Post #1411: COVID-19 booster shots for young men, part 1.

Posted on January 25, 2022

 

In brief:  Probably the only interesting thing you will learn in this post is that the U.S. has an injury compensation program covering COVID-19 vaccines.  If you’ve suffered significant harm as a result of a COVID-19 vaccine, you can file a claim and ask for monetary compensation.


The issue?  Is there an issue?

I got an email from a reader the other day, asking me to look into the safety and efficacy of COVID-19 boosters for young men.  I was floored by the request, because I didn’t think there was anything to discuss.

Among the known risks of the COVID-19 vaccine, including booster doses, is myocarditis or pericarditis, inflammation of the heart muscle or the sac around the heart.  That’s not that most common serious condition that can result from vaccination.  (I believe that anaphylactic shock is #`1.)  But that’s a risk that is much higher in young men, as is the risk of myocarditis in general.

This, apparently, has spawned yet another social media industry to feed disinformation to those who don’t want to get vaccinated.

Near as I can tell, every credible source still says that risks associated with vaccination or booster shots are vastly lower than the risks associated with not getting vaccinated or boostered.  Even now, with Omicron having a lower average severity but vastly higher incidence than prior variants. Even for young men.

But the assertion in this latest round is that all the mainstream experts are wrong, that boosters don’t actually do anything, and that the myocarditis risk in young men is so high that you actually increase risk of harm by requiring boosters for young men.  I a nutshell, it’s the same debunked claim that pro-vaccine zeal is killing people.  Only this time, it’s killing young men.

Near as I can tell, everything about that assertion is hooey, except for the fact that there is an excess myocarditis risk from COVID-19 vaccination for  young men.  I’ll get around to putting down the numbers to back that up in Part  2 of this post.

To be honest, it’s almost … well, boring … to have to grind through yet another one of these false claims.  The same techniques come up again and again.  Ignore what scientists say about their own data.  Ignore multiple warnings that you can’t infer cause and effect from certain observational data sets.  And when the numbers, by chance, fall your way, hop on that, ignore all the warnings, and make a big deal of it.   And when they don’t, say nothing.  And the credulous will believe that you’ve discovered some deep, dark secret that’s being purposefully ignored by mainstream experts.

Before I do the numbers, I want to put a little context around this issue.  Plus, this post has gotten ridiculously long.  So I’m going to do this in two part.

The current part is the context.  Why does this issue matter, what do we already do to track and compensate individuals with adverse events from COVID-19 vaccination?

The next part will be the exact numbers, as close as I can get them, on the risks of getting a booster shot , and not getting a booster shot, for young men most at risk for myocarditis and pericarditis.

 


College and University COVID-19 booster mandates.

I’m not keen on appeal-to-authority arguments.  E.g., I have a Ph.D., but I don’t bring it up on this website.  Arguments should rise or fall based on their merits, not on the credentials of the person offering them.

On the other hand, I’m very much in favor of paying attention to the smartest person in the room, on any given issue.  So let me just briefly summarize where U.S. colleges and universities stand on the issue of COVID booster mandates. A large fraction of their student population consists of the young men who are at elevated risk of myocarditis from a COVID-19 booster.  So if this is an issue, I’d expect them to have considered it.

In the United States, near as I can tell, virtually all colleges and universities (other than those legally barred form doing so) have required students to get COVID booster shots in order to return to campus for winter 2022 classes.   Those mandates are almost certainly why this issue is now circulating on social media.

Let me just list a few, so you know I’m not kidding.  In each case, I link to their instructions for their mandatory COVID-19 booster policy.

Here in Virginia, just to pick a few at random:

All of those colleges and universities above mandate a COVID-19 booster for their students.

I want to point out a few things.

First, nobody is making them do this.  These colleges and universities are themselves making the call that boosters are mandatory.   CDC Guidance for Institutions of Higher Learning (accessed 1/23/2022) merely recommends that colleges promote vaccination, and that they make it easy for students to get vaccinated.  CDC’s guidance never even mentions boosters, nor does it discuss the merits of having a vaccine mandate.

In Virginia, the official guidance from the state government is to do what CDC says. And far from promoting vaccine via mandate, Virginia state universities can no longer require that employees get vaccinated, thanks to our new Governor.  Under Executive Directive 2, it’s no longer legal even to ask a state employee if they’ve gotten vaccinated or not.

Second, that brief list represents one whole hell of a lot of intellectual firepower.  That’s the ten top-rated universities in the U.S., in 2022 U.S. News and World report list of the best universities in the U.S.

And, I repeat, all of them mandate a COVID booster.  Those decisions were made by smart people, running educational institutions with multi-billion-dollar annual budgets, most of whom have access to staff with a deep, deep understanding of the issues involved.  And all of them, independently, decided that a mandatory booster policy was a good idea.

