I know you're probably tired of hearing about boosters. But I figured it’s worth addressing what happened over the past week since it’s … extremely important.
A hypothetical debate is suddenly concrete. Pharmacies across the U.S. are now offering booster shots of the Pfizer-BioNTech vaccine. You could go get one right now.
And on the more important question of should you, the long-awaited official guidelines are ... not really guidelines at all. They amount to, "you may." Messages to the public about exactly who should get a booster have been contradictory and confounding. It's clear that certain high-risk groups benefit from a third shot, but experts at CDC and FDA also agreed nearly unanimously that not everyone should get one. And so, for most Americans the official guidance effectively amounts to: It's up to you.
For the majority of people who find themselves in a vast gray area between high risk and low—somewhere on the health spectrum between a centenarian with a lung transplant and an Olympic decathlete who eats only fiber and protein—the vagueness of recommendations means it will fall to individuals to decide.
So ... I’ll try to help add some context here as you do.
Ideally this decision would be made in collaboration with a thoughtful physician who’s readily accessible and knows your medical history, social circumstances, health priorities, et cetera. But since most of us don’t have one of those and are instead just wondering if it’s worth popping into a CVS or a van or tent and asking for a shot based on what we read online, I’m not going to leave it at: “talk to your doctor.” (As always, if possible, definitely do that.) (Also, make sure that any van you get into is indeed giving out vaccines prior to entry.)
Also, for purposes of this letter I’ll only be addressing Pfizer boosts for Pfizer-vaccinated people. (Next week I’ll get into Moderna, J&J, and mixing. Though similar challenges will apply; questions raised by Pfizer boosters aren’t unique.)
Finally, any discussion of boosters should start with two flashing neon caveats:
1. There’s really no way to justify countries giving third doses widely while many people have yet to get their first. It's almost like debating the usefulness of a second life jacket while people are drowning without one.
2. Boosters wouldn’t even be under consideration for widespread use if more people had gotten vaccinated. But because they didn't, and the virus continues to spread widely, that alters everyone's risk-benefit calculus.
Okay, having acknowledged the limitations of reason and morality, on to reality.
If you're grappling with this decision, or even just beginning to consider it, understanding how the booster authorization and guidelines came to be is essential. I’ll recap and keep it as brief as possible since I realize 98 percent of human eyes have a “glaze” reflex that kicks in upon mention of CDC or FDA committee meetings ...
Just nine short days ago, an FDA expert committee roundly rejected an application by Pfizer-BioNTech for emergency authorization of booster shots for all adults. The data simply weren't there to prove that boosters were safe and effective enough to roll out widely.
But the group did agree to authorize boosters for certain high-risk cases. On Wednesday, the FDA officially gave emergency-use authorization for booster shots to help specific high-risk populations remain protected against COVID-19. That effectively made the boosters legal to prescribe, very broadly.
The more relevant, more practical guidelines on who should get boosted are up to CDC. Those came in the middle of the night on Friday morning, in a statement from director Rochelle Walensky.
This was much anticipated, because doctors and scientists have been heatedly disagreeing for weeks about just who needs boosters. The uncertainty was on public display last Friday as the FDA debated (and ultimately granted) the authorization, and continued Thursday as CDC's panel of experts decided to recommend boosters only for people over 65, and younger people with certain medical conditions that put them at high risk for severe cases of COVID-19.
But as CDC director, Walensky has the final call and ultimately she "overruled" her agency's expert panel and opened boosters up to a much broader group. Some doctors applauded. Others were respectfully aghast. I'll get into why, but, first, here are the recommendations.
They boil down to four groups. The first two “should” receive a booster shot “at least 6 months after” initial vaccination:
People 65 and older, and residents in long-term care settings
The advice to the 65-and-older group is widely agreed upon, as are boosters for people with significantly compromised immune systems.
Where things start to get murky—at a practical level—is in defining “underlying medical conditions.” CDC’s list is expansive. It includes things like being overweight, having high blood pressure, being a current or former smoker, alcohol overuse, any type of cancer, asthma … basically, if you’re over 50 and have none of those, you’re in a small minority of people. (Or you actually do have one of those things and don't know it yet.)
The spirit of the recommendation seems more clearly directed at people with late-stage emphysema than at 52-year-old marathoners with slightly high blood pressure. But without more data, it's impossible to know precisely where to draw boundaries. So ultimately the reality of the recommendations is: almost anyone qualifies.
But that's not all. The still more vexing recommendations were for those of us under 50:
18-64 who are at increased risk for COVID-19 exposure and transmission because of occupational or institutional setting may receive a booster
Like so many people, I fixated on that “may.” CDC guidelines typically offer direction and advice, not permission. FDA is in charge of authorizing what medicines may be prescribed; CDC guides us in deciding what should. As Walensky herself said in an accompanying statement on Friday: “At CDC, we are tasked with analyzing complex, often imperfect data to make concrete recommendations that optimize health.”
That task is daunting. Everyone wants to stay ahead of another wave. Everyone also wants to make sure that medications are safe and effective before recommending them. And striking the balance between these priorities is the real, fundamental divide.
