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Tag: Vaccines

  • We Can Finally Do Something About the Third ‘Tripledemic’ Virus

    We Can Finally Do Something About the Third ‘Tripledemic’ Virus

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    Every fall, when the air turns chilly and the leaves red, pediatric ICUs begin preparing for the onslaught of the virus known as RSV. Not flu, not COVID, but RSV, or respiratory syncytial virus, is the No. 1 reason babies are hospitalized, year after year. Their tiny airways can become inflamed, and the sickest ones struggle to breathe. RSV is deadly on the other end of the age spectrum too, killing 6,000 to 10,000 elderly Americans every year.

    For decades though, there was no way to stop the virus’s seasonal tide. The quest for a vaccine always came up short. And then suddenly, the vaccines started working.

    This year, doctors have not just one but multiple new shots to prevent RSV. Three gained FDA approval in rapid succession in recent months: an antibody shot for infants called nirsevimab, a form of passive immunization for babies too young to get proper vaccines; a vaccine from Pfizer for both adults over 60 and pregnant mothers, who can pass the immunity on to their babies; and finally, a vaccine from GlaxoSmithKline also aimed at adults older than 60. Together, these herald a new era for RSV.

    That these three new RSV shots are coming out at once is no coincidence. They succeed where others failed because they all target a specific weak spot in the virus, first identified in 2013. This strategy of finding a virus’s most vulnerable points applies to other pathogens too, and experts say it can revolutionize the design of vaccines for other diseases. In fact, it was quietly used to make the COVID vaccines from Pfizer and Moderna. Scientists had originally perfected the idea with RSV, only to repurpose it for the COVID vaccine, which raced ahead, given the urgency of the pandemic. This year, though, the shots are coming for RSV.

    “We’re in a really good position, finally, after more than 65 years,” says Asunción Mejías, an infectious-diseases doctor at St. Jude Children’s Research Hospital.

    The first attempts to make an RSV vaccine began not long after the virus’s discovery, in 1956, but an early trial ended so catastrophically that it had a chilling effect for decades.

    It had started off with promise. The early vaccine was modeled after a successful one for polio, in which the virus is inactivated with a chemical called formalin. But when infants given the early RSV vaccine later caught the virus, a whopping 80 percent had to be hospitalized—compared with only 5 percent in the control group. Two of the babies died, their lungs ravaged. The vaccine did worse than offer no protection; it made the disease more severe. “It was such a disaster,” says Ann Falsey, an infectious-diseases doctor at the University of Rochester. Scientists spent years piecing together why—the vaccine riled up the wrong part of the immune system in very young babies—but they got no closer to making a vaccine that worked. The field was stuck.

    Then, in 2008, a serendipitous meeting led to an eventual breakthrough. A young, freshly minted Ph.D. named Jason McLellan, who studies the structure of proteins, began a new job at the National Institutes of Health to work on HIV vaccines. The lab he had joined, on the fourth floor, had run out of room, though, so he got put in another, on the second. There, he ran into Barney Graham, a virologist who had been trying to solve the puzzle of RSV since the 1980s. He convinced McLellan that this virus was worth a look too.

    By then, scientists had at least homed in on a plausible vaccine target. Much as COVID uses spike protein to infect cells, RSV uses a protein—called F for “fusion”—to physically fuse the virus particle to a human cell. F comes in two forms, though: an extremely unstable prefusion state and a far more stable postfusion state. And once it switches to the postfusion state—which can also happen spontaneously— “it can’t come back,” McLellan told me.

    When RSV vaccines are manufactured, all the F protein eventually switches to the postfusion state. But the antibodies against postfusion F weren’t very effective. McLellan soon figured out why. He found that extremely potent neutralizing antibodies bind to a specific site—the very tip of the prefusion F—that is lost when the protein rearranges into its postfusion form. With that, Graham told me, “you lose ten- to 1,000-fold potency.” An effective RSV vaccine would need to target the prefusion F.

    The team knew what to do, but had a practical dilemma: How to stabilize F in its prefusion form, so the team could put it in a vaccine? McLellan rejiggered the protein slightly, adding molecular “staples” and filling a hole in the protein structure. These changes froze F in its prefusion shape. When the team tested this version of the vaccine in mice, the results could not have been clearer. The vaccine induced the highest levels of neutralizing antibodies Graham had ever seen in his three decades of studying RSV. “This is it,” McLellan remembers thinking.

    Soon, pharmaceutical companies came calling, and the race was on. (The experts in this article—like nearly everyone who works on RSV vaccines—have all received research grants, consulted for, or worked in some other way with one or more of the companies developing shots for RSV.) Today, Pfizer’s and GlaxoSmithKline’s newly approved RSV vaccines target the prefusion F protein, as does nirsevimab, the antibody shot for infants from AstraZeneca and Sanofi. Both the vaccines and the antibody shot trigger immunity against RSV: Vaccines stimulate the immune system to make its own antibodies, and nirsevimab is a direct infusion of antibodies.

    Trials for all three shots were already under way when the coronavirus pandemic hit. But because RSV nearly disappeared during social distancing, the trials got delayed. Meanwhile, McLellan and Graham devised a similar molecular trick to stabilize COVID’s spike protein, which Pfizer and Moderna later used in their vaccines. (The stabilization wasn’t make-or-break for COVID, as it was for RSV, though—AstraZeneca’s COVID vaccine was effective despite not having this modification.) But unstable fusion proteins are found in many different classes of viruses beyond RSV. McLellan, now at the University of Texas at Austin, is working on shots against the prefusion structure of other stubborn viruses such as cytomegalovirus and Crimean-Congo hemorrhagic fever. (Graham is now a professor at Morehouse School of Medicine.) This approach—called structure-based vaccine design—could unlock new ways of targeting once-elusive viruses.

    For RSV, this fall and winter will be a test of how well the shots fare in the real world. As the adage goes, vaccines don’t save lives; vaccinations do. Falsey, the University of Rochester doctor, specializes in studying RSV in the elderly, and she worries that too few Americans over 60 will get the new vaccines this year. A CDC advisory panel decided that elderly Americans can get the vaccines through “shared clinical decision-making” with their doctors but did not go as far as to fully recommend vaccination, which would have triggered private insurers to cover the shots under the Affordable Care Act. Out of pocket, they can cost more than $300. The vaccine for pregnant women, meanwhile, has FDA approval, but the same CDC panel is voting today on whether to recommend it. The panel will likely scrutinize a possible link to premature births, which has shown up before with RSV vaccines.

    Nirsevimab, the antibody shot for infants, has gotten a full-throated endorsement, though, and it’s poised to have the biggest impact this season. It replaces an existing RSV-antibody shot called palivizumab, which is not widely used. Palivizumab targets a less potent site that is on both the pre- and postfusion F, and it needs to be administered up to five times a season (compared with once for nirsevimab), at a cost of some $1,500 a dose. For these reasons, it’s been reserved for the highest-risk babies, such as preemies with underdeveloped lungs. But most babies who end up hospitalized were healthy to begin with, says St. Jude’s Mejías, so the older shot didn’t put much of a dent in overall hospitalizations.

    Nirsevimab is meant to be more widely used: The shot is approved for all infants in their first RSV season. “It’s going to change the way we manage and treat RSV,” Mejías told me. It should be available for babies starting in October. And if all goes according to plan, pediatric ICUs could be a little quieter this winter.

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    Sarah Zhang

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  • Implant Offers Diabetes Control

    Implant Offers Diabetes Control

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    Newswise — CAMBRIDGE, MA — One promising approach to treating Type 1 diabetes is implanting pancreatic islet cells that can produce insulin when needed, which can free patients from giving themselves frequent insulin injections. However, one major obstacle to this approach is that once the cells are implanted, they eventually run out of oxygen and stop producing insulin.

    To overcome that hurdle, MIT engineers have designed a new implantable device that not only carries hundreds of thousands of insulin-producing islet cells, but also has its own on-board oxygen factory, which generates oxygen by splitting water vapor found in the body.

    The researchers showed that when implanted into diabetic mice, this device could keep the mice’s blood glucose levels stable for at least a month. The researchers now hope to create a larger version of the device, about the size of a stick of chewing gum, that could eventually be tested in people with Type 1 diabetes.

    “You can think of this as a living medical device that is made from human cells that secrete insulin, along with an electronic life support-system. We’re excited by the progress so far, and we really are optimistic that this technology could end up helping patients,” says Daniel Anderson, a professor in MIT’s Department of Chemical Engineering, a member of MIT’s Koch Institute for Integrative Cancer Research and Institute for Medical Engineering and Science (IMES), and the senior author of the study.

    While the researchers’ main focus is on diabetes treatment, they say that this kind of device could also be adapted to treat other diseases that require repeated delivery of therapeutic proteins.

    MIT Research Scientist Siddharth Krishnan is the lead author of the paper, which appears today in the Proceedings of the National Academy of Sciences. The research team also includes several other researchers from MIT, including Robert Langer, the David H. Koch Institute Professor at MIT and a member of the Koch Institute, as well as researchers from Boston Children’s Hospital.

    Replacing injections

    Most patients with Type 1 diabetes have to monitor their blood glucose levels carefully and inject themselves with insulin at least once a day. However, this process doesn’t replicate the body’s natural ability to control blood glucose levels.

    “The vast majority of diabetics that are insulin-dependent are injecting themselves with insulin, and doing their very best, but they do not have healthy blood sugar levels,” Anderson says. “If you look at their blood sugar levels, even for people that are very dedicated to being careful, they just can’t match what a living pancreas can do.”

    A better alternative would be to transplant cells that produce insulin whenever they detect surges in the patient’s blood glucose levels. Some diabetes patients have received transplanted islet cells from human cadavers, which can achieve long-term control of diabetes; however, these patients have to take immunosuppressive drugs to prevent their body from rejecting the implanted cells.

    More recently, researchers have shown similar success with islet cells derived from stem cells, but patients who receive those cells also need to take immunosuppressive drugs.

    Another possibility, which could prevent the need for immunosuppressive drugs, is to encapsulate the transplanted cells within a flexible device that protects the cells from the immune system. However, finding a reliable oxygen supply for these encapsulated cells has proven challenging.

