2019 Novel Coronavirus (CoVID-19): Part XXII
2019
Novel Coronavirus (2019-nCoV (first named); COVID-2019 (later named
disease); SARS-CoV-2 (final name of the virus causing COVID-2019),
COVID-2019 Pandemic:
August 23, 2021 update Part 22
Paul Herscu ND, MPH
Herscu Laboratory
Entering the third phase of this pandemic (Part 1 of 5)
A piece for those who have been vaccinated
Hello and welcome. It has been a while since I have written. We have just now arrived at the third phase, of my 5 phase stage of this pandemic. I imagine many of you are feeling frightened, angry and frustrated, as well as simply confused. Things have not gone as well as they should have. The question is how to proceed from where we are. I am bombarded by questions from family, friends, patients, and students. I would like to discuss several major aspects to help the general discourse. This is a difficult task as at this time as there are two paths, one for those who have been vaccinated and one for those who have not been vaccinated. As a result, I would like to break down the writing into 5 separate posts. They are:
1. A piece for those who have been vaccinated
2. A piece for those who have not been vaccinated
3. A piece on effective natural therapies
4. A piece on other pharmaceuticals
5. A short recap
Herein, I begin with a piece for those that have been vaccinated:
I include here all people who have been vaccinated with one of the four vaccines, produced by Pfizer, Moderna, Johnnson & Johnson, or AstraZeneca. I have some experience with several other vaccines, but my experience is too limited to discuss here. I am not avoiding those other vaccines, or being western-centric. I just do not have enough personal, clinical experience to discuss them in a practice-based fashion. For those who have taken one of those other vaccines, I hope that this discussion may still be of use to you. Also, I am leaving out adverse effects here, as that is a different topic that I have covered exhaustively for the past 30 years, and specifically again in April, May, and June of 2020, almost a year before the vaccines became widely available. Please refer to that previous writing to read about how both viruses and vaccines impact people based on underlying susceptibility.
What do we mean by efficacy, what was vaccine efficacy really supposed to be?
The news is full of reports of 'breakthrough' cases, people who were properly vaccinated but nevertheless caught the SARS-CoV-2 virus. I want to address this first, as both the government and the medical community keep skipping over the main point here. I wrote on this from the start, and the vaccine makers also wrote of this initially. Efficacy was supposed to be determined solely on the number of people having to be hospitalized, having to go on a respirator, or dying. All the initial vaccine trials, and the trials that were submitted to the FDA were based on this end goal. The FDA looked at and then allowed the vaccine to be marketed under emergency use based on this end goal.
As I wrote about this point last year, sadly, neither the FDA nor the vaccine manufacturers looked at transmission rates in those who had been vaccinated; that number was not considered. Efficacy was based solely on hospitalized or not hospitalized, intubated or not intubated, dying or not dying. And measuring the outcomes in that way, there were enormous differences between those who were vaccinated and those who were not vaccinated. For this endpoint measurement, there is not much debate on efficacy. Very clear. But the main point is that 'breakthrough' cases or cases where there was transmission, where the patient was asymptomatic, or only mildly ill, were not counted or even discussed.
Relatedly, when they looked at the severe version of the disease, they found that the vaccine worked pretty darn well, not 100%, but in the mid 90 percent. When you take both these facts together, one should expect to see 'breakthrough' cases just as were seen in the initial studies, and in the documents sent to FDA for approval. Which means that now when you read about this person or that person catching SARS-CoV-2, despite being vaccinated, this makes sense. (Now, please hold off with some other comments here, until reading further.)
Length of efficacy
This is another variable I wrote about, though public health authorities did not do a good enough job explaining it to the general population. Let me backtrack for a second. There are essentially 2 types of vaccines, ones that seem to work for an indefinite amount of time, lasting for decades, and then some that work more temporarily. Put another way, there are vaccines that you might take a few times and then not again for a very, very long time. Think polio vaccine. And then there are vaccines that are taken annually. Think here the influenza vaccine. Please note I am not writing about whether you should or should not take vaccines. Again, this is not the point here. I am trying to keep this section on just one point. Some vaccines are ‘one and done,’ and some have to be repeated. In other words, what we are discussing is the length of efficacy.
There has been and continues to be a disconnect between what the vaccine was supposed to do and what most people were expecting. Let me repeat my point from last year. The current set of vaccines were not designed to be ‘one and done,’ but were designed to be repeated 'frequently.' How often they would be needed was not known at the time, but for sure it was going to be frequent. My rough guess last year was somewhere between 6 months and 18 months-possibly 2 years, with my best guess being around a year. I wrote about this then.
