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Tag: Advisory Committee

  • Israeli committee recommends shutting down Army Radio, Katz to issue decision

    Advisory committee to Katz: Shut Army Radio down or suspend current affairs programming • Galgalatz, Army Radio’s music station, is expected to remain open

    The Israeli government must shut down Army Radio or suspend its current affairs programming, an advisory committee set up by Defense Minister Israel Katz found in a report issued to Katz on Tuesday.

    Defense Minister Israel Katz confirmed he received the recommendation and is expected to make an announcement shortly. “I thank the committee members for their thorough, serious, and professional work, and for their significant investment in examining all aspects related to the operations of Army Radio,” Katz stated.

    The committee held 19 days of discussion between August and October, and conducted a tour of both Army Radio and Galgalatz, Army Radio’s music station.

    In its recommendation, the committee suggested the station be rebranded in a way that could preserve its unique identity as “the soldiers’ house” by maintaining its programming for IDF soldiers without engaging in current affairs content.

    Incoming defense minister Israel Katz attends a discussion and vote on the inclusion of MK Gideon Saar as a Minister in the government at the plenum hall of the Knesset, the Israeli Parliament in Jerusalem on September 30, 2024. (credit: YONATAN SINDEL/FLASH90)

    This would include the closure of the news department, but the station would still be permitted to broadcast any news flashes produced by KAN, Israel’s public broadcasting corporation.

    The committee was established by Katz in June

    After its establishment, the Defense Ministry stated that the committee would be required to submit its conclusions and recommendations within 90 days, and would examine, among other things, the feasibility, advantages, and disadvantages of various operational options for Army Radio. This would also include the possibility of transferring its management to a civilian body or merging it with an external media organization.

    “At this time, when the State of Israel is engaged in an ongoing campaign on several fronts, it is necessary to reassess how well Army Radio fulfills its mission, and whether it succeeds in being the voice and ears for IDF soldiers and fighters at the front and on the home front,” Katz said.

    “There is no doubt that a comprehensive and significant change is needed, and I intend to implement it after receiving the committee’s recommendations.”

    Earlier this year, MK Nissim Vaturi from the Likud Party proposed a bill to privatize the military station through a tender process, which would be managed by the Second Authority for Television and Radio.

    Additionally, at the end of March, after Prime Minister Benjamin Netanyahu spoke out against the Kan 11 Broadcasting Corporation during a cabinet meeting, Communications Minister Shlomo Karhi presented Katz with a proposal to close Army Radio.

    In the same meeting, Netanyahu asked, “Why do we even need a military station? The Defense Minister and Communications Minister need to examine the matter of Army Radio.”

    Walla contributed to this report.

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  • RKF Jr.’s hand-picked committee changed its recommendations for key childhood shots

    A key committee of the U.S. Centers for Disease Control and Prevention voted Thursday to alter its recommendation on an early childhood vaccine, after a discussion that at times pitted vaccine skeptics against the CDC’s own data.

    After an 8 to 3 vote with one abstention, the CDC’s Advisory Committee on Immunization Practices will no longer recommend that children under the age of 4 receive a single-shot vaccine for mumps, measles, rubella and varicella (better known as chicken pox).

    Instead, the CDC will recommend that children between the ages of 12 to 15 months receive two separate shots at the same time: one for mumps, measles and rubella (MMR) and one for varicella.

    The first vote of the committee’s two-day meeting represents a relatively small change to current immunization practices. The committee will vote Friday on proposed changes to childhood Hepatitis B and COVID vaccines.

    But doctors said the lack of expertise and vaccine skepticism on display during much of the discussion would only further dilute public trust in science and public health guidance.

    “I think the primary goal of this meeting has already happened, and that was to sow distrust and instill fear among parents and families,” said Dr. Sean O’Leary, chair of American Academy of Pediatrics’ Committee on Infectious Diseases, during a Zoom press conference Thursday.

    “What we saw today at the meeting was really not a good faith effort to craft immunization policy in the best interest of Americans. It was, frankly, an alarming attempt to undermine one of the most successful public health systems in the world,” O’Leary said. “This idea that our current vaccine policies are broken or need a radical overhaul is simply false.”

    Giving the MMR and chickenpox vaccines in the same shot has been associated with a higher relative risk of brief seizures from high fevers in the days after vaccination for children under 4 — eight children in 10,000 typically have febrile seizures after receiving the combination shot, compared with four out of 10,000 who receive separate MMR and chickenpox shots at the same time.

    Distressing as they are for family members to witness, seizures are a relatively common side effect for high fevers in young children and have not been associated with any long-term consequences, said Dr. Cody Meissner, a former pediatric infectious diseases chief at Tufts-New England Medical Center who is serving on ACIP for the second time (he previously served under Presidents George W. Bush and Barack Obama).

    The problem with splitting vaccines into multiple shots is that it typically leads to lower vaccine compliance, Meissner said. And the risks of not vaccinating are real.

    “We are looking at a risk-benefit of febrile seizures … as compared to falling below a 95% coverage rate for herd immunity, and the consequences of that are devastating, with pregnant women losing their babies, newborns dying and having congenital rubella syndromes,” said Dr. Joseph Hibbeln, a psychiatrist and neuroscientist and another current ACIP member.

    Meissner, Hibbeln and Hilary Blackburn were the only three members to vote against the change.

    The meeting ended with a vote regarding continued coverage of the MMRV shot under the CDC’s Vaccines for Children Program, a publicly-funded service that provides immunizations to nearly half of the nation’s children. VFC currently only covers shots that ACIP recommends.

    As chair Martin Kulldorff called the vote, several committee members complained that they did not understand the proposal as it was written. Three abstained from the vote entirely.

    As the meeting broke up, members could be heard trying to clarify with one another what they had just voted for.

    The committee also spent several hours debating whether to delay the first dose of the Hepatitis B vaccine, a shot typically given at birth, until the child is one month old. They will vote on the proposal Friday.

    The medical reason for altering the Hepatitis B schedule was less clear.

    “What is the problem we’re addressing with the Hepatitis B discussion? As far as I know, there hasn’t been a spate of adverse outcomes,” said pediatrician Dr. Amy Middleman, one of several people to raise the point during the discussion and public comment period.

    Committee member Dr. Robert Malone replied that changing the recommendation for when children should get vaccinated for hepatitis B would improve Americans’ trust in public health messaging.

    “A significant population of the United States has significant concerns about vaccine policy and about vaccine mandates, [particularly] the immediate provision of this vaccine at the time of birth,” Malone said. “The signal that is prompting this is not one of safety, but one of trust.”

    Hepatitis B is often asymptomatic, and half of infected people don’t know they have it, according to the CDC. Up to 85% of babies born to infected mothers become infected themselves, and the risk of long-term hazards from the disease is higher the earlier the infection is acquired.

    Infants infected with the hepatitis B virus in the first year of life have a 90% chance of developing chronic disease, and 25% of those who do will die from it, according to the the American Academy of Pediatrics.

    Since the vaccine was introduced in 1991, infant hepatitis B infections have dropped by 95% in the U.S. Nearly 14,000 children acquired hepatitis B infections between 1990 and 2002, according to the CDC; today, new annual infections in children are close to zero.

    This week’s two-day meeting is the second time the committee has met since Kennedy fired all 17 previous ACIP members in June, in what he described as a “clean sweep [that] is necessary to reestablish public confidence in vaccine science.”

