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In August 2021, President Biden proposed making COVID boosters available to all American adults, and the public health profession responded with considerable outrage. That’s when I started writing what I expected would be a website column on the booster policymaking process. Throughout the twists and turns of that process, I kept revising – and lengthening – the column. By the time the process ended (for now) in November, my column was the length of a short book, with 44 numbered sections.
I decided to post it anyway – and you can get to it here. This column is excerpts from some of the sections, with each excerpt linked to that section. These excerpts capture some of the flavor of what I wrote and some of its main points – and just might seduce a few of you into reading some of the rest.
In 1869, poet John Godfrey Saxe wrote: “Laws, like sausages, cease to inspire respect in proportion as we know how they are made.” (The quote is often misattributed to Otto von Bismarck.)
That’s how public health professionals feel about policies in their field: If the public gets to watch them hashing out their many uncertainties and disagreements, they believe, public confidence in the final product will be shaken.
They’re not entirely wrong. The public does prefer to imagine that public health experts are in omniscient agreement. The question is whether public confidence is a blessing or a problem when it is grounded in not realizing how uncertain the experts actually are and how much they actually disagree with each other.
That’s not a question in the minds of most public health professionals. They’re quite sure that uncritical public confidence in their wisdom and their unanimity is a blessing, not a problem. That’s a big piece of why they believe so fervently that they should “speak with one voice” – a mantra with which I strongly disagree unless they all truly have the same opinion.
So most public health professionals have been dismayed by the transparent process that began on August 18, 2021 when the White House proposed making boosters available to every adult COVID vaccinee, and that ended on November 19 when the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) signed on to exactly that policy.
Whatever precautions fully vaccinated people are continuing to take even though they are fully vaccinated, it is bound to feel irrational to the point of craziness to tell them that they must keep taking those difficult, disruptive, unpleasant precautions but should absolutely not get a booster shot yet as well.
Consider boosters versus masks, for example. Both are COVID precautions whose value is difficult to measure but clearly greater than zero. Boosters are momentarily painful. Masks are endlessly uncomfortable. I know very few vaccinated people who would rather wear a mask for the duration than get another shot. And if it comes to that, I know very few vaccinated people who would rather wear a mask forever than get a shot every six months forever.
The people who craved a booster shot as the agencies were debating whether to give their okay and the people who got a booster shot as soon as they were allowed to do so are the public health profession’s “home team.” They’re the people who surfed kludgy websites late into the night to get an early vaccination appointment, who never wear their masks below their noses, who can discourse knowledgeably on the implications of aerosols versus droplets.
Public health professionals should ideally avoid sounding contemptuous of anybody. But their expressions of contempt for antivax activists are at least understandable. It’s even understandable that sometimes that contempt gets generalized to people who are more vaccine-hesitant than antivax…. But it was incredibly self-defeating for public health professionals to voice contempt for booster enthusiasts, their strongest supporters. That struck me as nearly pathological. “Booster enthusiasts are what politicians call your base!” I wanted to shout. “Stop dissing your peeps!”
Booster opponents have tended to claim that vaccines are “designed” to prevent severe threats to life, not mild inconveniences. So they think we should reserve boosters for people for whom the likelihood of a severe breakthrough infection is significantly reduced by a booster shot. Booster supporters, on the other hand, often argue that mild infections are not negligible. They add to human misery; they keep people away from their jobs (including healthcare workers and other essential frontline workers); they pose some threat of long COVID; they increase transmission and thus the total community burden of COVID….
There are scientific findings relevant to this debate, but it is fundamentally not about science. Everyone is entitled to an opinion about how useful it is to reduce the odds that a vaccinated person will get a mild breakthrough case of COVID. Whether that’s a good enough reason to get a booster shot is an individual judgment. Whether it’s a good enough reason to launch a booster rollout or even to authorize booster shots at all is a public health judgment and a political judgment. Neither is purely or even mostly a scientific judgment.
When public health officials want people to take or tolerate some precaution that might or might not turn out to add value, the catchphrase they often deploy is “abundance of caution.” … The ordinary term for the same concept is “better safe than sorry.” Both terms are grounded in the commonsense understanding that if a precaution has very little downside and an uncertain but potentially sizable upside, the rational thing to do is to take the precaution.
Perversely, this time it was the booster-seeking public demonstrating and advocating an abundance of caution. And far too many public health professionals decried the booster precaution, especially for healthy young people, because the evidence was still uncertain how useful it would turn out to be.