The problem is that in most people were thinking, "Should I or should I not get vaccinated?" as if it were a one-shot (or for most, 2-shots a few weeks apart) deal. You see the problem? There was and is a disconnect between what the vaccines were supposed to do and what people were thinking about. EVEN THOUGH the vaccine makers clearly stated that this vaccine will work for a period of time and then stop working. In fact, I remember one of the vaccine makers saying in late spring, 2021, that they assume this will be an annual vaccine. This was and continues to be a clear disconnect for the population based, not in small part, by the messaging from public health authorities, who were zooming in on the urgent need for vaccination. Period.
I wrote and lectured a fair amount on this topic, especially focusing on the specific danger that was considered at the time, which was developing a vaccine that would continually regenerate, the self-replicating mRNA vaccine. I wrote about my misgivings and asked you all to write vaccine makers to put a halt to this form of vaccine development. Strangely, likely due to pressure from members of the scientific community, that research they did stop! Okay, so the main point here that I want to focus on is that the current Covid vaccines are only meant to last for a 'short' period of time. (Now, please hold off with other comments here, until you read further.)
When were you vaccinated?
Clearly, then, an important question to ask is not, have you been vaccinated, but when were you vaccinated? The science is both complex and simple. Assume you get vaccinated. Assume it works, and you are protected. This means that you have made enough antibodies so that exposure to the germ will be met by antibodies and you will not become severely ill. Antibodies are present in a certain amount, at a certain point in time. After the vaccine, antibodies rise, and then in typical circumstances, they begin to drop, and continue to drop until there are not enough to successfully contend with the virus. At that point, you may fall sick or severely ill with exposure. That is what typically occurs with the short version vaccines.
Which means, at this time, we should be asking WHEN were you vaccinated? In other words, is it still likely that you have antibodies or not? But if you consider all the different places you have traveled to or visited, including flights, work, shopping, entertainment, or social gatherings, where you are asked for proof of vaccine, the date is not looked at. Asking if you have been vaccinated is the right question to ask only if it were a ‘one and done’ situation. The question this time may well become, WHEN were you vaccinated?
Testing deemphasized
Regarding path-dependency, one of the issues with society picking the path of vaccines is that as a society we deemphasized other variables, such as testing. I highlighted from the very beginning that testing be another essential tool for public health, but it continues to be deemphasized. For example, when you read comparisons of breakthrough infections or recurrences, in both instances, they leave out when the infection or the vaccine took place and what the antibody levels were at the time of reinfection or breakthrough illness. In the language of statistics and science, there are latent subclasses that are getting jumbled together with an imprecise understanding of what is actually occurring. This paints an incomplete picture and going forward, it would be helpful if this could change.
I guess I should give an image as an example. Let’s take the game of tennis, the ball is hit over the net to you and now you have to hit the ball back, to return it over the net to the other side. It is a bit like that with the immune system. Either the virus or the vaccine are like the ball being sent over the net to you. Now you have to send it back over the net. The way you do that is by creating antibodies that are similar enough, and enough of them to meet the ball. It could be that your body is not able to make these antibodies. It could be that the drugs you take keep you from making these antibodies. It could be that you are too old or infirm to make these antibodies. It could be that the vaccine or virus hit the ball too many months ago for you to still make these antibodies. The point here is what we want is to know if we are currently making these antibodies efficiently enough. (And here I am keeping the conversation only on antibodies and not the whole immune system, as that will be discussed in the natural therapy post.)
Increased cases of breakthroughs are coming
Taking the above points all together, what can be said is that, in the best-case scenario, with the vaccines that we are using, and having them work as intended, we will see efficacy for a half year to 18 months (my guess), by which time antibody levels drop low enough for breakthrough cases to rise. Put another way, if everyone who has gotten vaccinated does nothing else, after so many months or a year, they may be exposed and have a breakthrough infection. As that is the situation with most of us, this means that within the next six months you are going to see MANY instances of breakthrough infection! For me, that is not just likely, but a certainty. This was predicted by the type of vaccine manufactured.