    Some experimental devices, including one that has been tested in clinical trials, feature an oxygen chamber that can supply the cells, but this chamber needs to be reloaded periodically. Other researchers have developed implants that include chemical reagents that can generate oxygen, but these also run out eventually.

    The MIT team took a different approach that could potentially generate oxygen indefinitely, by splitting water. This is done using a proton-exchange membrane — a technology originally deployed to generate hydrogen in fuel cells — located within the device. This membrane can split water vapor (found abundantly in the body) into hydrogen, which diffuses harmlessly away, and oxygen, which goes into a storage chamber that feeds the islet cells through a thin, oxygen-permeable membrane.

    A significant advantage of this approach is that it does not require any wires or batteries. Splitting this water vapor requires a small voltage (about 2 volts), which is generated using a phenomenon known as resonant inductive coupling. A tuned magnetic coil located outside the body transmits power to a small, flexible antenna within the device, allowing for wireless power transfer. It does require an external coil, which the researchers anticipate could be worn as a patch on the patient’s skin.

    Drugs on demand

    After building their device, which is about the size of a U.S. quarter, the researchers tested it in diabetic mice. One group of mice received the device with the oxygen-generating, water-splitting membrane, while the other received a device that contained islet cells without any supplemental oxygen. The devices were implanted just under the skin, in mice with fully functional immune systems.

    The researchers found that mice implanted with the oxygen-generating device were able to maintain normal blood glucose levels, comparable to healthy animals. However, mice that received the nonoxygenated device became hyperglycemic (with elevated blood sugar) within about two weeks.

    Typically when any kind of medical device is implanted in the body, attack by the immune system leads to a buildup of scar tissue called fibrosis, which can reduce the devices’ effectiveness. This kind of scar tissue did form around the implants used in this study, but the device’s success in controlling blood glucose levels suggests that insulin was still able to diffuse out of the device, and glucose into it.

    This approach could also be used to deliver cells that produce other types of therapeutic proteins that need to be given over long periods of time. In this study, the researchers showed that the device could also keep alive cells that produce erythropoietin, a protein that stimulates red blood cell production.

    “We’re optimistic that it will be possible to make living medical devices that can reside in the body and produce drugs as needed,” Anderson says. “There are a variety of diseases where patients need to take proteins exogenously, sometimes very frequently. If we can replace the need for infusions every other week with a single implant that can act for a long time, I think that could really help a lot of patients.”

    The researchers now plan to adapt the device for testing in larger animals and eventually humans. For human use, they hope to develop an implant that would be about the size of a stick of chewing gum. They also plan to test whether the device can remain in the body for longer periods of time.

    “The materials we’ve used are inherently stable and long-lived, so I think that kind of long-term operation is within the realm of possibility, and that’s what we’re working on,” Krishnan says.

    “We are very excited about these findings, which we believe could provide a whole new way of someday treating diabetes and possibly other diseases,” Langer adds.

    ###

    The research was funded by JDRF, the Leona M. and Harry B. Helmsley Charitable Trust, and the National Institute of Biomedical Imaging and Bioengineering at the National Institutes of Health.

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    Massachusetts Institute of Technology (MIT)

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  • Medical Bioethics Expert Available – Philadelphia Lawmakers Vote to Prohibit Safe Injection Sites

    Medical Bioethics Expert Available – Philadelphia Lawmakers Vote to Prohibit Safe Injection Sites

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    What: According to The Philadelphia Inquirer, the Philadelphia City Council voted to prohibit supervised drug consumption sites across most of the city, greatly imperiling the future of such a facility if the legislation becomes law. 

    Peter Clark, S.J., PhD, director of the Institute of Clinical Bioethics at Saint Joseph’s University, has extensive knowledge of safe injection sites. In 2019, Father Clark published a constructive proposal for safe injection sites in the Internet Journal of Public Health, designed to prevent the deaths of thousands of Philadelphians vulnerable to opioid overdose.

    “By not implementing a safe injection site, we are choosing to stand by and watch as our neighbors, family members and future die due to overdose,” said Clark. 

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    Saint Joseph’s University

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  • 5 things to know about the new COVID-19 vaccine

    5 things to know about the new COVID-19 vaccine

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    It may be time to get your COVID-19 vaccine again.

    There’s a new booster that’s coming out to guard against the virus. The Centers for Disease Control and Prevention said Tuesday that it was recommending the vaccine, which is being produced in versions by Moderna
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    +3.18%
    and Pfizer
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    -0.20%
    -BioNTech
    BNTX,
    -2.06%    ,
    for people 6 months of age and older.

    Here are answers to some common questions about the shot — and what you may need to know before you receive it.

    Why are we seeing another booster?

    Boosters are all about maintaining protection against the virus as new COVID-19 variants emerge. The CDC said: “The updated vaccines should work well against currently circulating variants of COVID-19, including BA.2.86, and continue to be the best way to protect yourself against severe disease.” The CDC also noted that “protection from COVID-19 vaccines and infection decline over time. An updated COVID-19 vaccine provides enhanced protection against the variants currently responsible for most hospitalizations in the United States.”

    So, everyone who is 6 months or older should receive it?

    That’s the CDC’s recommendation, but not everyone sees this booster as a firm requirement, depending on various medical and other factors.

    Dr. Paul A. Offit, a pediatrician with the Children’s Hospital of Philadelphia who specializes in infectious diseases, told MarketWatch that the new vaccine is a must for some who are at higher risk for developing serious illness, such as people who are over 75, people who have certain health problems (including diabetes, obesity or chronic lung or heart disease) and people who are immune compromised.

    And what about the others? Offit said it can be a case of “low risk, low reward.” Meaning there’s little harm in getting the booster and it may buy “a few months protection against mild disease,” Offit said. But he stops short of saying the booster is an absolute necessity for such people.

    Still, CDC director Dr. Mandy K. Cohen counters such an argument. In a column for the New York Times, Cohen noted that all the members of her family, including her 9- and 11-year-old daughters, would be getting the booster. “Some viruses…change over time. This coronavirus is one of them. It finds ways to evade our immune systems by constantly evolving. That’s why our vaccines need to be updated to match the changed virus,” Cohen explained.

    What if you recently had COVID? Or have just gotten the previous COVID booster?

    Offit said you should wait at least two months — and possibly as long as four months — before receiving the new vaccine.

    The CDC said, “You should get a COVID-19 vaccine even if you already had COVID-19,” adding “you may consider delaying your next vaccine by 3 months from when your [COVID] symptoms started or, if you had no symptoms, when you received a positive test.”

    When and where can you get the new booster?

    The CDC said the vaccine “will be available by the end of this week at most places you would normally go to get your vaccines.”

    How much will it cost?

    The new shots are expected to have list prices of $110 to $130, but the CDC said, “Most Americans can still get a COVID-19 vaccine for free.” That is, most health-insurance plans will cover the cost.

    As for those without insurance, the CDC said there are still plenty of free options, including programs run by local health centers and health departments as well as pharmacies participating in the CDC’s Bridge Access Program. For more information about where to get the booster, go to Vaccines.gov.

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  • CDC recommends updated COVID shots for people 6 months of age and older

    CDC recommends updated COVID shots for people 6 months of age and older

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    The Centers for Disease Control and Prevention on Tuesday recommended updated COVID-19 vaccines for people 6 months of age and older.

    Director Mandy Cohen late Tuesday backed the findings of CDC advisers, who voted 13-to-1 for approval earlier in the day. The updated vaccines from Moderna Inc.
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    -0.53%
    and Pfizer Inc.
    PFE,
    +0.62%
    -BioNTech
    BNTX,
    -1.97%
    should become available later this week.

    “We have more tools than ever to prevent the worst outcomes from COVID-19,” Cohen said in a statement. “CDC is now recommending updated COVID-19 vaccination for everyone 6 months and older to better protect you and your loved ones.”

    The move comes just one day after the U.S. Food and Drug Administration approved the updated shots from Moderna and Pfizer. The FDA approved single-dose vaccines for people 12 and older and authorized emergency use of new shots for children as young as 6 months.

    The CDC recommendations Tuesday include some key changes from the recommendations that previously applied to the bivalent COVID vaccines. People age 65 and older were recommended to get a second bivalent dose, for example, but the CDC is not currently recommending two doses of the new shot for older adults. The CDC said it will monitor epidemiology and vaccine effectiveness to determine if additional doses are needed.

    The recommendations come as the vaccines are transitioning from federal procurement and distribution to the commercial market. The new shots are expected to have list prices of $110 to $130 per dose. But the Affordable Care Act requires insurers to cover most vaccines recommended by the CDC advisory committee at no cost to plan enrollees, and people with Medicare and Medicaid also have no-cost access to the vaccines. 

    The CDC meeting Tuesday addressed some concerns about the accessibility and cost of the vaccines for people without health-insurance coverage. The CDC’s new Bridge Access program will provide free shots to uninsured people within days at retail pharmacies as well as local health centers, the CDC said. The agency had previously said that the free shots might not arrive in retail pharmacies until mid-October. The federal government’s vaccines.gov website will be updated later this week to list Bridge Access program sites, the CDC said.

    Roughly 25 million to 30 million U.S. adults do not have health insurance. About 85% of people without coverage live within 5 miles of a Bridge Access program site, according to CDC data.

    Under the Bridge Access program, CVS Health Corp.
    CVS,
    +2.57%
    will administer doses in stores and Minute Clinics, the CDC said, and Walgreens Boots Alliance Inc.
    WBA,
    +1.35%
    will offer doses in stores and at off-site events that target areas of low access and uptake. Healthcare-services company eTrueNorth is also working with the program to reach lower-access areas without other coverage under the program, the CDC said.

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  • Mapping COVID-19 spike protein could improve vaccine design

    Mapping COVID-19 spike protein could improve vaccine design

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    Newswise — Although the COVID-19 pandemic was the first time most of humanity learned of the now infamous disease, the family of coronaviruses was first identified in the mid-1960s. In a new study, molecular biologist Steven Van Doren, a scientist in the University of Missouri College of Agriculture, Food and Natural Resources, has uncovered unexpected actions of a key player in how the coronavirus infects its target — a discovery that could guide further vaccine development.