    The next day, he named seven new members to the committee, and added the last five earlier this week. The new members include doctors with relevant experience in pediatrics, immunology and public health, as well as several people who have been outspoken vaccine skeptics or been criticized for spreading medical misinformation.

    They include Vicky Pebsworth, a nurse who serves as research director for the National Vaccine Information Center, an organization with a long history of sharing inaccurate and misleading information about vaccines, and Malone, a vaccinologist who contributed to early mRNA research but has since made a number of false and discredited assertions about flu and COVID-19 shots.

    In some cases, the new ACIP members also lack medical or public health experience of any kind. Retsef Levi, for example, is a professor of operations management at MIT with no biomedical or clinical degree who has nonetheless been an outspoken critic of vaccines.

    “Appointing members of anti-vaccine groups to policy-setting committees at the CDC and FDA elevates them from the fringe to the mainstream. They are not just at the table, which would be bad enough; they are in charge,” said Seth Kalichman, a University of Connecticut psychologist who has studied NVIC’s role in spreading vaccine misinformation. “It’s a worst-case scenario.”

    Though ACIP holds three public meetings per year, it typically works year-round, said Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia and a former ACIP member in the early 2000s.

    New recommendations to the vaccine schedule are typically written before ACIP meetings in consultation with expert working groups that advise committee members year-round, Offit said. But in August, medical groups including the American Medical Association, the American Academy of Pediatrics and Infectious Diseases Society of America were told they were no longer invited to review scientific evidence and advise the committee in advance of the meeting.

    That same month, Kennedy fired CDC director Dr. Susan Monarez — who had been appointed to the position by President Trump and confirmed by the Senate. This past Wednesday, Monarez told a Senate committee that Kennedy fired her in part because she refused to sign off on changes he planned to make to the vaccine schedule this month without seeing scientific evidence for them.

    She did not specify during the hearing what those changes would be.

    ACIP’s recommendations only become official after the CDC director approves them. With Monarez out, that responsibility now goes to Health and Human Services deputy secretary Jim O’Neill, who is serving as the CDC’s acting director.

    Asked by reporters on Wednesday whether the U.S. public should trust any changes ACIP recommends to the childhood immunization schedule, Sen. Bill Cassidy (Rep. – LA) was blunt: “No.”

    Cassidy chairs the Senate committee that oversees HHS, and cast the deciding vote for Kennedy’s nomination. Before running for office, Cassidy, a liver specialist, created a public-private partnership providing no-cost Hepatitis B vaccinations for 36,000 Louisiana children.

    He cast his vote after Kennedy privately pledged to Cassidy that he would maintain the CDC immunization schedule.

    As public trust in the integrity of CDC guidelines wobbles, alternative sources for information have stepped up. Earlier this year, the American Academy of Pediatrics announced that it would publish its own evidence-based vaccination schedule that differs from the CDC’s on flu and COVID shots. And on Wednesday, Gov. Gavin Newsom signed a law giving California the power to establish its own immunization schedule, the same day the state partnered with Oregon and Washington to issue joint recommendations for COVID-19, flu and RSV vaccines.

    On Tuesday, an association representing many U.S. health insurers announced that its members would continue to cover all vaccines recommended by the previous ACIP — regardless of what happened at Thursday’s meeting — through the end of 2026.

    “While health plans continue to operate in an environment shaped by federal and state laws, as well as program and customer requirements, the evidence-based approach to coverage of immunizations will remain consistent,” America’s Health Insurance Plans said in a statement. The group includes major insurers like Aetna, Humana, Kaiser Permanente, Cigna and several Blue groups. UnitedHealthcare, the nation’s largest insurer, is not a member.

    It’s unclear what will be covered after 2026.

    Corinne Purtill, Jenny Gold

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  • Why Are We Still Flu-ifying COVID?

    Why Are We Still Flu-ifying COVID?

    Four years after what was once the “novel coronavirus” was declared a pandemic, COVID remains the most dangerous infectious respiratory illness regularly circulating in the U.S. But a glance at the United States’ most prominent COVID policies can give the impression that the disease is just another seasonal flu. COVID vaccines are now reformulated annually, and recommended in the autumn for everyone over the age of six months, just like flu shots; tests and treatments for the disease are steadily being commercialized, like our armamentarium against flu. And the CDC is reportedly considering more flu-esque isolation guidance for COVID: Stay home ’til you’re feeling better and are, for at least a day, fever-free without meds.

    These changes are a stark departure from the earliest days of the crisis, when public-health experts excoriated public figures—among them, former President Donald Trump—for evoking flu to minimize COVID deaths and dismiss mitigation strategies. COVID might still carry a bigger burden than flu, but COVID policies are getting more flu-ified.

    Read: The flu-ification of COVID policy is almost complete

    In some ways, as the population’s immunity has increased, COVID has become more flu-like, says Roby Bhattacharyya, a microbiologist and an infectious-disease physician at Massachusetts General Hospital. Every winter seems to bring a COVID peak, but the virus is now much less likely to hospitalize or kill us, and somewhat less likely to cause long-term illness. People develop symptoms sooner after infection, and, especially if they’re vaccinated, are less likely to be as sick for as long. COVID patients are no longer overwhelming hospitals; those who do develop severe COVID tend to be those made more vulnerable by age or other health issues.

    Even so, COVID and the flu are nowhere near the same. SARS-CoV-2 still spikes in non-winter seasons and simmers throughout the rest of the year. In 2023, COVID hospitalized more than 900,000 Americans and killed 75,000; the worst flu season of the past decade hospitalized 200,000 fewer people and resulted in 23,000 fewer deaths. A recent CDC survey reported that more than 5 percent of American adults are currently experiencing long COVID, which cannot be fully prevented by vaccination or treatment, and for which there is no cure. Plus, scientists simply understand much less about the coronavirus than flu viruses. Its patterns of spread, its evolution, and the durability of our immunity against it all may continue to change.

    And yet, the CDC and White House continue to fold COVID in with other long-standing seasonal respiratory infections. When the nation’s authorities start to match the precautions taken against COVID with those for flu, RSV, or common colds, it implies “that the risks are the same,” Saskia Popescu, an epidemiologist at the University of Maryland, told me. Some of those decisions are “not completely unreasonable,” says Costi Sifri, the director of hospital epidemiology at UVA Health, especially on a case-by-case basis. But taken together, they show how bent America has been on treating COVID as a run-of-the-mill disease—making it impossible to manage the illness whose devastation has defined the 2020s.

    Each “not completely unreasonable” decision has trade-offs. Piggybacking COVID vaccines onto flu shots, for instance, is convenient: Although COVID-vaccination rates still lag those of flu, they might be even lower if no one could predict when shots might show up. But such convenience may come at the cost of protecting Americans against COVID’s year-round threat. Michael Osterholm, an epidemiologist at the University of Minnesota School of Public Health, told me that a once-a-year vaccine policy is “dead wrong … There is no damn evidence this is a seasonal virus yet.” Safeguards against infection and milder illness start to fade within months, leaving people who dose up in autumn potentially more susceptible to exposures by spring. That said, experts are still torn on the benefits of administering the same vaccine more than once a year—especially to a public that’s largely unwilling to get it. Throughout the pandemic, immunocompromised people have been able to get extra shots. And today, an advisory committee to the CDC voted to recommend that older adults once again get an additional dose of the most recently updated COVID vaccine in the coming months. Neither is a pattern that flu vaccines follow.

