Category: Corona Virus

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Remdesivir treatment is associated with significantly reduced mortality among patients hospitalized with COVID-19 requiring supplemental oxygen across SARS-CoV-2 variants of concern (VOC), report authors of a new study.

Researchers published their findings from the large, multicenter, retrospective cohort study in Open Forum Infectious Diseases, the journal of the Infectious Diseases Society of America.

Although over 3 years have passed since the emergence of severe acute respiratory syndrome coronavirus 2, patients critically ill with COVID-19 still face high mortality rates and have limited therapeutic options, wrote corresponding author Robert L. Gottlieb MD, PhD, deputy editor for Baylor University Medical Center Proceedings, and colleagues.

According to investigators, approximately 1 in 2 patients in the US with COVID-19 requiring invasive ventilation have died since the beginning of the COVID-19 pandemic.

It remains essential to continue to evaluate therapeutic options to treat patients throughout the spectrum of COVID-19 disease and VOC periods, stated Gottlieb and coauthors. Remdesivir has maintained effective antiviral activity against all clinically relevant VOC and retains an important role in the management of COVID-19.

Findings from previous randomized controlled trialssuch as the Adaptive COVID-19 Treatment Trial (ACTT-1) and the SOLIDARITY trialshow that remdesivir use improves time to recovery and reduces mortality in patients hospitalized with COVID-19.

It is less clear, however, how effective remdesivir is for patients with COVID-19 who are critically ill, noted researchers. To gain insight, Gottlieb and colleagues matched patients who were hospitalized for COVID-19 between December 2020 and April 2022 and received remdesivir upon admission 1:1 to patients not given remdesivir while hospitalized with the virus.

Analyses were stratified by supplemental oxygen requirement upon admissionlow-flow oxygen (LFO), high-flow oxygen/noninvasive ventilation (HFO/NIV), or invasive mechanical ventilation/extracorporeal membrane oxygenation (IMV/ECMO)and VOC periods (pre-Delta, Delta-predominant, and Omicron-predominant).

Cox proportional hazards models were used to derive adjusted hazard ratios (aHRs) and 95% confidence intervals (CIs) for 14- and 28-day mortality, stated authors.

According to the study, a total of 67 582 patients receiving LFO, 34 857 receiving HFO/NIV, and 4164 receiving IMV/ECMO, all treated with remdesivir, were matched to nonremdesivir-treated participants.

Researchers observed that unadjusted mortality rates were significantly lower for patients treated with remdesivir at 14 days (LFO: 6.4% vs 8.8%; HFO/NIV: 16.8% vs 19.4%; IMV/ECMO: 27.8% vs 35.3%) and 28 days (LFO: 9.8% vs 12.3%; HFO/NIV: 25.8% vs 28.3%; IMV/ECMO: 41.4% vs 50.6%).

In adjusted analyses, remdesivir treatment was associated with a statistically significant reduction in in-hospital mortality at 14 days (LFO: aHR 0.79, 95% CI 0.66-0.79; HFO/NIV: aHR 0.83, 95% CI 0.770.89; IMV/ECMO: aHR 0.73, 95% CI 0.650.82) and 28 days (LFO: aHR 0.79, 95% CI 0.730.85; HFO/NIV: aHR 0.88, 95% CI 0.820.93; IMV/ECMO: aHR 0.74, 95% CI 0.670.82) compared with nonremdesivir treatment.

This lower risk of mortality among patients who received remdesivir was observed across the specified VOC periods, although researchers noted that the association was most pronounced during the Omicron wave.

Where early remdesivir administration is not possible, robust findings from this study demonstrate that remdesivir administration is associated with a survival benefit even when the hyperinflammatory response has already developed as in patients requiring HFO/NIV or IMV/ECMO, concluded Gottlieb et al. Given the growing evidence supporting the clinical and survival benefits associated with remdesivir use in both severe and critically ill COVID-19 patients, clinical guidelines may merit further revisions.

Source: Mozaffari E, Chandak A, Gottlieb RL, et al. Remdesivir is associated with reduced mortality in COVID-19 patients requiring supplemental oxygen including invasive mechanical ventilation across SARS-CoV-2 variants. Open Forum Infect Dis.2023;10(10):ofad482. doi:10.1093/ofid/ofad482.

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Remdesivir Linked to Lower Mortality in Patients with COVID-19 ... - Patient Care Online

L.L. Bean has just added a third shift at its factory in Brunswick, Maine, in an attempt to keep up with demand for its iconic boot.

Orders have quadrupled in the past few years as the boots have become more popular among a younger, more urban crowd.

The company says it saw the trend coming and tried to prepare, but orders outpaced projections. They expect to sell 450,000 pairs of boots in 2014.

People hoping to have the boots in time for Christmas are likely going to be disappointed. The bootsare back ordered through February and even March.

"I've been told it's a good problem to have but I"m disappointed that customers not getting what they want as quickly as they want," said Senior Manufacturing Manager Royce Haines.

Customers like, Mary Clifford, tried to order boots on line, but they were back ordered until January.

