The Left and the Right Have Lost Their Minds Over Covid

Last week's news on the booster approvals and Florida's controversial vaccine mortality study was a low water mark for common sense and scientific reason.

I know, I know. Claiming that our American ideologues have lost their tether to reason is not exactly an aggressive position to stake. However, last week pushed my perspective on the discourse around Covid-19 in this country from dismay to disgust. To borrow from Elvis Costello, I am not seeing the path to amusement at this point.

What happened? Twin stories emerged in close proximity, both similarly disturbing for people who prefer their public health authorities to behave responsibly. First, right around beer thirty on a Friday night, Florida released this bulletin:

A few days later, the FDA rather quietly announced the approval of the bivalent Moderna booster for kids 6-17 — the first time any Moderna booster was approved for this age group — and Pfizer’s bivalent booster for children 5-17. No VRBAC meeting to hash this out first, nor ACIP convocation afterwards to advise the CDC, which quickly followed with a recommendation that these bivalent boosters are now required for everyone to be considered up to date on their vaccines.

Well, only “some people.” All people over the age of 5. Those people.

Much bickering ensued after these news stories broke, rightfully so. Both proclamations represent the workings of the minds of people who have lost the ability to express a nuanced thought. Both are asinine in their incompleteness. Hearing their supporters climb aboard with hardly an objection was more than I could bear.

I’ll dig into just what was so unacceptable about these stories momentarily. First, though, I need to define my terms. I am not equating “Left” with what we used to call “liberals” or Democrats, or “Right” with what we once termed “conservatives” or Republicans, although there is a fair bit of overlap. Rather, I refer to the “Covid Left” as the generally blue-state supporters who have pushed hard for prolonged school closures, mask-wearing, and Covid-19 vaccine mandates, and tend to treat Long COVID as an existential threat to humankind; and the “Covid Right” as the generally red-staters who happily dismantle public health organizations, were quick to equate Covid to the flu (and now a cold), dismiss Long COVID as a sort of neurotic hangnail, and equate mask and vaccine requirements to WW2 Nazi atrocities. You know both types. There might be a hundred million of them in our country these days.

Which brings us to Dr. Joe Ladapo and the great state of Florida, where he sits at the helm as State Surgeon General. The study he trotted out on a Friday evening as east coasters were settling down at the dinner table was… strange. It was written rather like a CDC Morbidity and Mortality Weekly Report, with the notable distinction that it did not list any authors. That’s unusual, really, in any setting whatsoever, except perhaps while passing notes in grade school. The study design itself was puzzling, a lightly used method called a “Self-Controlled Case Series” which required about 30 minutes of reading and re-reading on my part to even comprehend what they had done. Turns out they studied all the Floridians who had died of medical causes (i.e., not accidental death or suicide) excluding Covid-19 during the vaccination era within 25 weeks of a Covid-19 vaccine, and looked at whether they were more likely to die in the first 28 days after a vaccine, or in the days that followed over the next 5 months.

The headline news from Dr. Ladapo: YOUNG MEN 18-39 WERE 84% MORE LIKELY TO HAVE DIED OF A CARDIOVASCULAR EVENT IN THE FIRST 4 WEEKS AFTER A VACCINE!!! Not mentioned: they were actually 16-22% less likely to die of all-cause mortality in that first month.

Yes, there was actually a (not statistically significant) improvement in all-cause mortality for this cohort in the time immediately after vaccination. Surely, Dr. Ladapo mentioned that reassuring finding?

Uh, no. Here he is promoting his study, and Florida’s decision to not recommend mRNA vaccines for men 18-39, on FOX News:

I encourage folks to watch the entire interview. The quotation above is direct from Dr. Ladapo’s mouth. At no point does he share the lower all-cause mortality found in the study. Nor does he mention that the study itself is better designed to find a signal (i.e., “perhaps we should try to compare people who are unvaccinated to those who are vaccinated and see if one group is more likely to die than the other”) than to make any sort of statistical claim at all. Especially not a claim that young men have their risk of cardiac death increased by 84%, since that is not at all what the paper was studying; it was just comparing the risk immediately after vaccine to the 5 months following in people who were vaccinated and had already died.

I promise not to devote five paragraphs to all the flaws with the study. There were many. For one, with a tiny sample size (20 early deaths in that age group), counting the months after death as counting towards the “at risk of death” total is problematic. What’s more, with small numbers, issues with inaccurate counting based on medical coding and death certificates get magnified, as explained in this thorough blog post. But really, the flashing red light issue with this study was that, when you only study dead vaccinated people, it’s important not to make definitive claims about living unvaccinated people benefiting by avoiding vaccines. Very important.

