On Saturday the Star Tribune published my column on vaccines and Delta and the need for better public communication. Doug Tice, who has been exceptionally fair to me, put a nice headline on. Partly because of space, however, and partly because of concerns about whether it was too esoteric for the reading public, the first part of the column as I originally wrote it was deleted. That part dealt with the ongoing failure to give us important data that would help us better assess what is going on with the epidemic. Here is the full original column:
AT THIS MOMENT WE HAVE A CRITICAL NEED FOR BETTER DATA AND COMMUNICATION
As the epidemic takes yet another twist courtesy of Delta and vaccine effectiveness panic, the Department of Health and CDC must provide much greater transparency in data and better messaging about how vaccines work. The amount of misinformation regarding the effectiveness of the vaccines and about the Delta variant is staggering.
The DOH has in its possession or can easily obtain information which is critical to understanding the effectiveness of the vaccines. It has released some minimal information on “breakthrough” infections; those occurring in fully vaccinated persons. This data should be part of the routine information releases which feed the tables of cases, hospitalizations and deaths by date they occurred. Each of those tables should have two columns, one for vaccinated persons and one for unvaccinated ones. That will allow routine tracking of trends and will show just how effective vaccines are. People have been able to make rough estimates, but the state should provide the actual data.
The age structure of an epidemic, which is the proportion and absolute number of cases, hospitalizations and deaths occurring in various age groupings, is critical information. The state has provided this in its weekly reports, but now in addition should provide this data for the breakthrough cases as a subset. That will almost certainly show that cases and serious illness in the vaccinated are occurring in the elderly, just as you would expect and just as happened when the population was completely unvaccinated.
Last summer, when reinfections were a momentary cause of concern, the Department was providing data on those cases, which are analogous to breakthrough infections in the vaccinated. It would be very helpful to have a comparison now. What is the relative rate of reinfections in the unvaccinated compared to breakthrough cases among the vaccinated, what are the rates of serious outcomes and what is the age structure. I believe this comparison would demonstrate that vaccination works at least as well as prior infection in providing protection.
After denying during the prior course of the epidemic that it had or could produce this data, the DOH has now released some information on the proportion of hospitalizations that were actually for CV-19, as opposed to those in which the patient was hospitalized for another reason but happened to test positive for CV-19 on admission. According to an article in this paper about half of all breakthrough hospitalizations were in this category. That data needs to continue to be provided, but we should see it for the entire epidemic across the whole population so that an appropriate comparison can be made.
PCR testing has many issues, one of which is the use of “cycle number” thresholds that are too high leading to a strained relationship between test positivity and infectiousness; another is only a rough ability to provide insight into whether a person is infectious, and a third is the detection of mere fragments of virus. PCR cycle numbers do bear a relationship to viral load. The state should have been routinely sampling and providing information on the distribution of cycle numbers. It should also have been routinely culturing a sample of tests for the actual presence of viable virus. Now it is critical to do so, because that will indicate that cycle numbers are higher, and viral loads are lower, in fully vaccinated persons. Research to date has found that to be the case. People with lower viral loads are less infectious. In addition, culturing must be done on a sample of tests to identify how often people are returning positive tests that do not indicate the presence of viable virus.
As important as the release of better data is the need for more fulsome communication around vaccine expectations. The immune system generates several kinds of response. In the case of actual infection by or vaccination against a pathogen, the immune response is referred to as adaptive immunity. The body identifies the chemical sequence of portions of the virus and creates cells that are capable of recognizing those sequences if they are encountered again. We are all constantly exposed to respiratory pathogens; we breathe them in and exhale them out. CV-19 isn’t going away, we are going to have exposure to it. Calling infections in the vaccinated “breakthrough” is misleading; nothing is being broken through. Adaptive immunity is not some physical barrier; it is a rapid reaction force that leads to quick clearing of the pathogen when recognized. So people will be exposed, but will be unlikely to be truly infected or infectious.
