Mark Moran: [00:00:02] Welcome to TGen Talks. I'm Mark Moran. The world changed when COVID-19 hit, and for over a year now, people have asked when the vaccines will be ready. Well, they're here, but not without effort and certainly not without a lot of hard work. Sadly, a human toll that has now surpassed 95 million cases and over two million deaths worldwide. Joining us today is Dr. David Engelthaler, Director of TGen North, the pathogen and a microbiome division of TGen, located in Flagstaff, Arizona. He'll share his insights on the latest information and developments surrounding the COVID-19 vaccine rollout and what to expect as we enter 2021. Dr. Engelthaler. Welcome back. [00:00:47][44.8]

Dr. David Engelthaler: [00:00:48] Mark. It's a pleasure to be here. [00:00:49][1.0]

Mark Moran: [00:00:49] It seems the whole world held its collective breath awaiting this vaccine. Now it's here. There have been a few hiccups in terms of the rollout, outages and system crashes, lack of vaccine, things like that. What's your general observation to this point? What's working? What needs improvement? [00:01:03][13.8]

Dr. David Engelthaler: [00:01:04] It's exciting that the vaccines are rolling out. We do have an enormous logistical issue with rolling out vaccines to millions of people all at once, especially brand new vaccines, and in some cases, some that require some additional intricacies in handling it and how we have to keep it in very cold storage. So that really does add layers of complexity to really the logistics of getting it out. So it is no surprise to me that we're running into a variety of different issues. Good news. It is rolling out. We do have probably close to 10 million people vaccinated by now and that's going to continue to grow. It's not completely smooth and we really shouldn't expect it to be. [00:01:47][43.1]

Mark Moran: [00:01:47] The Pfizer in Moderna vaccines are the only two currently available. But a quick look at the CDC website indicates there are at least three more in phase three clinical trials. What is phase three and how soon can we expect one of these to be in the pipeline to help alleviate some of the congestion, for lack of a better word, that we're seeing now? [00:02:07][20.2]

Dr. David Engelthaler: [00:02:08] Another exciting thing that's happened is that there's been multiple vaccine targets that have been coming out. So the first two that were approved are these mRNA vaccines that we've talked about and require the cold storage but seem to have a really good effectiveness rate as it went through the different testing trials. The newer vaccines that are going to be coming out are a little bit more like what we would call old school vaccines, either killed vaccine. So it has the remnant viral particles in it, which really does get a good immune response to it. Or there's just specific proteins that have been developed and then those proteins help generate antibody to the virus. And so these are kind of new are tried and true technologies that have been used. Those would be coming out. And the good news is those in some cases don't even require much in the way of of cold storage or refrigeration. There's going to be less risk of them going bad if they're left out. And that's going to help in a lot of places where it is difficult to have cold storage even here in the U.S., but more importantly, in other parts of the world. [00:03:13][65.4]

Mark Moran: [00:03:14] Troubles aside, we have vaccine options. That's great news. Yet some individuals are still a bit wary of being vaccinated. Why do you think that is? [00:03:23][8.7]

Dr. David Engelthaler: [00:03:24] Mark, the vaccine controversy didn't it didn't start here with covid. It's been around for for a long period. And, you know, people have a natural fear of getting something injected into them. We know that. We also know, though, that vaccines are really one of the greatest human inventions of all time. We vanquish diseases completely from this country and in the case of smallpox, completely from the world. So we know that vaccines are incredibly useful. And in this particular case, there's what's going to get us out of the pandemic. But it doesn't mean that people are going to automatically lose their natural fears. And then some of that is actually pushed by certain groups that are just anti-vaccine, the quote unquote, "anti vaxxer" group kind of having a field day with this because it is brand new and it's easy to get people's attention and maybe stoke up fears. The good news is we are getting quite a bit of uptake. We'll see when it starts rolling out to the general public how that that plays out. [00:04:20][56.5]

Mark Moran: [00:04:21] Some countries are delaying the second dose to get more people the first doses. Why isn't the U.S. doing this? And in your opinion, will it be as effective? [00:04:30][9.0]

Dr. David Engelthaler: [00:04:30] It's an interesting strategy as a way to try to get more vaccine out to more people. It does look like from the trials that even the initial dose of vaccine does give a pretty good immune response. And so it probably isn't going to be ah, it'll probably be helpful in those countries. Here in the U.S., we really try to have the highest standards for approval of new medicines and vaccines. And the FDA that this was approved by the FDA was as a two. Strategy, it really hasn't been fully tested as a single dose strategy, even with a delayed dose and getting that second dose as a former public health official, I'm a bit wary of delaying the second dose only because we know that we're going to lose more and more people to follow up to get that second dose when it does come around. I think biologically waiting a couple of weeks or more for that second dose beyond what we would have normally probably won't have a negative effect. So I think there might be a strategy that maybe we can push out second dose a little bit further, but then have to put a lot of extra effort to make sure we don't lose those people to follow up to get that second dose. [00:05:42][71.4]