    Funded by a National Science Foundation (NSF) grant, Van Doren and his team studied the fusion peptide, an important feature of the spike protein that serves to bind the virus with the human cell, an essential step in the course of infection. In this study, they found that the fusion peptide plays a more invasive role in fusing the virus to the cell than previously thought, which is significant in understanding how infection occurs.

    “The fusion peptide is the most preserved part of the whole viral spike,” said Van Doren, a professor of biochemistry. “Throughout the evolution of this virus, the fusion peptide endured despite all the mutations and variants that we kept on hearing about in the news. The fusion peptide never changed much and stayed a constant feature on the virus spike because it’s too critically important for infection for it to be modified.”

     

    The fusion peptide on the SARS-CoV-2 spike (pictured here) plays a key role in virus/cell attachment.

    This research is interesting to compare to a recent study that surveyed asymptomatic patients who were infected by the coronavirus because they had developed a defense mechanism known as broadly neutralizing antibodies. Van Doren’s research on the functionality of the fusion peptide’s ability to puncture a cell membrane could further inform why the fusion peptide may be an important target for vaccine development capable of fighting all types of coronavirus infections.

    Another potential application of this research could be to create a novel strategy to penetrate cells.

    “There may be many strategies for crossing membranes, but it’s conceivable that the fusion peptide work could help further development of more ways to cross cellular membranes, which could be useful to deliver therapeutics through cell membranes,” Van Doren said.

    Further, this research broadens understanding of protein insertion in membranes, which has broader relevance to the scientific community.

    “I love what protein molecules look like and what they can do,” Van Doren said. “I got fascinated by the science when I was still a teenager, and it’s intriguing to me the things they can do, so studying how proteins work has been something that has stuck with me for decades now — I’d say going on almost 40 years.”

    The study “SARS-CoV-2 Fusion Peptide Sculpting of a Membrane with Insertion of Charged and Polar Groups” was published in Structure. Co-investigators include Benjamin S. Scott and Rama K. Koppisetti.

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    University of Missouri, Columbia

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  • LJI scientists harness ‘helper’ T cells to treat tumors

    LJI scientists harness ‘helper’ T cells to treat tumors

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    Newswise — LA JOLLA, CA—Scientists are on the hunt for a unique set of mutations, called “neoantigens,” that let the immune system distinguish tumor cells from normal cells. Their goal is to help the immune system react to neoantigens and target tumor cells for destruction.

    This area of research has led to life-saving antibody therapeutics, such as immune checkpoint inhibitors, which rely on antibodies to help immune cells kill tumors. Unfortunately, antibody-based cancer immunotherapies don’t work for all patients.

    At La Jolla Institute for Immunology (LJI), Professor Stephen Schoenberger, Ph.D., and his colleagues are looking beyond antibodies. Schoenberger’s lab leads pioneering research into how the immune system’s CD4+ “helper” T cells detect neoantigens.

    Now Schoenberger and his colleagues have published a pair of studies that show how we might harness CD4+ T cells while boosting the cancer-fighting power of CD8+ “killer” T cells. In fact, the researchers demonstrate a new kind of vaccine design that recruits both types of T cells to destroy large tumors.

    “Therapeutic cancer vaccines can work,” says Schoenberger, who serves as a member of the LJI Center for Cancer Immunotherapy. “But they should leverage the natural synergy of CD4+ and CD8+ T cells.”

    Researchers help CD4+ T cells detect tumors

    As Schoenberger points out, CD4+ and CD8+ T cells already work together when fighting viruses and bacteria. “Why not learn from the immune system’s natural way of keeping us protected and turn that against cancer?” he says.

    In a paper published recently in Nature Immunology, Schoenberger worked closely with LJI Professor Bjoern Peters, Ph.D,. to demonstrate the essential role of CD4+ T cells in recognizing tumor cells. Their strategy depends on an innovative way to predict which tumor neoantigens will spark a strong CD4+ T cell response. 

    As Schoenberger explains, tumor cells arise from normal cells in the body. This means the body has a harder time recognizing tumor cells as dangerous. Other threats, such as viruses, tend to carry around very un-human looking peptide sequences. “With prompting from CD4+ T cells, immune cells called dendritic cells can capture these peptide sequences and show them to CD8+ T cells—sending the immune system into red alert. “CD8+ T cells execute the tumor,” says Schoenberger, “but they require the cooperation of CD4+ T cells to do so efficiently.”

    But tumor cells share most of their peptide sequences with normal cells, and are therefore harder for the immune system to “see.” To get around this problem, Schoenberger and Peters have devised computational tools to identify the genetic mutations and specific peptides that serve as neoantigens to distinguish tumor cells from their neighbors.

    The Nature Immunology study shows that CD4+ T cells that recognize a single target mutation can  drive a diverse CD8+ T cell response that eradicates large established tumors . The researchers tested T cells recognizing this target mutation for “avidity,” which is how strongly their antigen receptors bind to the neoantigen. Their surprising results showed that neoantigen-specific CD4+ T cells can mediate their effect across a range of affinities.

    “This is brand new because no one has ever studied the neoantigen-specific CD4+ repertoire at the level of T cell receptors,” says Schoenberger.

    The researchers also found that the most effective responses happened when the transferred CD4+ T cells were induced to develop into stem cell memory-like CD4+ T cells. This type of T cell are endowed with special properties of longevity and the ability to generate powerful effector cells. As Schoenberger’s research spans the lab to the clinic, these findings will be translated to clinical trials in the near future.

    New vaccine brings T cells together

    In a second study, published recently in the Journal of Clinical Investigation, Schoenberger and his colleagues showed how a new vaccine strategy can induce CD4+ T cells and CD8+ T cells to work together to destroy large, aggressive tumors in a mouse model.

    For the study, Schoenberger collaborated with Joseph Dolina, Ph.D., a senior scientist at Pfizer Inc., and former member of the Schoenberger Lab (Pfizer has no financial disclosures to this specific study).

    The team began with an aggressive squamous cell tumor that contained a low number of mutations, as many human cancers do. The researchers identified 270 mutations that make this tumor stand out from normal cells, and they performed in-depth studies on 39 of these mutations. They narrowed that group down to five mutations that were recognized by the natural anti-tumor T cell response—with some mutations targeted by CD4+ T cells and others by CD8+ T cells. Remarkably, only mutations targeted by both CD4+ and CD8+ T cells were capable of triggering protective or therapeutic responses against the tumor.

    “These neoantigens had to be physically linked to mediate therapy,” says Schoenberger. “We could make large tumors go away so long as the vaccine activated both CD4+ and CD8+ T cells via the same antigen-presenting cell.”

    Going forward, Schoenberger plans to work with his clinical colleagues at the UC San Diego Moores Cancer Center to study whether this type of linked vaccine is effective in human patients. He hopes a future clinical trial can give hope to patients with especially aggressive tumors.

    “The other message here is that we think we can greatly increase the number of patients who could benefit from checkpoint blockade immunotherapy if we combine it with a personalized cancer vaccine,” says Schoenberger.

    Additional authors of the Nature Immunology study, “Neoantigen-specific stem cell memory-like CD4+ T cells mediate CD8+ T cell-dependent immunotherapy of MHC class II-negative solid tumors,” include Spencer E. Brightman (first author), Angelica Becker, Rukman R. Thota, Martin S. Naradikian, Leila Chihab, Karla Soria Zavala, Ryan Q. Griswold, Joseph S. Dolina, Ezra E. W. Cohen and Aaron M. Miller.

    This study was supported by the National Institutes of Health (grant UO1 DE028227), the San Diego Center for Precision Immunotherapy, and the Sandor and Rebecca Shapery Family.

    Nature Immunology DOI: https://doi.org/10.1038/s41590-023-01543-9

    Additional authors of the Journal of Clinical Investigation study, “Linked CD4+/CD8+ T cell neoantigen vaccination overcomes immune checkpoint blockade resistance and enables tumor regression,” include Joey Lee, Spencer E. Brightman, Sara McArdle, Samantha M. Hall, Rukman R. Thota, Karla S. Zavala, Manasa Lanka, Ashmitaa Logandha Ramamoorthy Premlal, Jason A. Greenbaum, Ezra E.W. Cohen and Bjoern Peters.

    This study was supported by the National Institutes of Health (grants U01 DE028227, P30CA23100, S10 RR027366 and S10 OD016262), the San Diego Center for Precision Immunotherapy, and the Sandor and Rebecca Shapery Family.

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    La Jolla Institute for Immunology

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  • Digging deeper into how vaccines work against parasitic disease

    Digging deeper into how vaccines work against parasitic disease

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    Newswise — COLUMBUS, Ohio – Scientists have established the effectiveness of vaccines they developed to prevent the disfiguring skin disease leishmaniasis in animal studies, and Phase 1 human trial planning is in motion for the most promising candidate. 

    But in new work, the research team has determined how these vaccine candidates, created using mutated disease-causing parasites, prompt molecular-level changes in host cells that have specific roles in helping generate the immune response. 

    Despite using the same CRISPR gene-editing technique to make the vaccines, the two species of Leishmania parasites on which the vaccines are based produced very different effects in the immunized host: One enables the immune response to unfold by inhibiting a host metabolite that suppresses immune activity, and the other drives up activation of a chemical pathway in a way that primes immune cells to fight pathogens. 

    “I think it’s an important finding in the sense that we show that in the big picture, yes, these vaccines are protective, but at the molecular level the mechanisms can be totally distinct,” said Abhay Satoskar, professor of pathology in The Ohio State University College of Medicine and co-leader of the research team. 

    “This is not only conceptually important, but if you can find how these things are modulating the immune response in the right direction, and identify the pathways, then perhaps those pathways could be used for developing new interventions,” said Satoskar, a senior author of two new papers describing the findings. 

    The primary vaccine was made by editing the genome of Leishmania major, which causes cutaneous leishmaniasis in tropical and subtropical regions of the Eastern Hemisphere, and a backup vaccine was made using Leishmania mexicana, a more virulent species found in South, Central and North America. 

    The study findings on the metabolic effects of the L. major and L. mexicana vaccines were published Aug. 29, 2023, in the journal iScience. 

