A Broader Conversation About Vaccines – Part #2
2019 Novel Coronavirus (CoVID-19): Part XVIII
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:
January 2, 2021 update Part 18 (Vaccines – Part #2)
Paul Herscu ND, MPH
A Broader Conversation About Vaccines
This Covid Update #18 is a companion piece to #17, and forthcoming updates #19, #20, and #21. The topic of vaccination is a difficult one, with a great deal of information and misinformation circulating. There is tremendous emotion, anxiety, fear and anger surrounding the topic of vaccines. The opinions here, are for your consideration. Make up your personal choice in consultation with your health care provider. But to help inform your choice, it is useful to have information. In this post, I briefly touch on some of the science for those interested in understanding vaccines in a broader context, and in learning about the different vaccine forms and how they relate to COVID-1 vaccines.
In the next update, I focus on the role organizational and educational institutions have in changing the course of this pandemic. What is the big ask we want from those in the position to effect change and how to shift the discussion and the focus of our efforts so they lead to better outcomes.
Update #20 will discuss the framework to understand vaccine reactions.
Lastly, I will take up the important topic of what you and your loved ones and your patients/clients might do to potentially prevent or mitigate side-effects from the vaccine if taken. I have broken this large topic up, as there is a lot to share from several angles!
This piece is about vaccines and how to think/talk about the topic in general, from the conceptual model, away from the operational specifics.
I am writing to those that actually believe we are in trouble here. (I had an interesting moment where Amy and I were presenting a talk for a professional organization last month and a physician there said something like, is this whole thing real? I have not seen anyone with this disease yet. I said, yes, very real. What I did not say was that right before our presentation, I had a patient who was waiting for a room in the hospital because the whole hospital was full, the ICU was full, the ED was full, and the hospital was setting up makeshift oxygen tents in peoples’ cars, just to keep them alive until someone either got better or died and there was room in the hospital.) So, I am writing for you. Dealing with the reality and tragedy upon us.
At this point, for many, the discussion hovers at the for or against vaccinations point. Vaccinations are good or vaccinations are bad. My goal is to permanently change this discourse so that it fits a bit closer to reality and offers you, your family, and your patients a clearer way to think about vaccines. This discussion is the same one I have given in 1990, in 2000, in 2010, and now here, again in 2020. I hope, at some point this discussion can become more mainstream to move the actual conversation to where it belongs, mirroring reality, predicting outcomes, lessening harm.
Let’s get started.
The first thing we have to bring up is that most people are arguing an issue using 1970s language and the reality of that time. Let’s take this and see how quickly we can pull it forward to 2020/2021. Broadly and basically the concept of vaccination is introducing something into the body, let’s say for example, an antigen, to produce an immune response, for instance, an antibody. It is much broader than that, but let’s just keep it at that conceptual level. I will keep this brief, having followed the evolution of vaccinations for my entire professional career in one form or another, starting with the reading of Lady Montague’s accounts and then Edward Jenner’s account all the way through today.
I would like to branch this out into two types of vaccines. At this time, there are vaccinations used for prevention, but there are also vaccinations used for treatment, a topic not often mentioned. The old fight was about immunizing via vaccine, which focuses on prevention. Let’s put that aside for now. But please realize we are in 2020. The concept has broadened into vaccines, of other sorts, including those used as part of a treatment.
The most compelling one here, from the orthodox medical model, are the immunotherapies that are used for cancer treatment. Many of them utilize the concept that you either inject an antigen, inject a protein, or inject another substance into the person in order to produce an immune response. The old one of these that led to TNF drugs, etc., some of you may recall, Coley’s toxins, is something we have taught about for over three decades.
Some new approaches move beyond that by removing some of the immune cells, and by attaching chimeric antigen receptors (CAR) to T cells from the patient, and then are put back into the patient’s body. Those cells find the cancer cells and destroy them. Broadly, these are the CAR-T or TCR therapies, or even the TIL cytokine additions.
Again, please don’t write me about how you or your family used this approach and it cured or it was horrible or did nothing. I am just offering an example of another type of ‘vaccine’ used for treatment rather than prevention, to catch us all up to an expanded view of the topic.
