vaccine update and novavax 62bc4a32ea837

Vaccine Update and NovaVax

Novavax shows promise in UK and South African Phase 3 trial numbers so are. We are closer to getting Johnson and Johnson’s vaccine in the U.S. Variants are a big wildcard for the current vaccine programs.

Oh hi, this is Dr. Jeffrey Mark. This week I’d like to talk to you about a new vaccine or vaccine that you have heard of that was not quite ready to report results through phase three results but this week they did report some preliminary results from their phase three studies from Britain or the UK, and this is with NovaVax. Now Novavax is different than the other vaccines that we talked about, which include Pfizer biotech and Moderna, which are messenger RNA technology based vaccines, which technically is not d true vaccine in the traditional sense, but here you actually are the factory that makes the spike protein and then your body reacts to the spike protein that you actually make. And then you build protection from that. AstraZeneca, which is basically a DNA based version from an adenovirus from the chimpanzee that gets infected and those are the delivery systems that we talked about previously. But Novavax represents more of a traditional type of vaccine, meaning, there is no genetic material for you to make anything. The material has already been made and presented to your body and recognizes this form. And therefore, your body reacts to it creating the antibodies and hopefully T cells and memory cells and other things like that so that it’s very much similar to the technology that’s been used to make other influenza vaccines. The human papillomavirus or HPV vaccine and also based loosely on Hepatitis B vaccines as well. So there is a presentation of the actual antigen or protein. Using nano particles are particles that are bits and pieces of the actual functioning unit, but without the rest of the unit just a small portion of it. So it’s a non functioning unit, I should say. There’s no way that you could get an active virus from this because this also uses the spike protein as well. So let me show you. Let me describe briefly how this works. So Novavax had started their phase three trials a little bit later toward the end of December, here in the US but they also had some trials going on in the UK Britain and South Africa, and it looks like a very promising results, meaning it produced a robust response with the antibodies and 89 to 90%. So over 89% or 89.3% of the recipients that were vaccinated, were protected from serious COVID infection. Much like Moderna  and Pfizer but without the recombinant messenger or DNA component. And NovaVax  had actually started their trials in May initially with phase one and then in June the US government had granted them $1.6. billion. In July, August, they did their phase two trials in South Africa, which we’ll talk about in a minute as well. And as you know there’s a South African variant. And it was found that unfortunately like Madonna and Pfizer BioNtech vaccines there was only 50 to 60% effective in the South African population that was enrolled in the study. Now it’s kind of interesting and that those that have HIV, which is a larger population of HIV in South Africa, had closer to the 50% or so response and those that are not HIV infected had response closer to the 60% response, which actually is still considered a good response. And in fact, meets the criteria for the CDC and FDA to approve a vaccine which is greater than 50% efficacy, but of course not near the 90% or the 95% that some of the other vaccines have as well to the original SARS-COV-2. But, they’re looking at creating a booster vaccination even as we’re speaking and the hope is that this additional spike protein modification based on the South African variant can make it in time by April, May or June when. Hopefully they get approval from the FDA to have the emergency use authorization for injection and administration. And so that would be that would be helpful but right now it is a two injection process as well. Injection on day one and then 21 days later. So, let me tell you exactly how this works and it’s pretty much what you have heard about from basic vaccines that we have right now. So, the coronavirus has spiked proteins.. And these are the proteins that allow them to bind to the ACE2 receptors to get a foothold into the door of the respiratory cells first and then eventually spread and manufacturer itself once it infects the host cells and cause problems with the cascade of cytokine and cytokine storm etc that we’ve reviewed and know about with a possible coagulation cascade as well. So we, again, the developers at  Novavax picked the spike proteins. And what they did was they selected the specific spike proteins from the first generation, or the original SARS COV-2 and they inserted the gene to make the spike protein into baculovirus, which is an arthropod virus that infects, so it doesn’t affect any humans are mammals and other things. So they infected it into a moth cell and like any virus it took over the genetic engine of the cells they started replicating the spike proteins