This post is part of an occasional series on health care. Here’s the prologue to the series, which originally preceded the post below.
Here’s a fairly straightforward story from The New York Times from a few days back, reminding us of the fact that immunity from some of the COVID vaccinations is limited in time, and may well require a booster shot.
WASHINGTON — Biden administration health officials increasingly think that vulnerable populations will need booster shots even as research continues into how long the coronavirus vaccines remain effective.
Senior officials now say they expect that people who are 65 and older or who have compromised immune systems will most likely need a third shot from Pfizer-BioNTech or Moderna, two vaccines based on the same technology that have been used to inoculate the vast majority of Americans thus far. That is a sharp shift from just a few weeks ago, when the administration said it thought there was not enough evidence to back boosters yet.
On Thursday, a key official at the Centers for Disease Control and Prevention said the agency is exploring options to give patients with compromised immune systems third doses even before regulators broaden the emergency use authorization for coronavirus vaccines, a step that could come soon for the Pfizer vaccine.
Skipping a bit:
Pfizer’s continuing global study of its clinical trial participants shows that four to six months after the second dose, the vaccine’s effectiveness against symptomatic infection drops from a high of 95 percent to 84 percent, according to the company.
As a (then) full-time hospital worker actively exposed to high concentrations of COVID, I got my second dose of the Pfizer-BioNTech shot on January 6. If the vaccine’s effectiveness definitely drops from 95% to 84% in four to six months, then I’m well past my due date for a booster. Though I’m no longer a full-time hospital worker, I’ve been waiting for twelve weeks now for the paperwork to go through on my bid to work per diem for Hunterdon Medical Center’s OR. Assuming it goes through, I’ll be back in the COVID-intensive environment I previously inhabited. And if it doesn’t go through, I intend to apply to do the same work at a different hospital. So one way or another, I intend to make my way back to hospital work, and (by implication) to re-immerse myself in COVID.
But even if I never return to hospital work, I kind of like being vaccinated at 95% effectiveness. It’s been nice (mostly) to take off my mask(s). And I don’t feel guilty about having gotten vaccinated despite no longer working in a hospital. It’s not as though there’s been any shortage of vaccinations in the United States. On the contrary, one of the few things the US did right during the pandemic was its vaccine roll-out, which both produced and distributed vaccines en masse faster and more effectively than virtually any other country in the world, with the possible exception of Israel. Israel started administering its booster dose of the Pfizer-BioNTech vaccine, at least to Israeli citizens, two weeks ago. Granted, Israel is a much smaller country than the US, and granted that in apartheid fashion, it has not taken seriously its responsibility to vaccinate the inhabitants of the Occupied Territories. But bracketing that, Israel has done an excellent job of vaccinating its own population. Instead of emulating Israeli apartheid, perhaps we should be emulating the Israeli approach to public health.
Oddly, though, despite the propaganda that the CDC et al has put out about the need to get vaccinated, the FDA now seems to be expressing hyper-caution about the need for the booster, fighting Pfizer’s contrary claims, and arbitrarily moving the goal-posts on its conception of “the goal” of vaccination, as though the federal government’s conception of that goal was the only legitimate one:
With so little data yet public, many health officials and experts have spoken cautiously about booster shots. Dr. Paul A. Offit, a member of the Food and Drug Administration’s outside advisory committee of vaccine experts, said a rise in mild or moderate cases of Covid-19 among vaccinated people did not necessarily mean a booster was required.
“The goal of this vaccine is not to prevent mild or low, moderate infectious disease,” he said. “The goal is to prevent hospitalization to death. Right now this vaccine has held up to that.”
Three things are worth noting about this statement.
First, note the slide from “so little data yet public” to the apparent need for “caution,” not only about administering booster shots but about verbally preparing the public to receive them. The slide from “little data” to “can’t give booster shot” involves a non-sequitur. There is no principle of statistics, ethics, or public health that implies that unless you have hard “data” in hand that absolutely demonstrates the necessity of getting a booster shot, you must not give one. That isn’t how medicine works in ordinary clinical contexts, and it’s not how it works in public health, either. Nor is it how the CDC has itself done things throughout the pandemic. The absence of data indicating “necessity” (whatever that would be) is perfectly compatible with giving shots in a spirit of risk-averse precaution. The “data” to which the article alludes would of necessity include breakthrough cases, something we’re trying to avoid. Why wait until cases break through before we take steps to avoid them?
It’s worth noting that experts in public health have, throughout the pandemic, helped themselves opportunistically to the precautionary principle: when the stakes were sufficiently high, they have not consistently taken lack of data to entail inaction; they’ve often inferred the reverse.** Suddenly, the FDA has decided, out of the blue, that the precautionary principle is to be thrown to the winds, in favor of what, for lack of better terminology, can be called epidemiological gambling. Now, we’re obliged to wait until they’re absolutely sure that the vaccine will give out before they permit us to be vaccinated. But the fact that the vaccines have been approved under an Emergency Use Authorization implies that they weren’t sure at the outset, and had no problem overlooking the relative “absence of data” involved in authorizing the vaccine. If anything, we ought by now to be more sure that the vaccines are safe than we were when the EUA was first granted. So the hesitation over booster shots is puzzling.