An added wrinkle, viruses mutate
As mentioned in almost every one of my posts since January, 2020, viruses like every other species, mutate. These mutations may be small or large, but as mutations add up, they may change the virus to the point that the antibodies you produce from the vaccine are no longer relevant. In other words, over time, the antibodies created by having the illness or taking the vaccine may be ineffective towards the virus that has since emerged. As I am write this, the Delta Variant is dominant, but that too will change. Life changes. Life adapts. Viruses do as well. Adding this variable to the above variables means that, over time, the antibodies drop but also that over time, the antibodies may also become less effective towards a virus that has changed enough to escape the antibodies currently being made.
There is more science to delineate, but this captures enough of the confusion and offers a roadmap on how to proceed for those who took the first series of vaccination.
For the population, as a whole, the vaccines worked as intended
As I write, Florida and Louisiana ICU and emergency rooms are flooded with cases, and hospitals in general, are running out of space. Again. And almost all of the patients at this time have not been vaccinated. At this time, finally, liberals, and conservative both agree that this is the case, and the narrative that there is no such thing as this virus, or that it is not dangerous, or that it is all false diagnoses, is, for the time being, put aside. The only people still working on conspiracy theories are conveniently not looking at the disaster that hit India, or any of the locations where the virus went super-epidemic. There is ample evidence to show the efficacy of the vaccine in these early stages is very, very high. This is why you did it, to contend with the first waves, in terms of preventing severe illness, avoiding long-haul symptoms, and preventing death. Many unvaccinated people are getting really sick and are dying, and you are not, for the most part. That is why you took the vaccine.
Divergence
I will come back to this point at a later time, but wanted to say that as time progresses, the overall mortality rate should drop. So, while at first, mortality rate was high for closed cases (where the patient either recovered or died) as high as 10%, and then settled by the time of designating this as a pandemic, it had a mortality rate of around 2.5%, I thought that as time progresses the mortality rate would eventually drop to around 0.5%-1.0%. We are still far from this but getting closer and closer. What do I mean by this, in practical terms? What you will find is a divergence between the number of people infected and the number of people who die. We are seeing this in this most recent upsurge of cases. If you look carefully, you will see that while the overall number of cases is starting to skyrocket, the number of people dying is, while more than a few weeks ago, not growing astronomically as it was last year. Here is my guess as to what is next. By next year this time, the mortality rate will be around 1%, give or take. People will point to that data at that time and say, see, there is not a big problem here with the virus, there never was, it is sort of similar to and a bit worse than the seasonal flu, no big deal. What they miss is the changing nature of an epidemic, and that over time, convergent evolution—of both we humans and the virus, occurs. Some very basic principles of biology that anyone could easily understand are not shared, which then fuels misunderstanding and ongoing conflict.
Epidemic, to Pandemic, to Endemic
As I wrote from the start of 2020, we have witnessed the start of a new disease. This is something that we have not seen since the AIDS epidemic emerged in the 1980s. As we enter this third stage of the pandemic this is starting to sink in. The question is what is the best way to move forward? One point I made last year, which seemed radical at the time, but I think seems more and more reasonable is that the pandemic will not end by some sort of biological or epidemiological event, but rather society saying, okay, it is over, we are ready to resume our life. With the virus still being present, and the population learning how to live with it.
What do I think will happen with the boosters?
To start with, let’s hope that the booster gives the recipient an incredibly good response with no side effects and much added lengthy immunity. If not, I cannot envision most people getting boosters, in an indefinite manner, one after the next, every few months. If we take the most rosey premise that people who got vaccinated already were thinking of this as a ‘one and done’ situation, and we see how hard has been to get a 70% of the population vaccinated, I cannot envision that the number will stay even at the current level of vaccinations, if we add the need for repeated booster shots to the equation. In short, I believe that the booster program will fail. Let me be one of the first to say this out loud. Here, I am not even discussing the science of it. Simply, the booster would have to be an incredible game changer. If not, as described at the start of this note, the public health messaging was flawed, and still failed. To now change the messaging to induce people to get re-vaccinated as a public health measure will probably fail too, with no more than 20%-40% getting the boosters. Here I am leaving out the efficacy question, whether you should or should not take it, but only highlighting the messaging debacle and likely outcome. Regarding efficacy, it seems from the latest news, that the current booster is in the mid 80% effective towards preventing serious illness, even towards the delta variant, in the short term, which, in the short term is good, though clearly dropped from the initial vaccine rate protection of mid 90%, and we still do not know how long this efficacy will last. More on this as it develops.
