re going to have to have studies periodic blood draws, tests to be done on recipients in the trials and probably sub samples of the larger population being immunized and measurements of the exact incidence of disease. How many people who’ve been immunized are going to come down with Covid in the future – so we can certainly track along those individuals, whether they have a unique strain and whether there's a certain escape that’s occurring among particular strains that are out there. I think that’s going to really guide the development in the future of the next generation of vaccines, whether we go from a monovalent to a bivalent or a trivalent or quadrivalent vaccine because of course for influenza we’ve had trivalent vaccines for a long time, ones with three different kinds of antigens in there and more recently we’ve had ones with four – to influenza A’s and to influenzas B’s that are in many vaccines now again flu – so that kind of vaccine in the future might be a fairly standard one against Sars-Cov-2
Thom: Thank you Dr. McKinney – Debb please feel free to go ahead with your second question.
Debb: Thank you again, Moderna announced this morning that its developing a new formula. I think its to cover the South African variant- how will we distribute that? Will people who’ve been fully vaccinated need to get a booster with the new formulation or will it just be something they start doing with the people that are going to get vaccinated?
Thom: Dr. Lee do you have any info about the new Moderna Vaccine?
Dr. Lee: I don’t have a lot of new info about the Moderna vaccine but its heartening to know that they're working on – I’ll call it strain specific even though I'm not sure that’s what they intended, but strain specific vaccines in light of these new variants that are out there, and the MRNA platform allows them to do that very quickly. I think what will be important is how they design their clinical studies and what the data actually shows in terms of how best to take advantage of that and I'm sure I would expect that they would look at what is the value and the benefit to the individual and to society of having it just be as a booster of the variant, they probably will do different forms of testing, different dosing strategies, and I think it’s a sign that the technology and the platforms are really starting to show their value. Unfortunately, we have to go through a global pandemic to drive some of these things forward, but its really remarkable the speed with which these companies are able to move.
Thom: Dr. Shen what would you add to that?
Dr. Shen: I think that whether or not it’s a booster to the first generation or whether or not its an actual specifically new and improvement – i.e. A second generation, it will still go through the regular processes in which the government asked his advisor committee, the VRBPAC – the advisory committee that advises FDA on what they think about the data in terms of these label indications and then more directly to your question about distribution and what that would look like – especially relative to an existing one if it isn’t a booster, then the advisory committee on immunization practices, who advises the CDC as well as the department itself, will talk about what that looks like in terms of guidance for use. Having said that, that then feeds into our process around how we distribute and what that administration looks like. Because Covid vaccines are vaccinations for adults, its anchored on the backbone – a lot of what we do we be well with kids, but just like in other countries we are more familiar with vaccinating and have a stronger system for vaccinating children than we do with adults. We have children in immunization registries, the data saturations around 96-97% - a little less for adolescents around 85%, but we only capture maybe around 60% of data for adults. And so while your question is very directed at the state and stage of where we are in distribution and what the implications are when more things come online, such as either a booster or a second generation Moderna – in this case, vaccine, it will go through first the VRBPAC for indication and maybe it is not the same indications as the first generation, and then through the advisory committee on immunization practices as to what’s the guidance for use, and then it will filter down into the distribution channels. The way in which we vaccinate routinely looks different than what we’re talking about now, and large volume, large throughput places like Dodgers Stadium, the Astrodome and drive through’s in large stadiums and things like that, as opposed to when you take your children or your grandchildren to the pediatrician in specific provider practices in the medical home. So, it will most likely go through similar to the way we’re moving now because we’re vaccinating adults and exactly how that will roll out will depend on its license authorization as well as its recommendation for use.