    Read: Fall’s vaccine routine didn’t have to be this hard

    Dropping the current COVID-isolation guideline—which has, since the end of 2021, recommended that people cloister for five days—may likewise be dangerous. Many Americans have long abandoned this isolation timeline, but given how new COVID is to both humanity and science, symptoms alone don’t yet seem enough to determine when mingling is safe, Popescu said. (The dangers are even tougher to gauge for infected people who never develop fevers or other symptoms at all.) Researchers don’t currently have a clear picture of how long people can transmit the virus once they get sick, Sifri told me. For most respiratory illnesses, fevers show up relatively early in infection, which is generally when people pose the most transmission risk, says Aubree Gordon, an epidemiologist at the University of Michigan. But although SARS-CoV-2 adheres to this same rough timeline, infected people can shed the virus after their symptoms begin to resolve and are “definitely shedding longer than what you would usually see for flu,” Gordon told me. (Asked about the specifics and precise timing of the update, a CDC spokesperson told me that there were “no updates to COVID guidelines to announce at this time,” and did not respond to questions about how flu precedents had influenced new recommendations.)

    At the very least, Emily Landon, an infectious-disease physician at the University of Chicago, told me, recommendations for all respiratory illnesses should tell freshly de-isolated people to mask for several days when they’re around others indoors; she would support some change to isolation recommendations with this caveat. But if the CDC aligns the policy fully with its flu policy, it might not mention masking at all.

    Read: No one really knows how much COVID is silently spreading … again

    Several experts told me symptom-based isolation might also remove remaining incentives to test for the coronavirus: There’s little point if the guidelines for all respiratory illnesses are essentially the same. To be fair, Americans have already been testing less frequently—in some cases, to avoid COVID-specific requirements to stay away from work or school. And Osterholm and Gordon told me that, at this point in the pandemic, they agree that keeping people at home for five days isn’t sustainable—especially without paid sick leave, and particularly not for health-care workers, who are in short supply during the height of respiratory-virus season.

    But the less people test, the less they’ll be diagnosed—and the less they’ll benefit from antivirals such as Paxlovid, which work best when administered early. Sifri worries that this pattern could yield another parallel to flu, for which many providers hesitate to prescribe Tamiflu, debating its effectiveness. Paxlovid use is already shaky; both antivirals may end up chronically underutilized.

    Flu-ification also threatens to further stigmatize long COVID. Other respiratory infections, including flu, have been documented triggering long-term illness, but potentially at lower rates, and to different degrees than SARS-CoV-2 currently does. Folding this new virus in with the rest could make long COVID seem all the more negligible. What’s more, fewer tests and fewer COVID diagnoses could make it much harder to connect any chronic symptoms to this coronavirus, keeping patients out of long-COVID clinics—or reinforcing a false portrait of the condition’s rarity.

    The U.S. does continue to treat COVID differently from flu in a few ways. Certain COVID products remain more available; some precautions in health-care settings remain stricter. But these differences, too, will likely continue to fade, even as COVID’s burden persists. Tests, vaccines, and treatments are slowly commercializing; as demand for them drops, supply may too. And several experts told me that they wouldn’t be surprised if hospitals, too, soon flu-ify their COVID policies even more, for instance by allowing recently infected employees to return to work once they’re fever-free.

    Early in the pandemic, public-health experts hoped that COVID’s tragedies would prompt a rethinking of all respiratory illnesses. The pandemic showed what mitigations could do: During the first year of the crisis, isolation, masking, distancing, and shutdowns brought flu transmission to a near halt, and may have driven an entire lineage of the virus to extinction—something “that never, in my wildest dreams, did I ever think would be possible,” Landon told me.

    Most of those measures weren’t sustainable. But America’s leaders blew right past a middle ground. The U.S. could have built and maintained systems in which everyone had free access to treatments, tests, and vaccines for a longer list of pathogens; it might have invested in widespread ventilation improvements, or enacted universal sick leave. American homes might have been stocked with tests for a multitude of infectious microbes, and masks to wear when people started to cough. Vaccine requirements in health-care settings and schools might have expanded. Instead, “we seem to be in a more 2019-like place than a future where we’re preventing giving each other colds as much as we could,” Bhattacharyya told me.

    Read: Next winter, what if we test for even more viruses?

    That means a return to a world in which tens of thousands of Americans die each year of flu and RSV, as they did in the 2010s. With COVID here to stay, every winter for the foreseeable future will layer on yet another respiratory virus—and a particularly deadly, disabling, and transmissible one at that. The math is simple: “The risk has overall increased for everyone,” Landon said. That straightforward addition could have inspired us to expand our capacity for preserving health and life. Instead, our tolerance for suffering seems to be the only thing that’s grown.

    Katherine J. Wu

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  • Paytm advisory panel discussing terms of reference with company: Damodaran

    Paytm advisory panel discussing terms of reference with company: Damodaran

    An advisory committee, set up by Paytm owner One97 Communications after the Reserve Bank’s action on its payments bank business, is at a stage of engagement with the company on matters related to the terms of reference for the panel, the panel’s head and former chairman of Sebi M Damodaran said.

    “We have been engaging with the group on matters relating to the Advisory Committee’s terms of reference,” Damodaran said on Sunday in response to a query about his engagement with Paytm.

    He said that the panel members are external advisors and at present Paytm is engaged in dealing with the RBI.

    On January 31, the RBI asked PPBL (Paytm Payments Bank Ltd) to stop further deposits, credit transactions, or top-ups in any customer accounts, prepaid instruments, wallets, FASTags, and National Common Mobility Cards, after February 29. Later, the central bank extended the deadline till March 15.

    Paytm on February 9 announced setting up of a group advisory committee headed by Damodaran. The committee was set up to advise the company on strengthening compliance and on regulatory matters.

    Meanwhile, the Reserve Bank on Friday asked the National Payments Corporation of India (NPCI) to examine the possibility of migrating Paytm Payments Bank customers using the UPI handle ‘@paytm’ to 4-5 other banks, in a bid to prevent any disruptions in the payment ecosystem.

    Damodaran was speaking at the release of his biography ‘The Turmeric Latte’ compiled by one of his former colleagues.

    During a panel discussion at the event, when he was asked about his views on the functioning of Sebi at present, Damodaran said the capital markets regulator has bandwidth problems with respect to the large amount of issues that it has to handle.

    “Sebi has a huge challenge. The bandwidth seems inadequate to tackle the large number of issues that they have to tackle. In the process, it sometimes feels like they are biting more than they can chew,” Damodaran said.

    The book, curated by former Tripura cadre IAS officer Dinesh Tyagi who last served as Managing Director of CSC E-Governance, has contributions from former colleagues of Damodaran including former mines secretary Sushil Kumar.

    The book also mentions about “threats” received by Damodaran, when he was the joint secretary in the information and broadcasting ministry, for some decisions taken by him.

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  • Flu Shots Need to Stop Fighting ‘Something That Doesn’t Exist’

    Flu Shots Need to Stop Fighting ‘Something That Doesn’t Exist’


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    Produced by ElevenLabs and NOA, News Over Audio, using AI narration.

    In Arnold Monto’s ideal vision of this fall, the United States’ flu vaccines would be slated for some serious change—booting a major ingredient that they’ve consistently included since 2013. The component isn’t dangerous. And it made sense to use before. But to include it again now, Monto, an epidemiologist and a flu expert at the University of Michigan, told me, would mean vaccinating people “against something that doesn’t exist.”

