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Tag: infectious diseases

  • It’s October and it’s not too late to get a flu shot

    It’s October and it’s not too late to get a flu shot

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    BYLINE: Eric Gorton, media relations coordinator

    HARRISONBURG, Va. — About a month into flu season JMU professor Suzanne Grossman says it is not too late to get a flu shot.

    “I get the flu shot every year and I usually get that sometime in October,” she said.

    As the months get colder viruses spread rapidly, said Grossman, a professor of health sciences who teaches a class on infectious diseases. “This means people are closer together, which increases the likelihood that the virus will spread and also because it’s cooler outside, we’re not opening windows and having better ventilation, which can also increase the spread of the virus,” she said.

    In addition to flu and the common cold, COVID cases are on the rise. Grossman said the newest vaccine is effective against the latest subvariant and is recommended for people who have not had the virus or the shot in the last two months.

    When talking about vaccine effectiveness Grossman offered, “They’re especially effective in preventing against severe illness as well as hospitalization and death. So, people who are vaccinated might still get ill with COVID or the flu but the illness that they get will likely be much less severe than if they hadn’t been vaccinated against the flu or COVID.” 

    There’s no vaccine for the common cold, but there are measures to help protect against it. Grossman suggests washing hands, covering your nose and mouth when coughing or sneezing, and wearing a mask if you must go out.

    Audio of Grossman’s comments is here: https://www.dropbox.com/scl/fi/qwaq5zalj5prw0nyvbtxx/230929-Grossman-update-clips.wav?rlkey=hzhksgw0tswsuml0r5mmoud12&dl=0

    A transcript of her comments is here: https://www.dropbox.com/scl/fi/axexlmnb551et5tk1qurw/230928-Grossman-transcript-flu-season.docx?rlkey=st8inzpracnnd17ivskgw6o5k&dl=0

     

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    James Madison University

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  • Nobel Prize in medicine awarded to two scientists whose work enabled creation of mRNA vaccines against COVID-19

    Nobel Prize in medicine awarded to two scientists whose work enabled creation of mRNA vaccines against COVID-19

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    STOCKHOLM (AP) — Two scientists won the Nobel Prize in medicine on Monday for discoveries that enabled the development of effective mRNA vaccines against COVID-19.

    The award was given to Katalin Karikó, a professor at Sagan’s University in Hungary and an adjunct professor at the University of Pennsylvania, and Drew Weissman, who performed his prizewinning research together with Karikó at the University of Pennsylvania.

    “Through their groundbreaking findings, which have fundamentally changed our understanding of how mRNA interacts with our immune system, the laureates contributed to the unprecedented rate of vaccine development during one of the greatest threats to human health in modern times,” the panel that awarded the prize said.

    Thomas Perlmann, secretary of the Nobel Assembly, announced the award and said both scientists were “overwhelmed” by news of the prize when he contacted them shortly before the announcement.

    The Nobel Prize in physiology or medicine was won last year by Swedish scientist Svante Paabo for discoveries in human evolution that unlocked secrets of Neanderthal DNA which provided key insights into our immune system, including our vulnerability to severe COVID-19.

    The award was the second in the family. Paabo’s father, Sune Bergstrom, won the Nobel Prize in medicine in 1982.

    Nobel announcements continue with the physics prize on Tuesday, chemistry on Wednesday and literature on Thursday. The Nobel Peace Prize will be announced Friday and the economics award on Oct. 9.

    The prizes carry a cash award of 11 million Swedish kronor ($1 million). The money comes from a bequest left by the prize’s creator, Swedish inventor Alfred Nobel, who died in 1896.

    The prize money was raised by 1 million kronor this year because of the plunging value of the Swedish currency.

    The laureates are invited to receive their awards at ceremonies on Dec. 10, the anniversary of Nobel’s death. The prestigious peace prize is handed out in Oslo, according to his wishes, while the other award ceremony is held in Stockholm.

    Corder reported from The Hague, Netherlands.

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  • Humans Can No Longer Ignore the Threat of Fungi

    Humans Can No Longer Ignore the Threat of Fungi

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    This article was originally published by Undark Magazine.

    Back at the turn of the 21st century, valley fever was an obscure fungal disease in the United States, with fewer than 3,000 reported cases a year, mostly in California and Arizona. Two decades later, cases of valley fever have exploded, increasing roughly sevenfold by 2019.

    And valley fever isn’t alone. Fungal diseases in general are appearing in places they have never been seen before, and previously harmless or mildly harmful fungi are becoming more dangerous for people. One likely reason for this worsening fungal situation, scientists say, is climate change. Shifts in temperature and rainfall patterns are expanding where disease-causing fungi occur; climate-triggered calamities can help fungi disperse and reach more people; and warmer temperatures create opportunities for fungi to evolve into more dangerous agents of disease.

    For a long time, fungi have been a neglected group of pathogens. By the late 1990s, researchers were already warning that climate change would make bacterial, viral, and parasite-caused infectious diseases such as cholera, dengue, and malaria more widespread. “But people were not focused at all on the fungi,” says Arturo Casadevall, a microbiologist and an immunologist at the Johns Hopkins Bloomberg School of Public Health. That’s because, until recently, fungi have caused humans relatively little trouble.

    Our high body temperature helps explain why. Many fungi grow best at about 12 to 30 degrees Celsius (roughly 54 to 86 degrees Fahrenheit). So though they find it easy to infect trees, crops, amphibians, fish, reptiles, and insects—organisms that do not maintain consistently high internal body temperatures—fungi usually don’t thrive inside the warm bodies of mammals, Casadevall wrote in an overview of immunity to invasive fungal diseases in the 2022 Annual Review of Immunology. Among the few fungi that do infect humans, some dangerous ones, such as species of Cryptococcus, Penicillium, and Aspergillus, have historically been reported more in tropical and subtropical regions than in cooler ones. This, too, suggests that climate may limit their reach.

    Today, however, the planet’s warming climate may be helping some fungal pathogens spread to new areas. Take valley fever, for instance. The disease can cause flu-like symptoms in people who breathe in the microscopic spores of the fungus Coccidioides. The climatic conditions favoring valley fever may occur in 217 counties of 12 U.S. states today, according to a 2019 study by Morgan Gorris, an Earth-system scientist at the Los Alamos National Laboratory, in New Mexico.

    But when Gorris modeled where the fungi could live in the future, the results were sobering. By 2100, in a scenario where greenhouse-gas emissions continue unabated, rising temperatures would allow Coccidioides to spread northward to 476 counties in 17 states. What was once thought to be a disease mostly restricted to the southwestern U.S. could expand as far as the U.S.-Canadian border in response to climate change, Gorris says. That was a real “wow moment,” she adds, because that would put millions more people at risk.

    Some other fungal diseases of humans are also on the move, such as histoplasmosis and blastomycosis. Both, like valley fever, are seen more and more outside what was thought to be their historical range.

    Such range extensions have also appeared in fungal pathogens of other species. The chytrid fungus that has contributed to declines in hundreds of amphibian species, for example, grows well at environmental temperatures from 17 to 25 degrees Celsius (63 to 77 degrees Fahrenheit). But the fungus is becoming an increasing problem at higher altitudes and latitudes, which likely is in part because rising temperatures are making previously cold regions more welcoming for the chytrid. Similarly, white-pine blister rust, a fungus that has devastated some species of white pines across Europe and North America, is expanding to higher elevations where conditions were previously unfavorable. This has put more pine forests at risk. Changing climatic conditions are also helping drive fungal pathogens of crops, like those infecting bananas and wheat, to new areas.

    Read: We’re giving up on the (frog) pandemic

    A warming climate also changes cycles of droughts and intense rains, which can increase the risk of fungal diseases in humans. One study of more than 81,000 cases of valley fever in California from 2000 to 2020 found that infections tended to surge in the two years immediately following prolonged droughts. Scientists don’t yet fully understand why this happens. But one hypothesis suggests that Coccidioides survives better than its microbial competitors during long droughts, then grows quickly once rains return and releases spores into the air when the soil begins to dry again. “So climate is not only going to affect where it is, but how many cases we have from year to year,” says Gorris.

    By triggering more intense and frequent storms and fires, climate change can also help fungal spores spread over longer distances. Researchers have found a surge in valley-fever infections in California hospitals after large wildfires as far as 200 miles away. Scientists have seen this phenomenon in other species too: Dust storms originating in Africa may be implicated in helping move a coral-killing soil fungus to the Caribbean.

    Researchers are now sampling the air in dust storms and wildfires to see if these events can actually carry viable, disease-causing fungi for long distances and bring them to people, causing infections. Understanding such dispersal is key to figuring out how diseases spread, says Bala Chaudhary, a fungal ecologist at Dartmouth who co-authored an overview of fungal dispersal in the 2022 Annual Review of Ecology, Evolution, and Systematics. But there’s a long road ahead: Scientists still don’t have answers to several basic questions, such as where various pathogenic fungi live in the environment or the exact triggers that liberate fungal spores out of soil and transport them over long distances to become established in new places.