Here’s the takeaway: cancer therapy used to be limited to surgery, chemotherapy and radiation and now the thinking is more about stimulating the body’s own immune system to address cancer cells. Focus here on the conceptual model, that putting something into the body so that the body will react in such a way as to create a specific or general immune response to treat a particular disease. We might call these by any name you prefer, but you can see the basic concept of vaccination at play.
Relatedly, in the integrative medicine world, ‘vaccines’ have moved on to treatment as well. There are any number of integrative doctors injecting peptides, protein pieces, and other materials into people to elicit a specific immune response, for a variety of diseases. When the political environment is welcoming, they call this a vaccine of sorts and when it is a less popular word, they call it a peptide antigen to elicit an immune response.
There are also those working with upregulating an immune response by use of traditional vaccines. For example, there are many integrative doctors that will inject a typical vaccine, such as yellow fever vaccine, into a person with a disease, say cancer, using the adjuvants in the vaccine to upregulate the immune system to recognize and address cancer cells.
There are many, many other examples, but as you can read, the topic of vaccinations is actually a large one, much larger than is often appreciated in the current debate. What to me sounds sort of funny, or sad, is when an integrative doctor that gives a vaccine to treat cancer say he is against vaccines for prevention of a potentially life-threatening disease. It is not logical! Some have a knee-jerk response to words or labels, even when the words represent similar things.
I remember some years ago I was working on a vaccine position paper and there was a great amount of in-fighting in the group. It sounded to me like it all started in the middle of the argument as if it was picked up from 50 years ago. I tried to make the point that even the folks that were ‘pro’ vaccines, that their practices which were against these newer cancer treatments, were not in keeping with their stated position on vaccine when it came to prevention, and some of those that were ‘anti’ vaccine for prevention were pretty happy with the newer cancer treatments. This discordance within a world view, simply due to the term used for the intervention, struck me as odd. After they listened politely, the argument returned. Which was sad to me. And an opportunity for further understanding lost.
REGARDING VACCINES FOR COVID-19, in December, 2020/Early January, 2021
Let me jump into the types of vaccines in general and then in COVID-19.
Different types of vaccines for prevention.
- Nucleic acid, RNA/DNA vaccine. The new technology is designed to be developed in a quick and inexpensive way, and since they are new, no one is completely sure of the full short term or long terms effects. It takes a couple of months to get to clinical trials, and 6 months to get to Phase III trials. The mRNA has you making the antigenic protein within your cell. Your immune system reacts to the protein that your cell made from the mRNA message. At this time, there are about 20 of these in testing phases for COVID-19, from different companies. There are two major forms here, which I describe below. This form is potentially going to become a very dominant form of vaccine into the future for many diseases.
2a. Whole virus LIVE vaccine. Here you take the actual virus, keeping it alive but weakening its pathogenicity, in other words, creating a less pathological form. It keeps on replicating itself for a while which means it lasts longer than a killed form. MMR is like this one. There are a half dozen or so of these being developed for COVID-19. One big problem, theoretically, is that species often want to revert to their more natural form. Follow me here for a bit, from an evolutionary biological point of view, it is important. If you take a highly bred dog and let it run wild, it moves toward, in subsequent generations, a more feral ‘wolf-like’ appearance. Species do this, moving closer to the wild type variant since that is what nature created, as best adapted to the environment. Well, with live form vaccinations, there is the possibility that the virus might revert back to its stronger pathogenic state. This happens, in fact, and no one debates that this happens. So instead of arguing whether vaccines are ‘good’ or ‘bad’, I think it is more useful to talk about how to make this form safer.
2b. Whole virus, but DEAD/INACTIVE vaccine form. Here you take the virus but kill it, instead of weakening it, in order to create an immune response. Some vaccine makers add adjuvants to upregulate the immune response. While it is true that you cannot become sick with that specific illness from this form of vaccine, as it is dead, other reactions may occur. There are a half dozen or so of this type being tested for COVID-19.
- Viral vector form of vaccines. There are around 20 COVID-19 vaccines of this form in experimental phases. This is a sort on interesting one. Here you use a common, simple, safer virus, like the one producing the common cold,as a delivery agent but you add a gene into the virus, and the virus does its usual thing, and it causes you to make a protein in question, for example, a spike protein. The virus keeps going for as long as typical, or you could introduce something else that stops its actions (I do not believe they are doing this yet, but this is clearly a pathway for cancer research, introducing a vector and then with it a ‘suicide’ gene to stop the process, so that it does not keep going, or stops the target in question. I know it sounds like science fiction, but I imagine this will be pretty common within 15 years or so.)
