Today, in an emergency meeting, CDC's vaccine advisory committee voted unanimously in favor of a profound expansion of giving COVID-19 "booster" doses to all adults.
For anyone who received two doses of the mRNA vaccines (Pfizer and Moderna) "booster" refers to a third dose of an mRNA vaccine at six months after your initial vaccination. For those who received the Johnson and Johnson vaccines, "booster" refers to a second shot (of any COVID vaccine) at two months after initial vaccination.
Until now, boosters had only been formally recommended for "high-risk groups." Appropriate as this may have been, that phrase was always impossible to define simply and clearly. Most people have at least one of the medical conditions on the long list (high blood pressure, asthma, diabetes) but most are overall healthy and don't see themselves as especially "high risk." Distinctions were a nightmare to communicate and adjudicate.
The experts gathered today clearly agreed. The tone was strikingly different from the debates in September. When officials first adjudicated the need for extra doses, it felt academic. Much was uncertain, and most experts were visibly torn over how strongly to recommend boosters, and for whom specifically.
Today there was almost no such hesitation. There was urgency.
Everyone was strongly in favor of clarifying, expanding, and simplifying access to boosters. Usually there's at least one wise guy at the table who plays contrarian and insists on "just asking questions" about some linear regression analyses but mostly seems to want to make sure he gets full credit for putting on a bow tie for this Zoom.
Not today. A lot of affirmative nodding. Watching the debate—which I wish more people did, but absolutely understand why they don't—even convinced me.
The only quibbles involved relatively minor details. (For example, how to word the official statement. Technically, everyone over 18 now "may" get a booster, and those with significant medical conditions definitely "should," as "should" anyone over 50.) All of this was almost instantly approved by CDC director Rochelle Walensky.
So this may seem like an abrupt change. Effectively, it is. This will surely be a criticism leveled by people who typically complain that the system is too full of regulations and red tape. Only a few weeks ago, most Americans were told that they probably didn't need a booster. Doctors met inquiries with a collective "it's kind of up to you." Many people who tried to get a dose were made to answer strings of questions about whether they "qualified" before booking an appointment. Now the dynamic will reverse. The gatekeepers are now ushers. Yesterday's "are you sure you need one?" is today's "please get one."
What changed? Is it really so urgent? What does may actually mean?
I think three things are worth considering as people approach this decision.
The fundamental tension in all of this—which it feels like no one is talking about—is that the American system of approving drugs isn't designed for this kind of decision.
Not to get too broad here, but every individual choice should consider the basis of a recommendation. Typically, our government agencies approve (or reject) drugs based on weighing a cost-benefit ratio for individuals. In most cases, that's fine and good. At the end of the day, the wellbeing of the patient taking the drug is what matters.
For example, our FDA will approve a drug if the data deem it safe and effective for an average patient—even if that drug would, for example, be wildly unaffordable and cause Medicare to go bankrupt (or at least divert funds to pay for it, and so deprive others of some essential treatment). That's not a side effect for the individual, so it's outside the jurisdiction of those who review clinical data. Not their problem. Approved.
And that's how the agencies have evaluated the data on vaccine doses at every step: Do these shots have benefits that outweigh the risks of side effects among individuals? Yes. After 26 million booster doses have been given, and the people who received them monitored for side effects and risks of getting COVID-19, there is now formally sufficient evidence to support widespread use. Many, many people clearly do benefit, as individuals. All are at a nearly zero risk of any significant side effect.
But that approach to decision-making also doesn't give the whole story.
It can't, by definition, whenever a drug has effects on those around us.
If a treatment for, say, erectile dysfunction were 100% safe and 100% effective for a patient, it would get approved. But if it caused fatal heart attacks among people who share a bed with that person, the system would be ill-equipped to debate its overall merits. And since the costs and benefits of vaccines play out at a societal level as well as an individual level, our system is similarly ill suited.
The process also isn't designed for emergencies. It's slow and elaborate and rightly favors caution. When emergency situations do arise, doctors and governments and drug companies try to make medicines available to people as soon as they prove to be safe and effective, and not a moment earlier or later.
Once again, that's usually good. If a drug results in two people dying from side effects, that's serious. But right now, more than 1,000 Americans are still dying of COVID each day. No other illness presents that level of risk. Perfection is never the goal, but this is a pressing situation where standards must take that level of risk into account.
In such cases, the agencies usually take actions as soon as the evidence is clear in some groups, while remaining unable to advise other groups, rolling out advice incrementally. This is why vaccine approvals for children came out later than adults. And boosters were advised for high-risk groups shortly after the data supported applying the advice to them, rather than waiting to see if boosters were advisable for all adults.
High-risk people were the first people to be vaccinated, and so the first to show evidence of breakthrough cases and to be enrolled in booster trials. Meanwhile, younger and healthier people have been on a time lag. They got vaccinated later, and their immunity has waned more slowly, so the case for boosting was not possible at an individual level. Hence the CDC focused on what it knew, and held off on advising other groups. Global equity was also part of the picture, as the World Health Organization urged wealthy countries not to horde extra doses while most people had yet to have their first.
Now the situation is markedly different. The need for boosters is clear even to our individual-centric, non-emergency-centric system. Initial concerns about adverse events—specifically myocarditis among younger males—haven't borne out as once thought possible. Among 26 million booster doses, there have been 12 confirmed cases. Meanwhile, Europe has provided a cautionary tale for the path on which the U.S. seems headed. For the past three weeks, cases of COVID-19 in the states have been increasing, and we are heading into winter holidays defined by travel and gatherings. Even if that's not part of the formal consideration of evidence, it's clearly on everyone's minds.