    Leishmaniasis is prevalent in 90 countries affecting about 12 million people globally at any given time, but no licensed human vaccine yet exists and the only drug treatment for the skin lesions requires weeks of daily injections with unpleasant side effects. The more lethal visceral leishmaniasis affects organs and is fatal if left untreated. 

    In developing these live attenuated vaccines, Satoskar and colleagues applied new technology to the century-old Middle Eastern practice of leishmanization – introducing the live parasite to the skin to create a small infection that, once healed, leads to life-long immunity against further disease. 

    The researchers previously reported using CRISPR to delete centrin, the gene for a protein that supports the parasite’s physical structure, from the genomes of both L. major and L. mexicana. Experiments showed vaccinated mice remained clear of skin lesions and the number of parasites at the infection site were held at bay. 

    Digging deeper into the vaccines’ effects in these new studies, researchers inoculated mouse ears with a normal parasite, a mutated parasite vaccine or a placebo, mimicking the bite of a sand fly – in humans and animals, leishmania is transmitted through the bite of infected sand flies. 

    The team used mass spectrometry at the inoculation site to identify the most prominent metabolites – the amino acids, vitamins and other small molecules produced as a result of metabolism, the many chemical reactions that keep the body functioning. 

    Results showed the L. major vaccine promoted a pro-inflammatory metabolic response in mice by using the amino acid tryptophan to block signals from a molecule that helps suppress immunity. The L. mexicana vaccine, on the other hand, enriched a series of metabolic reactions that activated the necessary pro-inflammatory work of front-line immune cells.  

    “We took an unbiased approach to analyze the metabolites detectable at the inoculation site. There is growing interest in understanding the role immune cell metabolism plays in modulating immune function,” said Satoskar, also a professor of microbiology at Ohio State. “We also learned that by removing the centrin gene, we got rid of the parasites’ ability to manipulate metabolic pathways in a way that would impair development of protective immunity and, in fact, promoted vaccine-induced immunity. That’s important to know for a live attenuated vaccine – there is a unique case for each parasite species.” 

    Though this information is not required for regulatory approval of these vaccines, the data could prove useful to supplementing vaccination. 

    “There are only four existing drugs for leishmaniasis,” Satoskar said. “We need to know the mechanism of vaccines so the knowledge can be used to develop newer vaccines or newer drugs that target these pathways. What you learn from immunomodulation can be used for developing other therapeutic agents.”

    This research was funded by the Global Health Innovative Technology Fund and the Center for Biologics Evaluation and Research within the Food and Drug Administration (FDA). The FDA is a co-owner of two U.S. patents associated with the mutated Leishmania species. 

    Co-authors of both papers include Sreenivas Gannavaram and Hira Nakhasi, who co-led the L. major study, and Nazli Azodi and Hannah Markle, all of the FDA; Greta Volpedo of Ohio State; Timur Oljuskin of the USDA Animal Parasitic Diseases Laboratory; Shinjiro Hamano of Nagasaki University; and Greg Matlashewski of McGill University. Thalia Pacheco-Fernandez of Ohio State co-authored the L. mexicana paper and Parna Bhattacharya of FDA co-authored the L. major paper.

     

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  • New coronavirus variant has experts on alert and WHO is urging countries to step up COVID surveillance

    New coronavirus variant has experts on alert and WHO is urging countries to step up COVID surveillance

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    A new variant of the SARS-CoV-2 coronavirus has put epidemiologists around the world on alert, and the World Health Organization is asking countries to sustain early warning, surveillance and reporting systems as it works to evaluate the current COVID-19 risk level.

    The BA.2.86 variant, which was first detected in Israel, was designated a new variant under monitoring by the WHO on Aug. 17, after the agency received nine sequences from five countries — three in the WHO’s European Region, one in the African Region and one in the Region of the Americas.

    The variant has more than 30 mutations in the spike protein compared with the XBB variants that are currently dominant in the U.S. and around the world, namely XBB.1.16 and EG.5, which has been dubbed Eris, following the Greek-alphabet designation used for other variants.

    The WHO made EG.5 a variant of interest, or VOI, earlier this month, which is an upgrade from the designation of variant under monitoring, or VUM.

    But BA.2.86 is worrying experts because there is too little data to assess its potential impact.

    “It is crucial to sustain early warning, surveillance and reporting, variant
    tracking, early clinical care provision, administration of vaccine boosters to high-risk groups, improvements in ventilation, and regular communication,” the agency said in its latest weekly update.

    That update, which reviews the state of the virus for the 28-day period through Aug. 20, contains no data from the WHO’s Region of the Americas, as reports for the period were incomplete. That’s a worry that the WHO has consistently warned about as countries pull back on their monitoring of the illness as they seek to put the pandemic behind them.

    The WHO officially declared the emergency phase of the pandemic to be over on May 5 but emphasized that COVID remains a major threat. Many countries have dismantled much of their systems of oversight and greatly reduced testing and data measurement.

    See also: New ‘Eris’ COVID variant is dominant in the U.S., but a shortage of data is making it hard to track

    The U.S. Centers for Disease Control and Prevention offered an update this week on BA.2.86 — which it said has been detected in Denmark, South Africa, Israel, the U.S. and the U.K. — and said the multiple locations are a sign of international transmission. The CDC acknowledged the surveillance challenge.

    “Notably, the amount of genomic sequencing of SARS-CoV-2 globally has declined substantially from previous years, meaning more variants may emerge and spread undetected for longer periods of time,” the U.S. agency said in its update.

    The CDC also noted a current increase in hospitalizations in the U.S., although it said that’s not likely driven by the BA.2.86 variant.

    “It is too soon to know whether this variant might cause more severe illness compared with previous variants,” said the CDC.

    Perhaps the bigger issue is whether the new variant has greater escape from existing immunity from vaccines and previous infections, compared with other recent variants.

    “One analysis of mutations suggests the difference may be as large as or greater than that between BA.2 and XBB.1.5, which circulated nearly a year apart,” the CDC said. “However, virus samples are not yet broadly available for more reliable laboratory testing of antibodies, and it is too soon to know the real-world impacts on immunity.”

    Americans gearing up for what’s expected to be an annual COVID vaccine booster this fall can be confident those vaccines will be designed to protect against all subvariants of XBB, including Eris, the agency said.

    The CDC said it’s likely that antibodies built up in the population through infection, vaccination or both will provide protection against BA.2.86. However, it said, “this is an area of ongoing scientific investigation.”

    Eric Topol, the chair of innovative medicine at Scripps Research in La Jolla, Calif., said the ability to neutralize the virus depends on the levels of neutralizing antibodies, and those are bound to be lower against BA.2.86 than earlier variants that people have been exposed to or immunized against.

    “Also to note, the burden of new mutations for BA.2.86 is not confined to the spike and is seen broadly across other components of the virus,” he wrote in commentary this week. “If BA.2.86 takes off, it will be a real test of how good our T-cell response can rev up to meet the challenge.”

    Meanwhile, the CDC’s weekly projections for where Eris and other variants are circulating continue to be hampered by a shortage of data. In early August, the CDC said it would unable to  publish its “Nowcast” projections because it did not have enough sequences to update the estimates.

    “Because Nowcast is modeled data, we need a certain number of sequences to accurately predict proportions in the present,” CDC representative Kathleen Conley told MarketWatch at the time.

    The agency had received data from just three U.S. regions. In its most recent weekly update for the week through Aug. 19, it also got data from just three regions.

    Separately, the CDC reported a 21.6% increase in U.S. hospitalizations for COVID in the week through Aug. 12. Deaths rose 21.4% in the week through Aug. 19.

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  • Study Shows Technology Boosts Public Health Programs

    Study Shows Technology Boosts Public Health Programs

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    Newswise — An examination of the SCALE-UP Counts program was recently published in the journal Pediatrics. This analysis, led by Yelena Wu, PhD, investigator at Huntsman Cancer Institute and associate professor in the department of dermatology at the University of Utah (the U), and David Wetter, PhD, MS, investigator at Huntsman Cancer Institute and professor in the department of population health sciences at the U, received support from RADx-Underserved Populations (RADx-UP) and funding from the National Institute of Health (NIH).

    The SCALE-UP Counts program was designed to promote COVID-19 testing through collaboration with local schools, especially those who serve historically marginalized populations. This was done using two-way texting, meaning that staff, parents, or guardians could respond. Scale Up COUNTS sought to make it easier for schools to have access to COVID-19 testing and provided guidance to families and staff on when to test.

    Wu’s research is typically focused on cancer prevention in children, teens, and young adults. However, during the pandemic, along with Wetter, Adam Hersh, MD, PhD, Guilherme Del Fiol, MD, PhD, Kim Kaphingst, ScD, Jonathan Chipman, PhD, and Ben Haaland, PhD, she used her expertise to advise local K-12 schools on COVID-19 testing policies and logistics.

    Tammy Stump, PhD, visiting instructor at Huntsman Cancer Institute, helped lead a special article, which described initial findings from the Scale Up COUNTS study. Results from the analysis of the SCALE-UP Counts program, and the accompanying piece led by Stump, show that texting can increase participation in public health programs.

    “Text messaging and health navigation are feasible ways to reach staff in K-12 schools to provide health screening messages,” says Stump. “We found that 99% of staff had a valid cell phone number for the program, and fewer than 4% chose to opt out of the program. At the time of these analyses, four months after the program started, 19% of staff had engaged with the SCALE-UP Counts system in some way.”

    These results not only show that the program helped schools and families navigate the pandemic, but can help researchers understand how to increase participation in cancer prevention, screening, and education initiatives in the future.

    “We wanted to see if the use of readily available technology increased the participation of the public in health programs,” says Wu. “COVID-19 was a unique opportunity to test this while providing what we thought was an important service to our communities in Utah.”

    Wu’s team will continue to evaluate the reach and engagement of the SCALE-UP program, as well as the cost-effectiveness of using texting to communicate health information to large groups of people.

    “Text messaging seems to be an effective, and low-resource opportunity to meet people where they are at,” says Stump. “This is important when looking into how we can make public health initiatives more accessible.”