Now, by way of full disclosure, I find Dr. Ladapo to have an engaging public persona, and his anti-mandated-anything policies rather play to my public health tastes. I also share his concern for the risks of mRNA vaccines in young, healthy men, and have written many thousands of words on the subject; put simply, I don’t think teenage and 20-something men should get an mRNA vaccine unless they are at unusual risk of severe disease, since hospitalization risk for post-vaccine myocarditis almost certainly exceeds hospitalization risk for Covid-19 in this cohort. These points could have been made by Dr. Ladapo to support Florida’s new policy last month, or 6 months ago, and I think they would have been evidence-based and appropriate if presented even-handedly (although I would quibble with including men in their 30s, given that post-vaccine myocarditis rates start to fall off a cliff around age 25, and people in their 30s have about twice the risk of severe Covid-19 disease than those in their 20s).

However, these points were not made even-handedly. The study findings were distorted, to present a headline which seemed designed to inspire fear of vaccination in men under 40. A lot of people have looked, but no one has found an actual increased rate of death in the time following mRNA vaccination in a proper study. I would like to cut Dr. Ladapo some slack for this, but despite his impeccable medical credentials, he has some history of making scientifically unvalidated claims. Yes, here he is standing with “America’s Frontline Doctors” in that infamous White Coat conference on the steps of the Supreme Court, advocating for the use of hydroxychloroquine against Covid:

This is July 2020; hydroxychloroquine had already been roundly exposed as having minimal evidence for its use for months at this point, and this was a strange intellectual hill on which to die. Also strange is Dr. Stella Immanuel tucked behind his left shoulder, she of demon sperm fame from prior to that SCOTUS media event. I don’t know about you, but when someone comes to me with a publicity opportunity in which I share the limelight with someone who publicly espouses the health ravages of having dream-sex with demons and witches, I politely demur.

So, OK — Florida makes a questionable policy decision based on an oddball study misrepresented by their state Surgeon General, who has a checkered past of medical credibility. We can all agree to call this move out, right?

Wrong.

The Left called it out, to be sure, but followed its unfortunate censorship playbook. Twitter briefly banned Dr. Ladapo, which is a fabulous way to convince his fans (and, by extension, those of Governor Ron DeSantis) that his pronouncement must be of such inherent truth and validity that the establishment is quaking in fear. Then, Science runs an editorial from its Editor-In-Chief, Holden Thorp, essentially asking the University of Florida to censure Dr. Ladapo for his comments, which reads a lot like Science with a capital “S” mixing with politics. This, in turn, led to an outcry from the Covid Right: “Here comes the Left with their pitchforks for someone who dares to disagree with them, simply for speaking his truth!”

What I don’t see anyone on the Covid Right doing — and I follow a lot of people in this category, since I generally find their takes on Covid-19 to be less beholden to the medical orthodoxy than their colleagues on the Left — is criticizing Dr. Ladapo for announcing a new policy in a disingenuous manner with a heavy reliance on a vacuous study. Only crickets. The theme I keep seeing is along the lines of, “Well, the study design has its flaws, but we know about that myocarditis signal, and the outcry against Dr. Ladapo is simply unacceptable.” Not: “This was a weak study without any obvious conclusions to draw, and Dr. Ladapo should know better.”

When we can’t call out our own for obvious indiscretions, credibility is rightfully lost.

So, that’s my disgust with the Right. The Left earned it with their rubber-stamped approval of the recent bivalent booster EUA for kids.

I want to be perfectly clear that I don’t think the bivalent boosters are a bust; again, I penned a few thousand words to the contrary. I think they are okay; maybe a little better than the original Pfizer and Moderna boosters (based on very modest increases in neutralizing antibodies vs BA.5), maybe a little worse (based on dubious early clinical data from the Wuhan/BA.1 bivalent used up north in Canada). I think moderate and higher risk adults without a recent infection or vaccine probably benefit from another one, if only for a few months; and high risk kids probably do, too. But there are a couple aspects to this EUA that are downright offensive to anyone who still values truth in science reporting.

For one, anyone billing these bivalent vaccines as “better” or “improved” is simply not telling the truth. We have no idea. It’s what we have, and we hope they do at least as well as their predecessors, but we simply have no vaccine efficacy data with which to compare them, since approvals preceded the trials. So let’s not pretend; because if the Wuhan/BA.4-5 bivalent data ends up as mediocre as the early returns on the Wuhan/BA.1 booster, people are going to wonder why they were sold a “better” product after so little study. That’s not the perspective of White House Covid-19 Response Coordinator, Dr. Ashish Jha, though:

It seems pretty straight-forward to Dr. Jha:

There is optimism, and then there is hubris, and I can’t stand to see our most visible public health officials cross that line.