    Helping existing fungal diseases reach new places isn’t the only effect of climate change. Warming temperatures can also help previously innocuous fungi evolve tolerance for heat. Researchers have long known that fungi are capable of this. In 2009, for example, researchers showed that a fungus—in this case, a pathogen that infects insects—could evolve to grow at nearly 37 degrees Celsius, some five degrees higher than its previous upper thermal limit, after just four months. More recently, researchers grew a dangerous human pathogen, Cryptococcus deneoformans, at both 37 degrees Celsius (similar to human body temperature) and 30 degrees Celsius in the lab. The higher temperature triggered a fivefold rise in a certain type of mutation in the fungus’s DNA compared with the lower temperature. Rising global temperatures, the researchers speculate, could thus help some fungi rapidly adapt, increasing their ability to infect people.

    Read: The bigger this fungus gets, the worse we’re doing

    There are examples from the real world too. Before 2000, the stripe-rust fungus, which devastates wheat crops, preferred cool, wet parts of the world. But since 2000, some strains of the fungus have become better adapted to higher temperatures. These sturdier strains have been replacing the older strains and spreading to new regions.

    This is worrying, says Casadevall, especially with hotter days and heat waves becoming more frequent and intense. “Microbes really have two choices: adapt or die,” he says. “Most of them have some capacity to adapt.” As climate change increases the number of hot days, evolution will likely select more strongly for heat-resistant fungi.

    And as fungi in the environment adapt to tolerate heat, some might even become capable of breaching the human temperature barrier.

    This may have happened already. In 2009, doctors in Japan isolated an unknown fungus from the ear discharge of a 70-year-old woman. This new-to-medicine fungus, which was given the name Candida auris, soon spread to hospitals around the world, causing severe bloodstream infections in already sick patients. The World Health Organization now lists Candida auris in its most dangerous group of fungal pathogens, partly because the fungus is showing increasing resistance to common antifungal drugs.

    “In the case of India, it’s really a nightmare,” says Arunaloke Chakrabarti, a medical mycologist at the Postgraduate Institute of Medical Education and Research in Chandigarh, India. When C. auris was first reported in India more than a decade ago, it was low on the list of Candida species threatening patients, Chakrabarti says, but now, it’s the leading cause of Candida infections. In the U.S., clinical cases rose sharply from 63 in the period from 2013 to 2016 to more than 2,300 in 2022.

    Where did C. auris come from so suddenly? The fungus appeared simultaneously across three different continents. Each continent’s version of the fungus was genetically distinct, suggesting that it emerged independently on each continent. “It’s not like somebody took a plane and carried them,” says Casadevall. “The isolates are not related.”

    Because all continents are exposed to the effects of climate change, Casadevall and his colleagues think that human-induced global warming may have played a role. C. auris may always have existed somewhere in the environment—potentially in wetlands, where researchers have recovered other pathogenic species of Candida. Climate change, they argued in 2019, may have exposed the fungus to hotter conditions over and over again, allowing some strains to become heat-tolerant enough to infect people—although the researchers cautioned that many other factors are also likely at play.

    Subsequently, scientists from India and Canada found C. auris in nature on the Andaman Islands in the Bay of Bengal. This “wild” version of C. auris grew much slower at human body temperature than did the hospital versions. “What that suggests to me is that this stuff is all over the environment and some of the isolates are adapting faster than others,” says Casadevall.

    Like other explanations for C. auris’s origin, Casadevall’s is only a hypothesis, says Chakrabarti, and still needs to be proved.

    One way to establish the climate-change link, Casadevall says, would be to review old soil samples and see whether they have C. auris in them. If the older versions of the fungus don’t grow well at higher temperatures, but over time they start to, that would be good evidence that they’re adapting to heat.

    In any case, the possibility of warmer temperatures bringing new fungal pathogens to humans needs to be taken seriously, says Casadevall—especially if drug-resistant fungi that currently infect species of insects and plants become capable of growing at human body temperature. “Then we find ourselves with organisms that we never knew before, like Candida auris.”

    Doctors are already encountering novel fungal infections in people, such as multiple new-to-medicine species of Emergomyces that have appeared mostly in HIV-infected patients across four continents, and the first record of Chondrostereum purpureum—a fungus that infects some plants of the rose family—infecting a plant mycologist in India. Even though these emerging diseases haven’t been directly linked to climate change, they highlight the threat that fungal diseases might pose. For Casadevall, the message is clear: It’s time to pay more attention.

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    Shreya Dasgupta

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  • Scientists discover method to boost immune response against TB

    Scientists discover method to boost immune response against TB

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    Newswise — Tuberculosis is old—ancient even. The infectious bacterial disease that plagued Old Testament Israelites and took down pharaohs was eventually stunted by vaccinations, antibiotics, and public health measures like isolation, but it hasn’t been cured yet. More than a million people around the world still die from TB every year.

    Now, a Boston University-led research team has found a way to tweak immune cells to better fight the disease and—with the right backing and funding—they say it could be ready for clinical trials as soon as next year. In a study published in Science Advances, the researchers identified the genetic signatures of TB-susceptible and TB-resistant white blood cells, called macrophages, and then tested the ability of different compounds to transform vulnerable cells into more resilient ones.

    “The TB vaccine is not really 100 percent efficient and antibiotic resistance is becoming more prevalent,” says Igor Kramnik, the study’s corresponding author and a BU Chobanian & Avedisian School of Medicine associate professor of medicine. His team’s approach could add another weapon to the arsenal that’s fighting TB: a host-directed therapy, a way of helping the body better control infection and reduce disease-related inflammation. “It’s a way of treating the host, the patient, rather than focusing on the pathogen.” The project mixed lab-based studies at BU’s National Emerging Infectious Diseases Laboratories (NEIDL) with a big data audit of potential compounds by scientists at University College Dublin, Ireland.

    “Tuberculosis, as one of my colleagues used to say, has studied us much longer than we have studied it,” says Kramnik, who’s also a NEIDL investigator. “It’s a serious and complex disease and our standard interventions are only partially efficient—none of them are sufficient to eradicate the disease.”

    But the latest work could help change that, according to Shivraj M. Yabaji, a NEIDL postdoctoral researcher.

    “We hope that our research will contribute to the development of more effective treatments for TB by better understanding how to fine tune the activation states of immune cells,” says Yabaji, the paper’s lead author. “This could potentially lead to therapies that target host immunity to tuberculosis.”

    Weak TB Vaccine, Rising Antimicrobial Resistance

    The cause of tuberculosis is a bacteria called Mycobacterium tuberculosis—a tiny rod-shaped germ less than 0.5 micrometers in diameter. Spread by a cough, sneeze, or even just a conversation, it can cause symptoms like fever, weight loss, and chest pain. In 2021—the most recent numbers available—more than 10 million people worldwide fell ill with TB, with the disease typically concentrating its attacks on their lungs.

    For 100 years, a vaccine—bacille Calmette-Guérin (BCG)—has been the first line of defense against TB, albeit a somewhat ramshackle one. A recent study from Boston University showed that BCG has limited impact: researchers found it was only about 37 percent effective in children under five years of age and offered no protection for adolescents and adults. And antibiotics, the fallback for those who do become infected, are losing their power. According to the World Health Organization, “drug-resistant tuberculosis is a major contributor to antimicrobial resistance worldwide and continues to be a public health threat;” it reports that around 500,000 people die annually from drug-resistant TB.

    Kramnik has been studying TB for 30 years, though he’d initially expected to only spend a few years scrutinizing it before turning his focus to tumor biology.

    “I thought that tuberculosis would be a nice stepping stone, but I’m still here, trying to understand it,” he says. “It’s a disease that’s very different from others. Thinking about tuberculosis as a battle between a pathogen and a host isn’t really productive. What we’re probably dealing with is an evolutionarily refined coexistence of a pathogen and a host that eventually leads to incurable disease at its terminal stage.”

    A New Treatment to Enhance Natural Defenses Against TB

    One of TB’s biggest mysteries is why some people get sick when most others don’t; in particular, why so many patients initially ward off infection, then eventually succumb to it. Kramnik is also interested in why the bacteria is so intent on destroying the lung, which enables its transmission by infectious aerosols. In recent studies, his lab has used experimental mouse models, which mimic what happens to humans when they contract TB, to try to provide some answers.

    “It all led us to identify the importance of macrophage cells as major determinants, and regulators and controllers, of local immune response in the lung,” he says, “and a major cell that affects susceptibility in cases of growing infection.”