    In addition to funding from ABC Science Collaborative, and RAD-x UP, this study was supported by the NCI including P30 CA042014 and Huntsman Cancer Foundation.

    About Huntsman Cancer Institute at the University of Utah

    Huntsman Cancer Institute at the University of Utah (the U) is the official cancer center of Utah and the only National Cancer Institute-designated Comprehensive Cancer Center in the Mountain West. The institute is leading the world in scientific discovery, and turning it into unsurpassed cancer care, transforming hope into a reality. Huntsman Cancer Institute focuses on delivering a cancer-free frontier to Utah, Idaho, Montana, Nevada, and Wyoming (The Area We Serve). Huntsman Cancer Institute is home to over 300 clinical trials, with over 237 research teams studying cancer at any given time and more genes for inherited cancers have been discovered at Huntsman Cancer Institute than at any other cancer center. Huntsman Cancer Institute’s scientists are world renown for understanding how cancer begins and using that knowledge to develop innovative approaches to treat each patient’s unique tumor. Huntsman Cancer Institute was founded by Jon M. and Karen Huntsman.

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  • COVID-19, Flu and RSV vaccines — what you need to know

    COVID-19, Flu and RSV vaccines — what you need to know

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    LOS ANGELES — Over the last few years, the nation has been through multiple rounds of COVID-19 vaccinations. This fall, the COVID-19 vaccine will be offered annually. The flu shot will also be recommended, as well as a newly approved vaccine for respiratory syncytial virus (RSV), a virus that is especially harmful to infants and older adults.  

    What can we expect from the vaccines, how important are they and can you get them at the same time? Keck Medicine of USC experts have the answers. 

     

    How COVID-19 vaccinations are changing this fall  

    The updated COVID-19 vaccine is designed as a single annual dose that will target the Omicron subvariant XBB.1.5, which is responsible for the majority of cases today. This formula should also offer protection against the new XBB substrains that have recently emerged. The vaccine will be offered by Pfizer, Moderna and a newcomer, Novavax. 

    We are still awaiting final approval and recommendations for the vaccine from the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). At that time, health officials will also make recommendations about who is eligible for the vaccine. 

    The U.S. Government COVID-19 Vaccine Distribution Program, which provided free vaccinations, will end. However, insurance should pick up the cost for COVID-19 vaccines, and for those uninsured or underinsured, the CDC is launching the Bridge Access Program for COVID-19 vaccines. The CDC will partner with state and local programs to provide and distribute the free vaccines.  

    — Edward Jones-Lopez, MD, MS, is an infectious disease expert with Keck Medicine of USC. He is available for interviews in English and Spanish.  

     

    Why COVID-19 vaccines are still needed  

    Research shows about 75% of Americans have retained at least some immunity from a prior infection of the virus. However, immunity fades over time and the individual risk of getting COVID-19, despite some immunity, is varied and inconsistent. The protection offered by vaccines also fades over time.  

    Despite advances in treating COVID-19, it still can be a difficult and deadly disease that can lead to hospitalization, long-term symptoms or death. The side effects of the vaccine have proven to be minimal, so it is recommended that everyone who is eligible gets vaccinated, especially as we are coming off a summer surge and there may be future outbreaks over the holidays.  

    If you have any concerns about the vaccine due to a health condition, consult your health care provider. Additionally, while most people can wait until the new COVID-19 vaccine is released rather than getting the still-available 2022 vaccine, if you feel your health requires a vaccination now, you should also talk to your health care provider.  

    — Earl Strum, MD, is the medical director of Employee Health Services for Keck Medicine of USC and clinical professor of population and public health science with the Keck School of Medicine of USC.  

     

    Timing your vaccines safely and effectively

    It is recommended that everyone six months or older be vaccinated against influenza every year. The best time to get the flu shot is September or October, so you will be inoculated in plenty of time before the high-flu season of the holidays. 

    It is safe to get the flu shot at the same time as your COVID-19 vaccine. For some people, one or both vaccines may result in mild flu-like symptoms that should pass within a few days. For those concerned about soreness at the site of the jab, consider getting one shot in one arm and one in the other arm to avoid overtaxing one limb. Also, if a local reaction does occur, you will know which vaccine was responsible. If not insured, you can find a free flu shot at a local health clinic, pharmacy or even grocery store.  

    RSV is a highly contagious virus that causes infections of the lungs and breathing passages, particularly among the young and old. The CDC recommends adults 60 years and older receive a single dose of the RSV vaccine in consultation with their health care provider. Additionally, the FDA just approved the RSV vaccine for use in pregnant individuals to protect infants from the virus.  

    Clinical trials have shown that there are minimal side effects of the vaccine, and any mild symptoms far offset the possible serious complications RSV can cause. Talk to your health care provider should you have any questions or concerns about this new vaccine, including payment/insurance options.  

    While co-administration of the RSV vaccine with other vaccines is in accordance with general best practice guidelines for immunization, recommendations have not yet been made whether or not this vaccine should be taken at the same time as the COVID-19 and flu vaccines.  

    — Krist Azizian, PharmD, MHA, is the chief pharmacy officer for Keck Medicine of USC. 

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     For more information about Keck Medicine of USC, please visit news.KeckMedicine.org.  

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  • Scientists Develop Efficient Spray Technique for Bioactive Materials

    Scientists Develop Efficient Spray Technique for Bioactive Materials

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    BYLINE: Kitta MacPherson

    Newswise — Rutgers scientists have devised a highly accurate method for creating coatings of biologically active materials for a variety of medical products. Such a technique could pave the way for a new era of transdermal medication, including shot-free vaccinations, the researchers said.

    Writing in Nature Communications, researchers described a new approach to electrospray deposition, an industrial spray-coating process. Essentially, Rutgers scientists developed a way to better control the target region within a spray zone as well as the electrical properties of microscopic particles that are being deposited. The greater command of those two properties means that more of the spray is likely to hit its microscopic target.

    In electrospray deposition, manufacturers apply a high voltage to a flowing liquid, such as a biopharmaceutical, converting it into fine particles. Each of those droplets evaporates as it travels to a target area, depositing a solid precipitate from the original solution.

    “While many people think of electrospray deposition as an efficient method, applying it normally does not work for targets that are smaller than the spray, such as the microneedle arrays in transdermal patches,” said Jonathan Singer, an associate professor in the Department of Mechanical and Aerospace Engineering in the Rutgers School of Engineering and an author on the study. “Present methods only achieve about 40 percent efficiency. However, through advanced engineering techniques we’ve developed, we can achieve efficiencies statistically indistinguishable from 100 percent.”

    Coatings are increasingly critical for a variety of medical applications. They are used on medical devices implanted into the body, such as stents, defibrillators and pacemakers. And they are beginning to be used more frequently in new products employing biologicals, such as transdermal patches.

    Advanced biological or “bioactive” materials – such as drugs and vaccines – can be costly to produce, especially if any of the material is wasted, which can greatly limit whether a patient can receive a given treatment.

    “We were looking to evaluate if electrospray deposition, which is a well-established method for analytical chemistry, could be made into an efficient approach to create biomedically active coatings,” Singer said.

    Higher efficiencies could be the key to making electrospray deposition more appealing for the manufacture of medical devices using bioactive materials, researchers said.

    “Being able to deposit with 100 percent efficiency means none of the material would be wasted, allowing devices or vaccines to be coated in this way,” said Sarah Park, a doctoral student in the Department of Materials Science and Engineering who is first author on the paper. “We anticipate that future work will expand the range of compatible materials and the material delivery rate of this high‐efficiency approach.”

    In addition, unlike other coating techniques used in manufacturing, such as dip coating and inkjet printing, the new electrospray deposition technique is characterized as “far field,” meaning that it doesn’t need highly accurate positioning of the spray source, the researchers said. As a result, the equipment necessary to employ the technique for mass manufacturing would be more affordable and easier to design.

    Other Rutgers scientists on the study included professors Jerry Shan and Hao Lin, former doctoral students Lin Lei (now at Chongqing Jiaotong University) and Emran Lallow (now at GeneOne Life Science, Inc.), and former undergraduate student Darrel D’Souza, all of the Department of Mechanical and Aerospace Engineering; and professors David Shreiber and Jeffrey Zahn, doctoral student Maria Atzampou, and former doctoral student Emily DiMartini, all of the Department of Biomedical Engineering. This work was supported by GeneOne Life Science, Inc.

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    Rutgers University-New Brunswick

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  • When Naomi Klein Realized People Regularly Confused Her With Naomi Wolf, She Went Down a Rabbit Hole

    When Naomi Klein Realized People Regularly Confused Her With Naomi Wolf, She Went Down a Rabbit Hole

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    “That’s you,” I tell Smoke in my most reassuring voice, but she always forgets. And this is the catch-22 of confronting your doppelganger: Bark all you want, but you inevitably end up confronting yourself.

    My commitment to non-involvement began to weaken during COVID, when the stakes of getting confused with Other Naomi rose markedly. Several months into the pandemic, Wolf emerged not as a scattershot peddler of conspiratorial speculation but as one of the most outspoken opponents of almost every anti-COVID public health measure, from masks to vaccines to vaccine-verification apps, which she equated with fascism while wantonly drawing comparisons with Nazi Germany. An NPR investigation found that Wolf was a primary spreader of the theory that vaccinated people shed dangerous particles onto unvaccinated people, possibly compromising their fertility, a theory that led a Florida private school to ban vaccinated teachers from the classroom.

    Mocked and deplatformed in liberal circles, she quickly became a full-fledged crossover star on the MAGA right, appearing regularly (sometimes daily) on Stephen Bannon’s podcast War Room, as well as on Tucker Carlson’s now canceled show on Fox News—that is, when she wasn’t testifying for Republicans (or attempting to) in statehouses or posting photos of her new firearm. A “biofascist” coup d’état was taking place under cover of mask mandates and vaccine-verification apps, she warned, and her new fans ate it up.

    Meanwhile, my doppelganger troubles escalated. No longer was it a periodic annoyance every few months. When I went online to try to find some simulation of the friendships and communities I missed during those achingly isolated months, I would invariably find, instead, The Confusion: a torrent of people discussing me and what I’d said and what I’d done—only it wasn’t me. It was her.