    That probably nonexistent something is Yamagata, a lineage of influenza B viruses that hasn’t been spotted by global surveyors since March of 2020, shortly after COVID mitigations plummeted flu transmission to record lows. “And it isn’t for lack of looking,” Kanta Subbarao, the director of the WHO’s Collaborating Centre for Reference and Research on Influenza, told me. In a last-ditch attempt to find the missing pathogen, a worldwide network of monitoring centers tested nearly 16,000 influenza B virus samples collected from February to August of last year. Not a single one of them came up Yamagata. “The consensus is that it’s gone,” Cheryl Cohen, the head of South Africa’s Centre for Respiratory Diseases and Meningitis, told me. Officially removing an ingredient from flu vaccines will codify that sentiment, effectively publishing Yamagata’s obituary.

    Read: The flu may never be the same

    Last year around this time, Subbarao told me, the WHO was already gently suggesting that the world might want to drop Yamagata from vaccines; by September, the agency had grown insistent, describing the ingredient as “no longer warranted” and urging that “every effort should be made to exclude it as soon as possible.” The following month, an advisory committee to the FDA unanimously voted to speedily adopt that same change.

    But the switch from a four-flu vaccine to a trivalent one, guarding against only three, isn’t as simple as ordering the usual, please, just hold the Yams. Trivalent vaccines require their own licensure, which some manufacturers may have allowed to lapse—or never had at all; manufacturers must also adhere to the regulatory pipelines specific to each country. “People think, ‘They change the strains every season; this should be no big deal,’” Paula Barbosa, the associate director of vaccine policy at the International Federation of Pharmaceutical Manufacturers and Associations, which represents vaccine manufacturers, told me. This situation is not so simple: “They need to change their whole manufacturing process.” At the FDA advisory-committee meeting in October, an industry representative cautioned that companies might need until the 2025–26 season to fully transition to trivalents in the Northern Hemisphere, a timeline that Barbosa, too, considers realistic. The South could take until 2026.

    In the U.S., though, where experts such as Monto have been pushing for expedient change, a Yamagata-less flu vaccine could be coming this fall. When I reached out to CSL Seqirus and GSK, two of the world’s major flu-vaccine producers, a spokesperson from each company told me that their firm was on track to deliver trivalent vaccines to the U.S. in time for the 2024–25 flu season, should the relevant agencies recommend and request it. (The WHO’s annual meeting to recommend the composition of the Northern Hemisphere’s flu vaccine isn’t scheduled until the end of February; an FDA advisory meeting on the same topic will follow shortly after.) Sanofi, another vaccine producer, was less definitive, but told me that, with sufficient notice from health authorities, its plans would allow for trivalent vaccines this year, “if there is a definitive switch.” AstraZeneca, which makes the FluMist nasal-spray vaccine, told me that it was “engaging with the appropriate regulatory bodies” to coordinate the shift to a trivalent vaccine “as soon as possible.”

    Quadrivalent flu vaccines are relatively new. Just over a decade ago, the world relied on immunizations that included two flu A strains (H1N1 and H3N2), plus one B: either Victoria or Yamagata, whichever scientists predicted might be the bigger scourge in the coming flu season. “Sometimes the world got it wrong,” Mark Jit, an epidemiologist at the London School of Hygiene & Tropical Medicine, told me. To hedge their bets, experts eventually began to recommend simply sticking in both. But quadrivalent vaccines typically cost more to manufacture, experts told me. And although several countries, including the U.S., quickly transitioned to the heftier shots, many nations—especially those with fewer resources—never did.

    Now “the extra component is a waste,” Vijay Dhanasekaran, a virologist at the University of Hong Kong, told me. It’s pointless to ask people’s bodies to mount a defense against an enemy that will never attack. Trimming Yamagata out of flu-vaccine recipes should also make them cheaper, Dhanasekaran said, which could improve global access. Plus, continuing to manufacture Yamagata-focused vaccines raises the small but serious risk that the lineage could be inadvertently reintroduced to the world, Subbarao told me, as companies grow gobs of the virus for their production pipeline. (Some vaccines, such as FluMist, also immunize people with live-but-weakened versions of flu viruses.)

    Some of the researchers I spoke with for this article weren’t ready to rule out the possibility—however slim—that Yamagata is still biding its time somewhere. (Victoria, a close cousin of Yamagata, and the other B lineage that pesters people, once went mostly quiet for about a decade, before roaring back in the early aughts.) But most experts, at this point, are quite convinced. The past couple of flu seasons have been heavy enough to offer even a rather rare lineage the chance to reappear. “If it had been circulating in any community, I’m pretty sure that global influenza surveillance would have detected it by now,” Dhanasekaran said. Plus, even before the pandemic began, Yamagata had been the wimpiest of the flu bunch, Jit told me: slow to evolve, crummy at transmitting, and already dipping in prevalence. When responses to the pandemic starved all flu viruses of hosts, he said, this lineage was the likeliest to be lost.

    Read: The pandemic broke the flu

    Eventually, companies may return to including four types of flu in their products, swapping in, say, another strain of H3N2, the most severe and fastest-evolving of the bunch—a change that Subbarao and Monto both told me might actually be preferable. But incorporating a second H3N2 is even more of a headache than returning to a trivalent vaccine: Researchers would likely first need to run clinical trials, experts told me, to ensure that the new components played nicely with each other and conferred additional benefits.

    For the moment, a slimmed-down vaccine is the quickest way to keep up with the flu’s current antics. And in doing so, those vaccines will also reflect the strange reality of this new, COVID-modified world. “A whole lineage of flu has probably been eliminated through changes in human behavior,” Jit told me. Humanity may not have intended it. But our actions against one virus may have forever altered the course of another.



    Katherine J. Wu

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  • This Fall’s COVID Vaccines Are for Everyone

    This Fall’s COVID Vaccines Are for Everyone

    Paul Offit is not an anti-vaxxer. His résumé alone would tell you that: A pediatrician at Children’s Hospital of Philadelphia, he is the co-inventor of a rotavirus vaccine for infants that has been credited with saving “hundreds of lives every day”; he is the author of roughly a dozen books on immunization that repeatedly debunk anti-vaccine claims. And from the earliest days of COVID-19 vaccines, he’s stressed the importance of getting the shots. At least, up to a certain point.

    Like most of his public-health colleagues, Offit strongly advocates annual COVID shots for those at highest risk. But regularly reimmunizing young and healthy Americans is a waste of resources, he told me, and invites unnecessary exposure to the shots’ rare but nontrivial side effects. If they’ve already received two or three doses of a COVID vaccine, as is the case for most, they can stop—and should be told as much.

    His view cuts directly against the CDC’s new COVID-vaccine guidelines, announced Tuesday following an advisory committee’s 13–1 vote: Every American six months or older should get at least one dose of this autumn’s updated shot. For his less-than-full-throated support for annual vaccination, Offit has become a lightning rod. Peers in medicine and public health have called his opinions “preposterous.” He’s also been made into an unlikely star in anti-vaccine circles. Public figures with prominently shot-skeptical stances have approvingly parroted his quotes. Right-leaning news outlets that have featured vaccine misinformation have called him up for quotes and sound bites—a sign, he told me, that as a public-health expert “you screwed up somehow.”