I started out envisioning three points to make. I think they blended together. But you get it, I hope.
The real challenge is ahead. Data are only truly convincing to those who look at them. Most of us consume a distilled take on YouTube, or from a mechanic with a strong feeling about what seems right. The most effective truth is one that can be conveyed concisely in 1-2 minutes and aligns with general vibes derived from prior affiliations.
Profiteers will continue working to promote themselves as unique enlightened influencers who are happy to take your money and tell you that all the experts are wrong, and you should do the opposite of whatever you're advised. Except by that person. You need to trust only them, and join their elite, uniquely enlightened group, and pay them if you want to be saved. Follow them. Buy their supplements. Subscribe to their newsletter.
Traditionally, in science, it's considered not good if you're the only one who thinks something. But that's also the central basis of guru profiteering. Every doctor thinks my book is nonsensical gibberish? Well that's yet more proof that you need to buy it and devote yourself to me.
More subtly, political opportunists take any such moment as opportunity to frame a change in scientific understanding or situational knowledge as a "flip flop." It's definite proof that science doesn't work. It's yet further proof of an ongoing conspiracy between the pharmaceutical industry and a global coalition of governments, scientists, journalists, celebrities, tech companies, schools, and doctors who secretly plan to encourage an endless series of vaccination.
(To whomever orchestrated that coalition and kept it from dissolving into conflict, wow. Also, technical question: Why? If the goal of the scheme were to insert tracking devices into everyone via these shots, then what's the idea behind boosters? Software update to the tracking devices? Also—sorry to draw this out, but—why didn't you take that technology to market. If you have a microchip so tiny as to be capable of being injected via a 0.25mL and then also remaining charged and transmitting data indefinitely, you'd be due several Nobel Prizes and, roughly, trillions of dollars.)
I didn't realize how widespread this idea was until I wrote in The Washington Post that you're never "fully vaccinated." In case you don't run in conspiratorial crowds, be aware that's the narrative. A nebulous "they" is secretly trying to give indefinite numbers of vaccine doses while also secretly trying to keep the pandemic going and ... it's impossible to follow. And it will be a shame if the fear of that crowd stops public-health experts and officials from doing their jobs. All that we can do is this:Say what you know, when you know it. Be transparent about its limitations. Give advice as best possible for the moment. Adjust it quickly and readily as soon as you learn more.
In a reasonable universe, the public would expect guidelines to evolve and change. It's intuitive. Each day we learn more about how our immunity is holding up, and how the virus is spreading. I find zero evidence of anyone ever promising that if you got two doses of a vaccine, you'd never ever benefit from another. More broadly, to hold fast to any belief regardless of evidence is malpractice, running contrary to the basis of the system by which we learn and grow.
It was unprecedented and bizarre. The safety system rightly stood up and said, wait, that's cool news about the antibodies, but it's just one step. We don't do approvals or recommendations based on blood tests. The fact that a drug produces a certain outcome in lab vials doesn't mean it works in the real world. An antibody response doesn't mean that boosters are useful, protective and safe in the real world. And, remember, this company has a pretty serious interest in selling additional doses that would mean enormous profits. Everyone's default should be skepticism.
But now that evidence is in, and the overall situation is concerning. Americans did not get vaccinated at the rates we so easily and profitably could have. Among the majority who did, immunity is waning. That didn't necessarily need to matter. If everyone were vaccinated it wouldn't. This would be over.
Despite the now compelling case for additional doses, the most effective approach to minimizing harm would still be to make sure that everyone gets their initial shots, globally and domestically. No one should be written off as unable to be reached. It's not a sustainable approach to simply boost the high-risk groups while others decline any sort of shot at all, of any sort by any company.
This would be no more effective than eliminating speed limits because people have seatbelts and airbags. Maybe a second later of seatbelts would be of some help when you're hit by someone going 120 MPH? Not a perfect comparison, but the point remains. The effectiveness of any dose of any vaccine depends on how much virus is circulating.
The tragedy is that while opportunists rant about a conspiracies surrounding additional doses—while also encouraging people to continue foregoing basic preventive measures, distrusting doctors, et cetera—are the ones making boosters more clearly necessary. People who willfully spread the virus, refusing the basic measures that help mitigate spread, necessitate continued caution they deride. They mock the idea of a second or third layer of seat belts while blindly driving 120.
Personally, I haven't felt much urgency to get another shot yet. I got vaccinated in May, so I hit my six-month mark last week. I didn't rush out to immediately get a booster. I've been busy, but everyone feels that way. So this has been clarifying for me. I'm getting a shot this weekend. If you're in a similar place—and especially if you plan on traveling to see family in coming weeks—it's good if this creates some sense of urgency to get boosted sooner rather than later.
(Pfizer or Moderna. There's no case for stressing that decision.)
So we boost on, boats against the current, borne back ceaselessly into the pandemic.
Take care, and thank you so much for considering all this.
Do you know why there seem to be no trials of mRNA vaccines against delta and its variants? Making a variant vaccine shouldn't be harder than editing a text file - and given that break-through infections are such an issue for both individuals' safety and the course of the pandemic, I assume I must be missing something. Any ideas?