And so, here’s my one-and-only appeal-to-authority argument for this post:

To believe this latest disinformation circulating on social media, you have to be able to look at that bulleted list above and say, nah, those jokers don’t know the real story.  None of ’em.  They’re all too dumb to admit what the real story is about boosters.  But I know the truth, because I found it on the internet.

If you have enough ego to do that, I can only guess that nothing I can say is going to sway your opinion.  If you lack the common sense to question your opinion, when it clearly conflicts with the opinions of the best and brightest in the U.S., ditto.  If this paragraph describes you, there’s no point in reading the rest of this.

Finally, some states bar any vaccination requirements, so that, for example, University of Texas cannot require vaccination, nor can University of Florida, based on laws or orders from their respective governors or legislators.  But even with a state-wide ban on vaccine mandates, both of those schools strongly endorse and recommend vaccination and boosters for their students. 

You really have to look around to find a plausibly legitimate institution of higher learning in the U.S. that doesn’t at least encourage booster shots for their students.  Based on my small search, those appear limited to religiously-affiliated institutions.  Liberty University is one, where they merely ask that you let the university know if you’ve been vaccinated.   (If you are familiar with their abysmal track record on COVID, that’s no surprise.)   Southern Methodist stops short of recommending vaccines, but makes them available on campus.  (As a Texas school, I believe they could not mandate them anyway.)  But not all religiously-affiliated universities seem indifferent to COVID vaccination.  Notre Dame, for example, has a COVID booster requirement for students, despite some controversy within the American Catholic church.


A little illustration of why colleges are doing this.

I just took a look at the College of William and Mary COVID-19 dashboard.  I’ve been tracking their COVID situation pretty closely for the past year and a half.

This semester, William and Mary mandated pre-arrival testing.  (They’ve been off-and-on about that from the start of the pandemic, but all for logical reasons.)

The results?  Even ignoring the significant potential for false negatives, six percent of the Williamsburg student body tested positive for COVID-19 and had to delay their return.

Source:  William and Mary COVID-19 dashboard, updated 1/21/2022, all marks in red and calculations are mine.

By contrast, when they came back for in January 2021, in the middle of the then-largest COVID-19 wave to date, they had a total of 66 pre-arrival positives.  The upshot is that the COVID case load within the student body is five times higher than it was at this time last year.  (That’s not unexpected — the COVID case load for the U.S. is five times higher than it was at the peak of last year’s winter wave.)

Even with Omicron having a lower average severity of illness, the sheer number of cases is a problem.  It’s a problem not just for the potential morbidity and mortality of all those cases, but it’s a problem for disrupting campus life due to the requirement to isolate or quarantine after known exposure to COVID-19.

Start with congregate housing.  Add in a disease that is about as contagious as any disease ever measured.  Toss in the fact that six percent of the incoming population is infected with it — that you know of.  Now realize that boosters are the only known way to provide significant immunity to this disease.

Of course they’re going to require boosters.  It’s the  most reasonable and safest course of action.


Vaccination involves risks, Part 1:  A simple orders-of-magnitude lesson from the National Vaccine Injury Compensation Program.

Vaccination involves risks.  There’s nothing new about that.  The important thing to keep in mind is the risk incurred without vaccines.

For more than a third of a century, the U.S. has run the National Vaccine Injury Compensation Program (VICP), covering injuries claimed from a specific list of (mostly childhood) vaccines.  Funded by a 75-cent tax on those vaccines, the VICP was primarily a way to keep these injury claims out of the courts, and shelter vaccine makers from lawsuit.  It more-or-less standardized and streamlined the process for making a claim for injury for injury attributable to the most common known risks of childhood vaccines.

Arguably the most telling aspect of this program is the number of awards madeIn FY 2021, this fund made a total of 719 awards, with average compensation of about $300,000.  (Calculated from the report listed on this US DHHS web page).  Keep in mind that the CDC recommends something like 40 different vaccine doses between birth and age 18, excluding annual flu shots (roughly estimated from this table).  If I were roughly to estimate 85% compliance with every recommended shot (based on this study of infants), then with 73M persons age 18 or younger in the U.S., roughly 1 in every 200,000 childhood vaccinations results in some claim compensated through this fund.

Not all vaccine injury claims are paid through that fund.  That said, the 719 awards for FY 2021 represents a large fraction of all awards to compensate for  childhood vaccine-related injuries in the U.S.

Let me take just one single childhood disease to try to put those 719 awards in FY 2021 into perspective.   Pertussis (whooping cough) used to be a common and serious disease of childhood.  Prior to the widespread use of vaccines, the U.S. routinely saw 9,000 deaths a year attributed to whooping cough alone, though the true number of likely higher due to non-reporting of the disease (reference, reference).  (Currently, there are about 10 deaths per year in the U.S. from pertussis.)

