Johnson and Johnson and Novavax

hi everyone live from warm sunny colorado today's video is a special video as many of i've been following the vaccines for a while as they've been going through clinical trials and there are many many different kinds of vaccines that are hitting the market so the first to hit market were the rna vaccines made by pfizer and moderna and then the next they hit market was the astrazeneca vaccine which is an adenovirus so basically they take a genetically engineered virus usually from an animal close to us but sufficiently far that it's not endemic in humans and then they put viral dna in it and they use that to make something from the virus to trigger immune response and then finally a protein subunit where they take an insect cell that's been genetically modified and then what they do with the insect cell is they have it produce these viral proteins and then they connect them to a nanoparticle that makes it look a lot a coronavirus and then it can trigger an immune response so this week there were two press releases one from johnson johnson and the other one from novavax and the johnson johnson press release i have it right here it says that the candidate is 72 percent effective in the u.s trial and 66 effective overall at preventing moderate to severe covet and 85 effective for severe disease and hospitalization and the other one the novovax trial the uk trial just came to an end and they've unblinded some of the data it's 89.3 percent effective that's the top line and there's some evidence that the south africa strain has there's been some escape from that and so anyway this is incredibly good news for two reasons one is that the johnson johnson vaccine is a single shot platform which means that you just inject and you're done and what we've noticed with all the vaccines that have hit market which have all been two shots is that there's a significantly higher degree of reactogenicity with the second shot what that means is when you get the second shot the second shot tends to trigger a very aggressive response and so people have reported arms being sore for days or weeks fever chills and it's pretty universal that that that's a very strong reaction the fact that you have a single shot platform there's no having to go back and do another thing which always causes problems and second the shots were very well received by the general public now the novovax is a two-shot platform and there was not much said the press release about the symptoms and side effect profiles and these types of things other than it was well received so what happens is that when these companies get to this stage they apply for something called emergency use authorization so what they'll do is they'll go to the food and drug administration they'll say hey we think that this is necessary for a big lost internet there for a second okay get this into market so we can start getting this to to people and so to do that they have to take all the data and put it to a big filing and then it's done in a very open transparent way it's given to not only the fda but it's also publicly available and then a committee will come together make a recommendation then the internal people at the fda will decide whether to approve or reject the eua now the committee meeting is also open and transparent and we've gone through this just last month in december with both pfizer and moderna and those filings they tend to be quite large and a huge amount of data that needs to be parsed the odds are that johnson johnson will apply for eua sometime in mid-february in that data package that they produced that the all the the run-up of what happened during the clinical trial will also become known now one thing i'm very interested to see is that there is evidence of transverse myelitis with and we're not sure if it was either in the placebo group or in the vaccine group but it was apparently just there and that was one of the reasons why the johnson johnson trial was a little late there was some delays as a consequence of that so that's going to be inside the eua package of what happened there and there's probably a few other things that were discovered that happened there so it's going to be interesting thing to look at novofax it's unknown whether the fda will allow them to apply for an eua with uk data there is also a clinical around the united states for the astrozenica vaccine the phase three clinical trial will probably conclude in april to may and it's unclear whether astrazeneca can also apply for emergency use authorization in february off of the uk data set it makes frankly no sense why not because they've already distributed that vaccine to millions of people in the uk and india and safety data looks reasonable although there are some efficacy questions above those over the age of 65. and there's some debates about that both germany and france so why is this important well it's important for two reasons one johnson johnson has gargantuan manufacturing capacity they're one of the largest pharmaceutical companies in the world and this particular platform is very easy to mass manufacture and it's stored at refrigeration temperature and it's also a single shop platform so what that means is that we can expect hundreds of millions of doses in circulation as we exit the spring spring and enter the summer time and those doses are going to be very easy to distribute throughout the world in fact this year alone we expect one to two billion doses produced so having a gargantuan manufacturer be successful releasing a vaccine is great and it's one of the reasons why i was very sad when sanofi and gfk gsk's trial turned out to be a failure because they had equivalent manufacturing capacity and yeah them being set behind by nine months was a very problematic novovex the protein subunit manufacturing process they have they seem to be very confident they can scale that to about 1.6 billion doses by the end of 2021.

