COVID-19 Vaccine Study Update: Phase 3 Studies Beginning

Aaron Hartman, MD, describes his site's role in Pfizer's phase 3 COVID-19 vaccine trial. The vaccine uses mRNA in lipid nanoparticles to instruct cells to make the spike protein. Phase 3 aims to enroll 30,000 participants across the US and Europe, with a booster expected around 28 days because the RNA breaks down quickly.
Questions this video answers
2010
A 2016 Lancet publication on nitazoxanide (antiparasitic repurposed as antiviral), conducted with NIH involvement.
About 30,000 participants across the United States and Europe.
Because injected mRNA is transient and is broken down in days; a typical booster is given at about 28 days.
By November 1 (year implied by context: 2020).
Chapters
Great to be with everybody once again. In this video I'd like to talk about my research company and our involvement with the new COVID 19 vaccine study. We are actually working with Pfizer right now in the phase three. I'm really excited to talk to you about that. First, a couple of caveats about myself. A lot of you all may or may not realize, but I started a clinical research company back in 2010 called Virginia Research Center. The goal of this research center was to focus on novel and new innovative medications and therapies and help introduce them to the population at large for people to be treated. And so we've done a lot of interesting studies. We did a study back in 2016 on an antiparasitic medication called nanozoxanide, which actually was used for an antiviral for flu. It had been used for Hep C and B and actually our research was published in Lancet in 2016 and we were doing the study with NIH. We've also done other innovative studies and we're really excited about this one because this is our biggest and most important study to date that we've done with this SARS Cov2 ie COVID 19 vaccine, mainly because of the impact that it potentially may have in the world. So what I want to do is I want to talk about, well, a couple other things about me, Sarsar. I'm also board certified in Family Medicine, Board certified and integrated in Holistic Medicine, certified in Functional Medicine. And I'm actually sitting for my board and integrative in Regenerative Medicine in the next week. So that's kind of like a little bit of my background. So let me talk about the vaccine. I want to talk about some details about the vaccine just so you all can know what's coming down the pike and be aware of it. Because the vaccine is not going to be for everybody and we're not even sure it's going to work or not. But I think that this is a good source of information from someone who's doing the research with it. On the research side, someone who's also seeing these patients. In the clinical side then on the functional side, someone who's using alternative methods to treat these patients. Because right now that's all we have. So I have an interesting perspective on this and I want to share that with you and hopefully that'll be useful, helpful information. So first of all about the vaccine, the first bound about vaccines. This is actually the cleanest vaccine I've ever seen. When I was looking at the investigator Brochure One thing I was struck by was how little is in the vaccine. A typical vaccine has aluminum, other adjuvants or things that irritate or agitate your immune system to create an immune response. And a lot of people actually interact with those, with those adjuvants or things that irritate your immune system. These are the things that cause a lot of people to have side effects from vaccines and this vaccine. The RNA itself is the adjuvant, and that's, that's kind of it. There's some different benzyl alcohol. It is a nanotechnology. So. So there are some lipids, phospholipids. If you're familiar with phosphylcholine, lecithin or sunflower lecithin, it has these ingredients in it, but all the ingredients are pretty clean and should be able to be cleaned up by your body within a week or two. This is unique because most vaccines actually have residual stuff either in the forms of thymosol, mercury type preservatives, benzyl alcohol preservatives, or aluminum itself. So that's one thing I'm really excited about, is the cleanliness of the vaccine per se. The next thing is the elegance of the vaccine. It's a really elegant mechanism. So the idea is this, and I like to compare things in nature and on functional medicine, clinical medicine, and then on the research side. And so RNA is what makes protein in our body. Our DNA makes messenger RNA or RNA that goes to our ribosomes and makes proteins, and that's what runs our body. Well, when you eat living food, when you eat broccoli that has Microrna in it, when you grab a piece of spinach off your backyard that has bacteria with MICRORNA in it, what happens is these small RNA molecules get in our GI tract. The viruses that we're exposed to actually get embedded. About 8 or 10% of our DNA is actually viral DNA. Interesting enough. And what happens is these food things will actually, the microrna will get in our GI tract and our immune system and actually change our genetic expression. Now, the thing about that is that that only lasts for 8 or 12 hours. So guess what? You have to eat broccoli every day. You can't just eat it once and say, five weeks from now, hey, the broccoli is still working. Food is actually information. And real unprocessed food is tons of information. So this vaccine is using that concept, but you're injecting it in your muscle and it's giving you this rna. And what happens with the rna? It gets actually into your cells and starts programming your cells to make this protein that is actually the spike protein. And for those of you who have been following this, know what the spike protein is? It's how the virus actually gets into our cells. And so each one of our cells has enzymes that break down rna. So when we get this injected into our system within three to five to seven days, our body breaks down and these RNA particles and so they're gone, hence the need for a Booster. In about 28 days, a typical vaccine needs to be boosted because your bias removed the aluminum adjuvant, this one needs to be boosted because the RNA has been broken down. So your body makes these antibodies to the spike protein. And the assumption here is that the proteins against the spike protein, which is how this virus gets into our body, will help prevent you from getting the infection if you're exposed. So it's a very elegant, it's almost like the smart bomb of all smart bombs, so to speak, as far as how it works. And we've already gone through phase one and phase two. There's been some misnomers about human studies. This is, you know, one of the ways research works actually. Phase one, phase two, phase one are kind of the basic. There's pre clinical studies, actually, I should go back. There's pre clinical studies where someone in a, and a lab somewhere has this idea that this might work a certain way. Let me try this new drug, this new vaccine. And they get enough data to suggest that actually might be effective. So they do phase one to figure out basic safety information. And is there a physiologic response? Usually that's a very, that's usually phase one of mainly animals, some human studies. Phase two is like, well, look, we've got something that appears to be effective. Let's see if it's safe and figure out dosing Right. And so phase two figures that out. Usually once you get through phase one, phase two, we figured out this is probably going to work. We think it's safe, but the numbers are too small to get ready to launch that into the whole population. So phase three is now let's expose in this study, about 30,000 people is what Pfizer is looking for across the United States and Europe to get into their study with that many people. By the end of the study, you'll kind of know how safe and effective it is. So this study is going to be about 30,000 people. And then we're in with phase two. So that's the basic information about the study. One thing I would like to say is that I realize this vaccine will not be for everybody. As if, as with any vaccine, not everybody's going to want to get it. And that's one of the things we have just to realize there's also going to be some distribution issues with this vaccine. Currently there's been about 50 million doses ordered of different manufacturers, which is not enough to treat the whole country. So if this vaccine is shown to be safe and effective, the next question is who gets it first? Is it healthcare workers first? Is it the frontliners first? Is it high risk individuals first? These are all questions we do not know the answer to as of yet. At this stage, there's no guarantees that it'll work, but the preliminary data is encouraging. So what I would say to people is stay tuned. I'll continue to talk about it as I learn more and as we read more and see more in the research. I'll continue to share that the goal most likely is to be done with most of the clinical database gathering by November 1st. It will then have to be crunched. The data has to be crunched last. Statisticians will look at things and determine does this actually work and is it efficacious? And after that stage there'll be actually deployment manufacturing. I'm not going to talk to that right now because it'd be mainly conjecture because we really don't know about that in. My area of expertise is actually in the data collection, gathering and the patient care part. So hope this was helpful. If you want to know more about this, please feel free to drop me some questions in the lines. Share this with friends, family like this. Follow this if you feel like this is useful information. I continue to talk more about the vaccine as things go forward if you want to know more about it. But I feel like that's a basic primer about the actual type of vaccine and how it works. And hopefully I was useful. Y' all take care and be well.
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