The reality wars, vaccine edition

This is absolutely true: One of the three coronavirus vaccines initially approved by the FDA causes a serious and sometimes deadly blood clotting disorder.

The vaccine is the Johnson & Johnson / Janssen viral vector COVID-19 vaccine. I'll refer to it as J&J. The disorder is thrombosis with thrombocytopenia syndrome (TTS), which causes blood clots in large blood vessels while simultaneously and paradoxically causing low platelet counts. The low platelet count makes administration of heparin, the standard treatment for acute thrombosis, highly problematic. The risk is that medical personnel would misunderstand the patient's situation and inappropriately (in this special case) administer heparin, putting the patient at severe risk from bleeding.

The CDC has concluded that the J&J vaccine causes TTS. It has made this determination despite the condition being extremely rare: just 4 cases per million doses administered.

As of March 18, 2022, there were 60 reported TTS cases, and 9 deaths, associated with 18 million J&J doses administered. On May 5, 2022, the FDA limited the use of the J&J vaccine. (A year earlier, in April 2021, FDA and CDC recommended pausing use of the vaccine pending a review of 6 reported TTS cases, and then lifted the pause after judging, correctly, that the vaccine's benefits outweighed its risks. In December 2021, a CDC advisory committee recommended the preferential use of mRNA COVID-19 vaccines over the J&J vaccine. CDC adopted the recommendation.)

Because you know how to think—which, after all, is what this blog is about—you were surely struck by two important realizations after considering these statistics. The first is that CDC and FDA surveillance of adverse events from vaccination is exceptionally fine-grained and meticulous. Despite TTS occurrences being extremely rare—less than one case per 250,000 doses—public health authorities have been able to identify, study, quantify, and react to these events. This should provide high confidence that the authorities are engaged in scrupulous monitoring of vaccine safety overall.

Your second realization is that compared to the risk of dying of Covid, the risk of death from receiving the J&J vaccine is minute: just 1 death per 2 million doses. You could easily calculate that at that rate, if every man, woman, and child in the U.S. received the J&J vaccine, there would be 165 deaths caused by the vaccine itself. That's in a country where, so far, 1,088,000—one million eighty eight thousand—people have died of Covid. The mRNA vaccines are even safer than J&J and are thus preferred, but if J&J were the only Covid vaccine available, it would be overwhelmingly to your benefit to receive it.

Indeed, the availability of safe and effective vaccines has been the preeminent success story of this pandemic, just as it, along with antibiotics, has been the preeminent success story of medicine in the 20th century. According to a report from the Commonwealth Fund and the Yale School of Public Health, COVID-19 vaccinations prevented an estimated 3.2 million deaths and 18.5 million hospitalizations in the U.S. from December 2020 through November 2022. A study published in June in The Lancet Infectious Diseases estimates that vaccination prevented 19.8 million deaths worldwide. And a study by Brown University School of Public Health et. al. found that 318,000 deaths could have been prevented in the U.S. if every eligible adult had gotten vaccinated. The tragedy is that many who could have didn't.

Even today, when vaccinated persons routinely become infected and even die, you're still far more likely to die of Covid if you've not been vaccinated than if you've been vaccinated and boosted. As of this fall, persons vaccinated and boosted with the updated bivalent booster had a 15 times lower risk of dying, and a 3 times lower risk of becoming infected, than unvaccinated persons. And persons who received the updated bivalent booster had almost 4 times lower risk of dying compared to vaccinated persons who haven't received it. Because plenty of people are still dying—at an annualized rate of around 130,000 through the fall, with even more expected this winter—relative risk still matters. That is so even without considering the problem of long Covid, which affects upwards of 30 percent of persons who get infected, and can cause serious long term health problems. Vaccination probably lowers that risk too.

All that is true, despite it also being true that more vaccinated than unvaccinated persons are now dying of Covid, in aggregate. How can that be?

Thinker that you are, you'll have no difficulty understanding that, either. The reason more vaccinated than unvaccinated persons are now dying is that by now more than three quarters of adults in the U.S. have been vaccinated, although many of them have not been boosted. That means there are now far more vaccinated persons available to die than unvaccinated persons. And because the vaccines are good but not perfect, some vaccinated persons will die. Indeed, if everybody was vaccinated, then only vaccinated persons would die. But it's still the case that your personal risk depends on your personal vaccination status, as described above.