"I was very surprised this is what they are known for and at Christmas time you can't get them when you need them," said Clifford.

People who do have boots are trying to capitalize on the shortage and are selling them on Ebay at a much higher cost.

L.L. Bean says it has hired dozens of new boot makers, but it takes up to six months to train someone to make a boot.

The company has also spent a million dollars on new equipment to try and keep pace with demand.

Some customers are having luck at the retail stores. They have a separate inventory, and while sizes are limited, those stores have boots on the shelves.

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Where can you get free COVID tests? Here's the latest - NBC Chicago

A federal appeals court has ruled that a former Connecticut prison official is not protected from facing accusations in civil court that she improperly allowed incarcerated people to be exposed to the coronavirus.

The decision was issued Tuesday to reject qualified immunity for former Osborn Correctional Institution Deputy Warden Nicole Thibeault and therefore affirm an earlier ruling by the United States District Court for the District of Connecticut. Qualified immunity protects officials from liability unless they violate a constitutional right.

The ruling sets the stage for people who were incarcerated at the brunt of the pandemic to take their civil cases to trial, a noteworthy circumstance given the lingering concerns about how the state handled the care of prisoners at the time.

Christopher Nazario, who was incarcerated at Osborn in March and April 2020, filed the lawsuit against Thibeault in 2021, claiming that the former deputy warden violated his Eighth Amendment rights, which prohibit cruel and unusual punishment.

In court filings, Nazario, who worked as a laundry worker while incarcerated at Osborn, says that he and his coworkers were transferred from a cell block with windows and solid metal doors to one with no windows and bar doors that were open to a hallway.

Nazario and his fellow laundry workers claim that they expressed concerns to Thibeault about COVID-19-positive and symptomatic people housed in the cell block they were being transferred to.

But Thibeault warned that if they did not move to the designated cell block, referred to as the E-Block, they would lose their jobs, receive a negative work evaluation, get a ticket for refusing housing, and lose their single cells, according to court documents.

As soon as they arrived at the top tier of E-Block, Plaintiff and five other laundry workers report that they heard and saw other inmates coughing and sneezing on the bottom tier of the unit and in the cells all around the laundry workers, the documents state.

The laundry workers also reported dust, dirt, and trash in the cells, the toilets smelled of urine and feces and the sinks smelled of sewage, and, in one of their cells, there was vomit on the walls near the toilet and the bars were caked with dried food and liquid.

They claim in the lawsuit that while working they were denied personal protective equipment, such as Tyvek suits, shields, N95 masks and boots.

Nazario contracted COVID-19, the lawsuit states. He was transferred to the now-closed Northern Correctional Institution, the facility that the Department of Correction designated for the medical isolation of sick people, and later to a University of Connecticut medical facility.

After experiencing the after effects of the coronavirus, including damage to his heart and circulatory system, Nazario suffered a heart attack at Northern. Following a trip to the ICU at Hartford Hospital, Plaintiffs heart stopped twice, and hospital staff revived him both times, according to court documents. Due to his heart attack, Plaintiff had a pacemaker permanently implanted in his chest.

Thibeault, who is being represented by Connecticut Attorney General William Tongs office, filed a motion for summary judgment, which, if granted, would have prompted the court to decide the case based on the statements and evidence provided without going to trial.

Tongs office sought the motion and qualified immunity on grounds that Nazario couldnt present sufficient evidence demonstrating that the former deputy warden was aware of any risk of harm to Plaintiff by changing his housing assignment, that Plaintiff was deprived of PPE, and that Defendant was personally involved in any constitutional violations.

U.S. District Judge Vanessa L. Bryant denied the motion and request for qualified immunity, which was upheld in Tuesdays ruling by the U.S. Court of Appeals for the Second Circuit.

This order does not foreclose Thibeault from raising timely legal challenges regarding the sufficiency of the evidence or qualified immunity at a later stage before the district court or on appeal from a final judgment, the ruling says. In sum, we determine only that Thibeault is not entitled to qualified immunity at this time. We have considered Thibeaults remaining arguments and find them to be without merit.

In response to an interview request on Wednesday, Elizabeth Benton, director of communications for the Office of the Attorney General, said, We are reviewing the decision and evaluating next steps.

Nazarios lawyer, Alexander T. Taubes, previously unsuccessfully sought to consolidate the case of Nazario currently incarcerated at Cheshire Correctional Institution with others who were incarcerated at Osborn and making similar claims against prison leadership.

Following Tuesdays decision, the New Haven-based civil rights attorney said he plans to renew the request to combine the cases, potentially as a class action lawsuit.

Institutional responsibility for violations of human rights its a relatively new concept. Its a fragile one, Taubes said in an interview with The Connecticut Mirror on Wednesday, adding that he believes Attorney General Tongs extremely broad reading of qualified immunity threatens to ensure that prisons arent held accountable.

But this ruling sets forth precedent that the prisons cannot simply turn their backs and ignore threats invisible, deadly threats within the confines of the big house, Taubes said. And were proud to continue this fight on their behalf.