Adaptive immunity components to a respiratory virus, including B cells that produce antibodies and T cells that orchestrate the immune response and can disable viruses, are present in the bloodstream, but more importantly in the actual upper respiratory tract. Cells referred to as memory cells are present in this location and can marshal a response to a recognized pathogen and clear it very rapidly. But given the weaknesses of PCR testing, “positives” may be found while this clearing process is occurring. Hence the need for more disclosure on PCR test results for infections in fully vaccinated persons. A too-lenient definition of fully vaccinated is also at fault, the reality is that full development of especially the memory cells may take several weeks. Breakthrough infections should therefore be reported with information on how long after the last dose the infection occurred.
The development of adaptive immunity tends to be weaker as we age and is also less potent in those who have certain health conditions or who are generally immune-compromised. This weakness includes a lesser response to vaccinations. We would therefore expect to see infections in the fully vaccinated follow the same age structure we have seen prior to the vaccination campaigns—most serious illness will be in the frail elderly and those in poor health. We are fighting a respiratory virus, these are omnipresent and mutate regularly; therefore vaccine effectiveness is generally lower than against other kinds of pathogens, as we see from both flu vaccines and RSV vaccine attempts. But these CV-19 vaccines nonetheless appear to be extremely effective, against serious illness in particular.
Finally, the hysteria about the Delta variant is unwarranted. It actually results in less serious illness and the data at this point suggests it is only slightly more transmissible. It does not affect children to any greater degree than did prior variants. The vaccines appear only slightly less efficacious against Delta.
After all this time, you would like to believe that the experts and political leaders we are supposed to rely on would have learned the importance of full transparency on needed data and on doing effective and accurate messaging to set realistic expectations on topics like vaccination and adaptive immunity. I am confident that the data will be consistent with exactly what we should expect; there will be a strong and durable adaptive immune response to CV-19 from both infection and vaccination and serious outcomes will be largely avoided, but we will see cases, especially among the elderly.
The Healthy Skeptic is a website about the health care system, and is written by Kevin Roche, who has many years of experience working in the health industry. Mr. Roche is available to assist health care companies through consulting arrangements through Roche Consulting, LLC and may be reached at 
Apple Podcasts
Google Podcasts
Spotify
Overcast
PocketCasts
Radio Public
Stitcher
Anchor
RSS - Posts
Kevin, thank you for all of your postings. I am a friend of Scott Johnson’s and last year asked him why the government was not spending more time trying to figure out the extent of people who have been exposed and recovered, especially since there seemed to be a meaningful amount of non-symptomatic cases. I think I even noted that tests existed that were pretty inexpensive. In his reply he indicated that he had spoken to you and, if I recall correctly, your opinion was that the tests at the time were not sufficiently reliable and that to get reliable results tests needed to measure T-cells. Correct me if I am wrong about that. My question is whether reliable tests are now available? Yesterday on another blog, someone posted that CVS is now offering T-cell tests; however, when I go to CVS’s website it says nothing about T-cells. Their antibody test is relatively inexpensive at $39. I have a second question, and that is whether the vaccines result in T-cells?
I get the space concern, I used to work in journalism as a reporter and editor. I’ve submitted to plenty of places, and I’ve done what this Tice fellow has done and edit for publication. Too esoteric? I’m laughing. If that was his other reason, that’s ridiculous. What they cut out is not esoteric, it was perfectly logical and understandable. I don’t read the ST, but I and anyone else with a brain could pull out obtusely-written stories or op-eds on any given day of the week. They could have split what you wrote in half and saved the first part for later. Or said: read more online and added it there, because there are no similar space concerns. Or published the whole thing as an online exclusive, or said, maybe you can work some of those thoughts in for a different op-ed, etc.
At least your voice is being heard. I just prefer intellectual honesty and not BS excuses.