In the case of these bivalent boosters for kids, we have absolutely no study data at all on these Wuhan/BA.4-5 boosters. None. The FDA admits this. Not safety data, not efficacy data; it’s all bootstrapped on other studies with other vaccines. From the FDA press release for the Pfizer booster for children:

If it was safe in a small number of adults over 55 who received an earlier bivalent booster, pretty much 100% sure a different bivalent booster will be safe in children.

For Moderna:

Same story, but at least it included some younger adults getting a different bivalent booster. Sigh.

They also granted the EUA based on the very small monovalent booster studies done for Pfizer and Moderna on these age groups which showed similar bumps in neutralizing antibodies to that of adults getting monovalent boosters; and since the boosters worked in adults, they figure they’ll probably work in kids. All that is probably true. It’s just not very scientific.

Again, if it were August 2021 and Delta was raging and vaccine effectiveness was still high, I’d probably be okay with moving without the data. Right now - I’d wait a couple months for some trials to report. Based on current ages 5-17 hospitalization rates, I don’t see an emergency lurking in that grey line down there (that’s not just a thick x-axis):

Then there’s the question that I also see the CDC, FDA, and their defenders completely and totally avoiding: is there any benefit to boosting an immune competent child or teenager with a bivalent booster who has already had Omicron? Since this applies to the vast majority of kids, you would think someone would want to know! Perhaps, even, ask Pfizer or Moderna to conduct their trial adequately powered to answer this question. Would there be any durable reduction in overall infections, which would reduce transmission and possibly reduce Long COVID rates; and would severe infections and hospitalizations be reduced? My guess based on studies like those coming out of Qatar is that there would be virtually no benefit, other than a brief, perhaps 1-3 month, reduction in overall infections.

That’s just a guess, of course, because we have no trial data. It’s very hard to recommend this booster to children or teens who have already been infected with Omicron without real data that it will have meaningful benefit. Otherwise, all we get is cost: expense, painful shoulders, the occasional annoying or lingering side effect, and the rare serious vaccine adverse event.

And that’s where I really draw the line at the latest approvals of the bivalent boosters, and now their impending uptake into the childhood vaccine schedule. I despise all the uncertainty cloaked as certainty, but sometimes it is less palatable than others:

Strong language. Especially because there is concern, absolutely, when it comes to myocarditis in boys in that 12-17 age group who just had their Moderna boosters approved for the first time. Studies have varied, but Moderna and its higher dose consistently causes myocarditis at a substantially higher clip than Pfizer. So much so, that no less fringe nations than Sweden, Norway and Finland, among others, have restricted Moderna use in young men. The most convincing study of this brand effect found triple the rate of post-vaccine myocarditis in Moderna.

Is overt post-mRNA-myocarditis rare? Yes, in the 1 in 2000 to 1 in 10000 range among men in their teens and 20s getting their 2nd or later shot, depending largely on how aggressively the study pursues the diagnosis. But we don’t know about the rates of symptomatic myocarditis or subclinical/“mild” myocarditis because this has not been properly studied in a trial setting. We do have a prospective study from Thailand which checked cardiac enzymes like troponin (when elevated, a sign of injured heart muscle) and imaged the hearts of some 200 non-randomized boys who received 2 doses of the Pfizer vaccine; they found 1 with symptomatic myocarditis (who ended up in the ICU) but 2 more with milder pericarditis, and another 4 with elevated heart enzymes but not clinical myocarditis. Yikes - around 3.5% with some form of heart inflammation. Lest this be viewed as a one-off outlier, Christian Müller, who directs the Cardiovascular Research Institute in Basel, Switzerland, has presented findings that 2.8% of hospital workers (not just young men) had elevated troponin 3 days after mRNA vaccination which he believed was due to the vaccine. No one was ill; we don’t know if any lasting damage was done; but can we say there is “no concern”?

Therein lies my frustration. It’s probably a bad idea to give a young man a booster if he is not at high risk of a severe Covid infection; and since it is not clear if any additional benefit accrues to said young man if he has already had an Omicron infection, that’s a cohort for which probably no one should be recommending a booster. Instead, we have a blanket recommendation. Most of all, to then recommend a Moderna booster, despite clear data that the risk is even higher with Moderna than Pfizer, is criminally ignorant. But here’s the CDC:

Pfizer? Moderna? Who cares. Just keep the message simple.

If a parent of a 15 year old boy was told it was just fine to get Moderna, and lost those 1/3000 odds and spent 3 days in the hospital with chest pain and a racing heart, and was told to lay off sports for a few months and come back for another echocardiogram in 3 months to make sure they’re in the majority whose heart heals fine… they would correctly blow a gasket on finding out that no one told them to avoid a Moderna shot. It’s unacceptable. Even when the truth is awkward, even when it raises questions, we have to tell it.

That’s it in a nutshell. That’s why I’m so grumpy about medicine right now. I expect ideology to trump honesty in politics. I just can’t stand to see it in medicine.