There's more to the explanation. Among the reasons that a good many vaccinated persons are now dying is that the persons most likely to be vaccinated are those who are most at risk: the elderly, and those with underlying medical conditions. These are exactly the persons most susceptible to a bad outcome if they get infected. It's also true that many older adults got vaccinated early—remember, they got priority when vaccines first became available—but they didn't keep up with their boosters. After all this time, their initial vaccine immunity has substantially waned.

Our experience with Covid has changed a lot since the early days, which makes fertile ground for all kinds of misunderstanding, or worse. When the vaccines first became available in late 2020, they prevented more than 90 percent of infections, which was simply amazing. But the virus has been mutating all that time, and there has been a succession of new variants that have increasingly developed ways to evade both the body's immune system and the protection conferred by vaccines. That means the vaccines are now far less effective at preventing infection than they once were. The good news, though, is that they still provide substantial protection against hospitalization and death, as the statistics above indicate. Which, in the end, is what matters most.

So all in all, the Covid vaccines have been a magnificent achievement, and are still keeping a lot of people alive. That hasn't prevented a constant torrent of misinformation and disinformation coming from certain quarters, almost entirely the political and ideological right and its media. The propaganda has had a devastating effect, as the Brown study of preventable deaths demonstrates.

The U.S., which has had a superb and abundant portfolio of vaccines, has a lower vaccination rate than many other advanced countries. After the early rush to get vaccinated had passed, an ideological divergence—one that had actually been lurking from the beginning—opened and became deeply entrenched. By the spring of 2021, vaccine skepticism on the right was evident and growing.

That skepticism was killing people. A number of compelling statistical analyses through 2021 showed that Republicans were dying of Covid at substantially higher rates than Democrats. That far fewer Republicans than Democrats were getting vaccinated was undeniable, as a long parade of media reporting shows.

As early as April 14, 2021, an AP article was headlined "Red states on U.S. electoral map lagging on vaccinations." In an April 17 analysis, the New York Times said: "Least Vaccinated U.S. Counties Have Something in Common: Trump Voters." On May 17, a PBS News Hour story was headlined: "As more Americans get vaccinated, 41% of Republicans still refuse COVID-19 shots." The story reported that whereas 41% of polled Republicans said they did not plan to get vaccinated, just 4% of Democrats said that. On May 23 CNN observed that "The 2021 vaccination map looks like the 2020 election map." A June 5 Politico story was headlined: "The partisan divide in vaccinations is starker than you realize." On June 9 NPR said: "There's A Stark Red-Blue Divide When It Comes To States' Vaccination Rates." A Forbes headline on June 22 was: "All 16 States That Have Hit Biden's Vaccine Goal Voted For Him In 2020." On July 6 The Hill said: "Risks rise as vaccination gap with Trump counties grows wider."

The vaccination gap between Republicans and Democrats has been thoroughly documented, with analyses combining publicly available election and vaccination data, and also by direct polling that asked about vaccination status and intentions. Republicans consistently said they were less willing to get vaccinated than Democrats. On July 29, 2021, Vox published this plot by Charles Gaba of vaccination rates for all 3,144 U.S. counties. The graph's x-axis is the county's vote percentage for Trump in 2020. The y-axis is the county's vaccination rate. The graph powerfully shows how Trump counties had lower vaccination rates than Biden counties across the entire country.

On September 2, 2021, Fortune reported that the 10 states with the highest levels of vaccine refusal were all red. On September 14, the Kaiser Family Foundation documented the widening vaccination gap between counties that voted for Biden and counties that voted for Trump. On September 17, Pew Research reported on the "Demographics of COVID-19 vaccination status within the Republican and Democratic Party." Pew reported that among all U.S. adults, 86 percent of Democrats had received at least one vaccine dose, whereas just 60 percent of Republicans had done so. On September 27, Gallup polling showed that 92 percent of Democrats said they'd received at least one vaccine dose, whereas 56 percent of Republicans said they had.