    Offit stands by his opinion, the core of which is certainly scientifically sound: Some sectors of the population are at much higher risk for COVID than the rest of us. But the crux of the controversy around his view is not about facts alone. At this point in the pandemic, in a country where seasonal vaccine uptake is worryingly low and direly inequitable, where health care is privatized and piecemeal, where anti-vaccine activists will pull at any single loose thread, many experts now argue that policies riddled with ifs, ands, or buts—factually sound though they may be—are not the path toward maximizing uptake. “The nuanced, totally correct way can also be the garbled-message way,” Anthony Fauci, the former director of the National Institute of Allergy and Infectious Diseases, told me.

    For the past two years, the United States’ biggest COVID-vaccine problem hasn’t been that too many young and healthy people are clamoring for shots and crowding out more vulnerable groups. It’s been that no one, really—including those who most need additional doses—is opting for additional injections at all. America’s vaccination pipeline is already so riddled with obstacles that plenty of public-health experts have become deeply hesitant to add more. They’re opting instead for a simple, proactive message—one that is broadly inclusive—in the hope that a concerted push for all will nudge at least some fraction of the public to actually get a shot this year.

    On several key vaccination points, experts do largely agree. The people who bear a disproportionate share of COVID’s risk should receive a disproportionate share of immunization outreach, says Saad Omer, the dean of UT Southwestern’s O’Donnell School of Public Health.

    Choosing which groups to prioritize, however, is tricky. Offit told me he sees four groups as being at highest risk: people who are pregnant, immunocompromised, over the age of 70, or dealing with multiple chronic health conditions. Céline Gounder, an infectious-disease specialist and epidemiologist at NYC Health + Hospitals/Bellevue, who mostly aligns with Offit’s stance, would add other groups based on exposure risk: people living in shelters, jails, or other group settings, for instance, and potentially people who work in health care. (Both Gounder and Offit also emphasize that unvaccinated people, especially infants, should get their shots this year, period.) But there are other vulnerable groups to consider. Risk of severe COVID still stratifies by factors such as socioeconomic status and race, concentrating among groups who are already disproportionately disconnected from health care.

    That’s a potentially lengthy list—and messy messaging has hampered pandemic responses before. As Gretchen Chapman, a vaccine-behavior expert at Carnegie Mellon University, told me last month, a key part of improving uptake is “making it easy, making it convenient, making it the automatic thing.” Fauci agrees. Offit, had he been at the CDC’s helm, would have strongly recommended the vaccine for only his four high-risk groups, and merely allowed everyone else to get it if they wanted to—drawing a stark line between those who should and those who may. Fauci, meanwhile, approves of the CDC’s decision. If it were entirely up to him, “I would recommend it for everyone” for the sheer sake of clarity, he told me.

    Read: Fall’s vaccine routine didn’t have to be this hard

    The benefit-risk ratio for the young and healthy, Fauci told me, is lower than it is for older or sicker people, but “it’s not zero.” Anyone can end up developing a severe case of COVID. That means that shoring up immunity, especially with a shot that targets a recent coronavirus variant, will still bolster protection against the worst outcomes. Secondarily, the doses will lower the likelihood of infection and transmission for at least several weeks. Amid the current rise in cases, that protection could soften short-term symptoms and reduce people’s chances of developing long COVID; it could minimize absences from workplaces and classrooms; it could curb spread within highly immunized communities. For Fauci, those perks are all enough to tip the scales.

    Offit did tell me that he’s frustrated at the way his views have frequently been framed. Some people, for instance, are inaccurately portraying him as actively dissuading people from signing up for shots. “I’m not opposed to offering the vaccine for anyone who wants it,” he told me. In the case of the young and healthy, “I just don’t think they need another dose.” He often uses himself as an example: At 72 years old, Offit didn’t get the bivalent shot last fall, because he says he’s in good health; he also won’t be getting this year’s XBB.1-targeting brew. Three original-recipe shots, plus a bout of COVID, are protection enough for him. He gave similar advice to his two adult children, he told me, and he’d say the same to a healthy thrice-dosed teen: More vaccine is “low risk, low reward.”

    The vax-for-all guideline isn’t incompatible, exactly, with a more targeted approach. Even with a universal recommendation in place, government resources could be funneled toward promoting higher uptake among essential-to-protect groups. But in a country where people, especially adults, are already disinclined to vaccinate, other experts argue that the slight difference between these two tactics could compound into a chasm between public-health outcomes. A strong recommendation for all, followed by targeted implementation, they argue, is more likely to result in higher vaccination rates all around, including in more vulnerable populations. Narrow recommendations, meanwhile, could inadvertently exclude people who really need the shot, while inviting scrutiny over a vaccine’s downsides—cratering uptake in high- and low-risk groups alike. Among Americans, avoiding a strong recommendation for certain populations could be functionally synonymous with explicitly discouraging those people from getting a shot at all.

    Offit pointed out to me that several other countries, including the United Kingdom, have issued recommendations that target COVID vaccines to high-risk groups, as he’d hoped the U.S. would. “What I’ve said is really nothing that other countries haven’t said,” Offit told me. But the situation in the U.S. is arguably different. Our health care is privatized and far more difficult to access and navigate. People who are unable to, or decide not to, access a shot have a weaker, more porous safety net—especially if they lack insurance. (Plus, in the U.K., cost was reportedly a major policy impetus.) A broad recommendation cuts against these forces, especially because it makes it harder for insurance companies to deny coverage.

    Read: The big COVID question for hospitals this fall

    A weaker call for COVID shots would also make that recommendation incongruous with the CDC’s message on flu shots—another universal call for all Americans six months and older to dose up each year. Offit actually does endorse annual shots for the flu: Immunity to flu viruses erodes faster, he argues, and flu vaccines are “safer” than COVID ones.

    It’s true that COVID and the flu aren’t identical—not least because SARS-CoV-2 continues to kill and chronically sicken more people each year. But other experts noted that the cadence of vaccination isn’t just about immunity. Recent studies suggest that, at least for now, the coronavirus is shape-shifting far faster than seasonal flu viruses are—a point in favor of immunizing more regularly, says Vijay Dhanasekaran, a viral-evolution researcher at the University of Hong Kong. The coronavirus is also, for now, simply around for more of the year, which makes infections more likely and frequent—and regular vaccination perhaps more prudent. Besides, scientifically and logistically, “flu is the closest template we have,” Ali Ellebedy, an immunologist at Washington University in St. Louis, told me. Syncing the two shots’ schedules could have its own rewards: The regularity and predictability of flu vaccination, which is typically higher among the elderly, could buoy uptake of COVID shots—especially if manufacturers are able to bundle the immunizations into the same syringe.

    Flu’s touchstone may be especially important this fall. With the newly updated shots arriving late in the season, and COVID deaths still at a relative low, experts are predicting that uptake may be worse than it was last year, when less than 20 percent of people opted in to the bivalent dose. A recommendation from the CDC “is just the beginning” of reversing that trend, Omer, of UT Southwestern, told me. Getting the shots also needs to be straightforward and routine. That could mean actively promoting them in health-care settings, making it easier for providers to check if their patients are up to date, guaranteeing availability for the uninsured, and conducting outreach to the broader community—especially to vulnerable groups.

    Offit hasn’t changed his mind on who most needs these new COVID vaccines. But he is rethinking how he talks about it: “I will stop putting myself in a position where I’m going to be misinterpreted,” he told me. After the past week, he more clearly sees the merits of focusing on who should be signing up rather than who doesn’t need another dose. Better to emphasize the importance of the shot for the people he worries most about and recommend it to them, without reservation, to whatever extent we can.