Sidney Wade, one of the people formerly incarcerated at Osborn who filed a complaint about the prisons conditions during the pandemic, told the CT Mirror that he sees the federal appeals court ruling as just a start.

The world needs to see how people get treated in these prison systems, even the guys that work for the prison and keep things afloat, he said.

The pandemic presented a bevy of concerns and frustrations from lawmakers, advocates and loved ones of incarcerated people, many of whom felt like the state wasnt doing enough to protect those behind bars from sickness.

As COVID-19 raged through the states correctional facilities, Gov. Ned Lamonts administration faced swift criticism for its early refusal to release people nearing the end of their sentences, as states across the country had started doing to combat the spread of the virus.

The ACLU of Connecticut filed a lawsuit at the time to force Lamont and then-DOC Commissioner Rollin Cook to reduce the number of people confined in prisons and jails.

Despite objections from incarcerated people that the consensus wasnt enough, the state and the ACLU agreed to a settlement mandating increased medical monitoring for people who tested positive for the coronavirus and that facilities make a serious effort to return people quarantined for COVID-19 to their prior housing, jobs and programs.

The DOC was also required to provide prisoners with cleaning materials and personal protective equipment. The agreement established a five-member monitoring panel to review the DOCs ongoing responses to the pandemic.

During this years legislative session, lawmakers came up short on a bill that would have allowed a panel under the Board of Pardons and Paroles to grant compassionate release during a major disaster, an emergency declaration by the president of the United States covering any part of the state or an emergency declaration issued by the governor.

If an incarcerated person met the eligibility requirements, the panel would have held the power to grant their release if it found that circumstances exist, such as COVID-19, that pose a higher risk of harm to a person than if the individual remained behind bars, or if the person presented a reduced risk of presenting a danger to society.

The proposal also would have mandated the DOC to award public health emergency release credits during any emergency declaration to certain people whose scheduled release date was within a year of the declaration.

The states ongoing response to the pandemic in correctional facilities has set the framework for the legal battles, spearheaded by the people directly affected by officials decisions, likely to play out in the months and years to come.

Wade, who said he currently lives out of a halfway house, works for a Bloomfield glass company and attends a tractor trailer school, said his and others hope is that people will listen and hear our stories out.

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Court: CT prison official not protected from claims in COVID case - The Connecticut Mirror

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Phillips: If Biden is nominated, he will lose to Trump - The Union Leader

A research team led by Dr. Adam C. Levine, director of the Watson Institute's Center for Human Rights and Humanitarian Studies, and Professor of Sociology and International and Public Affairs Patrick Heller recently published a paper examining the role that civil society organizations (CSOs) played in the response to the COVID-19 pandemic across the Global South.

"The role of civil society organizations (CSOs) in the COVID-19 response across the Global South: A multinational, qualitative study," appeared in the journal PLOS Global Public Health. In addition to Levine and Heller, the Watson research team included Anna Park a 2023 International and Public Affairs and Psychology graduate, Anindita Adhikari and Ieva Zumbyte, who earned Ph.D.s in Sociology in 2023, and current Ph.D. candidates in Sociology Maria F. Lopez-Portillo and Salma Mutwafy.

According to Levine, the effect of the pandemic on the Global South has been understudied. "Part of the problem," he said, "was for most of the pandemic, it was a bit of a black box because almost all of the media coverage focused on the effects of the pandemic in the United States, Europe and other high-income countries of the Global North."

As a result, Levine said, "The standard thinking was that somehow the pandemic had not impacted the Global South as much as it impacted the Global North." "But of course," he added, "we learned later that the pandemic was causing millions of deaths in the Global South. It's just that these were not being recorded because there just wasn't the resources or infrastructure. They didn't even have the tests to know who was infected with COVID-19."

In fact, despite the relative lack of attention paid to it, the Global South experienced a disproportionately high COVID-19 death rate compared to the Global North. Levine noted that research that used statistical modeling to estimate mortality rates published in The Lancet showed that nearly 80% of the 20 million deaths during the first two years of the pandemic occurred in the Global South.

Levine noted that the pandemic had a "double negative" impact on the Global South because some of the remedies that were effective in the Global North such as quarantines and shutting down the economy had more harmful side effects in the South. "It resulted in communities that were already on the edge being pushed into poverty," he said. "Widespread hunger became a huge issue during the pandemic because people were not allowed to leave their homes to go work, and they didn't have the social safety net or the savings built up that we had in the United States and Europe to be able to make it through those months of quarantine."

All these factors coupled with the fact that in many countries in the Global South, the governments lacked the capacity or the will to take the measures necessary to help their populations get through the pandemic created a vacuum that CSOs were forced to step into. Until now, the role of CSOs in the Global South during the pandemic has not been extensively or rigorously documented.

The researchers wanted to study a representative sample of CSOs so they chose high-impact countries from the three main regions of the Global South: Mexico, Kenya, South Africa, India and the Philippines. They then chose 10 CSOs from each country to gather information from. Levine said they wanted to get a representative sample of different types of organizations.