    Macrophages typically have two disease fighting states, says Kramnik: an active one that takes on and eliminates pathogenic intruders, and a regenerative one that helps rebuild tissue after infection. He discovered that in the case of TB, the cells can get stuck in a hyperactive, but ineffective, fight mode: a persistent and damaging inflammatory response that hurts the body, but doesn’t take down the pathogen. In the latest study, Kramnik, Yabaji, and their colleagues used the mouse models to look for ways to shut this response off and help the macrophages work more effectively.

    To start, they used RNA sequencing—a method for pinpointing which genes are expressed, or turned on—hoping it would help them zero in on the “genetic signature that differentiates the normal/resistant and aberrant/susceptible activation states,” says Kramnik. Using a test developed in collaboration with study coauthor Alexander A. Gimelbrant, an investigator at the Seattle-based Altius Institute for Biomedical Sciences, the team simultaneously measured the expression of 46 different genes that represented this signature. “This allowed us to look at gene expression patterns rather than individual genes to characterize the cell states and their changes in response to treatments.” They then tested a range of drugs to see if any would perturb, or change, the expression of the genes.

    Some molecules worked better than others, but no single one could shift a macrophage from a TB-vulnerable to a TB-resistant state. To uncover a potential combination that would work in synergy, the lab-based team sent all of their data to researchers at University College Dublin, Ireland, who had developed a machine learning algorithm they could use to predict whether particular combinations of drugs would be more effective. “We then went back to the bench and tested those predictions,” says Kramnik.

    They found two molecules that have shown promise as cancer treatments—Rocaglamide A (RocA) and a c-Jun N-terminal kinase (JNK) inhibitor—formed an especially good partnership. Together, they helped hinder cell signals related to inflammation and stress, while also boosting the pathways that carry stress resistance signals. “They would be good candidates for clinical trials, so it could change the medical treatment of tuberculosis,” says Kramnik.

    The researchers also discovered that using the two together allowed them to dial back on the effective dose of RocA, which can be potentially toxic at higher levels. Kramnik says their results show how to increase “therapeutic efficacy at lower drug doses and decrease toxic side effects. This is particularly important for chronic diseases that require long course treatments, such as tuberculosis.”

    Although the team is ready to move the research forward, bringing any therapy to trial would require fresh backing, whether from a pharmaceutical company or other institution. “We will be in position,” says Kramnik, “to partner with people who can bring it to the clinic. This is our goal.”

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    Boston University

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  • Ahead of UN General Assembly, pharmaceutical industry underscores need for pandemic preparedness plans to support innovation and equity

    Ahead of UN General Assembly, pharmaceutical industry underscores need for pandemic preparedness plans to support innovation and equity

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    • Global pharmaceutical industry trade body calls for pandemic preparedness plans to protect what worked well in response to COVID-19 pandemic and ensure equity in the roll out of vaccines and treatments.  

    • Industry underlines that future plans must ensure science and innovation can again deliver at record speed and scale. It is critical to ensure scientists continue to have unhindered access to pathogen data and supporting voluntary technology transfer. 

    • Pharmaceutical industry urges support for its proposals to ensure equitable access to vaccines, treatments, and diagnostics in lower income countries for future pandemics. 

    Newswise — 13 SEPTEMBER 2023, GENEVA – Ahead of discussions at the United Nations General Assembly (UNGA78), the trade association representing the innovative pharmaceutical industry, the IFPMA, has warned that current pandemic preparedness plans should not undermine what worked well in response to COVID-19 and must support both “innovation and equity.” 

    The UNGA will see world leaders consider a political declaration on pandemic prevention, preparedness, and response as one of three health-focused high-level meetings. IFPMA has called for current plans to be strengthened to support the development of vaccines and treatments that will be needed for the next pandemic, alongside practical measures to ensure there is equity in access to medical countermeasures in lower-income countries.  

    Pharmaceutical industry commitment to innovate to address future pandemics   

    Effective vaccines and treatments were critical in responding to the COVID-19 pandemic. Recent research estimates that if effective vaccines are rolled out 100 days after the discovery of a new pathogen, the likelihood of a pandemic as deadly as COVID-19 taking place in the next decade drops from 27.5% to 8.1%.   

    The pharmaceutical industry has committed to play an active role in plans to prevent and prepare for future pandemics, and is a partner to the 100 Days Mission, which sets the ambition to deliver safe and effective vaccines, treatments, and diagnostics within 100 days of a pandemic threat being identified.  

    Seven leading pharmaceutical companies have also established The INTREPID Alliance, working to accelerate progress in the discovery and development of new antiviral treatments for future pandemics. The Alliance seeks to have 25 antiviral therapies for respiratory viral diseases with pandemic potential ready for Phase II/III clinical trials by 2026.  

    Placing innovation at the heart of future pandemic preparedness  

    However, progress will require coordinated action by industry, governments, and multilateral organizations. This will include putting in place the right incentives to support the pipeline of vaccines and treatments that will be needed to respond to future pandemics; ensuring scientists have rapid and unhindered access to pathogens and their genetic information; and the ability for companies to partner on a voluntary basis to rapidly scale up production.   

    IFPMA calls for these measures to be integrated into pandemic preparedness plans, including in the pandemic preparedness Political Declaration being considered by the UN General Assembly, alongside the focus on ensuring greater equity of access.   

    To rapidly scale-up production and deliver vaccines and treatments to at risk groups in the most affected regions, alongside wider measures, the industry has underlined the importance of sustainably boosting local capabilities in underserved regions and the need to support voluntary collaborations between companies, necessary to rapidly scale up production. Almost 450 voluntary collaborations are in place to support the global supply of COVID-19 vaccines and treatments. Pharmaceutical companies continue to extend their manufacturing and supply chain footprint via partnerships and investments in such regions. 

     

    Delivering equitable access to medical countermeasures in future pandemics 

    IFPMA has reiterated that future pandemic plans must also tackle the inequity we saw in the roll out of vaccines and treatments in response to COVID-19.  

    Last year, the industry published plans to address this in the Berlin Declaration, proposing a commitment by pharmaceutical companies to reserve an allocation of real-time production of vaccines, treatments, and diagnostics for priority populations in lower-income countries. The plans were endorsed by the Developing Countries Vaccines Manufacturing Network and the Biotechnology Industry Organization. 

    The Berlin Declaration is designed to provide a concrete solution to avoid a small number of countries securing the majority of supply of vaccines and treatments in the early months of a pandemic. 

    Alongside this, the industry has repeated that governments of countries that host manufacturing facilities need to commit to facilitating the export and import of raw materials and finished products to prevent trade restrictions hampering equitable rollout as we saw in response to COVID-19.   

    Thomas Cueni, Director General of the International Federation of Pharmaceutical Manufacturers and Associations said:  

    “When the next pandemic hits, the success of our response will depend on how well we prepared and worked together in this moment between pandemics.  

    “The collective challenge facing us is to deliver innovation and equity: how to incentivize the research needed to develop the vaccines and treatments we will need, and how we make sure there is equitable access to these medical countermeasures across the globe when we have them.   

    “A new Political Declaration presents an opportunity to get all stakeholders around the table and get this right, but it is critical that we don’t undermine what worked well in response to COVID19 and instead strengthen the innovation ecosystem that underpins the development of new medicines and vaccines for when we need them most.” 

     

    Notes to editors 

    • The UNGA will see world leaders gather to consider political declarations on three important global health security priorities – pandemic preparedness, ending tuberculosis, and delivering universal healthcare coverage.  

    • The innovative pharmaceutical industry set out a vision for equitable access to medicines and vaccines in future pandemics in the Berlin Declaration. The Declaration includes the commitment to reserve an allocation of real-time production of vaccines, treatments, and diagnostics for priority populations in lower income countries and take measures to make them available and affordable. 

    • Following the publication of the Berlin Declaration, IFPMA also published five priorities for future pandemic preparedness and response, which set out action needed in the following areas: sustaining a thriving innovation ecosystem; building equitable access early on into pandemic responses; fostering sustainable manufacturing globally; removing barriers to trade; and ensuring greater country readiness. 

    • The 100 Days Mission was put forward by the UK during its G20 presidency in 2021. It aims to have safe and effective vaccines, therapeutics, and diagnostics within 100 days of an epidemic or pandemic threat being identified. IFPMA and the pharmaceutical industry continue to be a supporter of the 100 Days Mission. 

    • The INTREPID Alliance is a group of seven pharmaceutical companies who are working to accelerate progress in the discovery and development of new antiviral treatments for future pandemics and in support of the 100 Days Mission. The Alliance seeks to have 25 antiviral therapies for viral diseases with pandemic potential ready for Phase II/III clinical trials by 2026. 

