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Tag: vaccine-policy expert

  • Florida’s Experiment With Measles

    Florida’s Experiment With Measles

    The state of Florida is trying out a new approach to measles control: No one will be forced to not get sick.

    Joseph Ladapo, the state’s top health official, announced this week that the six cases of the disease reported among students at an elementary school in Weston, near Fort Lauderdale, do not merit emergency action to prevent unvaccinated students from attending class. Temporary exclusions of that kind while an outbreak is ongoing are part of the normal public-health response to measles clusters, as a means of both protecting susceptible children and preventing further viral spread. But Ladapo is going his own way. “Due to the high immunity rate in the community, as well as the burden on families and educational cost of healthy children missing school,” he said in a letter released on Tuesday, the state’s health department “is deferring to parents or guardians to make decisions about school attendance.”

    That decision came off as brazen, even for an administration that has made systematic efforts to lower vaccination rates among its constituents over the past two years. Ladapo’s letter acknowledges the benefits of vaccination, as well as the fact that vulnerable children are “normally recommended” to stay home. Still, it doesn’t bother giving local parents the bare-minimum advice that all kids who are able should get their MMR (measles, mumps, and rubella) shots, Dorit Reiss, a professor and vaccine-policy expert at UC Law San Francisco, told me. “I wouldn’t have expected him, in the middle of a measles outbreak, to be willing to sacrifice children in this way.”

    The Florida Department of Health has not responded to a request for comment on Ladapo’s future plans, should this situation worsen. For the moment, though, he has chosen to lower the guardrails from their standard height. It’s an escalation of his, and Florida’s, broader push against established norms in public health, especially as they relate to vaccination. So what happens now?

    At least in any immediate sense, Ladapo’s decision may not do much harm. In fact, there’s good reason to believe that its effects will end up being minimal. Parents who have children at the school, Manatee Bay Elementary, have until today to decide whether to pull out those kids for the next three weeks. Many seem to have already done so: About 200 students, and six teachers, have been absent, according to local news reports. In the meantime, Broward County Public Schools’ superintendent said yesterday that just 33 students out of the school’s nearly 1,100 were still unvaccinated. Given those two facts—some degree of self-imposed isolation, and 97 percent of the community now having some level of immune protection—the virus will have a hard time spreading no matter what the rules for attendance might be.

    Disease modeling, too, suggests that the risk of a larger outbreak is low. For a study released in 2019, a team of researchers based at Newcastle University and the University of Pittsburgh simulated thousands of measles outbreaks at schools in Texas, the most populous state to allow nonmedical exemptions from routine vaccine requirements. The researchers looked at the extent to which a policy of sequestering unvaccinated kids would help to reduce the outbreaks’ size. In the median outcome, even without any school-wide interventions, they found that an initial case of measles spreads only to a small handful of people. Adding in the rule that unvaccinated kids must stay at home has no effect on transmission. When the school’s vaccination rates are assumed to be unusually low, the rule reduces the outbreak’s size by one case.

    Not all the modeling outcomes are so rosy. For the very worst-case scenarios, in which a case of measles emerges in a school where unvaccinated kids happen to be clustered, the study found that forced suspensions have dramatic benefits. A major outbreak in the Dallas–Fort Worth area, for example, might end up infecting 477 people in the absence of any interventions, according to the model. When unvaccinated kids are kept from going to school, that number drops by 95 percent.

    Hypothetical models can’t tell us what will happen in a real-life school with real-life kids, like the one in Weston, Florida. But given Manatee Bay Elementary’s reported vaccination rate, it’s fair to assume that Ladapo’s policy won’t be catastrophic. Indeed, it may well end up sparing a few dozen families from the fairly serious inconvenience of being out of school without having much effect at all on the outbreak’s final size.

    But is the sparing of that inconvenience worth the risks that still remain? (And how should one value the time of a parent who could have vaccinated their child but chose not to?) As Reiss points out, if this policy leads to even one more case in the current outbreak, it will have put one more kid at risk of hospitalization, long-term complications, or even death. Worst-case outbreak scenarios do occur from time to time, as we all know well by now; and the Weston outbreak getting much worse is certainly within the realm of possibility. Any public-health authority would have to weigh these odds in the face of a six-case cluster; and surely almost every statewide health authority would choose to err on the side of caution. In Florida, though, the scale appears to tip the other way. Ladapo has rolled the dice on doing less.