Becker's Hospital Review has published a long-running ranking of states by "percentage of population fully vaccinated." The most vaccinated states have always been overwhelmingly blue, and still are. Here's the top 20, which is to say most vaccinated, as I write this: Rhode Island, District of Columbia, Vermont, Massachusetts, Maine, Connecticut, Hawaii, New York, Maryland, New Jersey, Virginia, Washington, New Mexico, California, Colorado, Delaware, Pennsylvania, Oregon, Minnesota, New Hampshire. The first Trump state on the list is Florida, at number 22. Of the 17 least vaccinated states, 16 were carried by Trump. The sole exception is Georgia.

Eventually and inexorably, the reporting on the partisan vaccination disparity transitioned to reporting on the partisan Covid death disparity, with Republicans dying at substantially higher rates than Democrats. Initially this disparity was demonstrated using solid statistical inference that combined county partisan political preference (using 2020 election results as a proxy), county vaccination rates, and CDC data on relative death risk between vaccinated and unvaccinated individuals. Later the county-by-county analysis was extended to incorporate actual death rates. Later still, a study provided hard data on the actual partisan affiliation associated with "excess deaths" in the two states that were studied.

On August 25, 2021, the Washington Post's Philip Bump presented graphs showing that red states had higher rates of cases, hospitalizations, and deaths than blue states. On December 6, NPR said "a nationwide comparison of 2020 presidential election results and COVID-19 death rates since vaccines became available for all adults, found that counties that voted heavily for Trump had nearly three times the COVID-19 mortality rate of those that went for Joe Biden. Those counties also had far lower vaccination rates." This graph was provided with the NPR story. Charles Gaba produced a striking graph that plotted Covid death rates against county-level election results from all of the nation's 3,144 counties. The deaths occurred between June 30 and December 26, 2021. Which is to say, after vaccines became widely available. The graph data was presented in population deciles, showing a strongly increasing death gradient from blue to red. At the extreme ends of the graph, the reddest tenth of the population had a death rate almost 6 times higher than the bluest tenth.

Even I weighed in with my own analysis. I sent an email that I called "Fun with math" , in which I calculate a mathematical inference using self-reported vaccination data and the CDC's risk data to show that a Republican would be almost three times as likely to die of Covid as a Democrat. I suspect the email's recipients were not impressed, but that can't be helped.

On March 28 of this year, ABC News said its own analysis of post-vaccine data found that Trump states had a 38 percent higher death rate than Biden states. "In the 10 states with the lowest percentage of full vaccinations, death rates were almost twice as high as that of states with the highest vaccination rates," ABC said. ABC produced this graph which shows yet again that Biden voters, who are more vaccinated, die at a substantially lower rates than Trump voters, who aren't.

A study by Yale Researchers, released in September of this year by the National Bureau of Economic Research [update: later published in JAMA Network July 24, 2023], found a sharp divergence in "excess deaths" between Democrats and Republicans in the two states that were studied—Ohio and Florida—in the summer of 2021. The study used voter registration data to determine partisan affiliation of the deceased. As this graph shows, by the end of 2021 Republicans had around a 35 percent excess death rate, compared to 12 percent for Democrats in the two states. In epidemiology, "excess deaths" is a statistical measure of actual versus expected deaths. Excess deaths nationwide shot up dramatically during the pandemic, as Covid became the third leading cause of death in the U.S. after heart disease and cancer, and U.S. life expectancy fell by more than 2 years. The study used the year 2019, before Covid, to establish baseline death data for several categories including party affiliation.

From the paper: "In 2018 and the early parts of 2020, excess death rates for Republicans and Democrats are similar, and centered around zero. Both groups experienced a similar large spike in excess deaths in the winter of 2020-2021. However, in the summer of 2021 — after vaccines were widely available — the Republican excess death rate rose to nearly double that of Democrats, and this gap widened further in the winter of 2021."

It's likely that differences in vaccination rates doesn't explain the entire death disparity. Researchers at Northeastern University found the death rate skewed against Republicans even in the latter part of 2020, before vaccines became available. This suggests that other behavioral differences, such as masking and distancing, played a role. Throughout the pandemic, there was more push-back by Republicans against a wide range of mitigation measures, and more demonization of public health authorities and their recommendations. Republicans have even been more likely to deny the existence of Covid.

So where does that leave us? Writing in The New York Times, David Wallace-Wells argues that Covid is no longer a disease of the unvaccinated, but is primarily a disease of the elderly. In the U.S., says Wallace-Wells, persons "65 and over account for 90 percent of new Covid deaths, an especially large share given that 94 percent of American seniors are vaccinated."