       

    About the IFPMA  

    The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) represents over 90 innovative pharmaceutical companies and associations around the world. Our industry’s almost three million employees discover, develop, and deliver medicines and vaccines that advance global health. Based in Geneva, IFPMA has official relations with the United Nations and contributes industry expertise to help the global health community improve the lives of people everywhere. For more information, visit ifpma.org. 

     

     

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    International Federation of Pharmaceutical Manufacturers Associations

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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
    MRNA,
    +3.18%
    and Pfizer
    PFE,
    -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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  • This Fall’s COVID Vaccines Are for Everyone

    This Fall’s COVID Vaccines Are for Everyone

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

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

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

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

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

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

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

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

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

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

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

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

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

    Read: The big COVID question for hospitals this fall

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

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

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

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

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    Katherine J. Wu

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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.
    MRNA,
    -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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  • Bangladesh’s worst ever dengue outbreak a ‘canary in the coal mine’ for climate crisis, WHO expert warns | CNN

    Bangladesh’s worst ever dengue outbreak a ‘canary in the coal mine’ for climate crisis, WHO expert warns | CNN

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    CNN
     — 

    Bangladesh is battling its worst dengue outbreak on record, with more than 600 people killed and 135,000 cases reported since April, the World Health Organization said Wednesday, as one of its experts blamed the climate crisis and El Nino weather pattern for driving the surge.

    The country’s health care system is straining under the influx of sick people, and local media have reported hospitals are facing a shortage of beds and staff to care for patients. There were almost 10,000 hospitalizations on August 12 alone, according to WHO.

    WHO director-general Tedros Adhanom Ghebreyesus said in a news briefing Wednesday that of the 650 people who have died since the outbreak began in April, 300 were reported in August.

    While dengue fever is endemic in Bangladesh, with infections typically peaking during the monsoon season, this year the uptick in cases started much earlier – toward the end of April.

    Tedros said WHO is supporting the Bangladeshi government and authorities “to strengthen surveillance, lab capacity, clinical management, vector control, risk communication and community engagement,” during the outbreak.

    “We have trained doctors and deployed experts on the ground. We have also provided supplies to test for dengue and support care for patients,” he said.

    A viral infection, dengue causes flu-like symptoms, including piercing headaches, muscle and joint pains, fever and full body rashes. It is transmitted to humans through the bite of an infected Aedes mosquito and there is no specific treatment for the disease.

    Dengue is endemic in more than 100 countries and every year, 100 million to 400 million people become infected, according to WHO.

    All 64 districts across Bangladesh have been affected by the outbreak but the capital Dhaka – home to more than 20 million people – has been the worst-hit city, according to WHO. Though cases there are starting to stabilize.

    “Cases are starting to decline in the capital Dhaka but are increasing in other parts of the country,” Tedros said.

    Dhaka is one of the most densely populated cities in the world and rapid unplanned urbanization has exacerbated outbreaks.

    “There is a water supply problem in Dhaka, so people keep water in buckets and plastic containers in their bathrooms or elsewhere in the home. Mosquitoes can live there all year round,” Kabirul Bashar, professor at Jahangirnagar University’s Zoology department, wrote in the Lancet journal last month.

    “Our waste management system is not well planned. Garbage piles up on the street; you see a lot of little plastic containers with pools of water in them. We also have multi-story buildings with car parks in the basements. People wash their vehicles down there, which is ideal for the mosquitoes.”

    To cope with the onslaught of infections, Bangladesh has repurposed six Covid-19 hospitals to care for dengue patients and requested help from WHO to help detect and manage cases earlier, WHO said.

    Climate crisis spreading and amplifying outbreaks

    The record number of dengue cases and deaths in Bangladesh comes as the country has seen an “unusual episodic amount of rainfall, combined with high temperatures and high humidity, which have resulted in an increased mosquito population throughout Bangladesh,” WHO said in August.

    Those warm, wet conditions make the perfect breeding ground for disease-carrying mosquitoes and as the planet continues to rapidly heat due to the burning of fossil fuels, outbreaks will become more common in new regions of the world.

    The global number of dengue cases has already increased eight-fold in the past two decades, according to WHO.

    “In 2000, we had about half a million cases and … in 2022 we recorded over 4.2 million,” said Raman Velayudhan, WHO’s head of the global program on control of neglected tropical diseases in July.

    As the climate crisis worsens, mosquito-borne diseases like dengue, Zika, chikungunya and yellow fever will likely continue to spread and have an ever greater impact on human health.

    “We are seeing more and more countries experiencing the heavy burden of these diseases,” said Abdi Mahamud, WHO’s alert and response director in the health emergencies program.

    Mahamud said the climate crisis and this year’s El Nino weather pattern – which brings warmer, wetter weather to parts of the world – are worsening the problem.

    This year, dengue has hit South America severely with Peru grappling with its worst outbreak on record. Cases in Florida prompted authorities to put several counties on alert. In Asia, a spike in cases has hit Sri Lanka, Thailand and Malaysia, among other nations. And countries in sub-Sarahan Africa, like Chad, have also reported outbreaks.

    Calling these outbreaks a “canary in the coalmine of the climate crisis,” Mahamud said “global solidarity” and support is needed to deal with the worsening epidemic.

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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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    Ohio State University

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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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    University of Utah Health

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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. 

     ###  

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

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  • Fact check: The first Republican presidential debate of the 2024 election | CNN Politics

    Fact check: The first Republican presidential debate of the 2024 election | CNN Politics

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    CNN
     — 

    Republican presidential candidates delivered a smattering of false and misleading claims at the first debate of the 2024 election – though none of the eight candidates on stage in Milwaukee delivered anything close to the bombardment of false statements that typically characterized the debate performances of former President Donald Trump, the Republican front-runner who skipped the Wednesday event.

    Sen. Tim Scott of South Carolina inaccurately described the state of the economy in early 2021 and repeated a long-ago-debunked false claim about the Biden-era Justice Department. Former New Jersey Gov. Chris Christie misstated the sentence attached to a gun law relevant to the investigation into the president’s son Hunter Biden. Florida Gov. Ron DeSantis misled about his handling of the Covid-19 pandemic, omitting mention of his early pandemic restrictions.

    Below is a fact check of those claims and various others from the debate, some of which left out key context. In addition, below is a brief fact check of some of Trump’s claims from a pre-taped interview he did with Tucker Carlson, which was posted online shortly before the debate aired. Trump made a variety of statements that were not true.

    DeSantis and the pandemic

    DeSantis criticized the federal government for its handling of the Covid-19 pandemic, claiming it had locked down the economy, and then said: “In Florida, we led the country out of lockdown, and we kept our state free and open.”

    Facts First: DeSantis’s claim is misleading at best. Before he became a vocal opponent of pandemic restrictions, DeSantis imposed significant restrictions on individuals, businesses and other entities in Florida in March 2020 and April 2020; some of them extended months later into 2020. He did then open up the state, with a gradual phased approach, but he did not keep it open from the start.

    DeSantis received criticism in March 2020 for what some critics perceived as a lax approach to the pandemic, which intensified as Florida beaches were packed during Spring Break. But that month and the month following, DeSantis issued a series of major restrictions. For example, DeSantis:

    • Closed Florida’s schools, first with a short-term closure in March 2020 and then, in April 2020, with a shutdown through the end of the school year. (In June 2020, he announced a plan for schools to reopen for the next school year that began in August. By October 2020, he was publicly denouncing school closures, calling them a major mistake and saying all the information hadn’t been available that March.)
    • On March 14, 2020, announced a ban on most visits to nursing homes. (He lifted the ban in September 2020.)
    • On March 17, 2020, ordered bars and nightclubs to close for 30 days and restaurants to operate at half-capacity. (He later approved a phased reopening plan that took effect in May 2020, then issued an order in September 2020 allowing these establishments to operate at full capacity.)
    • On March 17, 2020, ordered gatherings on public beaches to be limited to a maximum of 10 people staying at least six feet apart, then, three days later, ordered a shutdown of public beaches in two populous counties, Broward and Palm Beach. (He permitted those counties’ beaches to reopen by the last half of May.)
    • On March 20, 2020, prohibited “any medically unnecessary, non-urgent or non-emergency” medical procedures. (The prohibition was lifted in early May 2020.)
    • On March 23, 2020, ordered that anyone flying to Florida from an area with “substantial community spread” of the virus, “to include the New York Tri-State Area (Connecticut, New Jersey and New York),” isolate or quarantine for 14 days or the duration of their stay in Florida, whichever was shorter, or face possible jail time or a fine. Later that week, he added Louisiana to the list. (He lifted the Louisiana restriction in June 2020 and the rest in August 2020.)
    • On April 3, 2020, imposed a statewide stay-home order that temporarily required people in Florida to “limit their movements and personal interactions outside of their home to only those necessary to obtain or provide essential services or conduct essential activities.” (Beginning in May 2020, the state switched to a phased reopening plan that, for months, included major restrictions on the operations of businesses and other entities; DeSantis described it at the time as a “very slow and methodical approach” to reopening.)

