If COVID-19 vaccines weren’t tested on likely COVID-19 victims, how do we know that they will reduce COVID-19 deaths?

by philg

Sweden, in which coronaplague was allowed to rage while the population continued sending children to school, sending adults to work, restaurants, the gym, etc., will have about the same death rate in 2020 as compared to 2010 (stats; be sure to adjust for population growth of 9.5 percent from 9.34 million in 2010 to 10.23 million today). This suggests that most of the people whose deaths were tagged to COVID-19 were, as the Swedish MD/PhDs said, on track to die from some other cause at some point in 2020. In other words, COVID-19 kills humans who are already 98-99 percent dead (watch out, Joe Biden, even if you do have a Dr. in the house).

What we’ve heard so far from the vaccine trials are the following:

  • the vaccines don’t stop people from getting infected or spreading the infection to others
  • the vaccines cut down on symptoms and severity of an infection

So… the vaccines might actually make an epidemic worse, in terms of the percentage of the population infected, because people who are infected won’t feel sick and therefore won’t #StayHomeSaveLives.

Maybe this would be fine if we can be sure that vaccinated people won’t die with a COVID-19 toe tag. But do the clinical trials tell us that? Did they go to nursing homes and find the sickest oldest most machine-dependent humans? Given that nursing homes are completely locked down, even if they had found such trial subjects, what could be learned from folks who, by design, are shielded from all exposure?

Let’s have a look at the Moderna FDA paperwork. Only 3 people in the vaccine group, out of 15,208 total, died during the study (approximately 3 months; see pages 17 and 18), which tells you that Moderna picked a much healthier population with a much longer life expectancy than the kinds of people who have been tagged on death with COVID-19 positive test result. (If we assume that a typical COVID-19-tagged death is among those with a life expectancy of 4 years, we would have expected at least hundreds of deaths during a similar study of vaccination among people who really need the vaccination. Note that the Swedish data suggest that 4 years is an overestimate.)

Table 6 says that 4 percent of the study participants had “two or more high risk conditions” and that 25 percent were over 65 years of age, but here in Maskachusetts before the state pulled the age-related data, the median age of a “COVID-19 death” was 82 and more than 98 percent of those had an “underlying condition.”

It is nice that a healthy out-and-about 66-year-old develops a good immune response from these injections, but does that tell us that an extremely unhealthy 82-year-old with just a year or two of life expectancy will develop a similarly good immune response?

So… is it fair to say that we can hope, but not expect, these vaccines to stop the kinds of “COVID-19 deaths” that have been Americans’ consuming obsession?

(A med school professor friend: “Good question, probably not.”)

Loosely related…

21 thoughts on “If COVID-19 vaccines weren’t tested on likely COVID-19 victims, how do we know that they will reduce COVID-19 deaths?”

  1. So they had a relatively healthy group of people who were conferred some protection for an indeterminate amount of time; and this is a few months into a 25-month study. Reduction from 90 cases (placebo) to 5 cases (vaccine), out of about 14,000 participants in each group, with most of those happening in the age ranges of 18 <65, and this is called a Vaccine Efficacy (VE) of 94.5%. I'd say you have a good question there and we're certainly going to find out whether you and your medical doctor friend are correct. This certainly isn't terrible news, but it's not exactly Salvation, either.

    Relatively small point, maybe I don't understand how they calculate race and ethnicity demographics: looking at Page 20, Table 6, "Demographic Characteristics" for the Vaccine Group (N=13934) they show:

    Race
    White 11078 (79.5%)
    Black or African American 1369 (9.8%)
    and the rest of numbers for the other Race categories total to
    1054 (7.6%)

    Then, below that:

    Race and Ethnicity
    Non-Hispanic White 8858 (63.6%)
    Communities of Color 5054 (36.3%)

    Where the heck are they getting the 36.3% "Communities of Color" number when 79.5% of the participants are listed as "White" ? Is that the Elizabeth Warren cohort?

    I'm glad to see your upload speeds have improved with your new 5G neural connectivity. Hopefully that means you'll be able to make good backups with Crashplan while you're sleeping. 😉

  2. From a comment by Alex:
    —————————–
    Race and Ethnicity
    Non-Hispanic White 8858 (63.6%)
    Communities of Color 5054 (36.3%)

    Where the heck are they getting the 36.3% “Communities of Color” number when 79.5% of the participants are listed as “White” ?
    ——————————————–
    Non-Hispanic White = 63.6%
    100-63.6=36.4 which is reasonably close to 36.3

    • @Patrick: I understand that, but what is the accounting method when 79.5% of the total participants are listed as “White” ? How do some of the “White” people get counted as being members of “Communities of Color?”

    • @Patrick: It’s interesting to me, because at least in this set of paperwork they don’t discuss how they derive the “Communities of Color” number. Maybe there’s an appendix somewhere. I presume it’s self-reported, somehow. Can any person who participates as a member of the “White” race check a box to designate himself/herself/zirself as a member of a “Community of Color?” also? If not, why not? Maybe they’re leaving some people out! Maybe I’m making too much out of it, but I find it fascinating that they don’t explicitly state how they derive that number.