Russell: not to preempt Kevin, but this is the business I am in. To be clear everyone has B cells and T cells. Vaccines primarily work on the B cell side as they produce antibodies. Vaccines in particular primarily produce IgG, one of 5 different types of antibodies. These tend to fade, but in the case of CV 19, there are B cell subtypes called plasma cells that “remember”. So even if your antibody levels are negative, it does not rule out the possibility that you have indeed natural immunity from some past CV 19 infection or exposure. T cells, on the other hand, do not generally produce antibodies but attack foreign antigens directly. This can also be measured, but these tests arre not generally available through places like CVS. They are certainly more expensive than $39! We offer a highly accurate T cell test for $154 in our clinic performed by a German based immunology lab. Based on experience from SARS I, these cells are likely to confer natural immunity for a long time. In any case, there is absolutely no reason for an individual with such adaptive work acquired immunity to receive the vaccine because the immunity possessed by a surviving CV 19-infected individual is 700% greater than that which can be conferred by any vaccine. Of course, the vaccine also adds significant amounts of risk that is certainly not worth taking if you’re in unity is already outstanding.
A (partial) reply to Russell Swansen: To my knowledge, all tests for antibodies to SARS2 components are allowed under FDA EUAs, rather than approval. There is wide variability among tests. For example:
1) Simple, “Point of Care” antibody tests in supermarkets and pharmacies most often originate in China, and the two most common that I investigated (Kroger stores, for one) submitted data to FDA only in patients suspect of prior infection, not prior vaccination. The medical director of said company relayed to me that the test’s sensitivity and specificity for detecting antibody status of either the mRNA vaccines (which generate only anti-spike responses) vs. Astra and J&J (which generate both anti-spike and anti-capsid antibodies) is unknown.
2) Testing for anti-spike antibodies in top-tier labs (such as Quest) may involve any one of at least four assays EUA authorized. These tests differ in their sensitivity, with Siemens being the worst, at only ~78%. The medical director of one such lab informed me that their company is switching tests due to this data: Clin Chem Lab Med 2021; 59(6): 1143–1154
3) Whether the confirmation of anti-spike antibodies indicates “immunity” and to what extent is unknown. Conversely, after natural infection or vaccination, the absence of detectable anti-spike or anti-capsid antibodies does not imply the absence of adequate immunity. This is exactly the type of data that Mr. Roche is advocating government agencies to collect.
4) Testing for cellular immunity would appear to be complex (at least from the papers that I have read) such that a simple, “CVS-amenable” point-of-care test would seem to be far-fetched at this point. But, then again, nothing surprises me when true science (as opposed to politics, fear, control, etc.) is pursued. Correct me if I am wrong.
In the absence of the data above, the strongest evidence is what Mr. Roche cites: Regardless of the results of antibody or cellular immunity testing, vaccinated and previously infected C19 individuals who are basically healthy (even with risk factors) and who have normal immune systems can develop clinical infections, but these are overwhelmingly minor and rarely require hospitalization or death. For how long their capable responses will persist remains to be determined. Second, whether finding SARS2 RNA fragments in their PCR samples at 20, 30, or more PCR cycles constitutes “infectiousness” is doubtful. As he points out, such fragments may merely be evidence of a robust immune response leaving dead virus particles in its wake Indeed, my own hospital has a cycle length cut-off above which precautions are de-escalated and normal visitation and care are resumed.
I am not as expert as Mr. Roche, but I hope this helps.
Dr. Foley, can you tell me where the $154 T cell test is available, what its name is or who the manufacturer is? I would be interested in exploring more. Also, can you tell what this test called Tru-Immune from Ethos Laboratories is? It appears to only be offered through ARCpoint Labs for around $280 depending upon location. Here is a link: https://www.ethos-labs.com/tru-immune-test/
It would be interesting to have the data on cycle threshold geographically, chronologically, and by lab since this ridiculous debacle began. Of course, people in hell want ice water.
Sidebar: I’ve had a nasty cough for about a week. Went to the doc on day 4 and given my only symptom was the cough, he felt no need at this time to test for COVID. I asked if he has any idea what their lab is using for Ct. He said, “Oh, I have no idea” as if to say, why are you asking THAT? Go figure.