And what did they say about the people whose pre-authorization desire for a booster demonstrated an abundance of caution? “Finagling.” “Booster-mania.” “Mass hysteria.” “Unfounded panic.” “Gimme, gimme, gimme.” This was how they described their pro-vaccine home team!
The primary motive for understating the frequency of breakthrough infections wasn’t to reassure the vaccinated that they wouldn’t get a breakthrough. It was to encourage the vaccine-hesitant to get vaccinated too – by encouraging them to believe that just one shot (J&J – “one and done”) or at most two (Moderna or Pfizer) would pretty much end the pandemic as far as they were concerned. That’s still one of the key motives for discouraging boosters now: If we start giving boosters to fully vaccinated people, booster opponents reason, unvaccinated people will see that as evidence that the vaccines “don’t work.”
There is nothing “scientific” about a strategic communication decision to understate the risk of a breakthrough infection and the benefit of a booster because you want to deter unvaccinated people from underestimating the value of getting an initial shot. The two relevant fields of expertise are ethics and risk communication – not virology or epidemiology or immunology or public health.
It is now accepted – though not aggressively communicated – that breakthrough infections are common and getting more so. They’re still mostly mild or asymptomatic. Severe breakthrough infections are still uncommon. But “still” is a tell. Whenever you see that word, you know the speaker is aware that it’s possible what is “still” true now may not stay true for long.
Virtually no one argues that boosters are dangerous (except maybe for young males). Nor does anyone argue that boosters are useless. Expert opinion on the value of boosters ranges from “only a little useful, except for the most vulnerable” to “very useful for pretty much everybody.” That’s the whole scientific debate: Are boosters a little useful or very useful, for a few people or a lot of people? And even on that question, the experts pretty much agree that they don’t know the answer. They all know they’re all guessing.
So the scientific debate is how useful will boosters turn out to be, and for whom. And the two core underlying meta-debates aren’t about science at all:
The obvious reason boosters are hypothesized to increase vaccine hesitancy is because some unvaccinated people are likely to see the groundswell of booster enthusiasm as evidence that the vaccines “don’t work.” On the other hand, the purpose of boosters is to reduce the incidence of breakthrough infections, especially severe ones. Wouldn’t unvaccinated people also be likely to see breakthrough infections as evidence that the vaccines “don’t work” – especially breakthrough infections that end in hospitalization or death? And sure enough, that’s what the survey data show. In one study, two-thirds of unvaccinated people said breakthrough infections are evidence that the vaccines aren’t working. A roughly equivalent 71% said the same thing about boosters.
Which one will turn out to be the ammunition people use to justify not getting vaccinated, breakthrough infections or boosters? Whichever one is happening. If the news is full of breakthrough infections, that will be a big reason for unvaccinated people to say the vaccines don’t work. If a successful booster campaign reduces the number of breakthrough infections, that will be a big reason for unvaccinated people to say the vaccines don’t work.
In principle, which is better antivax ammunition, breakthroughs or boosters? My guess is breakthroughs. Knowing people who got vaccinated and got the disease anyway is a vivid demonstration that the vaccine “didn’t work” for those people – much more vivid than knowing people who decided they’d better get another shot and so far they’re fine. Flu vaccination might be a useful precedent here. When people tell you why they’re not getting a flu shot, “I know somebody who got a flu shot and got the flu anyway” comes up a lot more often than “I know somebody who gets a flu shot every year.” To the extent that boosters reduce breakthrough infections, I’m betting they reduce vaccine hesitancy more than they increase it.
COVID vaccinations are not the only inequity in the world, or even the worst one. And unlike vaccine doses, many resources are fungible. Everyone who lives a comfortable first-world life has the option of selling everything to give to the poor – or simply living less high on the hog so we can increase our charitable contributions. We do not have the option of sending “our” booster dose to a developing country. We do, however, have a range of other, more realistic options, from lobbying on behalf of government vaccine philanthropy to increasing our own personal philanthropy.
When I was a child, my mother sometimes cajoled me into eating my dinner on the grounds that there were starving children in China. Many public health professionals now want me to forgo a third dose of vaccine on the grounds that there are unvaccinated people in Africa. In hindsight, my mother made more sense. Like my childhood dinners, U.S. vaccine booster doses will not be shipped overseas. It seems ethically better to consume them than to waste them.