    -From CNN’s Daniel Dale

    Nikki Haley, the former South Carolina governor and US ambassador to the United Nations, said: “Donald Trump added $8 trillion to our debt, and our kids are never going to forgive us for this.”

    Facts First: Haley’s figure is accurate. The total public debt stood at about $19.9 trillion on the day Trump took office in 2017 and then increased by about $7.8 trillion over Trump’s four years, to about $27.8 trillion on the day he left office in 2021.

    It’s worth noting, however, that the increase in the debt during any president’s tenure is not the fault of that president alone. A significant amount of spending under any president is the result of decisions made by their predecessors – such as the creation of Social Security, Medicare and Medicaid decades ago – and by circumstances out of a president’s control, notably including the global Covid-19 pandemic under Trump; the debt spiked in 2020 after Trump approved trillions in emergency pandemic relief spending that Congress had passed with overwhelming bipartisan support.

    Still, Trump did choose to approve that spending. And his 2017 tax cuts, unanimously opposed by congressional Democrats, were another major contributor to the debt spike.

    -From CNN’s Daniel Dale and Katie Lobosco

    North Dakota Gov. Doug Burgum claimed that Biden’s signature climate bill costs $1.2 trillion dollars and is “just subsidizing China.”

    Facts First: This claim needs context. The clean energy pieces of the Inflation Reduction Act – Democrats’ climate bill – passed with an initial price tag of nearly $370 billion. However, since that bill is made up of tax incentives, that price tag could go up depending on how many consumers take advantage of tax credits to buy electric vehicles and put solar panels on their homes, and how many businesses use the subsidies to install new utility scale wind and solar in the United States.

    Burgum’s figure comes from a Goldman Sachs report, which estimated the IRA could provide $1.2 trillion in clean energy tax incentives by 2032 – about a decade from now.

    On Burgum’s claim that Biden’s clean energy agenda will be a boon to China, the IRA was specifically written to move the manufacturing supply chain for clean energy technology like solar panels and EV batteries away from China and to the United States.

    In the year since it was passed, the IRA has spurred 83 new or expanded manufacturing facilities in the US, and close to 30,000 new clean energy manufacturing jobs, according to a tally from trade group American Clean Power.

    -From CNN’s Ella Nilsen

    With the economy as one of the main topics on the forefront of voters’ minds, Scott aimed to make a case for Republican policies, misleadingly suggesting they left the US economy in record shape before Biden took office.

    “There is no doubt that during the Trump administration, when we were dealing with the COVID virus, we spent more money,” Scott said. “But here’s what happened at the end of our time in the majority: we had low unemployment, record low unemployment, 3.5% for the majority of the population, and a 70-year low for women. African Americans, Hispanics, and Asians had an all-time low.”

    Facts First: This is false. Scott’s claims don’t accurately reflect the state of the US economy at the end of the Republican majority in the Senate. And in some cases, his exaggerations echo what Trump himself frequently touted about the economy under his leadership.

    By the time Trump left office and the Republicans lost the Senate majority in January 2021, US unemployment was not at a record low. The US unemployment rate dropped to a seasonally adjusted rate of 3.5% in September 2019, the country’s lowest in 50 years. While it hovered around that level for five months, Scott’s assertion ignores the coronavirus pandemic-induced economic destruction that followed. In April 2020, the unemployment rate spiked to 14.7% — the highest level since monthly records began in 1948. As of December 2020, the unemployment rate was at 6.7%.

    Nor was the unemployment rate for women at a 70-year low by the end of Trump’s time in office. It reached a 66-year low during certain months of 2019, at 3.4% in April and 3.6% in August, but by December 2020, unemployment for women was at 6.7%.

    The unemployment rates for African Americans, Hispanics, and Asians were also not at all-time lows at the end of 2020, but they did reach record lows during Trump’s tenure as president.

    -From CNN’s Tara Subramaniam

    Scott said that the Justice Department under President Joe Biden is targeting “parents that show up at school board meetings. They are called, under this DOJ, they’re called domestic terrorists.”

    Facts First: It is false that the Justice Department referred to parents as domestic terrorists. The claim has been debunked several times – during the uproar at school boards over Covid-19 restrictions and anti-racism curriculums; after Kevin McCarthy claimed Republicans would investigate Merrick Garland with a majority in the House; and even by a federal judge. The Justice Department never called parents terrorists for attending or wanting to attend school board meetings.

    The claim stems from a 2021 letter from The National School Boards Associations asking the Justice Department to “deal with” the uptick in threats against education officials and saying that “acts of malice, violence, and threats against public school officials” could be classified as “the equivalent to a form of domestic terrorism and hate crimes.” In response, Garland released a memo encouraging federal and local authorities to work together against the harassment campaigns levied at schools, but never endorsed the “domestic terrorism” notion.

    A federal judge even threw out a lawsuit over the accusation, ruling that Garland’s memo did little more than announce a “series of measures” that directed federal authorities to address increasing threats targeting school board members, teachers and other school employees.

    -From CNN’s Hannah Rabinowitz

    Haley, the former ambassador to the United Nations and governor of South Carolina, said the US is spending “less than three and a half percent of our defense budget” on Ukraine aid, and that in terms of financial aid relative to GDP, “11 of the European countries have given more than the US.”

    Facts First: This is partly true. Haley’s claim regarding the US aid to Ukraine compared to the total defense budget is slightly under the actual percentage, but it is accurate that 11 European countries have given more aid to Ukraine as a percentage of their total GDP than the US.

    As of August 14, the US has committed more than $43 billion in military aid to Ukraine since the beginning of the war in Ukraine, according to the Defense Department. In comparison, the Fiscal Year 2023 defense budget was $858 billion – making aid to Ukraine just over 5% of the total US defense budget.

    As of May 2023, according to a Council of Foreign Relations tracker, 11 countries were providing a higher share in aid to Ukraine relative to their GDP than the US – led by Estonia, Latvia, Lithuania, and Poland.

    -From CNN’s Haley Britzky

    Former Vice President Mike Pence said Wednesday that the Trump administration “spent funding to backfill on the military cuts of the Obama administration.”

    Facts First: This is misleading. While military spending decreased under the Obama administration, it was largely due to the 2011 Budget Control Act, which received Republican support and resulted in automatic spending cuts to the defense budget.

    Mike Pence, a senator at the time, voted in favor of the Budget Control Act.

    -From CNN’s Haley Britzky

    Christie said President Biden’s son Hunter Biden was “facing a 10-year mandatory minimum” for lying on a federal form when he purchased a gun in 2018.

    Facts First: Christie, a former federal prosecutor, clearly misstated the law. This crime can lead to a maximum prison sentence of 10 years, but it doesn’t have a 10-year mandatory minimum.

    These comments are related to the highly scrutinized Justice Department investigation into Hunter Biden, which is currently ongoing after a plea deal fell apart earlier this summer.

    As part of the now-defunct deal, Hunter Biden agreed to plead guilty to two tax misdemeanors and enter into a “diversion agreement” with prosecutors, who would drop the gun possession charge in two years if he consistently stayed out of legal trouble and passed drug tests.

    The law in question makes it a crime to purchase a firearm while using or addicted to illegal drugs. Hunter Biden has acknowledged struggling with crack cocaine addiction at the time, and admitted at a court hearing and in court papers that he violated this law by signing the form.

    The US Sentencing Commission says, “The statutory maximum penalty for the offense is ten years of imprisonment.” There isn’t a mandatory 10-year punishment, as Christie claimed.

    During his answer, Christie also criticized the Justice Department for agreeing to a deal in June where Hunter Biden could avoid prosecution on the felony gun offense. That deal was negotiated by special counsel David Weiss, who was first appointed to the Justice Department by former President Donald Trump.

    -From CNN’s Marshall Cohen

    Burgum and Scott got into a back and forth over IRS staffing with Burgum saying that the “Biden administration wanted to put 87,000 people in the IRS,” and Scott suggesting they “fire the 87,000 IRS agents.”

    Facts First: This figure needs context.

    The Inflation Reduction Act, which passed last year without any Republican votes, authorized $80 billion in new funding for the IRS to be delivered over the course of a decade.

    The 87,000 figure comes from a 2021 Treasury report that estimated the IRS could hire 86,852 full-time employees with a nearly $80 billion investment over 10 years.

    While the funding may well allow for the hiring of tens of thousands of IRS employees over time, far from all of these employees will be IRS agents conducting audits and investigations.

    Many other employees will be hired for the non-agent roles, from customer service to information technology, that make up most of the IRS workforce. And a significant number of the hires are expected to fill the vacant posts left by retirements and other attrition, not take newly created positions.