The main problem with this form is that we are dealing with three living agents, the bug you are trying to protect against, the bug that is the carrier, and you. The bug that is the carrier ideally is a simple one that we typically see and have no problem with. But if we typically see it, then we may well have antibodies to it already. And if we have antibodies to it, then when you undergo this vaccine form, it might be that your own immune system inactivates the carrier virus before it has a chance to deliver the gene of interest. There are all sorts of go-arounds here, but I thought I would highlight this.
- Protein subunits vaccines are made from the surface of the pathogenic bug in question, like the spike protein of SARS-CoV-2, which you can upregulate by adding adjuvants. Here we have about 30 COVID-19 contenders in experimental phases. Again, you will not get the disease from this, even though it is up to your immune system to react to this protein or protein/adjuvant.
With COVID-19, we have the RNA/DNA option for now, as described above, and specifically the mRNA form delivering different parts of the SARS-CoV-2 antigen. The mRNA is not very stable, so you have to keep it at very low temperatures. Also, you have to somehow ‘wrap’ it up in a fatty coat, if you will. (Here there are issues, as for example the poly ethylene glycol that is included, which some people have a severe anaphylactic allergy to, which is known and clearly articulated.)
At this moment, in early January, 2021, the mode of administration is by injection, though my informed prediction is that in 6 months, an inhaled version will be added as a delivery system. As described above, the RNA causes your cell to produce this antigen, for now the one chosen is the spike protein, and then this is moved to the cell surface, at which point your immune system perceives the protein and starts producing antibodies to it.
The hope is, and what was borne out in clinical trials, is that the antibodies keep you from getting severe illness if you contract SARS-CoV-2, preventing patients from experiencing precipitous decline and leading to time in the ICU or worse. In a sense, your immune system has been primed to address the virus. Put another way, when you get sick, it takes time for your immune system to recognize that there is a problem, to identify the problem, and to then react appropriately to the problem. That valuable time allows the virus to replicate taking over more and more cells. If you could have get a head start so your body more quickly identifies a problem and reacts to it, then there is less virus to have to deal with in the body. That is how it is supposed to work.
Please note that I personally believe what is currently in these vaccines, is as stated by the manufacturers. In other words, I do not believe that they have added substances to control you, to track you, to kill you, to make you infertile, to control your thoughts, to add a kill switch to your life. I know you might think that these are preposterous things for me to mention, but I have had people from the left and the right, conservatives and liberals both, tell me all of the above and more. I will not further describe or discuss any conspiracy theory, since they are both unproductive and unending. What can I say? There is a lot of confusing information out there.
Really, for me, this is an example of worrying about the wrong thing. There are things to absolutely be concerned about with vaccines, but worrying about something completely unrelated takes and keeps your focus off the main issues such as described below. My personal suggestion to anyone worrying about what is in a vaccine, take a sample and see what is in it. The chemistry is not that difficult to investigate, and really should not cost that much to do. Form a group, test the chemistry in the vaccine, describe what you find and move on.
Concerns with the mRNA
Moving on here. There are two potential forms here when speaking about mRNA; a non-replicating form of mRNA vaccine and the self-replicating form of mRNA.
The non-replicating form is what we now have as the approved vaccine. It is the kind you inject into the body, the body takes up the mRNA, it goes into the cell, causes the cells own production line to make the protein in question. And then eventually the job of these mRNA is done, they get used up, destroyed. To keep this from occurring too quickly or having too many unintended consequences, they sort of chemically ‘freeze’ the shape of the mRNA, and then coat the whole thing in a lipid substance, as mentioned above. It is kept from denaturing by storing at low temperatures. The Moderna and Pfizer version of the vaccine use similar mRNA code for the whole spike protein and similar lipid coat technology. I imagine in the future this whole form will be modified to make the vaccine more shelf stable. They may also modify the target, as for example, target for a part of the spike protein instead of the whole, or target for the spike protein plus another part for better specificity, but that is a future engineering challenge and keeps the same overall concept of this type of vaccine. More on this below.
The self-replicating type is an up and coming vaccine not approved yet. It would be the next version of these mRNA vaccines, where you create the system by which the mRNA keeps replicating itself inside the person, and therefore can last for an indefinite amount of time, continually producing more and more protein, before it is processed itself and ceases to be active.