Path-dependency/first series/and extra time
I wrote about path-dependency before, about paths we could and should take to create the best outcomes and limit harm. I also wrote that, based on where we were heading, our path dependency moved to vaccines as an answer. Actually, what I wrote in January-April, 2020, was that there were other paths we should focus on, but if we do not, then we will end up at the vaccine as the only answer. An unnecessary outcome but one that we would be ending up at, and that by the time the vaccines were developed, that protests at that point would be sort of pointless. The window of time would have closed for that period. Nevertheless, nothing changed, the path continued and that is indeed where we ended up.
At the end of 2020, I wrote, emphatically, about getting the first series of vaccines. I stand by that, as the best solution, based on the path chosen by society for the preceding year. I want to comment on that decision. Based on where we were, the very best known choice would be to get the first series of vaccines. The hope was that if enough people were vaccinated, it would buy us, as a species, up to about a year of time to come up with a better solution than the booster. I wrote about that as well then. The idea was, and is, to buy us time to get to better solutions, and to buy time for the virus and for us to adapt towards each other. Unfortunately, not enough people got vaccinated, which shortened the timeline by allowing the virus to mutate in so many people. Sadly, due to messaging, conspiracy theories, miscalculations, etc., we have mostly squandered this time that we bought ourselves. But the problems remain, we still need to come up with a plan to get us to the fifth stage of this pandemic. As I wrote, the idea was to get the first series, not for an endless repetition of the vaccine, to allow the studies to come up with better solutions. I will describe some solutions when we get to natural and pharmaceutical treatments that have been developed, in upcoming posts.
One risk in path-dependency
The main risk we have with vaccines used as the path-dependent manner in getting us out of this pandemic, is that boosters are the natural extension, based on everything mentioned above. The problem is that boosters are tricky. It may be that they will be better for the long term, or better for the short term, it may be that they will be worse. It may be that they will work really well. It may be that they will not work. It may be that we may not even be able to tolerate them, biologically, as a species, in an indefinite manner. As of this time, just as when discussing this last year, we just do not know enough. But what we do know is that as the main public health strategy, it is likely to fail as the main strategy.
One conceptual strategy to move us forward
Before diving into some theory, I did want to mention that my primary solution, which I think might have ended this outbreak, before it turned into an epidemic, before turning into a pandemic, was to spend as much energy as possible in developing quick, cheap, easy to use, at-home testing for the virus. Test negative and you go about your business. Test positive and quarantine until safe. Everyone, every day, until it is over. And this would have ended in weeks to a couple of months, with a few thousand dead. By focusing on vaccine as the only path, both sides have given up on one very simple quick, clear solution as path. It still is a very important path that should be vigorously explored, as you will read about below.
Another way forward is to let people get sick with this virus, but in a very controlled manner so that they do not fall extremely ill or die from the virus, but at the same time, are able to develop immunity to the virus enough so that exposure is no longer dangerous to them. I think this is one very specific manner that science can lead us on a different path-dependence. This is a bit radical, and several pieces have to come into play, but I think this is one pathway forward. There is a lot said here, which I would like to describe, in sequence. THIS IS A THEORETICAL CONSTRUCT, HAS NOT BEEN TESTED, BUT PRESENTS ONE PATH FOR SCIENCE TO EXPLORE.
1. People get tested for SARS-CoV-2 before getting vaccinated. I wrote a lot about this before.
2. Get vaccinated. You have done this already.
3. Get tested for antibodies after the vaccine (more below). This is NOT routinely done, which is a big mistake. Remember that the main idea does not end by getting vaccinated but in the reaction that the vaccine is supposed to elicit, by hopefully priming the immune system with the antibodies. We should measure to see if the vaccine worked for that individual.
4. In the people who have really high antibodies, they are safe to be out in society assuming the virus has not mutated too far away from the vaccine type.
5. If the antibodies were nonexistent, either because it has been a long time since the vaccine or if the vaccine did not work for that person, it may be as if the person never got vaccinated in the first place.
6. If the antibody test shows that you have some antibodies, not that high, not that low, then it might be that we expose those people to the virus. And if done properly, these people develop mild Covid-19 in such a way that is safe for them in terms of symptoms, that is no more than a cold for them, but at the same time allows them to develop a full immune response that is primed to prevent future and worse infections.
I described this at length over the past 30 years, in general, and specifically with COVID-19 in writing from last May, so will not dive deeply here. The bottom line is that, in this path, you become more and more efficient at dealing with this virus. The whole immune system is better able to deal with the specific virus you get exposed to, but also the viruses that are similar, so that even if the virus evolves, it will not pose a serious health problem, as you remain primed to handle it. And potentially this benefit would grow over time. When I first described COVID-19 in January 2020, I spoke about my belief in co-evolution. This is what I mean. As the virus mutates and we change, it becomes less and less dangerous to us, and the mortality rate drops. THIS IS A THOUGHT EXPERIMENT AND NOT TO BE TRIED BY YOURSELF.