Thom: Thank you Dr. Shen. I want to ask Dr. Lee, we’re talking about Debb’s question about another new formulation getting started, but we’ve also got a few other vaccines that are close to the final steps of approval. What can you tell us about those forthcoming vaccines? How do they differ from that MRNA, how else do they differ in terms of storage, how many doses are needed – other things like that. What can we expect as those potentially come online into the fray –
Dr. Lee: I think it’s a really exciting time that there's more vaccines becoming potentially available. I think the new vaccines that are being talked about now, that are certainly in the news, the J&J company has talked about the promising results that they seem to have with their vaccine, that’s an adenovirus-based vaccine platform. It’s fundamentally a different type of way to inject somebody with the vaccine and solicit an immune response – but its also designed to work very, very quickly, that once you know what the sequence of the virus in this case is, that you could rapidly develop and manufacture a vaccine. The interest things about that platform are that the doses itself don’t require some of the very specialized delivery and storage conditions, they are a little bit more robust at higher temperatures, meaning that it might be easier to imagine getting those vaccines out to different communities where you don’t have to have the ultra-low temperature freezer for example, you can think about standard refrigerator temperatures, you can think about room temperature for periods of time, and I think that will make it easier for the shots to get into the arms, because you don’t need that set of logistics.
The data isn’t out there just yet on that, I think J&J has talked about their top-level observations and results but they are expected to file an emergency use authorization with the FDA and I think as that process unfolds and Dr. Shen just mentioned what some of the key steps in that are, that more of the data will become available that will show some of the specifics around the efficacy of their particular vaccine. At the top level they’ve reported I think between 65- 85% depending on how you look at its efficacy for the vaccine, and you might initially say that sounds lower than what I was hearing about the MRNA vaccines – but what you have to remember – and this is something that that company has talked about very openly, when they were doing their testing, they were testing at a time when the variants were now circulating in the UK and South Africa, near the end of 2020 – whereas when the Pfizer and Moderna were being tested, those variants hadn’t yet been identified, so it might not be surprising that the efficacy might be a little bit lower, but what they’ve reported is they’ve had very good efficacy on preventing hospitalization and death and once that data becomes available, I think those are really critical to proper functioning of our society and trying to get back to a sense of normal.
Dr. Shen: I would add just a cherry on top to what Kevin has said – is largely one dose is very key for dose completion and we all know that after you get in for that one shot, that if you have to go back for a second there's a change, there's a possibility or probability that may or may not happen – we see that in routine vaccines that require 3 or 4 shots. And so one dose I think is going to be really pivotal, on addition to have more supply because it’s a one dose regimen, but also to ensure that its complete because after you get the one, you're somewhat one and done.
Thom: Thank you Dr. Shen. We have another question from Dan Keller –
Dan Keller: There is kind of a shot in the dark – is there any thought of engineering a live non-pathogenic Sar-Cov-2 vaccine that could be transmitted person to person and the population just spread immunity even to those people who are vaccine resistant and I guess vaccinees could be encouraged to sneeze at each other.
Thom: Thank you, any of our panellists have any thoughts about that concept?
Dr. Shen: I think he's bringing something very controversial; I think that it’s probably analogous to focus his response on human challenge studies and I don’t know if any ones thinking about doing this, but its certainly a very creative question Dan.
Dr. McKinney: I'm just going to say that of course we have had in the past a vaccine that was developed a number of years ago actually – and that was temporarily off the market but its back again, a live influenza vaccine that can be administered nasally and that sort of general thought that you develop a virus that’s adapted to live in the nasal area, but can't reproduce well internally and does not cause disease in humans, that would be a really interesting advance, but that would take some time to have studies that prove its both safe and effective, that you're not going to cause an inadvertent disease, especially with the number of people we have in the US who are immune suppressed, you don’t want to give any kind of live immunisation to somebody whose immune system is not functioning properly, whose got an organ transplant and is on high dose – any kind of agents that would be suppressing immunity – its he’s on cancer chemotherapy etc, so that would be very tricky. It would be great in a sense to have it but the process of getting there and assuring safety would be a very complex one.
Thom: Dr. McKinney how do you feel that the new vaccines coming out hopefully in a short period of time, how should they fit in to the roll out of the national strategy, is there a justification for focusing maybe the single doze vaccines that don’t need cold storage, shipping those to certain areas whereas other vaccines are better handled in different cities and what are your thoughts about all of that?