    Katherine J. Wu

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  • The Cold-Medication Racket

    The Cold-Medication Racket

    You wake up with a stuffy nose, so you head to the pharmacy, where a plethora of options awaits in the cold-and-flu aisle. Ah, how lucky you are to live in 21st-century America. There’s Sudafed PE, which promises “maximum-strength sinus pressure and nasal congestion relief.” Sounds great. Or why not grab DayQuil in case other symptoms show up, or Tylenol Cold + Flu Severe should whatever it is get really bad? Could you have allergies instead? Good thing you can get Benadryl Allergy Plus Congestion, too.

    Unfortunately for you and me and everyone else in this country, the decongestant in all of these pills and syrups is entirely ineffective. The brand names might be different, but the active ingredient aimed at congestion is the same: phenylephrine. Roughly two decades ago, oral phenylephrine began proliferating on pharmacy shelves despite mounting—and now damning—evidence that the drug simply does not work.

    “It has been an open secret among pharmacists,” says Randy Hatton, a pharmacy professor at the University of Florida, who filed a citizen petition in 2007 and again in 2015 asking the FDA to reevaluate phenylephrine. This week, an advisory panel to the FDA voted 16–0 that the drug is ineffective orally, which could pave the way for the agency to finally pull the drug.

    If so, the impact would be huge. Phenylephrine is combined with fever reducers, cough suppressants, or antihistamines in many popular multidrug products such as the aforementioned DayQuil. Americans collectively shell out $1.763 billion a year for cold and allergy meds with phenylephrine, according to the FDA, which also calls the number a likely underestimate. That’s a lot of money for a decongestant that, again, does not work.

    Over-the-counter oral decongestants weren’t always this bad. But in the early 2000s, states began restricting access to pseudoephedrine—a different drug that actually is effective against congestion—because it could be used to make meth; the Combat Methamphetamine Epidemic Act, signed in 2006, took the restrictions national. You can still buy real-deal Sudafed containing pseudoephedrine, but you have to show an ID and sign a logbook. Meanwhile, manufacturers filled over-the-counter shelves with phenylephrine replacements such as Sudafed PE. The PE is for phenylephrine, but you would be forgiven for not noticing the different name.

    “Thet switch from pseudoephedrine to phenylephrine was a big mistake,” says Ronald Eccles, who ran the Common Cold Unit at Cardiff University until his retirement. Eccles was critical of the switch back in 2006. The evidence, he wrote at the time, was already pointing to phenylephrine as a lousy oral drug.

    Problems started showing up quickly. Hatton, who was then a co-director of the University of Florida Drug Information Center, started getting a flurry of questions about phenylephrine: Does it work? What’s the right dose? Because my patients are complaining that it’s not doing anything. He decided to investigate, and he went deep. Hatton filed a Freedom of Information Act request for the data behind FDA’s initial evaluation of the drug in 1976. He soon found himself searching through a banker’s box of records, looking for studies whose raw data he and a postdoctoral resident typed up by hand to reanalyze. The 14 studies the FDA had considered at the time had mixed results. Five of the positive ones were all conducted at the same research center, whose results looked better than everyone else’s. Hutton’s team thought that was suspicious. If you excluded those studies, the drug no longer looked effective at its usual dose.

    All told, the case for phenylephrine was not great, but the case against was no slam dunk either. When Hatton and colleagues at the University of Florida, including Leslie Hendeles, filed a citizen petition, they asked the agency to increase the maximum dose to something that could be more effective. They did not ask to pull the drug entirely.

    There was more damning evidence to come, though. The petition led to a first FDA advisory committee meeting, in 2007, where scientists from a pharmaceutical company named Schering-Plough, which later became Merck, presented brand-new data. The company had begun studying the drug, Hatton and Hendeles recalled, because it was interested in replacing the pseudoepinephrine in its allergy drug Claritin-D. But these industry scientists did not come to defend phenylephrine. Instead, they dismantled the very foundation of the drug’s supposed efficacy.

    They showed that almost no phenylephrine reaches the nasal passages, where it theoretically could reduce congestion and swelling by causing blood vessels to constrict. When taken orally, most of it gets destroyed in the gut; only 1 percent is active in the bloodstream. This seemed to be borne out by what people experienced when they took the drug—which was nothing. The scientists presented two more studies that found phenylephrine to be no better than placebo in people congested because of pollen allergies.

    These studies, the FDA later wrote, were “remarkable,” changing the way the agency thought about how oral phenylephrine works in the body. But experts still weren’t ready to write the drug off entirely. The 2007 meeting ended with the advisory committee asking for data from higher doses.

    The story for phenylephrine only got worse from there. In hopes of making an effective product, Merck went to study higher doses in two randomized clinical trials published in 2015 and 2016. “We went double, triple, quadruple—showed no benefit,” Eli Meltzer, an allergist who helped conduct the trials for Merck, said at the FDA-advisory-panel meeting this week. In other words, not only is phenylephrine ineffective at the labeled dosage of 10 milligrams every four hours, it is not even effective at four times that dose. These data prompted Hatton and Hendeles to file a second citizen petition and helped prompt this week’s advisory meeting. This time, the panel didn’t need any more data. “We’re kind of beating a dead horse … This is a done deal as far as I’m concerned. It doesn’t work,” one committee member, Paul Pisarik, said at the meeting. The advisory’s 16–0 vote is not binding, though, so it’s still up to the FDA to decide what to do about phenylephrine.

    In any case, phenylephrine is not the only cold-and-flu drug with questionable effectiveness in its approved form. The common cough drugs guaifenesin and dextromethorphan have both come under fire. But we lack the robust clinical-trial data to draw a definitive conclusion on those one way or the other. “What really helped our case is the fact that Merck funded those studies,” Hatton says. And that Merck let its scientists publish them. Failed studies from drug companies usually don’t see the light of day because they present few incentives for publication. Changing the consensus on phenylephrine took an extraordinary set of circumstances.

    It also required two dogged guys who have now been at this work for nearly two decades. “We’re just a couple of older professors from the University of Florida trying to do what’s best for society,” Hatton told me. When I asked whether they would be tackling other cold medications, he demurred: “I don’t know if either one of us has another 20 years in us.” He would instead like to see public funding for trials like Merck’s to reevaluate other over-the-counter drugs.

    There are other effective decongestants on pharmacy shelves. Even though phenylephrine does not work in pill form, “phenylephrine is very effective if you spray it into the nose,” Hendeles says. Neo-Synephrine is one such phenylephrine spray. Other nasal sprays containing other decongestants, such as Afrin, are also effective. But the only other common oral decongestant is pseudoephedrine, which requires that extra step of asking the pharmacist.
    Restricting pseudoephedrine has not  curbed the meth epidemic, either. Meth-related overdoses are skyrocketing, after Mexican drug rings perfected a newer, cheap way to make methamphetamine without using pseudoephedrine at all. This actually effective drug still remains behind the counter, while ineffective ones fill the shelves.

    Sarah Zhang

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  • America’s COVID Booster Rates Are a Bad Sign for Winter

    America’s COVID Booster Rates Are a Bad Sign for Winter

    And just like that, with the passing of Labor Day, fall was upon us. Seemingly overnight, six-packs of pumpkin beer materialized on grocery shelves, hordes of city dwellers descended upon apple orchards—and America rolled out new COVID boosters. The timing wasn’t a coincidence. Since the beginning of the pandemic, cases in North America and Europe have risen during the fall and winter, and there was no reason to expect anything different this year. Spreading during colder weather is simply what respiratory diseases like COVID do. The hope for the fall booster rollout was that Americans would take it as an opportunity to supercharge their immunological defenses against the coronavirus in advance of a winter wave that we know is going to come.