    And look, it was confusing, and also, in a gallows way, funny, even to me. We are both Naomis with a skepticism of elite power. We even had some of the same targets. I, for instance, was furious when Bill Gates sided with the drug companies as they defended their patents on lifesaving COVID vaccines, using the World Trade Organization’s insidious intellectual property agreement as a weapon, despite the fact that vaccine development was lavishly subsidized with public money, and that this lobbying helped keep the shots out of the arms of millions of the poorest people on the planet. Wolf was furious that people were being pushed to get vaccinated at all and boosted conspiracies about Gates using vaccine apps to track people and to usher in a sinister world order. To stressed-out, busy people inundated with thumbnail-size names and avatars, we’re just a blur of Naomis with highlights going on about Bill Gates.

    Again and again, she was saying things that sounded a little like the argument I made in The Shock Doctrine but refracted through a funhouse mirror of plots and conspiracies based almost exclusively on a series of hunches. I felt like she had taken my ideas, fed them into a bonkers blender, and then shared the thought purée with Carlson, who nodded vehemently. All the while, Wolf’s followers hounded me about why I had sold out to the “globalists” and was duping the public into believing that masks, vaccines, and restrictions on indoor gatherings were legitimate public health measures amid mass death. “I think she’s been got at!” @RickyBaby321 said of me, telling Wolf, “I have relegated Naomi Klein to the position of being: ‘The Other Naomi’!” It’s a vertiginous thing to be harangued on social media about your alleged misunderstanding of your own ideas—while being told that another Naomi is a better version of you than you are.

    Doppelganger comes from German, combining doppel (double) with gänger (goer). Sometimes it’s translated as “double-walker,” and I can tell you that having a double walking around is profoundly uncanny, the feeling Sigmund Freud described as “that species of the frightening that goes back to what was once well known and had long been familiar”—but is suddenly alien. The uncanniness provoked by doppelgangers is particularly acute because the thing that becomes unfamiliar is you. A person who has a doppelganger, Freud wrote, “may identify himself with another and so become unsure of his true self.” He wasn’t right about everything, but he was right about that.

    My first response to Other Naomi’s COVID antics was horror and a little rage: Surely now I needed to fight back in earnest, scream from my screen that she is not me. After all, lives were being lost to the kind of industrial-scale medical misinformation she was doing so much to help spread. Surely it was time to get serious about defending the boundaries of my identity.

    But then something happened that I didn’t expect. I stopped being so horrified and got interested. Interested in what it means to have a doppelganger. Interested in the conspiratorial world in which Other Naomi was now so prominent, a place that often felt like a doppelganger of the world where I live. Why were so many people drawn to fantastical theories? What needs were they fulfilling? And what would their proponents do next?

    In the hopes of picking up a few pointers on how others had handled their double trouble, I began reading and watching everything I could find about doppelgangers, from Carl Jung to Ursula K. Le Guin; Fyodor Dostoyevsky to Jordan Peele. The figure of the double began to fascinate me—its meaning in ancient mythology and in the birth of psychoanalysis. The way the twinned self stands in for our highest aspiration—the eternal soul, that ephemeral being that supposedly outlives the body. And the way the double also represents the most repressed, depraved, and rejected parts of ourselves that we cannot bear to see—the evil twin, the shadow self, the anti-self, the Hyde to our Jekyll. The doppelganger as warning or harbinger: Pay attention, they tell us.

    From these stories, I quickly learned that my identity crisis was likely unavoidable: The appearance of one’s doppelganger is almost always chaotic, stressful, and paranoia-inducing, and the person encountering their double is invariably pushed to their limits by the frustration and uncanniness of it all.

    Confrontations with our doppelgangers raise existentially destabilizing questions. Am I who I think I am, or am I who others perceive me to be? And if enough others start seeing someone else as me, who am I, then? Actual doppelgangers are not the only way we can lose control over ourselves, of course. The carefully constructed self can be undone in any number of ways and in an instant—by a disabling accident, by a psychotic break, or, these days, by a hacked account or deepfake. This is the perennial appeal of doppelgangers in novels and films: The idea that two strangers can be indistinguishable from each other taps into the precariousness at the core of identity—the painful truth that, no matter how deliberately we tend to our personal lives and public personas, the person we think we are is fundamentally vulnerable to forces outside of our control.

    In the age of artificial intelligence, many of us are feeling this particularly acutely now, which may be why twins and doppelgangers and multiverses seem suddenly ubiquitous in the culture, from Everything Everywhere All at Once to the remake of Dead Ringers. When machines can generate the voice and the style of any person, living or dead, do any of us control ourselves?

    “How many of everybody is there going to be?” asks a character in Jordan Peele’s 2019 doppelganger movie, Us.

    Answer: a lot.

    If doppelganger literature and mythology is any guide, when confronted with the appearance of one’s double, a person is duty bound to go on a journey—a quest to understand what messages, secrets, and forebodings are being offered. So that is what I have done. Rather than push my doppelganger away, I have attempted to learn everything I can about her and the movements of which she is a part. I burrowed deeper and deeper into a warren of conspiracy rabbit holes, places where it often seems that my own research has gone through the looking glass and is now gazing back at me as a network of fantastical plots that cast the very real crises we face—from COVID to climate change to Russian military aggression—as false flag attacks, planted by the Chinese Communists/corporate globalists/Jews.

    As I went, I found myself confronting yet more forms of doubling and doppelganging, these ones distinctly more consequential. Like the way that all of politics increasingly feels like a mirror world, with society split in two and each side defining itself against the other—whatever one says and believes, the other seems obliged to say and believe the exact opposite. The deeper I went, the more I noticed this phenomenon all around me: individuals not guided by legible principles or beliefs, but acting as members of groups playing yin to the other’s yang—well versus weak; awake versus sheep; righteous versus depraved. Binaries where thinking once lived.

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    Naomi Klein

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  • Top review says COVID lockdowns and masks worked, period

    Top review says COVID lockdowns and masks worked, period

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    Speedy implementation of a combination of measures such as face masks, lockdowns and international border controls, “unequivocally” reduced COVID-19 infections, a major review has shown.

    The report published Thursday by the Royal Society looked at findings from six evidence reviews that analyzed thousands of studies to assess the effect of masks, social distancing and lockdowns, test trace and isolate systems, border controls, environmental controls and communications. It found evidence that each of these measures — which are called “non-pharmaceutical interventions” — were effective, albeit to varying degrees, when looked at individually. However, the evidence in favor of using these tools was stronger when countries combined several measures.

    The report could have significant implications for decision-making in future outbreaks, with Mark Walport, chair of the report’s expert working group and foreign secretary of the Royal Society, saying that “having protocols in advance is really important.” He said what policymakers should take from the research is “there is evidence that non-pharmaceutical interventions are effective, but … they have to be applied as packages, and they have to be applied as early as possible.”

    The most effective measure, according to the review, was one of the most controversial — restrictions on movement and social interactions through lockdowns, distancing and rules around the size of gatherings. These were repeatedly found to be associated with a “significant reduction” in transmission of the virus, with the more stringent the measure, the greater the effect.

    For masks, 75 studies were assessed, with 63 of these finding positive effects. Unlike the January Cochrane review, which only looked at randomized controlled trials, this review also included observational studies. The Cochrane review was unable to find conclusive evidence that masks helped stop respiratory viruses. 

    Chris Dye, professor of epidemiology at the University of Oxford, who led the review on masks for the Royal Society, said if they had only looked at randomized controlled trials they would have come to the same conclusion as the Cochrane review. But the researchers behind the paper released Thursday chose to analyze a larger body of studies and found strong evidence that masks work. 

    A key finding from the research was these type of measures were most effective when implemented early on. Dye said that while there is a 100-day mission to develop drugs, therapeutics, vaccines and diagnostics for a future pandemic, “it would be marvelous” if there were a 100-day vision for non-pharmaceutical interventions. He said this would mean countries could “put in place the necessary mechanisms for preparedness, which would be to implement [non-pharmaceutical interventions] when some unknown new pathogen comes along.”

    While a future pandemic could be transmitted sexually or gastrointestinally, Salim Abdool Karim, a member of the working group on the report and pro-vice-chancellor for research at the University of KwaZulu-Natal, said the biggest concern was a respiratory virus. “The lessons of SARS-CoV-2 have to feature in our thinking as we prepare for a next pandemic that would be a respiratory virus of which we’ve got no prior exposure and so we don’t have a pre-existing immunity. The lessons of this report are going to feature strongly in anyone’s deliberations,” he said.

    However, responding to the report, Kevin McConway, emeritus professor of applied statistics at the Open University cautioned that impact on virus transmission is not the only factor that should be taken into account when deciding to use such measures. “The report does point out explicitly that NPIs can impose a great number of costs and burdens, in terms social and economic impacts, and indeed of increasing ill health … but makes it very explicit that this piece of work isn’t going to consider any of that.” “I think that limits quite severely its effectiveness in helping decisions on what should be done in the next pandemic, whenever it arises.”

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  • Extroverts More Likely to Resist Vaccines, Study Shows

    Extroverts More Likely to Resist Vaccines, Study Shows

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    Newswise — EL PASO, Texas (Aug. 2, 2023) – Which types of personalities were more hesitant about COVID-19 vaccination during the pandemic’s peak? Extroverts — according to a new study on more than 40,000 Canadians.

    “We expected that people who were especially high in extroversion would be more likely to get the vaccine,” said Melissa Baker, Ph.D., lead author and assistant professor at The University of Texas at El Paso. “We figured those people would want to get back out in the world and socialize, right? It’s actually the opposite.”

    The findings, published in the journal Frontiers in Psychology, can help with future public health messaging and vaccination campaigns, according to the team of scientists, based at UTEP and the University of Toronto. It also offers a unique perspective in vaccine hesitancy research, a field that has largely focused on political affiliation.

    “We wanted to look at vaccine hesitancy a different way,” said Baker who is a member of the Department of Political Science and Public Administration. “Of course, politics can help explain some of it, but there are personal differences between people, too — and that led us to this personality aspect.”