Here’s the ideal sausage-making process as public health professionals see it:
Experts → Agencies → Politicians → Public
The experts figure out what public health policies they consider appropriate, hashing out their dilemmas, doubts, and disagreements and eventually reaching something approaching a consensus – at least enough of a consensus that the outliers are deterred from kicking up much of a fuss. Some of the key experts are officials at agencies like the FDA and the CDC, and at the various state and city public health agencies; others are on agency advisory committees or in less formal networks with agency staff. Thus the expert consensus gets communicated to the agencies, which launch the policymaking process needed to flesh out the details and implement what the experts have decided.
Political leaders are brought into the discussion, partly so they can contribute political expertise to the implementation plan, but mostly so they feel some buy-in and don’t belatedly dispute the expert consensus. Eventually the time comes to clue in the public, telling it just as much as it needs to know to encourage it to watch approvingly from the sidelines as the policy is implemented.
This process is often summarized as “Follow the science.” But I have stressed enough already that many of the key dilemmas, doubts, and disagreements aren’t really scientific. Many of the policymaking decisions, therefore, aren’t really scientific either. A better summary than “Follow the science” would be “Follow the scientists.”
Boosters didn’t start becoming a major public controversy until July 8, when Pfizer went public about its evidence of waning antibodies and its plan to apply to the FDA for a booster Emergency Use Authorization. The FDA and the CDC immediately pushed back with a rare joint statement asserting unequivocally that “Americans who have been fully vaccinated do not need a booster shot at this time” – as if that meant that boosters wouldn’t be useful (as opposed to “needed” ) soon (as opposed to right now). It was clear that the two agencies didn’t want to talk about boosters, and didn’t want Pfizer to talk about boosters either….
The vaccinated public – especially the enthusiastically vaccinated public – had been successfully taught that COVID vaccines are safe and effective. They didn’t necessarily think “effective” meant permanent. Most were familiar with the booster phenomenon from their childhoods and parenthoods; lots of safe, effective vaccines need boosters. So when they started to see chinks in the COVID vaccines’ effectiveness, their minds naturally turned to boosters. Even before Pfizer’s July 8 announcement, some had started agitating for COVID boosters, while others simply went about getting themselves boosted.
By August 10, a confidential CDC estimate had been leaked to ABC News that 1.1 million U.S. residents had already received unauthorized boosters. Jody and I were two of them.
On August 18 the White House announced [its] plan, under which “a booster would be administered, eight months after an individual’s second dose, beginning the week of September 20.” The goal of the announcement was partly to increase public support for boosters among those who admired the president; partly to increase public support for the president among those who wanted boosters; and partly to forewarn the organizations that would be charged with actually delivering booster doses to get ready.
The goal was also, obviously, partly to put some pressure on the FDA and the CDC to hurry up and authorize boosters. “You’ve got one month to push the booster plan through your agency’s sausage-making factory and out the other end” was the announcement’s perfectly clear implicit message to the two agencies….
Fauci [top government expert Anthony Fauci] and the rest of the top scientific and public health leadership of the federal government were all publicly onboard with this White House plan, including the heads of both the FDA and the CDC – no doubt with varying degrees of enthusiasm or perhaps even suppressed disapproval. Their public support was another unmissable sort of pressure on their underlings: “Your boss has already signed onto this. Now you get to decide – quickly – whether you’re going to agree with your boss or undermine your boss.”
Pfizer’s application asked the FDA to approve boosters for everyone 16 and older. On September 17, the FDA’s advisory committee (VRBPAC) turned that down flat. It voted instead to authorize boosters only for elderly Pfizer vaccinees and those with high-risk medical conditions. That would have been seen as a substantial rebuff to the Biden White House. It would have put the FDA in an impossibly awkward position, torn between the boosters-for-all stance of the president and its own top brass and the boosters-for-only-the-most-vulnerable position of its advisory committee.
VRBPAC was about to adjourn when a top FDA official, Peter Marks (… a booster proponent), warned the committee that the agency might well decide to “tweak” the authorization to include also people whose occupational or institutional settings made them likelier than most to get infected – for example, healthcare workers, prisoners, grocery clerks, maybe even teachers. At Marks’s urging, the committee took what amounted to a straw poll. It belatedly, quickly, almost casually – and unanimously – endorsed this huge increase in who could get a booster.
So now no tweaks were needed, and the FDA could give the White House a lot more of what it wanted and still accurately say it was following the advice of its advisory committee.