    The IRS has not said precisely how many new “agents” will be hired with the funding. But it is already clear that the total won’t approach 87,000. And it’s worth noting that the IRS may not receive all of the $80 billion after Republicans were able to claw back $20 billion of the new funding as part of a deal to address the debt ceiling made earlier this year.

    -From CNN’s Katie Lobosco

    Trump repeated a frequent claim during his interview with Carlson that streamed during the GOP debate that his retention of classified documents at Mar-a-Lago after leaving the White House was “covered” under the Presidential Records Act and that he is “allowed to do exactly that.”

    Facts First: This is false. The Presidential Records Act says the exact opposite – that the moment presidents leave office, all presidential records are to be turned over to the federal government. Keeping documents at Mar-a-Lago after his presidency concluded was in clear contravention of that law.

    According to the Presidential Records Act, “upon the conclusion of a President’s term of office, or if a President serves consecutive terms upon the conclusion of the last term, the Archivist of the United States shall assume responsibility for the custody, control, and preservation of, and access to, the Presidential records of that President.”

    The sentence makes clear that a president has no authority to keep documents after leaving the White House.

    The National Archives even released a statement refuting the notion that Trump’s retention of documents was covered by the Presidential Records Act, writing in a June news release that “the PRA requires that all records created by Presidents (and Vice-Presidents) be turned over to the National Archives and Records Administration (NARA) at the end of their administrations.”

    -From CNN’s Hannah Rabinowitz

    While discussing electric vehicles, Trump claimed that California “is in a big brownout because their grid is a disaster,” adding that the state’s ambitious electric vehicle goals won’t work with the grid in such shape.

    Facts First: Trump’s claim that California’s grid is currently in a “big brownout” and is a “disaster” isn’t true. California’s grid suffered rolling blackouts in 2020, but it has performed quite well in the face of extreme heat this summer, owing in large part to a massive influx of renewable energy including battery storage. These big batteries keep energy from wind and solar running when the wind isn’t blowing and sun isn’t shining. (Batteries are also being deployed at a rapid rate in Texas, a red state.)

    Another reason California’s grid has stayed stable this year even during extreme temperature spikes is the fact that a deluge of snow and rain this winter and spring has refilled reservoirs that generate electricity using hydropower.

    As Trump insinuated, there are real questions about how well the state’s grid will hold up as California’s drivers shift to electric vehicles by the millions by 2035 – the same year it will phase out selling new gas-powered cars. California state officials say they are preparing by adding new capacity to the grid and urging more people to charge their vehicles overnight and during times of the day when fewer people are using energy. But independent experts say the state needs to exponentially increase its clean energy while also building out huge amounts of new EV chargers to achieve its goals.

    -From CNN’s Ella Nilsen

    Trump and the border wall

    Trump claimed to Carlson, “I had the strongest border in the history of our country, and I built almost 500 miles of wall. You know, they’d like to say, ‘Oh, was it less?’ No, I built 500 miles. In fact, if you check with the authorities on the border, we built almost 500 miles of wall.”

    Facts First: This needs context. Trump and his critics are talking about different things when they use different figures for how much border wall was built during his presidency. Trump is referring to all of the wall built on the southern border during his administration, even in areas that already had some sort of barrier before. His critics are only counting the Trump-era wall that was built in parts of the border that did not have any previous barrier.

    A total of 458 miles of southern border wall was built under Trump, according to a federal report written two days after Trump left office and obtained by CNN’s Priscilla Alvarez. That is 52 miles of “primary” wall built where no barriers previously existed, plus 33 miles of “secondary” wall that was built in spots where no barriers previously existed, plus another 373 miles of primary and secondary wall that was built to replace previous barriers the federal government says had become “dilapidated and/or outdated.”

    Some of Trump’s rival candidates, such DeSantis and Christie, have used figures around 50 miles while criticizing Trump for failing to finish the wall – counting only the primary wall built where no barriers previously existed.

    While some Trump critics have scoffed at the replacement wall, the Trump-era construction was generally much more formidable than the older barriers it replaced, which were often designed to deter vehicles rather than people on foot. Washington Post reporter Nick Miroff tweeted in 2020: “As someone who has spent a lot of time lately in the shadow of the border wall, I need to puncture this notion that ‘replacement’ sections are ‘not new.’ There is really no comparison between vehicle barriers made from old rail ties and 30-foot bollards.”

    Ideally, both Trump and his opponents would be clearer about what they are talking about: Trump that he is including replacement barriers, his opponents that they are excluding those barriers.

    -From CNN’s Daniel Dale

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  • Rather than providing protection, an Omicron infection may leave patients more susceptible to future COVID infections, researchers find after studying seniors in care

    Rather than providing protection, an Omicron infection may leave patients more susceptible to future COVID infections, researchers find after studying seniors in care

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    Newswise — HAMILTON, ON, Aug. 21, 2023 – Researchers at McMaster University have found that rather than conferring immunity against future infections, infection during the first Omicron wave of COVID left the seniors they studied much more vulnerable to reinfection during the second Omicron wave.

    The surprising finding from a study of 750 vaccinated seniors in Ontario retirement homes and long-term care settings suggests the we don’t understand how some Omicron variants can evade the immune system, according to Dawn Bowdish, an immunologist who holds the Canada Research Chair in Aging & Immunity.

    There have been four major waves of Omicron infections in Ontario, Canada, and researchers found that being infected during the first wave, which was caused by the Omicron BA.1 and BA.2 variants, caused older adults to be more susceptible to infections in the third wave, which was caused by the Omicron BA.5 variant. Surprisingly, people who had had an infection with an early Omicron variant were much more susceptible to becoming reinfected than people who had never had an infection at all.

    “This research highlights the need for continued vigilance and underscores the importance of ongoing preventive measures against COVID-19, says Bowdish, who is corresponding author of a study published today in eClinicalMedicine, an open-access journal published by The Lancet. “We must remain cautious and proactive in our approach to protecting public health.”

    Senior co-author Andrew Costa, an epidemiologist and associate professor in McMaster’s Department of Health Research Methods, Evidence and Impact, says the findings should serve as a warning that we don’t know how previous infections will impact susceptibility to the variants which are now in circulation.  

    “These findings strongly suggest broader research is required to understand whether the wider population shares the same susceptibility as the seniors our group studied,” says Costa. “Until we know more, we think it’s smart for everyone to protect themselves.”

    Long-term care residents are easier to study because COVID-19 infections were, until recently, monitored more closely, Bowdish explains, and while the results may or may not be the same among the wider population, it’s important to learn more, and for everyone to consider a COVID vaccine booster this fall. 

    Though the researchers were not able to identify which Omicron variant a person had, all the initial infections occurred during the BA.1/BA.2 wave, and all the reinfections occurred during the summer of 2022 when the BA.5 variant was responsible for the vast majority of infections.

    “We found that some individuals had normal immune responses after the first infection, while others had very low levels of protective antibodies, which we believe was one contributing factor to why they got reinfected,” says Bowdish.

    The researchers urge people not to assume immunity from a prior Omicron infection and to remain vigilant to prevent further spread of the virus.

    She and Costa emphasize the urgency of considering COVID vaccine boosters this fall to safeguard against potential reinfections. 

    “Our current vaccine schedules are based on the assumption that having had an infection provides some level of protection to future infections, but our study shows that may not be true for all variants in all people,” says Bowdish.

    Despite the significance of the findings, Bowdish highlights some caveats. The study focused on an older adult population, many of whom were frailty and had chronic health conditions, and the results may not directly apply to younger individuals.

    High resolution photos related to this study can be found at:

    https://photos.app.goo.gl/859Ydekv5bVRW5oj6

     

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  • COVID quelled GI viruses, but resurgence after 2 years

    COVID quelled GI viruses, but resurgence after 2 years

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    Newswise — Washington, D.C. –  Following the first stay-at-home orders issued in the U.S. to curb the spread of COVID-19, gastrointestinal viruses such as norovirus, rotavirus and adenovirus all but disappeared from California communities, and remained at very low levels for nearly 2 years. The research is published in the Journal of Clinical Microbiology, a journal of the American Society for Microbiology.

    Interestingly, these viruses surged back to pre-pandemic levels in late 2022, said Niaz Banaei, M.D., professor of Pathology and Medicine (Infectious Diseases), Stanford University, and Medical Director of Clinical Microbiology Laboratory, Stanford Health Care. “Adenovirus F40/41, the adenovirus strains most frequently associated with gastroenteritis, actually jumped to levels two-fold higher than pre-pandemic levels.” 

    Banaei suspects that the surge in viral infections was enabled by the waning of collective community immunity from lack of exposure during the pandemic. “Something similar has been described for the surge in respiratory syncytial virus infections in 2022,” he said. 

