It's Where I Am with Zandra Polard

Unknown Speaker 0:00
Good morning, Las Vegas Zondra Polare with it's where I am. Today. My guests are Dr. Levin of Anderson pediatrics. We're going to talk about the new COVID 19 vaccination. It's not FDA approved yet, but there is a another vaccination on the way. I'm gonna bring in Dr. Levin and we're going to talk about the double blind study that is going on right now. He's one of the investigators for the study. And we're going to talk some COVID Nevada has opened up, about half of Nevadans are vaccinated. And we have a new vaccination that will be coming sooner or sooner than later. So let's bring in Dr. Levin, of Henderson pediatrics. i Dr. Levin exam. Zander, can you do me a favor? We're going to start over and you're going to adjust your camera because you're sideways

Unknown Speaker 1:09
Do you want me to adjust the camera? You have to flip it? Because you are. There you go. Alright, there you go. Man, take it out of the case.

Unknown Speaker 1:34
Perfect, okay. Dr. Levin, thank you for being here. So welcome to it's where I am. So you are one of the investigators for a new vaccination for COVID-19. That is, in a double blind study has not been FDA approved yet. But we'll be coming to laws will be coming to the country. sooner than later. Can you tell us about this vaccine that's being sponsored by Nova Vax? Is that right?

Unknown Speaker 2:11
Right. No, but that's they, they produce a vaccine that is based on protein and not the messenger RNA or the adenovirus containing DNA for the spike protein, they actually produce the spike protein in a laboratory dish. And then that spike protein is then used, it's purified, and they use that as the as the, the vaccine, not messenger RNA, or an adenovirus vector with DNA for the genetic instructions for this

Unknown Speaker 2:49
meeting is being recorded. Stop. We gotta go. We gotta back up. So sorry, I paused it when I had to wait for you. So we're going to go back

Unknown Speaker 3:08
sorry guys, we got to go back Kevin, can you come here for a second? I'm so sorry.

Unknown Speaker 3:30
No problem.

Unknown Speaker 3:34
How do I get this back on mute? Because it's just showing Dr. Levin. Like even when I'm speaking it's not coming. It's not showing me as a gallery

Unknown Speaker 3:50
just on speaker I think it's because he's louder. No, it's just that his microphone is being picked up. Oh, maybe not.

Unknown Speaker 4:00
I'm not sure. So let me put him in the waiting room and then I'll do split gallery. How about that? Sure. Okay.

Unknown Speaker 4:06
Yeah. Okay. Damn, what I said was perfect. Oh, okay. Oh, but I can still Oh, it's not recorded. Nevermind.

Unknown Speaker 4:27
Good morning, Las Vegas. This is entrepreneur lard with it's where I am. Today. My guests are Dr. Levin of Henderson pediatrics. He's a he's the lead investigator for a new COVID-19 vaccination. Nevada's opening up, people have gotten the Pfizer vaccine they've gotten Maderna. Now there is another vaccination that will be coming our way. It is in a double blind study at the moment. It is not FDA approved yet. However, it's coming. So I wanted this guest to be on the show to tell us more about this new vaccination. So let's bring in Dr. Levin and discuss this new COVID-19 vaccination. Hello, Dr. Levin. Thank you for being on it's where I am. My pleasure. So I was telling our listeners about the new COVID 19 vaccination that is not FDA approved yet. However, it will be coming our way sometime in the near future. You've already worked with adults, or the study has already worked with adults, and now they are vaccinating adolescents. So can you tell us more about the new COVID-19 vaccine?

Unknown Speaker 5:58
So it's Novavax an older day. Yeah, x okay name me. And this takes the more conventional or traditional approach to vaccination, most of other vaccines and up to this up to the point of the messenger RNA vaccines were vaccines that had either attendee modified proteins from the pathogens, or pathogens that were disabled so that they could not cause disease but would create an immune response. And this, the Nova Vax vaccine uses the spike protein which they produce artificially in the laboratory to vaccinate individuals, in contrast with the messenger RNA vaccines that are ready, emergency use approved by the by the FDA, which are the moderna vaccine, and the Pfizer vaccine, and the Johnson and Johnson vaccine. The first two are used messenger RNA, which is injected, the messenger RNA gets into the cells of the body and uses our cells as factories to produce the spike protein, which then our body sees as foreign invaders and the body develops an immune system immune reaction to the Johnson and Johnson uses a adenovirus that's been disabled, that has spliced into it, a DNA code for the spike protein. And that gets injected, a few cells get infected with that virus, they become factories for producing the spike protein that our bodies then react to and develop the immunity to and Novavax takes the more traditional approach that we have with like, our appetite to see vaccine where there's a recombinant protein made in the lab, it's the recombinant protein which is injected, so it's skipped that step of turning ourselves in the factories that make the spike protein.

