Part III: The COVID-19 Vaccines
The Issue – Given the sudden dismissal of all former members of the ACIP, the recent replacement of these members, and the firing of the CDC Director, there was a need for the ACIP to issue its recommendations for the recently FDA-approved 2025 – 2026 Updated COVID-19 vaccines.
What were the considerations before the committee?
The ACIP needed to provide its recommendations to the CDC Director (currently the Acting CDC Director since the CDC Director was just recently terminated for refusing to agree to approve the ACIP recommendations in advance of them being made) on who is recommended to get the updated COVID-19 vaccines (generally based upon age and underlying medical conditions) as this would provide guidance to health care providers, the public, and determine coverage for the recommended vaccines by Medicaid, CHIP, ACA-compliant health plans, and the Vaccines for Children (VFC) program.
What was the recommendation put before the committee by the chair to be voted upon?
Unfortunately, there were four votes that would ultimately be called for, but these were not provided to the public in advance, and it appears likely that no one other than the chair of ACIP and the chair of the COVID-19 Vaccine Work Group knew what the four recommendations would be until the very end of the meeting.
As a consequence, the discussion of the COVID-19 vaccines was meandering, at times got into technical information that I would be very surprised if more than a couple of the committee members understood what the presenters were presenting; veered back and forth between data and facts to anecdotes, case reports, misinformation and pure speculation; and in the end, resulted in a series of recommendations from the Work Group with a separate minority report from other members of the Work Group who strongly disagreed with the Work Group’s recommendations.
The recommendations that were put to a vote were:
Vote #1 (but they actually considered this second) Passed 11-1-0
CDC should consider adding language accessible to patients and providers to disclose the six risks and uncertainties included in the Work Group presentation (benefits of seasonal boosters are of modest benefit and short duration; evidence that repeated seasonal mRNA boosters cause acquired changes in the immune system and may be associated with increased vulnerability to future infection, including SARS-CoV-2 and other respiratory viruses, as well as potential risks of autoimmunity, chronic inflammation, immune tolerance and suppressed immune surveillance including immune fatigue or suppression that is currently not well understood; there are documented deaths from symptomatic and subclinical myocarditis, pericarditis and potentially other cardiovascular conditions post-vaccination, including of healthy children with probable causal relationship to mRNA vaccines; post-vaccine syndrome; persistence of spike protein and lipid nanoparticles; the safety and efficacy of COVID-19 vaccine during pregnancy have never been tested in appropriate randomized clinical trials. In one randomized trial, there was observed numerical imbalance of a higher number of babies with congenital malformations from vaccinated mothers).
Vote #2 (this was actually the third vote to be taken) 6-6-0 Failed
State and local jurisdictions should require a prescription for administration of the COVID-19 vaccines.
Vote #3 (this was actually the fourth vote to take place) Passed 12-0-0
Health care providers should discuss the risks and benefits of vaccination for individual patients.
Vote #4 (this was actually the first item voted upon) Passed 12-0-0
The pediatric and adult immunization schedules for approved COVID-19 vaccines should be updated as follows:
- Adults 65 and older – vaccination based upon individual-based decision-making.
- 6 months of age – 64 years – individual-based decision-making with emphasis that the risk-benefit of vaccination is most favorable for individuals at increased risk for severe COVID-19 disease and lowest for those individuals who are not at increased risk.
My Take
One of these decisions was bad; one was mixed good and bad (perhaps even all good -see below); one was good; and one was irrelevant.
Let’s start with the vote that failed. This was a good decision. Had it passed, this would provide that states should require a prescription for administration of the COVID-19 vaccines. First of all, it is not the jurisdiction of ACIP to determine whether a vaccine should require a prescription, nor is it the ACIP’s providence to tell states what they should do.
Had this recommendation passed and the acting CDC director signed off on it, it would significantly impede access to the vaccine. In the most recent year, 90 percent of COVID-19 vaccines were administered by a pharmacist. However, many states do not permit pharmacists to write prescriptions. Thus, many people who wanted to be vaccinated would need a prescription from their physician or nurse practitioner, and I would not be surprised if many practices required the patient to come in for the counselling about the vaccine (see below) and the prescription. This would lead to delays in getting the vaccine and costs for deductibles and co-pays. Further, the way the recommendation was presented, it would mean that seniors and immunocompromised patients who would be recommended to get two vaccines per year (and potentially more for the later group) would need a prescription twice a year, even though the patient and doctor had already concluded previously that the patient’s age and/or underlying health conditions warranted the vaccine. For all of these reasons, this recommendation would just put more barriers in the way of getting the vaccine and discourage some patients from making the effort.