Mark Moran: [00:05:42] Following up on that, you hear from some that the vaccine's been rushed out too quickly. Others say the rollout has been too slow. What are your thoughts and what role has technology played in the development of the vaccine and the speed at which it all came together? [00:05:56][13.4]

Dr. David Engelthaler: [00:05:56] It is a good point. Both of those are probably true that this was rushed out faster than we normally would have done it. But I wouldn't say it was too fast. It was incredibly fast and more better and faster than we could have ever imagined. And it's because vaccine technology has advanced to a place that we can develop them and we can safely test them and trial them in order to get them out. And then and then technology allowing for so much production so quickly has been pretty remarkable. However, we can't just get it out and get into everybody's arms now that it's approved and being made as as quickly as as some would like. We we have to use kind of a prioritization system to as the vaccines roll off to get it to the people that either need it most or that we need most to stay in the fight. And that's obviously been the health care providers and and then some of the priority groups as more and more vaccines being developed. So I don't think it's been a perfect rollout at all, but I do think that it is moving both faster than we we could have hoped and unfortunately not fast enough to stem the pandemic as early as we'd like. [00:07:04][67.6]

Mark Moran: [00:07:05] You're listening to TGen Talks. I'm Mark Moran. Joining us today, Dr David Engelthaler, director of TGen North, the Pathogen and Microbiome Division of TGen, located in Flagstaff, Arizona. Dr. Engelthaler, with any vaccine or drug, there are side effects. What have we learned about the side effects of the COVID-19 vaccine and what should people look for after getting the shot? [00:07:28][23.2]

Dr. David Engelthaler: [00:07:28] What we know with at least the vaccines that are available now, the Moderna and the Pfizer vaccines is that there's really only been one serious side effect that's been documented and shown to occur, and that's in a very small group of individuals who have a hypersensitivity allergic reaction. And in this particular case, probably to some component of the vaccine. These are individuals that already carry your own epi-pens, for the most part. They know that they're they could have an anaphylactic reaction to something. And and so in a very small number, relatively small number, there have been anaphylactic reactions in that group, not in the general population. So for the general population, I'll tell you what it is, it's definitely true that the shot gives a bit of arm pain right there in the deltoid muscle, and that could last for a day or two. But that's common with a lot of shots that we get. And then more specifically, when you get that second dose, your immune system is responding in a way that also you start to feel some symptoms so you could feel sluggish, more tired. Some people have talked about some cold-like symptoms or mild flu-like symptoms that might last for a day or two, which we should expect that. [00:08:44][75.8]

Mark Moran: [00:08:45] Over the past few weeks, a number of new articles have focused on the COVID-19 strain that first appeared in the United Kingdom in South Africa, and now appears to be a predominant strain in the U.S. as well. Does this strain make the vaccine less effective? And will the vaccines under development be effective against this strain as well? [00:09:03][18.8]

Dr. David Engelthaler: [00:09:04] We've definitely been trying to watch this virus pretty closely and sequencing the genome to look for potential mutations that that say that the virus evolving in is changing in some cases now, it really has been documented that certain mutations that occur in the gene for the spike protein, everybody remembers that coronavirus has those spikes on the outside and that's what actually attaches to human cells during infection. And so when you get a little bit change in that, the virus might act a little bit different. And what we're seeing is that some mutations are related to increased viral replication in the cell and and also increased transmission between people. And that means that the virus is able to move faster and dominate an area pretty quickly. We think this happened very early on in the pandemic when we saw those first cases or those first outbreaks in Italy and in parts of Europe that were so devastating. And then that just rolled right into the Americas, that same strain certainly spread faster than some most of the other strains coming out of China. More recently, the strain seen in the United Kingdom and now one in South Africa also seem to now even, I guess, for lack of a better term, more supercharge that virus that was already spreading fast. And so, really, the virus is becoming more and more like other successful coronaviruses. And that success strategy has been to become more transmissible. And hopefully the case will be with this is to become less virulent, more like the common cold virus. We're not quite there yet. The concern is also, will some of those changes mean that our vaccine won't work? One mutation that's been seen in South Africa or the South African strain has been associated with potential antibody escape, meaning that the antibodies that would normally bind to that part of the spike protein may not effectively bind to that region. The good news is that we make a lot of antibodies, whether it's from the vaccine or from a natural infection, and we have other parts of our immune system that respond. So we might see a little bit of erosion from of our immunity from these new variants that are spreading. But we don't anticipate that it will fully escape the effect of the vaccine or if you already had an infection and the immunity that you got from that. But we have to watch this closely. This is really critical now and maybe eventually several maybe it maybe it would be multiple years from now we might have enough changes that a new vaccine will need to be developed. But for now, it looks like the vaccine will work. [00:11:43][158.7]