I have grave concerns here. At this time, late December 2020/early January 2021, I really do worry about this. We have not seen what mRNA vaccines looks like in the real world. I mean what really happens over a large population, in different subgroups, over a span of months? But at least it is over sooner rather than later with the injection, in this first phase of vaccines. However, the self-replicating form would keep going for a while in the body, and that seems unnecessarily dangerous at this time. Put another way, if there is a problem with this whole mRNA concept then let’s have at first the type that starts the immune response, ends its work and the immune system is prepared.
Having the mRNA go on and on indefinitely, as in the self-replicating types, seems like an unnecessary risk. At least for the first few years, until we have more answers from the epidemiology associated with this vaccine type. If I could make a VERY STRONG recommendation, it would be for the different medical societies to put the brakes on this form until we know more about the short-acting form. As an integrative medical society, this seems reasonable, and logical, and not at all alarmist, but uses the precautionary principle. This is something that can be written and acted upon today, not once they are developed and distributed.
Clearly, these current vaccines have known side-effects, which FDA lists, and the vaccine makers provides. No one is saying that these are simply safe and carry no risk. No one has or will say anything close to that in the near future. The makers of these and the government both acknowledge known risks. And there are the unknown risks as well. But this is what I was underscoring in my previous update. The math is the math. At the start, there are multiple pathways open to halting an epidemic. But if you close off, prevent, underfund, or dismiss such other pathways, you are left with this one, with its potential risks and impacts. Sad but true.
There are specific populations that I worry about that have not been discussed elsewhere to date. Aside from those whose age, or who have specific ailments that put them at risk for certain problem from the vaccine, and those that may have the allergic reaction to the poly ethylene glycol, I worry about the upcoming vaccines and the adjuvants that may upregulate the immune system in unspecific manners.
There are numerous populations that this vaccine is complex, for me, as there is not enough information yet. For example, anyone with added hardware, medical devices and implants of various sorts. A vaccine is as good or as bad as how specific it is in its short term and long term effects. The more ‘off target’ it goes, the more problems it might cause. While this is not in the current plan, I STRONGLY URGE OUR INTEGRATIVE MEDICAL ASSOCIATIONS to emphatically urge the FDA in their post-approval tracking to add, NOW, at the beginning, specific tracking of side-effects of the vaccine on those with added internal/medical devices etc. These should be tracked carefully, as a potential subpopulation data points to be gathered. Even simpler procedures like cataract surgeries where new lenses are implanted, we should watch these people carefully.
As importantly, AND SOMETHING ELSE THAT OUR MEDICAL SOCIETIES SHOULD urge is special protocols towards vaccinations, which may include stopping or creating a time gap between particular procedures or treatments and the vaccine. I am trying to address the real world that we find ourselves in, and to diminish the risk of additional problems for ourselves, our families, our patients, and our neighbors. And if FDA will not pick up on this call, one very useful addition to our knowledge here is to have the integrative medical societies create a tracking system, and publish what we find. Simply put, from our point of view, we are not all the same, and do not respond the same to any exposure, including vaccines. Having people that specialize on personalizing medicine keep track and articulate latent subclasses is a huge benefit to society in general and to integrative healthcare in particular.
Hang in there. We are halfway through the topic. In the next update, we discuss what Integrative physicians and Naturopathic physicians can do, in particular, to help the current situation.
Paul Herscu, ND, MPH
A Broader Conversation About Vaccines – Part #3
2019 Novel Coronavirus (CoVID-19): Part XIX
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:
January 7, 2021 update Part 19 (Vaccines – Part #3)
Paul Herscu ND, MPH
Hello and good day to you and yours.
This COVID-19 Update #19 is the companion piece to COVID-19 updates #17 & #18, and forthcoming updates #20 and #21 all of which focus on vaccines. I focus here on the role organizational and educational institutions have to change the course of this pandemic as related to vaccines.
The next update will focus on vaccine reactions. Lastly, I will write about what you, your loved ones and patients/clients can do to help prevent side effects from the vaccine if taken and to mitigate side effects that may arise.