now they're saying that they're going to start making 150 million doses a month is what their estimate is going to be as they scale up so the sooner that that can come to market the better now here's the reality variants included including the south africa variant which seems to lower the efficacy of the novovax vaccine the phase 2b trial to under 50 percent if one is vaccinated there would be no pandemic at least a traditional sense this virus would be endemic around the world and people would be getting it but honestly had just the johnson johnson vaccine been well distributed people had taken it we had naturally that level of immunity there'd be no social distancing there'd be no mass there would be no lockdowns because politically it'd be impossible to even have that conversation because the death rate would actually be lower than influenza if you do the math and you take a look at these things the level of production that's being claimed so what's going to happen in the next six months now that we have likely five vaccine platforms which are safe and effective before the end of june is that we're going to see a bottoming of lethality we've already seen this in israel over over half of the israeli population vaccinated and there's a incredibly positive data that's starting to flow out of this process where there's a latency with cases so they still are seeing a high case load and high mortality rate relative populations but within the next three to four months we're going to start seeing those curves move permanently in a very favorable direction and so by the end of the first half of this year if these vaccines can get into circulation especially johnson johnson and novavax then there's a very good possibility that we could see up to a 90 to 95 percent reduction in death that's optimistic but it's definitely doable and possible because the majority of the people who will likely die from this will have been vaccinated and all of these vaccine programs are showing platforms are showing a massive reduction in lethality so that is the first major stage in breaking the back of the pandemic is creating a degree of natural resistance and resilience in the community in the population for the disease as a whole and now there's the question of variance so the best adaptive platforms for variants of the virus the south africa variant or the uk variant and so forth is the the mrna platforms the ceo pfizer and the ceo of monera have both stated that they feel optimistic that they could have a booster shot available within a hundred days that is custom tailored against the uk and south africa variants that are discovered so to stay ahead of this there's two things that need to happen one genomic surveillance has to be done so basically in all developed countries as cases are being detected some subset of them are being analyzed and we say hey we go beyond just testing for covet we actually sequence it to see if it's the same type of code we expect to see or a variant of it and there are all kinds of scientists and techniques and epidemiological stuff that people do to know how to do that well unfortunately united states is number 43 in genomic sequ surveillance we need to be better at that so that gives you a sense of what you need to vaccinate against and the mrna platforms are extremely robust in being able to keep up with the mutations of the virus and it's a very important understanding that even as the virus mutates it's rare for it to completely escape the vaccine efficacy so what will happen is that if you contract the virus instead of it being a serious case if it was going to be a serious case it would still likely be a moderate to mild case and in many cases the the frustration with the variants are the lack of sterilizing immunity so normally you'd have it meaning that you don't spread it to people but you lose that because of the variant but you still have enough cushing in the in the immune response that it's not going to be a major problem so this pandemic is is going to be broken and i think in the next six months massive inroads and strategies are going to be made the world is going to get consensus on genomic sequencing and their surveillance and they're going to get to a point where we have the ability to modify the vaccines to keep up kick keep up with the mutations now modifications do not require new regulatory approvals such that you have to go back through a stage three clinical trial they don't for influenza there's no reason for them here so what's likely going to happen is that these vaccines towards the end of the year will be updated and rolled into likely the influential influenza platforms in fact this has already been suggested by the ceo of novovax saying they have an influenza platform called nanoflu and what they want to do is blend it with the novovax vaccine so the first step is get as many people vaccinated as possible ideally 70 to 75 percent that would break the back of the lethality of the disease and massively slow the spread slower spread less mutation less mutation less variance that can escape or develop some degree of resilience against the vaccination platform then genomic surveillance they basically get a good idea of the different strains floating around or variants floating around and then you can modify the vaccines within three months to target these new strains or variants and then give people boosters towards the in the ear there's still the doughnut hole of the developing world there's simply not enough vaccines to go around there so that is a problem because the virus will continue to mutate so it's very possible that coronavirus will be with us for decades if not forever if we do not find a way to vaccinate people in the developing world so the good news is that when we say with us forever the cold the common cold and influenza has been with us forever it's not really a huge problem for most of us so as strains common variants come the odds are will because it's no longer novel and the community has a high degree of resistance that it's not going to have the same impact that it had before so in other words i think by the end of the year the world is coming back to normal and the world's back to normal in 2022 but coronavirus is going to be part of our vocabulary forever and we're going to see a source code v3 and 4 and 5 that continues to flare up because of a lack of a global vaccination campaign that said there's probably going to be a blending as i mentioned with the influenza vaccine and the vulnerable will get vaccinated and then there's no political appetite for lockdowns or mass or social distancing when your disease is a hundred times less lethal than it was when it first came out so this is a huge huge step forward for the pandemic the fact that these two vaccine platforms appear to be both safe and effective and that they belong to manufacturing capacities in the billions many many more will come online in the second half of 2021 and we're going to get much better at mass manufacturing mrna in fact the vaccines in fact pfizer is already examining how to convert their vaccine to a freeze-dried vaccine so it can get rid of the deep cold requirements that they have and these platforms potentially could be placed into local manufacturing facilities like what kirvak is doing which is a german company that does mrna now why do i care so much about this i care so much about this because i want the world get back to normal and i want people to be able to travel again and i want businesses to reopen and restaurants to reopen and sending politics of the matter aside and the the insanity of these government responses the only way politically the world is going to come together and agree to reopen is when vaccinations or herd immunity has reached the level where and death rate has plummeted enough that it's politically palatable to do so so in essence vaccines are a mcguffin that politicians can latch on to and a target that politicians can latch on to and say okay we've reached the magic number we feel okay everything is back to normal now that's rosy colored glasses because there's a lot more to do and even after things are reopened the reality is the economic damage of this is tremendous in every respect and there are tens of millions of people suffering from long covet neurological conditions destroyed lungs permanent damage to their heart and other organs and what's going to end up happening is a whole subfield of medicine is going to form specifically the tree long coping government investigations class action lawsuits scandals corruption investigations you are all going to see this next five years to 10 years to basically clean through it you can't have an event of this scale and not have massive amounts of opinions on the matter the good news is that this has pushed medicine as a field the science of medicine ahead by decades especially the science of mrna vaccines in the science of technology in general so the whole point of making vaccines and deploying vaccines there's going to be a wave of innovation in that field that is unbelievable it's a golden age for it why should we care because i think within my lifetime there's a very good chance that we'll see dozens of cancer vaccines as a result for this that are custom made specifically for you the individual if you contract cancer i think within my lifetime we will also see an hiv vaccine as a direct result of this the field of virology will also gain tens of thousands of new researchers because of people inspired by this and the knowledge of virology will become far more global and so much more research will be done there's also been a great acceleration because of the wave of preprints in medicine of analyzing medical research faster also there's going to be a deeper discussion about emergency youth authorization and a deeper discussion about approving medicines faster for people and including fast review of old medicines when pandemics occur so all things considered there's some light at the end of the tunnel for everything that's bad you get something good and this is no different and we can always choose to look at a glass half full instead of a glass half empty but i am optimistic that the trends will continue my own country the vaccination rates 1.