Mark Moran: [00:11:43] Should people who've had covid-19 and recovered received the vaccine? Is this something they should be thinking about or have they built up enough immunity that it's not necessary? [00:11:52][8.7]

Dr. David Engelthaler: [00:11:53] Public health recommendation right now is is everybody get a vaccine regardless of your current immune status, whether or not you had documented infection from the cold virus in the past. And that's because not everybody's immune system reacts the same to an initial infection. And so some people does small small percentage of individuals who did get an infection probably didn't develop enough of immunity to ward off another infection. The vaccine will do that. So we do recommend that everybody still get the vaccine. [00:12:24][31.0]

Mark Moran: [00:12:24] TGen is an Arizona based institute and currently Arizona appears to be a hotbed for outbreaks lately. Why and what caution should we be taking? [00:12:33][9.0]

Dr. David Engelthaler: [00:12:34] It's a great question. This happened during the summer surge as well. There were a few weeks where Arizona was was really number one in the country as far as cases go. That's happened here now in the during the winter surge as well. That's already waning. The other states are surpassing the case rates that we've had here. But that's not to say that it hasn't been a really remarkable amount of transmission. We don't fully know why Arizona has been that particular hotbed. We do know that the the strains that we do see in Arizona seem to be very, very efficient at spreading between people like most other places in the country. And it could be that, you know, there's some some circumstances that are different in Arizona, but we can't say it's just because people are masking less, are being not following the recommendations as much, or that the recommendations are as strong because right next door in California, they're actually surpassing us in cases. And yet there they have a lot more restrictions in place. So it's it can't all be laid there at the at the feet of the recommendations or if people are following them, part of that is definitely the virus and the viral strains. Everybody's going to go through this misery and we're going to come out on the other end of this because the case numbers will start to drop because of more vaccine and more cases that overall immunity in our communities is building. So we will see this start to wane. [00:13:56][82.2]

Mark Moran: [00:13:57] Last question. And I'm sure that everyone would like an answer to how far are we as a nation from light at the end of the tunnel. In your opinion, what will the summer and fall of 2021 look like? [00:14:08][10.7]

Dr. David Engelthaler: [00:14:08] I already see the light at the end of the tunnel, Mark. I think the vaccines are going to allow this. It doesn't mean that we're we're stepping out of the tunnel right now. I think we saw several more months of of the pandemic as it is now. But as as we look at vaccine numbers, we're going to see probably an equal number of people vaccinated as we have total cases of covid in the U.S. in sometime in March or early April. Just looking at the trends right now and that total number of people with immunity is going to significantly impact the spread. And so we're going to we're really going to see drop offs when we look at late spring and into summer. So that really kind of best guesses right now looking, you know, July one. We're going to we're going to not necessarily feel like the pandemic is over, but the worst of the pandemic will be behind us as more and more people get vaccinated. [00:15:03][54.9]

Mark Moran: [00:15:04] There's always information that's ahead of the curve and setting the agenda nationwide and worldwide. Dr. Engelthaler, thanks for your insights today. We always appreciate your time. [00:15:11][7.4]

Dr. David Engelthaler: [00:15:12] Absolutely. Glad to be here. [00:15:13][1.0]

[00:15:13] Dr. David Engelthaler, former director of TGen North, located in Flagstaff, Arizona. You can listen to more TGen Talks at TGen.org/TGenTalks. TGen is an affiliate of City of Hope. Thanks for listening for TGen Talks. I'm Mark Moran. [00:15:13][0.0]

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More TGen Talks
It took under a year to develop, test and begin to deploy vaccines against COVID-19. And despite a few hiccups upon arrival, the rollout is underway... and that's great news for a world that's nearing 100 million cases and over 2 million deaths.
  Joining TGen Talks to discuss his take on COVID-19 vaccines is Dr. David Engelthaler, Director of TGen North, the Pathogen and Microbiome Division of TGen located in Flagstaff, Arizona.
  Dr. Engelthaler discusses the vaccine's available today, those that are currently in the development pipeline and why getting vaccinated is important. He also tackles the known side-effects, the speed at which the vaccines were developed, and the recent variant strains that were discovered in the UK, South Africa and elsewhere, and which of these are already being seen in the US. 
  All that and more on this month's edition of TGen Talks.
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