A bit radical, but if you think about it, it may make sense. So, for you, in this group, the vaccine may have kept you from getting really sick acutely or chronically, it may have kept you alive. But now it might be that the thing that makes most sense is that while you have some antibodies protecting you, you get exposed to Covid and develop a broad immune defense that can be built upon. PLEASE NOTE, THIS IS STRICTLY A THEORY AT THIS POINT, PLEASE DO NOT TRY IT ON YOUR OWN. But theory comes first. My hope is that clinical and research scientists will consider this concept and see how to best implement for safety and efficacy in a controlled environment. Again, this is not hard science, but it is a departure from the current path. I know this sound radical now, but in another three months this will be discussed by the larger scientific community in earnest.
What needs to happen NOW
We have enough time now, starting today, to learn how to get ourselves out of this bind. For the people that have been vaccinated consider the following:
1. Get two QUANTITATIVE antibody tests for the SARS-CoV-2, one for the vaccine and one for wild type. This will show you where you actually stand vis-a-vis the vaccine at this time. In the race to the path of vaccines, we as a society, deemphasized testing. This has to change. Quantitative testing for antibodies after vaccination and routinely thereafter, should be an important part of a broad sweeping public health plan.
2. If your antibodies are high, and/or if your wild type antibodies are present, then you might want to wait on a booster until others go ahead of you. (OBVIOUSLY, YOU SHOULD DISCUSS THIS WITH YOUR CAREGIVER, AND CONSIDER YOUR OVERALL HEALTH AND IMMUNE STATUS AND ANY UNDERLYING CHRONIC CONDITION WHICH WOULD IMPACT YOUR HEALTH CARE DECISION.)
3. If the antibodies are completely missing, you may be in the same exact category as those that were never vaccinated, or those that caught COVID-19 a long time ago and no longer have the antibodies.
4. For those that have some but not enough antibodies, getting the booster is the option that is proposed. But it might be that catching the virus is not the worst thing in the world. How to operationalize this in a safe, scalable manner is the challenge and to my knowledge, is not yet being explored. This is where clinical and research science needs to step in. We need those that have resources to do this work. It is a clear change in the path and it makes obsolete arguments that currently exist. Path changes do not happen out of the blue. There needs to be sound theory behind them and I sharing that here, in short form. I would absolutely love to be part of this game change.
5. For those that received a vaccination a long time ago it might be that the vaccine triggered antibodies that are so different from the current variant, that they are less effective, which again, may mean that you want to catch the virus while the antibodies still have some efficacy.
6. In all respects, as boosters are being readied, the vaccine manufacturer should conform the booster development to change the booster to match the current variant so that there is more optimal antibody formation. This again would buy you another set of months to allow science to perhaps develop to a more reasonable, effective and long lasting solution.
7. As highlighted for over a year, until we test everyone, there is an inexpensive manner to diminish viral and other microbe exposure in your environment by adding filtering systems to your surroundings. I have described previously how to build one in an inexpensive manner. This may cut down transmission rates as well.
I asked for help 8 months ago, in this respect, and said that if we do not change the discourse, all we do is waste the precious time the first set of vaccines offer us. We are well on our way to having squandered that time. There is enough time left, even now, to change this path. I hope that we take this work up in earnest or else the path continues as it is. Boosters will be offered, and if not fantastically effective, the public health program fails and then we are in a real mess.
And regardless, it really is time to take up the concept I suggested from the start as the main tool, of testing (with quantitative measures, that are inexpensive, easy to administer, and accurate) everyone, vaccinated or not, and if negative, they go about the normal, prepandemic life, and if positive quarantine until safe. This remains one of the quickest ways to get us out of this mess. Rates drop. Transmission drops. Latent subclasses are exposed. And better science can occur. This should be front and center as the main new development in science. It is not hard. We only have to demand it.
I want to end on a bright note though. These sorts of epidemics always start the same way with the highest rates of mortality and then settle down. As long as you are still alive, still not dealing with chronic ailments from the virus, you are buying time to let the epidemic calm down. Over time, the mortality rate will continue to drop. It is just getting you from here to there that we are in discussion.