"We tried to make sure they were representative in terms of having a good distribution of local versus national civil society organizations, of having civil society organizations that included religious, secular, academic, professional, all these different types of civil society organizations, and then ones that worked with different types of populations," said Levine.

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Researchers study the role of civil society organizations in response ... - The Watson Institute for International and Public Affairs

The coronavirus disease 2019 (COVID-19) pandemic had a substantial effect on surgeons and patients who require surgical care. Providing care for patients with surgical disease requires a unique and intimate relationship between patients and surgeons, and this interaction and contact in many scenarios cannot be replaced by telehealth. As such, the surgical workforce has faced distinct challenges compared with nonsurgical specialties during the COVID-19 pandemic.

Our hospital implemented a new policy during the COVID-19 pandemic to protect the patient and the hospital staff and to limit the spread ofthe COVID-19infection. This was done by providing personal protective equipment (PPE) such as masks and gowns, decreasing the length of hospital stay, saving intensive care unit (ICU) hospital beds and other resources needed for the care of hospitalized patients withthe COVID-19infection, and directing all available resources to control the COVID-19 pandemic.

Our hospital COVID-19 protective measures and staff reallocation in preponderance for surgery led to:

There is a shortage of hospital staff (anesthesia doctors, nursing staff, and surgical doctors) due to many reasons. As some of the staff were assigned to work on the COVID-19 team, the anesthesia doctors divided themselves into many teams to decrease exposure risk and isolate infected staff at home.

Shortage of hospital beds as the pediatric surgical beds were assigned to COVID-19 patients care and our surgical patients were admitted in the medical pediatric ward.

Preoperative preparation of urgent cases like acute appendicitis takes longer as COVID-19 PCR takes 972h to be released at the start of the pandemic, but this duration has decreased to 12h after that.

Lack of a CO2 filter in laparoscopic surgery changed our policy from laparoscopic to open procedure with its unsatisfactory outcome and drawbacks.

Therefore, we were obliged to apply the medical management for simple acute appendicitis after approval from the hospital ethical committee as the first-line treatment. The aim was to reduce the length of hospital stays, decrease costs, and save hospital resources. It also aimed to reduce exposure risk and surgical complications, decrease stress and the psychological effects of surgery on parents and children, and reduce the rate of negative appendectomies.

We faced many problems with the implementation of this modality of treatment: a small number of cases, a short period of follow-up, staff resistance, and a lack of experience and confidence. We overcame those problems by conducting many lectures with a review of recent literature, which strongly supported this modality of treatment with close observation and serial examination of patients during admission. Keeping patients in the hospital until we are sure that they are symptom-free and ready to go home with close follow-up at the virtual clinic. The length of hospital stay decreased gradually from 72 to 12h due to the initial positive outcome of gaining confidence and experience in medical treatment.

Patients were discharged after a minimum of 12h of intravenous antibiotics, and patients should tolerate oral feeding and antibiotics before being discharged home. During the first 6months of our study period, there were six cases (17%) that converted to surgical management due to fear of complications and a lack of clinical judgement in medical management. The intraoperative finding was that the appendicular inflammation was resolving. In the next 7months, conversion was zero. The follow-up of patients ranged from 1 to 6months with a mean period of 3.5months, and we had four recurrences and operated upon admission. These results showed that the application of the non-operative treatment increased the resolution of symptoms and the improvement of inflammatory markers. Besides, it decreases the psychological stress on children and families, especially in the situation of the COVID-19 pandemic. Certainly, this compares well with other reports applying non-operative management in acute appendicitis to be associated with a shorter hospital stay and a low risk of short-term recurrence15,16,17.

Though there is a report15 showing a 40% recurrence rate after 5years of follow-up, likewise, Salminen et al., 2018 study16, which is an observational multicenter randomized clinical trial that also includes follow-up for 5years, also showed a recurrence rate of 39.1% at 5years. This obviously revealed the need for a second-phase follow-up to evaluate the role of non-operative therapy in treating acute appendicitis.

We strongly support NOTA to decrease costs, and it is a feasible modality of treatment for simple acute appendicitis in children. We decided to adopt NOTA in our center as the standard management of appendicitis in the pediatric age group, even after the COVID-19 pandemic. We found the results of our research promising, and NOTA significantly decreased hospital stays, costs, and psychological stress.

The study still has many limitations; it is a single-center study with a small number of cases and a short period of follow-up. Staff still have resistance, a lack of experience, and confidence in the new approach. Also, there is resistance from the guardian to NOTA, and they prefer the surgery over medical treatment. There is a lack of data on complications, readmission, recurrence, parents stress, etc. So, the conclusion on safety needs more follow-up and more cases.