    That’s been his way since the very day he was appointed by Governor Ron DeSantis, in September 2021. Just hours after he was introduced, the state ended mandatory quarantines for low-risk students who had been exposed to COVID. The following March, just a few weeks after being confirmed into the job, Ladapo announced that Florida would be “the first state to officially recommend against the COVID-19 vaccines for healthy children.” He continued to scale up from there: That fall, he recommended against the use of mRNA vaccines by any men under the age of 40. A year later, in October 2023, his office warned everyone under the age of 65 about the risks of getting an mRNA-based COVID booster. And then, finally, just last month, Ladapo came out with a warning that mRNA-based COVID vaccines “are not appropriate for use in human beings.”

    The man’s commitment to undermining vaccination is truly unparalleled among leading public-health officials. “As a surgeon general he stands alone,” Reiss told me. Yet Ladapo’s policy activism, however grotesque it might seem, has been bizarrely ineffective in practice. Take his March 2022 move to lead the way on not vaccinating young people against COVID. Media coverage of that announcement dwelled on reasonable concerns that this policy would dampen immunization rates; vaccine experts said it was a dangerous and irresponsible move that would “cause more people to die.” In practice, though, it seems to have done almost nothing. At the time of Ladapo’s announcement, 24.2 percent of Florida’s kids and 66.3 percent of its teenagers had received at least one dose of a COVID vaccine. (The corresponding national numbers at the time were somewhat higher.) By the end of the year, and in spite of Ladapo’s contrarian guidance, Florida’s vaccination numbers for these age groups were up by about four and three points respectively—which is almost exactly the same amount, percentage-wise, as the increases in those numbers seen across the country.

    Or compare Florida’s experience to that of Nevada, a state which had very similar child and teen vaccination rates in March 2022: 23.1 percent and 64.0 percent. Through the end of 2022, while Ladapo was discouraging his constituents from getting shots, that state’s Democratic governor was engaged in a large-scale effort to do just the opposite. And yet the results were essentially the same: Nevada’s rates increased by pretty much the same amount as Florida’s.

    For all of Ladapo’s efforts to dampen his state’s enthusiasm for life-saving interventions, Florida’s age-adjusted rates of death from COVID do not appear to have increased relative to the rest of the country, at least according to reported numbers. In this way, one of the nation’s loudest and most powerful voices of vaccine skepticism seems to be shouting into the wind. His proclamations and decisions to this point have been exquisitely effective at producing outrage, but embarrassingly feeble when it comes to changing outcomes. Even taken on its own terms, as a means of changing public-health behavior, Ladapo’s anti-vaccine activism has been a demonstrable failure.

    Perhaps this week’s decision to relax the rules on fighting measles will mark just one more step along that path: Once again, Florida’s surgeon general will have taken an appalling stance that ends up having no effect. But then again, now could be different. By the time Ladapo got around to undermining COVID shots, more than two-thirds of the state’s population, and 91 percent of its seniors, were already fully vaccinated. The damage he could have done was limited, by definition. But the measles outbreak in Weston is unfolding in real time. More such outbreaks are nearly guaranteed to occur in the U.S. in the months ahead. Reiss worries that Ladapo’s new idea, of choosing not to separate out unvaccinated kids during a school outbreak, could end up spreading into other jurisdictions. “If this becomes a precedent, that becomes a bigger problem,” she told me.

    For the first time since taking office, Ladapo may finally have a real opportunity to make a difference through his vaccination policy. That’s a problem.

    Daniel Engber

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  • COVID Vaccines Are Turning Into Flu Shots

    COVID Vaccines Are Turning Into Flu Shots

    For all the legwork that public-health experts have done over the past few years to quash comparisons between COVID-19 and the flu, there sure seems to be a lot of effort nowadays to equate the two. In an advisory meeting convened earlier today, the FDA signaled its intention to start doling out COVID vaccines just like flu shots: once a year in autumn, for just about everyone, ad infinitum. Whatever the brand, primary-series shots and boosters (which might no longer be called “boosters”) will guard against the same variants, making them interchangeable. Doses will no longer be counted numerically. “This will be a fundamental transition,” says Jason Schwartz, a vaccine policy expert at Yale—the biggest change to the COVID-vaccination regimen since it debuted.

