Booster dose, Food and Drug Administration, Emergency Use Authorization, Vaccine, Pfizer want super immunity against COVID? 5 Scientific Questions after Biden's Vaccine Mandate

So this weeks, video topic is about president bidens vaccine mandate, announcement or executive order. Now i know this executive order has generated a lot of political debate on this topic. Now, since im a scientist, i want to make this video more scientifically focused on some of the questions or concerns that has come about because of this mandate, so without further ado lets get started. Music first lets have a quick summary of what the mandate is. So basically, business with more than 100 employees will have to follow this order or submit the weekly testing results of their unvaccinated employees now fail to comply will face a 14 000 fine per violation. In addition, every federal, employee or contractor will have to be vaccinated and there is no testo option now thats approximately 100 million adults in the usa – and i am one of those 100 million people, but i think many of us have already been vaccinated because of the Employer mandate, but that still create a few questions of concern and the first one is that how does the mende affect recover? The covet patient with natural immunity so about two months ago ive talked about how natural immunity compares to vaccine immunity and the lincolns there. You can check that out. The short answer is that natural immunity is not bad. Although the natural immunity drops, after a few months, the immunity stabilizes within a year – and this paper basically tells us up to eight months, the immune, logical memory are still there and, as time goes on, the length will probably be increased and showing how long the immunity.

Last, in naturally recovered patients, but then what we are asking here is what happens when previously infected or recovered patients are vaccinated. There are at least two studies that have looked into this question. Both of these studies basically concluded that, when natural immunity to source cov2 is combined with vaccine generated immunity, a greater than expected immune response arises, so, basically, you can think of it as a super immunity against the covet. The reason is that the memory b cells are gaining more diversity from different exposures, first, exposing to the whole virus and then exposing to the spike protein delivered by the mrna vaccine. And this enabled the b cells to be able to produce antibodies. That can bind to different areas of the virus now with the delta variant. I know there are increasing breakthrough infections after vaccination, so when the case is reversed, what happened is that we could probably expect a similar booster immunity like having um infection and then getting the vaccine. So what we are looking at is in this case is one plus. One is really greater than two in this case having a super strong immunity against covet when you combine infection, recovery and vaccination. So here comes the ethical question: now we know that naturally recovered patients have pretty good immunity against the suscov2 virus and with just one additional dose of the vaccine, it can basically boost the immunity to a super high level. But when the mandate comes, we are talking about everyone in that population need to get at least two dose, or maybe even three doses in the future.

Now, thats a lot of vaccines for people who may not need it or may not benefit as much, but when were looking at the covet as a global pandemic, many people in the world still lack vaccine access. Should we be using additional doses for people that may not need it thats, a question that we have to ask ourselves now here comes to the second question: how will the mandate affect the booster or the third dose decision now when youre looking at the decision for The third dose or booster dose, no matter how you call it. We need to look at efficacy and safety, and so far the fisa vaccine is only approved for the two dose regimen and the third dose is still under emergency use authorization and it will require a supplemental biological license, applications to prove its efficacy and safety and, according To the press, announcement from the fda pfizer has already submitted their supplemental biologics license. Applications to them for the third dose of its covet 19 vaccine in people 16 years and above and fda will meet september 17th. This coming friday, if you are watching it before september 17th, to discuss their decision on their full approval for pfizers third dose covert vaccine. They also intend to release the background material to the public, at least two businesses days before the meeting. So i will keep an eye on this in the next few days now notice that this uh meeting will be webcaster from the fda website.

So the link there i provide to you will probably be able to direct you to the meeting. It will be live streamed and if you have time everyone should go. Look at that and to be honest based on everything that is happening at the government level, i dont think they would disapprove the third dose right so the fda. It will likely to approve the third dose for everyone above 16, and when it does, it would imply that everyone under demanded the 100 million people, will be required to receive the third dose eight months after their second dose to be considered as fully vaccinated. Now, even though the fda approved would imply, the vaccine is safe and effective for the most part, but its still hard to argue mandating. The third dose could benefit the lower risk of population, and here is the big dilemma for us to think about again. Is that people could benefit most from the third dose? Are people who are over 65 years old or older people in general and with other health risk factors, but at the same time they are not the major workforce out there. However, the 100 million people who are covered under this mandate are working and a lot of them are less than 65 years old. So that is a problem like we are mandating the vaccine for people that may not most benefited again and we are leaving out some elderly people who could or who should use the third dose now.