which began to congregate together in the cell. But, they assembled at the cell surface of the coronavirus that is the typical SARS call to cell RNA virus. And so what happens is that they can’t cause infection. But they align the spike proteins outside the cells. And then what happens is that there’s a well- established harvesting technique that’s to harvest the spike protein. The baculovirus has also been used to make influenza vaccines. This type of vaccine is based on using virus-like particles, or in this case nanoparticles, well-established with using bits and pieces of the influenza virus or the human papilloma virus or the hepatitis B virus. The baculovirus infects the moth cell, the moth cell builds the spike protein, the congregate and can be extracted, then nanoparticles hold them in the correct position, and then antibodies can be made against this structure that will protect against the real fully intact and functional virus. Remember these  nanoparticles are  not active and can’t form a full virus. And then what happens is that the vaccine is created by mixing these nanoparticles with an extract from the soap bark tree. And this compound makes the immune cells much more stimulatory meaning it’s kind of a poke in the face or a jab in the arm. If you want to stimulate these immune cells because it gets them alert, angry, ready to respond or defend. And that’s what happens when you get the injection. They see these nanoparticles with the soap bar tree extracts and they start to react. So they immediately engulf the nanoparticles. And they break up and the spike proteins are then inside the cells. And once they’re inside the cells. The start to recognize this is a form of protein, and then it presents to the outside the cells and then there’s these T cells, T helper cells and recognize these foreign antibodies foreign antigens, which is a spike protein, and then a B cell comes and they actually will look at these activated T cells are presented to these B cells, and then the B cells start making antibodies against it saying, thinking that this is going to neutralize that foreign antigen which it does. And then it makes lots of these antibodies and has a vigorous response as the studies have shown. 89.3%, or more of people have protective antibodies that limits any severe disease and the nice thing about NovaVax as well is they did not have any significant serious side effects on people that even ministered to this group in the UK, or South Africa. And the additional thing that is stimulated is that there are these natural killer T cells that if the coronavirus does happen to get in or they search out to see these spike proteins that are floating or ingested inside cells they also can be activated and learn to kill the cells, and they also have memory. T cells hopefully that will form, and we don’t know how long these would be available, we know that we think that there is some memory T cells on T four T cells that naturally occur with the natural infection. We know the antibodies dissipate or decrease after three months or so, maybe up to four months, but the hope is that these memory T cells are there, that if there’s a re infection, they get reactivated and can make more antibodies. So, it is protective in that the spike protein, if it presents, like if you have someone that has the vaccine, especially Novavax, and they’ve been exposed to the coronavirus with the spike proteins and they have neutralizing antibodies to spike proteins, they bind to this bite proteins and spike proteins, no longer bind to the ACE2 receptors because they’re already occupied. And  the entry point is blocked so they can’t get into the cells and that’s where you get the protection. So, this looks like a very promising alternative to the Moderna, and to the Pfizer biotech options, and is  more of a traditional approach, something that we have many years of experience in the case of hepatitis B vaccines decades of using this type of vaccine. So, of course, having more vaccines available is good. Unfortunately, we already know that being that this already needs to be modified for the South African variant, and there’s a lot of interesting hypotheses and you would think that maybe these more aggressive mutations might occur because in the populations and other populations there may be other immunocompromised people such as people with HIV or that receive other medications because of cancer to suppress immune systems and the concern is that the more time the virus spends in the human body, the more can learn adapt and mutate. Of course we’re  in a race right now, to try to vaccinate as many people, so that the virus does not get a foothold and people to significantly replicate and possibly continue to mutate. But at this point, the concern is that this seems to be behaving like other coronaviruses and other coronaviruses do adapt. They mutate and dislike influenza and the flu, we get yearly injections based on variants that have sprung up in other parts of the world, or from previous after the previous season of the flu. So, with this coronavirus. This new variant of SARS COV 2  and the