    Hints of the annual approach have been dropping, not so subtly, for years. Even in the spring of 2021, Pfizer’s CEO was floating the idea of yearly shots; Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research, teased it throughout 2022. This past September, Joe Biden officially endorsed it as “a new phase in our COVID-19 response,” and Ashish Jha, the White House’s COVID czar, memorably highlighted the convenience of combining a flu shot and a COVID shot into a single appointment: “I really believe this is why God gave us two arms.”

    Still, in today’s meeting, FDA officials were pushier than ever in their advocacy for the flu-ification of COVID vaccines. “We think that simplification of the vaccination regimen would contribute to easier vaccine deployment, better communication, and improved vaccine coverage,” Jerry Weir, the FDA’s director of the division of viral products, said at the meeting. The timing is important: After renewing the U.S.’s pandemic-emergency declaration earlier this month, the Biden administration seems set to allow its expiration this coming April. That makes the present moment awfully convenient for repackaging a chaotic, crisis-caliber vaccination paradigm as a scheduled, seasonal, normal-seeming one. A once-a-year strategy, modeled on a routine recommendation, suggests that “we’re no longer in emergency mode,” says Maria Sundaram, a vaccine researcher at the Marshfield Clinic Research Institute. Or at least, that’s the message that the public is likely to hear.

    But federal regulators may be trying to fit a COVID-shaped peg into a flu-shaped hole. The experts I spoke with largely agreed: Eventually, someday, annual autumn shots for COVID “will probably be sufficient,” says Gregory Poland, a vaccinologist at Mayo Clinic. “Are we ready for that yet? I’m not sure that’s the case at all.”

    Even in the short term, COVID-vaccination tactics need a revamp. “It’s clear above all that the current approach isn’t working,” Schwartz told me. Despite abundant supply, demand for COVID boosters in the U.S. has been abysmal—and interest seems to be declining with each additional dose. Last fall’s bivalent shot has reached the arms of only 15 percent of Americans; even among adults over 65—a majority of whom sign up for flu shots each fall—the vaccination rate hasn’t yet reached 40 percent.

    For most of the time that COVID shots have been around, figuring out when to get them has been a hassle, with different guidelines and requirements that depend on age, sex, risk factors, vaccination history, and more. Pharmacies have had to stock an absurd number of vials and syringes to accommodate the various combinations of brands and dose sizes; record-keeping on flimsy paper cards has been a total joke. “I do this for a living, and I can barely keep track,” Schwartz said. Recommendations on the proper timing and number of doses have also changed so many times that many Americans have simply checked out. After the bivalent recipe debuted, polls found that an alarming proportion of people didn’t even know the shot was available to them.

    Streamlining COVID-vaccine recommendations will remove a lot of that headache, Sundaram told me. Most people would need to keep only one mantra in mind—one dose, each fall—and could top off their flu and COVID immunity at the same time. Burdens on pharmacies and clinics would be lower, and communication would be far easier—a change that could make an especially big difference for those with children, among whom COVID-vaccine uptake has been the lowest. “It’ll be more scheduled, more systematic,” says Charlotte Hobbs, a pediatric infectious-disease specialist at the University of Mississippi Medical Center. COVID shots could simply be offered at annual well-child visits, she told me. “It’s something we already know works well.”

    The advantages of a flu-ified COVID shot aren’t just about convenience. If we have to shoehorn COVID vaccines into an existing paradigm, Sundaram told me, influenza’s is the best candidate. SARS-CoV-2, like the flu, is excellent at altering itself to dodge our defenses; it spreads readily in winter; and our immunity to infection tends to fade rather quickly. All of that adds up to a need for regularly updated shots. Such a system has been in place for decades for the flu: At the end of each winter, a panel of experts convenes to select the strains that should be targeted by the next formulation; manufacturers spend the next several months whipping up big batches in time for an autumn-ish rollout. The pipeline depends on a global surveillance system for flu viruses, as well as regular surveys of antibody levels in the community to suss out which strains people are still protected against. The premise has been so well vetted by now that researchers can skip the chore of running large-scale clinical trials to determine the efficacy and safety of each new, updated recipe.