    The study is based on surveys of more than 40,000 Canadian adults, taken between November 2020 and July 2021. Online questions evaluated each participant’s personality, based on a model known as “big five,” which gauges an individual’s openness, conscientiousness, extraversion, agreeableness and emotional stability. 

    Additional questions probed how respondents felt about vaccination. One question, for example, asked, “When a COVID-19 vaccine becomes available, will you be vaccinated?” As the vaccine rollout began, questions were altered to reflect their availability.

    Most of the team’s hypotheses were supported. For instance, people who were more open and agreeable were more likely to get the vaccine.

    “Those are the kind of people who are open to new things, new information and just like to go with the flow,” Baker said. “We also expected that for people with high conscientious because they are detail-oriented and big planners.”

    On the other hand, those with low emotional stability — or those who experience extreme emotions — were less likely to be vaccinated. And extroverts, to their surprise, were 18 percent more likely to refuse the vaccine.

    While the pandemic is over, the team said the findings could help with future public health messaging strategies for vaccination from various diseases, not just COVID-19.

    Baker explained, “If we know you need to reach a certain type of personality, we can think about the message that will actually reach and persuade that person.

    ###

     About The University of Texas at El Paso 

    The University of Texas at El Paso is America’s leading Hispanic-serving University. Located at the westernmost tip of Texas, where three states and two countries converge along the Rio Grande, 84% of our 24,000 students are Hispanic, and half are the first in their families to go to college. UTEP offers 169 bachelor’s, master’s, and doctoral degree programs at the only open-access, top-tier research university in America.

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  • New algorithm may fuel vaccine development

    New algorithm may fuel vaccine development

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    Newswise — LA JOLLA, CA—Immune system researchers have designed a computational tool to boost pandemic preparedness. Scientists can use this new algorithm to compare data from vastly different experiments and better predict how individuals may respond to disease.

    “We’re trying to understand how individuals fight off different viruses, but the beauty of our method is you can apply it generally in other biological settings, such as comparisons of different drugs or different cancer cell lines,” says Tal Einav, Ph.D., Assistant Professor at La Jolla Institute for Immunology (LJI) and co-leader of the new study in Cell Reports Methods.

    This work addresses a major challenge in medical research. Laboratories that study infectious disease—even laboratories focused on the same viruses—collect wildly different kinds of data. “Each dataset becomes its own independent island,” says Einav.

    Some researchers might study animal models, others might study human patients. Some labs focus on children, others collect samples from immunocompromised senior citizens. Location matters too. Cells collected from patients in Australia might react differently to a virus compared with cells collected from a patient group in Germany, just based on past viral exposures in those regions.

    “There’s an added level of complexity in biology. Viruses are always evolving, and that changes the data too,” says Einav. “And even if two labs looked at the same patients in the same year, they might have run slightly different tests.”

    Working closely with Rong Ma, Ph.D., a postdoctoral scholar at Stanford University, Einav set out to develop an algorithm to help compare large datasets. His inspiration came from his background in physics, a discipline where—no matter how innovative an experiment is—scientists can be confident that the data will fit within the known laws of physics. E will always equal mc2.

    “What I like to do as a physicist is collect everything together and figure out the unifying principles,” says Einav.

    The new computational method doesn’t need to know precisely where or how each dataset was acquired. Instead, Einav and Ma harnessed machine learning to determine which datasets follow the same underlying patterns. 

    “You don’t have to tell me that some data came from children or adults or teenagers. We just ask the machine ‘how similar are the data to each other,’ and then we combine the similar datasets into a superset that trains even better algorithms,” says Einav. Over time, these comparisons could reveal consistent principles in immune responses—patterns that are hard to detect across the many scattered datasets that abound in immunology. 

    For example, researchers could design better vaccines by figuring out exactly how human antibodies target viral proteins. This is where biology gets really complicated again. The problem is that humans can make around one quintillion unique antibodies. Meanwhile a single viral protein can have more variations than there are atoms in the universe. 

    “That’s why people are collecting bigger and bigger data sets to try and explore biology’s nearly infinite playground,” says Einav. 

    But scientists don’t have infinite time, so they need ways to predict the vast reaches of data they can’t realistically collect. Already, Einav and Ma have shown that their new computational method can help scientists fill in these gaps. They demonstrate that their method to compare large datasets can reveal myriad new rules of immunology, and these rules can then be applied to other datasets to predict what missing data should look like.

    The new method is also thorough enough to provide scientists with confidence behind their predictions. In statistics, a “confidence interval” is a way to quantify how certain a scientist is of a prediction.

    “These predictions work a bit like the Netflix algorithm that predicts which movies you might like to watch,” says Einav. The Netflix algorithm looks for patterns in movies you’ve selected in the past. The more movies (or data) you add to these prediction tools, the more accurate those predictions will get.

    “We can never gather all the data, but we can do a lot with just a few measurements,” says Einav. “And not only do we estimate the confidence in predictions, but we can also tell you what further experiments would maximally increase this confidence. For me, true victory has always been to gain a deep understanding of a biological system, and this framework aims to do precisely that.”

    Einav recently joined the LJI faculty after completing his postdoctoral training in the laboratory of Jesse Bloom, Ph.D., at the Fred Hutch Cancer Center. As he continues his work at LJI, he plans to focus on the use of computational tools to learn more about human immune responses to many viruses, beginning with influenza. He’s looking forward to collaborating with leading immunologists and data scientists at LJI, including Professor Bjoern Peters, Ph.D., also a trained physicist.

    “You get beautiful synergy when you have people coming from these different backgrounds,” says Einav. “With the right team, solving these big, open problems finally becomes possible.”

    The study, “Using Interpretable Machine Learning to Extend Heterogeneous Antibody-Virus Datasets,” was supported by the Damon Runyon Cancer Research Foundation (grant DRQ 01-20) and by Professor David Donoho at Stanford University.

    DOI: https://doi.org/10.1016/j.crmeth.2023.100540

    View article as pdf

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  • Extensive Study Reveals Vaccination Numbers Required to Prevent COVID-19 Hospitalizations and ED Visits

    Extensive Study Reveals Vaccination Numbers Required to Prevent COVID-19 Hospitalizations and ED Visits

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    Newswise — An analysis of real-world data from more than 1.2 million patients from health systems in four geographically dispersed states — Indiana, Oregon, Texas and Utah — conducted by the U.S. Centers for Disease Control and Prevention’s VISION Network, has determined both the number of adults needed to be vaccinated to prevent one COVID-19 associated hospitalization and the number needed to be vaccinated to prevent one COVID-19 associated emergency department (ED) visit.

    This study is one of the first, largest and most comprehensive studies to present clear measurement, by age groups, of how widespread vaccination needs to be to provide protection against serious and moderate disease in adults.

    Preventing a hospitalization indicates that vaccination provided protection against severe disease. Preventing an ED visit indicates that vaccination provided protection against moderate disease.

    “The number needed to be vaccinated or more technically, ‘number needed to vaccinate,’ comes from the related concept of ‘number needed to treat’ — how many must be treated to avoid one bad outcome. One can think of number needed to treat or vaccinate as similar to how much gas you need, or how hard you need to push on the gas pedal to accelerate,” said study co-author Shaun Grannis, M.D., M.S., Regenstrief Institute Vice President for Data and Analytics and the Regenstrief Professor of Medical Informatics at Indiana University of School of Medicine. “Knowing the number of patients who need to be vaccinated is a way of measuring how effective the vaccine is. The lower the number of patients needed to be vaccinated, the more effective the vaccine. If we can prevent more hospitalizations with fewer vaccinations, that’s important to know.  

    “Knowing the number of patients needed to be vaccinated helps us plan on the volume of vaccine needed and the type of awareness and education that we want to provide. This number informs decision-making processes by public health officials, vaccine producers, health systems and others.”

    The study found that the number of patients needed to be vaccinated to prevent one COVID-19-associated hospitalization was higher than the number needed to vaccinate to prevent one COVID-19 associated ED visit, reflecting differences in outcome severity. These numbers were dependent on patient risk factors as well as local disease incidence.

    The number needed to be vaccinated to prevent one COVID-19-associated hospitalization ranged from 44 to 615 (median was 205) individuals and was lower for adults aged 65 years or older and for those with underlying medical conditions. The number needed to be vaccinated decreased as the population became older because older individuals are more susceptible to the adverse effects of the virus and, therefore, the vaccine provides greater protection.

    The number of patients needed to be vaccinated to prevent COVID-19-associated ED visits showed a different pattern because vaccines were more effective at preventing ED visits among younger adults than older ones. The median number needed to be vaccinated to prevent one ED visit ranged from 75 to 592 (median was 156) individuals.

    Information from patients who had received either two or three mRNA vaccine doses was analyzed. None were immunocompromised. Data was from December 2021- February 2022, a period of Omicron BA.1 variant predominance.

    “The reason why the number of patients needed to be vaccinated to prevent a COVID-19 related hospitalization is different from the number needed to prevent an ED (Emergency Department) visit is not fully understood, but it is likely because of how people seek healthcare. Many people, especially younger ones who lack health insurance or Medicare, are more likely to use the ED for primary healthcare. On the other hand, older people usually go to their regular doctor instead of going to the ED,” Dr. Grannis observed.

    “Number needed to vaccinate with a COVID-19 booster to prevent a COVID-19-associated hospitalization during SARS-CoV-2 Omicron BA.1 variant predominance, December 2021-February 2022, VISION Network: a retrospective cohort study” is published in The Lancet Regional Health–Americas.

    Regenstrief Institute co-authors, in addition to Dr. Grannis, are Interim Director of the Center for Biomedical Informatics Brian Dixon, PhD, MPA; William F. Fadel, PhD and Nimish R. Valvi, DrPH. Peter Embí, M.D., former president of the Regenstrief Institute and current affiliated scientist, is also a co-author.

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  • Bar-Ilan University study reveals disparity in quality of life among COVID-19 survivors from different ethnic groups

    Bar-Ilan University study reveals disparity in quality of life among COVID-19 survivors from different ethnic groups

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    Newswise — A new study conducted by researchers at Bar-Ilan University in Israel has shed light on the long-term impact of COVID-19 on the quality of life among different ethnic groups in the country. The study, part of a larger cohort project, highlights a significant discrepancy between Arabs and Druze, and Jews, with the two former groups experiencing a more pronounced decline in quality of life one year after infection.