variance from the UK, which appear to still be controlled with the current vaccine. The variants in California. We don’t have that much details. But, and also is a Brazilian variant as well. The UK variant is believed to be 50%, more contagious and possibly have a higher rate of mortality or morbidity or illness, possibly is as high as 30% higher than the standard SARS COV2 but this is not for certain yet. And the Brazilian and South African variants, also appear to spread more quickly, be more aggressive, and possibly have also more of a morbidity, or mortality. But, again, we’re trying to pay close attention to these variants, but it does put a lot of pressure right now on the vaccination program and all vaccines because they have some effects, obviously some vaccine is better than no vaccine and 50 to 60% efficacy is better than no protection, but definitely a determination, or diminution of the effectiveness of the vaccines that we have. So, this of course changes weekly with more information, and I hope to continue to update you as things come up. But I just want to let those of you that have asked me a lot of questions about their alternatives they have on the vaccines. Some have asked about the possibility of autoimmunity with the messenger RNA and DNA based vaccines. While there is no significant data to support an autoimmune risk, optimizing and balancing the immune system is always helpful.  Information on supporting the GI gut barrier can be found here. This one’s coming on the horizon. The other vaccine coming up is Johnson and Johnson’s vaccine, which is also based on Adenovirus DNA technology as well. Their efficacy ranged from 66% to 80% depending on the population studied or which study you examined.  So while it sounds like it’s less than the other two but it’s still effective and it’s a single dose injection, so that the way that the logistics for administering are much more straightforward and easier. Incidentally, both the Johnson and Johnson, and the Novavax can be kept in regular refrigerator for up to three months at a time, so they don’t need this deep freeze of minus 84 degrees Fahrenheit which is somewhat of a drawback for the Pfizer biontech vaccine/ The Johnson and Johnson vaccine , of course is easier because it’s a single dose the you don’t have to keep track of people to make sure, 21, or 28 days later, that they have a second dose. So that is a definite appeal as well and also Johnson and Johnson has the capability, and they’ve reaffirmed that they can make over a billion vaccines, rather easily because they have this huge capacity. Moderna has had to have outsourcing of their vaccine so there’s some variability, depending on which factories that are making their vaccine.  Pfizer biotech is pretty stable as well in terms of their vaccines.  Novavax we’ll just have to see where their sources will be and AstraZeneca is fairly stable as well but only available at this time in the UK. They have not been through the process here because they have an ongoing phase three trial that was delayed earlier this summer, and then resumed. And so we have yet to get the US data from them. Johnson and Johnson also has recently applied for the emergency use authorization. They may file as soon as next week. Today’s date is January 30 so next week, they may be filing and then maybe another week and a half to two weeks if they have the same FDA approval process as the first two. So maybe in the next three weeks or so. Johnson. Johnson may be entering the picture as well. So again, it looks like many of you have gotten the Pfizer biontech, and the or the magenta, especially those of you older than 65 here in California. And there are more vaccines on the way, as I mentioned Johnson and Johnson maybe the next one that’s maybe close to coming up and then maybe AstraZeneca and or Novavax, but I just wanted to update you it’s been a few weeks. And if you have more questions or comments, you can certainly let us know a

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Jeffrey Mark, M.D.


Our offices are conveniently located in the Bay Area, easily accessible from the Silicon Valley, South Bay/Palo Alto, Menlo Park, Burlingame, Carmel Valley, Santa Cruz, San Francisco, Wine Country/Napa, Santa Rosa, Marin County.  Our office in the Central Valley is located in Turlock and services the entire Central Valley region, including the UC Merced area, Modesto, Tracy, Oakdale, Fresno.  We have patients that travel as far as the Los Angeles area, San Diego, Montecito, and from the Tahoe, Incline Villiage and Reno, Nevada areas, and even as far as from New York.  Now with telemedicine/telehealth services, our services are essentially available wherever you have internet or phone service, even when you’re traveling and on the go.

Jeffrey Mark, M.D.

Helping clients with compassionate and comprehensive medical care for over 25 years with 4 board certifications in functional medicine, gastroenterology, internal medicine, and anti-aging/ regenerative medicine . IFMCP, ABIM Gastroenterology, NPAS Internal Medicine, ABAARM.

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