    But a seasonal strategy works best for a seasonal virus—and SARS-CoV-2 just isn’t there yet, says Hana El Sahly, an infectious-disease physician at Baylor College of Medicine. Though flu viruses tend to hop between the globe’s hemispheres, alternately troubling the north and the south during their respective cold months, this new coronavirus has yet to confine its spread to one part of the calendar. (Marks, of the FDA, tried to address this concern at today’s meeting, asserting that “we’re starting to see some seasonality” and that fall was indeed the very sensible for an annual rollout.) SARS-CoV-2 has also been spitting out concerning variants and subvariants at a faster rate than the flu (and flu shots already have a hard time keeping up with evolution). The FDA’s new proposal suggests picking SARS-CoV-2 variants in June to have a vaccine ready by September, a shorter timeline than is used for flu. That still might not be fast enough: “By the time we detect a variant, it will have ripped through the global population and, in a few more weeks, died down,” El Sahly told me. The world got a preview of this problem with last year’s bivalent shot, which overlapped with the dominance of its target subvariants for only a couple of months. A flu model for COVID would make more sense “if we had stable, predictable dynamics,” says Avnika Amin, a vaccine epidemiologist at Emory University. “I don’t think we’re at that point.”

    Murkiness around vaccine effectiveness makes this transition complicated too. Experts told me that it’s gotten much more difficult to tell how well our COVID vaccines are working, and for how long, fueling debates over how often they should be given and how often their composition should change. Many people have now been infected by the virus multiple times, which can muddy calculations of vaccine effectiveness; better treatments also alter risk profiles. And many researchers told me they’re concerned that the data shortcuts we use for flu—measures of antibodies as a proxy for immune protection—just won’t fly for COVID shots. “We need better clinical data,” El Sahly told me. In their absence, the hasty adoption of a flu framework could lead to our updating and distributing COVID shots too often, or not often enough.

    A flu-ish approach also wouldn’t fix all of the COVID vaccines’ problems. Today’s discussion suggested that, even if a new COVID-shot strategy change goes through, officials will still need to recommend several different dose sizes for several different age groups—a more complex regimen than flu’s—and may advise additional injections for those at highest risk. At the same time, COVID shots would continue to be more of a target for misinformation campaigns than many other vaccines and, at least in the case of mRNA-based injections, more likely to cause annoying side effects. These issues and others have driven down interest—and simply pivoting to the flu paradigm “is not going to solve the uptake problem,” says Angela Shen, a vaccine-policy expert at Children’s Hospital of Philadelphia.

    Perhaps the greatest risk of making COVID vaccines more like flu shots is that it could lead to more complacency. In making the influenza paradigm a model, we also threaten to make it a ceiling. Although flu shots are an essential, lifesaving public-health tool, they are by no means the best-performing vaccines in our roster. Their timeline is slow and inefficient; as a result, the formulations don’t always match circulating strains. Already, with COVID, the world has struggled to chase variants with vaccines that simply cannot keep up. If we move too quickly to the fine-but-flawed framework for flu, experts told me, it could disincentivize research into more durable, more variant-proof, less side-effect-causing COVID shots. Uptake of flu vaccines has never been stellar, either: Just half of Americans sign up for the shots each year—and despite years of valiant efforts, “we still haven’t figured out how to consistently improve that,” Amin told me.

    Whenever the COVID-emergency declaration expires, vaccination will almost certainly have to change. Access to shots may be imperiled for tens of millions of uninsured Americans; local public-health departments may end up with even fewer resources for vaccine outreach. A flu model might offer some improvements over the status quo. But if the downsides outweigh the pluses, Poland told me, that could add to the erosion of public trust. Either way, it might warp attitudes toward this coronavirus in ways that can’t be reversed. At multiple points during today’s meeting, FDA officials emphasized that COVID is not the flu. They’re right: COVID is not the flu and never will be. But vaccines can sometimes become a lens through which we view the dangers they fight. By equating our frontline responses to these viruses, the U.S. risks sending the wrong message—that they carry equal threat.

    Katherine J. Wu

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  • Are We Really Getting COVID Boosters Every Year Forever?

    Are We Really Getting COVID Boosters Every Year Forever?

