RKF Jr. May Have Just Ruined Our Best Weapon Against Bird FluHe just made two bad decisions on vaccines, and he made them in the worst way possible.
IMAGINE BEING HANDED the ultimate weapon to win a future war and throwing that weapon away. That’s a fair description of what Robert F. Kennedy Jr. did last week when he canceled a $766 million government contract to develop a new bird flu vaccine.¹ The contract was with Moderna, the Massachusetts-based biotech company that developed and continues to produce one of the original COVID-19 shots. The Biden administration awarded the contract last year, through a special government program designed to fund preparation for future public health threats. Moderna was trying to use its know-how from COVID to invent a vaccine platform it could deploy rapidly against several types of influenza, including the H5N1 bird flu—a version of which, if you haven’t heard, has spread to the United States and is ravaging poultry farms. But it’s not the price of eggs keeping infectious-disease doctors up at night. It’s the possibility that a strain mutates, jumps species, and ends up in humans, who then start transmitting it to each other. It’s happened before, in mostly isolated outbreaks, with mortality rates that reached 50 percent. That dwarfs the comparable figure for COVID-19, which in most countries was in the low single digits and yet still killed more than 7 million people around the world, including more than a million in the United States.² That death toll would have been even higher if not for speedy development of COVID vaccines, including Moderna’s, whose secret sauce is mRNA technology that generally allows for much quicker production.³ That’s why two of the scientists most responsible for the breakthrough won the Nobel Prize in Medicine. And it’s why that bird flu contract went to Moderna, whose early tests on the bird flu vaccine have already produced promising results. But the contract was through the Department of Health and Human Services, which thanks to Donald Trump is under the leadership of Kennedy, the longtime vaccination critic whose egregious lies about the COVID shot include grossly exaggerating the prevalence of side effects and claiming it offers no protection against severe disease. Kennedy didn’t trot out any of these lines when canceling the Moderna contract. In fact, he didn’t say anything at all. But an HHS spokesperson told reporters like me that the Moderna decision was “about safety, integrity, and trust” and described mRNA technology as “under-tested”—even though the mRNA COVID shots went through extensive, randomized clinical trials before approval, and have been closely monitored for adverse effects ever since. That last part is no small thing. Ashish Jha, dean of the Brown University School of Public Health, told me in a phone interview he estimates as many as 1 billion people have gotten at least one dose of an mRNA vaccine, with only rare reports of serious side effects.⁴ “I would argue that this has been extraordinarily well studied,” Jha said, “and turns out to be one of the safest vaccine platforms we have.” Jha, who served as the government’s COVID-19 coordinator during the Biden administration, went on to call the under-testing argument “absurd.” That’s pretty much the consensus among mainstream scientists, as I heard when I put the question to several more of them. Adam Lauring, chief of infectious diseases at the University of Michigan and a leading researcher into the biology and evolution of viruses, said “these vaccines have probably been studied more intensively over the last five years than pretty much any other vaccines.” Adam Ratner, a nationally recognized pediatric infectious diseases physician in New York City, told me via email that the “mRNA COVID vaccines have been extensively tested and have an excellent safety record.” Ratner, who is the author of the book Booster Shots, said he could not fathom why Kennedy would be cutting off development of a treatment that might offer the surest, quickest way to prevent a potentially catastrophic spread of bird flu—let alone slow progress on a treatment that holds out the promise of fighting a lot more than infectious disease.⁵ “This decision,” Ratner said, “represents an unforced error of potentially epic proportions.” Not how this is supposed to workCANCELLATION OF THE MODERNA CONTRACT was not the only vaccine-related news that Kennedy made last week. He also announced a major shift in the official recommendation about who should get COVID booster shots and when. Unlike the Moderna announcement, however, that decision may have been as remarkable for the way it was made and publicized as for what it actually dictated. The announcement came on Tuesday morning, when Kennedy said in a 60-second social media video that the Centers for Disease Control and Prevention (CDC) would stop recommending boosters for healthy children and healthy non-elderly adults, including pregnant women. The decision had been rumored for weeks, and even many of those who would prefer to keep the old recommendation for kids concede the risk-versus-reward calculation is open to debate.⁶ But the case for pregnant women getting boosters is a lot more clear-cut, as my Bulwark colleague Andrew Egger noted last week. Studies have linked COVID during pregnancy to pre-term births, preeclampsia, and other complications, as well as long-term damage to the mother’s kidneys, heart, and other systems. Vaccinating pregnant mothers is the surest way to protect newborns and infants, who are highly vulnerable to infection and its most serious effects—and who, for the first few months of life, rely on whatever antibodies they got in utero because they cannot get the shots. Kennedy’s announcement prompted a blistering statement from the American College of Obstetricians and Gynecologists, plus lots of questions about exactly who made the decision and why—especially because two top FDA officials had indicated in a much-ballyhooed article a week earlier that their agency still thought pregnancy was a valid reason for boosters. “If you look at the data and the science, it does show that COVID vaccination is important for pregnant women—we should be doing everything that we can to not only prevent COVID, but mitigating the severity of disease for people who still get it,” Krutika Kuppalli, a U.S.