    So far, reality isn’t living up to that hope. Since the new booster became available in early September, fewer than 20 million Americans have gotten the shot, according to the CDC—just 8.5 percent of those who are eligible. The White House COVID-19 response coordinator, Ashish Jha, said at a press conference earlier this month that he expects booster uptake to increase in October as the temperatures drop and people start taking winter diseases more seriously. That doesn’t seem to be happening yet. America’s booster campaign is going so badly that by late September, only half of Americans had heard even “some” information about the bivalent boosters, according to a recent survey. The low numbers are especially unfortunate because the remaining 91.5 percent of booster-eligible people have already shown that they’re open to vaccines by getting at least their first two shots—if not already at least one booster.

    Now the bungled booster rollout could soon run headfirst into the winter wave. The virus is not yet surging in the United States—at least as far as we can tell—but as the weather cools down, cases have been on the rise in Western Europe, which has previously foreshadowed what happens in the U.S. At the same time, new Omicron offshoots such as BQ.1 and BQ.1.1 are gaining traction in the U.S., and others, including XBB, are creating problems in Singapore. Boosters are our best chance at protecting ourselves from getting swept up in whatever this virus throws at us next, but too few of us are getting them. What will happen if that doesn’t change?

    The whole reason for new shots is that though the protection conferred by the original vaccines is tremendous, it has waned over time and with new variants. The latest booster, which is called “bivalent” because it targets both the original SARS-CoV-2 virus and BA.5, is meant to kick-start the production of more neutralizing antibodies, which in turn should prevent new infection in the short term, Katelyn Jetelina, a public-health expert who writes the newsletter Your Local Epidemiologist, told me. The other two goals for the vaccine are still being studied: The hope is that it will also broaden protection by teaching the immune system to recognize other aspects of the virus, and that it will make protection longer-lasting.

    In theory, this souped-up booster would make a big difference heading into another wave. In September, a forecast presented by the Advisory Committee on Immunization Practices (ACIP), which advises the CDC, showed that if people get the bivalent booster at the same rate as they do the flu vaccine—optimistic, given that about 50 percent of people have gotten the flu vaccine in recent years—roughly 25 million infections, 1 million hospitalizations, and 100,000 deaths could be averted by the end of March 2023.

    But these numbers shouldn’t be taken as gospel, because protection across the population varies widely and modeling can’t account for all of the nuance that happens in real life. Gaming out exactly what our dreadful booster rates mean going forward is not a simple endeavor “given that the immune landscape is becoming more and more complex,” Jetelina told me. People received their first shots and boosters at different times, if they got them at all. And the same is true of infections over the past year, with the added wrinkle that those who fell sick all didn’t get the same type of Omicron. All of these factors play a role in how much America’s immunological guardrails will hold up in the coming months. “But it’s very clear that a high booster rate would certainly help this winter,” Jetelina said.

    At this point in the pandemic, getting COVID is far less daunting for healthy people than it was a year or two ago (although the prospect of developing long COVID still looms). The biggest concerns are hospitalizations and deaths, which make low booster uptake among vulnerable groups such as the elderly and immunocompromised especially worrying. That said, everyone aged 5 and up who has received their primary vaccine is encouraged to get the new boosters. It bears repeating that vaccination not only protects against severe illness and death but has the secondary effect of preventing transmission, thereby reducing the chances of infecting the vulnerable.

    What will happen next is hard to predict, Michael Osterholm, an epidemiologist at the University of Minnesota, told me, but now is a bad time for booster rates to be this low. Conditions are ripe for COVID’s spread. Protection is waning among the unboosted, immunity-dodging variants are emerging, and Americans just don’t seem to care about COVID anymore, Osterholm explained. The combination of these factors, he said, is “not a pretty picture.” By skipping boosters, people are missing out on the chance to offset these risks, though non-vaccine interventions such as masking and ventilation improvements can help, too.

    That’s not to say that the immunity conferred by the vaccination and the initial boosters is moot. Earlier doses still offer “pretty substantial protection,” Saad Omer, a Yale epidemiologist, told me. Not only are eligible Americans slacking on booster uptake, but lately vaccine uptake among the unvaccinated hasn’t risen much either. Before the new bivalent shots came around, less than half of eligible Americans had gotten a booster. “That means we are, as a population, much more vulnerable going into this fall,” James Lawler, an infectious-diseases expert at the University of Nebraska Medical Center, told me.

    If booster uptake—and vaccine uptake overall—remains low, expecting more illness, particularly among the vulnerable, would be reasonable, William Schaffner, a professor of infectious diseases at Vanderbilt University Medical Center, told me. Hospitalizations will rise more than they would otherwise, and with them the stress on the health-care system, which will also be grappling with the hundreds of thousands of people likely to be hospitalized for flu. While Omicron causes relatively minor symptoms, “it’s quite capable of producing severe disease,” Schaffner said. Since August, it has killed an average of 300 to 400 people each day.

    All of this assumes that we won’t get a completely new variant, of course. So far, the BA.5 subvariant targeted by the bivalent booster is still dominating cases around the world. Newer ones, such as XBB, BQ.1.1, and BQ.1, are steadily gaining traction, but they’re still offshoots of Omicron. “We’re still very hopeful that the booster will be effective,” Jetelina said. But the odds of what she called an “Omicron-like event,” in which a completely new SARS-CoV-2 lineage—one that warrants a new Greek letter—emerges out of left field, are about 20 to 30 percent, she estimated. Even in this case, the bivalent nature of the booster would come in handy, helping protect against a wider crop of potential variants. The effectiveness of our shots against a brand-new variant depends on its mutations, and how much they overlap with those we’ve already seen, so “we’ll see,” Omer said.

    Just as it isn’t too late to get boosted, there’s still time to improve uptake in advance of a wave. If you’re three to six months out from an infection or your last shot, the best thing you can do for your immune system right now is to get another dose, and do it soon. Though there’s no perfect and easy solution that can overcome widespread vaccine fatigue, that doesn’t mean trying isn’t worthwhile. “Right now, we don’t have a lot of people that feel the pandemic is that big of a problem,” and people are more likely to get vaccinated if they feel their health is challenged, Osterholm said.

    There’s also plenty of room to crank the volume on the messaging in general: Not long ago, the initial vaccine campaign involved blasting social media with celebrity endorsers such as Dolly Parton and Olivia Rodrigo. Where is that now? Lots of pharmacies are swimming in vaccines, but making getting boosted even easier and more convenient can go a long way too. “We need to catch them where they come,” said Omer, who thinks boosters should be offered at workplaces, in churches and community centers, and at specialty clinics such as dialysis centers where patients are vulnerable by default.

    After more than two years of covering and living through the pandemic, believe me: I get that people are over it. It’s easy not to care when the risks of COVID seem to be negligible. But while shedding masks is one thing, taking a blasé attitude toward boosters is another. Shots alone can’t solve all of our pandemic problems, but their unrivaled protective effects are fading. Without a re-up, when the winter wave reaches U.S. shores and more people start getting sick, the risks may no longer be so easy to ignore.

    Yasmin Tayag

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  • Will the Bivalent Booster Cause Worse Side Effects?

    Will the Bivalent Booster Cause Worse Side Effects?

    For as long as my marriage lasts, my household will be divided by reactions to vaccines.