If a bad new variant emerges this fall—or even if it doesn’t, and immunity just wanes precipitously—and it turns out that boosted people are faring far better than un-boosted people, then it will seem like a serious failure not to recommend boosters urgently to more people. On the other hand, if protection remains strong based on initial vaccination, and if cases decline, and a some people who got boosters experience unforeseen untoward side effects, the recommendation will seem premature and ill-advised.
Accordingly, these guidelines are not “concrete recommendations.” They’re essentially an admission that we don’t know enough yet to make concrete recommendations. We don't have enough evidence. We get more every day, but, for now, for most vaccinated people, it wouldn't clearly help or hurt to get a booster. If and when clear signs of benefit or harm arise, the guidelines should become more concrete and meaningful.
For now, we are left to inhabit the ambiguity. If it’s tough to define “underlying medical conditions,” it’s even tougher to define “increased risk because of occupational or institutional setting.” Almost anyone could reasonably qualify.
And if a person seeks out a booster because they perceive their risk to be high, it’s tough to imagine a doctor quibbling that their job isn’t that risky. The volunteer in the vaccine van is even less likely to.
I don’t mean any of this as criticism; only to help show the actual sources of uncertainty and disagreement, which should inform your decision. Because the conflict is basically this: None of the convened experts suggested that everyone categorically needs a booster after 6 months. In fact the FDA committee voted almost unanimously against authorizing boosters for all adults. And yet, at the end of the process, the boosters are authorized for pretty much everyone, and the advice to us is that we “may” qualify to be boosted.
So, what does that mean, and why can't we just have a yes or no.
Frustrating as all this uncertainty may be, I take heart in seeing all of this debated publicly, and hope the process instills some trust among people who believe that the medical establishment is a monolithic entity trying to push an agenda or put shots in arms at any cost. Now more than ever, it's so clearly not.
Instead what we're witnessing is an ongoing attempt to be extremely careful about precisely how and when to recommend vaccine boosters. So careful, in fact, that no one wants to make a definitive call, and so most of us don’t even really have clear guidance yet.
Which is appropriate. And that also means that those of us who “may” get a booster are unlikely to go wrong in deciding. For now, we’re likely still very well protected, but also very likely to tolerate a booster shot without issue. The argument among experts isn’t over whether we definitely should or definitely should not; it’s over what to do in the absence of adequate data. And this isn’t a new dilemma, but one we confront often and have precedent in thinking through.
The default posture in medicine is usually to avoid doing something until you feel confident that it’s safe and effective (i.e. “first do no harm”). But sometimes people argue the inverse: in the face of a known risk, we should go ahead and take plausible measures in hopes that they’ll help until they prove not to be safe and effective.
This was the fringe argument for taking hydroxychloroquine, you may recall. Though the argument that it was plausible as a treatment for COVID-19 was razor thin, and the world subsequently ended up wasting tons of time and money researching the drug, which indeed was not helpful. But the “why not?” line of thinking does have merit in certain instances where risk is extremely high or even imminent, such as trying experimental chemotherapies in the terminal stages of metastatic cancer.
I'm not equating vaccines and horse paste. But some of the decision-making process is analogous. For most vaccinated people, as of now, going without a third dose does not constitute imminent risk. Post-vaccination infection “breakthrough” can occur, but illness tends to be shorter and milder than in unvaccinated people. And, for most people, we don’t know yet whether boosters would change that. But, unlike taking hydroxychloroquine or ivermectin, we have plausible reason to expect these boosters will help some people.
Ultimately, if you’re in the “may” category, the best advice I can give is not to stress over this decision. And as a community, our focus still belongs on helping unvaccinated people get their first doses.
Murky as the booster discussion may be, the risk-benefit calculus of getting vaccinated against COVID-19—while thousands of people die every day—is about as clear as anything medical science has ever had to offer. It’s like a version of the famous “trolley dilemma” (“Would you kill a person if it saved the lives of five others?”) designed for a preschool philosophy curricula: If you’re standing on the tracks and a trolley is coming, should you move off the tracks?
The decision over whether to get a booster may one day come with similar moral clarity. For now, for most of us, there's just not enough evidence to clearly frame the pros and cons. And there are social and political dynamics at play in this recommendation, which I won’t get into further for now. Instead I’ll close by continuing to torture this trolly dilemma metaphor to incorporate them.
A trolley is coming, and vaccinated people are no longer standing on the tracks, only nearby. But there has been a spate of trolly de-railings, and the conductor sometimes spits out the window. Also, it’s very foggy. And it’s possible for trolleys to mutate into variants that are wider than the trolleys we’re used to. Advising everyone to take a few steps back from the tracks might seem like the safe route. But if someone takes the advice and falls into a pot hole, new issues arise, in terms of distrust and “do no harm.” Some people will take offense at being “told” what to do and call it “tyranny,” and make a spectacle of actually going closer to the tracks to prove that they are high-testosterone patriots. There will be a “take back the tracks” rally where … anyway you get it.
Point being: it’s not hard to see why CDC might say something like “people standing close to the tracks may take a few steps backward.”
I’ll continue to follow this and update you. For now, take care, and please keep in touch,
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