Let’s dispense with Vote #3, which was actually the last vote to be held. This is the irrelevant one. The discussion of risks and benefits is already a legal duty for any health care provider who is administering a vaccine.
Let’s now deal with what was supposed to be Vote #1, but turned out to be the second voting item.
The new ACIP committee is operating under a number of misguided approaches to vaccine science, clinical trial design, and the doctrine of informed consent. I’ll address some of these as they relate to this vote.
First, the informed consent doctrine is based upon disclosing the risks and benefits of the intervention, including those associated with not undergoing the procedure, that a reasonable, prudent physician similarly situated would disclose (some jurisdictions) or that a reasonable patient would want to know (other jurisdictions). No court that I am aware of has ever held that a physician must disclose every known risk, no matter how rare or unlikely, and certainly not risks that are not known.
A fundamental ethical principle behind informed consent (autonomy on the part of the patient) is that the health care provider should not present the risks and benefits in an unbalanced manner so as to manipulate the patient into agreeing to or refusing a procedure so as to serve the best interests of the health care provider as opposed to the best interests of the patient. What I observed by listening in to these two days of meetings is that the discussions themselves were disproportionately focused on considering all real and imagined harms from vaccines, while spending almost no time trying to identify even all of the real benefits from those vaccines.
One can see even from the wording of this recommendation that it only mentions disclosing six additional “risks and uncertainties,” without any mention of fully disclosing the additional benefits of vaccination besides the primary ones of reducing the risk for severe illness and death.
The first such “risk” to be disclosed is that the benefits of seasonal boosters are of modest benefit and short duration. First of all, it is a bit ironic that a group that holds itself out to be vaccine scientists and experts refers to the “seasonal” vaccine as “boosters.” Boosters are a repeated dose of the same vaccine in order to “boost” the immune response generated by the prior dose of that same vaccine. The newly approved COVID-19 vaccines that these recommendations address are actually new formulations of the vaccines that are based upon more recently circulating variants, and thus, they are “updated” vaccines rather than “boosters.” Further, the statement is misleading. In children under age 2 years and adults over age 65, the benefits are more than modest. So far the COVID-19 vaccines have provided only short-term reductions in the risks of transmission and infection, but very durable and prolonged protection against severe disease, especially the most severe of the severe forms of COVID-19.
The next “risk or uncertainty” to be disclosed is “evidence that repeated seasonal mRNA boosters cause acquired changes in the immune system and may be associated with increased vulnerability to future infection, including SARS-CoV-2 and other respiratory viruses, as well as potential risks of autoimmunity, chronic inflammation, immune tolerance and suppressed immune surveillance including immune fatigue or suppression that is currently not well understood.” This statement seems clearly calculated to unduly scare people and to avoid acknowledging that any of these risks are far more likely in the setting of infection rather than vaccination. First, “evidence that repeated seasonal mRNA boosters cause acquired changes in the immune system” (I am not going to repeat my criticism of their terminology) can best be addressed by a response I sometimes get from my grandkids – “duh!” The reason we give vaccines is to cause the immune system to acquire changes, specifically we expose the immune system to, in the case of the COVID-19 vaccines, one of the virus’ key proteins so that the body can recognize it, hopefully before it is exposed to the actual infectious virus, and have a head start in making antibodies that interfere with the ability of the virus to infect our cells, as well as make memory cells so that in the future, when exposed to infectious virus, it doesn’t take our body as long to make antibodies (and the antibodies that we do make are often broader and better), and also so that we develop T-cells that trained to recognize infected cells so as to destroy those cells, thereby ridding us of and clearing the virus from our bodies.