    I am, fortunately, speaking of physical reactions rather than ideological ones; my partner and I are both shot enthusiasts, a fact we verified on our first date. But if my immune system is a bashful wallflower, rarely triggering more than a sore arm in the hours after I get a vaccine, then my spouse’s is a party animal. Every immunization I’ve watched him receive—among them, four doses of Moderna’s COVID-19 vaccine—has absolutely clobbered him with fevers, chills, fatigue, and headaches for about a full day. When he got the flu shot and the bivalent COVID jab together a few weeks ago, he ended up taking his first day off work in more than a decade. As usual, the same injections caused me so few symptoms that I wondered if I was truly dead inside.

    “Why don’t you feel anything?” my spouse howled at me from the bedroom, where his sweat was soaking through the sheets. “Sorry,” I yelled back from the kitchen, where I was prepping four days’ worth of meals between work calls after returning from an eight-mile run.

    If this is how every autumn will go from now on, so be it: A few hours of discomfort is still worth the rev-up in defenses that vaccines offer against serious disease and death. But it’s not hard to see that gnarly side effects will only add to the many other factors that work against COVID-vaccine uptake, including lack of awareness, sloppy messaging, dwindling access, and spotty community outreach. Back in the spring, when I spoke with several people who hadn’t gotten boosters despite being eligible for many, many months, several of them cited the post-shot discomfort as a reason. Now I’m getting texts and calls from family members and friends—all up to date on their previous COVID vaccines—admitting they’ve been dillydallying on the bivalent to avoid those symptoms too. “I don’t know if we’re going to continue to get strong buy-in from the public if they have this sort of reaction every year,” says Cindy Leifer, an immunologist at Cornell University.

    Read: America created its own booster problems

    The good news, at least, is that experts told me they don’t expect this bivalent recipe—or future autumn COVID shots, for that matter—to be worse, side-effect-wise, than the ones we’ve received before. It’ll take a while for data to confirm that, especially considering that more than a month into this fall’s rollout, fewer than 15 million Americans have received the updated shot. But Kathleen Neuzil, a vaccinologist at the University of Maryland School of Medicine who has studied the performance of COVID vaccines in clinical trials, pointed out to me that the mRNA shots’ ingredients have been swapped out before without altering the rate of side effects. As the alphabet soup of variants began to sweep the world in early 2021, she told me, vaccine makers started to tinker with alternate formulations, sometimes combining multiple versions of the spike protein into a single shot—“and they’re all comparable.” (If anything, early data suggest that bivalent shots containing an Omicron variant spike may be easier to take.) The same goes for flu vaccines, which are also retooled each year: When measured across the population, the frequency and intensity of side effects remain more or less the same.

    On average, then, mRNA-vaxxed people can probably expect to have an annual experience that’s pretty similar to the one they had with their first COVID booster. As studies have shown, that one was actually better for most people than dose No. 2, the most unpleasant of the injections so far. (The math, of course, becomes tougher for people getting another vaccine, such as the flu shot, at the same time.) There are probably two main reasons why side effects have lessened overall, experts told me. First, the spacing: Most people received the second dose in their Pfizer or Moderna primary series just three or four weeks after the first. That’s an efficient way to get a lot of people “fully vaccinated” in a short period of time, but it means that many of the immune system’s defensive cells and molecules will still be on high alert. The second shot could end up fanning a blaze of inflammation that was never quite put out. In line with that, researchers have found that spacing out the primary-series doses to eight weeks, 12 weeks, or even longer can prune some side effects.

    Dose matters a lot too: Vaccines are, in a way, stimulants meant to goad the immune system into reacting; bigger servings should induce bigger jolts. When vaccine makers were tinkering with their recipes in early trials, higher doses—including ones that were deemed too large for further testing—produced more side effects. Each injection in Moderna’s primary series contains more than three times the mRNA packaged into Pfizer’s, and Moderna has, on average, caused more intense side effects. But Moderna’s booster and bivalent doses contain a smaller scoop of the stimulating material: People 12 and older, for instance, get 50 micrograms instead of the 100 micrograms in each primary dose; kids 6 to 11 years old get 25 micrograms instead of 50. (All of Pfizer’s doses stay the same size across primaries and boosters, as long as people stay in the same age group.) People who switch between brands, then, may also notice a difference in symptoms.

    It’s a tricky balance, though. Sometimes, the immune system adjusts the magnitude of its protection to match the danger posed by a pathogen (or shot), a bit like titrating a crisis response to the severity of a threat—so it’s important that vaccine makers don’t undershoot. For better or worse, the mRNA-based COVID vaccines do seem to cause a rougher response than most other vaccines, including annual flu shots. One of the offending ingredients might be the mRNA itself, which codes for SARS-CoV-2’s spike protein. But Michela Locci, an immunologist at the University of Pennsylvania, told me that the mRNA’s packaging—a greasy fat bubble called a lipid nanoparticle—may be the more likely culprit. For some people, in any case, the side effects of COVID shots might be on par with those of the two-dose Shingrix vaccine, one of the most infamously reactogenic immunizations in our roster. Leifer, who has received both, told me the second dose of each “floored” her to about the same extent.

    The fact that I get fewer side effects than my spouse does not imply that I’m any less protected. A ton of factors—genetics, hormone levels, age, diet, sleep, stress, pain tolerance, and more—could potentially influence how someone experiences a shot. Women tend to have more reactive bodies, as do younger people. But there are exceptions to those trends: I’m one of them. The whole topic is understudied, Locci told me. Her own recent experience with the bivalent threw her for a loop. After her first, second, and third dose of Moderna each ratcheted up in side-effect severity, she cleared her calendar for the couple of days following her bivalent, “afraid I was going to be in bed with a fever again,” she said: “But it was a light headache for a morning, and then it was over.” She has no idea what next year will bring.

    Either way, side effects such as fevers and chills tend to be short-lived. “Very few side effects are severe,” Neuzil told me, “and COVID continues to be a severe disease.” Still, Grace Lee, a pediatrician at Stanford and the chair of the CDC’s Advisory Committee on Immunization Practices, hopes that scientists will keep developing new COVID vaccines that might come with fewer post-shot issues—including the very rare ones, such as myocarditis—without sacrificing immune protection. Lee doesn’t tend to react much to vaccines, but her daughter “always misses school the next day,” she told me. “I plan her shots for a Friday afternoon so she can lay out all Saturday.” Early on, when hardly anyone had immunity to the virus, signing everyone up for somewhat reactogenic shots was a no-brainer—especially given the hope that two doses would yield many, many years of protection. Now that we know it’s a repeated need, Neuzil said, “the equation changes a bit.”

    People aren’t totally helpless against side effects. Deepta Bhattacharya, an immunologist at the University of Arizona, had an “awful, terrible” experience with his second and third doses, which slammed him with 102- and 103-degree fevers, respectively. He weathered the side effects without intervention, worried that a painkiller would curb not just the agony, but also his protective immune response. This time, though, armed with new knowledge from his own lab that anti-inflammatory and pain-relieving drugs don’t blunt antibody levels, “the first sign I feel even the slightest bit shitty,” he told me, “I’m dosing up.”

    I’ll probably do the same for my spouse the next time he’s due for a vaccine of any kind … likely while I chill on the sidelines. Bhattacharya’s spouse, too, is kind of an immune introvert, a fact that he bemoans. “Her only side effect was she felt thirsty,” he said. “It’s just not fair.”

    Katherine J. Wu

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