Unknown Speaker 8:03
Okay. Okay. So you brought up Johnson and Johnson. Right. So, with this Novavax once it becomes approved, because it sounds as if it's going where it's gonna get there, it's gonna get approved. Right? It appears

Unknown Speaker 8:24
to be it's in the it's at the FDA. Now all the data is there, and they're looking to obtain an emergency use approval, like the other vaccines have already that expect to have this quarter.

Unknown Speaker 8:40
Oh, wow. So it's coming pretty soon. So by 2022, Novavax should, may be available.

Unknown Speaker 8:49
Right, it could be possibly, I mean, when the other vaccines got their new UAE approval, there was a vaccine available essentially already produced and ready and being distributed so that as soon as they got the UAE approval, we had vaccines to administer to the to the public and so presumably this will happen with no vaccine as soon as it gets the approval.

Unknown Speaker 9:14
So it will it be easier to store than the other vaccines because I know that was an issue at one time.

Unknown Speaker 9:21
Yes, this vaccine does not require freezing can be sorted refrigerated temperatures, okay. Okay, just that's gonna make it much easier. Some of the other like Pfizer right now it has to be stored, but once it's thought it can be held now for almost 30 days and that's what many offices in town are using. Right now that health district is distributed. In fact, Anderson Pediatrics has the Pfizer vaccine available for anyone 12 and above. They don't even have to be a patient there. They don't have to be a pediatric patient and So that to the storage situation even for that vaccine has changed since the it originally came out. This vaccine will be much easier to ship be much easier for worldwide distribution if it doesn't need those extreme freezing temperatures to maintain stability until it's open. So that's one of the advantages of Novavax vaccine. I think there may be others.

Unknown Speaker 10:31
And then so what about the variants with this vaccine? What are the what are the variants with that? How do they compare with the other vaccinations that are already or vaccines that are already here?

Unknown Speaker 10:45
So the press released, I think it was about two weeks ago and no vaccine. They were it was being submitted to the FDA, and overall efficacy, including all the strains of 90%.

Unknown Speaker 10:58
Oh, wow. Okay, so that's even better than then the other two is, I'm not even including Johnson and Johnson. I just like totally took them out of my brainwaves. A long time ago,

Unknown Speaker 11:10
Johnson and Johnson's lower moderna and Pfizer originally said 95%, roughly 95%. And that was before some of these other strains came in. So even I think, Pfizer's saying about 85 88% Don't quote me, but it looks like this is a composite comparable and protection. And we are still talking for all these vaccines relatively short times to see what they're doing and the story is still being written every day or with all these vaccines.

Unknown Speaker 11:44
Right. But this is this Novavax, it's the research has gone on longer than the than the Pfizer moderna Is that correct?

Unknown Speaker 11:54
No, the Nova Vax Vaccine Research got the trial started after the Pfizer moderna and Pfizer started last summer. Nova Vax, I believe was in the fall, I was brought on the site was brought on only to do the pediatric expansion of the of the adult study, which was done in the United States, one of the studies was done in the United States and Mexico and had 30,000 participants in it. And they did something slightly different than a double blinded trial, it's the same model they're using in pediatrics, where everyone what they have is called a blinded crossover. So and they also increase the number of patients initially getting the vaccine from 5050, like in the other studies, to two to one getting vaccine over placebo. And so patients enter the subjects enter the studies. And they don't know and the the only people who know what they got are what's called the unblinded staff who actually handle the vaccine are told by the randomization, software, what patient will get what and they actually draw, go into the refrigerator, drop the vaccine or the placebo. And they're the ones who know, so the patients don't know what they get, and I don't know what they get my staff are doing the, the intakes for this, they don't know what the patients are getting. And then in then they bring everybody back for a another round of injections. And if they got placebo in the first part of the study, they'll get the vaccine in the second part of this study, and vice versa. So that's called a a blinded crossover, whereas the studies did. Everybody came in got either placebo or vaccine. And they were followed to the point where they said enough data based on case collection of COVID infections to the in when they determined that the vaccine looked efficacious, they brought everybody back in, ordered over the phone, depending on the study, and let everybody who was a placebo patient know that they got the SIBO and then offer them the vaccine. So that's binding. So it's a slightly different way of doing this study.