That same risk statement goes on to state ”and may be associated with increased vulnerability to future infection, including SARS-CoV-2 and other respiratory viruses, as well as potential risks of autoimmunity, chronic inflammation, immune tolerance and suppressed immune surveillance including immune fatigue or suppression that is currently not well understood. Now, I know what they are talking about, but I doubt that any health care provider who doesn’t spend every waking hour studying this stuff the way I have would have any idea what they are talking about. They are referring to inconsistent findings that some persons will demonstrate a class switch in their antibody response (this is very complicated and technical, and so I am not going to go into detail here unless I get a lot of comments asking me to explain this in detail) after repeated vaccination. What this refers to is that we actually make many different classes of antibodies in response to an exposure. Some class switches are quite typical and normal, e.g., generally, we make IgM antibodies in the first week of infection that are generally replaced over the next week or weeks by IgG (due to a class switch), and this is very beneficial for reasons that I am not going to expound on right now. What the Work Group is referring to is a different class switch, which occurs in some people after the initial class switch from IgM to IgG in which subclasses of IgG switch (there are four subclasses of IgG, which fortunately are called IgG 1, IgG2, IgG 3 and IgG 4) and what the Work Group is pointing to is an increase in the relative proportion of IgG 4 antibodies in these individuals after repeated vaccination. They suggest that this class shift “may be associated with increased vulnerability to future infection, including SARS-CoV-2 and other respiratory viruses, as well as potential risks of autoimmunity, chronic inflammation, immune tolerance and suppressed immune surveillance including immune fatigue or suppression that is currently not well understood. First of all, I think I have read every paper that has been published on this phenomenon, and I am not aware of one instance where investigators have demonstrated that those with this class shift have demonstrated any of these adverse immunological or other health effects. I am going to ask all of the immunologists reading this to please forgive my overly simplistic generalization of the immune system here, but for all my other readers, I suggest that you can think of the immune system as too little being bad (for example people who have immune deficiencies) and too much being bad (e.g., the cytokine storm that we have previously discussed in the second week of severe disease in adults or the MIS-C I have previously written about in children). Its really all about getting enough of an immune response soon enough, without getting an overreaction of the immune response. Vaccination increases the likelihood of both of these conditions being met. Now, I have previously written about parts of the immune system that make sure we get enough of a response and in time. Those include the innate immune system, cytokines and chemokines (we have especially discussed interferons), and antibodies. We all have IgG4 in our blood (unless your have an immunodeficiency where you can’t make them), and generally its role is thought to be largely in constraining that immune response and making sure that we get enough, but not too much. There is some suggestion that IgG4 may be protective against developing Long COVID since some studies have found that after SARS-CoV-2 infection, those who went on to develop Long COVID had a much lower proportion of IgG4 than those who recovered from COVID-19 without developing Long COVID.
Where I think that the Work Group came up with this list of harms is that there are rare diseases for which IgG4 is central to the illness and is present in far greater proportions, e.g., IgG4-related disease and IgG4 autoimmune disease, which may manifest with some of these features. However, these conditions are completely unrelated to vaccines. I also am not aware of any evidence that repeated vaccination would actually increase your risk for COVID-19, in fact, I think the weight of the evidence would argue for exactly the opposite. While, I could write more on this, let me just close on this particular item by pointing out that “immune fatigue” is not a thing. I don’t know if the Work Group was confused and was referring to chronic fatigue syndrome or perhaps T-cell exhaustion, but frankly neither one of those would make any sense to me. Obviously, if they are not making any sense to me, it doesn’t seem like this is a good idea for the ACIP to be specifically asking busy health care providers to explain this to patients before they vaccinate them.
The next risk they offer is “there are documented deaths from symptomatic and subclinical myocarditis, pericarditis and potentially other cardiovascular conditions post-vaccination, including of healthy children with probable causal relationship to mRNA vaccines.” This is one of the best examples of a violation of the principles of informed consent. If I saw you in the office and determined that you had high blood pressure and needed to start you on medication, but I didn’t explain the risks of not treating your high blood pressure and only spent the time reviewing all the terrible and rare potential adverse effects that could occur with taking the medicine, my guess is that you might not be inclined to take the blood pressure medicine. Here there is no explanation that myocarditis and pericarditis occur more frequently and more severely in people with COVID-19 than in people who receive the vaccine. Second, if this is referring to the same case reports that I am thinking of, it was two children and the causal link is not established. When we start talking about “healthy children” dropping dead from the vaccine without context, without evidence, and without quantifying it, it seems intended to alarm and frighten more than inform.