Dr. McKinney: I think that makes a lot of sense, obviously everyone knows that the first vaccine introduced, the Pfizer vaccine requires ultra-cold storage down to -70 Celsius. That’s very difficult to maintain and achieve for sites that are remote and its hard to transport that vaccine safely from place to place over longer distances, into rural areas and things like that. That vaccine has to be thawed and then diluted and then withdrawn and then injected, so a lot of different steps as well. If the J&J vaccine can be safely stored at refrigerator temperatures which is the claim from manufacturer that it will be stable for a period of months at refrigeration temperatures which are around 40 degrees Fahrenheit or so – above freezing but around 40 – 42, to maintain there it will be much more safely transported to rural areas and with one dose injection its simpler to administer, there's no follow up, it would make a lot of sense in my view to have that vaccine targeted for those more remote sites and to have the more concentrated effort for these difficult to administer vaccines in major centres where they have the ultra-cold storage readily available and a lot more personnel who can be a part of this complex process of the thawing, diluting, withdrawing, administering process, which does get complicated when you do it on a large scale.
Thom: We mentioned briefly in another question that the testing of some of the new vaccines up against the different variants that are out there, so Dr. McKinney – I want to ask you for further thoughts about these different variants and while they do seem to be still be covered by these vaccines that are getting tested, maybe not as highly as the first strains that were out. How much risk is there that one of these mutations does escape the vaccines and what other thoughts should we understand about that possibility?
Dr. McKinney: Well there's a significant risk that it will happen eventually, everyone hoped that mutations would occur at a lower rate than they're occurring currently, with this virus, but its had such an unimpeded spread in the global population that you can't imagine how many times the virus has multiplied. It’s an RNA virus, its well know that RNA viruses have poor aero checking mechanism when they replicate, so mutations happen all the time, they happen randomly but certain ones assist the virus in being more transmissible, some may assist it in being more pathogenic, although we haven’t seen one that could definitely be more pathogenic yet – so, one of the things we really have to focus on is what other areas the virus are mutating? Are there portions of the viral genome that are well preserved? We know that the Spike protein, the S protein, which is the one we’re tracking – mutates very frequently, but what about the others? And is there a way to target them even more effectively because perhaps mutation rate in those areas is less frequent. So there's a lot we have to know and I don’t know of anyone who has that information yet for us, but it certainly is the reason that is driving the race to the finish line to get the target group immunised as quickly as possible and no one’s mentioned this yet, but of course all the studies that we have in the US so far are really done on adults- the Pfizer group did a few 16-17 year olds but largely 18 and above and Moderna exclusively 18 and above so to get to the children in the US, adolescents and kids, there have to be special studies done there. They're beginning but it’s a long way to go and roughly a quarter of our population is under the age of 18 here in the US, so what is that -that’s roughly 80 million or something like that, so it’s a large number that need to be addressed by these studies yet to be completed that show safety and efficacy of the existing vaccines in children. So getting to the finish line with adults is important but then we have to as well – the cognizant of the fact that kids should get protection as well and as quickly as possible.
Thom: Thank you Dr. McKinney – Dr. Shen – back to you, Dr. McKinney just referenced the uncheck spread as a major concern with the mutations, well – we have a new administration at the helm in United States and there's a lot of reporting that they're planning to get more involved in the process, what do you think are some of the positive impacts and how soon can we start to see some of the effects as they get their plans up and running.
Dr. Shen: It’s a good question, I think as you noted good things are happening and as I earlier opened with, more vaccine supply is coming and so I think that is a game changer from what I would expect from the administration at the federal level, perhaps in the two domains. I’d expect more coordination and more communication. So in terms of coordination, as more vaccines come out as soon as they are filled and vialed and packaged, they're literally out the door – and one of the main things we learned in the H1N1 response of 10 years ago, is that communication on those doses, when they're coming and where they're going, is really critical to the vaccination campaign itself. Because all the architecture and all the work behind the scenes related to the scheduling of vaccination appointments, the optimisation of the number of folks there, especially for high throughput doses and so I think that as we have more sites of service coming on, as we’re building and expanding where you can get vaccine, both high volume as well as low volume, that coordination will be key. I think there's potentially more funding for vaccine administration, whenever you take a vaccine you have to pay for the vaccine vial, the dose itself, as well as the administration of that, including the crinkly paper that you sit on, the band aid and things like that, and so some of those administration fees are very low and so I think there could be potentially more funding for administration, there is certainly going to be more support to the state, support meaning people support as well as funds – public health infrastructure and public health has been underfunded for over 10 years and then I think the fourth point I would expect, which we’re already seeing, is transparency and data and those dashboards around virus cases, around number of tests, around vaccinations per day and hospitalisation and those data are really important not just for transparency, in building trust in the community about the process and about the vaccine and vaccination, but also data for decision making all the way down to the state and local levels. Those are the things that I expect forthcoming and those that I think will have positive impacts both in the community as well as the practical operations of the deployment of vaccines itself.