The case for Moderna boosters was a bit weaker than the case for Pfizer boosters in several ways…. Nonetheless, the tone of the October 14 VRBPAC Moderna meeting was a lot less conflicted about boosters than at its September 17 meeting to consider Pfizer boosters. Partly that’s because additional data from Israel had emerged in the intervening month, more clearly indicating that vaccine efficacy was declining and boosters were reversing the decline. Even though the new evidence concerned Pfizer doses, not Moderna doses, some previously booster-skeptical VRBPAC members clearly took it to heart. Partly too, I think, the additional month gave some VRBPAC members time to get over their outrage at the Biden administration for launching a cart-before-the-horse process.
But mostly what changed is that Pfizer boosters had already been through the sausage-making process and were now going into arms with the FDA’s and the CDC’s official blessing. Several VRBPAC members commented that they really had no choice but to do for Moderna what they had done for Pfizer.
[T]he elephant in the room was the comparatively low efficacy of the J&J vaccine (or, rather, of the one-primary-dose J&J protocol). It was clear to the VRBPAC members that all J&J vaccinees needed a second dose ASAP….
VRBPAC voted unanimously that the FDA should authorize a second dose for every J&J vaccinee. This time there was no mention of age limitations or preexisting medical conditions or working/living situations – no eligibility criteria referencing high risk. If all you had going for you was a single J&J dose, VRBPAC implied, you were already high-risk, not really “fully vaccinated,” and you needed that second dose….
VRBPAC members were comfortable commenting at length about the inferiority of one J&J dose to two Pfizer or Moderna doses. But it was awkward for the FDA to state or even imply that there was something wrong with the J&J vaccine or its one-dose protocol – exactly what the FDA had authorized. That made it hard for the FDA to explain why it was so much more enthusiastic about J&J second shots than it was about Pfizer and Moderna third shots. Mostly it didn’t try. It just said all J&J vaccinees really ought to get another dose ASAP, and let the media explain why with quotes from outside experts, never from the FDA itself.
Certainly one main reason for this unaccustomed FDA speed [authorizing mix-and-match boosters] was the evidence that J&J vaccinees would be significantly better off with a Pfizer or Moderna booster than with a second J&J dose. That evidence was publicly available, much discussed in the media, and obviously especially salient to J&J vaccinees. For the FDA to authorize the second J&J shot and not authorize mix-and-match boosters for J&J vaccinees would infuriate J&J vaccinees. It would invite thoroughly justified criticism that FDA stodginess was endangering people’s lives. On the other hand, for the FDA to authorize mix-and-match boosters for J&J vaccinees but not anybody else would underline far too clearly the inferiority of the J&J vaccine….
The FDA authorized mix-and-match, but it didn’t take any position on who should probably switch vaccines and who would be better off sticking with the one they started with. If anything, the agency seemed to lean slightly toward sticking with the one you started with. Acting FDA head Janet Woodcock said on a call with reporters that the agency “would expect many people will continue to get the same series that they already received.”
That’s an admirably simple message. But did it follow the science? Did it even explain the science? Yes, the science on mix-and-match is still preliminary, but as public health professionals endlessly proclaim in other contexts, following the science means following what the science says so far. And the science so far surely says that J&J vaccinees would be wise to get Pfizer or Moderna boosters, not J&J boosters. The best I can say for the FDA’s mix-and-match messaging is that it allowed vaccinees and vaccinators to follow the science. It didn’t actually tell them what the science says.
Though the ACIP [the CDC’s Advisory Committee on Immunization Practices] votes were unanimous, there was some concern expressed about the signal those votes were sending to the “worried well” that maybe they should get a booster. (The people likeliest to notice that the eligibility criteria are a lot broader than they look are of course the people who wish they weren’t so broad.) As ACIP member Sarah Long put it: “I can’t say that I am comfortable that anybody under 50 – an otherwise healthy individual – needs a booster vaccine at this time with either Moderna or Pfizer.”
But the ACIP was bowing to reality. In an article in Medscape Medical News, infectious disease physician Jay Varkey (not involved in the ACIP deliberations) got to the nub of the matter: “The decision made by the FDA and the ACIP recommendations, I think, reflect the real world. The public is going to do what they feel driven to do. This at least adds a scientific review of the currently available data.” In other words, the agencies and their expert advisors had little choice but to follow the lead of the public and the White House….