Second, note the dogmatic assertion that there is exactly one legitimate goal of getting the vaccine, a goal decided not by patients, or by providers, or even by drug manufacturers, but by regulators, i.e., the one party to vaccination whose presence is not a matter of the informed consent of the other three. Somehow Paul Offit, not even formally an official at the FDA, has decided that a rise in “mild or moderate cases” of COVID is really not such a big deal. If you get mild or moderate COVID, too bad; avoiding that clinically trivial event was not what the vaccine was really for.
One problem with this claim is that “mild or moderate” is a very vague descriptor: there is no clear, clinically demonstrable cut-off between a “moderate” and a “severe” case of COVID. There are both borderline and hybrid cases, as there are with most clinical phenomena.
Beyond that, there is substantial evidence that “moderate” cases are actually pretty debilitating, and have (as-yet unknown) long-term adverse effects. Supposedly “moderate” cases will put you out of commission for long enough to put you out of work. What then? Is Paul Offit or the FDA going to come in and bail you out once you’re out of work, now that pandemic-related unemployment benefits are being phased out? Being sick and unemployed isn’t quite as bad as being hospitalized or dead, but it’s not a great place to be.
It’s remarkable that there is no discussion here of the need to vaccinate anyone but the immunocompromised (or the elderly, considered as immunocompromised), as though everyone but the immunocompromised were dispensable, and everything but hospitalization and death a mere triviality.
Put it this way: I’m not immunocompromised. But I clean and set up hospital operating rooms. Does Paul Offit think that I should go back to what I was doing before I got the vaccine, namely, walking into COVID-infected rooms and cleaning them without the protection of the vaccine? Does he think the same thing of the surgeons, anesthesiologists, nurses, respiratory technicians, and people in sterile processing who were (and are) my colleagues in the OR? We’ll be the break through cases. If we get sick because the FDA decided to wait around for “The Science” to deliver its verdict, discounting the so-called “moderate” cases in the process, who is going to run the hospitals while we nurse our “moderate” COVID? Once enough of us start calling out, or falling down, Science will suddenly decide that yes, it is time for a booster! There’s no need to wait that long. The time is now. Our arms are ready.
But forget hospital workers. I’ve played my OR EVS card here, but I shouldn’t have to. No one should be begging for a vaccine that anyone and everyone can and should be getting, whether they work in a hospital or not. The vaccine can be rolled out. It’s safe. The Paul Offits of the world should be facilitating access to it, not impeding access for no discernible or articulable reason.
And that leads me to my third observation. Paul Offit’s Vaccine Essentialism–the thesis that the vaccine has One Goal dictated by One Supreme Authority–would not get off the ground if the government had not arrogated to itself supreme authority on all matters of vaccine distribution. It’s a question why exactly it enjoys this authority. The FDA does not manufacture the vaccine. Nor does the FDA stick it into people’s arms. Nor does it coordinate its distribution. It simply vetoes the distributing and the jabbing. Why is there a need for veto power if there are manufacturers willing to manufacture, providers willing to provide, and patients willing to receive–in the context of an agency wielding veto power over their desire for safety while professing uncertainty about what to do?
In other words, a government (and its supporters and enablers) uncertain about whether a booster shot is needed insists on the authority to supervise what it claims not to understand. There appears to be no principle at work here beyond the desire for ultimate control, along with the demand to take public health authorities on faith, and to induce the rest of us to accept our role as a sacrifice to their conjectures and provisos.
Dr. Camille Kotton, an infectious disease expert with Massachusetts General Hospital, told the panel that some patients, especially those who are more educated or “empowered to take care of their own health care,” are managing to get a third dose on their own, despite the lack of a green light from the government.
“Many have taken matters into their own hands,” she said. “I am concerned about them doing this kind of in an unsupervised fashion,” she said, while doctors’ hands are tied because of the lack of regulatory approval.
“Many have taken matters into their own hands.” Isn’t it a mantra of biomedical ethics that our “own” health belongs in our “own” hands? What other hands are supposed to supersede the patient’s when the patient’s health is at issue? Is it so unreasonable to want to err on the side of caution with respect to a disease that has killed 600,000 Americans, and killed millions of people around the globe–setting aside the numbers it has debilitated, hospitalized, and put out of work? Apparently it is, as far as the FDA and its enablers are concerned, even with respect to their own colleagues in health care itself.
Sorry, Democrats (and liberals), but the Republicans are right on this one (however hypocritical it is for them to be right at this late stage of the game):
At Tuesday’s hearing of the Senate’s health committee, several senators grilled administration health officials on how soon they would act on the question of boosters. Senator Mitt Romney, a Utah Republican, said he was unhappy that officials could not provide a better timetable.
Senator Richard M. Burr, a North Carolina Republican, noted that Israel was already offering some of its most vulnerable citizens a third shot. “Why aren’t we making the same decisions?” he asked.