POTENTIAL FAILURE and CONTINUED NEED FOR A PLAN B
We know that the conventional medicine community has more money than integrative or naturopathic doctor communities do, and therefore more influence. Which means, if looking at only that medical model, there will be more and more vaccines for both prevention and treatment. The vaccines for SARS-CoV-2 are only the most current ones we are hearing, reading and thinking about. And because of all the controversy, anxiety, depression, and just bad time we have all had, this vaccine has garnered more controversy than others.
I have spent the last year describing workable simple options, numerous options really, and also the direction we were going, and that, if unchanged, we would end up with this this vaccine option as Plan A and only Plan A. I will not repeat myself here. The last two updates, this one, and the next two focus on the vaccine issue itself. We are stuck in the pro/con vaccine false dichotomy which has become even more entrenched. A very complex discussion is minimized to soundbites which does a great disservice to all. In these treacherous waters, many individuals and organizations decide to sit out the debate, put their heads down and remain ambiguous. I think this, too, misses the opportunity to help science move forward to help more people. This update is aimed at organizations, trying to give more support to positions they might be able to take today, as a way to build a solid middle, a way to break through the rhetoric, to get to a closer approximation of what really happens.
Let me start with an illustration of a problem from the past, to illustrate why vaccine makers and government officials would do well to engage with naturopathic and integrative physicians soon and more closely.
In 1998, FDA approved a Lyme Disease vaccine LYMErix, with protein antigens from Borrelia burgdorferi. The vaccine rollout failed miserably. It was unclear if the vaccine protected you and how long protection would last. Additionally, you would have had to take multiple doses. Some patients felt they became chronically ill post-vaccine. No one wanted to take the vaccine and it was discontinued. A complete rollout failure.
I believe the COVID-19 vaccine rollout may also fail. It has to do with what was tested, as I mentioned in the previous update. Most of us think of vaccines as a one and done effort or a series and then done. For example, when many of us received the polio vaccine, we had one series and were done. What was measured was how likely are were to become sick and/or how likely are we were to pass the bug to someone else. That is NOT what tested in the initial COVID vaccine trials. The main endpoint tested was how many people became SEVERELY SICK with the virus in the vaccinated group versus the placebo group. But they only measured SICKNESS if you were symptomatic. In other words, they did not test everyone to see if they were getting sick, potentially transmitting the virus, but who may have developed only mild symptoms or those who remained asymptomatic entirely.
In other words, it may be, as I wrote the first update, that transmission may be less, or be completely unchanged, or may even be worse. We simply do not know. What they were looking at was a binary question of how many people ended up in the hospital. (Sound familiar? It is odd to me that the only folks that took my study design endpoint of paying attention in a dichotomous fashion to hospital admission need or not, were the vaccine makers and not my brethren. It is that easy. If we did the same thing, natural treatments would have been adopted by the mainstream as quickly! Let’s not waste this opportunity to discuss vaccine issues in their full complexity.) So really, if the only thing that this vaccine does, is keep you out of the ICU that would be great, by itself, but it is extremely likely that other more natural means, with fewer potential side effects are able to achieve this without the vaccine. We don’t know, because research for such approaches has not been properly funded.
The point I am making is, if transmission rates are not substantially diminished, this rollout may go the way of the Lyme vaccine. And remember, at this point, late December/early January we have no other easy viable choice that society or public health institutions appears ready to adopt. If this result is revealed, which may be in the next 2-4 months, the rollout runs into difficulties.
We need a reliable Plan B. Being included in discussions, distributing research funding more equitably, and sharing from our naturopathic and integrative clinical findings and recommendations related to COVID-19.
For the government agencies, for the vaccine makers, the best way to roll out a successful program here is through open dialogue, and in this current environment, I cannot think of a better profession to have this dialogue with, then with licensed naturopathic doctors who have been working at individualizing care and supporting the immune response from the inception of the profession. Let us help, by establishing contact and communication and by working hard to create opportunities to engage in meaningful dialogue.
If we can shift the conversation of vaccines to ‘vaccines are a solution in this respect and not a solution in that respect,’ or ‘vaccines are a solution for this person and this same vaccine is not a solution for that person,’ then we come closer to understanding in which circumstances vaccines are an important option, and in which instances they are completely the wrong path. More specifically, as long as the conversation is limited to good versus bad, one side never sees a problem and the other side never sees a solution.
BUILDING A PLAN B FROM WHERE WE ARE NOW
Sadly, at times, the actual problem that needs solved is not clearly articulated. I hope I describe where the problem and potential solutions reside. Professional associations should call for, demand and stand ready to participate in creating a new integrative perspective, a true Plan B.