Unknown Speaker 14:29
So can you explain to our listeners, what is the benefit of even having a placebo? Why not just give the vaccination? Explain that for us?

Unknown Speaker 14:39
Okay, because while the placebo studies is where they determine does the vaccine work are the side effects due to the vaccine? The side effects that people afford after getting and are they are they are they due to a placebo or are they getting the vaccine the mind is very powerful as you know. Yes, and thanks for are getting an injection of vaccine, they may report symptoms. And but if they don't know whether they had the placebo or the vaccine it's people do report symptoms of placebos. And I can vouch for that from personal experience here. And that's a general construct for placebo studies. The case driven aspects of the studies were. So if you have a placebo and a vaccine, we don't know if these vaccines work yet. We only knew from phase one and phase two trials that they generated antibodies and the antibodies worked in a test tube against the virus. And the question was in the real world do these vaccines work? So people, the original studies, overall wanted people at high risk for severe complications of COVID, as well as people at high risk to get the infection, essential workers essentially. So people got these, the series of the two injections for the moderna. Pfizer was set up the same way. And Novavax is done the same way. And then they went about their lives of presumably distancing, wearing masks, washing their hands, but some of them were in high risk positions, working medical, taking care of patients working in front of frontline workers, as we say, and not necessarily just in the medical, but people in stores casinos for Las Vegas as things opened up. And if you recall, back around Thanksgiving, through January, there were huge numbers of cases of COVID. Overall, we had those high numbers. And so inevitably, when you're enrolling 30,000 patients across the country in a study, some of these people got COVID. So they were instructed, and plus there was surveillance phone calls, to reach out to the patients to remind them to contact if they had any symptoms at all of COVID people were brought in, and the cases monitored pretty quickly, much quicker than anybody expected. There were all these subjects who were in this study, and who got COVID. So once they had a certain number, and those numbers are determined by the sponsors, and their biostatistics, biostatisticians they needed a certain number of patients to develop COVID. And then they did what was called interim analysis. What that means is, at the sponsor level, that sponsors are the pharmaceutical companies and the organizations that run the studies for for them. They then looked at selected all these cases that say there were 100 people who got COVID They looked and see whether they got vaccine or placebo. Okay, okay. And if vaccine worked, that would be that work, and we can define what work would be of efficacy. But if there were more cases of COVID occurring in the placebo recipients that would tell you that the vaccine was protective. Okay, okay. That's where you get get those numbers. If it was random, that they exceed didn't do a thing, you would expect roughly equal numbers of people who got vaccine and people, we an equal number of people who got the SIBO to get the infection saving that meaning that vaccine didn't protect anybody. So those numbers with those initial messenger RNA vaccine trials were much better than we even get with our seasonal flu vaccines. Almost as good as some of the vaccines we consider nearly 100% effective like measles, for example, measles vaccine,

Unknown Speaker 18:57
but But wait a minute, Doctor, I want to ask you this since you brought up the flu. Are we supposed to get a booster with our vaccination of COVID-19? And will there need to be a booster with the Novavax as well? Is there like a booster shot necessary? Like after you get your two shots? And another year you have to get a booster another five years? Is that making sense?

Unknown Speaker 19:26
Questions are being looked at right now. Okay, you're going on? planned and I believe some have started looking at the third dose of these vaccines in subjects who were in the original studies.

Unknown Speaker 19:42
So then if you had say, if I had a Maderna shot or a Johnson and Johnson one had a Johnson and Johnson shot, can they then get a booster of the Novavax or do they have to stick with the same, you know, vaccine vaccine that they They took before.

Unknown Speaker 20:02
We don't know the answer yet. Okay, but they're looking at it. I know of people who aren't in studying so went out and got a second round of vaccines with the other messenger RNA vaccine. I'm aware of individuals like that who've taken it upon themselves. I get patients in the study in moderna, which I can talk about, who asked, Can I go get a booster shot, and they're not supposed to get a booster shot up there in the study, it is not recommended yet for anybody to get a booster shot officially. What, you know, this is why I want to get back to what constitutes a good vaccine. If a vaccine that prevents disease 100%. That's a great vaccine. We know already, even from the initial data that these were 95% 90 95% effective for the strains that were going on at the time. And there are breakthrough cases that occur. So it's not so in terms of preventing the infection, percent, they're not doing that right now. If the vaccine can reduce, or prevent someone from getting extremely sick, hospitalizing, or dying from COVID infection, that's also considered a very effective vaccine.