So that is something to think about and also lead to our next question. So far, weve only been talking about pfizer and pfizer. I know that and how will the mandate affect people who had received the modern or the johnson johnson vaccine? Now? In fact, i received a modern vaccine and actually most of the people that i know received the modern vaccine and my wife had the johnson and johnson vaccine and so far both moderner and the johnson johnson covey19 vaccine is still only under emergency use authorization and we Know that there is no direct safety efficacy data on mixing code vaccine yet because theres still a clinical trial that is going on and trying to determine the efficacy and safety about mixing vaccines. And here is a direct quote or statement from the cdc website is that cova vaccines are not interchangeable at this time, because the data on safety and efficacy of a mixed product series have not been evaluated so for moderna and johnson johnson covaxian recipients to be considered Fully vaccinated in the near future and comply to the mandate, the fda will have to follow some same routine procedure and both vaccine would need to be first approved for the original dosing regimen. That is two dose for more donor and one dose for the johnson johnson, and they would also need to submit another application for their booster dose or their next dose. At the very least, it need to be authorized for emergency use, and this process does take time and require rigorous review.

Now, when we are talking about reviewing the data, i think this is even more ambiguous now, for the science part is the fda settling for less now. What we are looking at here is a table from a journal that i pull from the british medical journal. Now it provides a nice summary of what is the original endpoint or primary endpoint of all the clinical trials. That was happening with all the kovic 19 vaccine now notice that the original physical vaccine phase 3 study primary endpoint is to prevent symptomatic covet 19 infections, and i highlight it in the box circle thats for pfizer. But when youre looking at moderna, astrazeneca, jensen or johnson, johnson and even other vaccines that are not available in the u.s were still looking at yet the why they are only looking at the prevention of symptomatic disease during the phase 3 trial. So that is the primary endpoint and unfortunately, with the delta variant and the waning effect of the antibodies. We know that vaccinated people now are having breakthrough cases and we dont even know uh the precise number for mild and moderate uh cases in the vaccinated populations. On a national level, because the cdc are not tracking anymore right now, the focus on vaccine seems to be preventing severe disease hospitalizations and death, which is still very, very important, and we know that one of the latest report unvaccinated people having a higher risk of dying About 11 times now, but at the same time when were looking at the clinical trial design in their phase 3 trial, they are not looking at these severe disease hospitalizations and deaths as their primary outcome.

So there is a little bit discrepancy between what they were trying to do and now what is happening at this given time now, the question is: is the fda shifting this finishing line for pfizer so that it can get approved? Well, could that be the reason for the two experts to resign from the fda panel now? That is something for us to think about again and the last question i think a lot of you will ask: how would the mandate affect people wanting a non mrna vaccine that is not a pfizer or not a moderner, and back in june i made a video About novovax, which is a protein based vaccine, and i have seen a lot of people left comments and hoping to get novavax vaccine because it is more traditional technology, and just this friday the company announced that they are still on track for emergency use. Authorization application with the fda in the fourth quarter and part of the reason for the delay is the manufacturing challenge and in fact it takes a lot more steps and time to make a purified of any type of proteins in the lab than synthesizing mrna or even Dna in the lab now here comes to concerns and question again. When the mandate requires more people to be vaccinated, it means fewer and fewer people would be eligible for the novel vaxcova vaccine and it would likely upset many people who are really hoping to get this vaccine instead of the mrna vaccines.

Now, as a result, novavax will probably find its market outside of the u.s and maybe only as a booster shot in the states. So clearly, the non political debates or concerns on this topic is more than the five points that i just talked about, and i would really appreciate if you could leave me a comment, and let me know what you think and, like i said the beginning of this Video, the vaccine can boost the immunity of recovered people to a very high degree, but the question is: do we really need that additional boost when many parts of the world still lack vaccine access? I know this is a very heavy topic and as much as i respect everyones individual choices, our government appeared to hold a different opinion at this point. Anyhow, that is all for this week and if you would like to continue to follow my covet 19 update and learn more about other health science topic, please consider subscribing to the channel. This channel needs your help to reach more people and thats all for this week. If you enjoy this content, please comment like and share and ill see you in my next video.

What do you think?

Written by freotech


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Booster dose, Food and Drug Administration, Emergency Use Authorization, Vaccine, Pfizer COVID-19 Vaccine FAQ’s for the General Public