    To identify changes in the prevalence of gastrointestinal pathogens, the investigators compared detection rates for community acquired gastrointestinal pathogens before, during and after California’s COVID-related shelter-in-place. To that end, they used a polymerase chain reaction (PCR) panel test called the BioFire FilmArray GI panel, which tests for 22 of the most common pathogens that cause diarrhea and analyzed about 18,000 tests that were taken from January 2018 to December 2022. 

    The motivation for the research was the change in the rate of positives for certain pathogens during the COVID-19 pandemic, said Banaei. “It immediately became clear that the pandemic lockdown and shelter-in-place had created a natural experiment to investigate the transmission dynamics of pathogens causing gastroenteritis.” 

    The research offers a unique window into the biology of gastrointestinal pathogens, raising some new research questions, said Banaei. “Why did some disappear while others persisted unaffected during lockdown? Why are some now surging to levels we haven’t seen before?” Improved understanding of these phenomena could lead to ways to interrupt pathogens’ spread, particularly in low- to middle-income countries where gastroenteritis remains a major cause of illness and death, especially among children. “It may also help us prepare for future unforeseen pandemics.”

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  • WHO names Eris a COVID variant of interest. Here’s what you need to know.

    WHO names Eris a COVID variant of interest. Here’s what you need to know.

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    The World Health Organization has upgraded COVID-19 variant EG.5 to a variant of interest, or VOI, from a variant under monitoring, or VUM, as it continues to become more prevalent around the world.

    The variant — which has been nicknamed Eris by some media, following the Greek-alphabet designation used for other variants — has been found in 51 countries, with most sequences, 30.6%, stemming from China, said the WHO.

    Other countries that have submitted at least 100 sequences to a central database include the U.S., the Republic of Korea, Japan, Canada, Australia, Singapore, the United Kingdom, France, Portugal and Spain, the WHO said in a statement.

    Eris is a descendent lineage of XBB.1.9.2, which is an omicron subvariant. It was first detected on Feb. 17 and designated as a VUM on July 19.

    Its latest designation means it’s more prevalent than it was, has a growth advantage over earlier variants and merits closer monitoring and tracking.

    Here’s what you need to know about Eris.

    Eris is spreading around the world

    The strain is increasing in global prevalence, accounting for 17.4% of cases sequenced in the week through July 23, up from 7.6% four weeks earlier. The WHO has been tracking COVID data on a 28-day basis, largely because countries have cut back on testing and surveillance as they emerge from the pandemic, meaning the agency has far less data than it did during the pandemic.

    It’s already dominant in the U.S.

    Eris has become dominant in the U.S., according to projections made by the Centers for Disease Control and Prevention, although a shortage of data is hampering the agency’s efforts to surveil the illness.

    The CDC said last week it was unable to publish its “nowcast” projections, which it releases every two weeks, for where EG.5 and other variants are circulating for every region, 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.

    “For some regions, we have limited numbers of sequences available and therefore are not displaying nowcast estimates in those regions, though those regions are still being used in the aggregated national nowcast,” she said.

    It is estimated that EG.5, an omicron subvariant, accounted for 17.3% of COVID cases in the U.S. in the two-week period through Aug. 5. That was up from an estimated 11.9% in the previous period and was more than any other variant.

    For more, see: New Eris COVID variant is dominant in the U.S., but a shortage of data is making it hard to track

    It’s no riskier than earlier variants

    The public-health risk is deemed to be low at the global level, lining up with the risk posed by XBB.1.16 and other currently circulating VOIs, according to the WHO statement. But it’s likely more infectious.

    “While EG.5 has shown increased prevalence, growth advantage, and immune escape properties, there have been no reported changes in disease severity to date,” said the WHO.

    That growth advantage and immune-escape properties mean Eris may cause a rise in case incidence over time and become dominant in some countries or even the world, according to the WHO.

    It has the same symptoms as other strains

    The Eris variant causes the same symptoms as seen with other strains of COVID, such as sore throat, runny nose, cough, congestion, fever, fatigue, body aches and a possible loss of taste or smell.

    The best defense against Eris is vaccination

    Like earlier strains of COVID, the best protection is to be vaccinated with any of the vaccines developed by Pfizer Inc.
    PFE,
    -0.03%
    and German partner BioNTech SE
    BNTX,
    -0.32%    ,
    Moderna Inc.
    MRNA,
    -1.01%
    or Novavax Inc.
    NVAX,
    +9.83%

    The vaccines that will be made available in the fall will be designed to protect against all subvariants of XBB, including Eris.

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  • A new look inside Ebola’s “viral factories”

    A new look inside Ebola’s “viral factories”

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    Newswise — LA JOLLA, CA—New research in the journal Nature Communications gives scientists an important window into how Ebola virus replicates inside host cells. The study, led by scientists at La Jolla Institute for Immunology (LJI), reveals the inner workings of “viral factories,” clusters of viral proteins and genomes that form in host cells.

    The research team, which included experts from Scripps Research and UC San Diego School of Medicine, found that Ebola virus’s replication machinery forms fascinating microscopic structures that become viral factories. By understanding the architecture and function of these microscopic manufacturing hubs, researchers may be closer to developing new therapies that interrupt the Ebola virus life cycle and prevent severe disease.

    “We are imaging these fluid and dynamic assembly centers for the first time. Understanding how they work and what they require gives us the information needed to defeat them,” says LJI President and CEO Erica Ollmann Saphire, Ph.D., senior author of the new study.

    What is a viral factory?

    Scientists first spotted what would turn out to be “virus factories” in virus-infected animal cells back in the 1960s, but they didn’t know what they were seeing. Within a sea of normal cellular proteins, these areas looked like fuzzy splotches.

    “People had already seen that Ebola-infected cells had these ‘inclusions,’” says LJI Postdoctoral Researcher Jingru Fang, Ph.D., first author of the new study. For a long time, scientists thought of these “inclusions” as helpful visual indicators of infection, without understanding their true purpose. “But in fact, these ‘inclusion bodies’ actively gather an enormous quantity of viral proteins and viral RNAs.”

    Many viral pathogens, including rabies virus and RSV (respiratory syncytial virus) form inclusions in host cells, Fang explains. “Recent studies suggest that these cellular inclusions are the site where viruses make their RNA genomes. They are ‘viral factories’ with actual functional purpose: to offer a secured space for viral RNA synthesis,” says Fang. “The process of viral RNA synthesis involves flux of viral building blocks. This means molecules gathered inside viral factories should be able to move freely rather than being static.”

    For the new study, Saphire, Fang and their colleagues wondered: Can we observe the movement of viral building blocks directly in living cells?

    Fang began by tagging a viral protein called VP35 with a fluorescent marker that makes the protein glow in the dark. VP35 is a critical component of the viral factory and is important for viral RNA synthesis (and the making of new copies of Ebola virus). Working with imaging experts in the LJI Microscopy and Histology Core, Fang followed the glowing proteins in live cells, which express a simplified and non-infectious version of Ebola viral factories.

    Under the microscope, Fang and colleagues could indeed see and even measure how molecules move inside the viral factories formed in host cells. This finding added evidence that viral proteins are clumping together like droplets so they can churn out the proteins needed to help the virus replicate. Those mysterious inclusions really are viral factories. The researcher dubbed these “droplet-like” viral factories.

    Then the scientists saw something odd. Some of the glowing proteins didn’t gather into clumps. Instead, they joined up with a smattering of other viral proteins, creating a fluorescent swirl that evoked van Gogh’s “Starry Night.” These trails of viral proteins still had the right ingredients to replicate Ebola virus, so the scientists dubbed them “network-like” viral factories.

    “These are two different flavors of the viral factory,” says Fang. “People have mostly focused on the droplet-like form, which is the majority, and not paid too much attention to this other form.”

    Besides their shapes, there was a key difference between the two factories. It appeared the network-like factories had the right ingredients for the incoming Ebola virus to express its genes, but they didn’t actually produce virus progenies.

    A multi-tasking machine

    Next, the researchers looked at a key player in infection: a protein called virus polymerase. Polymerase is a multifunctional nanomachine that comes with the virus. This machine not only copies the Ebola virus genomic material, it also transcribes the viral genome into messenger RNAs, which instruct infected cells to produce loads of viral proteins. The researchers wanted to understand how this viral machine functions inside viral factories.

    Ebola virus polymerase is already known as a hard-working protein—all Ebola viral proteins have to be. Ebola virus is a highly efficient pathogen because it gets by with just seven genes (humans have more than 20,000 genes). Saphire has led research showing that Ebola virus survives by making proteins that can transform and take on different jobs during the course of infection.

    Just last year, Saphire, Fang, and collaborators published a related discovery that viral polymerase actually harnesses a druggable human protein to help the virus replicate its genome. The team reported that while polymerase is essential for viral replication, the polymerase doesn’t actually jump into action until infection is well underway.