But bowing to reality isn’t the same thing as liking it. The most stunning evidence that many public health professionals still hated the booster rollout came in an October 25 New York Times article entitled “Are Vaccine Boosters Widely Needed? Some Federal Advisers Have Misgivings.” Actually, all the people quoted in the article expressed nothing but misgivings. Nearly all were VRBPAC or ACIP members who had just voted for wider booster eligibility criteria than they personally believed were appropriate – at least that’s how they came across in the Times article by Apoorva Mandavilli.
To really understand the COVID booster sausage-making process, you need to understand why I think the September Pfizer and October Moderna eligibility criteria – especially the inclusion of people at high risk of getting infected – represented a huge concession by the public health mainstream, which had steadfastly maintained that COVID vaccines are “designed” to prevent severe illnesses, not mild infections.
Arguably, “concession” is too weak. It was a defeat.
Healthcare workers have frequent occupational exposures to infected people, so they’re likelier than the rest of us to get infected. People who spend time in congregate settings (prisoners, for example) are similarly more exposed and therefore likelier to get infected. But there’s no reason to think that their infections are likelier to be severe. In fact, they may keep getting boosted by recurrent exposures, lowering their risk of serious outcomes. In some cases, even the claim of high occupational risk of infection is debatable. Healthcare workers and others in some high-exposure occupations tend to wear personal protective equipment and take other precautions; some studies find that their infections more often result from community exposures than from their occupational exposures. So why should they be prioritized for boosters? …
I can understand why even public health professionals who think vaccines are meant only to prevent severe outcomes might want to make an exception for healthcare workers – because they’re so badly needed on the frontlines, because they’re heroes of the pandemic, maybe just because public health professionals know lots of healthcare workers. But that exception let the camel’s nose in under the tent….
Based on the September Pfizer and October Moderna decisions, boosters-for-everybody won. Not officially, but in effect.
Here’s how the FDA and the CDC concealed it. Instead of just saying “boosters are okay for everybody,” they specified complicated, broad, porous categories of “okayness,” thereby giving the impression that the more restrictive view won. Booster opponents weren’t fooled; they knew they lost. Booster supporters – including the White House – weren’t fooled either; they knew they won. But the agencies preserved their brand. They looked like they were standing tall for Science, not just bowing to White House pressure. And they helped booster opponents save face.
The downside from the perspective of booster supporters: Some people who were eligible for Pfizer or Moderna boosters didn’t realize it. They weren’t sure if they were eligible or not, or they were mistakenly sure they weren’t. I have talked with a number of healthy young and middle-aged people who definitely wanted to get boosted but were dutifully waiting till the agencies said they could – not realizing that the agencies had already tacitly said they could.
Some vaccinator organizations were in the same pickle, trying to decide who’s entitled to a booster. Even if they knew it’s on the honor system, they wanted to be able to tell prospective vaccinees what the eligibility criteria were. A lot of media coverage exacerbated the problem by “explaining” the eligibility criteria in ways that implied they were limited to people who are elderly or “high-risk,” without explaining that the definition of “high-risk” was intentionally vague; you’re high-risk if you think you are.
At the October 14-15 meeting of the FDA’s VRBPAC advisory committee to come up with booster recommendations for Moderna and J&J vaccinees, CDC official Amanda Cohn told the group that 60% of all Pfizer vaccinees between the ages of 18 and 65 were covered by the booster eligibility criteria that had been promulgated the month before. Cohn apparently thought 40% of Pfizer vaccinees under 65 weren’t eligible for boosters – that is, had no qualifying medical condition or working or living situation.
To reach this determination, or any determination, Cohn would have needed to consult inclusive lists of which medical conditions count as high-risk of severe outcomes and which working and living situations count as high-risk of infection. I have no idea what lists she was using. I can’t find any lists that claim to be inclusive, only illustrative…. I wrote Cohn to ask what she based her 60% figure on, but didn’t get a response….
I have read endless media articles about who’s covered and who isn’t, and only one or two that explicitly agreed with me that the criteria were so vague and so porous that they actually covered everyone. Certainly if you casually perused FDA and CDC webpages you didn’t get the impression that everyone was covered. So there have got to be millions of people who thought they weren’t covered, and millions more who weren’t sure whether they were covered or not. On the other hand, if you scrutinized those same FDA and CDC webpages looking for an eligibility criterion you could squeeze yourself into, you would almost certainly end up deciding you’re covered if you want to be.
