Worldwide Vaccine Update and Review of Clinical Trials

You. It's great to be with everybody. Once again, this video is going to review some of the worldwide vaccine updates, what's going on the United States, as well as talk about the Russian Chinese vaccines that are already being deployed and how we do clinical trials here in the United States. That's the summary of this. The reason I'm doing this is the last video I did talking about the FDA recommending states get prepared for vaccination as of the end of October and beginning of November caused a lot of concern with patients. People weren't quite sure what that means. Are there safety concerns? Are we pushing things through that aren't safe? And so I want to address all those issues more from a big picture global perspective and then kind of bring it down to what does that mean for us in the next month or two. That's what I'm going to talk about. If you're interested, please continue on. So first what I'd like to do is talk about what's actually going on in the United States here and then what's going on in Russia. Just first to have a little bit of perspective. August 11th, the United States government put out about $1.5 billion in into some of the RNA based research into the COVID vaccine research information. The thing about that is they've also recommended pre buying $1.9 billion worth of the Pfizer vaccine. So the United States government is putting a lot of skin into the game for this and because of that things are happening super fast. The expectation is the Pfizer study of about 30,000 patients will be done soon. The Moderna study of another 30,000 patients will be done soon. The AstraZeneca study in the UK Oxford, UK will be done soon, maybe within the next two to four weeks. And so on knowledge of that. The FDA said states get ready for late October 1st November deployment of the vaccine to some people. So, you know, the biggest driver force of this has actually been the large amounts of funds that are being supplied by the United States government to all three of the major vaccine trials. The concern is is this safe? Is this causing too much stuff to happen too quickly? Are we missing out on things? So I want to compare this to what's going on in Russia and then come back to what's going on here. So in Russia they actually skipped their phase three trials. So their phase three trial actually is deployment to the Russian people for efficacy. Putin even said, hey, his daughter got it. It's got to be safe. Well, is that the case? We're not quite sure. Their phase two study is interesting because there was only about 76 people in their phase two study. It was an open, labeled, non randomized study of healthy adults between 18 and 60. So here in the United States, we do randomized, double blind, placebo controlled trials to verify efficacy and safety in phase three. That was the phase two, which is typical. They're deploying a vaccine based on 76 people being exposed to it, which is concerning, absolutely. But that's Russia, not the United States. They're calling phase three Sputnik 5. They have two formulations. You know, they're looking for all the same things we're looking for in our phase three studies here. The difference is it's being deployed to the Russian people. And there is some talk that Mexico might be getting as well as a part of a way to get the vaccine quicker. The issue with all this stuff is that it appears that the vaccine by other countries may be used as a geopolitical tool which is concerning to physicians, concerning to everybody involved. So what's going on in the United States? That's what's going on in Russia. Is that going on here? And the answer is emphatically no. A phase three trial to review research. There's three major phases and I'm going to be putting links on the video so people can verify everything I'm saying. So a phase one study in the United States usually is for safety and dosing. You might have anywhere from 20 to healthy adult, healthy adults, and it's a couple months. Only about 70% of drugs go on to phase two, which looks for further safety, efficacy. Sometimes up to a couple hundred patients. In the case of the phase two in Russia, you know, 72, 74 patients, and about 33% of drugs go to the next phase, which is phase three. Anywhere from 300 to 3,000 patients will go through this. It can take one to four years for this study to be finished, typically. And then the drug has to be manufactured. You have to create supply lines. And so it might take two to three years before a study, a medication makes it to market after this. So I do have clinical research company. We've done over 60 studies over the last 10 years. And there's been multiple drugs that my research company has done studies on. Great medications I thought were great, like Victozo, which is a diabetes medication. And then the drug reps come around to sell the medication to me one and a half to two years later, so far later, that I've totally forgot about the medication. I'm like, wait a second. Did I do this study? That's the typical timeframe and that's what people are kind of used to. And then phase four is post approval studies. That is, we keep on watching the population. That's how we picked up things like Vioxx having issues, if you remember that. We continue to watch drugs decades after they put it on the population. That's the standard of research protocol here in the United States. So what's unique about this that's going on is there's a lot of risk here, a lot at stake here. So what's happening is the federal government is funding the major companies to take major risks. And that's what we're seeing, is major companies taking major risks. So at the phase three, we're seeing the drug development happening at a rapid pace and we're seeing the manufacturing processes occurring at the same time. And now we're seeing FDA tell states to get ready for