Here are some of the main steps of such a path:
- PERMANENT WORKING SEAT AT THE TABLE
- FDA, FTC, and NIH (or professional associations and NHS in all countries) should come together to develop a fuller CORONAVIRUS TREATMENT ACCELERATION PROGRAM (CTAP see this link to read further on CTAPs) that properly funds integrative approaches, and that includes ND stakeholders on the relevant committees. For me this is essential, a major pivot point and a very clear ask from the integrative community. It is, actually a game changer.
- Recommendations can be based on the best science available, on the prevention and/or treatment of related viruses, and on understanding of immune system function. Naturopathic and integrative physicians should be invited into protocol development, to be studied, published and promoted to include natural products and therapies, that focus on prevention of COVID-19 from gaining access into cells, reducing viral replication, supporting innate immunity, and mitigating the short term and long term impact. Naturopathic and integrative doctors have an enormous role to play at this time and should make their way to the table.
- In the clinical world, NDs provide patients with a variety of interventions aiming at different parts of the individual to help the overall state. This is not classical study design where you test only one variable. But it is here, that NDs shine. For example, we already know that modifying chronic health status of blood sugar, weight, and blood pressure impacts COVID-19 disease expression. It is time to advocate for the testing of whole person, multi-factorial protocol rather than only investigating one variable at a time.
Many billions of dollars have gone into and continue to pour into each vaccine development vs. a paltry amount to fund natural medicine testing. Funding is essential to prove how interventions with natural medicine approaches and substances diminish the severity of expression of COVID-19 or can reduce chronic effects of COVID-19 infection. We also need to study how natural and integrative approaches can increase effectiveness/longevity of the vaccines, and diminish side-effects that may arise. As well, funding should also include for the development of new drugs and the repurposing of older drugs, both avenues were severely curtailed when the directive was to pursue vaccines.
- PHARMACOVIGILANCE AND PERSONALIZED MEDICINE
Within the vaccine world, away from the rhetoric, there is acknowledgement of potential harm to the recipient exemplified by vaccine makers’ own disclaimers. We need this information shared more widely so everyone understands inherent risks. Include NDs in the creation of vaccine information inserts, as a way to help further articulate potential risk/benefits. We should advocate for more detailed description of what potential harm or potential benefit exists, and for the creation of more refined tracking of actual harm. This cannot be done in the dichotomous ‘vaccines are good/vaccines are bad’ world. But they can be done in a world that establishes a more personalized approach to health care.
We need to allow for modifications of recommendations based on individual, personalized health concerns in order to limit harm, and at the same time increase efficacy of the vaccine. This could be done by, for example, latent class analysis, uncovering subgroups that might not be currently identified, yet nevertheless exist. If we are out front with understanding which groups of people or which kinds of people with which health concerns would be more at risk for poorer outcomes, this could be helpful information to share. NDs specialize in personalized care and could be of immense value here.
Over the years, my practice had many vaccine-injured individuals, according to the National Vaccine Injury Compensation Program. It is hard for me to believe that anyone wants this outcome! A much better outcome is a nuanced, individualized approach that seeks to prevent those more at risk and which develops specific protocols for those people. In other words, discussion how to make it safer and how to identify those more susceptible to potential harm ahead of time, and to prevent problems from arising is a much better discussion than we have right now. Join me in moving this discussion forward.
HOW THE INTEGRATIVE AND NATUROPATHIC PROFESSIONAL ASSOCIATIONS AND SOCIETIES CAN HELP WITH REGARD TO THE VACCINE QUESTION.
- Highlight clearly that for the next 6 months at least, even with vaccines, we will continue wearing masks, social distancing and following public health guidelines about businesses opening, with continual but slow easing of lockdowns when and if incidence numbers go down.
- Describe how there have been many billions of dollars spent on the creation of this vaccine and very little spent on natural treatment options.
- Work to further access funding, create study design and carry out research related to natural medicine approaches to the prevention and mitigation of COVID-19.
- Work to broadcast widely results of such studies so that specific approaches become standard of care. This is the important one. There is no mechanism in the USA to allow a natural product to become standard of care, unless FDA/FTC allows this to occur. Integrative organizations could ask for a seat at the table and together formulate minimal natural product recommendations for the prevention and treatment of disease. This would be a new, radical, and important modification in health care in the USA. This is the main focus of change that needs to occur, or else we maintain the status quo.