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Non-operative treatment for simple acute appendicitis (NOTA) in ... - Nature.com

Whether it begins next week, next year, or next decade, another pandemic is on its way. Researchers cant predict precisely when or how the outbreak might begin. Some 1.6 million viruses are estimated to lurk in the worlds mammalian and avian wildlife, up to half of which could spill into humans; an untold number are attempting exactly that, at this very moment, bumping up against the people hunting, eating, and encroaching on those creatures. (And thats just viruses: Parasites, fungi, and bacteria represent major infectious dangers too.) The only true certainty in the pandemic forecast is that the next threat will be here sooner than anyone would like.

But scientists can at least make an educated guess about what might catalyze the next Big One. Three main families of viruses, more than most others, keep scientists up at night: flu viruses, coronaviruses, and paramyxoviruses, in descending order of threat. Together, those groups make up the trifecta of respiratory death, Sara Cherry, a virologist at the University of Pennsylvania, told me.

Flu and coronavirus have a recent track record of trouble: Since 1918, flu viruses have sparked four pandemics, all the while continuing to pester us on a seasonal basis; some scientists worry that another major human outbreak may be brewing now, as multiple H5 flu viruses continue to spread from birds to mammals. The past two decades have also featured three major and deadly coronavirus outbreaks: the original SARS epidemic that began in late 2002; MERS, which spilled into humanslikely from camelsin 2012; and SARS-CoV-2, the pandemic pathogen thats been plaguing us since the end of 2019. Common-cold-causing coronaviruses, too, remain a fixture of daily livinglikely relics of ancient animal-to-human spillovers that we kept transmitting amongst ourselves.

Read: Bird flu has never done this before

Paramyxoviruses, meanwhile, have mostly been simmering in the background, says Raina Plowright, a disease ecologist at Cornell. Unlike flu viruses and coronaviruses, which have already clearly proven themselves as tier-one outbreak risks, paramyxoviruses havent yet been caught causing a bona fide pandemic. But they seem poised to do so, and they likely have managed the feat in the past. Like flu viruses and coronaviruses, paramyxoviruses can spread through the air, sometimes very rapidly. Thats certainly been the case with measles, a paramyxovirus that is literally the most transmissible human virus on the planet, says Paul Duprex, a virologist at the University of Pittsburgh. And, like flu viruses and coronaviruses, paramyxoviruses are found in a wide range of animals; more are being discovered wherever researchers look. Consider canine distemper virus, which has been found in, yes, canines, but also in raccoons, skunks, ferrets, otters, badgers, tigers, and seals. Paramyxoviruses, like flu viruses and coronaviruses, have also repeatedly shown their potential to hopscotch from those wild creatures into us. Since 1994, Hendra virus has caused multiple highly lethal outbreaks in horses, killing four humans along the way; the closely related Nipah virus has, since 1998, spread repeatedly among both pigs and people, carrying fatality rates that can soar upwards of 50 percent.

The human versions of those past few outbreaks have petered out. But that may not always be the casefor Nipah, or for another paramyxovirus thats yet to emerge. Its entirely possible, Plowright told me, that the world may soon encounter a new paramyxovirus thats both highly transmissible and ultra deadlyan absolutely catastrophic scenario, she said, that could dwarf the death toll of any epidemic in recent memory. (In the past four years, COVID-19, a disease with a fatality rate well below Nipahs, has killed an estimated 7 million people.)

All that said, though, paramyxoviruses are a third-place contender for several good reasons. Whereas flu viruses and coronaviruses are speedy shape-shiftersthey frequently tweak their own genomes and exchange genetic material with others of their own kindparamyxoviruses have historically been a bit more reluctant to change. That takes them down a level, says Danielle Anderson, a virologist at the Doherty Institute, in Melbourne. For one, these viruses sluggishness could make it much tougher for them to acquire transmission-boosting traits or adapt rapidly to spread among new hosts. Nipah virus, for instance, can spread among people via respiratory droplets at close contact. But even though its had many chances to do so, it still hasnt gotten very good at transmitting among humans, Patricia Thibault, a biologist at the University of Saskatchewan who studied paramyxoviruses for years, told me.

The genetic stability of paramyxoviruses can also make them straightforward to vaccinate against. Our flu and coronavirus shots need regular updatesas often as annuallyto keep our immune system apace with viral evolution. But weve been using essentially the same measles vaccine for more than half a century, Duprex told me, and immunity to the virus seems to last for decades. Strong, durable vaccines are one of the main reasons that several countries have managed to eliminate measlesand why a paramyxovirus called rinderpest, once a major scourge of cattle, is one of the only infectious diseases weve ever managed to eradicate. In both cases, it helped that the paramyxovirus at play wasnt great at infecting a ton of different animals: Measles is almost exclusive to us; rinderpest primarily troubled cows and their close kin. Most flu viruses and SARS-CoV-2, meanwhile, can spread widely across the tree of animal life; I dont know how you can eradicate that, Anderson told me.

The problem with all of these trends, though, is that they represent only what researchers know of the paramyxoviruses theyve studiedwhich is, inevitably, a paltry subset of what exists, says Benhur Lee, a virologist at Mount Sinais Icahn School of Medicine. The devil we dont know can be just as frightening, if not more, Lee told me. A pattern-defying paramyxovirus may already be readying itself to jump.