Now assess the relative risks.  On the one hand, you’d have 9,000 deaths per year with no U.S. use of the vaccine, from just one of the diseases covered.  On the other hand, you have 719 claims for compensation, for all childhood vaccines combined.

Childhood vaccine are recommended, despite the risks, because the estimated benefits outweigh the risks, to the U.S. population as a whole, by an extremely wide margin.


Vaccination involves risks, Part 2:  The U.S. has an injury compensation program for COVID-19 vaccines.

COVID-19 vaccination involves risks.  There’s nothing new about that, either.  What I found new, in looking at this, is that the U.S. already has a fund in place to compensate people injured by COVID-19 vaccines.

The U.S. Countermeasures Injury Compensation Program (CICP) was authorized by the U.S. Congress in 2005 (reference), as a way to deal with injuries that may arise from vaccines and other countermeasures specifically in the context of epidemics and pandemics.  It has covered injuries related to COVID-19 vaccine since March 2020 (same reference).

As with most Federal programs, they have to report periodically on what they are doing.  So you can get statistics on claims filed, adjudicated, and paid, at this U.S. DHHS web page.

The U.S. has now delivered more than 500 million COVID-19 vaccine doses (per CDC COVID data tracker).  Given the large numbers, involved, it’s worth taking a look at the number of claims filed and paid under the CIPC, for alleged serious injury relating to COVID-19 vaccines.

As with the VICP (childhood vaccines), not every serious injury will generate a claim.  For example, if all costs were covered by third parties (insurers, say), there’s likely no cause to pay a claim under CIPC.

And, as with the VICP, it looks like the processing of typical claim takes several years, so there is no hard data yet on the number of claims that will eventually be paid.  To date, just 29 claims have been paid, for injury from all countermeasures (for all relevant diseases, and all relevant countermeasures, vaccines, testing, and other). 

Of note, none of the 29 claims paid so for is for COVID-19 vaccine.  Most are for H1N1 flu vaccine, and smallpox vaccine.  Also of note, the one myocarditis claim paid so far was for smallpox vaccine, which apparently has a known risk of myocarditis among young men.

Even though there’s a huge backlog of un-examined claims, it’s well worth looking at total filings — payable or not — to get some handle on the extent to which those 500M vaccine shots are claimed to have generated some significant injury.

As of December 1, 2021, they show the following (about half of which relate to COVID-19 vaccines, half to other countermeasures):

  • 6032 eligible claims
  • 5630 in review or pending review
  •   402 reviewed
  •   362 denied
  •     40 eligible for compensation

So far, it looks like about 10 percent of claims are judged eligible for compensation.  Pro-rating the entire set of 6032, then, we would eventually expect about 600 claims to be eligible for compensation.  Of which, about half of claims were for COVID-19 vaccination.

Or, if I’ve done the math right, best guess, about 1 in 400,000 COVID-19 vaccinations will eventually result in a some claim compensated through this fund.  Which, given the approximations involved, is not hugely different from the rate of compensation for the childhood vaccination fund (VICP).

In other words, to a first approximation, risk of serious, compensable illness or death from COVID-19 vaccines appears to be about the same as all other vaccines.

It’s worthwhile, I think, to stop and illustrate just how small that is, compared to the risk incurred from not being vaccinated.  Taking that same population base of 400,000, the last few weeks of data from Virginia suggest that we’d see an average of seven excess deaths per week, from Omicron, among the unvaccinated.  (That is, death rate for the unvaccinated less death rate for the vaccinated).  If the Omicron wave last a couple of months in total, that will be excess 56 Omicron-related deaths in the unvaccinated population, for the current wave aloneCompare that one projected claim for vaccine-related injury. 

This sort of lopsided, orders-of-magnitude cost/benefit ratio occurs again and again when you look at vaccines.  COVID-19 vaccines appear to be no different in that regard.  And that’s why every responsible organization strongly recommends (and sometimes mandates) COVID-19 vaccination.

It’s really not magic, or self-delusion, or ignorance.  It’s that the case for vaccination is that strong.  Particularly here, for COVID-19, where there is so much of it in circulation that you don’t even have to appeal to the “public” part of public health.  But also for many other disease that were once scourges of mankind, and are now merely slight risks in the background of first-world existence.

Maybe if you still don’t get it, you ought to take a peek at Post #1247: Harking back to a more dangerous and less foolish era of public health in the U.S.A.

If I summarize the list of conditions for which compensation has been sought, separating out the pericarditis/myocarditis risk, it looks like this:

Source:  HRSA, calculation of rate per million is mine.