Dr. Rochelle Walensky, the director of the C.D.C., testified that scientists were studying the vaccines’ efficacy in tens of thousands of people, including nursing home residents and more than 5,000 essential workers.
“Fortunately, we’re anticipating that this will wane and not plummet,” she said of their efficacy. “As we see that waning, we — that will be our time for action.”
“As we see that waning…” If anyone can give me an English translation of Rochelle Walensky’s nonsensical answer to Senator Burr’s eminently sensible question, I’d be much obliged. But as one of the people who will be part of the “waning” to which Walensky so delicately alludes, what she seems to be saying is that my OR colleagues and I are to function as guinea pigs in an unconsenting epidemiological experiment, assuming the risks of “mild to moderate COVID” while we clean out operating rooms for $14 an hour–and while well-compensated FDA bureaucrats decide whether it’s worth their while to authorize a booster shot that America’s favorite ally started administering two weeks ago. All I can say is, I don’t know about whether my not getting COVID is worth your while, Rochelle, but it’s certainly worth mine.
Frankly, I don’t really care about the FDA’s (or anyone else’s) arbitrary “goal” for the vaccine. My goal in getting it was to push the chances of illness—any discernible illness, not just severe illness—as close to zero as possible. Part of the rationale was to stay working rather than have to go on unemployment for a second time. But part of it was simply that I hate getting sick. That, after all, is why I get the flu shot every year–something public health officials are pretty adamant about insisting that we do. I don’t get the flu shot because I’m immuno-compromised, or because I fear being hospitalized or killed by the flu. I get it simply to avoid getting the flu. And a bad flu, after all, is just like a “moderate” case of COVID. If it’s obligatory to get a flu shot right now to avoid the flu, why isn’t it permissible to get a COVID booster right now to avoid a moderate case of COVID? Evidently, though, permission is required in the latter case.
If my aversion to getting COVID means getting an “unsupervised” booster, you can bet that I’ll try my best to get one, regardless of what any FDA bureaucrat thinks, or even what my colleagues Dr Offit and Dr Kotton think. Evidently, they think that they have the authority to dictate whether or not I can get a booster, and that my “education” and “empowerment” are an obstacle to their bureaucratic goals. In that case, I can only reciprocate by regarding their rhetoric as an obstacle to my personal health, and their bureaucratic goals as subversive of the larger enterprise, health care, which we all take ourselves to be promoting.
“Single payer health care” is a feel-good slogan, but the preceding scenario is its inevitable consequence and downside. Once the government controls health care, as it would under a single-payer arrangement, both patients and providers lose the option of going around it to exercise and act on their own judgment. There ceases to be an “around it” in that case; the single-payer then becomes the only health care game in town. That, after all, is what “single payer” means: governmental or quasi-governmental judgment supersedes individual judgment as regards payment (as well as distribution), and supersedes collective judgment not affiliated with the State. The predictable result is the delusion that uniformity of opinion guarantees positive health care outcomes, a claim that has less going for it in terms of data than the COVID booster shot now causing such puzzlement.
It should be obvious at this point that public health officials under both the Trump and Biden Administrations have done their share of bluffing and bullshitting the public about COVID. I’m not one to demonize Anthony Fauci, but I find the uncritical valorization of powerful bureaucrats like him an embarrassing trend among liberals. There is no effective difference between dealing with the faceless bureaucrats at Aetna or Blue Cross, or the ones at CMS or the FDA. None of them are saints or angels, and none should ever be taken on faith. But single-payer arrangements often (perhaps inevitably) require us to take government officials (and their private sector enablers) on faith, closing off alternatives to the arbitrary judgments that they turn into enforceable regulations.
Liberals and leftists zealously eager to defend “single payer” health care ought to take the dangers of monopoly more seriously than they typically do. It’s well and good to insist that “single payer” would expand access to health care services beyond what our current system does. But it would do so at the price of concentrating the health care decision-making process in the hands of the single monopoly payer that holds all of the relevant cards, and calls all the relevant shots. “Medicare for All” means CMS regulations for all. It means “Paul Offit’s clinical decisions govern all.” It means that the mantras about “patient empowerment” that people nowadays like to spout are all window dressing for perpetual disempowerment. I myself don’t regard that as a conclusive, fool-proof argument against single-payer. It’s just one part of a more complex story. But defenders of single-payer health care ignore it at the price of realism and credibility. That may be a recipe for getting it passed into law some day, but it’s not a recipe for defending it to the rational satisfaction of anyone looking to get some.
*My use of the term “pragmatist” is not meant to conjure up images of “hard nosed pragmatism,” as per colloquial use; it’s meant to indicate an affinity with the American Pragmatist tradition associated with Charles Peirce, William James, and John Dewey.
**Classically, the precautionary principle has been applied so as to restrain rather than encourage the use of an untested technology. But the underlying principle holds that it is rational to act so as to avoid significant risks even if we lack certainty or hard evidence that the risks will materialize.
I am a full time employee at Aergo Solutions, and am pending per diem status in OR EVS at Hunterdon Medical Center. The views expressed here are solely my own, and do not necessarily reflect the views of either of my employers.