Researchers are keyed into these looming threats. The World Health Organization highlights Nipah virus and its close cousins as some of its top-priority pathogens; in the U.S., paramyxoviruses recently made a National Institute of Allergy and Infectious Diseases list of pathogens essential to study for pandemic preparedness. Last year, the Bill & Melinda Gates Foundation announced a hefty initiative to fund paramyxovirus antiviral drugs. Several new paramyxovirus vaccinesmany of them targeting Nipah viruses and their close relativesmay soon be ready to debut.

Read: We have a mink problem

At the same time, though, paramyxoviruses remain neglectedat least relative to the sheer perils they pose, experts told me. Influenza has been sequenced to death, Lee said. (Thats now pretty true for SARS-CoV-2 as well.) Paramyxoviruses, meanwhile, arent regularly surveilled for; development of their treatments and vaccines also commands less attention, especially outside of Nipah and its kin. And although the family has been plaguing us for countless generations, researchers still dont know exactly how paramyxoviruses move into new species, or what mutations they would need to become more transmissible among us; they dont know why some paramyxoviruses spark only minor respiratory infections, whereas others run amok through the body until the host is dead.

Even the paramyxoviruses that feel somewhat familiar are still surprising us. In recent years, scientists have begun to realize that immunity to the paramyxovirus mumps, once thought to be pretty long-lasting and robust, wanes in the first few decades after vaccination; a version of the virus, once thought to be a problem only for humans and a few other primates, has also been detected in bats. For these and other reasons, rubulavirusesthe paramyxovirus subfamily that includes mumpsare among the potential pandemic agents that most concern Duprex. Emmie de Wit, the chief of the molecular-pathogenesis unit at Rocky Mountain Laboratories, told me that the world could also become more vulnerable to morbilliviruses, the subfamily that includes measles. If measles is ever eradicated, some regulators may push for an end to measles shots. But in the same way that the end of smallpox vaccination left the world vulnerable to mpox, the fall of measles immunity could leave an opening for a close cousin to rise.

The next pandemic wont necessarily be a paramyxovirus, or even a flu virus or a coronavirus. But it has an excellent chance of starting as so many other known pandemics havewith a spillover from animals, in parts of the world where weve invaded wild habitats. We may not be able to predict which pathogen or creature might be involved in our next big outbreak, but the common denominator will always be us.

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The Other Group of Viruses That Could Cause the Next Pandemic - The Atlantic

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Repeated outbreaks of bat-derived coronaviruses among humans and other mammals have heightened the need for a broad range of therapeuticsmonoclonal antibodies and antiviralstreatments that can come immediately "off-the-shelf" to address newly-emerging zoonotic threats.

A groundbreaking series of experiments by scientists at collaborating U.S. research centers has not only identified a "pre-emerging bat coronavirus," but investigators have additionally demonstrated that an off-the-shelf monoclonal antibody neutralized it potently. Additionally, in vitro tests of widely-used antivirals were also effective against the virus, researchers found.

The bat-derived coronavirus is more specifically known as BtCoV-422. And a neutralizing monoclocal antibody developed to treat Middle East respiratory syndrome coronavirusMERS-CoVhas been available for years and is known as mAb JC57-11. MERS-CoV is a bat-derived zoonotic virus that infects dromedary camels, the animals that transmit the virus to people. BtCoV-422 is genetically similar to MERS-CoV.

Writing in Science Translational Medicine, investigators from Saint Louis University in Missouri worked with a team of scientists throughout the U.S. who underscored a deceptively simple principle: the types of countermeasures that have worked against other coronaviruses, such as MERS-CoV and SARS-CoV-2, should impact BtCoV-422. But while investigators found that most MERS-CoVneutralizing monoclonal antibodies had very limited activity against the virus, mAb JC57-11 delivered a powerful one-two punch.

Preparedness is critical to avoid future pandemics, experts say, and among the goals of the World Health Organization is identifying potential pandemic viruses and developing strategies to blunt outbreaks before they start.

New coronaviruses have infiltrated human populations with episodic regularity throughout the 21st century: SARS CoV-1 in 2002, MERS-CoV in 2012 and SARS-CoV-2 in 2019. Others may emerge in the not-too-distant future, WHO scientists have predicted.

"The repeated emergence of zoonotic human betacoronaviruses dictates the need for broad therapeutics and conserved epitope targets for countermeasure design," asserted Dr. Longping V. Tse, a molecular virologist at Saint Louis University referring to the urgent need to identify the part of suspect virusesthe epitopethat the human immune system recognizes. "Middle East respiratory syndromerelated coronaviruses remain a pressing concern for global health preparedness," he added.

As Earth's only flying mammals, bats harbor a vast array of viruses that cause them no harm. Ebola, Marburg and Nipah viruses, along with multiple types of coronaviruses, have emerged from various bat species. Scientists attribute the animals' tolerance of otherwise deadly pathogens to a remarkable immune system. Bats live longer than other animals their size, thwart most infectious organisms, and rarely get cancer.