    School is in session, pumpkin spice is in season, and Americans are heading to pharmacies for what may soon become another autumn standby: your annual COVID shot. On Tuesday, the White House announced the start of a “new phase” of the pandemic response, one in which “most Americans” will receive a COVID-19 vaccine just “once a year, each fall.” In other words, your pandemic booster is about to become as routine as your physical exam or—more to the point—your flu shot. One more health-related task has been added to your calendar, and it’s likely to remain there for the rest of your life.

    From a certain standpoint, this regimen makes a lot of sense. The pandemic’s biggest surges so far have come in the winter, and a fall booster could go a long way toward mitigating the next of those surges. What’s more, the new plan greatly simplifies COVID-vaccination regimens, both for the public and for providers. “It has been bewildering in many cases to understand who is eligible for a booster, how many boosters, when, which boosters, how far apart,” Jason Schwartz, a vaccine-policy expert at Yale, told me. “I think that has held down booster uptake in some really discouraging ways.” In a sense, White House COVID-19 Response Coordinator Ashish Jha told me, the new plan just codifies the way things already worked: The last time low-risk Americans became eligible for another shot was last fall. (The elderly and immunocompromised have operated on a different schedule and will likely continue to do so, Jha said.)

    Still, some public-health experts worry that the White House is jumping the gun. Back in April, a number of them told Stat News’s Helen Branswell they were concerned that the U.S. would adopt such a policy without the data needed to support it. When the White House made its announcement on Tuesday, many felt their concerns had been vindicated. “We’ve had twists and turns and surprises every single step of the way with COVID, and the idea that we’re going to have one shot and then we’re done is not really consistent with how things have worked in the past,” Walid Gellad, a professor at the University of Pittsburgh School of Medicine, told me. The plan, in his view, glosses over considerable uncertainties.

    For one thing, it assumes that the virus will follow an annual schedule with peaks in the fall and winter—not unlikely, but also not a given. For another, we still don’t have a firm grasp on the magnitude or duration of the benefits offered by the new Omicron-specific vaccine. For all we know, Gellad told me, the added protection afforded to someone who gets the shot tomorrow may have largely dissipated by New Year’s Eve.

    And that’s not to mention the massive uncertainty presented by the specter of future variants. In a briefing Tuesday, Jha acknowledged that “new variant curveballs” could change the government’s plans. But the announcement itself includes no such caveats, which some public-health experts worry could cause problems if course corrections are needed down the line. For all we know, new variants could necessitate more frequent updates, or, if viral mutation slows, we might not even need annual shots, Paul Thomas, an immunologist at St. Jude Children’s Research Hospital, in Tennessee, told me.

    If the routine the White House describes sounds a lot like flu shots, that’s no accident. The announcement explicitly recommends that COVID vaccines be taken between Labor Day and Halloween—“just like your annual flu shot.” That comparison, though, is part of what concerns critics, who worry that the shift into a more flu-like framework will entail the adoption of a vaccines-only approach to COVID prevention. Many of the interventions that have proved so effective over the past two and a half years—masking, distancing, widespread testing—have not traditionally been a major part of our flu-season protocols. If we treat COVID like flu, the thinking goes, such interventions risk falling even further by the wayside. The announcement, which makes no mention of any other prevention tactics, doesn’t offer much reassurance to the contrary.

    But that reading, Jha told me, is “just clearly wrong.” Although vaccines are “the central pillar of our strategy,” he said, testing, masking, and improving indoor air quality are all important as well. But as my colleague Katherine Wu has written, the country has been relying more and more on vaccines—and less and less on the other interventions at our disposal—for some time. Even if you do read the new policy as an abnegation of masking, ventilation, and the like, it may not functionally be much of a departure from the status quo.

    For now, Thomas said, the White House’s plan makes sense—as long as it stays sensitive to changing circumstances. “We keep learning new things about this virus,” he told me. “The rate of mutation is changing. The spread through the population is changing.” And as such, he said, our response must be flexible.

    The White House announcement seems like a good-faith attempt to balance competing priorities: on the one hand, the need to communicate uncertainty and acknowledge complexity; on the other, the need to keep the message from getting so complex that it confuses people to the point that they tune it out entirely. In this case, the administration seems to have come down on the side of simplicity. That could be a mistake, Gellad says—one that public-health authorities have made over and over throughout the pandemic. “When you try and make things simple and understandable and present them without sufficient uncertainty,” he told me, “you get into trouble when things change.”

    Jacob Stern

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