deployment. Usually these things would not happen in parallel, they would happen sequentially. And it would take two to three years for anything to go through. Because you don't want to prepare manufacturing, prepare drug reps, prepare physicians, prepare states for a product, spend the money if the drug is found not to be effective. And that's what's happening right now is that everybody's saying, look, we're taking a massive gamble. If this medication makes it through a phase three, it's found not to be effective, we're wasting a lot of money. Which is what the statement last week that Pfizer, Johnson and Johnson, and then I believe it was AstraZeneca came out and said, we are going to be doing extra patients, extra study stuff to make sure this vaccine is safe and efficacious. And these three major studies each have 30,000 patients. So by the time all three are out, there'll be over 120,000 patients that will have been exposed to this vaccine. So this is probably going to have more safety data than, than any other vaccine that's ever gone out there in the market. So I think if you keep things in perspective, that's super, super helpful. Also when you have phase one, two and three studies, they're human studies, not animal studies. Animal studies are all the pre clinical stuff that happens before this phase. That's another misunderstanding of what's going on. So we talked about the Russian study and we talked about clinical trials in the United States. And so what's happening now is the three major companies are finishing up their studies, probably will be done with the actual Phase 3 trial by mid to late September and then the data has to be crunched. Staticians have to look at it, the information has to be presented to the fda. And the FDA actually put out a statement saying that they want extra strong proof of the safety of this vaccine because of how fast things are happening. Which is one of the reasons why some of the major manufacturers are actually trying to get more patients in to make the data points for safety stronger. So that's what's going on right now. Saying we're preparing for a vaccine deployment in November does not mean it's going to happen. It does not mean that the phase three trials are going to be stated to be ready. It doesn't mean that everything's going to work out the way we expect. It's just saying we're doing all these things at the same time. Instead of taking two years for this to happen, it's happening over a period of months. And that is exciting. And it's also concerning people like myself. When you see the data, whoever your doctor provider is, that's why want to see the data, want to read the FDA what their final statement is on this, as any practitioner should. So, you know, this is a, this is an interesting, this is a first in a lifetime historic event. We all should realize that we all should have be careful. But we all should also should realize that things are happening as they usually happen. It's just instead of happening sequentially over the period of years, things are happening in parallel at the same time. And companies are taking big risks and the government is actually putting out large sums of money between the three studies. It's almost $4 billion either guaranteed pre purchases or actual money being put out on this research. So there's a lot of things at stake here because we're talking about a worldwide pandemic and that's one of the things we kind of expect governments to do, whether it's the WHO or the UN or in this case, these are mainly being sponsored through the United States government. Then the next question is how are these things deployed? We have no idea. We have no who will get these first? Will it be first responders? Will it be school, teachers, etc. That's to be discovered? We don't know quite yet, but hopefully this was helpful to help you understand what's going on with the vaccine development. I know there's a lot of misinformation, a lot of concern and fear out there. I think that's understandable. But the way we dispel fear is with knowledge. And you want to dispel False knowledge with true knowledge. And that's kind of, you know, where we're at. Hopefully this is helpful. Please share this if you feel like it's helpful. I've been getting lots of questions. You know, we've done lots of videos to date over, I don't know, over 40 or 50 videos. I'd recommend people refer back to those for information. Things have been changing as we've learned new things and we continue to share. So continue to watch us continue to share. Continue to click the little like button. I know I got some unhappy faces about the last week's notification. I'm trying to notify people what's going on. Me informing people should be helpful. It shouldn't be discouraging, it shouldn't be negative. That's what I'm doing. And so if this is not a source you trust, then you should find a source you trust that you can feel like the information is useful, that the people giving information are doing it objectively. And you should find two to three sources so you can compare and contrast. Because I don't know everything. And any researcher that says they do know everything is not read enough to know that they are just covering the surface of information out there. So, anyway, y' all take care. This is Monday on Labor Day, so I'm gonna hopefully go back to some family time here after I do a little more research on a few things. And the kids finish school downstairs because we're doing school today because we're at home and we gotta do some school anywhere. Anyway, y' all take care, be safe, be well. Dispel fear with knowledge, with information, and sometimes maybe just unplugging for a while from all the chaos will help you gain a little bit more sense of ease and rest. And if that needs to happen, maybe that should happen as well. Anyway, take care, be well, and we will talk to you soon.