In September 2021, the unvaccinated accounted for 77 percent of deaths in the U.S. In January 2022, amidst the Omicron surge (there were almost 85,000 deaths that month), the rate was down to 59 percent. And by summer, almost as many vaccinated and boosted as unvaccinated Americans were dying. As we've seen, more vaccinated persons are now dying than unvaccinated.

With statistics like these, you can see how easy it would be to construct an antivax disinformation campaign.

And yet, says Wallace-Wells, the high death rate "is not because the vaccines are ineffective — we know, also from the Centers for Disease Control and Prevention data, that they work very well. Estimates of the effectiveness of updated bivalent boosters suggest they reduce the risk of mortality from Covid in Americans over the age of 12 by more than 93 percent compared with the population of unvaccinated. That is a very large factor."

The high death rate among the elderly, despite that group's high 94 percent vaccination rate, is in large part due to far higher susceptibility to severe disease as a consequence of the immune system weakening with age. That weakening also reduces—but does not eliminate—the effectiveness of vaccines. Vaccinated Americans between 65 and 79 had an 8-fold reduction in mortality risk, whereas those over 80 had a 3.8-fold reduction. Both are much lower than the 15-fold mortality reduction in the overall population of vaccinated and bivalent-boosted Americans. And to that latter point in particular, although the elderly have been vaccinated at a high rate, many have not been boosted, especially with the new bivalent booster.

The obvious conclusion is that vaccination still confers substantial protection for the elderly despite high death rates and high vaccination rates in that group. Unvaccinated elderly still have a far higher mortality risk than the vaccinated. The question is not principally how many people have died, but, rather, how many more would have died but for vaccination. As we've seen, vaccination has saved millions of lives across the pandemic.

We've also seen that public health authorities have kept a careful watch for adverse events, which have proved to be almost nonexistent. (Guillain-Barré syndrome, for example, which according to a recent Rutgers University study isn't associated with any of the Covid vaccines as some had feared.) As of October, 613 million vaccine doses have been administered in the U.S., and 12.7 billion worldwide. If the vaccines were causing widespread adverse events, we'd surely know about it.

Some insist, falsely, that we do know about it. On May 6, 2021, Fox News host Tucker Carlson said on his show that more than 3,000 people have died from Covid vaccines. It's hard to imagine a more irresponsibly despicable claim. "The actual number is almost certainly higher than that," Carlson said. "Perhaps vastly higher than that." Carlson's assertion was based on a gross misuse—whether cynical or ignorant—of data from the government's Vaccine Adverse Event Reporting System (VAERS). Carlson's false claim coincided, as we've seen above, with rapidly escalating vaccine refusal among Republicans, and is itself surely responsible for untold deaths.

You might wonder how a CDC that teased out less than 10 TTS deaths linked to 18 million J&J doses somehow missed those thousands of other deaths. The answer is that it didn't, because they didn't happen. But try to explain that to a reality-challenged Republican. You might also expect a base level of journalistic competence and integrity from what purports to be a news network. But not Fox. Thus are many millions continually misinformed about almost every aspect of reality, including but not limited to Covid. (In addition to vaccine disinformation, Fox massively hyped hydroxychloroquine and ivermectin, both of which have been shown to be unhelpful for Covid treatment or profylaxis.)

Thus have Republicans been taught by their media to eschew life-saving vaccination and to seek unproven and disproven and even quack cures. In a Wall Street Journal OpEd entitled "Hardly Anyone is Buying Biden's Bivalent Boosters," one Allysia Finley, a member of the Journal's editorial board, concluded her piece by recommending that "the best way to protect yourself from getting sick with Covid or any other respiratory illness is by getting enough sleep, nutrition and exercise." I'm not making this up. But no: Assuming you're not interested in masking and distancing, the single best way to protect yourself from Covid is to get the bivalent booster that Finley says hardly anyone is buying. (And the single best way to protect yourself from influenza is to get your flu shot, which this year in particular is a good match for the strains currently circulating in an early and bad flu season.)