Thom: Dr. Lee what’s your perspective on the better federal coordination and what the results ma be in the manufacturing end of the equation where you have the most familiarity, what are your thoughts about that?
Dr. Lee: Well I think one of the interesting things is there's kind of a stated intent to be more engaged and more involved and help with that coordination. I think that’s very important. I think the companies themselves do a lot of that manufacturing and the extent to which there could be supply chain limitations knowing that the federal government might be willing to step in and alleviate some bottlenecks, I think is important – I don’t know that there are easy fixes on substantially increasing the manufacturing rate where the government can have a direct impact today, but that said – it’s not just about what is in the vial. There's a need for syringes, there's the need of course for the PPE to administer the vaccine, so all of that I think are also important areas where federal coordination can certainly accelerate the availability of vaccines –and when it comes to distribution of vaccines, I think what Dr. Shen was saying is exactly right – I think we’ve seen right now a very distributed – in my opinion – way of encouraging that vaccination to happen, there's high level guidance from the CDC but a lot of the details are left to the states and at the state level there's some activity and in other states it gets pushed to the county and as you go down into organisations, each of those entities then has to think about – how do you schedule this? How do I ensure that how many dozes I'm going to have, how many people are going to line up, where are they going to line up? Where are they going to wait for 15 minutes? And I think that’s a lot of reinventing of the wheel is happening all across the country. There is benefits to being close to the patients, because you know what’s happening locally, but I think greater federal coordination would probably smooth out some of the bumps that we’ve seen.
I’ll add one additional perspective which is – not if – but when we’ve finished vaccinating the majority of the US population, to go back to the earlier point, I think we also have to turn our attention to making sure that the rest of the world is also adequately vaccinated, because as we talked about before, variants can emerge and as long as this virus is circulating in other parts of our globalised world, we still have a risk here and so I think being a part of that global community to ensure that developed and developing nations have access to vaccines I think is going to be important for our own public health.
Thom: Digging into that a little bit further, what is the current limiting factor for how well the vaccine is getting distributed in those other countries, both developed and less developed – is it the power of their governments to purchase these things or are there other factors?
Dr. Lee: I think from what I know about this is – there is a globalized community that has established some principals and ways to ensure that not only the developed and wealthier nations have access to the vaccines, but the developing world does as well. And so, I think there are frameworks in place and I think what we want to do is make sure – I would argue we want to make sure that we are supportive of that infrastructure, because at the end of the day as I mentioned before, its going to come back to get us if we don’t ensure that the population on the planet to the extent possible is vaccinated.
Thom: Dr. Shen how could you explain some of the differing rates of success at administering the vaccine across different nations and you mentioned supply as the factor in this question – what are your thoughts?
Dr. Shen: Building on what Dr. Lee has said – supply is very limited not just here but in the global distribution. The covax facility is the vaccine arm of the Act accelerator, which is the global effort that Dr. Lee had mentioned within global frameworks on how to get equitable access across all nations to Covid products. Therapeutics, diagnostics and so on – so Covax is the one specifically for vaccines, with their mission to ensure equitable access to these lower middle-income countries. And so, the initial plans for Covax are to start with 3% of the population in terms of allocating doses there and ramping up to 20% beyond – that really covers a fraction of the population at large, but the idea is getting a little bit to all – a lot of it confounded by the numbers and a lot of deals being made with manufacturers both in developing countries as well as in industrial like countries with these multinational companies in addition to Indian manufacturers, Chinese manufacturers to ramp up just the number of doses purely. I think that relative to us in the united states, it’s a really good sign that the Biden administration has re-joined the WHO and in this regard signalled some optimism in terms of addressing these issues about global equity, in that these vaccines, these strains – I think I said in another press conference that vaccine nationalism only helps the virus itself, so towards this end, it’s important not just for equitable access and distribution in this country, but across all countries globally since this is something that’s impacting all of us collectively together.