Unknown Speaker 21:27
You know, I told a few people that you were coming on the show, and I got quite a few questions. And I want to ask you, some of them, and one of them was about the booster. Another was about someone mentioned, things that have happened to them after they've gotten vaccinated from either Maderna or Pfizer, and not reading the side effects. You know, often a lot of people feel like, you know, something happens to them. Coincidentally, it's related to the vaccine. And so that ties in with a lot of fear that people have and why people are choosing not to get vaccinated, or those who have gotten vaccinated are still afraid that, you know, it's having some, they're having some reaction to it. Can you explain what the side effects are for Novavax?

Unknown Speaker 22:30
What we are seeing with no evacs are local and systemic reactions that you see with many other vaccines. This is what I'm an excerpt serving in the small bowel six our patients in the pediatric study sore arms. Headaches, fevers, malaise, tinnitus, feeling yucky for a couple of days at most. The chills and fevers that have been reported have been like 12 hours similar to what we saw with with moderna, the concerning problems now with Nova Vax COVID. Any vaccine that's being tried being studied. And again, these studies because it's a pandemic, because the government said this is a serious health problem. People are dying, we need to get vaccines is they do an emergency use authorization based on 30,000 People 15. In originally, it's only about half of them that got the vaccines. So it's still not 100 million people that are getting vaccinated now. So if there's a more severe side effect than the expected local reactions and the system, local game and the systemic reactions that we consider tolerable, I think most people would say, I'm okay with having a headache and being tired and having a fever for a day or two or three rather than ending up with pneumonia and long COVID or dead. And these other problems, then, people are willing to take that But sure, when you giving a vaccine and let's say you have a, you'd say you have a side effect which occurs but it's only occurring in one and 500,001 in 1,000,001 and 100,000. Until you get large numbers of people vaccinated, which they do is an emergency basis. That's when you start seeing the rare side effects. I think you could say that's the example with the Johnson and Johnson and the thrombocytopenia, low platelets with the blood clots that are are rare but devastating. And we're starting to in there's now moderna and Pfizer put warnings on their labels now saving them Thursday. Risk of myocarditis and inflammation of the heart.

Unknown Speaker 25:03
Okay. Thanks for explaining that.

Unknown Speaker 25:07
So, well, anyway, those things have not been seen with Novavax in the 30,000 in the US Plus there were studies in England. I know that's two. Okay. So so will we see those, it's only once it gets the UAE approval. And we, I would anticipate if there's, we're not going to see those things, because these are different vaccines made a different way. We have a lot more experience with protein based vaccines. And the DNA and RNA vaccines are brand new in terms of being given to hundreds of millions of people.

Unknown Speaker 25:46
So, Dr. Levin, I need you to I would like you to give your information for the clinic for your clinic so that people can find you. We searched you look on the website, can you give us the information to Henderson pediatrics?

Unknown Speaker 26:04
Right? Well, Anderson Pediatrics says, My phone number is 702-893-8968. That's a private practice of Pediatrics, start seeing the babies when they're born. And when you go up to 18. We've extended it slightly because people were having trouble with access to health care, during COVID, but generally we go to 18 when they're adults. And then the research being done there as being done with me as the investigator and I work as a contractor for rake research. They that's a company which acquired the entity that I've worked with for 20 years. So it's called awake research, clinical research center of Nevada. And we have a number of trials going on here for COVID. I'm only allowed to talk about the sponsors who allow us to announce their names like moderna like Pfizer, the phone number is 702-893-8968. And there is the website as well, if they look up weight research CRC and, and they'll give some give them more information. I believe we'll be having studies just in a meeting. To do some there are some new because the messenger RNA vaccines are now out there. With COVID the COVID trials they're in for a number of years, they've worked on this platform for vaccines that COVID came about and got it out. So they're looking at influenza vaccines using messenger RNA which should should be a lot more effective than our our regular flu vaccines, which are protein based as well as there are some live attenuated vaccines. If people recall the nasal mist vaccine for the flu, that's actually a live virus that's been changed so it doesn't make you sick. So there's a lot there will be other. There are always opportunities to do research or always things coming up coming. So if you have if anyone out there is interested in participating in clinical trials were one of we will have other things for that.

Unknown Speaker 28:26
Alrighty, where am I? Where's my

Unknown Speaker 28:30
Oh, if I gave you much needed but

Unknown Speaker 28:34
wait one second doctor. Um, Kevin, where's my video I went over the Zoom time. So where is it?