It should be no surprise that Republican politicians have themselves clamored onto the antivax bandwagon, because trafficking in misunderstanding, misinformation, and even mindless conspiracy theories is what Republicans do. Perhaps the most stunning example is Florida's governor Ron DeSantis, who reliably and continually strokes all the right-wing anti-reality erogenous zones on every imaginable topic. DeSantis recently empaneled a "Public Health Integrity Committee" to investigate imagined wrongdoings by drug companies and federal health agencies with regard to Covid vaccines. The governor has filed "a petition for a Statewide Grand Jury to investigate crimes and wrongdoing committed against Floridians related to the COVID-19 vaccine."

Which is just amazing. In DeSantis-world, public health officials doing their jobs during a devastating pandemic somehow demonstrates nefarious intent or negligent action. "The Biden Administration and pharmaceutical corporations continue to push widespread distribution of mRNA vaccines on the public, including children as young as 6 months old, through relentless propaganda while ignoring real-life adverse events," said a statement released by the governor's office. "Push," of course, is antivax-speak for "strongly recommend," which the Feds and other experts have done for no better reason than it's been unambiguously established that vaccines save enormous numbers of lives. If you believe that such evidence-based recommending—what DeSantis calls "relentless propaganda"—is the rightful role of public health authorities, then please explain that to the governor.

The governor's statement said that DeSantis had convened a "roundtable discussion joined by Surgeon General Dr. Joseph Ladapo and world-renowned physicians, researchers, and public health experts to discuss adverse events of the mRNA COVID-19 vaccines." Ladapo has been a disparager of vaccination and a proponent of hydroxychloroquine and ivermectin, both of which have been discredited by multiple high quality studies, which is how such determinations are properly made. Naturally, he was just the guy to become DeSantis's surgeon general.

One of the panel's members is Joseph Fraiman, the lead author of a paper questioning initial determinations of mRNA vaccine safety—a paper that one critic called "a huge flaming dumpster fire." That paper, which was cited by the governor, is a "reanalysis" of the data from Moderna's and Pfizer's phase III clinical trials involving some tens of thousands of participants (which is not many for detecting extremely rare adverse events) that were conducted prior to vaccine emergency use authorization. Oddly, that reanalysis was published long after the vaccines were in extremely wide use, with hundreds of millons of doses having been administered, and after studies such as this one in JAMA Network, which had been published a year earlier and involved millions of patients. This is their best stuff?

At that roundtable, said the statement, "the Governor and health experts discussed data covering serious adverse events. These risks include coagulation disorders, acute cardiac injuries, Bell's palsy, encephalitis, appendicitis, and shingles." Incredibly, that very sentence in the governor's statement linked to a paper published in The New England Journal of Medicine on adverse events associated with the BNT162b2 (Pfizer/BioNTech) mRNA vaccine. From the paper's conclusion: "The BNT162b2 vaccine was not associated with an elevated risk of most of the adverse events examined [my italics -mb]."

The study did find a link between the vaccine and a low (1 to 5 in 100,000) risk of myocarditis, which is an inflammation of the heart. The study's conclusion also pointed out that the "risk of this potentially serious adverse event and of many other serious adverse events was substantially increased after SARS-CoV-2 infection [my italics -mb]." In other words, it's the infection, not the vaccine, that confers the far greater risk of a bad outcome. Many of the adverse events imagined to be associated with the vaccine are far more likely if you actually get the disease, so there's a sense in which the vaccines actually protect against the particular adverse events attributed to them.

Indeed, we've known about "COVID-19-associated myocarditis," and the serious cardiac risks associated with Covid infection, since the summer of 2020. It should be noted, too, that "long Covid" (see above) is associated with increased long term cardiac risk. Contrast that with myocarditis associated with Covid vaccination, in which most of the rare cases occur in adolescents and young adult males, and most recover quickly.

[Update Apr 30 2023: The Washington Post's editorial board reminds us that last October Florida's antivax surgeon general, Joseph A. Lapado, recommended that men 18 to 39 years old not receive mRNA Covid vaccines due to "abnormally high risk of cardiac-related death" in that age group. The recommendation was based on an analysis by Florida's Department of Health, an analysis the Post calls "shoddy" and that was criticized in a seven-page report circulated among faculty at the University of Florida’s College of Medicine for possibly violating a university policy against "careless, irregular, or contentious research practices." Dr. Lapado is a faculty member of the college. The Post points out that earlier drafts of the health department's analysis found "no increased risk for cardiac mortality following mRNA vaccinations." This review notes that the first draft had findings that were "completely opposite" the final draft. When so-called "sensitivity analysis" was incorporated in the third through fifth drafts, there is no association between vaccination and cardiac-related death in any of the subgroups analyzed. The fifth draft says that "the risk associated with COVID-19 infection clearly outweighs any potential risk associated with mRNA vaccination." But the sixth draft, which was personally edited by Dr. Lapado, warned that "COVID-19 vaccination was associated with a modestly increased risk for cardiac-related mortality 28 days following vaccination." The good doctor ultimately inserted the result he wanted, and then used it in his public warning that falsely claimed "abnormally high" risk.]