Having committed themselves to the position that mild breakthrough COVID infections are a negligible problem, public health professionals faced the dilemma of how to justify boosters for healthcare workers. As we have seen, VRBPAC initially stayed consistent, confining its support for Pfizer boosters to the elderly and those with comorbidities – people with a high risk of severe outcomes if they’re infected. But at the last minute the FDA’s Peter Marks got the committee to give its informal approval to expanding from “high risk” of severe outcomes to “high risk” of infection – opening the door not just to healthcare workers but to all kinds of people whose working or living situations put them at high risk of infection….
Pretty clearly, VRBPAC acceded to Marks’s request because Marks was signaling pretty clearly that if it didn’t the FDA might have do what Marks called “tweaking” its recommendations but the media would surely have called “overruling” them. VRBPAC didn’t want the FDA to overrule it, so it went along. A few days later CDC Director [Rochelle] Walensky urged the ACIP to do likewise. The ACIP voted the other way, 9-6, so Walensky had to tweak/overrule (reject) its advice.
In order to support boosters for healthcare workers, prison employees, grocery clerks, and residents of congregate living situations (and maybe crowded apartments too), you have to decide that mild infections matter after all. Give boosters to hospital workers because hospitals are already desperately understaffed and can’t afford additional absenteeism when employees are mildly infected with COVID. Give boosters to nursing home workers because their patients are very vulnerable and can’t afford to get infected by a staff member. Give boosters to poor people who live in crowded conditions and are in frontline, outside-the-home jobs because they have already suffered more from the pandemic than anyone else. But in each case, your rationale for giving them boosters relies on believing that their mild infections matter.
As I’ve already pointed out, booster administration was on the honor system. But it wouldn’t have to be. All of us have some condition that we can honorably judge makes us high-risk for a severe outcome. And all of us have some aspect of our working or living situation that we can honorably judge makes us high-exposure….
That doesn’t necessarily ensure that everybody who might like a booster would understand that the FDA and the CDC have tacitly said okay. The face-saving language fooled more than a few journalists, who reported the agencies’ decisions as if they restricted booster access. A lot of prospective booster candidates got the wrong impression too. I have talked with several acquaintances, friends, and family members who wanted boosters, considered themselves ineligible, and were dutifully waiting their turn, not realizing that their turn had come.
And as I noted earlier, maybe this is just fine. Prospective booster candidates who wanted it badly enough figured out that they could get it. They didn’t have any reason to raise a fuss at the authorities. Prospective booster candidates who preferred not to get it yet felt okay not getting it yet. Nobody would have any reason to raise a fuss at them.
In the face of this intrinsic and unavoidable confusion [about the COVID pandemic itself], I think trying not to confuse the public can easily do more harm than good – for example, if it leads the agencies to stick to prior recommendations because updating those recommendations based on new science could confuse the public. (I’ve seen that story before.) I think the public health profession has to trust the public to be grownups (and help teach the public to be grownups) – to tolerate uncertainty and expert disagreement and changing recommendations; and to make our own decisions knowing that those decisions may not always turn out the way we hoped.
There’s a natural OMG reaction when people learn how messy the process of scientific discovery is – and how much messier, even, the policymaking process is when the science isn’t clear and isn’t necessarily dispositive anyway. It’s natural that experts and policymakers prefer to shield the public from that reaction. But when they try and fail, they set themselves up for mistrust. And when they try and succeed, the success is temporary and the mistrust is that much greater when the public belatedly realizes it has been hoodwinked with a sanitized, overconfident myth.
Better to come out of the closet – to teach the public that uncertainty and expert disagreement are normal, and that when uncertainty and expert disagreement become publicly visible (as they have with regard to boosters), that’s a good thing. Normalize the sausage-making process and help the public bear its OMG reaction.
Much too often, public health agencies try to leave as little space as possible between behaviors that are required and those that are forbidden. That is too often their goal: Make people do what’s good for them; don’t let them do what’s bad for them. In the too-often-excluded middle is voluntary behavior. Officials have terminology for this middle ground. The CDC, for example, has long had a category of “permissive recommendations,” which are less strongly recommended than ordinary recommendations. But they don’t use such intermediate categories nearly enough.
Ideally, even the middle should be subdivided. Among the things you’re allowed to decide for yourself, there are some the experts think you should do and some they think you shouldn’t do, and in between are some they have no opinion on, no advice to give you. Put the pieces together and you get a coherent scale with required on one end and forbidden on the other: Must / Should / May / Shouldn’t / Can’t….