      Elizabeth Warren has famously defined herself as an American Indian Community of Color in 1986 on her registration form for the State Bar of Texas, and nobody questioned it. Then it became a huge thing because all sorts of different people wrangled over that definition.

      https://twitter.com/AmyEGardner/status/1092941590555971585

  3. Is there a rationale for only vaccinating people who are not at risk themselves? In most countries (may be less true of places like Japan and Italy where the population skews older) most of the population is probably at low risk of death or serious illness from Covid-19. But low-risk people are a big part of the chain of transmission which ends up infecting high risk people. If enough low-risk people were vaccinated, maybe the epidemic would fizzle out?

    • Patrick: Your idea sounds good, but I think the problem is that we don’t have proof that the vaccines reduce infections and transmission. What the trials have established is that vaccinated people are less likely to develop symptoms.

  4. A mathematician analyzed the Pfizer data and suggests the study didn’t include enough participants over 75 to be able to draw useful conclusions:

    https://garycornell.com/2020/12/09/statistics-in-the-pfizer-data-how-good-is-the-vaccine/
    “And when we get to people over 75, what they describe isn’t a confidence interval, it’s a joke. A confidence interval of -12.1 to 100 is a lot like saying they threw a bunch of darts at a dart board at random and did everything from hit bystanders (i.e. the vaccine made things worse) to a bullseye (perfect protection). They simply didn’t have enough cases to say anything meaningful and so what they say is just totally useless.”

    A retired physicist confirmed the mathematician’s analysis:

    https://www.someweekendreading.blog/pfizer-vaccine-efficacy-confidence-intervals/
    “But when we consider the 95% confidence intervals, Pfizer’s own table tells us there is no reason to claim efficacy in 16-17 year olds, and in 75+ year olds.[…] This explains why some of the VRBPAC committee members balked at endorsing the vaccine for 16-17 year olds. They probably would not balk at 75+ year olds, since they desperately need a vaccine and have little other recourse.”

    I hadn’t explored anything on the Moderna vaccine.

  5. I forget if I’d posted this here before. A respected Science magazine blogger did a post on the issue of “Antidbody-Dependent Enhancement” (without mentioning the ethics issue) which is a bit technical, but some comments noted risks the blogger missed and below is a just the beginning of a comment there (unsure if too many links send this to moderation):

    https://blogs.sciencemag.org/pipeline/archives/2020/12/18/antibody-dependent-enhancement

    The Emergency Use Authorization for the Pfizer vaccine, and its briefing document for the review meeting, states there is an unknown risk of future vaccine enhanced disease (which includes other potential enhancement modes and not just antibody enhancement) after the initial immunity fades:

    https://www.fda.gov/media/144416/download
    “The Sponsor identified vaccine-associated enhanced disease including vaccine-associated enhanced respiratory disease as an important potential risk [….] risk of vaccine-enhanced disease over time, potentially associated with waning immunity, remains unknown and needs to be evaluated further in ongoing clinical trials and in observational studies that could be conducted following authorization and/or licensure.”

    i.e. the study simply hasn’t gone on long enough to see if people have sterilizing immunity producing the initial good results that fades, and then when people do actually get infections: the immune response they learned from the vaccine might lead to a worse case of covid-19. Hopefully not: but the trials just haven’t run long enough to demonstrate that.

    Yet the FDA isn’t telling patients about this risk, nor is the media. The FDA’s fact sheet for recipients of the Pfizer vaccine for covid-19 is here and there isn’t a peep about it:
    https://www.fda.gov/media/144414/download

    Nor is there in its doc for healthcare providers, nor is it in the UK’s NHS or Canadian equivalents.

    • PS, continued (see that Science magazine blog entries comments for more, this isn’t all of it):

      An International Journal of Clinical Practice article on
      https://onlinelibrary.wiley.com/doi/10.1111/ijcp.13795
      “Informed consent disclosure to vaccine trial subjects of risk of COVID‐19 vaccines worsening clinical disease”

      explains that the vaccine trials didn’t meet medical ethics standards regarding fully informed consent since the issue of vaccine enhanced disease wasn’t explained in a way they’d comprehend. The FDA’s information doesn’t even mention it, let alone explain it in the way people comprehend, which seems an obviously major violation of medical ethics. Its also doesn’t make sense: since enough people will likely risk it anyway, but they should get that choice because even some experts wouldn’t yet.

    • @Reality Engineer: It’s too late now. You’ve played Doom 2016. You should have been talking to Andrea Merkel a few months ago. That’s all fun legalistic stuff, but forget it. America is going to get the vaccine, we have to reach 90% herd immunity before going back to anywhere near normal, so those poor shitheads are out of luck.