"Bats are a reservoir for a vast number of viruses that fuel zoonotic transmission of coronaviruses to other mammals, including humans," reported Tse, lead author of the new research. "Recently, a MERS-like coronavirus was isolated from pangolins, indicating the widespread host range of MERS-like coronaviruses." As with BtCoV-422, the pangolin-specific MERS-like coronavirus is considered a pre-emerging virus.

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In experiments reported in Science Translational Medicine, Tse and colleagues analyzed BtCoV-422, and found that it has a 65% genetic sequence similarity with the receptor binding domain of MERS-CoV, a highly infectious coronavirus with a fatality rate in humans of 34.4%, according to the U.S. National Institutes of Health.

The research team analyzed BtCoV-422's adaptation pathways by investigating its ability to use the entry receptor known as DPP4. This protein stipples the surface of mammalian cells and serves as the doorway that BtCoV-422 unlocks to enter the cellular inner sanctum. Once inside the cell, the infection process unfolds.

SARS-CoV-2, by comparison, unlocks an entirely different doorway, entering cells by way of the ACE-2 receptor. BtCoV-422 uses DPP4 to gain entry into the cells of multiple species, including humans, Tse and colleagues found.

While the discovery of BtCoV-422 is an important find, the virus doesn't appear to be a threat at this time. "Further mutation-driven evolution would be required," for BtCoV-422 to gain the genetic capability to infect humans, Tse noted in his findings.

But while that may sound comforting, the virus has already found a way to efficiently hijack the DPP4 receptor. "We assessed replication efficiency of BtCoV-422 in multiple primary human cells, including airway epithelia, lung fibroblasts, and lung endothelial cells," Tse wrote.

Scientists found that BtCoV-422 replicated efficiently in primary human airway, lung endothelial, and fibroblast cells, although less efficiently than MERS-CoV.

"We then tested current countermeasures," Tse added, which in addition to monoclonal antibodies included antiviral drugs and vaccine-elicited murine serum. Several antivirals, Remdesivir, Paxlovid and Lagevrio, an investigational nucleoside analog medication currently used to treat mild to moderate COVID-19.

All demonstrated potent inhibition against BtCoV-422 in vitro. Serum from mice that received a MERS-CoV mRNA vaccine showed reduced neutralizing activity against BtCoV-422.

The large research team included scientists from the Marsico Lung Institute and other divisions of the University of North Carolina at Chapel Hill; the National Institute of Allergy and Infectious Diseases in Bethesda, Maryland, and the University of Texas at Austin.

"Our research objective was to understand the potential of BtCoV-422 in infecting clinically relevant human airway cultures and testing potential antivirals and antibodies against BtCoV-422," Tse concluded.

More information: Longping V. Tse et al, A MERS-CoV antibody neutralizes a pre-emerging group 2c bat coronavirus, Science Translational Medicine (2023). DOI: 10.1126/scitranslmed.adg5567

Journal information: Science Translational Medicine

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Scientists isolate 'pre-emerging' bat coronavirus but also identify existing medication that potently neutralizes it - Medical Xpress

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New partnership will harness Moderna's mRNA rapid-response platform, clinically validated during the COVID-19 pandemic, to accelerate epidemic and pandemic vaccine development First project will enable rapid pre-clinical testing of antigen designs for high-risk viral families, to advance global outbreak readiness

CAMBRIDGE, MA / ACCESSWIRE / October 30, 2023 / The Coalition for Epidemic Preparedness Innovations (CEPI) and Moderna, Inc. (NASDAQ:MRNA) have entered into a strategic partnership that will harness Moderna's mRNA platform to accelerate the development of vaccines against viral disease outbreaks that threaten global health. The work undertaken as part of this partnership could expand the infectious disease targets for mRNA vaccine technology and strengthen pandemic preparedness and public health efforts in alignment with the 100 Days Mission, a global goal to compress vaccine development timelines to 100 days.

mRNA technology has been identified as a pivotal enabler of the 100 Days Mission due to its flexibility as a rapid-response platform on which new vaccine candidates can be designed and quickly made ready for clinical testing and subsequent scale-up, potentially within days from the moment a new viral threat is identified. Moderna's leading mRNA platform has enabled the development of a highly effective COVID-19 vaccine, which has subsequently been approved by multiple stringent regulatory authorities worldwide.

Dr Richard Hatchett, CEO of CEPI, said: "Future outbreaks are inevitable, but another pandemic is not. Thanks to the scientific and technological innovations advanced during COVID-19, the world now has the tools and capabilities to prevent the next outbreak from spiraling into a global catastrophe. Chief among them is the now proven mRNA vaccine technology, which can be used to develop safe and effective vaccines with remarkable speed that can be rapidly manufactured at scale. Our partnership with Moderna will harness the company's clinically validated mRNA platform and its world-leading team of scientists to help prepare to respond to future epidemic and pandemic threats in as little as 100 days."