Under the CDC’s October recommendations for Pfizer and Moderna vaccinees, you should get a booster if you’re 65+, or if you’re 50+ and have a medical condition that puts you at high risk for severe COVID. You may get a booster if your working or living situation makes you high-risk for getting infected, or if you’re younger than 50 and have a medical condition that makes you high-risk for severe COVID – and whether you fit into these categories is up to you. You can’t get a booster unless you had two doses more than six months ago.
COVID vaccines are not free-market commodities at all. At least so far, the U.S. government is the only U.S. buyer of any COVID vaccine. Every vaccine dose in the country is therefore U.S. government property. And at least so far, the government is giving away all its doses without charge. If the government decides to give you a dose, it’s free. If the government decides not to give you a dose, you can’t buy it on the free market. There is no such market in the United States.
So when the FDA decides to authorize boosters or the CDC decides to recommend them, they are authorizing or recommending a U.S. government rollout at U.S. government expense.
Suppose the FDA and CDC believe that a booster will do a particular group of fully vaccinated people only a little good but practically no harm. The booster’s expected benefit exceeds its expected harm, so in principle people ought to be able to get it if they choose to – but its expected benefit isn’t compelling enough to justify rolling out a government-funded campaign to give away millions of government-owned doses. As things stand right now, there is simply no way for the FDA and CDC to allow people (or their insurance companies) to decide whether or not they want to pay for a booster shot.
It’s worth remembering that the FDA and the CDC both have outside vaccine advisory committees (VRBPAC and the ACIP respectively). Both committees operate with excruciating transparency; these days you can review their pre-meeting slide sets, then watch the meetings themselves, in real time or afterwards as you prefer, all of it online….
The FDA and the CDC are decision-makers (though in the case of the CDC, most of its decisions are nonbinding recommendations). Their advisory committees give them advice. Any differences in opinion between agency and advisory committee are simply part of the sausage-making process. So are differences of opinion within an advisory committee.
The problem (at least many public health professionals consider it a problem; I do not) is that the public gets to watch these differences of opinion get expressed. When an issue is hot and the attention is sizable, watching the sausage-making has the potential to undermine the public’s faith in the omniscient consensus of the experts. This was a serious concern during the September and October VRBPAC and ACIP meetings on the pros and cons of offering people COVID boosters.
Even mildly contentious booster meetings provoked expert tweets regretting that the façade of public health consensus might be crumbling. Even when advisory committee votes were unanimous, as they usually were, it was considered unfortunate that some of the discussion expressed doubts. When the doubts led to a split vote, that was considered more unfortunate still.
Much of the controversy over boosters has focused on whether people who have already received their primary vaccine doses “need” an additional dose. Almost every article on COVID boosters frames the question in terms of whether or for whom a booster dose is “necessary” or “needed.” …
“Need” is a reasonable criterion for an otherwise unacceptable medical intervention. You wouldn’t want brain surgery, for example, unless you really needed it. But for an intervention with little or no downside, we usually talk about “benefit” instead. If a vitamin pill seems likely to benefit you, you’ll probably want to take it, even if you’re not convinced you really need it….
Most people who want a booster shot aren’t worried about rare vaccine side effects. So even if they’re not confident the extra dose will benefit them enormously, they’re quite confident it won’t do them any lasting harm. For them, getting a booster shot is at worst like taking a vitamin pill they might not need. But for the government, opponents imply, offering them a booster shot they might not need is like doing unnecessary brain surgery.
I became convinced that the tide was turning when I saw the expert response on Twitter and elsewhere to a November 11 New York Times article entitled “What We Know So Far About Waning Vaccine Effectiveness.” The article summarized a number of studies showing that vaccine efficacy was declining against infection. But its main focus is captured in its lede paragraph:
As tens of millions who are eligible in the United States consider signing up for a Covid-19 booster shot, a growing body of early global research shows that the vaccines authorized in the United States remain highly protective against the disease’s worst outcomes over time, with some exceptions among older people and those with weakened immune systems….
For a sampling of the expert vituperation that followed, check out this Twitter thread. Writing mostly to each other, top experts called the article “misleading,” “incomplete,” “skewed,” “bad messaging.”
A month earlier I think this article would have seemed unexceptionable. But expert opinion was changing, and the Times was behind the times.