Thom: Thank you Dr. Shen. A little bit of a free play question, I'm not sure which of our panellists might like to answer but in doing some research about some possible misinformation out there about the vaccine, one question has come up about rumours speculating that it could lead to infertility. Is there anything to this rumour? Is there any information backing this up or is that something that needs to be debunked? Any of the panellists have any thoughts about that or any knowledge about it?
Hate to throw a curveball but it is one of the things that we were doing some research about and it came up as a question from the public.
Dr. McKinney: I don’t have any specific data for you but I can tell you that people in the vaccine trials became pregnant after immunisation or in the process of immunisation, so I don’t think there's any evidence that supports the notion that people who are immunised are infertile. So, I don’t know where the rumour is coming from, there's a lot of wild speculation and a lot of different areas of course that are circulating in this current period of time that has different views against each other and different political factions and things like that, but in terms of scientific data there is nothing at all that supports that that I'm aware of and in fact definitely some contrary evidence in terms of the pregnancies occurring in people who have been immunised.
Thom: Dr. Shen go ahead.
Dr. Shen: I think my only quick comment is – aside from always being intrigued by what comes up in terms of the myths and the unfounded and misinformation, often times the genesis of this has to do with kind of an association of something else that’s happening often times in those peoples lives and so given the context of – if certain folks are trying to get pregnant, if its associated with getting a Covid vaccine, then things kind of spiral out from there and so in terms of the world of misinformation, rumour – often times association itself is not [inaudible 53:05] it just happens that two things happen at the same time and we don’t have enough times for stories but usually I tell a story –
Thom: Thank you Dr. Shen – I think it would be remarkable if that were true and it had somehow been kept quiet. It seems like something like that would be widely reported and widely investigated and not be something that could be chalked up to a myth.
Dr. McKinney: Just to be clear that that myth had circulated in foreign countries with regard to things like polio vaccine – the polio vaccine might in fact cause infertility – and that’s clearly been debunked, so there's no reason to suspect that there's any greater credence to be attached to the links proposed in social media to infertility with Covid vaccine.
Thom: Yeah, more likely then that someone brushed off some old propaganda from a previous vaccine 60 years ago and decided to see if it would get traction today.
Time enough for one last question, I want to go to Dr. Lee and it’s a question similar of what I asked Dr. Shen earlier but – your thoughts on continuing with public health measures and the importance of that even while the vaccine gets out there and what would you say to convince people to stick with that in the rare case that maybe they can still be a carrier after they get a vaccine and infect someone else or any other thoughts about those issues?
Dr. Lee: Yeah that’s a really important topic and I think the messaging that we’re hearing from officials is exactly what we want to hear, which is – that just because you’ve got the vaccine doesn’t mean you should stop wearing the mask and doesn’t mean you should stop your physical distancing in certain situations. Its particularly important – it’s going to help you, it’s going to help your loved ones, it’s going to help the first responders, it’s going to help the healthcare workers by continuing to keep this pandemic spread as limited as possible. There's a number of reasons why one could still get sick immediately after you take your first dose for example – you haven’t built up that immunity yet – so you want to make sure that you are fully protected and even then there isn't enough data – I don’t think yet to suggest that even if you are fully protected that you might not be able to transmit the disease and so you want to make sure that you are being as safe as possible to protect you and your loved ones and so we have more information to suggest that maybe it’s not – and I'm sure the health officials will come out and let everyone know when its safe to start to relax.
Thom: Thank you very much Dr. Lee – I want to just remind everyone on the call that we’ll have a video and a transcript of todays event that we’ll share with you afterwards.
I want to thank our panellists, Dr. Shen, Dr. McKinney, and Dr. Lee – we appreciate having you and we’ll say now to everyone, thank you very much for joining and stay safe, stay healthy and good luck.
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