We've already covered, above, what the governor calls "coagulation disorders" associated with the J&J vaccine. All these adverse events are quite rare, and deaths from them are rarer still. This, in a country where 1 in 305 persons has actually died of Covid, and where U.S. life expectancy has declined by almost 3 years since the beginning of the pandemic. The apparent inability to grasp magnitudes of relative risk is one of the great failures of the antivax crowd, and is entirely consistent with the right's inability to discern reality generally.

And so it happens that the right's decades-long campaign to discredit all our organs and institutions of knowledge and intellectual discourse—academia, science, the press—and to pollute our politics and governance, has found its way to vaccination and public health. Why should we be surprised? All the ways we properly know what's real have long been under systematic attack.

Conspiracy theories, which extend far beyond just questions of vaccination, have been a prominent feature of these dreadful times. A quarter of Republicans believe the central views of QAnon, for gawdsake. I have personally had it explained to me that jet airplane contrails are evidence of the government deliberately injecting chemicals into the atmosphere for nefarious purposes involving control of the citizenry, and also that the government has been constructing concentration camps with the intention of rounding up a large proportion of the populace.

Ignorant yokels, who don't know much about anything, are just sure the experts have no idea what they're doing. Voter fraud is rampant, they believe, even though it can never be found whenever anybody looks for it. Elections are stolen, they're certain, maybe even by the ghost of Hugo Chavez, or by Italian satellites. Tens of millions of our fellow citizens think so, at least those who haven't yet died of Covid for want of life-saving vaccination against a disease many of them aren't even convinced exists.

The mindlessness is unrelenting. Book banning is all the rage. Pedophile teachers are grooming our children for a life of homosexuality. Sure they are. Those same children mustn't be taught about the history of race in America, lest too many unpleasantries be uncovered, and myths upended. Our schools, ever a pernicious threat to children, are indoctrinating them not just with the godless "theory" of evolution (the fundamental organizing principle of modern biology), but also with "Critical Race Theory," which in point of fact is actually only taught as part of graduate curricula, mostly in law schools. Don't try to explain that to a Republican. Nobody in authority can be trusted—certainly not the evil Fauci, who by all rights ought to be in jail. (But for what?)

It's all a steaming hot mess, a mess which is overwhelmingly a phenomenon of the deranged ideological right. A slick operator like DeSantis plays this crowd masterfully, pushing all their buttons, whether from a position of genuine belief (which would be shocking, but you never know), or merely as a cynical political operator. Over at Fox, Tucker Carlson and his colleagues construct an entirely made-up reality which their viewers willingly inhabit. Having been long taught to distrust and even loathe the "mainstream media," those viewers wear their inbred ignorance as a badge of honor, remaining proudly snuggled in their information cocoons, and never letting in anything from outside. It's no wonder they have no idea what's real.

The whole thing feeds on itself, and spreads into other areas such as vaccination. There are society-wide consequences, of course, and not just the hundreds of thousands of needless Covid deaths. We have become a nation whipsawed by idiots.

For example, Gallup has documented a divergence between Democrats and Republicans with respect to "confidence in science." Republican confidence in science has declined from 72 percent in 1975 to just 45 percent today, whereas for Democrats it has increased from 67 percent in 1975 to 79 percent today. With respect to vaccination, a recent survey from the Kaiser Family Foundation finds that 44 percent of Republicans think parents should be allowed to opt out of school vaccine mandates. Just 12 percent of Democrats think that. If that generalized antivax sentiment grows or is tolerated, the society-wide herd immunity (against measles, for example) we've enjoyed for half a century will evaporate. Which would be just par for our sorry course.

Happy New Year.

Copyright (C) 2022 James Michael Brennan, All Rights Reserved

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