At the end of the sentence, the Work Group has actually identified a big problem that I have with their recommendations – “causal relationship to mRNA vaccines.” Even if the “causal relationship” was proven, why is ACIP adopting the recommendation to include all six “risks and uncertainties” in the disclosures and risk-benefit discussions with patients for the “seasonal boosters” when not all updated COVID-19 vaccines are mRNA vaccines, and to my knowledge, no evidence was presented at the ACIP meeting or by the COVID-19 Vaccine Work Group that any or all of these risks and uncertainties apply to the protein subunit vaccine (Novavax)?
As far as the risk or uncertainty included that there can be persistence of spike protein and lipid nanoparticles following vaccination, the manufacturers testified that their studies showed and the FDA reviewed and approved that the spike protein did not persist more than 2 weeks. Where we have seen persistence is in cases of Long COVID following infection. Dr. Drew Weissman, a co-recipient of the 2023 Nobel Prize in physiology or medicine for his discoveries related to the development of the mRNA-based COVID-19 vaccines explained why the Work Group got this wrong to a Stat News reporter. According to Weissman, the mRNA from the vaccine is gone in days. It doesn’t go to the brain or the eyes. “What those studies did is they put huge doses of RNA into a mouse and used very sensitive assays, and that’s where it went.” Instead, if you give the mouse a vaccine equivalent dose, “you see it in the muscle, you see it in the draining lymph node, and that’s about it.”
The Stat News reporter asked Dr. Weissman, “How sure are you? How sure are you that there is not case of mRNA being distributed more widely in the body?” He responded, “I know it’s not distributed widely. I mean, we showed that back in 2017 at vaccine doses. We’ve looked at mice, we’ve looked at macaques, we’ve looked at rabbits, and we’ve done as much as we could on humans at a vaccine dose. You don’t see RNA circulating in the placenta, in the testes, in the heart, in the eye, in the brain, all the places that they list. We and many others have looked and we just don’t see it.”
“And the mRNA could not be persistent? Could one dose of mRNA continue to make spike protein for months in a rare patient?” Answer: “It is absolutely impossible. MRNA is degraded incredibly rapidly. When you modify it, it’s a little slower. It’ll last 24 hours. It never, ever lasts six months. That’s just impossible.”
Finally, let me address the claim that “the safety and efficacy of COVID-19 vaccine during pregnancy have never been tested in appropriate randomized clinical trials. In one randomized trial, there was observed numerical imbalance of a higher number of babies with congenital malformations from vaccinated mothers.” Notice the inherent contradiction: the safety and efficacy in pregnancy has never been tested in a randomized clinical trial. However, in the next sentence, but in one randomized trial (what? I thought there were no randomized trials?) There was in fact a randomized clinical trial, however, that trial was stopped when data became overwhelmingly clear that pregnant women greatly benefitted from COVID-19 vaccination and the study could not ethically continue to have patient abstain from vaccination once its benefit was clear. Now, congenital malformations are scary. Notice the peculiar language used here – “observed numerical imbalance of a higher number.” That is because of two things. First, there was not a statistically significant difference between the two groups, and the rates in the two groups was not statistically different from the background rate of congenital malformations. Second, the overwhelming majority of congenital malformations occur during the first trimester (12 weeks) or pregnancy. None of these women received the vaccine before the 22nd week of pregnancy. Thus, trying to attribute cause of the malformation to the vaccine doesn’t make any sense.
Vote #4, which was actually the first vote taken is the one that is at least mixed – good and bad, but possibly all good.
It states that the vaccine schedules should be modified to reflect:
- Adults 65 and older – vaccination based upon individual-based decision-making.
- 6 months of age – 64 years – individual-based decision-making with emphasis that the risk-benefit of vaccination is most favorable for individuals at increased risk for severe COVID-19 disease and lowest for those individuals who are not at increased risk.
So, the good news is that this actually expands eligibility for the vaccine far beyond what the Secretary announced on social media. Assuming that the acting Director signs off on this, any child over the age of 6 months and all adults could qualify for the vaccine. Why I stated that it was mixed is that it was my understanding that if the ACIP didn’t actually recommend the vaccine for all these age groups, Medicaid and CHIP, the small and individual health plans, and potentially VFC would not cover the cost of the vaccine. However, the chair of the committee stated that they would be covered under this proposal and the CMS and VFC representatives at the meeting didn’t say otherwise, so if he is right, then this would be fantastic news.
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