      It’s about as safe and effective as anything we’ve ever done, maybe it’s a prophylactic for a few months, but look, our society is desparate! What’s the alternative? There isn’t one.

    • re: “That’s all fun legalistic stuff, but forget it. America is going to get the vaccine, ”

      You don’t get the point. This risks people *not* getting the vaccine even if its proven safe after the experiment has gone on longer. Imagine in a few months this issue gets past the media silence and the general public hears: the FDA says there is an “important risk” but they didn’t bother telling patients or healthcare providers. Those who were unsure about the vaccine will say: “You didn’t tell us about all the risks upfront. Why the heck should we trust that you are telling us all the risks now?”

      I’ve gotten all the recommended vaccines in the past, and have no regrets, and hope this one proves itself eventually: and i’m concerned they will undermine trust in vaccines due to this. Before the election the media was full of experts concerned the vaccines were being approved too quickly since they were essentially going to still be experimental. Then they went silent after the election: but the risks remain, and the public may eventually realize it.

      Its also not “fun legalistic stuff”: its basic ethics: people are being experimented on without their consent and that isn’t right: regardless of whether people think the risk is low or have good intentions to try to dupe people into taking it. Its possible it could turn out to be a huge problem if there is “vaccine enhanced disease” that makes it more likely for people who are later infected several months down the road to get severe covid-19 than if they hadn’t been vaccinated. Hopefully not: but no one knows yet since the trials haven’t lasted long enough. Its wishful thinking at this point: not science. Some experts see little risk: others wouldn’t take the vaccine themselves yet.

  6. “the vaccines don’t stop people from getting infected or spreading the infection to others” In absolute terms this is true, of course, however I thought by its very definition a vaccine improves immune response and reduces the likelyhood that an individual’s exposure to the infectuous agent will result in disease. Philip, are you claiming this is not the case for the covid vaccines in particular? As distinct from e.g. the polio vaccine? And, if yes, do you have a reference? Thanks

  7. Can someone who knows more biology enlighten me on something? I have been reading about these mRNA “vaccines”, and it seems to me that they basically send some of this RNA into your cells to convince them to make some antibodies, at least for a limited time. So can they even be called vaccines? They don’t actually cause your body to develop immunity, they just create come temporary protection: it seems like it give yo usome fish, but it doesn’t teach you to fish like a normal vaccine does. Am I completely off base on this?

    • The mRNA vaccines actually get your cells to produce the spike protein of the virus, but not the rest of the virus. The circulation of those spike proteins triggers your immune system to react and produce antibodies against that spike. A more typical vaccine would have injected you with the spike protein directly, with this being a more indirect approach that gets your body to produce the vaccine.

      Those antibodies initially seem to be at a high enough level that they comprise whats called “sterilizing immunity” where they latch onto any circulating virus and clear it before it can infect cells. After a while the level of antibodies fades and the circulating virus would actually infect cells: however the body would have been taught by the vaccine to respond quickly to produce more antibodies, and there may be an immediate response from T-cells and other aspects of the immune system.

      The problem is: severe covid-19 isn’t due to a *lack* of immune system reaction, its due to a dysfunctional one. The initial sterilizing immunity of the vaccines seems to be fine: but the trials have simply not been going on long enough to determine what happens once that fades and people do get actual infections. What are the odds the immune response that happens then will be even more likely to be dysfunctional than if someone hadn’t been vaccinated? No one knows. Some experts think its a high enough risk they wouldn’t take the vaccine yet, while others would be first in line. Unfortunately people aren’t being informed of this risk: essentially they are being experimented on without their fully informed consent.

      After the dengue vaccines initial immunity waned, children of a particular age range were 8 times more likely to be hospitalized if they were infected if they’d been vaccinated than if they hadn’t been.

  8. Is there a reason to think that reducing symptoms won’t also reduce spread? I think it has been pretty clearly established at this point that there is essentially no spread from asymptomatic individuals (for instance https://www.aier.org/article/asymptomatic-spread-revisited/ for some recent discussion). So if fewer people develop symptoms on exposure to coronavirus, the spread should be slowed.

  9. I am curious how the effectiveness of this vaccines is tested. The simplest way would be to expose the test subjects to Covid and see who gets infected. But exposing anyone to a potentially deadly virus on purpose would be very dangerous, especially the placebo group. Does anyone know how is it really done?

    • @Dave D: Read from page 13 on in the FDA paperwork, it’s all there. In essence they selected approximately 30,000 volunteers for a double-blind trial and divided them into roughly equal placebo and control groups. Neither the participants nor the administrators knew which group anyone belonged to. Then they basically waited for people to catch COVID-19 in the course of their daily lives and performed two efficacy analyses, the first at 95 adjudicated cases and the final one at 151 cases. They had initially planned three efficacy analyses but that was scrapped.

      So they didn’t intentionally expose anyone, and now the question is, as I understand it: since they’ve established good efficacy according to their statistical methods and the limits of the study, should they unblind the placebo recipients and give everyone the vaccine?

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