- SPECIFICALLY, with relation to COVID-19 vaccine:
- Emphasize that it is not known how long the vaccine effect will last. Hopefully it lasts longer than the disease immunity.
- Share that we do not know how people will tolerate a second or third series of vaccination. (Because of this we need a Plan B, as in the other effective natural medicine options to help prevent and mitigate COVID-19.)
- Explain that we do not know if the vaccines will continue to be effective, as the virus mutates. (I mention this for completeness sake only). (Because of this we need a Plan B, as in the other effective natural medicine options to help prevent and mitigate COVID-19.)
- Explain that at this time, we do not know what the rates of transmission are for the different vaccine forms. But also ask the question, why were these not properly tracked originally.
- Request explanation of what the main goal of each of the vaccine forms is. Which ones lessen transmission? Which ones lessens severity?
- Help describe the need for and help develop special protocols towards these vaccinations, which may include stopping or creating a time gap between particular medical procedures or treatments, and the vaccine, as for example, dermal fillers, cataract lenses, etc.
- Continue to articulate that NDs and integrative physicians should be included in the development of protocols to lessen potential side-effects of the vaccine. h. NDs and integrative physicians should be included in the development of and updating post-approval side-effect surveillance, as they are uniquely trained to uncover latent subpopulations.
- Up front and center, should be a close following of vaccine during pregnancy.
- I also suggest that there should be a slowing down of the development of self-replicating mRNA vaccines until we see what the effects of the non-replicating mRNA forms is on the population.
I also believe there needs to be a rethinking of the prioritization of who receives vaccinations. No one has said this openly, but broadly speaking, you could say the choice is whether to vaccinate those that will ‘restart’ the economy first, or to vaccinate those most likely to die first. In the USA we chose the open the economy first plan. I think ethically it may be that medical societies might have a problem with this sequence. For example, I think vaccinating those most likely to die might be the most ethical first step as it limits mortality. If this were the case then some of the stage 2 groups might move up to stage 1. There is an ethical imperative that speaks to a better sequence. Regardless of the result of that debate, my point is that integrative physicians should be part of the discussion on the rollout.
We need scientific testing to prove efficacy. We need our medical societies, schools and leadership across all integrative and natural medicine stakeholder groups to take bold steps to investigate and generalize our work, without apology, and in partnership with funding organizations and government agencies. Our work could become standard of care across the full medical landscape. The driver of this in the short term is the need for a PLAN B now and for the longer term as a way to discuss the future of vaccinations in the clear light of day. When is it an appropriate option and when should it be the absolute last option as better ones exist? We lost this first round of opportunities, a year wasted and lives lost. That said, I have faith that our different medical societies and leadership decide to engage in developing and promoting these other pathways now. It is not too late to alter our path forward. This is the perfect time to help lead change in a structural, institutional fashion. We have, I think 6 months or so to do so.
In the next update, I propose a conceptual model of how to talk about vaccine reactions. And in the last update on this topic some things you might want to do in preparation of the vaccine if you choose to take it.
With much hope,
Paul Herscu, ND, MPH
Some useful resources or links referred to in the above:
1.CORONAVIRUS TREATMENT ACCELERATION PROGRAM (CTAP): https://www.fda.gov/drugs/coronavirus-covid-19-drugs/coronavirus-treatment-acceleration-program-ctap
2.The 70 plus COVID-19 vaccine programs, their trial stage and side effects may be tracked in a variety of sites. Some of which are listed here:
3.In the last update, I suggested that people with ‘altered’ structures inside their body may need to be tracked separately, just in case they at risk for side effects. Since that time the American Society for Dermatologic Surgery released guidance that looked carefully for side effects in those patients with recent dermal fillers. As an example of what these look like, to emulate, please see: https://www.asds.net/Portals/0/PDF/secure/ASDS-SARS-CoV-2-Vaccine-Guidance.pdf .
- There is further information related to special populations to consider, including the pediatric population and pregnant and nursing women, which I think needs a clear understanding of as soon as possible. For those populations, where these are not possible, there should be a PLAN B that does not focus on vaccines, and for which the naturopathic physician and integrative communities can play an essential role.https://www.fda.gov/media/144585/download