    This work was important for understanding how polymerase stepped into action, but scientists also needed to know where polymerase was active. Fang knew it would be important to look at what polymerase might be up to in viral factories.

    The researchers discovered that polymerase actually builds its own special structures inside viral factories. Many copies of polymerase gather in small bundles, called foci. The researchers found that these bundles spread out when a droplet-like viral factory starts replicating viral material.

    Scientists aren’t sure exactly why polymerase needs to form bundles before it can do its job, but the spatial arrangement of the bundles must be important. As Fang points out, the idea of many small components coming together to build a structure isn’t a new concept in nature. “You can use a beehive or coral reef as the analogy to help understand why a specific spatial arrangement is important for a biological system to function,” she says.

    With this finding, scientists now know how to find different kinds of viral factories and how polymerase organizes itself down on the factory floor.

    Fighting back

    More than 30 human pathogens are known to assemble viral factories inside host cells, including respiratory syncytial virus (RSV) and even rabies virus. With this new view of Ebola’s viral factories, the scientists are curious whether other viruses construct similar forms of viral factories—and whether other viruses use their own versions of polymerase in the same way.

    “If that’s true, maybe we can target the feature of viral factory formation that has been shared by multiple different viruses,” says Fang.

    Going forward, Fang would also like to study how Ebola virus forms viral factories in different kinds of host cells. Do these viral factories look different in cells from animals (such as the virus’s natural hosts, the fruit bats) that can carry the virus around without getting sick? “Can we find some explanation for host-specific viral pathogenesis?” she asks.

    The new study also demonstrates the importance of collaboration across San Diego’s Torrey Pines Mesa. The LJI team worked closely with Scripps Research Professor Ashok Deniz, Ph.D., and UC San Diego Professor Mark H. Ellisman, Ph.D., Director of the National Center for Microscopy and Imaging Research.

    “The combination of state-of-the-art tools available on the Torrey Pines Mesa allowed us to combine the biophysical characterization with the human health insight,” says Saphire

    Additional authors of the study, “Spatial and functional arrangement of Ebola virus polymerase inside phase-separated viral factories,” include Guillaume Castillon, Sebastien Phan, Sara McArdle, Chitra Hariharan, and Aiyana Adams.

    This study was supported by the National Institute of Health (grants NIH S10OD021831, R24GM137200, and S10OD021784), an Imaging Scientist grant (2019‐198153) from the Chan Zuckerberg Initiative, LJI institutional funds, and the Donald E. and Delia B. Baxter Foundation Fellowship.

    DOI: 10.1038/s41467-023-39821-7

    ###

    About La Jolla Institute

    The La Jolla Institute for Immunology is dedicated to understanding the intricacies and power of the immune system so that we may apply that knowledge to promote human health and prevent a wide range of diseases. Since its founding in 1988 as an independent, nonprofit research organization, the Institute has made numerous advances leading toward its goal: life without disease. Visit lji.org for more information.

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

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

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    A new variant of COVID-19 dubbed EG.5 has become dominant in the U.S., according to projections made by the Centers for Disease Control and Prevention, although a shortage of data is hampering the agency’s efforts to surveil the illness.

    The CDC said on Friday it was unable to publish its “Nowcast” projections for where EG.5 and other variants are circulating for every region, which it releases every two weeks, 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 said in a statement to CBS News.

    “For some regions, we have limited numbers of sequences available, and therefore are not displaying nowcast estimates in those regions, though those regions are still being used in the aggregated national nowcast.”

    It is estimated that EG.5, an omicron subvariant, accounted for 17.3% of COVID cases in the U.S. in the two-week period through Aug. 5. That was up from an estimated 11.9% in the previous period and more than any other variant.

    But the data are based on sequencing from just three regions; Region 2, comprising New Jersey, New York, Puerto Rico and the U.S. Virgin Islands; Region 4, comprising Alabama, Florida, Georgia, Kentucky, Mississippi, North Carolina, South Carolina and Tennessee; and Region 9, comprising Arizona, California, Hawaii, Nevada, American Samoa, Commonwealth of the Northern Mariana Islands, Federated States of Micronesia, Guam, Marshall Islands and Republic of Palau.

    The next most common variants are XBB.1.16, accounting for 15.6% of cases, and XBB.2.3, accounting for 11.2% of cases.

    All are subvariants of XBB, which COVID vaccines in the fall will be designed to protect against.

    The symptoms of EG.5, which Twitter users have nicknamed “Eris,” are similar to early variants, and it’s not deemed to be more virulent than early variants. It may be more infectious, however, as has been the pattern with new strains. Symptoms include a cough, fever, chills, shortness of breath, fatigue and a loss of taste or smell.

    The World Health Organization said last week that EG.5 increased in prevalence globally to 11.6% in the week through July 30 from 62% four weeks earlier.

    The variant is for now a variant under monitoring, or VUM, for the agency, which is a less serious designation than a variant of interest, or VOI, according to its weekly epidemiological update.

    The WHO is monitoring two VOIs, XBB.1.5 and XBB.1.6.

    It is tracking seven VUMs and their descendent lineages, namely BA.2.75, CH.1.1, XBB, XBB.1.9.1, XBB.1.9.2, XBB.2.3 and EG.5.

    CDC data show that hospital admissions with COVID started to rise again in July after being flat or falling for several months. But the number of deaths continues to decline with 81.4% of the overall population in the U.S. having had at least one vaccine dose.

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  • DeSantis on Trump’s 2020 claims: ‘Of course he lost’ | CNN Politics

    DeSantis on Trump’s 2020 claims: ‘Of course he lost’ | CNN Politics

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    CNN
     — 

    Florida Gov. Ron DeSantis said “of course” Donald Trump lost the 2020 election, his the most direct comments on the matter in the nearly three years since the former president’s defeat.

    “Of course he lost,” DeSantis told NBC News in an interview that aired Sunday. “Joe Biden’s the president.”

    The remarks follow DeSantis’ comments on Friday in which he told reporters in Decorah, Iowa, that “theories” put out by the former president and his associates following the 2020 election were “unsubstantiated” and “did not prove to be true.”

    DeSantis had previously avoided such forceful pronouncements about Trump’s defeat. He was among the first to suggest that state legislatures could change election results in certain states, earning public praise from Trump’s inner circle at the time. In the years after, though, DeSantis has largely ducked questions about the veracity of the election results.

    Yet DeSantis continues to argue it was not a “perfect election” – citing actions taken by states to ease voting access during the pandemic – and went on to criticize Trump for funding mail-in ballots through the CARES Act, the $2.2 trillion economic stimulus bill passed in 2020 in response to the coronavirus crisis.

    “But here’s the issue that I think is important for Republican voters to think about: Why did we have all those mail votes? Because of Trump turned the government over to (Anthony Fauci, former director of the National Institute of Allergy and Infectious Diseases). They embraced lockdowns. They did the CARES Act, which funded mail-in ballots across the country,” DeSantis told NBC.

    Unmentioned by DeSantis is that he once praised the CARES Act when it was signed, saying it provided “critical resources” in the fight against Covid-19.

    “We thank President Trump for this much-needed support and look forward to our continued work to defeat Covid-19 and emerge stronger than before,” DeSantis said at the time.

    Nor did DeSantis note that he, too, took unilateral action as governor to let local election offices process mail-in ballots earlier than state law allows to address concerns about adequate staffing and a surge in voting remotely due to the coronavirus. Elsewhere, Republican state legislatures blocked Democratic requests to take similar measures in states like Pennsylvania, where the prolonged counting of ballots became fodder for election conspiracies.

    Voting by mail is incredibly popular in Florida, including by voters from his party. Nearly 2.8 million Floridians voted by mail in 2022 – when DeSantis was reelected by a historically wide margin – including more than 1 million registered Republicans.

    As he often does when faced with questions about the 2020 election, DeSantis in his interview with NBC motioned toward the future and how the 2024 election must be a “referendum on Joe Biden’s policies” and “failures” rather than relitigating the past.

    He argued Republicans will lose if they focus on “January 6, 2021, or what document was left by the toilet at Mar-a-Lago.” However, as Trump stares down three criminal indictments related to the alleged mishandling of classified documents, hush money payments to adult film star Stormy Daniels and efforts to overturn the 2020 election, these issues have taken center stage, all while Trump maintains an overwhelming lead.

    On Friday in Waverly, Iowa, DeSantis made the case for “healing divisions” and moving beyond Trump’s legal woes.

    “We got to look forward. We got to start healing divisions in this country,” DeSantis told reporters. “All of this stuff that’s going on, I think it’s just exacerbating the divisions. And so sometimes there’s a larger picture that you have to look at, and I will be looking at that larger picture wanting to move forward for the sake of the country.”

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