The only point here is that out of roughly 500M COVID-19 vaccine doses so far, there are 95 claims of significant injury from myocarditis and pericarditis.  Not all of those will be found to have merit.  But that raw claim rate — basically, the count of persons who believe they were significantly harmed by vaccine-induced myocarditis and pericarditis — works out to one per every half-million doses of vaccine.


A quick cut of the VAERS data.

This next bit uses the Vaccine Adverse Event Reporting System data maintained by U.S. DHHS.  You can find the background in Post #1208, A funny thing about deaths in the elderly.

In case you can’t be bothered to read that post, the important point is that VAERS asks people to report any adverse event that followed COVID-19 vaccination.  There’s no guarantee of cause-and-effect here.  And in the case of death, I looked in detail, and most deaths in the period following COVID-19 vaccination were directly attributed to other causes, by the individuals reporting those deaths. (That’s in Post #1208 above).

You should also be aware the VAERS is a voluntary self-reporting system, with all the data integrity and quality that implies.

I just want to check the number of people who died, with some mention of myocarditis or pericarditis, at some point following COVID-19 vaccination.  Without trying to guess whether the heart condition or the death was due to the vaccination or not.

To be clear, I’m checking all the symptom keyword fields for “DEATH” and any mention of “MYOCARDITIS” or “PERCARDITIS”.

There were a total of 17 reports that included both death and myo/pericarditis.  Of these, one (1) was a male under age 40.  The median age of all 17 was 60 years.  Roughly half were men, half were women.

I think that, by itself, this suggests that all the talk about large numbers of excess deaths resulting from a mandatory booster policy is pretty clearly bullshit.  While VAERS is not perfect, if there had been a material risk of death from this cause, in this population, for this vaccine, we’d likely have seen more than one reported so far.

That is not to dismiss the risk of myocarditis, only the fear-mongering.

More generally, there were 1854 records in VAERS with mention of myocarditis/pericardits at some point after COVID-19 vaccination.  Of those where age was reported, 55% were men under age 40.  Interestingly, the apparent highest-risk group is high-school age, not college age.

Source:  Analysis of VAERS 2021 file, downloaded 1/25/2022 from this website.

In short, there is a real and fairly well-known risk of myocarditis / pericarditis.  Using Federal data sources, I can document over 1800 cases with some mention of it, the majority of which were in young men.  Without doing the formal math, I think that’s above the background rate at which you would expect to see myocarditis in this population.


Summary

There’s a claim afoot that the potential harm from booster shots outweighs the benefits, for young men.  This is attributed to the risk of myocarditis from the vaccine.

I can only assume this latest claim is gaining currency now because  universities are mandating boosters in the face of Omicron.  They are doing this because the benefits grossly outweigh the risks.  (Quantifying that is the aim of my next post in this series).

More to the point, if we look at the top ten universities in the country, all of them are mandating booster shots.  To believe that risks outweigh benefits from booster shots is to believe that all of these extremely bright people are wrong.  And that some random internet source has it right.

For sure, there is a myocarditis risk from COVID-19 vaccines.  That’s been fairly well established.  Myocarditis risk from vaccination is not a new idea and is not unique to COVID-19 vaccines).

Looking at Federal data sources, there have been over 1800 instances where myocarditis/endocarditis was reported some time after COVID-19 vaccination.  There have been nearly 100 persons who have submitted a claim for compensation for vaccine-induced harm from it.  There are 17 cases where the VAERS record mentions this condition and death (though the median age for those records was 60). And there is one record showing that a young man died, with mention of myocarditis, some time after COVID-19 vaccination.

But the real point is that this risk is small, and has been well-recognized and well-examined.   My secondary point is that hyping this as some great wave of deaths resulting from misguided pro-vaccination zeal is just the worst sort of fear-mongering.  That argument — large numbers of excess deaths — is clearly not borne out by the facts.

Once upon a time, I did a lot of professional work on end-of-life care in the United States.  (e.g., this reference).  People in the health care field take claims about excess deaths with the utmost seriousness.  As a consequence, if you make some extraordinary claim (young men dying) you’d better have some extraordinary proof to back that up.  It’s only the amateurs who are willing to mouth off about something as serious as that without bother to check their facts first.

I’ll look in detail at the estimates risks of booster and non-booster status tomorrow.  That’s the only way to put the myocarditis risk into perspective.  But I wouldn’t expect any surprises.

I’m guessing that Harvard, Columbia, Yale at al. have made the right decision.

And I’ll tell you one thing for damned sure.  I wouldn’t contradict all of that reasoned judgment unless I had the overwhelming and undisputed facts in hand.  Extraordinary claims require extraordinary proof.  Except on social media.