-based infectious-disease physician and researcher who worked on COVID response for the World Health Organization, told me in a phone interview. “I’m not really understanding how this decision came about.” Normally, CDC issues vaccine guidelines by following a clear, methodical process that starts with government scientists at CDC and other agencies collecting and analyzing data, which then goes to an advisory committee of outside scientists who meet and discuss the evidence in public. The CDC director presides over those meetings and makes a recommendation, which in turn requires a (usually perfunctory) signoff from the HHS secretary. That clearly didn’t happen here, because the advisory committee hasn’t met yet. Even if it had, there would have been no permanent or acting CDC director to preside or follow up with a recommendation. As best as anybody can tell—and, yes, it’s totally bonkers that this is even an open question—the person currently performing the CDC director’s duties is the chief of staff, who among other things is not a scientist. He’s a lawyer with a background in aviation.⁷ That might explain why, as the Washington Post reported, CDC staff learned about the decision the same way the public did: by watching that Tuesday video, in which Kennedy was, bizarrely, flanked by directors of two other health agencies but nobody from the CDC. Mixed signals and chaosWHAT CAME NEXT was even weirder. Two days went by with no more official communication, except for a “directive” with Kennedy’s signature that circulated internally and eventually landed in the inboxes of reporters like me. It was just one page without HHS letterhead or other trappings of official documentation, and it contained what looked to me like a typo⁸ that seemed to contradict Kennedy’s central message. CDC finally updated its online vaccine information on Thursday night, though the new material didn’t line up with what Kennedy had outlined in the video. Under the new guidelines, CDC has completely withdrawn the recommendation of COVID vaccine boosters for pregnant women, but it has given some support for boosters among healthy kids, albeit with a caveat suggesting parents consult their doctors through “shared decision-making.” CDC has done so even though the case for giving boosters to healthy kids is weaker than it is for giving boosters to pregnant women. And just to make things even more confusing, the HHS media office has responded to media queries (again, including mine⁹) by saying “the old COVID-19 vaccine recommendations for healthy children under 18 and for pregnant women have been removed from the CDC vaccine schedule.” That makes it sound like CDC is treating the two groups the same way, when the online guidance for them is plainly different. The ambiguous, conflicting messages and shambolic, unprofessional presentations will not surprise you if you have been watching the Trump administration closely these past few months—or if you read last week’s exposé by two NOTUS reporters showing Kennedy’s highly touted “Make America Healthy Again” report contained bogus and sometimes misleading citations. But the saga around the boosters provides something new: the clearest evidence yet that Kennedy was lying when he promised congressional overseers—and the American people—that his goals were to increase transparency and scientific accountability rather than impose his own agenda. “I don’t think people should be taking medical advice from me,” he told a House committee in May. “What you have here is the secretary—not even the CDC director, because there is no CDC director—the secretary jumping in and saying the way he interprets the science is X, and so he’s going to make a decision unilaterally to preempt any decision or recommendation that [the advisory committee] would make,” University of Michigan law professor Sam Bagenstos—who served as HHS general counsel during the Biden administration—told me. “That’s a completely irregular process.” A confused mess for doctors, patients, and insurersThe full effect of the revised COVID booster guidance is impossible to know at this point—in part because its meaning still isn’t totally clear. But there’s a real possibility that it will affect people’s access to the vaccines, making it difficult for people who want or need them to get them. The “shared decision” recommendation for kids would be enough to keep boosters on the list of vaccines insurers must cover, under the Affordable Care Act’s preventative care requirement, experts told me. But it could at the very least complicate the process for people who would get shots at pharmacies, where consultations aren’t always easy. As for the lack of guidance on pregnant women, that could give insurers more freedom to drop full coverage. On the other hand, other CDC webpages continued to recommend the shot for pregnant women as late as Friday night. And some insurers might opt to keep covering the boosters regardless of the recommendation—especially for pregnant women, given the high cost of treating serious COVID complications should they occur. But CDC recommendations have implications that go beyond legal requirements for insurers. They influence public attitudes. CDC recommendations also serve as guidance for physicians all over the country, many of whom don’t have time—or specific technical background—to spend days weighing research evidence on their own. “If you’re a primary-care physician and you’re trying to decide what to recommend to your patient, it gets to the point where you can’t necessarily trust the recommendations that are being made by HHS and CDC anymore,” Bagenstos said. And even for experts following the research more closely, Jha said, “the usual process has a few advantages, because it’s super