Unknown Speaker 28:54
I don't know where

Unknown Speaker 28:55
I just put I just put Are you still there, doctor? Okay, you want

Unknown Speaker 29:04
to want to do another zoom to continue? Or?

Unknown Speaker 29:08
I just need my meeting back. Where am I? Should I just start one right now?

Unknown Speaker 29:14
I know what this quick time down here? I don't know.

Unknown Speaker 29:18
It just went away.

Unknown Speaker 29:20
I believe it it sounds like you. Jesus Christ. You're 40 minutes I'm meeting is over. So you may want to start another meeting.

Unknown Speaker 29:27
Right. But where's the meeting? Where's the

Unknown Speaker 29:29
you probably have to schedule a meeting or host a probably hosted meeting. Do it right here. Just host a meeting with video on. Yes.

Unknown Speaker 29:44
Yes. Start new meeting. Leave and start. I don't want to leave in start. I want to keep what a half. There we go. All righty. So maybe it'll just charge me later.

Unknown Speaker 29:56
Maybe I don't know. Okay, never work. Okay.

Unknown Speaker 30:01
Well, we're gonna I just want to thank you for your time. Thank you for being here. Thank you for your explanation. And thank you for your expertise. Dr. Levin and I will have your information on my website. So everyone you can go to it's where I am.com Look, click on the community resource page, and you will see Dr. Levin's practice there, which is Henderson pediatrics. So thank you so much for being here, Dr. Levin, my pleasure.

Unknown Speaker 30:33
Anytime. I'd be happy to speak anytime you want to speak.

Unknown Speaker 30:37
Awesome. Thank you so much. I appreciate it. Because I will ask you to come back. Okay, thank you, sir.

Unknown Speaker 30:44
Thank you. Bye. Bye. Bye. Bye.

Unknown Speaker 30:48
There you are, is that Curtis? You have to unmute yourself.

Unknown Speaker 30:55
Okay. Are you doing?

Unknown Speaker 30:57
Hi Curtis, I'm well. Thank you for joining us. So this this segment is going to be called the community spotlight. And we're going to take a few moments to talk about what you do in the community. Okay, so tell us

Unknown Speaker 31:15
well, I'm a martial artist. So I've been teaching martial arts in this community for about I say about six or seven years now.

Unknown Speaker 31:21
Okay, so where do you do that? Do that

Unknown Speaker 31:25
down and do little community centered?

Unknown Speaker 31:29
Love Doolittle.

Unknown Speaker 31:32
I do that on Monday, Tuesdays and Wednesdays. 5am To 9am 9am 5pm to 9pm Yes.

Unknown Speaker 31:41
5pm to 9pm. And so you're teaching children correct or adults or both. I teach children and adults, children and adults at Doolittle Community Center martial arts and boxing.

Unknown Speaker 31:55
Yes. And also do boxing with Richard Steel's gym. I'm amateur promoter for Richard Steel's. But,

Unknown Speaker 32:03
okay. Well, thank you for being a part of the community spotlight. I will put your information on the website. I just want, you know, Las Vegas to know what's out there, what's happening, how they can get involved, and who's there to help. So I want to thank you for what you do. Is there anything else did you want to put out any social media handles or anything?

Unknown Speaker 32:27
Social media handles. I'm on Facebook, I really haven't got my social media network together yet. I am working on it. And I need to step up my

Unknown Speaker 32:35
but if people want to get lessons from you, they can find you at Doolittle Community Center. And the address there is

Unknown Speaker 32:44
they do if I was better prepared.

Unknown Speaker 32:47
It's on the west side of Las Vegas. And I believe it's on J Street and the cross streets are Lake Mead and Martin Luther King. So there you go.

Unknown Speaker 32:57
There you go. Coffee, Lake, Lake, me and J Street.

Unknown Speaker 33:01
Like me and J Street. All righty. So you can just Google do a little community center and find out the hours of Curtis's classes and get involved. All right. All righty. Thank you. It's where I am. You're welcome.

Unknown Speaker 33:19
You are beautiful this morning. Oh, thank

Unknown Speaker 33:21
you. Thank you. I want to thank all my 91.5 Jazz and more listeners for tuning in this morning. I'll be with you next month. Saturday at 8:30am. Thank you. It's where I am.

Unknown Speaker 33:37
Well

Transcribed by https://otter.ai