    In this cohort study, researchers regularly followed up with individuals who had been infected with the SARS-CoV-2 virus to assess various aspects of their health. The findings, published in the International Journal of Public Health, demonstrate that the disparity in quality of life between ethnic groups remained even after accounting for socio-economic differences.

    “We embarked on this study to investigate the long-term effects of COVID-19 on minority groups in Israel given existing health inequalities in the country,” explains the study’s lead author Prof. Michael Edelstein, of the Azrieli Faculty of Medicine of Bar-Ilan University. Well-being was assessed using the EQ-5D quality of life instrument measuring five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. “Our results revealed that, while pre-COVID quality of life among Jews, Arabs, and Druze in our study was initially comparable, at the 12-month mark after infection the Arab and Druze participants reported a quality of life 11% lower than their Jewish counterparts,” adds Edelstein.

    The study’s findings carry important implications for understanding the enduring impact of COVID-19 beyond the acute phase of the pandemic. The research suggests that certain populations may be more susceptible to long-term symptoms and a diminished quality of life, exacerbating pre-existing health disparities. These findings not only have implications for Israel, but also provide valuable insights for global efforts to address the long-term consequences of the COVID-19 pandemic.

    “The significance of our research lies in the ability to shed light on the ongoing impact of COVID-19, even as the disease transitions from a public health emergency to a persistent health concern,” emphasizes Prof. Edelstein. “By understanding how the virus affects different communities, we can work towards developing targeted interventions and support systems to mitigate the long-term effects on quality of life.”

    Dr. Jelte Elsinga, from Amsterdam University Medical Centre in Holland, led the analysis. The study was partially funded by a donation from the Harvey Goodstein Charitable Foundation.

    As part of the larger cohort project, multiple papers have already been published and several more are in progress. Moving forward, the research team will continue to explore the role of vaccines in mitigating the long-term impact of COVID-19, as well as investigate the pandemic’s economic consequences on employment and income among the study participants.

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  • New study finds COVID-19 mRNA booster vaccinations in early pregnancy did not increase miscarriage risk

    New study finds COVID-19 mRNA booster vaccinations in early pregnancy did not increase miscarriage risk

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    Newswise — HealthPartners Institute researchers have published new data in JAMA Network Open that shows monovalent COVID-19 booster vaccinations administered in early pregnancy (before 20 weeks’ gestation) were not associated with miscarriage. The research adds to the growing understanding about the safety of COVID-19 booster vaccinations among people who are pregnant.

    The researchers analyzed data from more than 100,000 pregnancies between six and 19 weeks’ gestation from eight large health systems participating in the Vaccine Safety Datalink (VSD). The data was collected between Nov. 1, 2021, and June 12, 2022. Researchers found, using a 28- or 42-day window, that receipt of a booster vaccination was not associated with miscarriage.

    “COVID infection during pregnancy increases risk of poor outcomes, yet many people who are pregnant or thinking about getting pregnant are hesitant to get a booster dose because of questions about safety. Our data supports the safety of booster vaccination in early pregnancy,” said Elyse Kharbanda, MD, MPH, senior investigator at HealthPartners Institute and lead author of the study.

    More safety data to support COVID-19 vaccination

    Separate research recently published in Obstetrics & Gynecology – also led by HealthPartners Institute – showed that COVID-19 booster vaccination at any point during pregnancy was not associated with increased risk for serious acute adverse events.

    In that study, researchers evaluated data from more than 80,000 pregnancies that occurred between September 23, 2021 and June 30, 2022. Booster vaccination in pregnancy did not increase risks for thrombocytopenia, myocarditis, venous thromboembolism, ischemic stroke, or other serious adverse events within 21 or 42 days after vaccination.

    “We continue to find that COVID-19 vaccinations in pregnancy are safe,” said Malini DeSilva, MD, MPH, investigator at HealthPartners Institute and lead author of the study. “Ongoing vaccine surveillance work is important because it provides reassurance and helps people feel confident in their vaccinations.”

    Data for both studies came from HealthPartners and seven other large health systems that make up the Vaccine Safety Datalink (VSD). VSD is a research network funded by the Centers for Disease Control and Prevention that conducts post-marketing surveillance of vaccines licensed and used in the United States. Both studies evaluated safety of the monovalent COVID-19 vaccine booster. Future studies will evaluate safety of the bivalent booster.

    About HealthPartners Institute 

    HealthPartners Institute is part of HealthPartners, the largest consumer governed nonprofit health care organization in the nation with a mission to improve health and well-being in partnership with our members, patients and the community. HealthPartners Institute supports this mission through research and education—advancing care delivery and public health around the globe. The Institute annually conducts more than 350 research studies and trains 700+ medical residents and fellows and 1,200+ medical and advanced practice students. Its integration with HealthPartners’ hospitals, clinics and health plan strengthens the Institute’s ability to discover and develop evidence-based solutions and translate them into practice. Visit healthpartnersinstitute.org for more information. 

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  • How countries are throwing away their best chance to prevent the next pandemic 

    How countries are throwing away their best chance to prevent the next pandemic 

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    It’s meant to be a legally binding deal that could prevent the next pandemic.

    Originally proposed by European Council President Charles Michel in the worst days of the COVID-19 pandemic, the aim is to create a new set of rules to guide countries on pandemic preparedness and response. 

    But with countries fiercely divided on key issues and just 12 months left to agree, it’s looking increasingly likely that the text will end up as a damp squib.

    As the who’s who of global health descends on Geneva in the coming days for the World Health Assembly — the annual meeting of the decision-making body of the World Health Organization — the fate of the treaty will be the main topic of discussion over glasses of champagne at swanky receptions. 

    The behemoth draft version of the text was ambitious, covering everything from access to vaccines to strengthening health systems so they can respond to health crises.

    But with countries facing off over intellectual property rights and the rules around sharing medical products developed during a pandemic, a compromise with any substance looks increasingly difficult to reach. 

    “If the groups can give up a little bit and try to compromise, I think that in the middle, we might have something left … we might have something that is useful for the future,” said a Geneva-based diplomat, who requested anonymity to talk about confidential negotiations. However, they added that the “fallback position might be a treaty with a little bit of content — just a little bit.”

    And then there’s the all-important question: How to ensure that countries actually comply with what’s agreed.  “A treaty with no compliance mechanism is just a piece of paper,” warned Nina Schwalbe, founder of the public health think tank Spark Street Advisers and former senior official at UNICEF and Gavi, the Vaccine Alliance.

    POLITICO walks you through the biggest sticking points:

    Face-off with Big Pharma

    There are two highly contentious proposals in the draft text. One calls on countries to take measures to support time-bound waivers of IP rights so that companies other than patent holders could make vaccines or treatments — an issue that countries never truly succeeded in solving during the COVID-19 pandemic. The second is to ensure that countries that share information about dangerous pathogens can access any resulting treatments and vaccines developed using this data.

    Developing countries see these as central to ensuring equity in the next pandemic. But both are fiercely opposed by Big Pharma, which has the backing of some wealthy Western nations.

    On intellectual property rights, the U.S. has taken a big red pen to the draft text, stripping out mention of waivers of intellectual property rights. It also wants to weaken provisions that would require pharmaceutical companies to license other manufacturers to produce their products.

    The U.S. wants to weaken provisions that would require pharmaceutical companies to license other manufacturers to produce their products | Thibaud Moritz/AFP via Getty Images

    For the debate over whether sharing information regarding new pathogens should be linked to some kind of benefit — potentially monetary — the line is less clear. The Global South, which is pushing to include the benefits link, has the biggest ask, said a second Geneva-based diplomat who also requested anonymity to talk about confidential negotiations. But a flat no from the Global North could see them lose timely access to those pathogens — something that could delay the development of pathogen-specific vaccines or treatments, and cost lives.

    Too many cooks, too little time

    When WHO members agreed in December 2021 to negotiate a pandemic treaty by May 2024, the deadline seemed a lifetime away. But a lot of time was lost at the start of the process on procedural matters, said the first diplomat. That delay was likely “strategic at some point also for some groups,” they said, without specifying who they were referring to.

    There’s no denying that the text tries to cover a lot of ground, much of it highly controversial. Given that, the deadline of May 2024 is “an extreme challenge,” said the second diplomat. What may be necessary is a streamlining of sorts. “It’s not about lowering the ambition but maybe lowering the level of detail,” they said.

    Ambassador Nora Kronig, head of the international affairs division in the Swiss Federal Office of Public Health, told POLITICO that there is still uncertainty about the scope and content of the treaty. “There’s still a lot of work ahead of us to make it tangible and realistic and implementable,” she said. 

    ‘Just a piece of paper’ 

    Perhaps the biggest question is how the treaty will actually be enforced. 

    “There hasn’t been a lot of discussion about this because it touches on the difficult issue about sovereignty and about having an international organization or other countries, [having] a look on what you do, [and] on how you prepare,” said the second diplomat. 

    In a draft text, countries including China, Russia, Iran, Namibia and Egypt express strong reservations about monitoring mechanisms such as a peer review process, where countries would carry out regular reviews of each others’ pandemic preparedness. Meanwhile, the EU, Canada and Switzerland have put forward proposals for stronger language on monitoring how ready a country is for a health crisis.

    Some countries fear a naming and shaming process, but it doesn’t matter how well-prepared one country is, if another isn’t, said the first diplomat. “I think that we should be accountable to each other, and we should be transparent, and we should try our best to allocate resources and also to make the necessary changes to improve, and also to help others to improve,” they said.

    Some observers want to go even further. Schwalbe would like to see a committee of independent people reporting on the treaty. “Whatever’s in it, we need to hold states accountable for what they’ve agreed to,” she said. 

    Ultimately, the outcome will be “the fruit of international negotiations,” said the second diplomat. “Of course, it will be the [lowest] common denominator.”

    But their view is that if it binds countries on anything new then it’s worth something. “One could see anything that those countries agree upon [as] progress, even if it is watered down and it is incremental or iterative,” they said.

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