transparent. Everybody has seen the data. You can disagree with the decisions, but at least you’ve seen the data on which it is based, and the CDC scientists have had a chance to share that data in a public function.” In short, Kennedy is introducing more uncertainty into everyday medicine while undercutting CDC’s institutional credibility. And he’s doing so in a way that could render this particular decision vulnerable to a court challenge, Bagenstos noted, because administrative law prohibits federal agencies like CDC from arbitrary or capricious action. That’s one reason officials deliberate so methodically and so publicly—or did in non-Trumpian times, at any rate. But litigation takes time. And even if Kennedy’s guidance on COVID boosters eventually falls in court, he’s sent a message about how unreliable federal support for vaccines has become and will be. The companies that manufacture vaccines are sure to notice. They have other ways to make money, after all, and other places to do it too. That includes China, whose government has been investing heavily in biotech at precisely the time when—thanks again to Trump and Kennedy—the U.S. government is cutting back support for medical research. Put it all together, and it’s easy to see how vaccine development and production could slow or move overseas, or maybe both. With any of those scenarios, Americans could find themselves waiting longer for help in a future pandemic. And if it’s bird flu or a new COVID strain or some other yet-to-be-seen pathogen, waiting longer for a vaccine could mean not surviving the outbreak at all. 1 You may see several different numbers used in the press to describe the size of this contract. Here’s why: The government actually made two separate awards, one for about $170 million and one for about $590 million. So some news reports refer to cancellation of a $590 or $600 million contract, while others say it was $760 (or, to be more precise, $766) million. 2 To be clear, a bird flu that jumped to humans and spread easily might be less lethal, plus that 50 percent figure isn’t rock solid. But “might” is the key word. As Adam Lauring from the University of Michigan put it to me, “We don’t know if that’s going to happen, when it’s going to happen, or how severe it would be, but I think what is scary is what’s already happened—and we want to be prepared if the worst happens.” 3 Vaccines work by teaching the body to recognize and then fight pathogens, and traditionally they’ve done that by introducing a weakened or dead version of the threat—or a piece of it—that will trigger an immune response without causing the disease. But mass-producing that style of vaccine can be difficult and take a lot of time. Vaccines like Moderna’s commandeer the body’s own machinery inside cells, by feeding instructions to produce pieces of the pathogens rather than the proteins they would normally make. These instructions are in the form of messenger RNA, or mRNA, the chemical instructions that cells already use for protein construction. The idea has been kicking around since the 1970s, but it was only about a decade ago scientists finally figured out how to get vaccine mRNA into cells. Now it’s possible to imagine using that method to develop vaccines for new pathogens as quickly as scientists built a COVID vaccine. To learn more, check out this NIH explainer (while you still can). 4 The main and best-known of these is myocarditis, or inflammation of the heart, which is usually treatable. 5 Earlier this year, doctors at Memorial Sloan Kettering announced an experimental mRNA treatment was preventing recurrences of pancreatic cancer, which is notorious for its persistence and ultra-high death rate. 6 Mandy Cohen, the physician and public health expert who led CDC under President Biden, told me in a phone interview that one reason to keep recommending boosters for kids is the danger of Long COVID: “Kids get Long COVID. And the only thing we know about how to prevent Long COVID—because we don’t understand it, we’re still studying it—is that getting vaccinated reduces your risk of Long COVID. And the reason is because if you can fight it off faster, rev up your immune system . . . you are less likely to have Long COVID.” 7 The backstory here is that Trump withdrew the nomination for his original choice of CDC director, and instead tapped the then-acting director, Susan Monarez—who, because she’s now up for Senate confirmation, cannot serve in the acting role. Two weeks ago, while appearing before a Senate committee, Kennedy said that the CDC’s chief of staff, Matt Buzzelli, was performing the director’s duties in the interim. But Buzzelli may not meet various legal requirements to serve as acting director. Reporters at STAT were not able to get a direct answer on Buzzelli’s status when they inquired, and neither evidently has the senator who asked about it at the hearing. Like I was saying . . . it’s bonkers. 8 The directive said that the risks of COVID boosters did “not” outweigh the benefits for children, which is the opposite of what Kennedy has been saying. If he didn’t think the risks outweighed the benefits, he’d have no reason to dial back the recommendation. 9 I actually submitted a whole list of questions, covering everything from arguments about mRNA vaccines to who’s in charge of the CDC. All I got was the same brief statement—from which I’ve quoted—that went to every other reporter. Which is to say, HHS declined to answer most of my questions. You’re a free subscriber to The Bulwark—the largest pro-democracy news and analysis bundle on Substack. For unfettered access to all our newsletters and to access ad-free and member-only shows, become a paying subscriber. We’re going to send you a lot of content—newsletters and alerts for shows so you can read and watch on your schedule. Don’t care for so much email? You can update your personal email preferences as often as you like. To update the list of newsletter or alerts you received from The Bulwark, click here.
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