As I noted earlier, the October porous-but-seemingly-restrictive eligibility criteria worked pretty well from an individual liberty perspective. They allowed determined people to insist on getting boosted and they simultaneously allowed more lackadaisical people to decide not to bother. Both could cite the eligibility criteria in support of their decisions. Neither had reason to complain and neither was vulnerable to criticism.
But the criteria worked less well from a medical perspective. Determination to get boosted is bound to be more highly correlated with variables like education, class, and race than with actual vulnerability. So healthy, highly educated, upper-middle-class white people were getting the boosters they badly wanted, while less healthy, less educated, working-class people of color didn’t necessarily get the boosters they badly needed.
In September and October, most experts and public health professionals thought this was okay, mostly because they thought boosters weren’t very important anyway, since they judged that fully vaccinated people were adequately protected from severe outcomes. By November they had come to think that maybe it’s important to get vulnerable people boosted – which made it important to be clear that everybody is entitled to get boosted.
The booster decision chain of influence ran from public to politicians to agencies to experts – exactly the opposite of the ideal process in the judgment of most public health professionals. That’s one thing they hated about the process.
The other thing they hated about the process was its transparency. As a rule, public health professionals try to reach some kind of working consensus behind the scenes. Not secretly, exactly; their doubts, dilemmas, and disagreements are there to be analyzed if you look for them – especially now that experts spend a lot of time tweeting at each other about, well, their doubts, dilemmas, and disagreements.
But this time it was all vividly public. You didn’t have to go looking. Everyone got to see the public health policy sausage getting made. To most public health professionals, that transparency was almost as infuriating as the nearly intolerable fact that the public and the politicians were largely dictating the sausage-making outcome.
Insofar as I have a quarrel with the White House effort to push a COVID booster policy, it isn’t that the White House failed to “follow the science” or to follow the scientists. It’s that the White House ever pretended that that’s what it would or should do. One of the ways Biden distinguished himself from his predecessor, both as candidate and as president, was by repeatedly and explicitly saying that he wouldn’t disdain the experts’ advice the way Trump did. Promising to listen to the experts is fine. Promising (or seeming to promise) to always do what the experts tell you is awful. Actually keeping that latter promise would be more awful still.
When scientific experts complain that a politician isn’t “following the science,” what they often mean is that the politician isn’t following them, the actual scientists. Following the scientists is often impossible because scientists often disagree. Worse, they often hide their disagreements, so you could easily end up following the winning side that forced the losers to shut up. Even worse than that, scientists like everyone else have opinions that go beyond their expertise. Their expert judgments are affected by their inexpert opinions – and they often pretend or imagine that their inexpert opinions are expert judgments too. Getting ethics advice, communication advice, or policy advice from scientists isn’t “following the science.” Often it is getting bad, blinkered, inexpert advice….
So if you’re a political leader in the midst of a pandemic, you should definitely listen to scientists – the outliers as well as the majority – and do your best to distinguish their expert judgments from their inexpert opinions. Listen to other sorts of experts on other sorts of issues. And listen to the public, both because you work for them and because policies don’t work well if the public won’t accept them. Then filter all of that through your own political wisdom, your own sense of what the science says, and your own sense of whom to trust and whom to discount. Come up with a policy – listening to all but following none. Finally, take responsibility for what you decided. You’re not following, you’re leading.
I am … a longtime opponent of letting experts hash out their disagreements behind closed doors – at least not when the issue at stake matters to the rest of us. Without transparency, the process by which experts “reach consensus” is all too often a process by which they enforce an artificial consensus, cowing the minority into silence.
Here I diverge from the views of most of my risk communication peers, whose mantra on the subject is “speak with one voice.” (Somehow they manage to pair this mantra with equally vehement support for transparency, as if the two ideals were compatible when experts disagree.) I think hiding or suppressing dissent is harmful when it backfires – when the minority viewpoint leaks out and the public starts talking about “coverup.” It’s even more harmful when it succeeds, misleading political leaders and the public about the extent of expert doubts, disagreements, and dilemmas; and depriving them of the chance to take the dissenters’ opinions into consideration….
Most public health professionals are unhappy with the booster decision process because the politicians didn’t follow the scientists and the experts didn’t speak with one voice. I am delighted with the booster decision process for precisely those same reasons. First we all got to launch the sausage-making process, and then we got to watch it.
Copyright © 2021 by Peter M. Sandman
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