Stphane Bancel, CEO of Moderna, said: "We are pleased to announce our strategic partnership with CEPI, harnessing the power of Moderna's mRNA platform to accelerate the development of mRNA vaccines against viral disease outbreaks that pose global public health threats. Our mRNA Access program reinforces our dedication to public health by offering researchers the opportunity to utilize our mRNA technology in the development of vaccines for emerging and neglected infectious diseases. We believe this program can play a key role in helping the next generation of researchers and engineers to advance mRNA science."

Selecting successful pandemic vaccine designs

The partnership will kick off with an initial project to evaluate the performance of novel AI-generated antigen designs and mRNA technology against a range of viral families that carry the greatest risk of causing the next pandemic. Building upon Moderna's existing mRNA Access program, CEPI-funded vaccine researchers will send their cutting-edge computational antigen designs to Moderna, who will rapidly manufacture the related vaccine candidates using Moderna's mRNA platform technology to provide material for preclinical testing funded by CEPI.

The project will enable CEPI-funded researchers to swiftly test multiple antigen designs targeting a specific viral family and quickly identify which, if any, are most promising. It will also generate data on the performance of mRNA vaccine technology against selected viral families and assess the suitability and effectiveness of mRNA for different disease targets. This would contribute vital scientific knowledge to inform further vaccine development targets and could give the world a headstart in response to future emerging outbreaks to advance the 100 Days Mission.

CEPI and Moderna will discuss additional vaccine development projects which fall under the remit of this strategic partnership, with further announcements to follow in due course.

Enabling Equitable Access

CEPI and Moderna are committed to enabling equitable access to the outputs of this strategic partnership. CEPI will retain rights to antigen designs which have been generated using CEPI funding, with CEPI-funded partners committed to submitting their data generated by this project for publication in open-access journals for the benefit of the global scientific community.

Any licensed vaccines developed as a result of this strategic partnership are expected to be made available at affordable prices in low- and middle-income countries.

CEPI and Moderna

CEPI and Moderna first worked together in early 2020, when CEPI provided early catalytic investment of $0.9 million to support the production of Moderna's COVID-19 vaccine (mRNA-1273).

About CEPI

CEPI is an innovative partnership between public, private, philanthropic, and civil organisations, launched at Davos in 2017. Its mission is to accelerate the development of vaccines and other biologic countermeasures against epidemic and pandemic threats so they can be accessible to all people in need.

CEPI has supported the development of over 30 vaccine candidates against its priority pathogens-Chikungunya virus, Ebola Virus Disease, Lassa virus, Middle East Respiratory Syndrome coronavirus, Nipah virus, Rift Valley Fever virus and SARS-CoV-2-and is a leading funder of research into broadly protective coronavirus vaccines, which could protect against future variants of COVID-19 as well as other coronaviruses with epidemic and pandemic potential. The organization has also invested in the development of rapid response platforms to develop vaccines against Disease X (the threat of an unknown virus).

CEPI has overseen a number of scientific breakthroughs, including the first Phase 3 trial of a Chikungunya vaccine and the advancement of the first ever Nipah and Lassa vaccines into Phase 1 trials. The organization played a central role in the global response to COVID-19, supporting the development of one of the world's largest portfolios of vaccines against SARS-CoV-2, seven of which have been approved for domestic or global use. It also co-led COVAX, the global initiative to deliver fair and equitable access to COVID-19 vaccines, which has delivered approximately 2 billion doses of vaccine to 146 countries around the world.

CEPI's five-year plan for 2022-2026 aims to dramatically reduce or even eliminate the future risk of pandemics and epidemics. Central to the plan is CEPI's goal to compress the time taken to develop safe, effective, globally accessible vaccines against new threats to just 100 days. Achieving this 100 Days Mission', which has been embraced by the G7 and G20, would give the world a fighting chance of containing a future outbreak before it can spread to become a global pandemic.

Visit ournews pagefor the latest updates. Follow us via@CEPIvaccines,@DrRHatchett,LinkedIn, and Facebook.

About Moderna

In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio and integrated manufacturing facilities that allow for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.

Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and auto-immune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past eight years. To learn more, visit http://www.modernatx.com.

Moderna forward-looking statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including regarding: Moderna and CEPI entering a strategic partnership to harness Moderna's mRNA platform to accelerate the development of vaccines against viral disease outbreaks that threaten global health. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna's control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include those other risks and uncertainties described under the heading "Risk Factors" in Moderna's Annual Report on Form 10-K for the year ended December 31, 2022, filed with the U.S. Securities and Exchange Commission (SEC) and in subsequent filings made by Moderna with the SEC, which are available on the SEC's website at http://www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna's current expectations and speak only as of the date of this press release.

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CEPI press@cepi.net +44 7387 055214

Moderna

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Luke Mircea-Willats Senior Director, International Communications Luke.mirceawillats@modernatx.com

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Lavina Talukdar Senior Vice President & Head of Investor Relations 617-209-5834| Lavina.Talukdar@modernatx.com

SOURCE: Moderna, Inc.

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CEPI and Moderna Harness mRNA Technology to Advance 100 ... - Moderna Investor Relations